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D^sitin ArzneimitteIGmbHo mm - Laetus-Code: 150/300 ^mgPL, 11/15 1.3.2.EN-PL-UKpage 1 of 2

PATIENT INFORMATION LEAFLET

▼ This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Episenta® 150 mg prolonged-release capsule Episenta® 300 mg prolonged-release capsule

(sodium valproate)

(Referred to in this leaflet as Episenta)

In this leaflet:

1.    What Episenta is and what it is used for

2.    Before you take Episenta

3.    How to take Episenta

4.    Possible side effects

5.    How to store Episenta

6.    Further information

1. What Episenta is and what it is used for

Episenta contains the active ingredient sodium valproate, which belongs to a group of medicines called antiepileptics which are used to control epileptic seizures and mania.

Episenta is used in the treatment of

•    various types of epilepsy (seizures)

•    mania, where you may feel very excited, elated, agitated, enthusiastic or hyperactive. Mania occurs in an illness called „bipolar disorder". Episenta can be used when lithium cannot be used.

2. Before you take Episenta

Do NOT take Episenta capsules if:

•    you are allergic (hypersensitive) to sodium valproate or any of the other ingredients of the capsules (listed in Section 6 Further Information)

•    you, or a member of your family, have or have had severe liver problems

•    you suffer from a disease called porphyria (a rare condition that affects the breakdown of components of red blood cells)

•    you have a genetic problem causing a mitochondrial disorder (e.g. Alpers-Huttenlocher syndrome).

Before you take Episenta tell your doctor if:

•    you have systemic lupus erythematous (an allergic condition which causes joint pain, skin rashes and fever)

•    you have any metabolic disorders, particularly inherited enzyme deficiency disorders such as urea cycle disorder, because of a risk of an increased ammonia level in your blood

•    you have reduced kidney function. Your doctor may want to monitor the levels of sodium valproate in your blood and change your dose as necessary

•    you are pregnant, think you might be, or are planning to become pregnant

•    you are a woman of childbearing age. You should be informed of the risks and benefits of treatment with Episenta in pregnancy

•    you are breast feeding

•    you are being tested for diabetes, as Episenta may affect the results of urine tests

•    you know that there is a genetic problem causing a mitochondrial disorder in your family.

Taking/using other medicines

Tell your doctor if you are taking or have recently taken

any of the following medicines, as they may affect the

way Episenta works or they may be affected by Episenta:

•    colestyramine - used to reduce the level of blood lipids (fats)

•    other antiepileptic medicines e.g. phenytoin, primidone, carbamazepine, phenobarbital, lamotrigine, topiramate, felbamate

•    mefloquine and chloroquine - used to prevent and treat malaria

•    cimetidine - used to treat ulcers

•    antipsychotics - used to treat psychological disorders e.g. olanzapine

•    antidepressant - used to treat depression, including monoamine oxidase inhibitors

•    anticoagulation therapy- used to thin the blood e.g. warfarin

•    salicylates e.g. aspirin

•    antibiotics e.g. erythromycin, imipenem, meropenem

•    benzodiazepines - used as sleeping tablets and to treat anxiety

•    zidovudine - used to treat HIV and AIDS

•    temozolomide - used to treat cancer

•    r ifampicin - used to treat tuberculosis and other infections.

It may still be possible for you to take Episenta; your doctor will advise you on what is suitable for you.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Take special care with Episenta Capsules

A small number of people being treated with antiepileptics such as sodium valproate have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor. Children and adolescents Children and adolescents under 18 years of age: Episenta should not be used in children and adolescents under 18 years of age for the treatment of mania.

Pregnancy:

•    It is very important that you tell your doctor before you take Episenta if you are pregnant or are planning to become pregnant.

•    Tell your doctor immediately if you become pregnant whilst taking Episenta.

Important advice for women

•    Valproate can be harmful to unborn children when taken by a woman during pregnancy.

•    Valproate carries a risk if taken during pregnancy. The higher the dose, the higher the risks but all doses carry a risk.

•    It can cause serious birth defects and can affect the way in which the child develops as it grows. Birth defects which have been reported include spina bifida (where the bones of the spine are not properly developed); facial and skull malformations; heart, kidney, urinary tract and sexual organ malformations; limb defects.

•    If you take valproate during pregnancy you have a higher risk than other women of having a child with birth defects that require medical treatment. Because valproate has been used for many years we know that in women who take valproate around 10 babies in every 100 will have birth defects. This compares to 2 - 3 babies in every 100 born to women who don’t have epilepsy.

•    It is estimated that up to 30 - 40% of preschool children whose mothers took valproate during pregnancy may have problems with early childhood development. Children affected can be slow to walk and talk, intellectually less able than other children, and have difficulty with language and memory.

•    Autistic spectrum disorders are more often diagnosed in children exposed to valproate and there is some evidence children may be more likely to develop symptoms of Attention Deficit Hyperactivity Disorder (ADHD).

