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Amoxil Syrups Sucrose-Free/Dye-Free 125 mg/5 ml and 250 mg/5 ml

amoxicillin

PLEASE READ THIS LEAFLET BEFORE TAKING THIS MEDICINE OR GIVING YOUR CHILD THIS MEDICINE

Always follow your doctor’s advice. If there is anything you do not understand, or if you have any questions, please ask your doctor or pharmacist (chemist).

Amoxil Syrups are mainly prescribed for children but may also be prescribed for adults. The leaflet is just as important for adults taking this medicine.

Your Amoxil comes in a bottle containing 100 ml of an off-white liquid mixture, called a syrup.

Contents

The active ingredient in this medicine is amoxicillin. This is the new name for amoxycillin. The ingredient itself has not changed.

This medicine is supplied to your pharmacist as a powder. The pharmacist will have made it into a syrup before it is given to you.

Amoxil Syrups Sucrose-Free/Dye-Free contain the active ingredient amoxicillin. The syrups come in two strengths containing either 125 mg or 250 mg of amoxicillin in each 5 mls. The other ingredients in the syrups are: disodium edetate, sodium benzoate, saccharin sodium, silica (E551), xanthan gum (E415), peach, strawberry and lemon dry flavours and sorbitol (E420). Each 5 ml dose of the 125 mg syrup contains 1.3 mg of sodium and 752 mg of sorbitol. Each 5 ml dose of the 250 mg syrup contains 4.2 mg of sodium and 576 mg of sorbitol.

Product Licence holder:

Beecham Group plc
trading as GlaxoSmithKline UK
Stockley Park West
Uxbridge

Alu-cap capsules

What you need to know about ALU-CAP capsules

Please read this carefully before you start to take your medication. This leaflet only provides a summary of the information available on your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

The name of your medication is ALU-CAP capsules

The name of the active ingredient is aluminium hydroxide. Each capsule contains 475 mg of Dried Aluminium Hydroxide Gel Ph. Eur. and is green and red, and marked 3M.

It also contains the following inactive ingredients: polyethylene glycol, purified talc, Solka Floc BW 100, E104, E110, E127, E131. The original pack contains 120 capsules.

Who produces your medication

The name and address of the product licence holder is

Meda Pharmaceuticals Ltd
Skyway House
Parsonage Road
Takeley
Bishop’s Stortford
CM22 6PU
UK

The product is manufactured by

3M Health Care Limited
Loughborough
Leicestershire
LE11 1EP
UK

What your medication is prescribed for

Aluminium hydroxide c

1. Name Of The Medicinal Product

ALLEGRON TABLETS

2. Qualitative And Quantitative Composition

Tablets containing Nortriptyline Hydrochloride EP equivalent to 10mg nortriptyline base tablets are white, unscored and have a diameter of 5.5mm. Marked 'KING'.

Tablets containing Nortriptyline Hydrochloride EP equivalent to 25mg nortriptyline base tablets are orange, scored and have a diameter of 8mm. Marked 'KING'.

3. Pharmaceutical Form

Tablet

4. Clinical Particulars

4.1 Therapeutic Indications

Allegron is indicated for the relief of symptoms of depression. It may also be used for the treatment of some cases of nocturnal enuresis.

4.2 Posology And Method Of Administration

For oral administration.

Adults: The usual adult dose is 25mg three or four times daily. Dosage should begin at a low level and be increased as required. Alternatively, the total daily dose may be given once a day. When doses above 100mg daily are administered, plasma levels of nortriptyline should be monitored and maintained in the optimum range of 50 to 150ng/ml. Doses above 150mg per day are not recommended.

Lower than usual dosages are recommended for elderly patients and adolescents. Lower dosages are also recommended for outpatients than for hospitalised patients who will be under close supervision. The physician should initiate dosage at a low level and increase it gradually, noting carefully the clinical response and any evidence of intolerance. Following remission, maintenance medication may be required for a longer period of time at the lowest dose that will maintain remission.

