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1. Name Of The Medicinal Product

Vedrop 50 mg/ml oral solution

2. Qualitative And Quantitative Composition

Each ml contains 50 mg of d-alpha-tocopherol, in the form of tocofersolan, corresponding to 74.5 IU of tocopherol.

Excipients:

Each ml contains 3 mg sodium methyl parahydroxybenzoate (E219), 0.90 mg sodium propyl parahydroxybenzoate (E217), 0.03 mmoles of potassium and 0.14 mmoles of sodium.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Oral solution.

Slightly viscous, pale yellow solution.

4. Clinical Particulars

4.1 Therapeutic Indications

Vedrop is indicated in vitamin E deficiency due to digestive malabsorption in paediatric patients suffering from congenital chronic cholestasis or hereditary chronic cholestasis, from birth (in term newborns) to 16 or 18 years of age, depending on the region.

4.2 Posology And Method Of Administration

The treatment with Vedrop should be initiated and supervised by a physician experienced in the management of patients suffering from congenital chronic cholestasis or hereditary chronic cholestasis.

Bioavailability of vitamin E from Vedrop differs from that of other medicinal products. The dose should be prescribed in mg of d-alpha-tocopherol in the form of tocofersolan. Plasma vitamin E level should be monitored monthly for at least the first few months of therapy, thereafter at regular intervals and the dose adjusted accordingly if necessary.

Posology

The recommended total daily dose in paediatric patients suffering from congenital chronic cholestasis or hereditary chronic cholestasis is 0.34 ml/k

1. Name Of The Medicinal Product

Vividrin Nasal Spray

2. Qualitative And Quantitative Composition

Active

Sodium cromoglycate EP 2.00% w/v.

3. Pharmaceutical Form

Nasal spray.

4. Clinical Particulars

4.1 Therapeutic Indications

For the prevention and relief of seasonal and perennial allergic rhinitis.

4.2 Posology And Method Of Administration

Route of Administration

For intra-nasal use.

Adults, Children and the Elderly

One spray into each nostril four to six times daily.

Note: Due to the prophylactic nature of sodium cromoglycate the patient should be encouraged to continue use even when symptoms have ceased.

4.3 Contraindications

Known hypersensitivity to benzalkonium chloride, sodium cromoglycate or other constituents.

4.4 Special Warnings And Precautions For Use

Addition of Vividrin Nasal spray to existing sodium cromoglycate or steroid controlled asthma therapy may exaggerate the effects of that therapy.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

It may be possible to reduce concomitant antihistamine therapy.

4.6 Pregnancy And Lactation

Use in Pregnancy: Vividrin Nasal Spray should be used cautiously during pregnancy and lactation. The widespread use of sodium cromoglycate has yet to reveal any adverse effects to mother or child during pregnancy.

Use in Lactation: It is not known whether sodium cromoglycat

1. Name Of The Medicinal Product

Vallergan tablets 10mg

2. Qualitative And Quantitative Composition

Alimemazine tartrate 10mg

3. Pharmaceutical Form

Circular, film coated biconvex tablet with bevelled edge, dark blue in colour, one face impressed V/10. The reverse side is plain

4. Clinical Particulars

4.1 Therapeutic Indications

Vallergan has a central sedative effect comparable to that of chlorpromazine but largely devoid of the latter's anti adrenaline action. It has powerful antihistamine and anti-emetic actions. In the management of urticaria and pruritus.

In pre-medication as a sedative before anaesthesia in children aged between 2 to 7 years.

4.2 Posology And Method Of Administration

The product is administered orally

Not recommended for infants less than 2 years old.

Urticaria and pruritus

Adults: 10mg two or three times daily; up to 100mg per day have been used in intractable cases.

Elderly: Dosage should be reduced to 10mg once or twice daily.

Children over2 years of age: The use of Vallergan Syrup is recommended.

As a sedative before anaesthesia

The dosage for children is best achieved by use of Vallergan Syrup.

4.3 Contraindications

Vallergan should be avoided in patients with hepatic or renal dysfunction, epilepsy, Parkinson's disease, hypothyroidism, phaeochromocytoma, myasthenia gravis, prostatic hypertrophy. It should be avoided in patients known to be hypersensitive to phenothiazines or to any of the excipients or with history of narrow angle glaucoma.

