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1. Name Of The Medicinal Product

Lamisil® AT 1% Spray

2. Qualitative And Quantitative Composition

10mg terbinafine hydrochloride per 1g spray solution

For excipients, see Section 6.1.

3. Pharmaceutical Form

Cutaneous spray, solution

4. Clinical Particulars

4.1 Therapeutic Indications

The treatment of tinea pedis (athlete's foot) and tinea cruris, (dhobie (jock) itch) caused by Trichophyton (e.g. T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum) and Epidermophyton floccosum.

4.2 Posology And Method Of Administration

Adults

Lamisil AT 1% Spray is applied once daily, for one week. Cleanse and dry the affected areas thoroughly before applying Lamisil AT 1% Spray from a distance of 5 to 10 cm. A sufficient amount of spray solution should be applied to wet the treatment area(s) thoroughly, and to cover the affected skin and surrounding area.

Duration and frequency of treatment:

Interdigital type tinea pedis, and tinea cruris: Once a day for one week.

Relief of clinical symptoms usually occurs within a few days. Irregular use or premature discontinuation of treatment carries the risk of recurrence. If there are no signs of improvement after two weeks, a physician should be consulted.

Use of Lamisil AT 1% Spray in the elderly

There is no evidence to suggest that elderly patients require different dosages or experience side effects different from those in younger patients.

Use of Lamisil AT 1% Spray in children

Not to be used in children under 16 years

6911901D

7-04

222

LIDOCAINE HYDROCHLORIDE INJECTION

BP MINIJET 1% & 2% w/v

SOLUTION FOR INJECTION

Please read this leaflet carefully. It contains important information about your medicine. If there is anything you do not understand, please ask your doctor.

What is this medicine?

This medicine is called Lidocaine hydrochloride Injection BP Minijet. There are two strengths available. One contains 10mg lidocaine hydrochloride per ml in vials of 10ml and the other 20mg lidocaine hydrochloride per ml in vials of 5ml, as the active ingredient.

The active ingredient in this medicine is Lidocaine hydrochloride. This is the new name for Lidocaine (Lignocaine) hydrochloride. The ingredient itself has not changed.

They also contain hydrochloric acid, sodium chloride, sodium hydroxide and water for injections.

Lidocaine is a local anaesthetic. It numbs the area of the body it is applied to.

Who makes it?

Marketing Authorisation Holder:

International Medication Systems (UK) Limited
208 Bath Road
Slough
Berkshire
SL1 3WE
UK

Manufacturer:

International Medication Systems (UK) Ltd.
Unit 14

LIORESAL Tablets 10 mg

(baclofen)

What you need to know about Lioresal 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 Lioresal Tablets are, and what they are used for
  • 2. Things to consider before you start to take Lioresal Tablets
  • 3. How to take Lioresal Tablets
  • 4. Possible side effects
  • 5. How to store Lioresal Tablets
  • 6. Further information

What Lioresal Tablets are and what they are used for

Lioresal Tablets contain 10 mg of the active ingredient baclofen.

Baclofen is a muscle-relaxant drug. Lioresal Tablets are used to relieve muscle spasms which may occur as a result of certain illnesses affecting the nervous system including multiple sclerosis, motor neurone disease, cerebral palsy and meningitis, or following stroke or injuries to the head or spine.

1. Name Of The Medicinal Product

Lemsip Max All in One Lemon

Powder for Oral Solution

2. Qualitative And Quantitative Composition

Each sachet (4.8g) of this product contains:

Active Ingredients:

Excipients:

1000mg Paracetamol

61.5mg Aspartame – a source of phenylalanine

200mg Guaifenesin

1973.3mg per sachet of sucrose

12.2mg Phenylephrine Hydrochloride

129.0mg (5.6mmol) of sodium

For full list of excipients, see Section 6.1.

3. Pharmaceutical Form

Powder for oral solution

Pale yellow powder.

4. Clinical Particulars

4.1 Therapeutic Indications

For the relief of symptoms of colds and influenza, including the relief of aches and pains, sore throat, headache, nasal congestion, lowering of temperature and chesty coughs.

4.2 Posology And Method Of Administration

Oral administration after dissolution in water.

Adults and adolescents 12 years and over: One sachet dissolved by stirring in hot water and sweeten

1. Name Of The Medicinal Product

Librium 10mg Capsules

2. Qualitative And Quantitative Composition

Each 10mg capsule contains 10mg of the active ingredient chlordiazepoxide hydrochloride BP.

3. Pharmaceutical Form

Librium Capsules 10mg

4. Clinical Particulars

4.1 Therapeutic Indications

Short-term (2

Muscle spasm of varied aetiology.

