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1. Name Of The Medicinal Product

CAPASAL™ THERAPEUTIC SHAMPOO

2. Qualitative And Quantitative Composition

Salicylic Acid 0.5% w/w; Coconut Oil 1.0% w/w; Distilled Coal Tar 1.0% w/w.

3. Pharmaceutical Form

Viscous, golden brown shampoo.

4. Clinical Particulars

4.1 Therapeutic Indications

For use as a shampoo in the treatment of dry, scaly scalp conditions such as seborrhoeic eczema, seborrhoeic dermatitis, pityriasis capitis, psoriasis, and cradle cap in children. It may also be used to remove previous scalp applications.

4.2 Posology And Method Of Administration

For adults, children and the elderly: Use as a shampoo, daily if necessary. Wet the hair thoroughly. Massage a small amount of the shampoo into the scalp, leaving on for a few minutes before washing out. Repeat, producing a rich lather. Rinse hair well and dry.

4.3 Contraindications

Not to be used in cases of sensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

Keep away from the eyes. Keep out of the reach of children. For external use only. In case of irritation, discontinue treatment.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

No known side-effects.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

None known.

4.9 Overdose

There are no known toxic effects resulting from excessive use of Capasal.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

1. Name Of The Medicinal Product

CETRIMIDE CREAM BP

BELLS ANTISEPTIC CREAM

LLOYDSPHARMACY ANTISEPTIC CREAM

WILKO ANTISEPTIC CREAM

GALPHARMMEDICAL ANTISEPTIC CREAM

ASDA ANTISEPTIC FIRST AID CREAM

NUMARK ANTISEPTIC CREAM

2. Qualitative And Quantitative Composition

Cetrimide BP 0.5% w/w

3. Pharmaceutical Form

Cream

4. Clinical Particulars

4.1 Therapeutic Indications

For application to minor burns, minor wounds, cuts, grazes, minor abrasions and minor scalds to prevent infection.

4.2 Posology And Method Of Administration

For topical application to the affected areas, there is no difference in use for children, adults or the elderly.

4.3 Contraindications

Avoid contact with eyes, brain, meninges and middle ear. Do not use in body cavities or as an enema.

4.4 Special Warnings And Precautions For Use

Cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis).

Hydroxybenzoates may cause allergic reactions (possibly delayed).

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None stated

4.6 Pregnancy And Lactation

None stated

4.7 Effects On Ability To Drive And Use Machines

None stated

4.8 Undesirable Effects

Some patients may become hypersensitive to cetrimide on repeated application.

4.9 Overdose

Overdose may cause nausea and vomiting. The product has depolarising muscle relaxant properties and toxic symptoms including dyspnoea and cyanosis (due

1. Name Of The Medicinal Product

Covonia Night Time Formula.

2. Qualitative And Quantitative Composition

Dextromethorphan Hydrobromide Ph.Eur.

6.65mg/5ml dose.

Diphenhydramine Hydrochloride Ph.Eur.

10.0mg/5ml dose.

Excipients : Each 5ml contains Liquid Maltitol 1.125g, Ethanol (alcohol) 7.3 Vol %

For full list of excipients see section 6.1

3. Pharmaceutical Form

Oral Solution.

4. Clinical Particulars

4.1 Therapeutic Indications

For the night time symptomatic relief of unproductive cough and congestive symptoms associated with colds.

4.2 Posology And Method Of Administration

Posology

Adults, the Elderly and Children over 12 years

3 X 5ml spoonfuls at bedtime. Repeat after 6 hours if required

4.3 Contraindications

Contraindicated in known hypersensitivity to any of the ingredients. Contraindicated in persons under treatment with monoamine oxidase inhibitors or within 2 weeks of discontinuation of MAOI use.

Dextromethorphan, in common with other centrally acting antitussive agents, should not be given to patients in, or at risk of developing, respiratory failure.

Covonia Night Time Formula should not be used in liver dysfunction. It should not be administered to pat

1. Name Of The Medicinal Product

Cream of Magnesia BP

2. Qualitative And Quantitative Composition

Active ingredient

% w/v

Light magnesium oxide

5.98

Magnesium sulphate

0.075

3. Pharmaceutical Form

A white emulsion.

4. Clinical Particulars

4.1 Therapeutic Indications

For the relief of indigestion and constipation.

