EPILIM 500 GASTRO-RESISTANT TABLETS - patient leaflet, side effects, dosage

5. how to store epilim

Keep this medicine out of the sight and reach of children. Do not take this medicine after the expiry date shown on the blister and carton after “EXP”. The expiry date refers to the last day of that month.

Do not remove the tablets from the foil until just before you take them. Do not cut the blister strips.

Store in a dry place below 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 measureswill help protect the environment.

6. contents of the pack and other informationwhat epilim gastro-resistant tablets contain each 200mg gastro-resistant tablet contains 200mg of the active substance, sodium valproate.

• Each 500mg gastro-resistant tablet contains 500mg of the active substance, sodium valproate.
• The other ingredients are povidone (El201), talc, calcium silicate (E552), magnesium stearate (E572), hypromellose (E464), citric acid monohydrate (E330), macrogol 6000, polyvinyl acetate phthalate, diethyl phthalate, stearic acid (E570), titanium dioxide (El71), amaranth aluminium lake (E123), indigo carmine lake (E132) and hydroxypropyl cellulose (E463).

What Epilim Gastro-resistant Tablets look like and contents of the pack

Epilim tablets are round and lilac coloured. The tablets are supplied in blister packs of 30 or 100.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire,

RG61PT, UK

Tel: 0800 035 2525

email:

Manufacturer

Sanofi-aventis S.A,

Carretera C-35 (La Ballloria-Hostalric). Km 63.09

17404 Riel Is i Viabrea (Girona), Spain

This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

This leaflet was last revised in January 2022 © Sanofi, 2006–2022

Other sources of information

For the most up to date patient information leaflet and important safety information on this product for girls and women of childbearing potential, scan the QR code included in this leaflet with a smartphone. The same information is also available on the following URL: qr.valproatean­dme.co.uk

PACKAGE LEAFLET: INFORMATION FOR THE USER Epilim® 200mg and 500mg Gastro-resistant Tablets sodium valproate

SANOFI O

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Phone 0800 035 2525 for help

▼ 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.

WARNING

Epilim, sodium valproate, can seriously harm an unborn baby when taken during pregnancy. If you are a female able to have a baby, you must use an effective method of birth control (contraception) at all times during your entire treatment with Epilim. Your doctor will discuss this with you, but you must also follow the advice in section 2 of this leaflet.

Schedule an urgent appointment with your doctor if you want to become pregnant or if you think you are pregnant.

Do not stop taking Epilim unless your specialist tells you to as your condition may become worse.

If you are a parent or caregiver of a female child treated with Epilim, you must also read section 2 of this leaflet carefully and contact your child’s doctor once they experience their first period.

Read all of this leaflet carefully before you 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, please ask your doctor or pharmacist.
• This medicine has been prescribed for you. 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.

• 1. What Epilim is and what it is used for

• 2. What you need to know before you take Epilim

• 3. Howto take Epilim

• 4. Possible side effects

• 5. Howto store Epilim

• 6. Contents of the pack and other information

1. what epilim is and what it is used forwhat epilim isthe name of your medicine is epilim 200mg or 500mg gastro-resistant tablets (called epilim in this leaflet). epilim 200mg or 500mg gastro-resistant tablets are “enteric coated” this means that the tablets have a protective coating that allows them to reach the intestines (gut) without being dissolved in the stomach first. this helps stop them from causing a stomach upset.

What Epilim contains

Epilim contains sodium valproate. It belongs to a group of medicines called anti-convulsants or anti-epileptic agents. It works by helping to calm the brain down.

What Epilim is used for

Epilim is used to treat epilepsy (fits) in adults and children.

2. what you need to know before you take epilim

H Do not take Epilim if:

X You are allergic (hypersensitive) to sodium valproate or any of the other ingredients of Epilim (listed in section 6). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat

or tongue.

X You have liver problems, or you or your family have a history of liver problems, especially if caused by taking a medicine.

X You have a rare illness called porphyria which affects your metabolism.

X You have a known metabolic disorder, i.e. a urea cycle disorder.

X You have a genetic problem caused by a mitochondrial disorder (e.g. Alpers-Huttenlocher syndrome).