If a patient develops minor side-effects, the dosage should be reduced. The drug should be discontinued promptly if adverse e

1. Name Of The Medicinal Product

Amoxicillin 500 mg Capsules BP.

2. Qualitative And Quantitative Composition

Each capsule contains Amoxicillin 500mg (as the trihydrate).

3. Pharmaceutical Form

Capsule, Hard.

Scarlet (body) and Ivory (cap) capsules. The capsules are printed with K and AMOXI 500.

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of infection:

Amoxicillin is a broad spectrum antibiotic indicated for the treatment of commonly occurring bacterial infections such as:

Upper respiratory tract infections

Otitis media

Acute and chronic bronchitis

Chronic bronchial sepsis

Lobar and bronchopneumonia

Cystitis, urethritis, pyelonephritis

Bacteriuria in pregnancy

Gynaecological infections including puerperal sepsis and septic abortion

Gonorrhoea

Peritonitis

Intra-abdominal sepsis

Septicaemia

Bacterial endocarditis

Typhoid and paratyphoid fever

Skin and soft tissue infections

Dental abscess (as an adjunct to surgical management)

Helicobacter pylori eradication in peptic (duodenal and gastric) ulcer disease.

In children with urinary tract infection the need for investigation should be considered.

Prophylaxis of endocarditis

Amoxicillin may be used for the prevention of bacteraemia, associated with procedures such as dental extraction, in patients at risk of developing bacterial endocarditis.

Consideration should

1. Name Of The Medicinal Product

Ammonia and Ipecacuanha Mixture BP 1999

2. Qualitative And Quantitative Composition

Ammonium Hydrogen Carbonate 100.0 mg per 5ml dose

Ipecacuanha Tincture BP 1999 0.15 ml per 5 ml dose

For full list of excipients, see 6.1

3. Pharmaceutical Form

Oral solution.

A dark brown liquid

4. Clinical Particulars

4.1 Therapeutic Indications

For the symptomatic relief of productive coughs.

4.2 Posology And Method Of Administration

Oral.

Dose and dosage schedule

Adults, the elderly and children over 12 years: 10- 20ml, repeated after 4 hours if required. Not more than 4 doses to be taken in any 24 hours.

4.3 Contraindications

Contraindicated in patients with known sensitivity to ipecacuanha, ammonium salts or any of the other ingredients. Contraindicated in patients with hepatic or renal impairment, cardiovascular disorders, patients in shock or at risk from seizures.

4.4 Special Warnings And Precautions For Use

Do not exceed the stated dose.

If symptoms persist consult your doctor.

Keep all medicines away from children.

Discard any unused mixture 2 months after opening.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

As with all medicines, use should be avoided during pregnancy, especially in the first trimester, and in lactation unless recommended by a doctor.

4.7 Effects On Ability To Drive And Use Machines

No or

1. Name Of The Medicinal Product

Amilamont 5mg/5ml Oral Solution

2. Qualitative And Quantitative Composition

Amiloride Hydrochloride BP 5.675mg equivalent to anhydrous Amiloride Hydrochloride 5mg

3. Pharmaceutical Form

Solution for oral administration

4. Clinical Particulars

4.1 Therapeutic Indications

Potassium - conserving agent; diuretic.

Although Amiloride Hydrochloride may be used alone, its principal indication is as concurrent therapy with thiazides or more potent diuretics to conserve potassium during periods of vigorous diuresis and during long term maintenance therapy.

In hypertension, it is used as an adjunct to prolonged therapy with thiazides and similar agents to prevent potassium depletion.

In congestive heart failure, Amiloride Hydrochloride may be effective alone, but its principal indication is for concomitant use in patients receiving thiazides or more potent diuretic agents.

In hepatic cirrhosis with ascites, Amiloride Hydrochloride usually provides adequate diuresis, with diminished potassium loss and less risk of metabolic alkalosis, when used alone. It may be used with more potent diuretics when a greater diuresis is required while maintaining a more balanced serum electrolyte pattern.