•    If you are a woman capable of becoming pregnant your doctor should only prescribe valproate for you if nothing else works for you.

•    Before prescribing this medicine to you, your doctor will have explained what might happen to your baby if you become pregnant whilst taking valproate. If you decide later you want to have a child you should not stop taking your medicine until you have discussed this with your doctor and agreed a plan for switching you onto another product if this is possible.

•    Ask your doctor about taking folic acid when trying for a baby. Folic acid can lower the general risk of spina bifida and early miscarriage that exists with all pregnancies. However, it is unlikely that it will reduce the risk of birth defects associated with valproate use.

FIRST PRESCRIPTION

If this is the first time you have been prescribed valproate your doctor will have explained the risks to an unborn child if you become pregnant. Once you are of childbearing age, you will need to make sure you use an effective method of contraception throughout your treatment. Talk to your doctor or family planning clinic if you need advice on contraception.

Key messages:

•    Make sure you are using an effective method of contraception.

•    Tell your doctor at once if you are pregnant or think you might be pregnant.

CONTINUING TREATMENT AND NOT TRYING FOR A BABY

If you are continuing treatment with valproate but you don’t plan to have a baby make sure you are using an effective method of contraception. Talk to your doctor or family planning clinic if you need advice on contraception.

Key messages:

•    Make sure you are using an effective method of contraception.

•    Tell your doctor at once if you are pregnant or think you might be pregnant.

CONTINUING TREATMENT AND CONSIDERING TRYING FOR A BABY

If you are continuing treatment with valproate and you are now thinking of trying for a baby you must not stop taking either your valproate or your contraceptive medicine until you have discussed this with your prescriber. You should talk to your doctor well before you become pregnant so that you can put several actions in place so that your pregnancy goes as smoothly as possible and any risks to you and your unborn child are reduced as much as possible.

Your doctor may decide to change the dose of valproate or switch you to another medicine before you start trying for a baby.

If you do become pregnant you will be monitored very closely both for the management of your underlying condition and to check how your unborn child is developing.

Ask your doctor about taking folic acid when trying for a baby. Folic acid can lower the general risk of spina bifida and early miscarriage that exists with all pregnancies. However, it is unlikely that it will reduce the risk of birth defects associated with valproate use.

Key messages:

•    Do not stop using your contraception before you have talked to your doctor and worked together on a plan to ensure your epilepsy/bipolar disorder is controlled and the risks to your baby are reduced.

•    Tell your doctor at once when you know or think you might be pregnant.

UNPLANNED PREGNANCY WHILST CONTINUING TREATMENT

Babies born to mothers who have been on valproate are at serious risk of birth defects and problems with development which can be seriously debilitating. If you are taking valproate and you think you are pregnant or might be pregnant contact your doctor at once. Do not stop taking your medicine until your doctor tells you to. Ask your doctor about taking folic acid. Folic acid can lower the general risk of spina bifida and early miscarriage that exists with all pregnancies. However, it is unlikely that it will reduce the risk of birth defects associated with valproate use.

Key messages:

•    Tell your doctor at once if you know you are pregnant or think you might be pregnant.

•    Do not stop taking valproate unless your doctor tells you to.

Make sure you read the patient booklet and sign the Acknowledgement of Risk form which should be given to you and discussed with you by your doctor or pharmacist.

Driving and using machines:

You may experience drowsiness when you first start taking Episenta, or if you are taking it with other medicines, such as other antiepileptic drugs or benzodiazepines. If affected you should not drive or operate machinery.

3. How to take Episenta

Always take Episenta capsules exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Episenta treatment must be started and supervised by a doctor specialised in the treatment of epilepsy or bipolar disorders.

Epilepsy:

Your doctor will decide the number of capsules you should take. This will depend on your age and weight and will be adjusted to achieve adequate control of your seizures.

The daily dosage may be taken as one single or two divided doses (half in the morning and half in the evening).

Dose for adults including the elderly:

The usual starting dose is 600mg daily increasing by 150 - 300mg every three days until the seizures are controlled.

This dose is usually within the range of 1,000mg to 2,000mg daily, but can be increased to a maximum of 2,500mg daily if necessary.

Your doctor may alter your dose if you are taking other antiepileptic drugs, have poor kidney function or you are an elderly patient.

Dose for children:

The dose for children will depend on their weight:

For children over 20kg the usual starting dose is 300mg daily. This can be increased up to a maximum of 35mg for each kg of bodyweight to control the seizures.

For children under 20kg the usual dose is 20mg for each kg of bodyweight, which can be increased up to a maximum of 40mg for each kg of bodyweight daily.

Do not stop taking Episenta without consulting your doctor. If you stop, your seizures may return. You should continue to take Episenta for as long as your doctor tells you to.

Mania

The daily dosage should be established and controlled individually by your doctor. Initial dose: The recommended initial daily dose is 750mg. Mean daily dose: The recommended daily doses usually range between 1,000 and 2,000mg.

