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Telfast 180 mg

Film coated tablets

Fexofenadine 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 serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

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

What Fexofenadine Is And What It Is Used For

The name of this medicine is Telfast 180mg Film Coated Tablets, referred to as Fexofenadine throughout this leaflet.

Fexofenadine is an antihistamine.

Fexofenadine is used in adults and adolescents of 12 years and older to relieve the symptoms that occur with long term allergic skin reactions (chronic idiopathic urticaria) such as itching, swelling and rashes.

Before You Take Fexofenadine

Do not take fexofenadine

  • if you are allergic (hypersensitive) to fexofenadine or any of the other ingredients (see section 6

1. Name Of The Medicinal Product

Famciclovir 250 mg film-coated tablets

2. Qualitative And Quantitative Composition

Each Famciclovir 250 mg tablet contains 250 mg of famciclovir.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Film-coated tablet.

250 mg film-coated tablets: white, round, biconvex, film-coated tablets, scored on one side with diameter of 10.6 mm approximately.

Famciclovir 250 mg, 500 mg film-coated tablets:

The tablet can be divided into equal halves.Use lower dosage strength tablets, where these are available.

4. Clinical Particulars

4.1 Therapeutic Indications

- Treatment of genital herpes infections (initial and recurrent epidoses) in immunocompetent patients.

- Suppression of recurrent genital herpes infections in immunocompetent patients.

- Treatment of herpes zoster infections of the skin and mucous membranes in immunocompetent patients in whom a severe course of infection is anticipated,including herpes zoster ophthalmicus.

- Treatment of herpes zoster and herpes simplex infections in immunocompromised patients.

4.2 Posology And Method Of Administration

Adults

First-episode genital herpes infections:

250 mg three times daily for 5 days

The first dose should be taken as soon as possible after the onset of the infection.

Recurrent genital herpes infections:

250 mg twice daily for 5 days

Initiation of treatment is recommended during the prodromal period or as soon as possible after th

Famciclovir 125mg, 250mg, 500mg, 750mg film-coated tablets

Read all of this leaflet carefully before you start using 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 serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

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

What Famciclovir Is And What It Is Used For

Famciclovir belongs to a group of medicines called antiviral agents. These are medicines used in the treatment of infections caused by viruses.

Famciclovir is used in patients with a normal immune system to treat attacks of genital herpes. Genital herpes is a viral infection which is normally spread by sexual contact. It causes blisters and burning around your genitals, which may be painful.

It is also sometimes used to prevent further episodes of genital herpes in patients with a normal immune system.

Famciclovir is used in the treatment of shingles in both patients with a normal immune system and in patients with a weakened immune system. Shingles is caused by a virus called herpes zost

1. Name Of The Medicinal Product

Furosemide Tablets 40mg.

2. Qualitative And Quantitative Composition

Furosemide BP 40.0mg.

3. Pharmaceutical Form

Tablet.

4. Clinical Particulars

4.1 Therapeutic Indications

The treatment of fluid retention associated with heart failure, including left ventricular failure, cirrhosis of the liver and renal disease including nephrotic syndrome.

The treatment of mild to moderate hypertension when brisk diuretic response is required. Alone or in combination with other antihypertensive agents in the treatment of more severe cases.

4.2 Posology And Method Of Administration

For oral administration.

Adults

The initial adult dose is 40mg daily, reduced to 20mg daily or 40mg on alternate days. In some patients daily doses of 80mg or higher (given in divided doses) may be required.

Children

The usual dose is 1-3 mg/kg body weight daily up to a maximum dose of 40mg/day.

Elderly

Caution is advised as furosemide is excreted more slowly in the elderly. Treatment should be started with 20mg and titrated upwards as required.

4.3 Contraindications

Furosemide is contraindicated in the presence of anuria, electrolyte deficiency, precoma associated with hepatic cirrhosis, digitalis intoxication, porphyria and hypersensitivity to furosemide or sulphonamides.

4.4 Special Warnings And Precautions For Use

Furosemide should be discontinued before a glucose tolerance test.

Furosemide should be used with particular caution in elderly p

1. Name Of The Medicinal Product

Furosemide 20mg Tablets.

2. Qualitative And Quantitative Composition

Each tablet contains 20mg furosemide.