4.2 Posology And Method Of Administration

Adults:

Amiloride Hydrochloride alone. The usual initial dosage is 10mg (as a single dose or 5mg twice a day). The total daily dose should not exceed 20mg (20ml) a day.

After diuresis has been achieved, the dosage may be reduced by 5mg (5ml) increments to the least amount required.

Amiloride Hydrochloride with other diuretic therapy

W

1. Name Of The Medicinal Product

Anbesol Teething Gel

2. Qualitative And Quantitative Composition

Lidocaine hydrochloride

1.0%w/w

Chlorocresol

0.1%w/w

Cetylpyridinium chloride

0.02%w/w

3. Pharmaceutical Form

Gel for oral administration.

4. Clinical Particulars

4.1 Therapeutic Indications

For the temporary relief of pain caused by recurrent mouth ulcers, denture irritation and teething.

4.2 Posology And Method Of Administration

Adults, children and the elderly: Apply a small amount to the affected area with a clean fingertip. Two applications immediately will normally be sufficient to obtain pain relief. Use up to four times a day.

Babies teething: Apply a small amount to the affected area with a clean fingertip. Use up to four times a day.

4.3 Contraindications

In patients with a known history of hypersensitivity or allergic type reactions to any of the constituents of the product.

4.4 Special Warnings And Precautions For Use

The following statements will appear on the packaging:

If symptoms persist for more than 7 days, consult your doctor or dentist.

1. Name Of The Medicinal Product

Azocan-P

2. Qualitative And Quantitative Composition

Each capsule contains fluconazole 150mg.

For excipients, see 6.1.

3. Pharmaceutical Form

Hard capsule.

A hard gelatin size “1” capsule with a blue cap and blue body containing a white free flowing powder.

4. Clinical Particulars

4.1 Therapeutic Indications

Azocan-P is indicated for the treatment of the following conditions:-

Vaginal candidiasis, acute or recurrent; or candidal balanitis associated with vaginal candidiasis.

4.2 Posology And Method Of Administration

For oral use.

In Adults aged 16-60 years: Vaginal candidiasis or candidal balanitis – 150mg single oral dose.

In Children: Not recommended in children aged under 16 years.

Use in the Elderly: Not recommended in patients aged over 60 years.

Use in renal impairment: Fluconazole is excreted predominantly in the urine as unchanged drug. No adjustments in single dose therapy are required.

4.3 Contraindications

Patients with known hypersensitivity to fluconazole or to related azole compounds or to any of the other ingredients.

Co-administration of terfenadine or cisapride is contra-indicated in patients receiving fluconazole. (See “Interactions with other medicinal products and other forms of interaction”).

4.4 Special Warnings And Precautions For Use

Patients with rare hereditary problems of galactose intolerance, the LAPP lactase deficiency or glucose-galactose malabsorption should not take this medicine.

The product intended for pharmacy availability without prescription will carry a l

1. Name Of The Medicinal Product

Aprinox Tablets 2.5 mg

Aprinox Tablets 5 mg

2. Qualitative And Quantitative Composition

Each Aprinox Tablet 2.5 mg contains bendroflumethiazide 2.5 mg

Each Aprinox Tablet 5 mg contains bendroflumethiazide 5 mg

For excipients, see section 6.1

3. Pharmaceutical Form

White tablets

4. Clinical Particulars

4.1 Therapeutic Indications

For the treatment of oedema and hypertension. Aprinox may also be used to suppress lactation.

4.2 Posology And Method Of Administration

For oral administration.

Adults:

Oedema

Initially, 5-10 mg in the morning, daily or on alternate days; maintenance dose 5-10 mg one to three times weekly.

Hypertension

The usual dose is 2.5 mg taken in the morning. Higher doses are rarely necessary.

Suppression of lactation

5 mg in the morning and 5 mg at midday for about five days.

Children: Dosage in children may be up to 400 mcg/kg bodyweight initially, reducing to 50-100 mcg/kg bodyweight daily for maintenance.