4.2 Posology And Method Of Administration

As an antacid

Adults and children over 12 years: 5 to 10ml (1 to 2 teaspoonfuls)

Children 6 to 12 years: 2.5 to 5 ml (0.5 to 1 teaspoonful) according to age.

These doses should be taken in a little water after meals or when required.

Elderly: Dosage may need to be reduced.

As a laxative

Adults and children over 12 years: 25 to 50ml (5 to 10 teaspoonfuls).

Children 6 to 12 years: 5 to 15ml (1 to 3 teaspoonfuls) according to age.

These doses should be taken in a little warm water at bedtime.

Children up to 6 years: As recommended by the doc

1. Name Of The Medicinal Product

Cetirizine Hydrochloride 10mg Tablets.

2. Qualitative And Quantitative Composition

Each film-coated tablet contains 10mg of Cetirizine Hydrochloride.

Excipient: 91 mg lactose /film-coated tablet.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Film-coated Tablet.

White, capsule shaped, biconvex film coated tablets with score line on one side and 'C' and 'L' imprints on either side of score line, other side being plain.

4. Clinical Particulars

4.1 Therapeutic Indications

Adults and adolescents over 12 years of age:

Symptomatic treatment of allergic rhinitis (seasonal and perennial), associated allergic conjunctivitis, and chronic idiopathic urticaria.

Children 6-12 years:

Symptomatic treatment of allergic rhinitis (seasonal and perennial), and chronic idiopathic urticaria.

4.2 Posology And Method Of Administration

Adults and adolescents over 12 years of age: One tablet daily.

If drowsiness occurs, the tablet can be administered in the evening.

Children 6-12 years old, weighing 30 kg and more:

One tablet daily or 5 mg (? tablet) taken twice daily (morning and evening).

Childern 6-12 years old, weighing less than 30 kg:

5 mg (? tablet) taken once daily.

Children 2-5 years:

Cetirizine hydrochloride 10 mg Table

CAMCOLIT 250mg film coated tablets

Lithium carbonate

Read all of this leaflet carefully before you start taking this medicine

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
  • If any of the side effects become serious, or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

  • 1. What CAMCOLIT is and what it is used for
  • 2. Before you take CAMCOLIT
  • 3. How to take CAMCOLIT
  • 4. Possible side effects
  • 5. How to store CAMCOLIT
  • 6. Further information

What CAMCOLIT is and what it is used for

CAMCOLIT 250mg tablets contain lithium carbonate, which is used to treat and prevent mania or manic depressive illness and recurrent depression. It is sometimes used to treat other behavioural disorders.

Before you take CAMCOLIT

Do not take CAMCOLIT if you:

  • are hypersensitive (allergic) to lithium or to any of the other ingredients
  • have severe kidney disease
  • have hypothyroidism (low thyroid hormones) that is difficult to treat
  • have problems with the rhythm of your heart
  • have low sodium levels

1. Name Of The Medicinal Product

Coracten SR Capsules 10mg

BIDNIF 10

Coracten SR Capsules 20mg

BIDNIF 20

2. Qualitative And Quantitative Composition

Each capsule contains 10mg Nifedipine USP in sustained release form.

Each capsule contains 20mg Nifedipine USP in sustained release form.

For excipients, see 6.1

3. Pharmaceutical Form

Modified-release capsule, hard

10 mg - Sustained release capsules with opaque grey body and opaque brownish-pink cap, overprinted in white with 'Coracten' on the body and '10mg' on the cap, and filled with yellow pellets.

20 mg - Sustained release capsules with opaque brownish-pink body and opaque reddish-brown cap, overprinted in white with 'Coracten' on the body and '20mg' on the cap, and filled with yellow pellets.

4. Clinical Particulars

4.1 Therapeutic Indications

Coracten SR Capsules are indicated for the prophylaxis of chronic stable angina pectoris and the treatment of hypertension.

They are also indicated for the treatment of Prinzmetal (variant) angina when diagnosed by a cardiologist.

4.2 Posology And Method Of Administration

Adults only: The recommended starting dose of Coracten SR Capsules is 10mg every 12 hours swallowed with water with subsequent titration of dosage according to response. The dose may be adjusted to 40mg every 12 hours.

Children: Coracten SR Capsules are not recommended for use in children.

