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1. Name Of The Medicinal Product

TRADOREC XL® 100 mg prolonged-release tablets

TRADOREC XL® 200 mg prolonged-release tablets

TRADOREC XL® 300 mg prolonged-release tablets

2. Qualitative And Quantitative Composition

One prolonged-release tablet contains 100mg, 200mg or 300mg tramadol hydrochloride

For a full list of excipients, see section 6.1

3. Pharmaceutical Form

Prolonged-release tablet.

White to off white, plain, bevelled edge, round biconvex tablet

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of moderate to severe pain.

4.2 Posology And Method Of Administration

The dosage should be adjusted according to the severity of pain and the response of the individual patient.

The tablets should be swallowed whole, with a sufficient quantity of liquid and not divided or chewed. The tablets can be taken with or without food.

Alternative tablet strengths of TRADOREC XL® are available. Where necessary, appropriate tablet strengths should be used to achieve the required dose.

TRADOREC XL® should be taken once every 24 hours as follows:

Adults and adolescents (12 years and over):

The starting dose is one 100 mg prolonged-release tablet once daily. The usual dose is one 200 mg prolonged-release tablet once daily, to be taken preferably in the evening. If this does not provide sufficient pain relief, the dosage can be increased in 100 mg dose increments to 300 mg or to a maximum of 400 mg once daily.

In general, the lowest effective analgesic dose should be chosen. A daily dose of 400mg of trama

1. Name Of The Medicinal Product

Trazodone Hydrochloride 100mg Capsules

2. Qualitative And Quantitative Composition

Trazodone hydrochloride 100mg per capsule.

For excipients see 6.1

3. Pharmaceutical Form

Capsules.

4. Clinical Particulars

4.1 Therapeutic Indications

Anxiety, depression, mixed anxiety and depression.

4.2 Posology And Method Of Administration

Route of administration: Oral.

DEPRESSION:

Adults:

Initially 150mg/day in divided doses after food or as a single dose on retiring.

This may be increased up to 300mg/day in a single or divided doses. The major portion of a divided dose to be taken on retiring. The dose may be further increased to 600mg/day in divided doses in hospitalised patients.

Elderly:

For very elderly or frail patients, the recommended initial starting dose is reduced to 100mg/day given in divided doses or as a single night-time dose. This may be incrementally increased, under supervision, according to efficacy and tolerance. In general, single doses above 100mg should be avoided in these patients. It is unlikely that 300mg/day will be exceeded.

Children:

There are insufficient data on safety to recommend the use of Trazodone in children below the age of 18 years.

DEPRESSION ACCOMPANIED BY ANXIETY:

As for depression.

ANXIETY:

75mg/day increasing to 300mg/day as necessary.

A decrease in side-effects (increase of the resorption and decrease of the peak plasma concentration) can be reached by taking Trazodone after a meal..

Hepatic Impairment:

1. Name Of The Medicinal Product

Typherix, solution for injection in a pre-filled syringe

Typhoid Polysaccharide vaccine.

2. Qualitative And Quantitative Composition

Each 0.5 ml dose of vaccine contains:

Vi polysaccharide of Salmonella typhi (Ty2 strain) 25 micrograms

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Solution for injection in a pre-filled syringe.

Clear isotonic colourless solution.

4. Clinical Particulars

4.1 Therapeutic Indications

Typherix is indicated for active immunisation against typhoid fever for both adults and children two years of age and older.

4.2 Posology And Method Of Administration

Posology

A single dose of 0.5 ml is recommended for both adults and children two years of age and older.

The vaccine should be administered at least two weeks prior to risk of exposure to typhoid fever.

Subjects who remain at risk of typhoid fever should be revaccinated using a single dose of vaccine with an interval of not more than 3 years.

Method of administration

Typherix is for intramuscular injection.

Typherix should under no circumstances be administered intravascularly.

4.3 Contraindications

Typherix should not be administered to subjects with known hypersensitivity to any component of the vaccine or to subjects having shown signs of hypersensitivity after previous administration.

As with other vaccines, the administration of Typherix should be postponed in subjects suffering from acute febrile illness. The presence of a minor infection, however, is

TAMOXIFEN FILM-COATED 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 Tamoxifen Tablets

Tamoxifen Tablets contain the active ingredient tamoxifen citrate. The tablets come in three strengths, 10mg, 20mg and 40mg.