Elderly: The dosage of thiazide diuretics may need to be reduced in the elderly, particularly when renal function is impaired, because of the possibility of electrolyte imbalance.

4.3 Contraindications

Aprinox is contra-indicated in patients with known hypersensitivity to thiazides; refractory hypokalaemia, hyponatraemia, hyperca

1. Name Of The Medicinal Product

Adalat 10 mg soft capsules

2. Qualitative And Quantitative Composition

Each soft capsule contains 10 mg nifedipine.

For excipients see Section 6.1.

3. Pharmaceutical Form

Capsule, soft.

Orange, softgel capsule (6 minims, oblong) containing a yellow viscous fluid.

4. Clinical Particulars

4.1 Therapeutic Indications

For the prophylaxis of chronic stable angina pectoris, the treatment of Raynaud's phenomenon and essential hypertension.

For patients suffering from essential hypertension or chronic stable angina pectoris, and treated with fast release forms of nifedipine (Adalat capsules), a dose dependent increase in the risk of cardiovascular complications (e.g., myocardial infarction) and mortality may occur. Due to this, Adalat capsules should only be used for treatment of patients with essential hypertension or chronic stable angina pectoris if no other treatment is appropriate.

4.2 Posology And Method Of Administration

Method of administration

Oral use.

Adalat capsules should be swallowed whole with a little liquid, either with or without food.

Adalat capsules should not be taken with grapefruit juice (see Section 4.5).

Dosage regimen

The maximum total daily dose is 60 mg. The recommended starting dose is 5 mg every eight hours with subsequent titration of dose according to response permitting an increase to a maximum of 20 mg every eight hours.

Co-administration with CYP 3A4 inhibitors or CYP 3A4 inducers may result in the recommendation to adapt the nifedipine dose or not to use nifedipine at all (see Section

1. Name Of The Medicinal Product

Avelox 400 mg film-coated tablets

2. Qualitative And Quantitative Composition

Each film-coated tablet contains 400 mg moxifloxacin as hydrochloride.

Excipient: The film-coated tablet contains lactose monohydrate (see section 4.4).

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Film-coated tablet

Dull red tablets marked with “M400” on one side and “BAYER” on the reverse.

4. Clinical Particulars

4.1 Therapeutic Indications

Avelox 400 mg film-coated tablets are indicated for the treatment of the following bacterial infections in patients of 18 years and older (see section 4.4, 4.8 and 5.1):

- Acute bacterial sinusitis (ABS)

- Acute exacerbations of chronic bronchitis (AECB)

Moxifloxacin should be used to treat adequately diagnosed ABS and AECB only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of these infections or when these have failed to resolve the infection.

- Community acquired pneumonia, except severe cases

Moxifloxacin should be used only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of this infection.

- Mild to moderate pelvic inflammatory disease (i.e. infections of female upper genital tract, including salpingitis and endometritis), without an associated tubo-ovarian or pelvic abscess.

Avelox 400 mg film-coated tablets are not recommended for use in monotherapy of mild to moderate pelvic inflammatory disease but should be given in combination with another appropriate antibacterial agent (e.g. a cep

1. Name Of The Medicinal Product

Asmanex Twisthaler 200 micrograms Inhalation Powder

2. Qualitative And Quantitative Composition

Each delivered dose contains 200 micrograms mometasone furoate.

For excipients, see 6.1.

3. Pharmaceutical Form

Inhalation powder.

White to off-white powder agglomerates.

4. Clinical Particulars

4.1 Therapeutic Indications

Regular treatment to control persistent asthma.

4.2 Posology And Method Of Administration

This product is for inhalation use only.

For use in adult and adolescent patients 12 years of age and older.

Dosage recommendations are based on severity of asthma (see criteria below).

Patients with persistent mild to moderate asthma: The recommended starting dose for most of these patients is 400 micrograms once daily. Data suggest that better asthma control is achieved if once daily dosing is administered in the evening. Some patients may be more adequately controlled on 400 micrograms daily, given in two divided doses (200 micrograms twice daily).

