g PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

¹ LEVETIRACETAM Crescent 250 mg, 500 mg, 750 mg & / 000 mg Film Coated Tablets

Read all of this leaflet carefully before you or your child start taking this medicine because it contains important information for you.

•    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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See Section 4.

What is in this leaflet

1.    What Levetiracetam Crescent is and what it is used for

2.    What you need to know before you take Levetiracetam Crescent

3.    How to take Levetiracetam Crescent

4.    Possible side effects

5.    How to store Levetiracetam Crescent

6.    Contents of the pack and other information

1.    What Levetiracetam Crescent is and what it is used for

Levetiracetam Crescent is an antiepileptic medicine (a medicine used to treat seizures in epilepsy). Levetiracetam is used:

•    on its own in adults and adolescents from 16 years of age with newly diagnosed epilepsy, to treat a certain form of epilepsy. Epilepsy is a condition where the patients have repeated fits (seizures). Levetiracetam

is used for the epilepsy form in which the fits initially affect only one side of the brain, but could thereafter extend to larger areas on both sides of the brain (partial onset seizure with or without secondary generalisation). Levetiracetam has been given to you by your doctor to reduce the number of fits.

•    as an add-on to other antiepileptic medicines to treat:

-    partial onset seizures with or without generalisation in adults, adolescents, children and infants from one month of age

-    myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy

-    primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in adults and adolescents from 12 years of age with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).

2.    What you need to know before you take Levetiracetam Crescent

Do not take Levetiracetam:

•    if you are allergic to levetiracetam, pyrrolidone derivatives or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor before taking levetiracetam

•    If you suffer from kidney problems, follow your doctor’s instructions. He/she may decide if your dose should be adjusted.

•    If you notice any slow down in the growth or unexpected puberty development of your child, please contact your doctor

•    A small number of people being treated with anti-epileptics such as levetiracetam have had thoughts of harming or killing themselves. If you have any symptoms of depression and/or suicidal ideation, please contact your doctor.

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Levetiracetam is not indicated in children and adolescents below 16 years on its own (monotherapy).

Other medicines and Levetiracetam Crescent

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Do not take macrogol (a drug used as a laxative) for one hour before and one hour after taking levetiracetam as this may result in a loss of its effect.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Levetiracetam should not be used during pregnancy unless clearly necessary. A risk of birth defects for your unborn child cannot be completely excluded.

Levetiracetam has shown unwanted reproductive effects in animal studies at dose levels higher than you would need to control your seizures.

Breast-feeding is not recommended during treatment.

Driving and using machines

Levetiracetam may impair your ability to drive or operate any tools or machinery, as it may make you feel sleepy. This is more likely at the beginning of treatment or after an increase in the dose. You should not drive or use machines until it is established that your ability to perform such activities is not affected.

Levetiracetam Crescent 750 mg Tablets contain Sunset Yellow

These tablets contain Sunset Yellow (E110) a colouring agent which may cause allergic reactions.

3.    How to take Levetiracetam Crescent

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Take the number of tablets following your doctor’s instructions.

Levetiracetam must be taken twice a day, once in the morning and once in the evening, at about the same time each day.

Monotherapy

Dose in adults and adolescents (from 16 years of age):

General dose: between 1,000 mg and 3,000 mg each day.

When you will first start taking Levetiracetam Crescent, your doctor will prescribe you a lower dose (500mg each day) during 2 weeks before giving you the lowest general dose of 1000mg.

Add-on therapy

Dose in adults and adolescents (12 to 17 years) weighing 50 kg or more:

General dose: between 1,000 mg and 3,000 mg each day.

Example: if your daily dose is 1,000 mg, you might take 2 tablets of 250 mg in the morning and 2 tablets of 250 mg in the evening.

Dose in infants (1 month to 23 months), children (2 to 11 years) and adolescents (12 to 17 years) weighing less than 50 kg:

Your doctor will prescribe the most appropriate pharmaceutical form of Levetiracetam according to the age, weight and dose. Levetiracetam Crescent 100 mg/ml oral solution is a formulation more appropriate to infants and children under the age of 6 years and to children and adolescents (from 6 to 17 years) weighing less than 50kg and when tablets don’t allow accurate dosage.

Method of administration:

Swallow Levetiracetam Crescent tablets with a sufficient quantity of liquid (e.g. a glass of water). You may take the tablets with or without food.

Duration of treatment:

•    Levetiracetam is used as a chronic treatment. You should continue Levetiracetam treatment for as long as your doctor has told you.

<-■		Measure bar shi	ould be 150mm at 100% scale -		->
f		Customer	Crescent Pharma |		Colours Used ^
		Description	Levetiracetam 250, 500, 750 & lOOOmg Tablets	□	Process Black
		Item Code	P0393T	D	Keyline
		Profile	N/A
		Size	180 x 400mm
		Min. Point Size	9pt (Main body) 6pt (Item Code)
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		Market	UK
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		Language	English
Warning! We cannot accept responsibility for any errors in this proof after approval. Whilst we take extreme care at all times to ensure accuracy to our client's brief, the final responsibility must be taken by our client. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING ^ FULL APPROVAL OF DESIGN AND TEXT.		Proof By		—
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•    Do not stop your treatment without your doctor’s advice as this could increase your seizures.