Other ingredients in your tablets are lactose, maize starch, pregelatinised maize starch, magnesium stearate, methylhydroxypropylcellulose, propylene glycol, Opaspray white (E171 and E464).

Tamoxifen 10mg Film-Coated Tablets are white, circular, film-coated tablets marked TAM10 on one face and CP on the reverse and contain 15.2mg of tamoxifen citrate equivalent to 10mg tamoxifen.

Tamoxifen 20mg Film-Coated Tablets are white, circular, film-coated tablets marked TAM20 on one face and CP on the reverse and contain 30.4mg of tamoxifen citrate equivalent to 20mg tamoxifen.

Tamoxifen 40mg Film-Coated Tablets are white, circular, film-coated tablets marked TAM40 on one face and CP on the reverse and contain 60.8mg of tamoxifen citrate equivalent to 40mg tamoxifen.

Tamoxifen Tablets are available in strip packs of 30 tablets.

Marketing Authorisation Holder:

Wockhardt UK Limited
Ash Road North
Wrexham
LL13 9UF
UK

1. Name Of The Medicinal Product

Teoptic 2% w/v Eye Drops, Solution

2. Qualitative And Quantitative Composition

Carteolol hydrochloride 2% w/v

Excipients: Benzalkonium chloride 0.005%.

For the full list of excipients, see Section 6.1

3. Pharmaceutical Form

Eye drops solution.

A clear, colourless solution.

4. Clinical Particulars

4.1 Therapeutic Indications

For the reduction of intraocular pressure e.g. in ocular hypertension, chronic open angle glaucoma, some secondary glaucomas.

4.2 Posology And Method Of Administration

Adults: Initially one drop of 1% eye drops instilled twice daily in each affected eye. If the clinical response is not adequate the dosage may be altered to one drop of 2% eye drops twice daily in each affected eye.

Elderly: There is no indication that dosage needs to be modified for the elderly.

Children: Safety and effectiveness of carteolol has not been established.

Nasolacrimal occlusion or closing the eyelids after drug instillation can reduce the systemic absorption. This may result in a decrease in systemic adverse events and an increase in local activity. It is recommended that the period of occlusion is five minutes in duration.

The dispenser remains sterile until the original closure is broken. Patients must be instructed to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures as this may contaminate the solution.

If the patients IOP is not at a satisfactory level with this regimen, concomitant treatment with other IOP lowering drugs may be considered.

If more than one medication needs to be instilled in the eye, an interval of

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

The name of this medicine is TOPAL. Its active ingredients are Dried Aluminium Hydroxide Gel, Magnesium Carbonate and Alginic Acid.

What Is In This Medicine?

Each tablet contains:

  • Dried Aluminium Hydroxide Gel 30mg
  • Magnesium Carbonate 40mg
  • Alginic Acid 200mg

The tablets also contain Sucrose, Lactose, Silica Gel, Polyvidone, Sodium Bicarbonate, Citric Acid, Magnesium Stearate, Caramel flavour, Vanillin, Strawberry flavour.

TOPAL Tablets are supplied in cartons of 28 and 42 chewable tablets.

TOPAL is an antacid which means that it counteracts the effects of stomach acid.

The manufacturer is:

PIERRE FABRE MEDICAMENT PRODUCTION
Rue du Lyc?e
Z-I de Cuiry
F-45502 Gien Cedex

The Product Licence holder is:

PIERRE FABRE Limited
Hyde Abbey House
23 Hyde Street
Winchester
Hants
SO23 7DR
Uni

Tilade

CFC-Free Inhaler 2mg per actuation pressurised inhalation suspension

nedocromil sodium

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Phone 01483 505515 for help

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

What Tilade is and what it is used for

Tilade CFC-Free Inhaler (called Tilade throughout this leaflet) contains a medicine called nedocromil sodium. Tilade is used to treat asthma.

  • It works by helping to stop tissues from swelling
  • This helps stop the narrowing of the airways that happens in asthma

Tilade is used to prevent asthma attacks and may be called a ‘preventer’.