Symptomatic relief of acute alcohol withdrawal.

4.2 Posology And Method Of Administration

Adults

Anxiety states

Usual dose

Up to 30mg daily in divided doses.

 

 

Maximum dose

Up to 100mg daily in divided doses.

Adjusted on an individual basis.

 

 

 

 

 

 

1. Name Of The Medicinal Product

Lemsip Max Cold & Flu Capsules

2. Qualitative And Quantitative Composition

Active ingredients

mg/capsule

Specification

Paracetamol

500

Ph Eur

Caffeine

25

Ph.Eur

Phenylephrine hydrochloride

6.1

Ph Eur

3. Pharmaceutical Form

Red/yellow hard gelatine capsules

4. Clinical Particulars

4.1 Therapeutic Indications

For the relief of symptoms associated with the common cold and influenza, including relief of aches and pains, sore throat, headache, fatigue and drowsiness, nasal congestion, and lowering of temperature.

4.2 Posology And Method Of Administration

1. Name Of The Medicinal Product

Levitra 10 mg orodispersible tablets

2. Qualitative And Quantitative Composition

Each orodispersible tablet contains 10 mg of vardenafil (as hydrochloride).

Excipients:

7.96 mg sorbitol (E420), and 1.80 mg aspartame (E951) per orodispersible tablet.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Orodispersible tablet.

White round tablets.

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of erectile dysfunction in adult men. Erectile dysfunction is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance.

In order for Levitra to be effective, sexual stimulation is required.

4.2 Posology And Method Of Administration

Posology

Levitra 10 mg orodispersible tablet is not bioequivalent to Levitra 10 mg film-coated tablet (see section 5.1). The maximum dose for Levitra orodispersible tablet is 10 mg/day.

Use in adult men

Levitra 10 mg orodispersible tablets are taken as needed approximately 60 minutes before sexual activity.

Special populations

Elderly population (

Dose adjustments are not required in elderly patients. However, an increase to a maximum dose of Levitra 20 mg film-coated tablets should be carefully considered depending on the individual tolerability (see sections 4.4 and 4.8).

Hepatic impairment

Levitra 10 mg orodispersible tablets are not indicated as a starting dose in patien

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 50/12.5MG FILM-COATED TABLETS

Read all of this leaflet carefully before taking this medicine.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, 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 if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

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

What Losartan Potassium And Hydrochlorothiazide Is And What It Is Used For

  • Losartan potassium and Hydrochlorothiazide is a combination of an angiotensin-II receptor antagonists (losartan) and a diuretic (hydrochlorothiazide).
  • Losartan potassium and Hydrochlorothiazide is indicated for the treatment of essential hypertension (high blood pressure).

Before You Take Losartan Potassium And Hydrochlorothiazide

Do not take Losartan potassium and Hydrochlorothiazide

  • If you are allergic (hypersensitive) to losartan, hydrochlorothiazide or any of the other ingredients in this medicine
  • If you are al

1. Name Of The Medicinal Product

LUSTRAL™ 50mg film coated tablets

LUSTRAL™ 100mg film coated tablets

2. Qualitative And Quantitative Composition

Each tablet contains Sertraline hydrochloride equivalent to 50 mg or 100 mg sertraline.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Film-coated tablet

50mg white, capsular shaped, film-coated scored tablets coded 'ZLT-50' on one side and 'PFIZER' on the other. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

100mg white, capsular shaped, film-coated tablets coded 'ZLT-100' on one side and 'PFIZER' on the other.

4. Clinical Particulars

4.1 Therapeutic Indications

Sertraline is indicated for the treatment of:

Major depressive episodes. Prevention of recurrence of major depressive episodes.

Panic disorder, with or without agoraphobia.

Obsessive compulsive disorder (OCD) in adults and paediatric patients aged 6-17 years.

Social anxiety disorder.

Post traumatic stress disorder (PTSD).

4.2 Posology And Method Of Administration

Sertraline should be administered once daily, either in the morning or evening.

Sertraline tablet can be administered with or without food.

Initial treatment

Depression and OCD

Sertraline treatment should be started at a dose of 50 mg/day.

Panic Disorder, PTSD, and Social Anxiety Disorder

Therapy should be initiated at 25 mg/day. After one week, the

1. Name Of The Medicinal Product

LAMOTRIGINE 25mg TABLETS

2. Qualitative And Quantitative Composition

Each tablet contains 25mg Lamotrigine.

For excipients, see 6.1

3. Pharmaceutical Form

Tablet.