For excipients, see 6.1

3. Pharmaceutical Form

Tablet.

Appearance: A white, circular, flat bevelled edge tablet with 'F' scoreline 20' embossed on one face and plain on the reverse.

4. Clinical Particulars

4.1 Therapeutic Indications

In the treatment of oedema associated with congestive heart failure, cirrhosis of the liver, renal disease including nephrotic syndrome.

In the treatment of peripheral oedema due to mild to moderate hypertension (alone, or in combination with other antihypertensive agents in the treatment of more severe cases).

Management of oliguria due to acute or chronic renal insufficiency.

4.2 Posology And Method Of Administration

Adults: The usual initial daily dose is 40mg. This may require adjustment until the effective dose is achieved. In mild cases 20mg daily or 40mg on alternate days may be sufficient, whereas in cases of resistant oedema daily doses of 80mg and above may be used.

In patients with chronic renal insufficiency, an initial daily dose of 250mg is employed. If a satisfactory diuresis is not produced then the dose may be increased in steps of 250mg at four to six hourly intervals up to a maximum daily dose of 1,500 mg in 24 hours. In exceptional cases up to 2,000 mg in 24 hours may be given.

Children: The oral dose for children ranges from 1-3mg/kg body weight daily, up to a maximum total dose of 40mg per day.

Elderly: The usual adult dose, but caution is advised as furosemide is excreted more slowly in the elderly.

Method of administration:

1. Name Of The Medicinal Product

Fersaday 100mg Tablets

2. Qualitative And Quantitative Composition

Each tablet contains 322.0mg Ferrous Fumarate BP

3. Pharmaceutical Form

Film-coated Tablets

4. Clinical Particulars

4.1 Therapeutic Indications

Prophylaxis and treatment of iron deficiency states.

4.2 Posology And Method Of Administration

Adults and the elderly: One tablet daily (the foil enclosing the tablet is printed with days of the week in sequence).

In severe or refractory iron deficiency, one tablet may be given twice a day.

Children: Fersaday tablets are not intended for the treatment of children.

Method of administration: Oral

4.3 Contraindications

Known hypersensitivity to any of the ingredients of the product.

Paroxysmal nocturnal haemoglobinuria, haemosiderosis, haemochromatosis, active peptic ulcer, repeated blood transfusions, regional enteritis, and ulcerative colitis. Ferasday tablets must not be used in anaemias other than those due to iron deficiency.

4.4 Special Warnings And Precautions For Use

Some post gastrectomy patients show poor absorption of iron. Care is needed when treating patients with iron deficiency anaemia in patients with treated or controlled peptic ulceration. Duration of treatment of uncomplicated iron deficiency anaemia should not usually exceed 6 months (or 3 months after reversal of the anaemia has been achieved).

Since anaemia due to combined iron and vitamin B12 or folate deficiencies may be microcytic in type, p

1. Name Of The Medicinal Product

Famciclovir 125 mg film-coated tablets

2. Qualitative And Quantitative Composition

Each Famciclovir 125 mg tablet contains 125 mg of famciclovir.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Film-coated tablet.

125 mg film-coated tablets: white, round, biconvex, film-coated tablets with diameter of 7.6 mm approximately.

4. Clinical Particulars

4.1 Therapeutic Indications

- Treatment of genital herpes infections (initial and recurrent epidoses) in immunocompetent patients.

- Suppression of recurrent genital herpes infections in immunocompetent patients.

- Treatment of herpes zoster infections of the skin and mucous membranes in immunocompetent patients in whom a severe course of infection is anticipated,including herpes zoster ophthalmicus.

- Treatment of herpes zoster and herpes simplex infections in immunocompromised patients.

4.2 Posology And Method Of Administration

Adults

First-episode genital herpes infections:

250 mg three times daily for 5 days

The first dose should be taken as soon as possible after the onset of the infection.

Recurrent genital herpes infections:

250 mg twice daily for 5 days

Initiation of treatment is recommended during the prodromal period or as soon as possible after the onset of lesions.