Elderly: The pharmacokinetics of nifedipine are altered in the elderly so that lower maintenance doses of nifedipine may be required compared to younger patients.

Hepatic impairment: Caution

1. Name Of The Medicinal Product

CYTACON 35 micrograms in 5ml LIQUID

2. Qualitative And Quantitative Composition

One 5ml spoonful contains 35 micrograms of cyanocobalamin

3. Pharmaceutical Form

Syrup

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of nutritional Vitamin B12 deficiency.

Treatment of vitamin B12 deficiency following partial gastrectomy.

Treatment of tropical sprue, alone or with folic acid.

Treatment of pernicious anaemia when parenteral administration is not possible or not advised.

4.2 Posology And Method Of Administration

Dosage:

Adults: - One or two 5ml spoonfuls of Cytacon liquid two or three times daily, or more at the discretion of the physician.

Elderly: - The normal adult dose is appropriate for the elderly.

Children: - One 5 ml spoonful of Cytacon liquid two or three times daily, or more at the disacretion of the physician.

In pernicious anaemia intramuscular therapy is preferable for initial correction of vitamin B12 deficiency. However, if necessary, the oral route may be used tofollow this, in which case at least 300 micrograms should be given daily.

When possible, Cytacon doses should be taken between meals.

Metho

Catapres Tablets 100 micrograms and 300 micrograms

(clonidine hydrochloride)

Read all of this leaflet carefully before you start taking this medicine.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
  • If any of the side effects gets troublesome or serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

  • 1. What CATAPRES Tablets are and what they are used for
  • 2. Before you take CATAPRES Tablets
  • 3. How to take CATAPRES Tablets
  • 4. Possible side effects
  • 5. How to store CATAPRES Tablets
  • 6. Further information

What Catapres Tablets Are And What They Are Used For

CATAPRES Tablets contain a medicine called clonidine. This belongs to a group of medicines called antihypertensives.

CATAPRES is used to lower high blood pressure (to treat hypertension).

Before You Take Catapres Tablets

Do not take CATAPRES if:

  • You are pregnant, likely to get pregnant or are breast-feeding
  • You are allergic (hypersensitive) to clonidine or any of the other ingredients of CATAPRES (see section 6: Further information)
  • You have a slow h

1. Name Of The Medicinal Product

Clove Oil BP.

2. Qualitative And Quantitative Composition

Clove Oil BP 100% v/v.

3. Pharmaceutical Form

Dental Solution

4. Clinical Particulars

4.1 Therapeutic Indications

For the temporary relief of toothache.

4.2 Posology And Method Of Administration

Local.

Adults, the elderly and children:

Apply on cotton wool to the tooth cavity as required.

4.3 Contraindications

Contra-indicated in patients hypersensitive to clove oil or eugenol.

4.4 Special Warnings And Precautions For Use

Use with caution in the mouth or if sensitive to clove oil.

Avoid contact with the skin.

Repeated use may cause gum damage.

Seek dental attention as soon as possible.

Use with caution in children under 2 years.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

May enhance inhibition of platelet activity in patients receiving anti-coagulant therapy.

4.6 Pregnancy And Lactation

As for all medicines, use only with caution during pregnancy and lactation.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Contact with skin or soft tissue may cause transient irritation, contact dermatitis, inflammation of the lips, and inflammation or ulceration of the mouth.

Patients may become sensitive to clove oil.

4.9 Overdose

Accidental oral ingestion of clove oil may lead to CNS depression, urinary abnormalities, anion-gap acidosis,

1. Name Of The Medicinal Product

Cardene 20 mg

Cardene 30 mg

2. Qualitative And Quantitative Composition

Nicardipine hydrochloride 20 mg

Nicardipine hydrochloride 30 mg

3. Pharmaceutical Form

Capsules

4. Clinical Particulars

4.1 Therapeutic Indications

Cardene is indicated for the prophylaxis of patients with chronic stable angina. For the treatment of hypertension considered to be mild to moderate in severity.

4.2 Posology And Method Of Administration

Nicardipine should be taken with a little water.

Prophylaxis of chronic stable angina:

Starting dose: 20 mg every 8 hours titrating upwards as required.

Usual effective dose: 30 mg every 8 hours (range of total dose 60 mg - 120 mg per day).