VOLTAROL Rapid Tablets 25 and 50 mg

(diclofenac potassium)

What you need to know about Voltarol Rapid Tablets

Your doctor has decided that you need this medicine to help treat your condition.

Please read this leaflet carefully before you start to take your medicine. It contains important information. Keep the leaflet in a safe place because you may want to read it again.

If you have any other questions, or if there is something you don’t understand, please ask your doctor or pharmacist.

This medicine has been prescribed for you. Never give it to someone else. It may not be the right medicine for them even if their symptoms seem to be 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 Voltarol Rapid Tablets are, and what they are used for
  • 2. Things to consider before you start to take Voltarol Rapid Tablets
  • 3. How to take Voltarol Rapid Tablets
  • 4. Possible side effects
  • 5. How to store Voltarol Rapid Tablets
  • 6. Further information

What Voltarol Rapid Tablets are and what they are used for

Diclofenac potassium, the active ingredient in Voltarol Rapid Tablets, is one of a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs reduce pain and inflammation.

Voltarol Rapid Tablets relieve pain, reduce swelling and ease inflammation in:

  • Rheumatoid arthritis, osteoarthrosis, acute gout, low back pain, ankylosing spondylitis
  • Migraine
  • Conditions affecting the jo

1. Name Of The Medicinal Product

VIAZEM XL

2. Qualitative And Quantitative Composition

Diltiazem hydrochloride: 180 mg capsule.

For excipients, see section 6.1

3. Pharmaceutical Form

Prolonged release capsule, hard.

White and blue-green opaque capsules. Each capsule is printed on the cap and body, in black ink, with Viazem XL 180.

4. Clinical Particulars

4.1 Therapeutic Indications

VIAZEM XL is indicated for the management of stable angina pectoris and the treatment of mild to moderate hypertension.

4.2 Posology And Method Of Administration

Dosage requirements may differ between patients with angina and patients with hypertension. In addition individual patients response may vary, necessitating careful titration. The range of strengths facilitates titration to the optimal dose.

One capsule of VIAZEM XL is to be taken before or during a meal. The dose should be taken at approximately the same time each day.

The capsule should not be chewed but swallowed whole, with a glass of water.

Due to the variability of release profile in individual patients, when changing from one type of sustained release diltiazem preparation to another, it may be necessary to adjust the dose.

Adults:

Hypertension: The usual starting dose is 180 mg once daily. The dose may be increased after 2-4 weeks according to the patient's response and the usual maintenance dose is 240mg-360mg once daily. The maximum daily dose is 360 mg. However, the single daily doses of 300 mg and 360 mg should only be administered to patients when no satisfactory therapeutic effect has been effected

1. Name Of The Medicinal Product

VentolinTM Respirator Solution.

2. Qualitative And Quantitative Composition

Aqueous, colourless to light yellow solution, pH 3.5, providing 5mg/ml of salbutamol (as Salbutamol Sulphate BP).

3. Pharmaceutical Form

Solution for nebulisation.

4. Clinical Particulars

4.1 Therapeutic Indications

Ventolin Respirator Solution is indicated for use in the routine management of chronic bronchospasm unresponsive to conventional therapy, and in the treatment of acute severe asthma.

4.2 Posology And Method Of Administration

Ventolin Respirator Solution is for inhalation use only, to be breathed in through the mouth, under the direction of a physician, using a suitable nebuliser. The solution should not be injected or swallowed. Ventolin Respirator Solution may be administered intermittently or continuously. Salbutamol has a duration of action of 4 to 6 hours in most patients.

Intermittent administration

Adults: Ventolin Respirator solution 0.5ml (2.5mg of salbutamol) should be diluted to a final volume of 2ml with sterile normal saline. This may be increased to 1ml (5mg of salbutamol) diluted to a final volume of 2.5ml. The resulting solution is inhaled from a suitably driven nebuliser until aerosol generation ceases. Using a correctly matched nebuliser and driving source this should take about ten minutes.

