EPILIM 200 MG / 5ML SYRUP - patient leaflet, side effects, dosage

Epilim® 200mg/5ml Syrup

(sodium valproate)

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.

WARNING

Epilim Syrup, sodium valproate, can seriously harm an unborn baby when taken during pregnancy. If you are a female able to have a baby you should use an effective method of birth control (contraception) without interruptions during your entire treatment with Epilim Syrup.

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 Syrup unless your doctor tells you to as your condition may become worse.

If you are a parent or caregiver of a female child treated with Epilim Syrup, 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 symptoms 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.

Your medicine is called Epilim 200mg/5ml Syrup but will be referred to as Epilim Syrup throughout this leaflet.

What is in this leaflet:

riBWhat Epilim Syrup is and what it is used for

^2| what you need to know before you take epilim syrup

How to take Epilim Syrup

Possible side effects

How to store Epilim Syrup

[6b contents of the pack and other information

jlWhat Epilim Syrup is and what it is used for

What Epilim Syrup is

The name of your medicine is Epilim Syrup 200mg/5ml (called Epilim Syrup in this leaflet).

What Epilim Syrup contains

Epilim Syrup contains a medicine called sodium valproate.

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

What Epilim Syrup is used for

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

^2|what you need to know before you take epilim syrup

Epilim® 200mg/5ml Syrup

(sodium valproate)

Patient Information Leaflet (continued)

Make sure you read the Patient Guide that you will receive from your doctor. Your doctor 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 Syrup 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 Syrup. 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 Syrup contains

• Sucrose: This medicine contains 3.5g per 5ml. People with diabetes need to take this into account. It may also be harmful to the teeth. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

• Sorbitol (E420): This medicine contains 647.5mg per 5ml. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take this medicine. Sorbitol may cause gastrointestinal discomfort and mild laxative effect.

• * Sodium: This medicine contains 28.72mg sodium (main component of cooking/table salt) per 5ml. This is equivalent to less than 2% of the recommended maximum daily dietary intake of sodium for an adult per 5ml.

0

How to take Epilim Syrup

Always take Epilim Syrup exactly as your doctor has told you.

You should check with your doctor or pharmacist if you are not sure.

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

Taking this medicine

• Your doctor will decide how much Epilim Syrup to give you or your child depending on you or your child’s body weight.

• Take this medicine by mouth.

• Take Epilim Syrup with or after food. This will help to stop the feelings of sickness that may happen after taking Epilim Syrup.

• Only dilute the syrup if your doctor or pharmacist tells you to.

• If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself but ask your doctor.

• Take this in 2 separate doses – half in the morning and half in the evening.

• You will be able to measure the dose in the marked measuring cup supplied with the syrup.

• The marks of the cup show you how to measure between 5ml (200mg) and 15ml (600mg).

• If the dose is less than 5ml (200mg), talk to your doctor or pharmacist about how to measure the dose.

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 be taking other medicines for epilepsy at the same time as Epilim Syrup. If so, your doctor should gradually initiate treatment depending on you or your child’s condition.

• Your doctor may increase the dose of Epilim Syrup by 5–10mg for each kilogram of body weight each day depending on which other medicines you are taking.

If you take more Epilim Syrup than you should

If you take more Epilim Syrup 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, pupils of the eye become smaller, dizziness, loss of consciousness, weak muscles and poor reflexes, breathing problems, headaches, fits (seizures), confusion, memory loss and unusual or inappropriate behaviour.

If you forget to take Epilim Syrup

If you 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 Syrup

Keep taking until your doctor tells you to stop. Do not stop taking Epilim Syrup just because you feel better. If you stop your fits may come back. Tests

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

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

^■Possible side effects

Like all medicines, Epilim Syrup 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 Syrup. 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 Syrup immediately if you have these symptoms.

• Blood disorders that can be shown in blood tests. Signs may include:

• – Spontaneous bruising or bleeding due to blood clotting problems or decreased platelet count, or getting more infections than usual (thrombocytopenia)

• – Severe decrease of white blood cells or bone marrow failure, sometimes revealed by fever and breathing difficulty (agranulocytosis)

• – Decreased red blood cell count (anaemia) or abnormally increased red blood cell size (macrocytosis)

• – Bone marrow disorders that affect red blood cells, white blood cells and platelets (pancytopenia)

• Drowsiness, change in consciousness level (including coma), confusion, loss of memory, abnormal behaviour including changes in attention, concentration and mood. This could also be associated with hallucinations or more frequent or severe fits. This is more likely if other medicine to treat fits such as phenobarbital and topiramate are taken at the same time or if the Epilim Syrup starting dose is high or has been suddenly increased.

