Boots Pharmacy Flu Strength Liquid

Boots Pharmacy Flu Strength Liquid

Specifically to:

Give full strength dose of paracetamol

Relieve fever, aches and pains

Relieve congestion and coughing

Give antibacterial sore throat relief

160 ml

Read all of this carton for full instructions.

For the short term relief of the symptoms of colds and flu, including aches and pains, headache, blocked nose and sinuses, dry tickly sore throat and chesty coughs.

Before you take this medicine

Contains Paracetamol

Do not take with any other paracetamol -containing products.

Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.

Do not take:

• 
  If you are allergic to any of the ingredients


• 
  If you are taking monoamine oxidase inhibitors (for depression) or have taken them in the last 14 days


• 
  If you have an intolerance to some sugars, unless you doctor tells you to (this medicine contains maltitol and sorbitol)


• 
  With other medicines containing decongestants
  


• 
  If you are pregnant
  

Talk to your pharmacist or doctor:

• If you have heart, liver or kidney problems


• If you have diabetes, high pressure in the eye (glaucoma), high blood pressure, an overactive thyroid


• If you suffer from alcoholism or epilepsy (this medicines contains alcohol which may be harmful to you)


• If you are a man with prostate problems


• If you take other medicines – metoclopramide or domperidone (for feeling sick and being sick), warfarin or other blood thinners, medicines to treat high blood pressure, colestyramine (to reduce blood fat levels), medicines for heart rhythm problems (e.g. digoxin), tricyclic antidepressants, alcohol


• If you are breastfeeding

Information about some of the ingredients: This medicine contains 3 g of sorbitol per 20 ml. This provides 7.8 kcal per 20 ml.

Each 20 ml contains 3000 mg of alcohol (ethanol), equivalent to 76 ml of beer or 32 ml of wine. This should be taken into account for children.

Sorbitol may have a mild laxative effect.

How to take this medicine

Check the cap seal is not broken before first use. If it is, do not take the medicine.

Shake the bottle well before use. Use the measuring cup provided.

Adults and children of 12 years and over: Take 20 ml every 4 hours if you need to. Don't take more than 80 ml in 24 hours.

This medicine should be swallowed.

Do not give to children under 12 years.

Do not exceed the stated dose.

If symptoms persist consult your doctor.

Possible side effects

Most people will not have problems, but some may get some.

If you get any of these serious side effects, stop taking the medicine.

See a doctor at once:

• Difficulty in breathing, swelling of the face, neck, tongue or throat (severe allergic reactions)

These other effects are less serious. If they bother you talk to a pharmacist:

• Skin rash, stomach upset, being sick, diarrhoea


• Headache, dizziness, difficulty sleeping


• Fast or irregular heart rate, increase in blood pressure


• Unusual bruising or infections such as sore throats – this may be a sign of very rare changes in the blood

If any side effect becomes severe, or you notice any side effect not listed here, please tell your pharmacist or doctor.

How to store this medicine

Do not store above 25°C.

Keep the container tightly closed. Keep the container in the outer carton.

Keep all medicines out of the sight and reach of children.

Use by the date on the end flap of the carton.

Active ingredients

Each 20 ml of oral solution contains Cetylpyridinium Chloride 3 mg, Guaifenesin 200 mg, Paracetamol 1000 mg, Phenylephrine Hydrochloride 12.18 mg.

Also contains: liquid maltitol (E965), sorbitol, (E420), ethanol, propylene glycol, glycerol (E422), saccharin sodium, sodium cyclamate, acesulfame potassium, sodium citrate, anhydrous citric acid (E330), xanthan gum, levomenthol, eucalyptus oil, quinoline yellow (E104), patent blue V (E131), purified water.

PL 16028/0006 [P]

Text prepared 10/07

Manufactured for

Boots Pharmacy

Nottingham

NG2 3AA

by

Pinewood Healthcare

Ballymacarbry Clonmel County Tipperary

Ireland

Marketing Authorisation held by

Galpharm Healthcare Limited

Hugh House Upper Cliffe Road

Dodworth Business Park

Dodworth South Yorkshire

S75 3SP

If you need more advice ask your pharmacist.

idursulfase

Generic Name: idursulfase (EYE dur SUL fase)

Brand Names: Elaprase

What is idursulfase?

Idursulfase is used to treat some of the symptoms of a genetic condition called Hunter's syndrome. Hunter syndrome is also called mucopolysaccharidosis (MYOO-koe-pol-ee-SAK-a-rye-DOE-sis).

Hunter syndrome is a metabolic disorder in which the body lacks the enzyme needed to break down certain sugars and proteins. These substances can build up in the body, causing enlarged organs, abnormal bone structure, changes in facial features, breathing problems, heart problems, vision loss, and changes in mental or physical abilities.

Idursulfase may improve walking ability in people with this condition. However, this medication is not a cure for Hunter syndrome.

Idursulfase may also be used for purposes not listed in this medication guide.

What is the most important information I should know about idursulfase?

Idursulfase may improve walking ability in people with Hunter syndrome. However, idursulfase is not a cure for this condition. Some people receiving an idursulfase injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, light-headed, or have hives, seizure (convulsions), trouble breathing, or swelling of your face, lips, tongue, or throat.