Light yellow, round, flat, uncoated tablets with a score line on one side.

4. Clinical Particulars

4.1 Therapeutic Indications

Epilepsy

Adults and adolescents aged 13 years and above

? Adjunctive or monotherapy treatment of partial seizures and generalised seizures, including tonic-clonic seizures.

? Seizures associated with Lennox-Gastaut syndrome. Lamotrigine Tablets is given as adjunctive therapy but may be the initial antiepileptic drug (AED) to start with in Lennox-Gastaut syndrome.

Children and adolescents aged 2 to 12 years

? Adjunctive treatment of partial seizures and generalised seizures, including tonic-clonic seizures and the seizures associated with Lennox-Gastaut syndrome.

? Monotherapy of typical absence seizures.

Bipolar disorder

Adults aged 18 years and above

? Prevention of depressive episodes in patients with bipolar I disorder who experience predominantly depressive episodes (see section 5.1).

Lamotrigine Tablets is not indicated for the acute treatment of manic or depressive episodes.

4.2 Posology And Method Of Administration

Metho

1. Name Of The Medicinal Product

Levofloxacin 250 mg Film-coated Tablets

2. Qualitative And Quantitative Composition

Each film coated tablet contains 250 mg of levofloxacin as active substance corresponding to 256.23 mg of levofloxacin hemihydrate.

For a full list of excipients, see section 6.1

3. Pharmaceutical Form

Film-coated tablet

For 250 mg tablets: Pink coloured, capsule shaped, biconvex, film coated tablet with break line on both sides. Debossed 'L' and 'F' either side of the break line on one face.

The tablets can be divided into equal halves.

4. Clinical Particulars

4.1 Therapeutic Indications

In adults with infections of mild or moderate severity, Levofloxacin Tablets are indicated for the treatment of the following infections when due to levofloxacin-susceptible microorganisms: (see section 5.1)

• Acute sinusitis (adequately diagnosed according to national and/or local guidelines on the treatment of respiratory tract infections, and when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of this infection or when these have failed to resolve the infection),

• Acute exacerbations of chronic bronchitis (adequately diagnosed according to national and/or local guidelines on the treatment of respiratory tract infections, and when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of this infection or when these have failed to resolve the infection),

• Community-acquired pneumonia (when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of this infection),

• For 250mg onl

1. Name Of The Medicinal Product

Levofloxacin 5mg/ml Solution for Infusion

2. Qualitative And Quantitative Composition

250mg levofloxacin (as hemihydrate) in 50ml solution.

500mg levofloxacin (as hemihydrate) in 100ml solution.

1ml of solution for infusion contains 5mg levofloxacin.

Each 50ml bag contains approximately 7,7mmol (177mg) sodium.

Each 100ml bag contains approximately 15,4mmol (354mg) sodium.

1ml of solution for infusion contains approximately 154 micromol (3,54mg) sodium.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Solution for infusion.

Levofloxacin 5mg/ml solution for infusion is a clear yellow to a greenish-yellow solution with pH ranging from 3.8 to 5.8 and osmolality ranging from 285 to 310 mOsm/kg.

4. Clinical Particulars

4.1 Therapeutic Indications

In adults for whom intravenous therapy is considered to be appropriate, Levofloxacin solution for infusion is indicated for the treatment of the following infections when due to levofloxacin-susceptible microorganisms:

• Community-acquired pneumonia (when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of this infection).

• Complicated urinary tract infections including pyelonephritis.

• Chronic bacterial prostatitis.

• Skin and soft tissue infections.

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

4.2 Posology And Method Of Administration

Intravenous use

Levofloxacin solution for infusion is admi

1. Name Of The Medicinal Product

Lomont 70mg/5ml Oral Suspension

2. Qualitative And Quantitative Composition

Active Ingredient Per 5ml
Lofepramine Hydrochloride, 76.1mg
(equivalent to Lofepramine base) 70mg

3. Pharmaceutical Form

A white to pale yellow/orange suspension with odour of Cherry.

4. Clinical Particulars

4.1 Therapeutic Indications

For the treatment of symptoms of depressive illness.

4.2 Posology And Method Of Administration

Adults: The usual dose 70mg twice daily (140mg) or three times daily (210mg) depending upon patient response.

Elderly: Elderly patients may respond to lower doses in some cases.

Children: Not recommended

4.3 Contraindications

Lofepramine should not be used in patients hypersensitive to dibenzazepines, in mania, severe liver impairment and/or severe renal impairment, heart block, cardiac arrhythmias, or during the recovery phase following a myocardial infarction.

