1. Name Of The Medicinal Product

Welldorm Elixir

2. Qualitative And Quantitative Composition

Each 5ml of Welldorm Elixir contains 143.3mg of Chloral Hydrate BP.

For excipients see 6.1

3. Pharmaceutical Form

Oral Solution

4. Clinical Particulars

4.1 Therapeutic Indications

Welldorm elixir is used for the short-term treatment of severe insomnia which is interfering with normal daily life and where other therapies have failed.

Welldorm should be used as an adjunct to non pharmacological therapies.

In children aged 2-11 years treatment should be as an adjunct to behavioural therapy and sleep hygiene management, and usually for duration of less than 2 weeks

The use of hypnotics in children and adolescents is not generally recommended and if used should be under the supervision of a medical specialist

4.2 Posology And Method Of Administration

Route of administration: oral. Welldorm should be administered as a single daily dose, 15-30 minutes before bedtime with water or milk.

Adults and children 12 years and over: The usual dose is 15-30ml (430 –860 mg). Higher doses should not exceed a maximum of 70ml of elixir (2g chloral hydrate) per dose.

Elderly: Dosage as for adults except for the frail elderly or those with hepatic impairment, where a reduction in dose may be appropriate.

Children (between 2 and 11 years): 1–1.75 ml/kg (30-50mg/kg) of bodyweight. The dose should not exceed 35ml (1g) chloral hydrate.

Children (under 2 years): not recommended

4.3 Contraindications

Welldorm Elixir should not be used in patients with a

1. Name Of The Medicinal Product

Witch Doctor 81.5%w/w Gel

2. Qualitative And Quantitative Composition

Contains Liquid Extract of Witch Hazel 81.539% w/w

For excipients, see 6.1

3. Pharmaceutical Form

Gel

4. Clinical Particulars

4.1 Therapeutic Indications

Itching, insect bites, stings, sunburn, minor burns, grazes, personal irritation, chafing, minor rashes and skin irritations.

4.2 Posology And Method Of Administration

Squeeze gel directly onto affected area. Smooth over gently. Allow to dry.

4.3 Contraindications

Do not use in eyes.

4.4 Special Warnings And Precautions For Use

If symptoms persist consult doctor.

Keep out of the reach of children

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known

4.6 Pregnancy And Lactation

Not applicable

4.7 Effects On Ability To Drive And Use Machines

Not applicable

4.8 Undesirable Effects

None stated

4.9 Overdose

Not applicable

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Liquid Extract Witch Hazel – Astringent

Ethanol – bactericidal, antiseptic and disinfectant, astringent and skin-cooling properties.

5.2 Pharmacokinetic Properties

Not applicable

5.3 Preclinical Safety Data

Not applicable

6. Pharmaceutical Particulars

6.1 List Of Excipients

Ethanol

Propylene glyco

1. Name Of The Medicinal Product

Water for Injections BP 1.2ml, 2ml, 5ml, 10ml and 20ml glass ampoules.

2. Qualitative And Quantitative Composition

Water for Injections BP/Ph. Eur. 1.2ml, 2ml, 5ml, 10ml and 20ml ampoules.

3. Pharmaceutical Form

Solvent for parenteral use.

Clear, colourless, odourless, sterile solution intended for parenteral administration to human beings.

4. Clinical Particulars

4.1 Therapeutic Indications

For the reconstitution, dilution and making-up of appropriate drugs where Water for Injections is the diluent of choice, and for use as an irrigant.

4.2 Posology And Method Of Administration

Route of administration: As appropriate to the reconstituted drug.

Dosage: In accordance with the particular situation for which Water for Injections BP is being used.

4.3 Contraindications

None known.

4.4 Special Warnings And Precautions For Use

None known.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

May be used during this period.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

None known.

4.9 Overdose

No effects anticipated with the proposed use.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Not applicable.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

No further relevant informati

1. Name Of The Medicinal Product

Wasp-Eze Spray.

2. Qualitative And Quantitative Composition

Benzocaine 1.0% w/w

Mepyramine Maleate 0.5% w/w

For excipients, see 6.1.

3. Pharmaceutical Form

Aerosol spray.

4. Clinical Particulars

4.1 Therapeutic Indications

For the treatment of all insect bites and stings, nettle stings and jellyfish stings.