X You are pregnant, unless nothing else works for you (see ‘Pregnancy, breast-feeding and fertility – Important advice for women’ below).

qr.valproatean­dme.co.uk

If you are a woman able to have a baby, you must not take Epilim unless you use an effective method of birth control (contraception) at all times during your entire treatment with Epilim. Do not stop taking Epilim or your contraception until you have discussed this with your specialist. Your specialist will advise you further (see below under‘Pregnancy, breast-feeding and fertility-Important advice for women’).

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Epilim.

0

i Warnings and precautions

• 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.
• As with other anti-epileptic drugs, convulsions may become worse or happen more frequently whilst taking this medicine. If this happens contact your doctor immediately.

Talk to your doctor or pharmacist before taking Epilim if: ▲ You have a brain disease or a metabolic condition affecting your brain.

▲ You have problems with your pancreas.

▲ You have diabetes or are being tested for diabetes. This medicine may affect the results of urine tests.

▲ You have a carnitine palmitoyltran­sferase type II deficiency.

▲ You have kidney problems. Your doctor may monitor your valproate level or adjust your dose.

▲ You have a ‘urea cycle disorder” where too much ammonia builds up in the body.

▲ You have an illness called ‘systemic lupus erythematosus (SLE)’ – a rare disease of the immune system which affects skin, bones, joints and internal organs.

▲ You know that there is a genetic problem caused by a mitochondrial disorder in your family.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Epilim.

Weight gain

Taking Epilim may make you put on weight. Talk to your doctor about how this will affect you.

Blood tests

Your doctor may do blood tests and liver function tests before and during your treatment with this medicine. Epilim can change the levels of liver enzymes shown up in blood tests. This can mean that your or your child’s liver is not working properly.

B other medicines and Epilim

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Epilim can affect the way some other medicines work. Also, some medicines can affect the way Epilim works.

In particular, check with your doctor if you are taking any of the following:

• Some medicines used for pain and inflammation (salicylates) such as aspirin.
• Some other medicines used to treat fits (epilepsy) – see section 3, ‘Patients taking other medicines for fits’. This includes medicines such as phenobarbital, primidone, phenytoin, carbamazepine, rufinamide, topiramate, acetazolamide, lamotrigine and felbamate.
• Medicines used to calm emotional and mental health disorders (including schizophrenia, bipolar disorder and depression) such as quetiapine, diazepam and olanzapine.
• Monoamine oxidase inhibitors (MAOIs) such as moclobemide (used to treat depression and anxiety), selegiline (used to treat Parkinson’s di­sease), linezolid (used to treat infections).
• Anticoagulants such as warfarin – used to thin the blood and prevent clots. Your doctor may change your doseof the blood thinning medicineand monitoryour treatment closely.
• Zidovudine and protease inhibitors such as lopinavir and ritonavir- used to treat HIV infection and Al Ds.
• Carbapenem agents (antibiotics used to treat bacterial infections) such as panipenem, imipenem, meropenem, rifampicin and erythromycin. The combination of Epilim and carbapenems should be avoided because it may decrease the effect of your medicine.
• Some medicines used to treat or prevent malaria such as mefloquine and chloroquine.
• Temozolomide – used to treat cancer.
• Cimetidine-used to treat stomach ulcers.
• Cholestyramine- used to lower blood fat (cholesterol) levels)
• Nimodipine – used to treat bleeding in the brain (subarachnoid haemorrhage).
• Propofol – used for anaesthesia.
• Oestrogen-containing products (including some birth control pills).
• Metamizole- used to treat pain and fever.

Epilim with alcohol

Alcohol intake is not recommended during treatment.

Pregnancy, breast-feeding and fertility

Important advice for women

• You must not use Epilim if you are pregnant, unless your specialist has determined that no alternative treatment works for you.
• If you are a woman able to have a baby, you must not take Epilim unless you use an effective method of birth control (contraception) at all times duringyour entire treatment with Epilim.
• Do not stop taking Epilim or your birth control (contraception), until you have discussed this with your specialist. Your specialist will advise you further.
• Talk to your doctor immediately if you are planning to have a baby or are pregnant.
• Valproate carries a risk if taken during pregnancy. The higher the dose, the higher the risks but all doses carry a risk, including when valproate is used in combination with other medicines to treat epilepsy.
• It can cause serious birth defects and can affect the physical and mental development of the child as it grows after birth. 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 11 babies in every 100 will have birth defects. This compares to 2–3 babies in every 100 born to women from the general population.