It may still be possible for you to receive idursulfase even after you have had a reaction to it. There are other medications that can be given to you before your idursulfase infusion to help prevent any reaction symptoms.

You may be more likely to have a reaction to idursulfase if you have a breathing disorder. Tell your doctor if you have asthma or other lung disease.

Your name may need to be listed on a Hunter Outcome Survey while you are using this medication. The purpose of this registry is to track the progression of this disorder and the effects that idursulfase has on long-term treatment of Hunter syndrome.

What should I discuss with my health care provider before receiving idursulfase?

You should not receive this medication if you are allergic to idursulfase.

Before receiving idursulfase, tell your doctor if you are allergic to any drugs, or if you have asthma or other breathing disorder.

You may be more likely to have a reaction to idursulfase if you have a breathing disorder. You may need to receive other medications to prevent an symptoms of a reaction to idursulfase. Follow your doctor's instructions.

Your name may need to be listed on a Hunter Outcome Survey while you are using this medication. The purpose of this registry is to track the progression of this disorder and the effects that idursulfase has on long-term treatment of Hunter syndrome.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether idursulfase passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How is idursulfase given?

Idursulfase is given as an injection through a needle placed into a vein. You will most likely receive this injection in a clinic or hospital setting. Idursulfase is usually given once per week.

The medicine must be given slowly through an IV infusion, and can take up to 3 hours to complete.

What happens if I miss a dose?

Call your doctor if you miss an appointment for your idursulfase injection.

What happens if I overdose?

Seek emergency medical attention if you think you have received too much of this medicine.

Symptoms of an idursulfase overdose are not known.

What should I avoid while receiving idursulfase?

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are receiving idursulfase.

Idursulfase side effects

Some people receiving a idursulfase injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, light-headed, or have hives, seizure (convulsions), trouble breathing, or swelling of your face, lips, tongue, or throat.

It may still be possible for you to receive idursulfase even after you have had a reaction to it. There are other medications that can be given to you before your idursulfase infusion to help prevent any reaction symptoms.

Call your doctor at once if you have any of these serious side effects:

• 
  

  worsened asthma;

  
  


• 
  

  uneven heartbeats;

  
  


• 
  

  blue lips or fingernails;

  
  


• 
  

  fever;

  
  


• 
  

  vision problems; or

  
  


• 
  

  increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure).

  
  

Less serious side effects may include:

• 
  

  joint pain;

  
  


• 
  

  pain in your arms or legs;

  
  


• 
  

  headache;

  
  


• 
  

  itching, mild skin rash; or

  
  


• 
  

  weakness.

  
  

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Idursulfase Dosing Information

Usual Adult Dose for Mucopolysaccharidosis Type II:

Recommended dose: 0.5 mg/kg of body weight every week administered as an intravenous infusion

Usual Pediatric Dose for Mucopolysaccharidosis Type II:

>= 5 years old
Recommended dose: 0.5 mg/kg of body weight every week administered as an intravenous infusion

What other drugs will affect idursulfase?

There may be other drugs that can interact with idursulfase. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More idursulfase resources

• Idursulfase Side Effects (in more detail)
• Idursulfase Dosage
• Idursulfase Use in Pregnancy & Breastfeeding
• Idursulfase Support Group
• 0 Reviews for Idursulfase - Add your own review/rating

• idursulfase Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information


• Idursulfase Professional Patient Advice (Wolters Kluwer)


• Idursulfase MedFacts Consumer Leaflet (Wolters Kluwer)


• Idursulfase Monograph (AHFS DI)


• Elaprase Prescribing Information (FDA)


• Elaprase Consumer Overview

Compare idursulfase with other medications

• Mucopolysaccharidosis Type II

Where can I get more information?

• Your doctor or pharmacist can provide more information about idursulfase.

See also: idursulfase side effects (in more detail)

Pulmicort Flexhaler

Generic Name: budesonide inhalation (byoo DES oh nide)

Brand Names: Pulmicort Flexhaler, Pulmicort Respules

What is Pulmicort Flexhaler (budesonide inhalation)?

Budesonide is a steroid. It prevents the release of substances in the body that cause inflammation.

Budesonide inhalation is used to prevent asthma attacks. It will not treat an asthma attack that has already begun.

Budesonide may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Pulmicort Flexhaler (budesonide inhalation)?

Do not use budesonide inhalation to treat an asthma attack that has already begun. It will not work fast enough to reverse your symptoms. Use only a fast-acting inhalation medicine to treat an asthma attack.

Contact your doctor if your asthma symptoms do not improve after using budesonide inhalation for 2 weeks.

Call your doctor right away if you think any of your asthma medications are not working as well as usual. An increased need for medication could be an early sign of a serious asthma attack.

Your dosage needs may change if you have surgery, are ill, are under stress, or have recently had an asthma attack. Talk with your doctor if any of your asthma medications do not seem to work as well in treating or preventing asthma attacks.

If you also use an oral steroid medication, do not stop using the steroid suddenly or you may have unpleasant withdrawal symptoms. Talk with your doctor about taking less and less of the steroid before stopping completely.

What should I discuss with my healthcare provider before using Pulmicort Flexhaler (budesonide inhalation)?

You should not take this medication if you are allergic to budesonide, or if you are having an acute asthma attack.