Ventolin Respirator Solution may be used undiluted for intermittent administration. For this, 2ml of Ventolin Respirator Solution (10mg of salbutamol) is placed in the nebuliser and the patient allowed to inhale the nebulised solution until bronchodilatation is achieved. This usually takes 3 - 5 minutes. Some adult patients may req

Ventolin Evohaler

100 micrograms

salbutamol sulphate

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

In this leaflet:

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

What Ventolin Evohaler is and what it is used for

Ventolin Evohaler contains a medicine called salbutamol. This belongs to a group of medicines called bronchodilators.

  • Bronchodilators help the airways in your lungs to stay open.
    This makes it easier for air to get in and out.
  • They help to relieve chest tightness, wheezing and cough.

Ventolin Evohaler is used to treat breathing problems in people with asthma and similar conditions. This includes relieving and preventing asthma brought on by exercise or other “triggers”. These are things, which bring on asthma symptoms in some people. Common triggers include house dust, pollen, cats, dogs and cigar

1. Name Of The Medicinal Product

Vagifem 10 micrograms vaginal tablets.

2. Qualitative And Quantitative Composition

Each vaginal tablet contains:

Estradiol hemihydrate equivalent to estradiol 10 micrograms.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Vaginal tablet.

White, film-coated, biconvex tablet, engraved with NOVO 278 on one side. Diameter 6 mm.

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of vaginal atrophy due to oestrogen deficiency in postmenopausal women (see section 5.1).

The experience treating women older than 65 years is limited.

4.2 Posology And Method Of Administration

Vagifem is administered intravaginally using the applicator.

Initial dose: One vaginal tablet daily for two weeks.

Maintenance dose: One vaginal tablet twice a week.

Treatment may be started on any convenient day.

If a dose is forgotten, it should be taken as soon as the patient remembers. A double dose should be avoided.

For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration (see also section 4.4) should be used.

A switch to the higher dose product Vagifem 25 micrograms should be considered if the response after three months is insufficient for satisfactory symptom relief.

Vagifem may be used in women with or without an intact uterus.

During treatment, especially during the first two weeks of daily administration, minimal systemic absorption may occur but as plasma estradiol levels usually do not exceed normal postmenopausal levels the addition of a pr

1. Name Of The Medicinal Product

Voltarol® Tablets 25mg and 50mg

2. Qualitative And Quantitative Composition

The active substance is sodium-[o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate (diclofenac sodium).

Each enteric coated tablet contains 25mg or 50mg diclofenac sodium Ph.Eur.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Enteric coated tablet.

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 (aged 1-12 years): Juvenile chronic arthritis (25mg tablet only).

4.2 Posology And Method Of Administration

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

For oral administration

75-150mg daily in two or three divided doses.

The recommended maximum daily dose of Voltarol is 150mg.

Children (aged 1-12 years): 1-3mg/kg per day in divided doses. (25mg tablet only)

Elderly: Although the pharmacokinetics of Voltarol are not impaired to any clinically re

Vallergan 10mg Tablets

alimemazine tartrate

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

What Vallergan Tablets are and what they are used for

Vallergan Tablets contain a medicine called alimemazine tartrate. This belongs to a group of medicines called phenothiazines. It works by blocking a natural substance (histamine) that your body makes during an allergic reaction. It also works directly on the brain to help you feel more relaxed.

What Vallergan Tablets are used for

  • To treat itching (pruritus) or an itchy, lumpy rash (urticaria)
  • As a sedative for children aged between 2 and 7 years. This is a medicine given to reduce awareness or make the child feel relaxed and at ease before an operation

1. Name Of The Medicinal Product

Valsartan 160 mg film-coated tablets

2. Qualitative And Quantitative Composition

Valsartan 160 mg film-coated tablets: One film-coated tablet contains 160 mg of valsartan

Excipients:

Valsartan 160 mg film-coated tablets:

Each tablet contains

sorbitol.................... 18.5 mg

lactose...................... 2.16 mg

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Film-coated tablet.

Valsartan 160 mg film-coated tablets: oblong, biconvex, coated, ochre tablets, scored on one side, 'snap-tab' tablets.. The tablet can be divided into equal halves.

