Package Leaflet: Information for the User

Med \

Levetiracetam Medsolutions 100mg/ml

“ Oral solution

' Levetiracetam

iRead all ofthis leaflet carefully before you start taking this medicine because it contains important information for you.

» Keep this leaflet. You may need to read it ¹ again.

|> If you have any further questions, ask your doctor or pharmacist.

|> This medicine has been prescribed for you. Do not pass it onto 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 Oral Solution is and what it is used for

2.    What you need to know before you take Levetiracetam Oral Solution

3.    How to take Levetiracetam Oral Solution |4. Possible side effects

.5. How to store Levetiracetam Oral Solution 6. Contents of the pack and other information

Driving and using machines

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

activities is not affected.    i

Levetiracetam Oral Solution contains

Levetiracetam oral solution includes methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed).

Levetiracetam oral solution also contains maltitol. If you have been told by your doctor that you have I an intolerance to some sugars, contact your doctor, before taking this medicinal product.    ¹

3. How to take Levetiracetam Oral Solution

f Take the syringe and put it in the adaptor I opening(figure4). Turnthebottleupsidedown ¹ (figure 5).

|> Fill the syringe with a small amount of solution by pulling the piston down (figure 5A), then push the piston upward in order to remove any possible bubble (figure 5B). Pull the piston

down to the graduation mark corresponding to the quantity in milliliters (ml) prescribed by your doctor (figure 5C).

Uncommon: (may affect 1 to 10 users in 1000)

*    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 (loss of concentration);    i

*    decreased number of blood platelets, ' decreased numberofwhite blood cells;

* weight decrease, weight increase;    ¹

*    diplopia (double vision), vision blurred;|_ _

*    injury

*    muscle weakness, myalgia (muscle pain);

*    elevated/abnormal values in a liver function test;

*    hair loss, eczema, pruritus;

ktt

ention

1. What Levetiracetam Oral Solution is and what it is used for

Levetiracetam 100 mg/ml oral solution is an ^ntiepileptic medicine (a medicine used to treat seizures in epilepsy).

Levetiracetam is used:

L 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 i 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 I numberoffits.

. as an add-on to other antiepileptic medicines to ' treat:

i . 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

I (the type of epilepsy that is thought to have I    a genetic cause).

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

2. What you need to know before you take Levetiracetam Oral Solution

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

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

Take Levetiracetam Oral Solution following your doctor's instructions.

Monotherapy

Dose in adults and adolescents (from 16years ofaae):

General dose: between 10 ml (1,000 mg) and 30 ml (3,000 mg) each day, divided in 2 intakes per day.

When you will first start taking Levetiracetam, your doctor will prescribe you a lower dose during 2 weeks before giving you the lowest general dose.

Add-on therapy

Dose in adults and adolescents (12to17 years) weighing 50 kg or more:

General dose: between 10 ml (1,000 mg) and 30 ml (3,000 mg) each day, divided in 2 intakes per day.

Dose in infants (6 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 your age, weight and dose.

General dose: between 0.2 ml (20 mg) and 0.6 ml (60 mg) per kg bodyweight each day, divided in 2 intakes per day. The exact quantity of oral solution formulation should be delivered using the syringe provided in the cardboard box.

• Turn the bottle the right way up (figure 6A). Remove the syringe from the adaptor (figure

water or baby's bottle by pushing the piston to the bottom of the syringe (figure 7).

*    Drink the whole contents of the glass/baby's bottle.

*    Drink the whole contents of the glass/baby's bottle

* Close the bottle with the plastic screw cap.

.Duration of Treatment:

l Levetiracetam is used as a chronic treatment.

, You should continue Levetiracetam treatment I for as long as your doctor has told you.

• Do not stop your treatment without your ' doctor's advice as this could increase your i seizures.

Rare: (may affect 1to10 users in 10,000)

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

*    infection;

*    decreased number of all blood cell types;

*    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;

*    hepatic 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% ofthe body surface (toxic epidermal necrolysis).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via

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 Oral Solution

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

Do not use this medicine after the expiry date stated on the cardboard box and bottle after EXP:. The expiry date refers to the last day of the month. Do not use after 7 months of first opening the bottle.

Store in the original container in order to protect from light.