4.2 Posology And Method Of Administration

Route of administration

Topical.

Adults, the elderly and children:

Hold nozzle approximately five inches from the skin and spray once for 2-3 seconds. Stop spraying immediately if a white deposit or “frost” appears. Repeat once after 15 minutes if necessary. If pain persists, seek medical advice.

4.3 Contraindications

Do not apply to broken skin.

Do not use near the eyes.

Do not use if you are sensitive to benzocaine.

4.4 Special Warnings And Precautions For Use

Patients with any known allergy should seek medical advice. If pain persists seek medical advice.

For external use only. Keep out of reach of children.

Flammable. Do not use near fire or flame. Pressurised container. Protect from sunlight and do not expose to temperatures exceeding 50^oC. Do not pierce or burn, even after use. Do not spray on a naked flame or any incandescent material. Do not use near or place container on polished or painted surfaces.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

No known effects in pregnancy and lactation.

1. Name Of The Medicinal Product

Winfex XL 150mg Prolonged Release Capsules

2. Qualitative And Quantitative Composition

Each prolonged release capsule contains venlafaxine hydrochloride equivalent to 150mg of venlafaxine.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Prolonged Release capsules

Winfex XL 150mg Capsules are opaque scarlet capsules containing three 50mg tablets.

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of major depressive episodes.

For prevention of recurrence of major depressive episodes.

Treatment of social anxiety disorder.

4.2 Posology And Method Of Administration

Major depressive episodes

The recommended starting dose for prolonged-release venlafaxine is 75mg given once daily. Patients not responding to the initial 75mg/day dose may benefit from dose increases up to a maximum dose of 375mg/day. Dosage increases can be made at intervals of 2 weeks or more. If clinically warranted due to symptom severity, dose increases can be made at more frequent intervals, but not less than 4 days.

Because of the risk of dose-related adverse effects, dose increments should be made only after a clinical evaluation (see section 4.4). The lowest effective dose should be maintained.

Patients should be treated for a sufficient period of time, usually several months or longer. Treatment should be reassessed regularly on a case-by-case basis. Longer-term treatment may also be appropriate for prevention of recurrence of major depressive episodes (MDE). In most of the cases, the recommended dose in prevention of recurrence of MDE is the same as the one used during t

1. Name Of The Medicinal Product

Warticon

2. Qualitative And Quantitative Composition

Podophyllotoxin 5 mg/ml (0.5% w/v). The quality of podophyllotoxin fulfills in-house specification.

3. Pharmaceutical Form

Topical solution

4. Clinical Particulars

4.1 Therapeutic Indications

For the topical treatment of condylomata acuminata affecting the penis and the external female genitalia.

4.2 Posology And Method Of Administration

The affected area should be thoroughly washed with soap and water, and dried prior to application.

Warticon is applied twice daily for 3 days. If residual warts persist, this 3-day treatment may be repeated weekly, if necessary, for a total of 4 weeks of treatment.

Where lesions are greater than 4 cm², it is recommended that treatment takes place under the direct supervision of medical staff.

4.3 Contraindications

Open wounds following surgical procedures should not be treated with podophyllotoxin.

Hypersensitivity to podophyllotoxin is a contra-indication.

Use in children.

Concomitant use with other podophyllotoxin containing preparations.

Pregnancy and lactation.

4.4 Special Warnings And Precautions For Use

Avoid contact with eyes. Should the solution accidentally come into contact with the eye, the eye should be thoroughly rinsed with water.

The hands should be thoroughly washed after each application. Prolonged contact with healthy skin must be avoided since the solution contains an active pharmaceutical substance which could be harmful on healthy skin.

4.5 Interaction With Other Medicinal Products And Other F

1. Name Of The Medicinal Product

Warfarin Tablets 1mg

2. Qualitative And Quantitative Composition

Each tablet contains 1 mg warfarin sodium (as clathrate).

3. Pharmaceutical Form

Round brown uncoated tablet, scored and marked 'W1' on one side with company logo on reverse.

4. Clinical Particulars

4.1 Therapeutic Indications

For prophylaxis against venous thrombosis and pulmonary embolism, and for use in the treatment of these conditions to prevent their extension. For the prophylaxis of systemic embolisation in patients with rheumatic heart disease and atrial fibrillation.