4. Clinical Particulars

4.1 Therapeutic Indications

Hypertension

Treatment of essential hypertension in adults, and hypertension in children and adolescents 6 to 18 years of age.

Recent myocardial infarction

Treatment of clinically stable adult patients with symptomatic heart failure or asymptomatic left ventricular systolic dysfunction after a recent (12 hours- 10 days) myocardial infarction (see sections 4.4 and 5.1).

Heart failure

Treatment of symptomatic heart failure in adult patients when Angiotensin Converting Enzyme (ACE) inhibitors cannot be used, or as add-on therapy to ACE inhibitors when beta blockers cannot be used (see sections 4.4 and 5.1).

4.2 Posology And Method Of Administration

Posology

Recent myocard

1. Name Of The Medicinal Product

Varilrix® 10 3.3 PFU/0.5ml, powder and solvent for solution for injection.

2. Qualitative And Quantitative Composition

One dose (0.5 ml) contains:

Live attenuated varicella-zoster (Oka strain) virus* 103.3 plaque forming units (PFU)

*propagated in MRC5 human diploid cells

For excipients, see 6.1.

3. Pharmaceutical Form

Powder and solvent for solution for injection.

Clear peach to pink coloured solution.

4. Clinical Particulars

4.1 Therapeutic Indications

Varilrix is indicated for active immunisation against varicella in healthy adults and adolescents (

Varilrix is not indicated for routine use in children. However, it may be administered to seronegative healthy children of 1-12 years of age who are close contacts (e.g. household) of persons considered to be at high risk of severe varicella infections.

4.2 Posology And Method Of Administration

Posology

Children 1-12 years, adolescents (

Two doses (each of 0.5 ml of reconstituted vaccine) should be given, with an interval between doses of at least 6 weeks but in no circumstances less than 4 weeks.

One dose of Varilirix may be administered after a first dose of another varicella containing vaccine (see section 5.1).

There are insufficient data to determine the long-term protective efficacy of the vaccine. However, there is currently no evidence that further doses are routinely required following completion of a two-dose regimen in healthy adolescents and adults (see section 5.1).

If Varilrix is to be admini

1. Name Of The Medicinal Product

Vigam®Liquid is a sterile liquid of 5 g% normal immunoglobulin

2. Qualitative And Quantitative Composition

2.1 Active ingredient

Human normal immunoglobulin for intravenous administration. This product is prepared from plasma from screened donors. Donors are selected from the USA.

2.2 Quantitative composition

Vigam® Liquid contains 7 g/100 mL of human protein of which 5 g is human normal immunoglobulin.

For excipients see 6.1.

Vigam®Liquid has an IgA content of less than 0.02% w/w of the total protein and a sub-class distribution of IgG1:IgG2:IgG3:IgG4 of approximately 64:29:6:1; this is similar to plasma.

3. Pharmaceutical Form

Vigam®Liquid is a sterile liquid for intravenous administration which varies from colourless to pale amber or pale green.

4. Clinical Particulars

4.1 Therapeutic Indications

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 spontaneously or prior to surgery to correct the platelet count; Guillain Barr? Syndrome and Kawasaki disease.

Allogeneic bone marrow transplantation.

4.2 Posology And Method Of Administration

Posology

The dose and dosage r

1. Name Of The Medicinal Product

Abdine Cold Relief Powder

Bell's Hot Lemon Cold Relief Powders

Abdine Hot Lemon Cold Relief Powders

Cold & Flu Relief Powders Lemon Flavour

Cold Relief Powders Lemon Flavour

2. Qualitative And Quantitative Composition

Paracetamol BP 650 mg

3. Pharmaceutical Form

Powder for oral solution

4. Clinical Particulars

4.1 Therapeutic Indications

To give effective relief from the symptoms of cold and flu.

4.2 Posology And Method Of Administration

Adults, the elderly and children over 12 years: one sachet every four hours to a maximum of 4 sachets in any 24 hour period.

If symptoms persist for more than 3 days, consult your doctor.

4.3 Contraindications

Hypersensitivity to paracetamol or any of the other constituents.