Suppression of genital herpes infections in immunocompetent patients:

250 mg twice daily. The duration of treatment depends on th

1. Name Of The Medicinal Product

Benzoin Tincture Compound BP or Friars Balsam BP

2. Qualitative And Quantitative Composition

Storax prepared BP 10.0% w/v

Benzoin sumatra crushed BP 10.0% w/v

3. Pharmaceutical Form

Tincture

4. Clinical Particulars

4.1 Therapeutic Indications

1. As an inhalant for relief of the symptoms of colds.

2. As a mild antiseptic dressing.

4.2 Posology And Method Of Administration

1. Through the mouth and nasal passages.

2. Topical.

1. As an inhalant

Adults, children over 3 months of age and the elderly: Add one 5ml spoonful to a pint of hot, but not boiling water.

The dose may be repeated after 4 hours if required.

The product is suitable for use under this clinical indication by adults, children over 3 months and the elderly.

Not suitable for children under 3 months of age.

2. As an antiseptic

Adults, children and the elderly: Apply undiluted to the affected area twice daily. The product is suitable for use under this clinical indication by adults, children and the elderly.

4.3 Contraindications

Contraindicated in patients with known sensitivity to sumatra benzoin or storax.

4.4 Special Warnings And Precautions For Use

Not suitable for children under 3 months when used as an inhalant.

For external use only.

Keep all medicines away from children.

Caution: Highly flammable. Keep away from a naked flame.

4.5 Interaction With O

1. Name Of The Medicinal Product

Fortipine LA 40mg Modified-Release Tablets

2. Qualitative And Quantitative Composition

Active Ingredient

Nifedipine (international non-proprietary name): 40mg chemical name: Dimethyl 1, 4 dihydro-2, 6-dimethyl-6 (2-nitrophenyl) pyridine-3, 5-dicarboxylate.

3. Pharmaceutical Form

Modified release tablets (matrix tablets) for oral administration.

4. Clinical Particulars

4.1 Therapeutic Indications

For the prophylaxis of chronic stable angina pectoris and the treatment of mild to moderate hypertension.

4.2 Posology And Method Of Administration

Adults:

Patients should be treated individually depending on the severity of the disease and the therapeutic response. Nifedipine should not be taken with Grapefruit juice (see Section 4.5).

The following recommendations for dosing in adults and adolescents over 14 years are applicable:

In general, one modified release tablet of FORTIPINE LA 40 (40mg) once daily should be adequate. If necessary this dose can be increased to 80 mg given once daily, or 40 mg twice daily.

The modified release tablets are to be taken after meals, e.g. breakfast. The modified release tablets should be swallowed whole with half a glass of water and must not be broken or chewed.

In patients with renal dysfunction, a slight alteration of the pharmacokinetics of nifedipine may be seen. However, dose adjustment in these patients is not usually required.

In patients with liver cirrhosis and chronic liver failure, significant alterations of the pharmacokinetics of nifedipine is usually seen. These patients should usually be caref

1. Name Of The Medicinal Product

Flebogamma® 5%.

Solution for infusion.

2. Qualitative And Quantitative Composition

Human normal immunoglobulin (IVIg)

The percentage of IgG subclasses is approximately 68.7% IgG1, 25.9% IgG2, 3.7% IgG3 and 1.78% IgG4.

Human protein content is 50 g/l of which at least 97% is IgG.

IgA content is lower than 0.05 mg/ml.

For excipients, see 6.1.

3. Pharmaceutical Form

Solution for infusion

4. Clinical Particulars

4.1 Therapeutic Indications

Flebogamma® 5% is indicated for:

Replacement therapy in:

Primary immunodeficiency syndromes such as:

- congenital agammaglobulinaemia and hypogammaglobulinaemia

- common variable immunodeficiency

- severe combined immunodeficiency

- Wiskott Aldrich syndrome

Myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections.

Children with congenital AIDS and recurrent infections.

Immunomodulation

Idiopathic thrombocytopenic purpura (ITP), in children or adults at high risk of bleeding or prior to surgery to correct the platelet count.

Guillain Barr? Syndrome.

Kawasaki disease.

Allogeneic bone marrow transplantation.

4.2 Posology And Method Of Administration

4.2.1. Posology

The dose and dosage regimen is dependent on the indication.

In repla

1. Name Of The Medicinal Product

Fenactol Retard 100mg

(own label name for distributor Whatdrug T/A Discovery Pharmaceuticals)

2. Qualitative And Quantitative Composition

Diclofenac sodium 100 mg

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Prolonged-release tablet.