Before using budesonide inhalation, tell your doctor if you are allergic to any drugs, or if you have:

• liver disease;


• 
  

  osteoporosis;

  
  


• 
  

  herpes simplex infection of your eyes;

  
  


• 
  

  any type of bacterial, fungal, or viral infection; or

  
  


• 
  

  a history of tuberculosis.

  
  

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Budesonide can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Budesonide can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using this medication.

Do not give this medicine to a child younger than 6 years old without the advice of a doctor.

Long-term use of steroids may lead to bone loss (osteoporosis), especially if you smoke, if you do not exercise, if you do not get enough vitamin D or calcium in your diet, or if you have a family history of osteoporosis. Talk with your doctor about your risk of osteoporosis.

How should I use Pulmicort Flexhaler (budesonide inhalation)?

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the directions on your prescription label.

Do not use budesonide inhalation to treat an asthma attack that has already begun. It will not work fast enough to reverse your symptoms. Use only a fast-acting inhalation medicine to treat an asthma attack.

Read all patient instructions that come with your inhaler device. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

To reduce the chance of developing a yeast infection in your mouth, rinse your mouth with water after using budesonide inhalation. If you are using a nebulizer with a face mask, wash the mask area of your face after each use.

If you also use a steroid medication, do not stop using the steroid suddenly or you may have unpleasant withdrawal symptoms. Talk with your doctor about taking less and less of the steroid before stopping completely.

Contact your doctor if your asthma symptoms do not improve after using budesonide inhalation for 2 weeks.

Asthma is usually treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Do not change your doses or medication schedule without advice from your doctor.

Your dosage needs may change if you have surgery, are ill, are under stress, or have recently had an asthma attack. Talk with your doctor if any of your asthma medications do not seem to work as well in treating or preventing asthma attacks.

Call your doctor right away if you feel that this medicine makes your condition worse. If it seems like you need to use more of any of your medications in a 24-hour period, talk with your doctor.

To be sure budesonide inhalation is not causing harmful effects, your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.

Using a steroid can lower the blood cells that help your body fight infections. This can make it easier for you to get sick from being around others who are ill.

Store this medication at room temperature away from moisture and heat. Keep the cover on your inhaler device while not in use.

Keep the strip of Pulmicort Respules in the foil envelope, protected from light until you are ready to use the medication. After tearing off one ampule, return the strip to the envelope to protect the remaining ampules from light. Store the foil envelope upright. Once you have opened an envelope, you must use the ampules within 2 weeks.

The Pulmicort Flexhaler device has indicator marks to show you how many doses are left inside. These dose-counter marks show increments of 20 doses. The indicator may not appear to move until about 5 doses have been used.

Do not use an extra dose just because the Flexhaler indicator has not visibly moved to a lower number after one use. Ask your pharmacist if you have questions about using your inhaler device.

Get your budesonide prescription refilled before you run out of medicine completely. Throw the old inhaler device away. It is a disposable container and cannot be refilled with budesonide.

What happens if I miss a dose?

Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

An overdose of budesonide inhalation is not expected to produce life-threatening symptoms. However, long-term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

What should I avoid while taking Pulmicort Flexhaler (budesonide inhalation)?

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medication.

Pulmicort Flexhaler (budesonide inhalation) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

• 
  

  weakness, tired feeling, nausea, vomiting, feeling like you might pass out;

  
  


• 
  

  wheezing or breathing problems after using this medication;

  
  


• 
  

  worsening respiratory symptoms;

  
  


• 
  

  ear pain with fever;

  
  


• 
  

  vision problems; or

  
  


• 
  

  changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

  
  

Less serious side effects may include:

• 
  

  white patches or sores inside your mouth or on your lips;

  
  


• 
  

  runny or stuffy nose, sneezing;

  
  


• 
  

  sore throat, cough;

  
  


• 
  

  nausea, vomiting, diarrhea, stomach pain;

  
  


• 
  

  nosebleed; or

  
  


• 
  

  headache.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Pulmicort Flexhaler (budesonide inhalation)?

The following drugs can interact with budesonide. Tell your doctor if you are using any of these:

• 
  

  HIV /AIDS medicine such as nelfinavir (Viracept) or ritonavir (Norvir);

  
  


• 
  

  an antibiotic such as clarithromycin (Biaxin) or erythromycin (E.E.S., E-Mycin, Ery-Tab, Erythrocin);

  
  


• 
  

  an antifungal medication such as itraconazole (Sporanox) or ketoconazole (Nizoral);

  
  


• 
  

  an "SSRI" antidepressant such as fluoxetine (Prozac), fluvoxamine (Luvox), or paroxetine (Paxil); or

  
  


• 
  

  a tricyclic antidepressant such as amitriptyline (Elavil, Vanatrip), doxepin (Sinequan), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), and others.