Allow at least 3 days before increasing the dose of Cardene to ensure steady state plasma levels have been achieved.

Hypertension:

Starting dose: 20 mg every 8 hours titrating upwards as required.

Usual effective dose: 30 mg every 8 hours (range of total dose 60 mg - 120 mg per day).

Use in elderly:

Starting dose is 20 mg 3 times a day. Titrate upwards with care as nicardipine may lower systolic pressure more than diastolic pressure in these patients.

Children:

Cardene is not recommended in patients under the age of 18.

Cardene capsules are for oral administration.

4.3 Contraindications

(1) Pregnancy and lactation.

(2) Hypersensitivity to nicardipine hydrochloride or other dihydropyridines because of the theoretical risk of

1. Name Of The Medicinal Product

Clove Oil BP.

2. Qualitative And Quantitative Composition

Clove Oil BP 100% v/v.

3. Pharmaceutical Form

Dental Solution

4. Clinical Particulars

4.1 Therapeutic Indications

For the temporary relief of toothache.

4.2 Posology And Method Of Administration

Local.

Adults, the elderly and children:

Apply on cotton wool to the tooth cavity as required.

4.3 Contraindications

Contra-indicated in patients hypersensitive to clove oil or eugenol.

4.4 Special Warnings And Precautions For Use

Use with caution in the mouth or if sensitive to clove oil.

Avoid contact with the skin.

Repeated use may cause gum damage.

Seek dental attention as soon as possible.

Use with caution in children under 2 years.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

May enhance inhibition of platelet activity in patients receiving anti-coagulant therapy.

4.6 Pregnancy And Lactation

As for all medicines, use only with caution during pregnancy and lactation.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Contact with skin or soft tissue may cause transient irritation, contact dermatitis, inflammation of the lips, and inflammation or ulceration of the mouth.

Patients may become sensitive to clove oil.

4.9 Overdose

Accidental oral ingestion of clove oil may lead to CNS depression, urinary abnormalities, anion-gap acidosis,

Due to technical difficulties in printing the label-leaflet format, please find the relevant text below. Text is representative of the leaflet portion of label leaflet spec no 50416573.

Co-dydramol tablets 10/500mg

(dihydrocodeine tablets and paracetamol)

Read all of this leaflet carefully before you start taking this medicine.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

Index

1. What Co-dydramol tablets are and what they are used for
2. Before you take
3. How to take
4. Possible side effects
5. How to store
6. Further information

What Co-dydramol tablets are and what they are used for

Co-dydramol tablets belong to a group of medicines called analgesics and are used for the relief of mild to moderate pain.

Before you take

Do not take Co-dydramol tablets and tell your doctor if you:

  • are allergic (hypersensitive) to paracetamol, dihydrocodeine or other opioids, or any of the ingredients in the tablet (see section 6)
  • have diarrhoea caused by poisoning or severe bloody diarrhoea (pseudomembranous colitis)
  • have difficulty breathing, or other chronic lung disease

1. Name Of The Medicinal Product

CAMCOLIT 400 mg, Lithium Carbonate

2. Qualitative And Quantitative Composition

The active ingredient is Lithium Carbonate; 400mg/tablet

3. Pharmaceutical Form

White film coated tablet engraved "CAMCOLIT-S" around one face and having a breakline on the reverse. The tablet is a controlled release formulation. If sold as LITHONATE the tablet is engraved on one side “LIT 400”

For oral administration.

4. Clinical Particulars

4.1 Therapeutic Indications

The treatment and prophylaxis of mania, manic depressive illness and recurrent depression, and the treatment of aggressive or self mutilating behaviour.

4.2 Posology And Method Of Administration

CAMCOLIT 400mg tablets are usually administered according to a twice daily regimen. When lithium levels have stabilised, a once daily regimen may be preferred.

4.2.1 Dosage

Lithium carbonate has a narrow therapeutic window. Regular monitoring of plasma lithium concentration is always obligatory when Lithium is used; lithium therapy should not be initiated unless adequate facilities for routine monitoring of plasma concentrations are available. On initiation of treatment, plasma therapy concentrations should be measured weekly until stabilisation is achieved, then weekly for one month and at monthly intervals thereafter.