4.2 Posology And Method Of Administration

Warfarin tablets are for oral administration.

An initial daily dose of 10mg on the first two days. Subsequent daily doses should be adjusted according to the results of the prothrombin time or other appropriate coagulation tests. The single daily maintenance requirement is usually between 5mg and 12mg, but can vary between 2mg and 30mg.

The maintenance dose is omitted if the prothrombin time is excessively prolonged.

Use in elderly patients: The elderly are generally more sensitive to the effects of warfarin and often require a smaller dose on a weight for weight basis than younger patients.

Target INR

By referring to the target INR (see below), the dosage of warfarin can be adjusted depending on the deviation of the patient's INR from the target value. An INR within 0.5 INR units of the target is considered to be generally satisfactory.

The following target INR values are based on guidelines from The British Society for Haematology:

1. Name Of The Medicinal Product

Wind-Eze

2. Qualitative And Quantitative Composition

Simeticone [Equivalent to Poly(Dimethylsiloxane)], 11.57% w/w, approx. 125.00mg

3. Pharmaceutical Form

Chewable tablets for oral administration.

4. Clinical Particulars

4.1 Therapeutic Indications

Antiflatulent defoaming agent for the symptomatic relief of flatulence, wind pains, bloating, abdominal distension and other similar symptoms associated with gastrointestinal gas.

4.2 Posology And Method Of Administration

Adults, elderly and children over 12 years:

One tablet to be taken three or four times daily or as required for relief, after meals and upon retiring. The tablets are to be chewed before swallowing.

Not recommended for children under 12 years.

4.3 Contraindications

The product should not be used in patients with known hypersensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

If symptoms persist or worsen, medical advice should be sought.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

Since simeticone is not absorbed by the gastro intestinal tract, Wind-Eze may be taken during pregnancy and lactation.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Rarely hypersensitivity reactions such as rash, pruritus, facial oedema, tongue oedema, respiratory difficulty.

4.9 Overdose

In the unlikely event of deliberate or accidental overdosage, treat

1. Name Of The Medicinal Product

Woodward's Gripe Water- Alcohol Free & Sugar Free.

2. Qualitative And Quantitative Composition

Terpeneless Dill Seed Oil 2.3mg/5ml; Sodium Hydrogen Carbonate 52.5mg/5ml.

3. Pharmaceutical Form

Oral solution.

4. Clinical Particulars

4.1 Therapeutic Indications

For the symptomatic relief of distress associated with wind in infants up to one year old.

4.2 Posology And Method Of Administration

For oral use.

Adults including the elderly: not applicable.

Children 1-6 months: one 5ml spoonful.

Children 6-12 months: two 5ml spoonsful.

Children under 1 month: not to be used.

These doses may be given during or after each feed or up to six times in 24 hours.

4.3 Contraindications

Should not be used where impaired kidney function or hypersensitivity to hydroxybenzoates exists.

4.4 Special Warnings And Precautions For Use

If symptoms persist, medical advice should be sought. Keep all medicines out of the reach of children.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

Not applicable.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

None known.

4.9 Overdose

Symptoms following overdose are rare and are generally due to the effects of sodium hydrogen carbonate. These may include diarrhoea, metabolic alkalosis and hypernatraemia. In the event of severe overdosing, medical advice should be

1. Name Of The Medicinal Product

Wilzin 50 mg hard capsules

2. Qualitative And Quantitative Composition

Each hard capsule contains 50 mg of zinc (corresponding to 167.84 mg of zinc acetate dihydrate).

For excipients, see section 6.1.

3. Pharmaceutical Form

Hard capsule.

Size 1 hard capsule with orange opaque cap and body, imprinted "93-377”.

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of Wilson's disease.

4.2 Posology And Method Of Administration

Wilzin treatment should be initiated under the supervision of a physician experienced in the treatment of Wilson's disease (see section 4.4). Wilzin is a life-long therapy.

There is no difference in dosage between symptomatic and presymptomatic patients.

Wilzin is available in hard capsules of 25 mg or 50 mg.

•Adults:

The usual dosage is 50 mg 3 times daily with a maximum dose of 50 mg 5 times daily.