• – The most frequently reported birth defects 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 and multiple associated malformations affecting several organs and parts of the body. Birth defects may result in disabilities which may be severe.

• – Hearing problems or deafness have been reported in children exposed to valproate during pregnancy.

• – Eye malformations have been reported in children exposed to valproate during pregnancy in association with other congenital malformations. These eye malformations may affect vision.

• It is estimated that up to 30–40% of children whose mothers tookvalproate 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.

– Autism and related disorders are more often diagnosed in children exposed to valproate during pregnancy and there is some evidence that children exposed to valproate during pregnancy are at increased risk of developing Attention Deficit Hyperactivity Disorder (ADHD).

• Before prescribing this medicine to you, your specialist will have explained what might happen to your baby if you become pregnant whilst taking valproate. If you decide later that you want to have a baby, you must not stop taking your medicine or your method of birth control (contraception) until you have discussed this with your specialist.
• If you are a parent or a caregiver of a female child treated with valproate, you must contact their doctor once your child using valproate experiences their first period (menarche).
• Some birth control pills (oestrogen-containing birth control pills) may lower valproate levels in your blood. Make sure you talk to your doctor about the method of contraception (birth control) that is the most appropriate for you.
• Ask your doctor about taking folic acid when planning to have 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.

Please choose the situations which apply to you and read the descriptions below:

• I AM STARTING TREATMENT WITH EPILIM
• I AM TAKING EPILIM AND NOT PLANNING TO HAVE A BABY
• I AM TAKING EPILIM AND PLANNING TO HAVE A BABY
• I AM PREGNANT AND I AM TAKING EPILIM

I AM STARTING TREATMENT WITH EPILIM

If this is the first time you have been prescribed Epilim your specialist will have explained the risks to an unborn child if you become pregnant. Once you are able to have a baby, you must use an effective method of birth control (contraception) at all times during your entire treatment with Epilim. Talk to your doctor or family planning clinic if you need advice on birth control (contraception).

Key messages:

• Pregnancy must be excluded before start of treatment with Epilim with the result of a pregnancy test, confirmed by your specialist.
• You must use an effective method of birth control (contraception) at all times during your entire treatment with Epilim.
• You must discuss appropriate and effective methods of birth control (contraception) with your doctor.

Your doctor will give you information on preventing pregnancy and may refer you to a specialist for advice on birth control (contraception).

• You must get regular (at least annual) appointments with a specialist experienced in the management of epilepsy. During this visit your specialist will make sure you are well aware of and have understood all the risks and advice related to the use of valproate during pregnancy.
• Tell your doctor if you want to have a baby.
• Tell your doctor immediately if you are pregnant or think you might be pregnant.

I AM TAKING EPILIM AND NOT PLANNING TO HAVE A BABY

If you are continuing treatment with Epilim but you are not planning to have a baby, you must use an effective method of birth control (contraception) at all times during your entire treatment with Epilim. Talk to your doctor or family planning clinic if you need advice on birth control (contraception).

Key messages:

• You must use an effective method of birth control (contraception) at all times during your entire treatment with Epilim.
• You must discuss appropriate and effective methods of birth control (contraception) with your doctor.

Your doctor will give you information on preventing pregnancy and may refer you to a specialist for advice on birth control (contraception).

• You must get regular (at least annual) appointments with a specialist experienced in the management of epilepsy. During this visit your specialist will make sure you are well aware of and have understood all the risks and advice related to the use of valproate during pregnancy.
• Tell your doctor if you want to have a baby.
• Tell your doctor immediately if you are pregnant or think you might be pregnant.

I AM TAKING EPILIM AND PLANNING TO HAVE A BABY

If you are planning to have a baby, first schedule an appointment with your doctor.

Do not stop taking Epilim or your birth control (contraception) until you have discussed this with your specialist. Your specialist will advise you further.