  • Tilade will not help an asthma attack that has already started
  • You will need to use a different inhaler, called a ‘reliever’, for these attacks (see Section 3)

Before you use Tilade

1. Name Of The Medicinal Product

Tagamet 800 mg Tablets

2. Qualitative And Quantitative Composition

Each tablet contains Cimetidine 800 mg.

For excipients, see 6.1.

3. Pharmaceutical Form

Film-coated tablet.

Pale green, oval, film-coated tablet engraved with Tagamet on one face and 800 on the reverse

4. Clinical Particulars

4.1 Therapeutic Indications

Tagamet is a histamine H2-receptor antagonist which rapidly inhibits both basal and stimulated gastric secretion of acid and reduces pepsin output.

Tagamet is indicated in the treatment of duodenal and benign gastric ulceration, including that associated with non-steroidal anti-inflammatory agents, recurrent and stomal ulceration, oesophageal reflux disease and other conditions where reduction of gastric acid by Tagamet has been shown to be beneficial: persistent dyspeptic symptoms with or without ulceration, particularly meal-related upper abdominal pain, including such symptoms associated with non-steroidal anti-inflammatory agents; the prophylaxis of gastrointestinal haemorrhage from stress ulceration in critically ill patients; before general anaesthesia in patients thought to be at risk of acid aspiration (Mendelson's) syndrome, particularly obstetric patients during labour; to reduce malabsorption and fluid loss in the short bowel syndrome; and in pancreatic insufficiency to reduce degradation of enzyme supplements. Tagamet is also recommended in the management of the Zollinger-Ellison syndrome.

4.2 Posology And Method Of Administration

The total daily dose should not normally exceed 2.4g. Dosage should be reduced in patients with impaired renal function (see Section 4.4).

Adults: For patients with duodenal or

1. Name Of The Medicinal Product

Tambocortm XL 200mg capsules

2. Qualitative And Quantitative Composition

Each capsule contains flecainide acetate 200mg

For excipients see 6.1

3. Pharmaceutical Form

Prolonged release capsule hard.

Size 1 hard gelatin capsule with light grey cap and opaque pink body with 3M 200 printed in black ink.

4. Clinical Particulars

4.1 Therapeutic Indications

Tambocor is a potent sodium channel blocking agent for the treatment of the conditions listed below:

The effect on the JT interval is insignificant at therapeutic levels.

Tambocor XL capsules are indicated for:

a) AV nodal reciprocating tachycardia, arrhythmias associated with Wolff-Parkinson-White Syndrome and similar conditions with accessory pathways.

b) Paroxysmal atrial fibrillation in patients with disabling symptoms when treatment need has been established and in the absence of left ventricular dysfunction (see 4.4, Special warnings and precautions for use).

Arrhythmias of recent onset will respond more readily. Tambocor XL capsules can be used for the maintenance of normal rhythm following conversion by other means.

Tambocor XL capsules are for oral administration.

4.2 Posology And Method Of Administration

The controlled-release form of flecainide acetate is administered as a once-daily dose. Tambocor XL should not be used for control of arrhythmias in acute situations. Treatment should be initiated with either Intravenous or oral Tambocor IR formulations then switched to Tambocor XL.

Adults: Supraventricular arrhythmias: The recommended starting dosage is 50mg twice daily (IR formulation) and most p

1. Name Of The Medicinal Product

Tamiflu 12 mg/ml powder for oral suspension.

2. Qualitative And Quantitative Composition

1 g of powder for oral suspension contains oseltamivir phosphate equivalent to 30 mg of oseltamivir.

After reconstitution, each ml of suspension contains 12 mg oseltamivir.

One bottle of reconstituted suspension (75 ml) contains 900 mg of active substance (oseltamivir).

A bottle of 30 g Tamiflu powder for oral suspension contains 25.713 g of sorbitol.

30 mg oseltamivir suspension delivers 0.9 g of sorbitol.

45 mg oseltamivir suspension delivers 1.3 g of sorbitol.

60 mg oseltamivir suspension delivers 1.7 g of sorbitol.

75 mg oseltamivir suspension delivers 2.1 g of sorbitol.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Powder for oral suspension

The powder is a granulate or clumped granulate with a white to light yellow colour.