•Children and adolescents:

Data are very limited in children under 6 years but since the disease is fully penetrant, prophylactic treatment should be considered as early as possible. The recommended dosage is as follows:

- from 1 to 6 years: 25 mg twice daily

- from 6 to 16 years if bodyweight under 57 kg: 25 mg three times daily

- from 16 years or if bodyweight above 57 kg: 50 mg three times daily.

•Pregnant women:

A dosage of 25 mg 3 times daily is usually effective but the dosage should be adjusted to copper levels (see

1. Name Of The Medicinal Product

Warfarin 3mg Tablets

2. Qualitative And Quantitative Composition

Each tablet contains 3mg Warfarin Sodium Ph.Eur.

3. Pharmaceutical Form

Tablet

4. Clinical Particulars

4.1 Therapeutic Indications

Prophylaxis of systemic embolism in patients with rheumatic heart disease and atrial fibrillation.

Prophylaxis after insertion of prosthetic heart valves.

Prophylaxis and treatment of venous thrombosis and pulmonary embolism.

Transient attacks of cerebral ischaemia.

4.2 Posology And Method Of Administration

Adults: The typical induction dose is 10mg daily for 2 days but this should be tailored to individual requirements. The daily maintenance dose is usually 3 to 9mg taken at the same time each day. The exact maintenance dose depends on the prothrombin time or other appropriate coagulation tests.

Control tests should be made at regular intervals and the maintenance dose should be adjusted according to the results obtained. Once the maintenance dose is established, it is rarely necessary to alter it.

In emergencies, anticoagulant therapy should be initiated with heparin and warfarin together.

Concomitant therapy with heparin affects the results of control tests, and should be discontinued at least six hours before the first test is carried out.

Elderly: As for adults, but dosage may need to be lowered.

Children: Dosage for children has not been established.

Method of administration: Oral.

4.3 Contraindications

• Known hypersensitivity to warfarin or to any of the excipients

• Haemorrhagic stroke (see

1. Name Of The Medicinal Product

Wellvone 750 mg/5 ml oral suspension

2. Qualitative And Quantitative Composition

Each ml of suspension contains 150 mg atovaquone

A unit dose of 5 ml contains 750 mg atovaquone.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Oral suspension.

Wellvone oral suspension is a bright yellow liquid

4. Clinical Particulars

4.1 Therapeutic Indications

Wellvone Suspension is indicated for:

Acute treatment of mild to moderate Pneumocystis pneumonia (PCP, caused by Pneumocystis jiroveci, formerly classified as P. carinii) (alveolar - arterial oxygen tension difference [(A-a) DO₂] < 45 mmHg (6 kPa) and oxygen tension in arterial blood (PaO₂)

4.2 Posology And Method Of Administration

The importance of taking the full prescribed dose of Wellvone with food should be stressed to patients. The presence of food, particularly high fat food, increases bioavailability two to three fold.

Dosage in adults

Pneumocystis pneumonia:

The recommended oral dose is 750 mg twice a day (1 x 5 ml morning and evening) administered with food each day for 21 days.

Higher doses may be more effective in some patients (see section 5.2).

Dosage in Children

Clinical efficacy has not been studied.

Dosage in the Elderly

There have been no studies of Wellvone in the elderly (see section 4.4).

Renal or hepatic impairment

Wellvone has not been specifically studied in

1. Name Of The Medicinal Product

Warfarin 1mg Tablets

2. Qualitative And Quantitative Composition

Each tablet contains 1mg Warfarin Sodium Ph. Eur.

3. Pharmaceutical Form

Tablet

4. Clinical Particulars

4.1 Therapeutic Indications

Prophylaxis of systemic embolism in patients with rheumatic heart disease and atrial fibrillation.

Prophylaxis after insertion of prosthetic heart valves.

Prophylaxis and treatment of venous thrombosis and pulmonary embolism.

Transient attacks of cerebral ischaemia.

4.2 Posology And Method Of Administration

Adults: The typical induction dose is 10mg daily for 2 days but this should be tailored to individual requirements. The daily maintenance dose is usually 3 to 9mg taken at the same time each day. The exact maintenance dose depends on the prothrombin time or other appropriate coagulation tests.

Control tests should be made at regular intervals and the maintenance dose should be adjusted according to the results obtained. Once the maintenance dose is established, it is rarely necessary to alter it.