4.4 Special Warnings And Precautions For Use

Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic, alcoholic liver disease.

Do not exceed the recommended dose.

Patients should be advised not to take other paracetamol-containing products concurrently.

If symptoms persist, consult your doctor.

Keep out of the reach of children.

On the label:

'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.'

On the leaflet (or label if no leaflet exists):

'Immediate medical advice should be sought

VALNI XL 30MG & 60MG PROLONGED RELEASE TABLETS

Nifedipine

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

In this leaflet:

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

What Valni Xl Is And What It Is Used For

VALNI XL Prolonged Release Tablets contain nifedipine which belongs to a group of medicines called calcium-channel blockers that act on the cardiovascular system (the heart and blood vessels). VALNI XL has been prescribed by your doctor to treat your high blood pressure or to reduce the frequency of your anginal attacks. They are called prolonged release tablets because they are manufactured in a way that allows the nifedipine to be released and slowly absorbed by your body over a period of several hours.

In high blood pressure, nifedipine works by widening the blood vessels. This creates less resistance to the blood flow, and results in lower blood pressure, which in turn reduces the strain on your heart.

In angina, nifedipine works by opening up the arteries supplying the heart muscle

1. Name Of The Medicinal Product

Vimpat 50 mg film-coated tablets

Vimpat 100 mg film-coated tablets

Vimpat 150 mg film-coated tablets

Vimpat 200 mg film-coated tablets

Vimpat 10 mg/ml solution for infusion

2. Qualitative And Quantitative Composition

Tablets:

Each film-coated tablet contains 50 mg lacosamide, 100 mg lacosamide, 150 mg lacosamide or 200 mg lacosamide.

Solution for infusion:

Each ml of solution for infusion contains 10 mg lacosamide.

1 vial of 20 ml solution for infusion contains 200 mg lacosamide.

Excipient: each ml of solution for infusion contains 2.99 mg sodium.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Tablets:

Film-coated tablet

50 mg: Pinkish, oval film-coated tablet debossed with 'SP' on one side and '50' on the other side.

100 mg: Dark yellow, oval film-coated tablet debossed with 'SP' on one side and '100' on the other side.

150 mg: Salmon, oval film-coated tablet debossed with 'SP' on one side and '150' on the other side.

200 mg: Blue, oval film-coated tablet debossed with 'SP' on one side and '200' on the other side.

Solution for infusion:

Clear, colourless solution.

4. Clinical Particulars

4.1 Therapeutic Indications

Vimpat is indicated as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 16 years and older.

Solution for infusion:

Vimpat solution for infusion is an alternative for patients when oral administration is temporarily not feasible.

1. Name Of The Medicinal Product

Vagifem® 25 micrograms film-coated vaginal tablets

2. Qualitative And Quantitative Composition

One vaginal tablet contains:

Estradiol hemihydrate equivalent to estradiol 25 micrograms.

Excipients:

For a full list of excipients, see section 6.1

3. Pharmaceutical Form

Film-coated vaginal tablet inset in disposable applicator.

4. Clinical Particulars

4.1 Therapeutic Indications

Hormone replacement therapy for the treatment of vaginal atrophy due to oestrogen deficiency.

The experience of treating women older than 65 years is limited.

4.2 Posology And Method Of Administration

4.2.1 Dosage

Vagifem® is administered intravaginally using the applicator. An initial dose of one tablet daily for two weeks will usually improve vaginal atrophy and associated symptoms; a maintenance dose of two tablets per week should then be instituted.

Treatment may be started on any convenient day.

If a dose is forgotten, it should be administered as soon as the patient remembers. A double dose should be avoided.

For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration (see also section 4.4) should be used.

Vagifem® may be used in women with or without an intact uterus.

The addition of a progestogen is not recommended during treatment with Vagifem® (but see section 4.4)

Not intended for children or males.

Use in the elderly: there are no special dosage requirements.

4.2.2 Administration

The applicat

1. Name Of The Medicinal Product

Viramune 50 mg prolonged-release tablets

2. Qualitative And Quantitative Composition

Each prolonged-release tablet contains 50 mg of nevirapine (as anhydrous).