  
  

This list is not complete and there may be other drugs that can interact with budesonide inhalation. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More Pulmicort Flexhaler resources

• Pulmicort Flexhaler Side Effects (in more detail)
• Pulmicort Flexhaler Use in Pregnancy & Breastfeeding
• Pulmicort Flexhaler Drug Interactions
• Pulmicort Flexhaler Support Group
• 2 Reviews for Pulmicort Flexhaler - Add your own review/rating

• Pulmicort Flexhaler Advanced Consumer (Micromedex) - Includes Dosage Information


• Pulmicort Flexhaler Prescribing Information (FDA)


• Pulmicort Flexhaler Powder MedFacts Consumer Leaflet (Wolters Kluwer)


• Budesonide Monograph (AHFS DI)


• Budesonide Professional Patient Advice (Wolters Kluwer)


• budesonide Advanced Consumer (Micromedex) - Includes Dosage Information


• Entocort EC Prescribing Information (FDA)


• Entocort EC Sustained-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Pulmicort Respules Suspension MedFacts Consumer Leaflet (Wolters Kluwer)


• Pulmicort Turbuhaler Powder MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Pulmicort Flexhaler with other medications

• Asthma, Maintenance

Where can I get more information?

• Your pharmacist can provide more information about budesonide inhalation.

See also: Pulmicort Flexhaler side effects (in more detail)

Hydroxyzine Tablets

Generic Name: hydroxyzine hydrochloride

Dosage Form: tablet, film coated
HydrOXYzine Hydrochloride Tablets USP

Revised: June 2009

Rx only                    190944

DESCRIPTION

Hydroxyzine hydrochloride is designated chemically as (±)-2-[2-[4-(p- Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol dihydrochloride.

M.W. 447.83           

Hydroxyzine hydrochloride occurs as a white, odorless powder which is very soluble in water.

Hydroxyzine Hydrochloride Tablets USP, 10 mg, 25 mg and 50 mg contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, FD&C Yellow No. 6, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80 and titanium dioxide.

Hydroxyzine Hydrochloride Tablets USP, 25 mg and 50 mg also contain D&C Yellow No. 10 and FD&C Blue No. 2.

CLINICAL PHARMACOLOGY

Hydroxyzine hydrochloride is unrelated chemically to the phenothiazines, reserpine, meprobamate, or the benzodiazepines. Hydroxyzine hydrochloride is not a cortical depressant, but its action may be due to a suppression of activity in certain key regions of the subcortical area of the central nervous system.

Primary skeletal muscle relaxation has been demonstrated experimentally. Bronchodilator activity, and antihistaminic and analgesic effects have been demonstrated experimentally and confirmed clinically. An antiemetic effect, both by the apomorphine test and the veriloid test, has been demonstrated.

Pharmacological and clinical studies indicate that hydroxyzine in therapeutic dosage does not increase gastric secretion or acidity and in most cases has mild antisecretory activity.

Hydroxyzine is rapidly absorbed from the gastrointestinal tract and hydroxyzine hydrochloride’s clinical effects are usually noted within 15 to 30 minutes after oral administration.

INDICATIONS AND USAGE

For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested.

Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus.

As a sedative when used as premedication and following general anesthesia, hydroxyzine may potentiate meperidine and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent.

The effectiveness of hydroxyzine as an antianxiety agent for long term use, that is more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.

CONTRAINDICATIONS

Hydroxyzine, when administered to the pregnant mouse, rat, and rabbit, induced fetal abnormalities in the rat and mouse at doses substantially above the human therapeutic range. Clinical data in human beings are inadequate to establish safety in early pregnancy. Until such data are available, hydroxyzine is contraindicated in early pregnancy.

Hydroxyzine is contraindicated for patients who have shown a previous hypersensitivity to it.

PRECAUTIONS

THE POTENTIATING ACTION OF HYDROXYZINE MUST BE CONSIDERED WHEN THE DRUG IS USED IN CONJUNCTION WITH CENTRAL NERVOUS SYSTEM DEPRESSANTS SUCH AS NARCOTICS, NONNARCOTIC ANALGESICS AND BARBITURATES. Therefore, when central nervous system depressants are administered concomitantly with hydroxyzine their dosage should be reduced.

Since drowsiness may occur with use of this drug, patients should be warned of this possibility and cautioned against driving a car or operating dangerous machinery while taking hydroxyzine hydrochloride. Patients should be advised against the simultaneous use of other CNS depressant drugs, and cautioned that the effect of alcohol may be increased.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Since many drugs are so excreted, hydroxyzine should not be given to nursing mothers.

Geriatric Use

A determination has not been made whether controlled clinical studies of hydroxyzine included sufficient numbers of subjects aged 65 and over to define a difference in response from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

The extent of renal excretion of hydroxyzine has not been determined. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selections.

Sedating drugs may cause confusion and over sedation in the elderly; elderly patients generally should be started on low doses of hydroxyzine and observed closely.

ADVERSE REACTIONS

Side effects reported with the administration of hydroxyzine hydrochloride are usually mild and transitory in nature.

Anticholinergic: Dry mouth.

Central Nervous System: Drowsiness is usually transitory and may disappear in a few days of continued therapy or upon reduction of the dose. Involuntary motor activity including rare instances of tremor and convulsions have been reported, usually with doses considerably higher than those recommended. Clinically significant respiratory depression has not been reported at recommended doses.

OVERDOSAGE

The most common manifestation of hydroxyzine hydrochloride overdosage is hypersedation. As in the management of overdosage with any drug, it should be borne in mind that multiple agents may have been taken.

If vomiting has not occurred spontaneously, it should be induced. Immediate gastric lavage is also recommended. General supportive care, including frequent monitoring of the vital signs and close observation of the patient, is indicated. Hypotension, though unlikely, may be controlled with intravenous fluids and norepinephrine or metaraminol. Do not use epinephrine as hydroxyzine hydrochloride counteracts its pressor action.