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of influenza

In patients one year of age and older who present with symptoms typical of influenza, when influenza virus is circulating in the community. Efficacy has been demonstrated when treatment is initiated within two days of first onset of symptoms. This indication is based on clinical studies of naturally occurring influenza in which the predominant infection was influenza A (see section 5.1).

Tamiflu is indicated for the treatment of infants below 12 months of age during a pandemic influenza outbreak (see section 5.2).

Prevention of influenza

- Post-exposure prevention in ind

1. Name Of The Medicinal Product

TEPADINA 100 mg powder for concentrate for solution for infusion

2. Qualitative And Quantitative Composition

One vial contains 100 mg thiotepa.

After reconstitution with 10 ml of water for injection, each ml of solution contains 10 mg thiotepa (10 mg/ml).

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Powder for concentrate for solution for infusion.

White crystalline powder.

4. Clinical Particulars

4.1 Therapeutic Indications

TEPADINA is indicated, in combination with other chemotherapy medicinal products:

1) with or without total body irradiation (TBI), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (HPCT) in haematological diseases in adult and paediatric patients;

2) when high dose chemotherapy with HPCT support is appropriate for the treatment of solid tumours in adult and paediatric patients.

4.2 Posology And Method Of Administration

TEPADINA administration must be supervised by a physician experienced in conditioning treatment prior to haematopoietic progenitor cell transplantation.

TEPADINA is administered at different doses, in combination with other chemotherapeutic medicinal products, in patients with haematological diseases or solid tumours prior to HPCT.

TEPADINA posology is reported, in adult and paediatric patients, according to the type of HPCT (autologous or allogeneic) and disease.

Posology in adults

AUTOLOGOUS HPCT:

Haematological diseases

The

Tenormin 100 mg Tablets

atenolol

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

What Tenormin is and what it is used for

Tenormin contains a medicine called atenolol. This belongs to a group of medicines called beta-blockers. Tenormin is used to:

  • Treat high blood pressure (hypertension).
  • Treat uneven heart beats (arrhythmias).
  • Help prevent chest pain (angina).
  • Protect the heart in the early treatment after a heart attack (myocardial infarction).

It works by making your heart beat more slowly and with less force.

Before you take Tenormin

Do not take Tenormin if:

  • You are allergic (hypersensitive) to atenolol or any of the other ingredi

1. Name Of The Medicinal Product

Tegretol® Retard 200mg and 400mg Tablets

2. Qualitative And Quantitative Composition

The active ingredient is 5H-dibenzo[b,f]azepine-5-carboxamide.

Each coated tablet contains 200mg or 400mg carbamazepine Ph.Eur.

3. Pharmaceutical Form

The 200mg tablets are beige-orange, oval, slightly biconvex, coated tablets with a score on each side. One side bears the imprint “H/C”, the other “C/G”.

The 400mg tablets are brownish-orange, oval, slightly biconvex coated tablets with a score on each site. One side bears the imprint “ENE/ENE”, the other “C/G”.

4. Clinical Particulars

4.1 Therapeutic Indications

Epilepsy - generalised tonic-clonic and partial seizures. Tegretol Retard is indicated in newly diagnosed patients with epilepsy and in those patients who are uncontrolled or unable to tolerate their current anti-convulsant therapy.

Note: Carbamazepine is not usually effective in absences (petit mal) and myoclonic seizures. Moreover, anecdotal evidence suggests that seizure exacerbation may occur in patients with atypical absences.

The paroxysmal pain of trigeminal neuralgia.

For the prophylaxis of manic-depressive psychoses in patients unresponsive to lithium therapy.

4.2 Posology And Method Of Administration

Tegretol Retard is given orally, generally in the same total daily dose as conventional Tegretol dosage forms but usually in two divided doses. In a few patients when changing from other oral dosage forms of Tegretol to Tegretol Retard the total daily dose may need to be increased, particularly when it is used in polytherapy. When starting treatment with Tegretol Retard in monotherapy, 100-200mg once or twice daily is recomm

1. Name Of The Medicinal Product

Triapin mite 2.5mg/2.5mg prolonged release tablets

Triapin 5mg/5mg prolonged release tablets

2. Qualitative And Quantitative Composition

Triapin mite: Each tablet contains 2.5 mg of felodipine and 2.5 mg of ramipril.