Pink, round, biconvex tablet, marked "DICL100" on one face.

4. Clinical Particulars

4.1 Therapeutic Indications

Adults and elderly

Relief of all grades of pain and inflammation in a wide range of conditions, including:

i) arthritic conditions: rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute gout,

ii) acute musculo-skeletal disorders such as periarthritis (for example frozen shoulder), tendinitis, tenosynovitis, bursitis,

iii) other painful conditions resulting from trauma, including fracture, low back pain, sprains, strains, dislocations, orthopaedic, dental and other minor surgery.

Children

Diclofenac Sodim tablets 100mg prolonged-release tablets are not suitable for children.

4.2 Posology And Method Of Administration

For oral administration.

To be taken whole with liquid, preferably with or after food.

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4).

Adults: One 100 mg diclofenac sodium prolonged-release tablet daily. If necessary, the daily dosage can be increased to 150 mg by supplementation with the conventional dosage forms containing diclofenac sodium 25

1. Name Of The Medicinal Product

Furosemide 10mg/ml Solution for Injection or Infusion

2. Qualitative And Quantitative Composition

Each ml contains 10mg of furosemide.

Each 2ml ampoule contains 20mg of furosemide.

Each 25ml vial contains 250mg of furosemide.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Solution for injection or infusion

The solution is colourless or almost colourless.

4. Clinical Particulars

4.1 Therapeutic Indications

Furosemide 10mg/ml Injection is a diuretic indicated for use when a prompt and effective diuresis is required. The intravenous formulation is appropriate for use in emergencies or when oral therapy is precluded. Indications include cardiac, pulmonary, hepatic and renal oedema.

4.2 Posology And Method Of Administration

Route of administration: intramuscular or intravenous use.

Adults

Intravenous furosemide must be injected or infused slowly; a rate of 4 mg per minute must not be exceeded. In patients with severe impairment of renal function (serum creatinine>5 mg/dl), it is recommended that an infusion rate of 2.5 mg per minute is not exceeded.

Intramuscular administration must be restricted to exceptional cases where neither oral nor intravenous administration are feasible. It must be noted that intramuscular injection is not suitable for the treatment of acute conditions such as pulmonary oedema.

To achieve optimum efficacy and suppress counter-regulation, a continuous furosemide infusion is generally to be preferred to repeated bolus injections. Where continuous furosemide infusion is not feasible for follow-up treatment afte

FOLIC ACID 5MG TABLETS

Please read this leaflet carefully before you start to take this medicine. It gives an outline of the more important things you should know. If you want to know more about this medicine, or you are not sure about anything, ask your doctor or pharmacist. You should keep this leaflet throughout your course of treatment.

The Name Of Your Medicine Is Folic Acid 5Mg Tablets

Folic Acid 5mg Tablets contain the active ingredient folic acid. The tablet comes in one strength, 5mg.

Other ingredients in your tablet are lactose, maize starch, acacia spray-dried, magnesium stearate and stearic acid.

Folic Acid 5mg Tablets are plain yellow, biconvex tablets with breakline on one face and CP on the reverse.

Folic Acid 5mg Tablets are available in polypropylene or polyethylene tablet containers containing 100, 500 or 1000 tablets, glass bottles containing 100, 500 or 1000 tablets and blister packs containing 28 tablets.

Marketing Authorisation Holder:

Wockhardt UK Limited
Ash Road North
Wrexham
LL13 9UF
UK

Manufacturer:

CP Pharmaceuticals Limited
Ash Road North
Wrexham
LL13 9UF
UK

How Does Your Medicine Work?

Folic acid is a vitamin used to prevent or treat a deficiency (lack) of folic acid in the body.

1. Name Of The Medicinal Product

Fucidin® Cream

2. Qualitative And Quantitative Composition

Fucidin® Cream contains fusidic acid Ph.Eur. 2%.