There is no specific antidote. It is doubtful that hemodialysis would be of any value in the treatment of overdosage with hydroxyzine. However, if other agents such as barbiturates have been ingested concomitantly, hemodialysis may be indicated. There is no practical method to quantitate hydroxyzine in body fluids or tissue after its ingestion or administration.

DOSAGE AND ADMINISTRATION

For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested: in adults, 50-100 mg q.i.d.; children under 6 years, 50 mg daily in divided doses and over 6 years, 50-100 mg daily in divided doses.

For use in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus: in adults, 25 mg t.i.d. or q.i.d.; children under 6 years, 50 mg daily in divided doses and over 6 years, 50-100 mg daily in divided doses.

As a sedative when used as a premedication and following general anesthesia: 50-100 mg in adults, and 0.6 mg/kg of body weight in children.

When treatment is initiated by the intramuscular route of administration, subsequent doses may be administered orally.

As with all medications, the dosage should be adjusted according to the patient’s response to therapy.

HOW SUPPLIED

Hydroxyzine Hydrochloride Tablets USP, 10 mg are 7/32”, unscored, round, orange, film-coated tablets imprinted DAN and 5522 supplied in bottles of 100 and 500.

Hydroxyzine Hydrochloride Tablets USP, 25 mg are 7/32”, unscored, round, green, film-coated tablets imprinted DAN and 5523 supplied in bottles of 100, 500 and 1000.

Hydroxyzine Hydrochloride Tablets USP, 50 mg are 10/32”, unscored, round, yellow, film-coated tablets imprinted DAN and 5565 supplied in bottles of 100, 500 and 1000.

Dispense in a tight container with child-resistant closure.

Store at 20°-25°C (68°-77°F). [See USP controlled room temperature.]

Manufactured By:

Watson Pharma Private Ltd.

Verna, Salcette Goa 403 722 INDIA

Distributed By:

Watson Pharma, Inc.

Corona, CA 92880 USA

Revised: June 2009                                                                        190944

                                                                                                             0609B

PRINCIPAL DISPLAY PANEL

NDC 0591-5522-01

HydrOXYzine

Hydrochloride

Tablets USP

10mg

100 Tablets

PRINCIPAL DISPLAY PANEL

NDC 0591-5523-01

HydrOXYzine

Hydrochloride

Tablets USP

25 mg

100 Tablets

PRINCIPAL DISPLAY PANEL

NDC 0591-3423-01

HydrOXYzine

Hydrochloride

Tablets USP

50 mg

100 Tablets

HYDROXYZINE HYDROCHLORIDE  hydroxyzine hydrochloride  tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0591-5522 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) HYDROXYZINE HYDROCHLORIDE 10 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE   COLLOIDAL SILICON DIOXIDE   CROSCARMELLOSE SODIUM   FD&C YELLOW NO. 6   HYPROMELLOSES   MAGNESIUM STEARATE   CELLULOSE, MICROCRYSTALLINE   POLYETHYLENE GLYCOL   POLYSORBATE 80   TITANIUM DIOXIDE

Product Characteristics Color ORANGE Score no score Shape ROUND Size 6mm Flavor Imprint Code DAN;5522 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0591-5522-01 100 TABLET In 1 BOTTLE None 2 0591-5522-05 500 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA088348	11/21/2011

HYDROXYZINE HYDROCHLORIDE  hydroxyzine hydrochloride  tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0591-5523 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) HYDROXYZINE HYDROCHLORIDE 25 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE   COLLOIDAL SILICON DIOXIDE   CROSCARMELLOSE SODIUM   FD&C YELLOW NO. 6   HYPROMELLOSES   MAGNESIUM STEARATE   CELLULOSE, MICROCRYSTALLINE   POLYETHYLENE GLYCOL   POLYSORBATE 80   TITANIUM DIOXIDE   D&C YELLOW NO. 10   FD&C BLUE NO. 2

Product Characteristics Color GREEN Score no score Shape ROUND Size 6mm Flavor Imprint Code DAN;5523 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0591-5523-01 100 TABLET In 1 BOTTLE None 2 0591-5523-05 500 TABLET In 1 BOTTLE None 3 0591-5523-10 1000 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA088349	11/21/2011

HYDROXYZINE HYDROCHLORIDE  hydroxyzine hydrochloride  tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0591-3423 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) HYDROXYZINE HYDROCHLORIDE 50 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE   COLLOIDAL SILICON DIOXIDE   CROSCARMELLOSE SODIUM   FD&C YELLOW NO. 6   HYPROMELLOSES   MAGNESIUM STEARATE   CELLULOSE, MICROCRYSTALLINE   POLYETHYLENE GLYCOL   POLYSORBATE 80   TITANIUM DIOXIDE   D&C YELLOW NO. 10   FD&C BLUE NO. 2

Product Characteristics Color YELLOW Score no score Shape ROUND Size 8mm Flavor Imprint Code DAN;5565 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0591-3423-01 100 TABLET In 1 BOTTLE None 2 0591-3423-05 500 TABLET In 1 BOTTLE None 3 0591-3423-10 1000 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA088350	11/21/2011

Labeler - Watson Laboratories, Inc. (966714656)

Establishment
Name	Address	ID/FEI	Operations
Watson Laboratories, Inc. - Florida		014759176	LABEL, LABEL, LABEL, PACK, PACK, PACK

Establishment
Name	Address	ID/FEI	Operations
Watson Pharma Private Limited		677605709	ANALYSIS, ANALYSIS, ANALYSIS, LABEL, LABEL, LABEL, MANUFACTURE, MANUFACTURE, MANUFACTURE, PACK, PACK, PACK

Revised: 11/2011Watson Laboratories, Inc.