The dose of Asmanex Twisthaler 200 micrograms Inhalation Powder should be individualised and titrated to the lowest dose at which effective control of asthma is maintained. Dose reduction to 200 micrograms once daily given in the evening may be an effective maintenance dose for some patients.

Patients with severe asthma: The recommended starting dose is 400 micrograms twice daily, which is the maximum recommended dose. When symptoms are controlled, titrate Asmanex Twisthaler 200 micrograms Inhalation Powder to the lowest effective dose.

In patients with severe asthma and previously receiving oral corticosteroids, Asmanex

1. Name Of The Medicinal Product

Arzip 250mg Capsules

2. Qualitative And Quantitative Composition

Each capsule contains 250 mg mycophenolate mofetil.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Capsules, hard.

Arzip 250 mg Capsules: light blue/peach, size '1' hard gelatin capsule imprinted with 'MMF' on cap and '250' on body.

4. Clinical Particulars

4.1 Therapeutic Indications

Arzip 250 mg Capsules are indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.

4.2 Posology And Method Of Administration

Treatment with Arzip 250 mg Capsules should be initiated and maintained by appropriately qualified transplant specialists.

Use in renal transplant:

Adults: oral Arzip 250 mg Capsules should be initiated within 72 hours following transplantation. The recommended dose in renal transplant patients is 1.0 g administered twice daily (2 g daily dose).

Children and adolescents (aged 2 to 18 years): the recommended dose of mycophenolate mofetil is 600 mg/m? administered orally twice daily (up to a maximum of 2 g daily). Arzip 250 mg Capsules should only be prescribed to patients with a body surface area of at least 1.25 m?. Patients with a body surface area of 1.25 to 1.5 m2 may be prescribed Arzip 250 mg Capsules at a dose of 750 mg twice daily (1.5g daily dose). Patients with a body surface area greater than 1.5m2 may be prescribed Arzip 250 mg Capsules at a do

1. Name Of The Medicinal Product

Adipine MR 10

Adipine MR 20

2. Qualitative And Quantitative Composition

One modified release tablet contains: 10mg of Nifedipine

One modified release tablet contains: 20mg of Nifedipine

3. Pharmaceutical Form

Modified release tablets for oral use.

Round, slightly biconvex, pink coated tablets with smooth surface.

4. Clinical Particulars

4.1 Therapeutic Indications

Hypertension

Prophylaxis of chronic stable angina pectoris

4.2 Posology And Method Of Administration

The treatment should be as individual as possible according to the seriousness of the disease and the responsiveness of the patient.

Dependent on the respective clinical picture stabilisation with reference to the final dose should be made slowly.

Nifedipine should be taken with a little water.

The recommended starting dose of nifedipine 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.

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

Nifedipine is metabolised primarily by the liver and therefore patients with liver dysfunction should be carefully monitored. Patients with renal impairment should not require adjustment of dosage.

Nifedipine is not recommended for use in children.

The simultaneous intake of food delays, but does not reduce overall absorption.

The intervals between the recommended individual maximal daily doses of nifedipine should be not

1. Name Of The Medicinal Product

ANUGESIC HC CREAM

2. Qualitative And Quantitative Composition

Each 100g of cream contains zinc oxide EP 12.35g, balsam peru EP 1.85g, benzyl benzoate EP 1.2g, pramocaine hydrochloride USP 1g, bismuth oxide 0.875g, hydrocortisone acetate EP 0.5g.

Excipients

Contains:

Propyl Hydroxybenzoate (E216) 0.11g

Methyl Hydroxybenzoate (E218) 0.01g

Propylene Glycol 8.0g

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

A smooth, homogeneous, buff coloured cream with the characteristic odour of balsam peru.

4. Clinical Particulars

4.1 Therapeutic Indications

Anugesic HC cream provides antiseptic, astringent, emollient and decongestant properties. In addition hydrocortisone exerts an anti-inflammatory effect. Pramocaine is a rapidly acting local anaesthetic. The cream may be used to provide lubrication for suppositories.