Excipient: butylhydroxyanisole

Excipient: cetyl alcohol

Excipient: potassium sorbate

For full list of excipients, see section 6.1

3. Pharmaceutical Form

Cream for topical administration

4. Clinical Particulars

4.1 Therapeutic Indications

Indicated either alone or in combination with systemic therapy, in the treatment of primary and secondary skin infections caused by sensitive strains of Staphylococcus aureus, Streptococcus spp and Corynebacterium minutissimum. Primary skin infections that may be expected to respond to treatment with fusidic acid applied topically include: impetigo contagiosa, superficial folliculitis, sycosis barbae, paronychia and erythrasma; also such secondary skin infections as infected eczematoid dermatitis, infected contact dermatitis and infected cuts / abrasions.

4.2 Posology And Method Of Administration

Adults and Children:

Uncovered lesions - apply gently three or four times daily.

Covered lesions - less frequent applications may be adequate.

4.3 Contraindications

Known hypersensitivity to fusidic acid/sodium fusidate or to any of the excipients

Infection caused by non-susceptible organisms, in particular, Pseudomonas aeruginosa.

4.4 Special Warnings And Precautions For Use

Bacterial resistance has been reported to occur with the use of fusidic acid. As with all antibiotics, extended or recurrent use may increase the risk of developing antibiotic resistance.

1. Name Of The Medicinal Product

FlixotideTM DiskhalerTM250 Micrograms

2. Qualitative And Quantitative Composition

Fluticasone Propionate (micronised) 250 micrograms

3. Pharmaceutical Form

Inhalation Powder.

4. Clinical Particulars

4.1 Therapeutic Indications

Fluticasone propionate given by inhalation offers preventative treatment for asthma. At recommended doses it has a potent glucocorticoid anti-inflammatory action within the lungs, with a lower incidence and severity of adverse effects than those observed when corticosteroids are administered systemically.

Prophylactic management in:-

Adults

Mild asthma:

Patients requiring intermittent symptomatic bronchodilator asthma medication on a regular daily basis.

Moderate asthma:

Patients with unstable or worsening asthma despite prophylactic therapy or bronchodilator alone.

Severe asthma:

Patients with severe chronic asthma and those who are dependent on systemic corticosteroids for adequate control of symptoms. On introduction of inhaled fluticasone propionate many of these patients may be able to reduce significantly, or to eliminate, their requirement for oral corticosteroids.

Route of administration: by inhalation.

4.2 Posology And Method Of Administration

The onset of therapeutic effect is within 4 to 7 days.

Adults and children over 16 years: 100 to 1,000 micrograms twice daily.

Patients should be given a starting dose of inhaled fluticasone propionate, which is approp

1. Name Of The Medicinal Product

Fluorouracil Injection, 50 mg / ml, solution for injection

2. Qualitative And Quantitative Composition

One vial of Fluorouracil Injection contains:

500 mg fluorouracil in 10 ml solution (50 mg/ml)

1000 mg fluorouracil in 20 ml solution (50 mg/ml)

2500 mg fluorouracil in 50 ml solution (50 mg/ml)

5000 mg fluorouracil in 100 ml solution (50 mg/ml)

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Solution for injection

Fluorouracil Injection, 50 mg / ml, solution for injection is a clear, colourless or almost colourless solution.

4. Clinical Particulars

4.1 Therapeutic Indications

Fluorouracil Injection, 50 mg/ml, solution for injection, may be used alone or in combination, for its palliative action in the management of common malignancies particularly cancer of the colon and breast, either as single agent or in combination with other cytotoxic agents.

4.2 Posology And Method Of Administration

Routes of administration:

Fluorouracil Injection can be given by intravenous injection or intravenous or intra-arterial infusion.

Adults:

Selection of an appropriate dose and treatment regime depends upon the condition of the patient, the type of carcinoma being treated and whether fluorouracil is to be administered alone or in combination with other therapy. Initial treatment should be given in hospital and the total daily dose should not exceed 1 gram. It is customary to calculate the dose in accordance with the patient's actual bodyweight unless there is obesity, oedema or some other form of abnormal fl

Flixonase

Aqueous Nasal Spray

fluticasone propionate

50 micrograms

Read all of this leaflet carefully before you start using 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 serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

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

What Flixonase Aqueous Nasal Spray is and what it is used for

Flixonase Aqueous Nasal Spray (called ‘Flixonase’ in this leaflet) contains a medicine called fluticasone propionate. This belongs to a group of medicines called steroids (also called ‘cortico-steroids’).