In emergencies, anticoagulant therapy should be initiated with heparin and warfarin together.

Concomitant therapy with heparin affects the results of control tests, and should be discontinued at least six hours before the first test is carried out.

Elderly: As for adults, but dosage may need to be lowered.

Children: Dosage for children has not been established.

Method of administration: Oral.

4.3 Contraindications

• Known hypersensitivity to warfarin or to any of the excipients

• Haemorrhagic stro

1. Name Of The Medicinal Product

Water for Injections BP.

2. Qualitative And Quantitative Composition

Each 1ml of solution contains 1ml of Water for Injections.

3. Pharmaceutical Form

Solution for Injection.

Clear, colourless, odourless, sterile solution.

4. Clinical Particulars

4.1 Therapeutic Indications

Water for Injections is indicated to serve as a vehicle for dilution and reconstitution of suitable medicinal products for parenteral administration.

4.2 Posology And Method Of Administration

Dosage: The dosage administered will be dictated by the nature of the additive used. The administration rate will be dependent upon the dose regimen of the prescribed drug.

Administration: For parenteral use. The directions for use related to the added medicinal product will dictate the appropriate volumes as well as the administration route.

4.3 Contraindications

None known. The contraindications related to the added medicinal product should be considered.

4.4 Special Warnings And Precautions For Use

Water for Injections is hypotonic and it should not be administered alone because it may cause haemolysis.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

May be used during pregnancy and lactation. The risks during use in pregnancy and in lactating women are determined by the nature of the added medicinal products.

4.7 Effects On Ability To Drive And Use Machines

None.

1. Name Of The Medicinal Product

Winfex XL 75mg Prolonged Release Capsules

2. Qualitative And Quantitative Composition

Each prolonged release capsule contains venlafaxine hydrochloride equivalent to 75mg of venlafaxine.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Prolonged Release capsules

Winfex XL 75mg Capsules are opaque flesh capsules containing two 37.5mg tablets.

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of major depressive episodes.

For prevention of recurrence of major depressive episodes.

Treatment of social anxiety disorder.

4.2 Posology And Method Of Administration

Major depressive episodes

The recommended starting dose for prolonged-release venlafaxine is 75mg given once daily. Patients not responding to the initial 75mg/day dose may benefit from dose increases up to a maximum dose of 375mg/day. Dosage increases can be made at intervals of 2 weeks or more. If clinically warranted due to symptom severity, dose increases can be made at more frequent intervals, but not less than 4 days.

Because of the risk of dose-related adverse effects, dose increments should be made only after a clinical evaluation (see section 4.4). The lowest effective dose should be maintained.

Patients should be treated for a sufficient period of time, usually several months or longer. Treatment should be reassessed regularly on a case-by-case basis. Longer-term treatment may also be appropriate for prevention of recurrence of major depressive episodes (MDE). In most of the cases, the recommended dose in prevention of recurrence of MDE is the same as the one used during the cu

1. Name Of The Medicinal Product

Warfarin Tablets 5mg

2. Qualitative And Quantitative Composition

Each tablet contains 5 mg warfarin sodium ( as clathrate).

3. Pharmaceutical Form

Round pink uncoated tablet, scored and marked 'W5' on one side with company logo on reverse.

4. Clinical Particulars

4.1 Therapeutic Indications

For prophylaxis against venous thrombosis and pulmonary embolism, and for use in the treatment of these conditions to prevent their extension. For the prophylaxis of systemic embolisation in patients with rheumatic heart disease and atrial fibrillation.

4.2 Posology And Method Of Administration

Warfarin tablets are for oral administration.

An initial daily dose of 10mg on the first two days. Subsequent daily doses should be adjusted according to the results of the prothrombin time or other appropriate coagulation tests. The single daily maintenance requirement is usually between 5mg and 12mg, but can vary between 2mg and 30mg.

The maintenance dose is omitted if the prothrombin time is excessively prolonged.

Use in elderly patients: The elderly are generally more sensitive to the effects of warfarin and often require a smaller dose on a weight for weight basis than younger patients.

Target INR

By referring to the target INR (see below), the dosage of warfarin can be adjusted depending on the deviation of the patient's INR from the target value. An INR within 0.5 INR units of the target is considered to be generally satisfactory.