• Underactive thyroid gland, which may cause tiredness or weight gain (hypothyroidism)

• Breathing difficulty and pain due to inflammation of the envelope of the lungs (pleural effusion)

• An increase in the number and severity of convulsions

• Muscle pain and weakness (rhabdomyolysis)

• Joint pain, fever, fatigue or rash. These may be signs of systemic lupus erythematosus (SLE).

• Problems with balance and co-ordination, feeling lethargic or less alert, associated with being sick (vomiting). This may be due to an increased amount of ammonia in your blood.

• Shakiness (tremor), jerky muscle movements, unsteadiness when walking (parkinsonism, extrapyramidal disorder, ataxia)

• Rapid, uncontrollable movement of the eyes

• Kidney disease or kidney problems (renal failure, tubulointerstitial nephritis and Fanconi syndrome) which may manifest as reduced urinary output or blood in the urine

• Confusion, that could be due to decreased levels of sodium in your blood, identified by a blood test, or to a condition named ‘Syndrome of Inappropriate Antidiuretic Hormone (SIADH) secretion’

Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days, or if you notice any side effects not listed in this leaflet:

• Feeling sick (nausea), being sick (vomiting), stomach ache or diarrhoea, especially when starting treatment. This may be helped by taking the syrup with food.

• Overgrowth of gums (gingival hypertrophia), swelling of gums or mouth, sore mouth, mouth ulcers and burning feeling of mouth (stomatitis)

• Headache

• Hearing loss, hearing problems or deafness

• Double vision

• Nail and nail bed disorders

• Skin problems such as rashes. These happen rarely, but more often in people also taking lamotrigine.

• Transient hair loss, abnormal hair growth, abnormal hair texture, changes in hair colour

• Increased levels of some hormones (androgens), which may lead to increased hair growth on the face, breasts or chest (particularly in women), acne or thinning hair

• Skin rash caused by inflammation of small blood vessels (vasculitis)

• Irregularity or absence of women’s period, pain during women’s period, cysts in the ovaries (polycystic ovaries)

• Breast enlargement in men, male infertility (usually reversible after treatment discontinuation and may be reversible after dose reduction. Do not stop your treatment without speaking to your doctor first)

• Swelling of the feet and legs (oedema)

• Obesity, weight gain – as your appetite may be increased

• Bedwetting or increased need to pass urine, urinary incontinence (unintentional passing of urine)

• Seeing, feeling or hearing things that are not there (hallucinations)

• Aggression, agitation, disturbance in attention, abnormal behaviour, restlessness/hy­peractivity, memory impairment, or cognitive or learning disorder

• Tingling or numbness in the hands and feet

• * Lowering of normal body temperature

^■How to store Epilim Syrup

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

Do not store above 25°C

Store it in the original container

Protect from light.

The diluted product has a 14-day shelf-life.

Do not take this medicine after the month shown on the bottle label and outer carton.

If your medicine becomes discoloured or shows any other signs of deterioration, consult your pharmacist who will tell you what to do.

Medicines should not be disposed of via household wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

^■Contents of the pack and other information

What Epilim Syrup contains

Each 5 ml of Epilim Syrup contains 200 mg Sodium Valproate.

The syrup also contains sucrose, sorbitol (E420), sodium methyl parahydroxyben­zoate, sodium propyl parahydroxyben­zoate, saccharin sodium, purified water, ponceau 4R (E124) and cherry flavour.

What this medicine looks like and contents of the pack

Epilim Syrup is a red, cherry flavoured oral solution, supplied in amber bottles of 300 ml with a child resistant cap and a clear seal. Also with a small clear plastic measuring cup.

Manufacturer and Licence Holder

Your medicine is manufactured by Unither Liquid Manufacturing, 1–3 allee de la Neste Z.I. d’en Sigal, 31770 Colomiers, France and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.

POM PL 15184/1933 Epilim 200mg/5ml Syrup

Epilim is a registered trademark of Sanofi Synthelabo UK Ltd.

Revision date: 23/02/22

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited,

Tel: 01527 505414 to obtain the leaflet in a format suitable for you

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