Excipient: each prolonged-release tablet contains 50 mg of lactose monohydrate.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Prolonged-release tablet

Yellow, round and biconvex prolonged-release tablets. The prolonged-release tablets are approximately 7 mm in diameter, debossed with V5 on one side and company symbol on the other side. The prolonged-release tablet should not be divided.

4. Clinical Particulars

4.1 Therapeutic Indications

Viramune is indicated in combination with other anti-retroviral medicinal products for the treatment of HIV-1 infected adolescents and children three years and above and able to swallow tablets (see section 4.2 and 4.4.).

Prolonged-release tablets are not suitable for the 14-day lead-in phase for patients starting nevirapine. Other nevirapine formulations, such as immediate-release tablets or oral suspension should be used (see section 4.2).

Most of the experience with Viramune is in combination with nucleoside reverse transcriptase inhibitors (NRTIs). The choice of a subsequent therapy after Viramune should be based on clinical experience and resistance testing (see section 5.1).

4.2 Posology And Method Of Administration

Viramune should be administered by physicians who are experienced in the treatment of HIV infection.

Posology

Paediatric population

Children three years

1. Name Of The Medicinal Product

VASCALPHA 10 mg PROLONGED RELEASE TABLETS

(FELODIPINE)

2. Qualitative And Quantitative Composition

One prolonged release tablet contains 10mg of felodipine.

Lactose monohydrate 21.45mg

For excipients, see 6.1.

3. Pharmaceutical Form

Prolonged release tablet.

Reddish brown, round, biconvex, film coated prolonged release tablets with imprint 10.

4. Clinical Particulars

4.1 Therapeutic Indications

Essential hypertension

4.2 Posology And Method Of Administration

Vascalpha (felodipine) prolonged release tablets should usually be administered as follows:

The recommended starting dose is 5 mg felodipine once daily.

If necessary, the dose may be increased to 10 mg felodipine once daily or another antihypertensive agent added. Dose increases should occur at intervals of at least 2 weeks. The usual maintenance dose is 5-10mg once daily.

The maximum daily dose is 10 mg felodipine.

The dose should be adjusted to the individual requirements of the patient.

Elderly

The recommended starting dose should be 2.5mg.

Subsequent dose increases should be undertaken with particular caution.

Impaired hepatic function

In patients with mild to moderate hepatic impairment, the recommended starting dose should be lowered to the minimal therapeutic effective dose of felodipine.

The dose should only be increased after carefully balancing the benefits against the risks (see 5.2 Pharmacokinetic properties). It is contraindicated in patients with severe hepatic

1. Name Of The Medicinal Product

Voltarol® 1.16% Emulgel®, gel

2. Qualitative And Quantitative Composition

Diethylammonium-{-o-[2,6-dichlorophenyl)-amino]-phenyl}-acetate.

1g of Voltarol Emulgel contains 11.6mg of the active substance diclofenac diethylammonium, which corresponds to 10mg diclofenac sodium.

For full list of excipients, see section 6.1

3. Pharmaceutical Form

Gel for topical administration

Oil emulsion in an aqueous gel. White to off white, soft, homogeneous, cream like

4. Clinical Particulars

4.1 Therapeutic Indications

For the local symptomatic relief of pain and inflammation in:

- trauma of the tendons, ligaments, muscles and joints, e.g. due to sprains, strains and bruises

- localised forms of soft tissue rheumatism

It is recommended that treatment be reviewed after 14 days in these indications.

For the treatment of osteoarthritis of superficial joints such as the knee.

In the treatment of osteoarthritis, therapy should be reviewed after 4 weeks.

4.2 Posology And Method Of Administration

Adults: Voltarol Emulgel should be rubbed gently into the skin. Depending on the size of the affected site to be treated 2-4g (a circular shaped mass approximately 2.0-2.5cm in diameter) should be applied 3 - 4 times a daily. After application, the hands should be washed unless they are the site being treated.

Use in the elderly: The usual adult dosage may be used.

Children and adolescents: There are insufficient data on efficacy and safety available for the children and adolescents below 14 years of age (see also contraind