Lofepramine should not be administered with or within 2 weeks of cessation of therapy with monoamine oxidase inhibitors (see Section 4.5).

Use of lofepramine with amiodarone should be avoided (see Section 4.5).

Use of lofepramine with terfenadine should be avoided (see Section 4.5).

4.4 Special Warnings And Precautions For Use

It should be rememb

1. Name Of The Medicinal Product

Levothyroxine 100micrograms Tablets (Thyroxine 100 micrograms Tablets).

2. Qualitative And Quantitative Composition

Each tablet contains 100 micrograms Levothyroxine Sodium anhydrous also known as thyroxine sodium tablets.

3. Pharmaceutical Form

Tablet.

White uncoated biconvex tablets engraved on one face FW31 and with a breakline on the other.

4. Clinical Particulars

4.1 Therapeutic Indications

Recommended clinical indications: Control of hypothyroidism, congenital hypothyroidism and juvenile myxoedema.

4.2 Posology And Method Of Administration

Adults:

Initially 50 to 100 micrograms daily, preferably taken before breakfast. Adjust at three to four week intervals by 50 micrograms until normal metabolism is steadily maintained: this may require doses of 100 to 200 micrograms daily.

For patients over 50 years, it is not advisable to exceed 50 micrograms daily initially and where there is cardiac disease, 25 micrograms daily or 50 micrograms on alternate days is more suitable initially. In this condition the daily dose may be increased by 25 micrograms at intervals of perhaps 4 weeks.

For patients younger than 50 years, and in the absence of heart disease, a serum Levothyroxine (T4) level of 70 to 160 nanomoles per litre, or a serum thyrotrophin level of less than 5 milli-units per litre should be targeted. For patients aged over 50 years, with or without cardiac disease, clinical response is probably a more acceptable criteria of dosage rather than serum levels.

A pre-therapy ECG is valuable because ECG changes due to hypothyroidism may be confused with ECG evidence of cardiac ischaemia. If too rapid an inc

1. Name Of The Medicinal Product

Lemsip Max Cold & Flu Direct Lemon.

2. Qualitative And Quantitative Composition

Active ingredients

mg/Sachet

Paracetamol

1000.0

Phenylephrine hydrochloride

*12.2

*This is equivalent to 10 mg phenylephrine base.

For excipients, see 6.1.

3. Pharmaceutical Form

Oral powder.

A white to off-white unit-dose powder with the odour and flavour of lemons.

4. Clinical Particulars

4.1 Therapeutic Indications

For relief of symptoms associated with the common cold and influenza, including the relief of aches and pains, sore throat, headache, nasal congestion and lowering of temperature.

4.2 Posology And Method Of Administration

Oral administration.

Adults and children 12 and over: One single-dose container. The product is taken orally without water.

The dose may be repeated in 4 hours.

No more than four doses should be taken in 24 hours.

Not to be given to children under 12 without m

1. Name Of The Medicinal Product

Lemsip Max All in One Cold & Flu Capsules.

2. Qualitative And Quantitative Composition

Each capsule contains paracetamol 500mg, phenylephrine hydrochloride 6.1mg and guaifenesin 100mg

For a full list of excipients, see Section 6.1.

3. Pharmaceutical Form

Capsule, hard

Capsules with a red cap and green body, printed 'Lemsip' on the cap in white ink, containing white, free flowing powder.

4. Clinical Particulars

4.1 Therapeutic Indications

For the relief of symptoms of cold and influenza, including the relief of aches and pains, sore throat, headache, nasal congestion, lowering of temperature and chesty coughs.

4.2 Posology And Method Of Administration

Adults (over 16 years and over): Two capsules every 4-6 hours to a maximum of four doses in any 24 hours.

Do not exceed eight capsules in any 24 hours.

Children (12-15 years): One capsule every 4-6 hours to a maximum of four doses in any 24 hours.

Do not exceed 4 capsules in any 24 hours.

Swallow whole with water. Do not chew.

Not recommended for children under 12 years of age.

4.3 Contraindications

Hypersensitivity to any of the ingredients. Severe coronary heart disease and cardiovascular disorders. Hypertension. Hyperthyroidism. Contraindicated in patients currently receiving or within two weeks of stopping therapy with monoamine oxidase inhibitors.