Anugesic HC cream is indicated for the comprehensive symptomatic treatment of severe and acute discomfort or pain associated with internal and external haemorrhoids and pruritus ani.

4.2 Posology And Method Of Administration

For topical use.

Adults:

Apply cream to the affected area at night, in the morning and after each evacuation. Thoroughly cleanse the affected area, dry and apply cream by gently smoothing onto the affected area. For internal conditions use rectal nozzle provided and clean it after each use.

Not to be taken orally.

Elderly (over 65 years):

As for adults.

1. Name Of The Medicinal Product

Amoxicillin Sodium for Injection BP 250mg

Amoxicillin Sodium for Injection BP 500mg

Amoxicillin Sodium for Injection BP 1g

2. Qualitative And Quantitative Composition

Sodium Amoxicillin equivalent to Amoxicillin Ph Eur 250mg

Sodium Amoxicillin equivalent to Amoxicillin Ph Eur 500mg

Sodium Amoxicillin equivalent to Amoxicillin Ph Eur 1g

3. Pharmaceutical Form

Powder for solution for injection.

4. Clinical Particulars

4.1 Therapeutic Indications

Amoxicillin is a broad-spectrum aminopenicillin and is indicated in the treatment of bacterial infections such as actinomycosis, biliary-tract infections, bone and joint infections, acute exacerbations of chronic bronchitis, gastroenteritis, (including Escherichia coli enteritis and Salmonella enteritis, but not shigellosis), gonorrhoea, mouth infections, sinusitis, otitis media, pneumonia (except where Mycoplasma suspected), typhoid and paratyphoid fever, urinary-tract infections, bacterial meningitis and the prophylaxis of endocarditis.

It is also used in the treatment of Lyme disease.

4.2 Posology And Method Of Administration

Treatment of Infections in Adults and the Elderly

By intramuscular injection:

500mg every eight hours.

By intravenous injection or infusion:

1. Name Of The Medicinal Product

Alphanate®, powder for injection.

2. Qualitative And Quantitative Composition

Alphanate® is a high purity solvent detergent and heat treated preparation of human coagulation factor VIII, freeze-dried, Ph. Eur. Alphanate® also contains human von Willebrand factor at pharmacologically effective levels.

Alphanate® is presented as a powder and solvent for solution for injection containing nominally 500 I.U., 1000 I.U. or 1500 I.U. human coagulation factor VIII per container. Alphanate® contains no less than 400 I.U. of von Willebrand factor activity per 1000 I.U. of factor VIII activity (i.e. VWF:RCo/FVIII:C ratio

Alphanate® 500 I.U. contains approximately 100 I.U./ml human coagulation factor VIII and no less than approximately 40 I.U./ml human von Willebrand factor activity when reconstituted with 5 ml sterile Water for Injections, Ph. Eur.

Alphanate® 1000 I.U. contains approximately 100 I.U./ml human coagulation factor VIII and no less than approximately 40 I.U./ml human von Willebrand factor activity when reconstituted with 10 ml sterile Water for Injections, Ph. Eur.

Alphanate® 1500 I.U. contains approximately 150 I.U./ml human coagulation factor VIII and no less than approximately 60 I.U./ml human von Willebrand factor activity when reconstituted with 10 ml sterile Water for Injections, Ph. Eur.

Each container is labelled with the number of International Units of factor VIII and von Willebrand factor activity.

The factor VIII potency is determined using the Activated Partial Thromboplastin Time method, which gives results comparable to the European Pharmacopoeia chromogenic assay, and a reference standard calibrated against the WHO International Standard

1. Name Of The Medicinal Product

Anacal Rectal Ointment

2. Qualitative And Quantitative Composition

Mucopolysaccharide polysulphuric acid ester (Heparinoid) 0.2%w/w Oxypolyethoxydodecane (Lauromacrogol 400) 5.0%w/w

3. Pharmaceutical Form

Rectal Ointment

4. Clinical Particulars

4.1 Therapeutic Indications

Anacal rectal ointment is indicated for the treatment of the following conditions:

Relief of symptoms associated with haemorrhoids (including perianal haematomas), perianal eczema, pruritus, anal fissure, proctitis, periproctitis, and aftercare of haemorrhoids treated by surgery or injection.