How to take Episenta:

The capsules should be swallowed whole without chewing with plenty of liquid, e.g. a full glass of water. If you have difficulty in swallowing, the contents of the capsule may be sprinkled or stirred into soft food or drinks and swallowed immediately without chewing or crushing the granules.

The food or drink should be cold or at room temperature. A mixture of the granules with liquid or soft food should not be stored for future use. If the granules are taken in a drink, some may stick to the glass after the drink has been finished, you should rinse the glass with a small amount of water and drink this as well. The granules should not be given in babies’ bottles as they can block the teat.

If you take more Episenta capsules than you should or if someone else accidentally takes your medicine contact your nearest casualty department or tell your doctor or pharmacist immediately. Remember to take the pack, this leaflet and any remaining capsules with you.

If you forget to take a dose of Episenta:

Take it as soon as you remember. If your next dose is due within 2 hours, take a single dose now and do not take the next dose. Never double up the next dose to make up for the one missed.

011/2015 Episenta150_300-GB MOCKUP_121115

4.    Possible side effects

Like all medicines Episenta can cause side effects, although not everyone will get them.

Tell your doctor IMMEDIATELY if you notice any of the following serious side effects. You may require urgent medical attention.

•    You suddenly feel ill, particularly in the first 6 months of treatment, which may include:

-    repeated vomiting, stomach pain, nausea, dislike of usual food, loss of appetite

-    extreme tiredness, drowsiness, weakness

-    j aundice (yellowing of the skin or white of the eyes)

-    swelling of the feet, legs or eyelids, bruising, nosebleed

-    worsening of your epilepsy

These symptoms may indicate a serious effect on your liver. Your blood may be taken before or during treatment to check for any effects on the liver, particularly in very young children and those at risk

•    Severe pain in abdomen and back, nausea and vomiting. You may have a serious, rare problem with your pancreas

•    Blistering of the skin, mouth, eyes and genitals

If you experience any of the side effects listed below tell your doctor if they become troublesome or you are worried:

•    nausea, mild stomach ache or diarrhoea, especially when starting the treatment

•    weight gain as your appetite may be increased

•    shakiness (tremor), drowsiness, unsteadiness when walking

•    tiredness and confusion which may rarely progress to hallucinations and loss of consciousness

•    headache, convulsions, delirium and coma have been reported rarely

•    i ncreased alertness, and occasionally aggression, hyperactivity and worsening behaviour

•    loss of co-ordination, vomiting and reduced levels of consciousness may indicate changes in the amount of ammonia in the blood

•    allergic reactions

•    skin reactions such as acne or rashes

•    kidney problems which will be detected by testing your urine, bedwetting or an increased need to pass urine

•    change in women’s periods

•    i ncreased hair growth in women

•    temporary hair loss, which may be more curly on re-growth

•    breast enlargement in men

•    i oss of hearing

•    i mmune disorders e.g. vasculitus (inflammation of the blood vessels often with skin rash)

•    severe reduction in number of white blood cells which makes infections more likely

•    nail and nail bed disorders (common)

•    obesity (rare)

•    see your doctor if you develop bruising or bleeding

Many of these effects will normally reverse when you stop taking Episenta capsules.

There have been reports of bone disorders including osteopenia and osteoporosis (thinning of the bone) and fractures. Check with your doctor or pharmacist if you are on long-term antiepileptic medication, have a history of osteoporosis, or take steroids.

You may notice the remains of the white shells of the granules in your stools (faeces). This is normal and the active part of the medicine will already have been released from the granule.

If you, or your carer, notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.

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 national reporting system (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

5.    How to store Episenta

Keep out of reach and sight of children.

Store the capsules in the original packaging below 30 °C.

Keep the container tightly closed.

Do not use Episenta capsules after the expiry date printed on the container label and carton.

6.    Further information

What Episenta capsules contain:

•    The active substance is sodium valproate

•    The other ingredients are calcium stearate, colloidal anhydrous silicon dioxide (methyl ated), ammonium methacrylate copolymer Type B, sorbic acid, sodium hydroxide, ethyl cellulose, dibutyl sebacate, oleic acid, gelatin, sodium lauryl sulfate, indigo carmine (E132) and (for 300mg capsules only) quinoline yellow (E104).

What Episenta capsules look like and contents of the pack:

Episenta 150mg capsules are blue/transparent hard gelatine capsules containing white granules.

Episenta 300mg capsules are green/transparent hard gelatine capsules containing white granules.

Each pack contains 50, 100 or 200 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Desitin Arzneimittel GmbH Weg beim Jager 214 D-22335 Hamburg Germany

Manufacturer:

Desitin Arzneimittel GmbH Weg beim Jager 214 D-22335 Hamburg Germany

Date of revision: November 2015

DESITIN

Confidential 11/2015 S-00-0027 Episenta 150/300/500/1000 mg