Each tablet contains 52 mg lactose anhydrous.

Triapin: Each tablet contains 5 mg of felodipine and 5 mg of ramipril.

Each tablet contains 51.5 mg lactose anhydrous.

For a full list of excipients, see section 6.1

3. Pharmaceutical Form

Triapin mite 2.5mg/2.5mg tablets are circular (diameter approx 9 mm), apricot coloured, biconvex and engraved

Triapin 5mg/5mg tablets are circular (diameter approx 9 mm), reddish-brown coloured, biconvex and engraved

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of essential hypertension. Triapin mite/Triapin fixed dose combination is indicated in patients whose blood pressure is not adequately controlled on felodipine or ramipril alone.

4.2 Posology And Method Of Administration

Posology

Use in adults, including elderly:

Triapin mite: One tablet Triapin mite once daily. The maximum dose is two tablets Triapin mite once daily.

Triapin: One tablet Triapin once daily, which is also the maximum dose.

Use in patients with impaired liver function:

See sections 4.3 and 4.4.

Use in patients with impaired renal function or patients already on diuretic treatment:

See sections 4.3 and 4.4.

Individual dose titration with the

Tracleer 62.5 mg film-coated tablets

Bosentan

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

What Tracleer Is And What It Is Used For

Tracleer tablets contain bosentan and belong to the class of medicines called “endothelin receptor antagonists”.

Tracleer is used to treat pulmonary arterial hypertension (PAH). PAH is high blood pressure in the blood vessels (the pulmonary arteries) that carry blood from the heart to the lungs. Tracleer widens the pulmonary arteries, making it easier for the heart to pump blood through them. This lowers the blood pressure and relieves the symptoms.

Tracleer is also used to treat digital ulcers (ulcers of the fingers) in people with a condition called scleroderma. Tracleer reduces the number of new finger ulcers that appear.

Before You Take Tra

1. Name Of The Medicinal Product

Traxam Gel - Prescription Only

Traxam Pain Relief Gel - Pharmacy Product

2. Qualitative And Quantitative Composition

Active Ingredient:

Felbinac (Biphenylacetic Acid) 3% w/w

3. Pharmaceutical Form

A clear non-greasy, non-staining gel containing 30mg felbinac in each gram.

4. Clinical Particulars

4.1 Therapeutic Indications

Prescription Only Medicine

TRAXAM gel is a topical anti-inflammatory and analgesic. It is indicated for the relief of rheumatic pain, pain of non-serious arthritic conditions and soft tissue injuries such as sprains, strains and contusions.

TRAXAM gel may be used as a coupling agent for ultrasound where both treatments are indicated.

Pharmacy Only Medicine

TRAXAM Pain Relief Gel is a topical anti-inflammatory and analgesic. It is indicated for the relief of rheumatic pain, pain of non-serious arthritic conditions and soft tissue injuries such as sprains, strains and contusions.

4.2 Posology And Method Of Administration

Prescription Only Medicine

Rub 1g Traxam Gel (approximately 1 inch (2.5cm) of gel) into the affected area(s) 2 to 4 times a day. If symptoms do not resolve within 14 days, the patient should be reviewed.

The total daily dose should not exceed 25g per day irrespective of the number of affected areas.

Elderly: No special dosage recommendations are made for elderly patients.

Children: Safe use of felbinac in early childhood has not been established.

Hands should be washed following application of Traxam Gel unless they are the treatment site.

TRAZODONE 50MG AND 100MG CAPSULES

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 further questions, please ask your doctor or your 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 you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist
  • Your doctor may have given you this medicine before, made by another company. It may have looked slightly different, but either brand will have the same effect.

In this leaflet:

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

What Trazodone Is And What It Is Used For

The name of this medicine is Trazodone Hydrochloride 50mg or 100mg Capsules (called trazodone throughout this leaflet). This belongs to a group of medicines called anti-depressants.

Trazodone is used to treat anxiety and depression.