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Salmonella Enteric Fever Medications

Definition of Salmonella Enteric Fever:

Typhoid fever and paratyphoid fever, often referred to collectively as 'Enteric Fever', are diseases caused by bacteria called Salmonella typhi and Salmonella paratyphi.

Untreated, the illness can last for three to four weeks and is fatal in about ten percent of cases. Fatal complications happen only in the latter stages of the disease, however, and if caught early enough the disease can be cured with a course of antibiotics.

Drugs associated with Salmonella Enteric Fever

The following drugs and medications are in some way related to, or used in the treatment of Salmonella Enteric Fever. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Learn more about Salmonella Enteric Fever

Medical Encyclopedia:

• Typhoid fever

Drug List:

Cipro

Cipro-I-V

Cipro-Xr-Extended-Release-Tablets

Floxin

Maxaquin

Noroxin

Vinate AZ Extra

Generic Name: prenatal multivitamins (PRE nay tal VYE ta mins)

Brand Names: Advance Care Plus, Bright Beginnings, Cavan Folate, Cavan One, Cavan-Heme OB, Cenogen Ultra, CitraNatal Rx, Co Natal FA, Complete Natal DHA, Complete-RF, CompleteNate, Concept OB, Docosavit, Dualvit OB, Duet, Edge OB, Elite OB 400, Femecal OB, Folbecal, Folcaps Care One, Folivan-OB, Foltabs, Gesticare, Icar Prenatal, Icare Prenatal Rx, Inatal Advance, Infanate DHA, Kolnatal DHA, Lactocal-F, Marnatal-F, Maternity, Maxinate, Mission Prenatal, Multi-Nate 30, Multinatal Plus, Nata 29 Prenatal, Natachew, Natafort, Natelle, Neevo, Nestabs, Nexa Select with DHA, Novanatal, NovaStart, O-Cal Prenatal, OB Complete, OB Natal One, Ob-20, Obtrex DHA, OptiNate, Paire OB Plus DHA, PNV Select, PNV-Total, PR Natal 400, Pre-H-Cal, Precare, PreferaOB, Premesis Rx, PrenaCare, PrenaFirst, PrenaPlus, Prenatabs OBN, Prenatabs Rx, Prenatal 1 Plus 1, Prenatal Elite, Prenatal Multivitamins, Prenatal Plus, Prenatal S, Prenatal-U, Prenate Advanced Formula, Prenate DHA, Prenate Elite, Prenavite FC, PreNexa, PreQue 10, Previte Rx, PrimaCare, Pruet DHA, RE OB Plus DHA, Renate, RightStep, Rovin-NV, Se-Care, Se-Natal One, Se-Plete DHA, Se-Tan DHA, Select-OB, Seton ET, Strongstart, Stuart Prenatal with Beta Carotene, Tandem OB, Taron-BC, Tri Rx, TriAdvance, TriCare, Trimesis Rx, Trinate, Triveen-PRx RNF, UltimateCare Advance, Ultra-Natal, Vemavite PRX 2, VeNatal FA, Verotin-BY, Verotin-GR, Vinacal OR, Vinatal Forte, Vinate Advanced (New Formula), Vinate AZ, Vinate Care, Vinate Good Start, Vinate II (New Formula), Vinate III, Vinate One, Vitafol-OB, VitaNatal OB plus DHA, Vitaphil, Vitaphil Aide, Vitaphil Plus DHA, Vitaspire, Viva DHA, Vol-Nate, Vol-Plus, Vol-Tab Rx, Vynatal F.A., Zatean-CH, Zatean-PN

What are Vinate AZ Extra (prenatal multivitamins)?

There are many brands and forms of prenatal vitamin available and not all brands are listed on this leaflet.

Prenatal vitamins are a combination of many different vitamins that are normally found in foods and other natural sources.

Prenatal vitamins are used to provide the additional vitamins needed during pregnancy. Minerals may also be contained in prenatal multivitamins.

Prenatal vitamins may also be used for purposes not listed in this medication guide.

What is the most important information I should know about prenatal vitamins?

There are many brands and forms of prenatal vitamin available and not all brands are listed on this leaflet.

Never take more than the recommended dose of a multivitamin. Avoid taking any other multivitamin product within 2 hours before or after you take your prenatal vitamins. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Many multivitamin products also contain minerals such as calcium, iron, magnesium, potassium, and zinc. Minerals (especially taken in large doses) can cause side effects such as tooth staining, increased urination, stomach bleeding, uneven heart rate, confusion, and muscle weakness or limp feeling. Read the label of any multivitamin product you take to make sure you are aware of what it contains.

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of vitamins A, D, E, or K can cause serious or life-threatening side effects and can also harm your unborn baby. Certain minerals contained in a prenatal multivitamin may also cause serious overdose symptoms or harm to the baby if you take too much.