  • Steroids work by reducing inflammation.
  • They reduce swelling and irritation in your nose.
  • This helps to relieve itching, sneezing and your blocked or runny nose.

Flixonase is used to prevent and treat:

  • Inflammation in the lining of your nose (rhinitis) due to seasonal allergies, such as Hayfever.
  • Inflammation in the lining of your nose (rhinitis) due to year round (perennial) allergies, such as animal al

Fareston 60 mg tablets

Toremifene

Read all of this leaflet carefully before you start using 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 serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

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

What Fareston Is And What It Is Used For

Fareston contains the active substance toremifene, an anti-estrogen. Fareston is used for the treatment of a certain type of breast tumour in women who have had their menopause.

Before You Take Fareston

Do not take Fareston

  • if you are allergic (hypersensitive) to toremifene or any of the other ingredients of Fareston
  • if you have a thickening of the womb lining
  • if you have severe liver problems.
  • if your were born with or have had any condition with certain abnormal electrocardiogram (ECG, electrical recording of the heart changes,
  • have salt imbalance in the blood, especially low concentrations of potassium in the blood (hypokalaemia) which are currently not corrected by treatment,
  • have a very slow heart rate (brad

1. Name Of The Medicinal Product

Furadantin® tablets 50mg.

Nitrofurantoin 50mg tablets

2. Qualitative And Quantitative Composition

Furadantin tablets contain 50mg Nitrofurantoin Ph Eur.

3. Pharmaceutical Form

Furadantin tablets are yellow and pentagonal. Each tablet has a break line on one face and the tablet strength on the opposite face.

4. Clinical Particulars

4.1 Therapeutic Indications

For the treatment of and prophylaxis against acute or recurrent, uncomplicated lower urinary tract infections or pyelitis either spontaneous or following surgical procedures.

Nitrofurantoin is specifically indicated for the treatment of infections due to susceptible strains of Escherichia coli, Enterococci, Staphylococci, Citrobacter, Klebsiella and Enterobacter.

4.2 Posology And Method Of Administration

Dosage:

Adults

Acute Uncomplicated Urinary Tract Infections: 50mg four times daily for seven days

Severe Chronic Recurrence: 100mg four times day for seven days

Long Term Suppression: 50mg - 100mg once a day.

Pophylaxis: 50mg four times daily for the duration of procedure and 3 days thereafter.

Children and Infants over three months of age

Acute Urinary Tract Infections: 3mg/kg/day in four divided doses for seven days.

Suppressive: 1mg/kg, once a day.

For children under 25kg body weight consideration should be given to the use of Furadantin® Suspension.

Elderly

Provided there is no significant renal i

1. Name Of The Medicinal Product

Fluvastatin 20 mg and 40mg Capsules

2. Qualitative And Quantitative Composition

Each 20mg capsule contains 21.06 mg fluvastatin sodium corresponding to 20 mg fluvastatin.

Each 40mg capsule contains 42.12 mg fluvastatin sodium corresponding to 40 mg fluvastatin.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Capsule, hard

Brown coloured capsule containing off-white to pale-yellow powder.

4. Clinical Particulars

4.1 Therapeutic Indications

Fluvastatin is indicated as an adjunct to diet for the reduction of elevated total cholesterol (total-C) and low-density lipoprotein cholesterol (LDL-C) when response to diet and other non- pharmacological treatments (e.g. exercise, weight reduction) is inadequate in adults with primary hypercholesterolaemia (heterozygous variant) and mixed dyslipidaemia (Fredrickson Types IIa and IIb).

Fluvastatin is also indicated for the secondary prevention of major adverse cardiac events (cardiac death, non-fatal myocardial infarction and coronary revascularisation) in patients with coronary heart disease after coronary transcatheter therapy.

4.2 Posology And Method Of Administration

Prior to initiating treatment with fluvastatin, the patient should be placed on a standard cholesterol-lowering diet, which should be continued during treatment.

The recommended starting dose is 20 mg or 40 mg once daily. A dose of 20 mg once daily may be adequate in mild cases. Most patients will require a dose of 20 mg to 40 mg once daily but the dose may be increased to 80 mg daily (1 capsule fluvastatin 40 mg twice daily), individualized according to the baseline LDL-cholesterol (LDL-C) levels and the r