4.4 Special Warnings And Precautions For Use

Use with caution in patients with Raynaud's phenomenon or diabetes mellitus. Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impair

P023853

Losec Infusion 40 mg

Powder for solution for infusion

omeprazole

Please read all of this leaflet carefully before you are given this medicine.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor, nurse or pharmacist.
  • 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 Losec Infusion is and what it is used for
  • 2. Before Losec Infusion is given to you
  • 3. How Losec Infusion is given to you
  • 4. Possible side effects
  • 5. How to store Losec Infusion
  • 6. Further information

What Losec Infusion is and what it is used for

Losec Infusion contains a medicine called omeprazole. This belongs to a group of medicines called ‘proton pump inhibitors’. They work by reducing the amount of acid that your stomach produces.

Losec Infusion is used when you are unable to have treatment by mouth. It is used to treat:

  • ‘Gastro-oesophageal reflux disease’ (GORD).
  • Ulcers in the upper part of the intestine (duodenal ulcer) or stomach (gastric ulcer). If you have had an ulcer in the past and need to keep taking a medicine called an NSAID (Non-Steroidal Anti-Inflammatory Drug), Losec Infusion can stop ulcers from forming or heal one that is already there.
  • Prevention of d

1. Name Of The Medicinal Product

Lisinopril 40 mg tablets

2. Qualitative And Quantitative Composition

Each tablet contains 40 mg anhydrous lisinopril (as lisinopril dihydrate).

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Tablet.

40 mg tablets are light yellow coloured, capsule shaped, biconvex, uncoated tablets, debossed with 'L' on one side and on other side with '40'.

4. Clinical Particulars

4.1 Therapeutic Indications

Hypertension

Treatment of hypertension.

4.2 Posology And Method Of Administration

Lisinopril should be administered orally in a single daily dose. As with all other medication taken once daily, Lisinopril should be taken at approximately the same time each day. The absorption of Lisinopril tablets is not affected by food.

The dose should be individualised according to patient profile and blood pressure response (see section 4.4).

Hypertension

Lisinopril may be used as monotherapy or in combination with other classes of antihypertensive therapy.

Starting dose

In patients with hypertension the usual recommended starting dose is 10 mg. Patients with a strongly activated renin-angiotensin-aldosterone system (in particular, renovascular hypertension, salt and /or volume depletion, cardiac decompensation, or severe hypertension) may experience an excessive blood pressure fall following the initial dose. A starting dose of 2.5-5 mg is recommended in such patients and the initiation of treatment should take place under medical supervision. A lower starting dose is required in the presence of r

1. Name Of The Medicinal Product

Levetiracetam 1000 mg film-coated tablets

2. Qualitative And Quantitative Composition

Each film-coated tablet contains 1000 mg levetiracetam.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Film-coated tablet

White, oblong, biconvex coated tablets, scored on both sides and debossed with L9TT on one side and 1000 on the other side.

The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

4. Clinical Particulars

4.1 Therapeutic Indications

Levetiracetam is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy.

Levetiracetam is indicated as adjunctive therapy

• in the treatment of partial onset seizures with or without secondary generalisation in adults, children and infants from 1 month of age with epilepsy.

• in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy.

• in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with Idiopathic Generalised Epilepsy.

4.2 Posology And Method Of Administration

Posology

Monotherapy for adults and adolescents from 16 years of age

The recommended starting dose is 250 mg twice daily which should be increased to an initial therapeutic dose of 500 mg twice daily after two weeks. The dose can be further increased by 250 mg twice daily every two weeks depending upon

1. Name Of The Medicinal Product

Lamotrigine 100 mg dispersible/ chewable tablets

2. Qualitative And Quantitative Composition

Each Lamotrigine 100 mg dispersible/ chewable tablet contains 100 mg lamotrigine.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Dispersible/ chewable tablet

White to off-white, rounded square shaped uncoated tablets debossed with 'H' on multifaceted side and '78' on flat side.

4. Clinical Particulars

4.1 Therapeutic Indications

Epilepsy:

Adults and adolescents aged 13 years and above

• Adjunctive or monotherapy treatment of partial seizures and generalised seizures, including tonic-clonic seizures.

• Seizures associated with Lennox-Gastaut syndrome. Lamotrigine is given as adjunctive therapy but may be the initial antiepileptic drug (AED) to start with in Lennox-Gastaut syndrome.

Children and adolescents aged 2 to 12 years

• Adjunctive treatment of partial seizures and generalised seizures, including tonic-clonic seizures and the seizures associated with Lennox-Gastaut syndrome.

• Monotherapy of typical absence seizures.

Bipolar disorder:

Adults aged 18 years and above

• Prevention of depressive episodes in patients with bipolar I disorder who experience predominantly depressive episodes (see section 5.1).

Lamotrigine is not indicated for the acute treatment of manic or depressive episodes.

4.2 Posology And Method Of Administration