Overdose symptoms may include stomach pain, vomiting, diarrhea, constipation, loss of appetite, hair loss, peeling skin, tingly feeling in or around your mouth, changes in menstrual periods, weight loss, severe headache, muscle or joint pain, severe back pain, blood in your urine, pale skin, and easy bruising or bleeding.

Do not take this medication with milk, other dairy products, calcium supplements, or antacids that contain calcium. Calcium may make it harder for your body to absorb certain ingredients of the multivitamin.

What should I discuss with my healthcare provider before taking prenatal vitamins?

Many vitamins can cause serious or life-threatening side effects if taken in large doses. Do not take more of this medication than directed on the label or prescribed by your doctor.

Before taking prenatal vitamins, tell your doctor about all of your medical conditions.

You may need to continue taking prenatal vitamins if you breast-feed your baby. Ask your doctor about taking this medication while breast-feeding.

How should I take prenatal vitamins?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Never take more than the recommended dose of prenatal vitamins.

Many multivitamin products also contain minerals such as calcium, iron, magnesium, potassium, and zinc. Minerals (especially taken in large doses) can cause side effects such as tooth staining, increased urination, stomach bleeding, uneven heart rate, confusion, and muscle weakness or limp feeling. Read the label of any multivitamin product you take to make sure you are aware of what it contains.

Take your prenatal vitamin with a full glass of water.

Swallow the regular tablet or capsule whole. Do not break, chew, crush, or open it.

The chewable tablet must be chewed or allowed to dissolve in your mouth before swallowing. You may also allow the chewable tablet to dissolve in drinking water, fruit juice, or infant formula (but not milk or other dairy products). Drink this mixture right away.

Use prenatal vitamins regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store at room temperature away from moisture and heat. Keep prenatal vitamins in their original container. Storing vitamins in a glass container can ruin the medication.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of vitamins A, D, E, or K can cause serious or life-threatening side effects and can also harm your unborn baby. Certain minerals contained in a prenatal multivitamin may also cause serious overdose symptoms or harm to the baby if you take too much.

Overdose symptoms may include stomach pain, vomiting, diarrhea, constipation, loss of appetite, hair loss, peeling skin, tingly feeling in or around your mouth, changes in menstrual periods, weight loss, severe headache, muscle or joint pain, severe back pain, blood in your urine, pale skin, and easy bruising or bleeding.

What should I avoid while taking prenatal vitamins?

Avoid taking any other multivitamin product within 2 hours before or after you take your prenatal vitamins. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Avoid the regular use of salt substitutes in your diet if your multivitamin contains potassium. If you are on a low-salt diet, ask your doctor before taking a vitamin or mineral supplement.

Do not take this medication with milk, other dairy products, calcium supplements, or antacids that contain calcium. Calcium may make it harder for your body to absorb certain ingredients of the prenatal vitamin.

Prenatal vitamins side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

When taken as directed, prenatal vitamins are not expected to cause serious side effects. Less serious side effects may include:

• 
  

  upset stomach;

  
  


• 
  

  headache; or

  
  


• 
  

  unusual or unpleasant taste in your mouth.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect prenatal vitamins?

Vitamin and mineral supplements can interact with certain medications, or affect how medications work in your body. Before taking a prenatal vitamin, tell your doctor if you also use:

• 
  

  diuretics (water pills);

  
  


• 
  

  heart or blood pressure medications;

  
  


• 
  

  tretinoin (Vesanoid);

  
  


• 
  

  isotretinoin (Accutane, Amnesteen, Clavaris, Sotret);

  
  


• 
  

  trimethoprim and sulfamethoxazole (Cotrim, Bactrim, Gantanol, Gantrisin, Septra, TMP/SMX); or

  
  


• 
  

  an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Cataflam, Voltaren), indomethacin (Indocin), meloxicam (Mobic), and others.

  
  

This list is not complete and other drugs may interact with prenatal vitamins. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

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• Cal-Nate MedFacts Consumer Leaflet (Wolters Kluwer)


• CareNatal DHA MedFacts Consumer Leaflet (Wolters Kluwer)


• CitraNatal 90 DHA MedFacts Consumer Leaflet (Wolters Kluwer)


• CitraNatal Assure Prescribing Information (FDA)


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• Docosavit Prescribing Information (FDA)


• Duet DHA with Ferrazone MedFacts Consumer Leaflet (Wolters Kluwer)


• Folbecal MedFacts Consumer Leaflet (Wolters Kluwer)


• Folcal DHA Prescribing Information (FDA)


• Folcaps Care One Prescribing Information (FDA)


• Gesticare DHA Prescribing Information (FDA)


• Gesticare DHA MedFacts Consumer Leaflet (Wolters Kluwer)


• Inatal Advance Prescribing Information (FDA)


• Inatal Ultra Prescribing Information (FDA)


• Multi-Nate DHA Prescribing Information (FDA)


• Multi-Nate DHA Extra Prescribing Information (FDA)


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• Natelle One Prescribing Information (FDA)


• Neevo Caplets MedFacts Consumer Leaflet (Wolters Kluwer)


• Neevo DHA MedFacts Consumer Leaflet (Wolters Kluwer)


• OB Complete 400 MedFacts Consumer Leaflet (Wolters Kluwer)