The following target INR values are based on guidelines from The British Society for Haematology:

1. Name Of The Medicinal Product

Wilzin25 mg hard capsules

2. Qualitative And Quantitative Composition

Each hard capsule contains 25 mg of zinc (corresponding to 83.92 mg of zinc acetate dihydrate).

For excipients, see section 6.1.

3. Pharmaceutical Form

Hard capsule.

Size 1 hard capsule with aqua blue opaque cap and body, imprinted "93-376”.

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of Wilson's disease.

4.2 Posology And Method Of Administration

Wilzin treatment should be initiated under the supervision of a physician experienced in the treatment of Wilson's disease (see section 4.4). Wilzin is a life-long therapy.

There is no difference in dosage between symptomatic and presymptomatic patients.

Wilzin is available in hard capsules of 25 mg or 50 mg.

•Adults:

The usual dosage is 50 mg 3 times daily with a maximum dose of 50 mg 5 times daily.

•Children and adolescents:

Data are very limited in children under 6 years but since the disease is fully penetrant, prophylactic treatment should be considered as early as possible. The recommended dosage is as follows:

- from 1 to 6 years: 25 mg twice daily

- from 6 to 16 years if bodyweight under 57 kg: 25 mg three times daily

- from 16 years or if bodyweight above 57 kg: 50 mg three times daily.

•Pregnant women:

A dosage of 25 mg 3 times daily is usually effective but the dosage should be adjusted to copper levels (se

1. Name Of The Medicinal Product

Wind-eze Gel Caps

2. Qualitative And Quantitative Composition

Each soft capsule contains: 125mg Simeticone (activated dimeticone)

For excipients see 6.1

3. Pharmaceutical Form

Capsule, soft.

The capsules are oval gelatin capsules with a white to off white opaque gelatin shell.

4. Clinical Particulars

4.1 Therapeutic Indications

The symptomatic relief of flatulence, wind pains, bloating, abdominal distension and other symptoms associated with gastrointestinal gas.

4.2 Posology And Method Of Administration

For oral administration:

Adults, children (12 years and above) and elderly:

One gel capsule to be taken three or four times daily or as required for relief, after meals and upon retiring.

Not recommended for children under 12 years of age.

4.3 Contraindications

The product should not be used in patients with known hypersensitivity to simeticone or to any excipients of the medicinal product.

4.4 Special Warnings And Precautions For Use

If symptoms persist or worsen, the patient should consult their medical practitioner for further investigation.

This medicinal product contains glycerol. Harmful in high doses. Can cause headache and can cause stomach upset and diarrhoea.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Although no studies have been presented, the concomitant use of this drug and mineral oil (paraffin) based laxatives is not recommended since mixing of these two will diminish the efficacy.

4.6 Pregnancy And Lactation

As thus far kno

1. Name Of The Medicinal Product

Welldorm Elixir

2. Qualitative And Quantitative Composition

Each 5ml of Welldorm Elixir contains 143.3mg of Chloral Hydrate BP.

For excipients see 6.1

3. Pharmaceutical Form

Oral Solution

4. Clinical Particulars

4.1 Therapeutic Indications

Welldorm elixir is used for the short-term treatment of severe insomnia which is interfering with normal daily life and where other therapies have failed.

Welldorm should be used as an adjunct to non pharmacological therapies.

In children aged 2-11 years treatment should be as an adjunct to behavioural therapy and sleep hygiene management, and usually for duration of less than 2 weeks

The use of hypnotics in children and adolescents is not generally recommended and if used should be under the supervision of a medical specialist

4.2 Posology And Method Of Administration

Route of administration: oral. Welldorm should be administered as a single daily dose, 15-30 minutes before bedtime with water or milk.

Adults and children 12 years and over: The usual dose is 15-30ml (430 –860 mg). Higher doses should not exceed a maximum of 70ml of elixir (2g chloral hydrate) per dose.

Elderly: Dosage as for adults except for the frail elderly or those with hepatic impairment, where a reduction in dose may be appropriate.

Children (between 2 and 11 years): 1–1.75 ml/kg (30-50mg/kg) of bodyweight. The dose should not exceed 35ml (1g) chloral hydrate.

Children (under 2 years): not recommended

4.3 Contraindications

Welldorm Elixir should not be used in patients with a