Additional measurements should be made if signs of lithium toxicity occur, on dosage alteration, development of significant intercurrent disease, signs of manic depressions or depressive relapse and if significant change in sodium or fluid intake occurs. More frequent monitoring is required if patients are receiving any drug treatment that affects renal clearance of lithiu

1. Name Of The Medicinal Product

Ceftazidime 2g Powder for solution for injection or infusion

2. Qualitative And Quantitative Composition

Each vial contains ceftazidime 2g (as pentahydrate)

Each gram of ceftazidime contains approximately 52mg (2.26mmol) of sodium.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Powder for solution for injection or infusion (Powder for injection/infusion).

White to cream coloured, crystalline powder

4. Clinical Particulars

4.1 Therapeutic Indications

Ceftazidime is indicated for the treatment of the following infections when known or likely to be due to one or more susceptible microorganisms (see section 5. 1) and when parenteral therapy is required:

- Respiratory tract infections, including lower respiratory tract infections in patients with cystic fibrosis

- Urinary tract infections; ceftazidime may also be used for peri-operative prophylaxis during trans-urethral prostatectomy

- Skin and soft tissue infections

- Biliary tract infections

- Intra-abdominal infections

- Bone and joint infections

- Infections associated peritoneal dialysis and with continuous ambulatory peritoneal dialysis (CAPD)

- Meningitis due to aerobic gram-negative organisms

Whenever possible, it is recommended that the results of bacterial cultures and susceptibility tests are known before commencing treatment. This is especially important if ceftazidime is to be used as monotherapy. Ceftazidime should be used in combination with an additional antibacterial agent(s) when treating infections that are likely to be due to a mixture of susceptible and resista

1. Name Of The Medicinal Product

Captopril 50 mg Tablets.

2. Qualitative And Quantitative Composition

Each tablet contains captopril, 50mg.

For a full list of excipients, see section 6.1

3. Pharmaceutical Form

Tablet

White, circular flat tablets scored on one side.

4. Clinical Particulars

4.1 Therapeutic Indications

Hypertension: The management of mild to moderate hypertension. In severe hypertension it should be used where standard therapy is ineffective or inappropriate.

Congestive heart failure: Captopril is indicated for the treatment of congestive heart failure. The drug should be used together with diuretics and, where appropriate, digitalis and beta-blockers.

In patients on doses of over 100 mg daily plus or minus a diuretic, in those with severe renal impairment or those with severe congestive heart failure use of captopril should be under specialist supervision.

Myocardial Infarction:

- short-term (4 weeks) treatment: Captopril is indicated in any clinically stable patient within the first 24 hours of an infarction.

- long-term prevention of symptomatic heart failure: Captopril is indicated in clinically stable patients with asymptomatic left ventricular dysfunction (ejection fraction

Before starting therapy, cardiac function should be determined by radionuclide ventriculography or echocardiography.

Type I Diabetic nephropathy: Captopril is indicated in insulin dependent diabetics for the treatment of macroproteinuric diabetic nephropathy (microalbuminuria greater than 30 mg/day) (see section 5.1). Captopril may prevent the progression of the renal dis

1. Name Of The Medicinal Product

Captopril 25 mg Tablets.

2. Qualitative And Quantitative Composition

Each tablet contains captopril, 25 mg.

For a full list of excipients, see section 6.1

3. Pharmaceutical Form

Tablet

White, round flat tablets scored on one side.

4. Clinical Particulars

4.1 Therapeutic Indications

Hypertension: The management of mild to moderate hypertension. In severe hypertension it should be used where standard therapy is ineffective or inappropriate.

Congestive heart failure: Captopril is indicated for the treatment of congestive heart failure. The drug should be used together with diuretics and, when appropriate, digitalis and beta-blockers.

In patients on doses of over 100 mg daily plus or minus a diuretic, in those with severe renal impairment or those with severe congestive heart failure use of captopril should be under specialist supervision.

Myocardial Infarction:

- short-term (4 weeks) treatment: Captopril is indicated in any clinically stable patient within the first 24 hours of an infarction.

- long-term prevention of symptomatic heart failure: Captopril is indicated in clinically stable patients with asymptomatic left ventricular dysfunction (ejection fraction

Before starting therapy, cardiac function should be determined by radionuclide ventriculography or echocardiography.