Babies born to mothers who have been on valproate are at serious risk of birth defects and problems with development (behaviour and learning disorders), which can be seriously debilitating. Your doctor will refer you to a specialist experienced in the management of epilepsy, so that alternative treatment options are evaluated early on. Your specialist 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 specialist may decide to change the dose of Epilim, switch you to another medicine, or stop treatment with Epilim a long time before you become pregnant – this is to make sure your illness is stable.

Ask your doctor about taking folic acid when planning to have 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 taking Epilim unless yourspecialist tells you to.
• Do not stop using your birth control (contraception) before you have talked to your specialist and worked together on a plan to ensure your condition is controlled and the risks to you and your baby are reduced.
• First schedule an appointment with yourspecialist. During this visit your specialist will make sure you are well aware of and have understood all the risks and advice related to the use of valproate during pregnancy.
• Your specialist will try to switch you to another medicine or stop treatment with Epilim a long time before you become pregnant.
• Schedule an urgent appointment with your doctor if you are pregnant or think you might be pregnant.

I AM PREGNANT AND I AM TAKING EPILIM

Do not stop taking Epilim unless your specialist tells you to as your condition may become worse.

Schedule an urgent appointment with your doctor if you are pregnant or think you might be pregnant. Your doctor will advise you further.

Babies born to mothers who have been on valproate are at serious risk of birth defects and problems with development (behaviour and learning disorders) which can be seriously debilitating. You will be referred to a specialist experienced in the management of epilepsy so that alternative treatment options can be evaluated.

In the exceptional circumstances when Epilim is the only available treatment option during pregnancy, you will be monitored very closely both for the management of your underlying condition and to check how your unborn child is developing. You and your partner should receive counselling and support regarding the valproate-exposed pregnancy.

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:

• Schedule an urgent appointment with your doctor if you are pregnant or think you might be pregnant.
• Do not stop taking Epilim unless your specialist tells you to.
• Make sure you are referred to a specialist experienced in the treatment of epilepsy to evaluate the possibility of alternative treatment options.
• You must get thorough counselling on the risks of Epilim during pregnancy, including malformations and physical and mental development disorders in children.
• Make sure you are referred to a specialist for prenatal monitoring to examine for potential malformations.

Make sure you read the Patient Guide that you will receive from your doctor or pharmacist. Your specialist will discuss the Annual Risk Acknowledgement Form and will ask you to sign it and keep it. You will also receive a Patient Card from your pharmacist to remind you of valproate risks in pregnancy.

Newborn babies of mothers who took valproate during pregnancy may have:

• Blood clotting problems (such as blood not clotting very well). This may appear as bruising or bleeding which takes a long time to stop.
• Hypoglycaemia (low blood sugar).
• Hypothyroidism (underactive thyroid gland, which can cause tiredness or weight gain).
• Withdrawal syndrome (including agitation, irritability, hyperexcitability, jitteriness, hyperkinesia, muscle problems, tremor, convulsions and feeding problems). In particular, this may occur in newborns whose mothers have taken valproate during the last trimester of their pregnancy.

Breast-feeding

Very little Epilim gets into the breast milk. However, talk to your doctor about whether you should breast-feed your baby. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

You may feel sleepy when taking Epilim. If this happens to you, do not drive or use any tools or machines. Taking other medicines used to treat fits or calm emotional and mental health problems may increase sleepiness.

Epilim contains sodium

Epilim Ga st ro-resista nt 200 Tablets contains 27.68mg sodium (main component of cooking/table salt) in each tablet. This is equivalent to less than 2% of the recommended maximum daily dietary intake of sodium for an adult per tablet.

Epilim Ga st ro-resista nt 500 Tablets contains 69.19mg sodium (main component of cooking/table salt) in each tablet. This is equivalent to less than 4% of the recommended maximum daily dietary intake of sodium for an adult per tablet.

3. how to take epilim

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

Epilim treatment must be started and supervised by a doctor specialised in the treatment of epilepsy.

Your doctor will decide how much Epilim to give you or your child depending on your or your child’s body weight. If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself but ask your doctor.