• Paire OB Plus DHA Prescribing Information (FDA)


• PreNexa MedFacts Consumer Leaflet (Wolters Kluwer)


• PreNexa Prescribing Information (FDA)


• PreferaOB Prescribing Information (FDA)


• Prenatal Plus Prescribing Information (FDA)


• Prenatal Plus Iron Prescribing Information (FDA)


• Prenate Elite Prescribing Information (FDA)


• Prenate Elite MedFacts Consumer Leaflet (Wolters Kluwer)


• Prenate Elite tablets


• Prenate Essential Prescribing Information (FDA)


• PrimaCare Advantage MedFacts Consumer Leaflet (Wolters Kluwer)


• PrimaCare ONE capsules


• PrimaCare One MedFacts Consumer Leaflet (Wolters Kluwer)


• Renate DHA Prescribing Information (FDA)


• Se-Natal 19 Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Se-Natal 19 Prescribing Information (FDA)


• Tandem DHA Prescribing Information (FDA)


• Tandem OB Prescribing Information (FDA)


• TriAdvance Prescribing Information (FDA)


• Triveen-One MedFacts Consumer Leaflet (Wolters Kluwer)


• Triveen-PRx RNF Prescribing Information (FDA)


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Where can I get more information?

• Your pharmacist can provide more information about prenatal vitamins.

Cedocard Retard 20 Tablets

1. Name Of The Medicinal Product

Cedocard Retard 20 Tablets

2. Qualitative And Quantitative Composition

Isosorbide Dinitrate BP 20.0 mg

3. Pharmaceutical Form

Uncoated sustained release tablets for oral administration.

4. Clinical Particulars

4.1 Therapeutic Indications

For the prophylaxis of angina pectoris.

4.2 Posology And Method Of Administration

By oral administration, the tablets should be swallowed, with a little water without chewing.

Children:

There is no recommended dose for children.

Adults:

One tablet in the morning and one before retiring to sleep.

Elderly:

The dosage of nitrates in cardiovascular disease is usually determined by patient response and stabilisation. Clinical experience has not necessitated alternative advice for use in elderly patients. The pharmacokinetics of isosorbide dinitrate in patients with severe renal failure and liver cirrhosis are similar to those in normal subjects.

The onset of action is 20-30 minutes.

The duration of action is 10-12 minutes.

4.3 Contraindications

A history of sensitivity to the drug.

4.4 Special Warnings And Precautions For Use

Tolerance and cross-tolerance to other nitrates may occur.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Alcohol may potentiate the effect of isosorbide dinitrate.

4.6 Pregnancy And Lactation

No data have been reported which would indicate the possibility of adverse effects resulting from the use of isosorbide dinitrate in pregnancy. Safety in pregnancy however, has not been established. Isosorbide dinitrate should only be used in pregnancy if, in the opinion of the physician, the possible benefits of treatment outweigh the possible hazards. Lactation – there are no data available on the transfer of isosorbide dinitrate in breast milk or its effect on breast-fed children.

4.7 Effects On Ability To Drive And Use Machines

Side effects include throbbing headache and dizziness. Patients are advised not to drive or operate machinery is so affected.

4.8 Undesirable Effects

Headaches may occur (common), these are usually temporary. Less frequent, cutaneous vasodilation with flushing. Transient episodes of dizziness and weakness and other signs of cerebral ischaemia may occur with postural hypotension.

4.9 Overdose

In rare cases of overdosage, gastric lavage is indicated. Passive exercise of the extremities of the recumbent patient will promote venous return.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Vasodilator.

5.2 Pharmacokinetic Properties

After administration of one tablet of Cedocard Retard 20 at least two peak concentration of ISDN occurred in the plasma. The initial peak (mean 1.9 ng/ml, range 1.0-3.4 mg/ml) occurred during 0.5 to 2 hours, and then mean plasma concentrations declined to 1.3 ng/ml at 3 hours. The concentration then increased again to reach a major peak level (mean 6.2 ng/ml, range 1.6-12.3 ng/ml) during 4-6 hours after dosing.

Plasma concentrations of ISDN have been measured after administration of increasing doses in the range 20-100 mg (as Cedocard Retard 20 tablets).

Means of peak concentrations of 4.2 ng/ml, 13.1 ng/ml, 20.7 ng/ml, 36.8 ng/ml and 34.9 ng/ml were measured after doses of 20 mg, 40 mg, 60 mg, 80 mg and 100 mg respectively.

5.3 Preclinical Safety Data

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Lactose

Talc

Magnesium Stearate

Polyvinyl Acetate

Quinoline Yellow (E104)

Yellow Orange S (E110)

Methylene Chloride

Water

6.2 Incompatibilities

None known.

6.3 Shelf Life

60 months.

6.4 Special Precautions For Storage

Protect from heat and moisture.

6.5 Nature And Contents Of Container

PVC/Aluminium foil blister strip.

Pack size: 60 tablets

6.6 Special Precautions For Disposal And Other Handling

There are no special instructions for handling.

Administrative Data

7. Marketing Authorisation Holder

Pharmacia Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

8. Marketing Authorisation Number(S)

PL 00032/0331

9. Date Of First Authorisation/Renewal Of The Authorisation

30 September 2002

10. Date Of Revision Of The Text

August 2007

Company Ref: CD1_0