Do not take Levetiracetam Oral Solution:

•    if you are allergic (hypersensitive) to

' Levetiracetam or any of the other ingredients of i this medicine (see section 6).

gamings and Precautions

Talk to your doctor or pharmacist before taking |Levetiracetam Oral Solution:

•    if you notice any slow down in the growth or unexpected puberty development of your child

•    if you suffer from kidney problems, follow your

I doctor's instructions. Doctor may decide if your I dose should be adjusted.

I 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.

Children and adolescents

Levetiracetam Oral Solution is not indicated in children and adolescents below 16 years on it's own (monotherapy)

Other medicines and Levetiracetam:

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,

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

Levetiracetam Oral solution with food, drink nd alcohol

his solution can be taken with or without food. Do |not take Levetiracetam with alcohol, as a safety precaution.

Pregnancy, breast-feeding and fertility

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

Dose in infants (1 month to less than 6 months):

General dose: between 0.14 ml (14 mg) and 0.42 ml (42 mg) per kg bodyweight each day, divided in 2 intakes per day. The exact quantity ofsolution should be delivered using the syringe provided in the cardboard box.

Method ofadministration:

Levetiracetam Oral Solution may be diluted in a glass ofwater or baby's bottle. You may take Levetiracetam with or without food.

Instructions for Use:

* Open the bottle: press the cap and turn it anticlockwise (figure 1)

Jfyou take more Levetiracetam than you should

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

You should contact your doctor if you took more Levetiracetam than you should. Your doctor will establish the best possible treatment of overdose.

If you forget to take Levetiracetam

Ilf you forget to take one or more doses then contact your doctor.

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

Ifyou stop taking Levetiracetam

|lf 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 ^bout the gradual withdrawal of Levetiracetam.

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

^sk your doctor or pharmacist if you have any further questions on the use ofthis product,

4. Possible Side Effects

[This solution should not be used in pregnancy unless clearly necessary. A risk of birth defects for ^our 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.

L

Separate the adaptor from the syringe (figure2). Insert the adaptor into the bottle neck (figure 3). Ensure it is well fixed.

Like all medicines, this medicine can cause side effects, although not everybody gets them. The most frequently reported adverse reactions were nasopharyngitis, somnolence (sleepiness), headache, fatigue and dizziness. Some of the side effects like sleepiness, tiredness and dizziness may be more common at the beginning of the treatment or at dose increase. These effects phould however decrease over time.

Tell your doctor if you notice any of the following side effects or notice any other effects not listed:

^ery common (may affect more than 1 user in

,10):

*    somnolence (sleepiness), headache |> nasopharyngitis

Common (may affect 1to10 users in 100):

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

*    depression, hostility or aggression, anxiety, insomnia, nervousness or irritability;

*    vertigo (sensation of rotation);

|> anorexia (loss of appetite);

*    abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea;

*    cough;

|> rash;

*    asthenia/fatigue (tiredness).

What Levetiracetam Oral Solution contains

The active substance is Levetiracetam. Each 1 ml ofsolution contains 100 mg ofthe active ingredient.

The other ingredients are sodium citrate, citric acid anhydrous, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), ammonium glycyrrhizate, acesulfame potassium (E950), glycerol (E422), Liquid maltitol (E965), grape flavour, sucralose and purified water.

What Levetiracetam Oral Solution looks like and contents of the pack

Levetiracetam Oral Solution is a clear, colourless to light yellow colour liquid.

The 300 ml glass bottle (for children aged 4 years and above, adolescents and adults) is packed in a cardboard box containing a10ml oral syringe (graduated every 0.25ml) and an adaptor for the syringe.

The 150 ml glass bottle (for infants and young children aged from 6 months to less than 4 years) is packed in a cardboard box containing a3ml oral syringe (graduated every 0.1ml) and an adaptor for the syringe.

The 150 ml glass bottle (for infants aged 1 month to less than 6 months) is packed in a cardboard box containing a 1 ml oral syringe (graduated every 0.05ml) and an adaptor for the syringe.

Marketing Authorisation Holder and Manufacturer:

The Marketing Authorisation Holder for your solution are:

Medsolutions (Europe) Limited,

Cavendish House, 369 Burnt Oak Broadway, Edgware, HA8 5AW, United Kingdom

The manufacturers for your solution is:

Wave Pharma Limited,

4th Floor Cavendish House,

369 Burnt Oak Broadway,

Edgware, HA8 5AW, United Kingdom

If you would like this leaflet in different format information or want to report any side effects please contact marketing authorisation holder listed above.

This leaflet was last revised in October 2016

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