How to take this medicine

• Take this medicine by mouth. Do not crush or chew the tablets.
• Take Epilim with or after food. This will help to stop the feelings of sickness that may happen after taking Epilim.
• The dose is normally split and given half in the morning and half in the evening.

How much to take

Adults (including the elderly)

• The starting dose is 600mg daily. Your doctor should gradually increase this dose by 200mg every 3 days depending on your condition.
• The usual dose is 1000–2000mg (20–30mg per kilogram of body weight) each day.
• This may be increased to 2500mg each day depending on your illness.

Children over 20 kilograms

• The starting dose should be 400mg daily. Your doctor should increase this dose depending on your child’s illness.
• The usual dose is then 20–30mg for each kilogram of body weight each day.
• This may be further increased to 35mg for each kilogram of body weight each day depending on your child’s illness.

Children under 20 kilograms

• The usual dose is 20mg for each kilogram of body weight each day.
• Depending on the child’s condition your child’s doctor may decide to increase this dose.

Patients with kidney problems

• Your doctor may decide to adjust your or your child’s dose.

Patients taking other medicines for fits (epilepsy)

• You or your child may betaking other medicines for epilepsy at the same time as Epilim. If so, your doctor should gradually initiate treatment depending on your oryour child’s condition.
• Your doctor may increase the dose of Epilim by5–10mg for each kilogram of body weight each day depending on which other medicines you are taking.

If you take more Epilim than you should

If you oryour child take more Epilim than you should, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you have taken.

The following effects may happen: feeling sick or being sick, headache, blurred vision due to pupil of the eye becoming smaller, dizziness, poor reflexes, confusion, memory loss and tiredness. You may also have weak or ‘floppy’ muscles, fits (seizures), loss of consciousness, behavioural changes and breathing difficulties such as fast breathing, shortness of breath or chest pain.

If you forget to take Epilim

If you oryour child forget to take a dose, take it as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Epilim

Do not stop taking Epilim or alter your oryour child’s dose without checking with your specialist. If you or your child stop taking Epilim without your specialist’s ad­vice, your condition may get worse.

Tests

Make sure you oryour child keep your regular appointments for a check-up. They are very important as your oryour child’s dose may need to be changed. If you or your child go into hospital or visit another doctor or a dentist, tell them you are taking Epilim.

0lf you have any further questions on the use of this product, ask your doctor or pharmacist.

4. possible side effects

Like all medicines, Epilim can cause side effects, although not everybody gets them. Side effects are more likely to happen at the start of treatment

Tell your doctor or go to a hospital straight away if you notice any of the following serious side effects – you may need urgent medical treatment:

• You have an allergic reaction which may manifest as: – Blisters with skin detachment (blistering, peeling or bleeding on any part of your skin (including your lips, eyes, mouth, nose, genitals, hands or feet) with or without rash), sometimes with flu-like symptoms such as fever, chills, or aching muscles. These may be signs of conditions named ‘Toxic epidermal necrolysis’ or ‘Stevens-Johnson Syndrome’.

– Skin rash or skin lesions with a pink/red ring and a pale centre which may be itchy, scaly or filled with fluid. The rash may appear especially on the palms or soles of your feet. These may be signs of a condition named ‘erythema multiforme’.

– Allergy-triggered swelling with painful itchy welts (most often around the eyes, lips, throat and sometimes hands and feet) and swallowing or breathing problems. These may be signs of ‘angioedema’ or an anaphylactic reaction.

– Syndrome with skin rash, fever, lymph node enlargement and possible impairment of other organs. These may be signs of a condition named ‘Drug Rash with Eosinophilia and Systemic Symptoms (DRESS)’.

• Liver problems and problems of the pancreas may show as a sudden illness which may happen in the first six months of treatment. This happens in a very small number of people taking Epilim. It includes feeling sick (nausea) and being sick (vomiting) many times; extreme tiredness, drowsiness and weakness; stomach pain including severe upper stomach pain; yellowing of the skin or whites of the eyes (jaundice); loss of appetite; swelling of the legs and feet (may also include other parts of the body); worsening of your fits or a general feeling of being unwell. Your doctor may tell you to stop taking Epilim immediately if you have these symptoms.

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