4.2 Posology And Method Of Administration

Adults and the elderly:

To be applied one to four times daily.

Children:

Not recommended.

4.3 Contraindications

Known sensitivity to any active or inactive component of the formulation.

Not recommended for use in children.

4.4 Special Warnings And Precautions For Use

Not to be taken orally. If symptoms persist or worsen, seek medical advice.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

There is no evidence to suggest that Anacal Rectal Ointment should not be used during pregnancy and lactation.

4.7 Effects On Ability To Drive And Use Machines

None.

4.8 Undesirable Effects

None known.

4.9 Overdose

In the absence of any reports of the accidental ingestion of Anacal, no specific advice is available. General supportive m

1. Name Of The Medicinal Product

ANUSOL PLUS HC OINTMENT

2. Qualitative And Quantitative Composition

Each 100 g of ointment contains the following active ingredients:-

Hydrocortisone acetate 0.25 g

Benzyl benzoate 1.25 g

Bismuth subgallate 2.25 g

Bismuth oxide 0.875 g

Balsam peru 1.875 g

Zinc oxide 10.75 g

For excipients, see 6.1

3. Pharmaceutical Form

Ointment.

4. Clinical Particulars

4.1 Therapeutic Indications

Symptomatic treatment of internal and external haemorrhoids and pruritus ani.

4.2 Posology And Method Of Administration

Topical administration.

ADULTS (over 18 years)

To be applied sparingly to the affected area at night, in the morning and after each evacuation up to a maximum of 4 applications a day. Thoroughly cleanse the affected area, dry and apply ointment on a gauze dressing. For internal conditions use rectal nozzle provided. Remove the nozzle cap. Clean the nozzle after each use. Use for a maximum period of one week.

ELDERLY (over 65 years)

As for adults

CHILDREN (under 18 years)

Not recommended.

4.3 Contraindications

Tubercular, fungal and most viral lesions including herpes simplex, vaccinia and varicella. History of sensitivity to any of the constituents.

4.4 Special Warnings And Precautions For Use

As with all products containing topical steroids, the possibility of systemic absorption should be borne in mind.

Prolonged or excessive use may produce systemic corticosteroid effects and use for periods l

1. Name Of The Medicinal Product

Ancotil 2.5 g/250 ml Solution for Infusion.

2. Qualitative And Quantitative Composition

Flucytosine Ph. Eur. 2.5 g in 250 ml.

3. Pharmaceutical Form

Infusion bottles containing 2.5 g flucytosine Ph. Eur. in 250 ml isotonic sodium chloride solution.

4. Clinical Particulars

4.1 Therapeutic Indications

Ancotil is indicated for the treatment of systemic yeast and fungal infections due to sensitive organisms: such infections include cryptococcosis, candidiasis, chromomycosis and infections due to torulopsis glabrata and hansenula.

In the treatment of cryptococcal meningitis and severe systemic candidiasis it is recommended that Ancotil should be given in combination with amphotericin-B. Amphotericin-B may also be given in combination with Ancotil in severe or long-standing infections due to other organisms. In cases of cryptococcal meningitis, where toxicity of amphotericin B, or a combination of flucytosine with amphotericin B is dose limiting, a combination of flucytosine with fluconazole has demonstrated successful cure, but at a lower rate than in combination with amphotericin B.

4.2 Posology And Method Of Administration

Adults and Children

Ancotil for Infusion should be administered using a giving set. It may be administered directly into a vein, through a central venous catheter, or by intra-peritoneal infusion. The recommended daily dosage in adults and children is 200 mg/kg body-weight divided into four doses over the 24 hours. In patients harboring extremely sensitive organisms a total daily dose of 100 to 150 mg/kg body-weight may be sufficient. Adequate effects can, however, often be obtained with a lower dose.