Type I Diabetic nephropathy: Captopril is indicated in insulin dependent diabetics for treatment of macroproteinuric diabetic nephropathy (microalbuminuria greater than 30 mg/day) (see section 5.1). Captopril may prevent the progression of the renal disease and reduce associated clinical even

1. Name Of The Medicinal Product

Heminevrin 192 mg Capsules.

Clomethiazole 192 mg Capsules.

2. Qualitative And Quantitative Composition

Clomethiazole 192 mg (base) per capsule.

10 mg Sorbitol (E420) per capsule.

For a full list of excipients, see 6.1.

3. Pharmaceutical Form

Soft Capsules.

Greyish-brown, soft gelatin capsules.

4. Clinical Particulars

4.1 Therapeutic Indications

Clomethiazole is a short acting hypnotic and sedative with anticonvulsant effect. It is used for the: management of restlessness and agitation in the elderly, short term treatment of severe insomnia in the elderly and treatment of alcohol withdrawal symptoms where close hospital supervision is also provided.

4.2 Posology And Method Of Administration

For oral use.

The capsules should be swallowed whole.

Management of restlessness and agitation in the elderly: one capsule three times daily.

Severe insomnia in the elderly: 1 - 2 capsules before going to bed. The lower dose should be tried first. As with all psychotropic drugs, treatment should be kept to a minimum, reviewed regularly and discontinued as soon as possible.

Alcohol withdrawal states: Clomethiazole is not a specific 'cure' for alcoholism. Alcohol withdrawal should be treated in hospital or, in exceptional circumstances, on an outpatient basis by specialist units when the daily dosage of clomethiazole must be monitored closely by community health staff. The dosage should be adjusted to patient response. The patient should be sedated but rous

1. Name Of The Medicinal Product

Cetirizine hydrochloride 10 mg film-coated tablets

2. Qualitative And Quantitative Composition

Each film-coated tablet contains 10 mg cetirizine hydrochloride.

Excipient: 155.2 mg lactose monohydrate/ film-coated tablet

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Film-coated tablet.

White to off-white, film-coated, off-rectangular tablets, debossed with 'X' on one side with '20' on the other side. Score line between '2' and '0'.

The tablet can be divided into equal halves.

4. Clinical Particulars

4.1 Therapeutic Indications

In adults and paediatric patients 6 years and above:

• Cetirizine is indicated for the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis.

• Cetirizine is indicated for the relief of symptoms of chronic idiopathic urticaria.

4.2 Posology And Method Of Administration

Oral use.

Children aged from 6 to 12 years: 5mg twice daily (a half tablet twice daily).

Adults and adolescents over 12 years of age: 10mg once daily (1 tablet).

The tablets need to be swallowed with a glass of liquid.

Elderly subjects: data do not suggest that the dose needs to be reduced in elderly subjects provided that the renal function is normal.

Patients with moderate to severe renal impairment: there are no data to document the efficacy/safety ratio in patients with renal impairment. Since cetirizin

1. Name Of The Medicinal Product

Capoten Tablets 12.5mg

2. Qualitative And Quantitative Composition

Each tablet contains 12.5mg captopril.

For excipients, see 6.1

3. Pharmaceutical Form

Tablets

4. Clinical Particulars

4.1 Therapeutic Indications

Hypertension: Capoten is indicated for the treatment of hypertension.

Heart Failure: Capoten is indicated for the treatment of chronic heart failure with reduction of systolic ventricular function, in combination with diuretics and, when appropriate, digitalis and beta-blockers.

Myocardial Infarction:

- short-term (4 weeks) treatment: Capoten is indicated in any clinically stable patient within the first 24 hours of an infarction.

- long-term prevention of symptomatic heart failure: Capoten is indicated in clinically stable patients with asymptomatic left ventricular dysfunction (ejection fraction

Type I Diabetic Nephropathy: Capoten is indicated for the treatment of macroproteinuric diabetic nephropathy in patients with type I diabetes.

(See Section 5.1).

4.2 Posology And Method Of Administration

Dose should be individualised according to patient's profile (see 4.4) and blood pressure response. The recommended maximum daily dose is 150 mg.

Capoten may be taken before, during and after meals.

Hypertension: the recommended starting dose is 25-50 mg daily in two divided doses. The dose may be increased incrementally, with intervals of at least 2 weeks, to 100-150 mg/day in two divided doses as needed to reach target blood pressure. Captopril may be used alone or with other antihypertensive age