Before You Take Trazodone

Do not take trazodone and tell your doctor if

  • You are allergic (hypersensitive) to trazodone, or any of the other ingredients in these capsules (see Section 6: Further Information).

1. Name Of The Medicinal Product

Tildiem LA 200

Tildiem LA 300

2. Qualitative And Quantitative Composition

Each capsule contains a combination of immediate-release and coated sustained-release pellets with 200mg or 300mg diltiazem hydrochloride as the active ingredient.

For a full list of excipients, see Section 6.1

3. Pharmaceutical Form

Sustained-release oral capsules

Tildiem LA 200: Opaque capsules with a grey body and pink cap, containing white to off-white pellets.

Tildiem LA 300: Opaque capsules with a white body and yellow cap, containing white to off-white pellets.

4. Clinical Particulars

4.1 Therapeutic Indications

Mild to moderate hypertension and angina pectoris.

4.2 Posology And Method Of Administration

Tildiem LA 200 and Tildiem LA 300 are sustained release products for once daily dosing. The capsules should not be chewed but swallowed whole with water, ideally before or during a meal. The dosage requirements may differ in patients with angina or hypertension.

Tildiem (diltiazem hydrochloride) is available in a range of presentations to enable dosage to be adjusted to meet the individual requirements of the patient. Careful titration of the dose should be considered where appropriate, as individual patient response may vary. When changing from one type of Tildiem formulation to another it may be necessary to adjust the dosage until a satisfactory response is obtained. To ensure consistency of response once established, particularly in the sustained release formulations, Tildiem LA 200 should continue to be prescribed by brand name.

Adults:

Angina and hypertension: The usual starting

1. Name Of The Medicinal Product

TOPAL chewable tablets.

2. Qualitative And Quantitative Composition

Dried aluminium hydroxide 30 mg

Magnesium carbonate (light) 40 mg

Alginic acid 200 mg

This product contains 11 mg sodium, 220 mg lactose and 880 mg sucrose per tablet.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Chewable tablet.

Round, off-white or light cream coloured, 18mm diameter, flat faced bevel-edged chewable tablet, with a score-line on one face. The score-line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

4. Clinical Particulars

4.1 Therapeutic Indications

Relief of discomfort due to gastric reflux or mucosal irritation in conditions such as:

• Heartburn

• Reflux oesophagitis

• Hiatus hernia

• Gastritis

• Acid dyspepsia.

4.2 Posology And Method Of Administration

Oral route.

Adults including the elderly: 1 to 3 tablets 4 times a day.

Children: half the adult dose.

4.3 Contraindications

Hypersensitivity to the active substances or to any of the excipients.

4.4 Special Warnings And Precautions For Use

Due to the presence of lactose, and sucrose patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Care should be taken if used by patients with diabetes mellitus or low sugar diet because of the sugar content: sucrose 880 mg, lactose 220 mg.

1. Name Of The Medicinal Product

TRAMACET 37.5 mg/325 mg, film coated-tablets

2. Qualitative And Quantitative Composition

One film-coated tablet contains 37.5 mg tramadol hydrochloride and 325 mg paracetamol

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Film-coated tablet

Pale yellow film-coated tablet, marked with the manufacturer's logo

4. Clinical Particulars

4.1 Therapeutic Indications

TRAMACET tablets are indicated for the symptomatic treatment of moderate to severe pain.

The use of TRAMACET should be restricted to patients whose moderate to severe pain is considered to require a combination of tramadol and paracetamol (see also Section 5.1).

4.2 Posology And Method Of Administration

Posology

ADULTS AND ADOLESCENTS (12 years and older)

The use of TRAMACET should be restricted to patients whose moderate to severe pain is considered to require a combination of tramadol and paracetamol.

The dose should be individually adjusted according to intensity of pain and response of the patient.

An initial dose of two tablets of TRAMACET is recommended. Additional doses can be taken as needed, not exceeding 8 tablets (equivalent to 300 mg tramadol and 2600 mg paracetamol) per day.

The dosing interval should not be less than six hours.

TRAMACET should under no circumstances be administered for longer than is strictly necessary (see also section 4.4 - Special warnings and precautions for use). If repeated use or long term treatment with TRAMACET is required as a result of the nature and severity of the illness, then careful, regular monitoring should take pl