If you take more Levetiracetam Crescent than you should

The possible side effects of an overdose of Levetiracetam Crescent are sleepiness, agitation, aggression, decrease of alertness, inhibition of breathing and coma.

Contact your doctor if you took more tablets than you should.

Your doctor will establish the best possible treatment of overdose.

If you forget to take Levetiracetam Crescent

Contact your doctor if you have missed one or more doses.

Do not take a double dose to make up for a forgotten dose.

If you stop taking Levetiracetam Crescent

If stopping treatment, Levetiracetam should be discontinued gradually to avoid an increase of seizures. Should your doctor decide to stop your Levetiracetam treatment, he/she will instruct you about the gradual withdrawal of Levetiracetam.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.    Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The most frequently reported side effects are nasopharyngitis, somnolence (sleepiness), headache, fatigue and dizziness. At the beginning of the treatment or at dose increase side effects like sleepiness, tiredness and dizziness may be more common. These effects should however decrease over time.

Very common: may affect more than 1 in 10 people

•    nasopharyngitis

•    somnolence (sleepiness), headache.

Common: may affect up to 1 in 10 people

•    anorexia (loss of appetite)

•    depression, hostility or aggression, anxiety, insomnia, nervousness or irritability

•    convulsion, balance disorder (equilibrium disorder), dizziness (sensation of unsteadiness), lethargy (lack of energy and enthusiasm), tremor (involuntary trembling)

•    vertigo (sensation of rotation)

•    cough

•    abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea

•    rash

•    asthenia/fatigue (tiredness).

Uncommon: may affect up to 1 in 100 people

•    decreased number of blood platelets, decreased number of white blood cells

•    weight decrease, weight increase

•    suicide attempt and suicidal ideation, mental disorder, abnormal behaviour, hallucination, anger, confusion, panic attack, emotional instability/mood swings, agitation

•    amnesia (loss of memory), memory impairment (forgetfulness), abnormal coordination/ataxia (impaired coordinated movements), paraesthesia (tingling), disturbance in attention (loss of concentration)

•    diplopia (double vision), vision blurred

•    elevated/abnormal values in a liver function test

•    hair loss, eczema, pruritus

•    muscle weakness, myalgia (muscle pain)

•    injury.

Rare: may affect up to 1 in 1000 people

•    infection

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•    severe allergic reactions (DRESS, anaphylactic reaction [severe and important allergic reaction], Quincke’s oedema [swelling of the face, lips, tongue and throat])

•    decreased blood sodium concentration

•    suicide, personality disorders (behavioural problems), thinking abnormal (slow thinking, unable to concentrate)

•    uncontrollable muscle spasms affecting the head, torso and limbs, difficulty in controlling movements, hyperkinesia (hyperactivity)

•    pancreatitis

•    liver failure, hepatitis

•    skin rash, which may form blisters and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme), a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and a more severe form causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis).

Reporting of side effects

If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Levetiracetam Crescent

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP:”.

The expiry date refers to the last day of that month.

Do not store above 30°C

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.    Contents of the pack and other information

What Levetiracetam Crescent contains

Levetiracetam Crescent is available in 4 strengths. Each tablet contains either 250mg, 500mg, 750mg or 1000mg of levetiracetam as the active ingredient.

The other ingredients are: macrogol 4000, croscarmellose sodium, talc, magnesium stearate and film coating containing polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc. Also the 250mg tablets contain indigo carmine aluminium lake (E132), the 500mg tablets contain iron oxide yellow (E172), and the 750mg tablets contain sunset yellow FCF aluminium lake (E110) and iron oxide red (E172).

What Levetiracetam Crescent looks like and contents of the pack

Levetiracetam Crescent 250mg film coated tablets are blue and oblong with a single score line on one side. Levetiracetam Crescent 500mg film coated tablets are yellow and oblong with a single score line on one side. Levetiracetam Crescent 750mg film coated tablets are light salmon and oblong with a single score line on one side.

Levetiracetam Crescent 10OOmg film coated tablets are white and oblong with a single score line on one side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Each pack contains 60 tablets.

Marketing Authorisation Holder and Manufacturer

Crescent Pharma Limited, Units 3 and 4, Quidhampton Business Units, Polhampton Lane, Overton, Hampshire, RG25 3ED, UK.

This leaflet was last revised in June 2016.

If you require this leaflet in a different format please contact the Marketing Authorisation Holder at the address above.

-■		Measure bar shi	ould be 150mm at 100% scale -		->
f		Customer	Crescent Pharma |		Colours Used ^
		Description	Levetiracetam 250, 500, 750 & lOOOmg Tablets	□	Process Black
		Item Code	P0393T	D	Keyline
		Profile	N/A
		Size	180 x 400mm
		Min. Point Size	9pt (Main body) 6pt (Item Code)
Approval
		Market	UK
Signature
		Language	English
Warning! We cannot accept responsibility for any errors in this proof after approval. Whilst we take extreme care at all times to ensure accuracy to our client's brief, the final responsibility must be taken by our client. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING ^ FULL APPROVAL OF DESIGN AND TEXT.		Proof By		—
		Proof No.	2
		Date	27/06/2016
		Artwork No.	666125 Code™ n/a		J