Epilizine Intravenous Solution

EPILIZINE INTRAVENOUS 400 is used to treat epilepsy (fits). The injection is given when it is not possible to take EPILIZINE by mouth.

You or your child should not be given EPILIZINE INTRAVENOUS 400

• If you or your child is hypersensitive (allergic) to sodium valproate (the active ingredient of EPILIZINE INTRAVENOUS 400).
• If you are breastfeeding your baby (see Pregnancy, breastfeeding and fertility).
• If you are pregnant or able to have a baby:
• For the treatment of epilepsy:
• If you or your female (girl) child is pregnant, unless there is no suitable alternative treatment (see Pregnancy, breastfeeding and fertility: Pregnancy – Important information for women).
• If you or your female (girl) child is able to have a baby, unless the conditions of the Pregnancy Prevention Programme are met (see Pregnancy, breastfeeding and fertility: Pregnancy – Important information for women).
• If you or your child has an active disease of the liver, including the following:
• If you or your child has short- or long-term (severe) inflammation of the liver (hepatitis).
• If you or your child (or any of your close relatives) has a past history of severe hepatitis (inflammation of the liver), especially when caused by medicines.
• If you or your child suffers from liver porphyria (a very rare metabolic disease).
• If you or your child has been told you have a genetic problem caused by a mitochondrial disorder (e.g. Alpers-Huttenlocher syndrome).
• If you or your child has a known metabolic disorder, i.e. a urea cycle disorder.
• If you have an inborn deficiency in carnitine (a very rare metabolic disease) that is untreated.

If you think you or your child may have any of these problems, or if you have any doubt at all, consult your doctor before receiving EPILIZINE INTRAVENOUS 400.

Warnings and precautions

Talk to your doctor or health care provider before being given the injection:

• If you are a woman or female adolescent able to have a baby:
• If you are a woman or female adolescent that is old enough to become pregnant, your doctor should only treat you with EPILIZINE INTRAVENOUS 400 if you are not pregnant and you fulfil the requirements of the Pregnancy Prevention Programme (see Pregnancy, breastfeeding and fertility: Pregnancy – Important information for women).
• If you are pregnant or planning to have a baby, talk to your doctor immediately (see section 2 and Pregnancy, breastfeeding and fertility).

Do not share medicines that are prescribed for you with any other person. You will not be expected to give yourself or your child EPILIZINE INTRAVENOUS 400. It is always given to you by a doctor or a nurse. This is because it needs to be given as an injection into the vein.

If you are not sure why you are being given EPILIZINE INTRAVENOUS 400 or have any questions about how much EPILIZINE INTRAVENOUS 400 is being given to you, speak to your doctor or nurse.

Your doctor will decide on the appropriate dose and administration procedure. EPILIZINE INTRAVENOUS 400 treatment must be started and supervised by a medical practitioner specialised in the treatment of epilepsy. Your doctor will decide how much to give you depending on your illness. The amount of EPILIZINE INTRAVENOUS 400 given to you or your child will depend on your age and body weight or your child’s age or body weight. EPILIZINE INTRAVENOUS 400 is usually given as a slow intravenous injection over 3 – 5 minutes which may be followed by a continuous or repeated infusion (see section 6 for reconstitution information). Your doctor will stop giving you EPILIZINE INTRAVENOUS 400 and change you to EPILIZINE tablets or a liquid formulation as soon as possible.

Female children, women of childbearing potential and pregnant women Pregnant women as well as female children and women that are able to have a baby must not use EPILIZINE unless their doctor determined that there is no suitable alternative (see section 2).

EPILIZINE INTRAVENOUS 400 can have side effects. Not all side effects reported for EPILIZINE INTRAVENOUS 400 are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving this medicine, please consult your doctor, pharmacist or other health care provider for advice.

Tell your doctor or other health care provider immediately if you notice any of the following serious side effects. You may need urgent medical attention:

• allergic reactions, which cause joint pain, skin rashes and fever (systemic lupus erythematosus)
• an allergy-triggered swelling with painful itchy welts (angioedema); most often around the eyes, lips, tongue and throat with difficulty in breathing or swallowing and sometimes the hands and feet
• syndrome with medicine rash, fever, lymph node enlargement and possible impairment of other organs (DRESS syndrome)
• repeated vomiting, extreme tiredness, abdominal pain, drowsiness, weakness, loss of appetite, severe upper stomach pain, nausea, jaundice (yellowing of the skin or whites of the eyes), swelling of the legs, worsening of your epilepsy or a general feeling of being unwell
• severe decrease in white blood cells or bone marrow failure, sometimes, revealed by fever and breathing difficulty or recurring infection
• blood clotting problems (bleeding for longer than normal)
• bruising or bleeding for no reason
• EPILIZINE INTRAVENOUS 400 may also decrease blood platelets or red blood cell count (pancytopenia)
• memory impairment and cognitive disorders (changes in mood, loss of memory, lack of concentration)
• loss of consciousness (coma)
• underactive thyroid gland, which causes tiredness or weight gain (hypothyroidism)
• breathing difficulty and pain due to inflammation of the lungs (pleural effusion)
• changes in consciousness level, bizarre behaviour associated or not with more frequent or more severe fits, loss of drive, particularly if phenobarbital (phenobarbitone) and topiramate are taken at the same time or if an EPILIZINE INTRAVENOUS 400 dose has been increased suddenly
• changes in the amount of ammonia in the blood. Symptoms of this condition are feeling and being sick, problems with balance and co-ordination, feeling lethargic or less alert
• confusion that may be due to decreased levels of sodium in your blood
• extrapyramidal disorder (feeling shaky [tremor], sleepy or unsteady when walking or jerky muscle movements)
• blisters and skin detachment (skin flaking away)
• rapid, uncontrollable movements of the eyes
• muscle pain and muscle weakness (rhabdomyolysis)
• an increase in the number and severity of convulsions. These are all serious side effects. You may need urgent medical attention.

Other side effects are:

Frequent:

• vomiting, nausea (feeling sick) or stomach ache, diarrhoea
• dizziness
• hearing problems
• headache
• hair loss; when it grows back it may be curlier than before
• hair, including body and facial hair, grows more than normally in women (polycystic ovarian syndrome)
• menstrual changes (changes in a woman’s period)
• weight gain (as your appetite may be increased)
• decrease in carnitine levels (shown in blood or muscular tests)
• aggression, agitation, disturbance in attention
• allergic reactions
• tingling or numbness of the hands or feet
• gingival (gum) problems especially overgrowth
• sore mouth, woollen mouth, mouth ulcers and burning feeling of mouth (stomatitis).

Less frequent:

• fainting, hallucinations (seeing, feeling or hearing things that are not there)
• skin reactions such as rashes
• acne, lowered voice
• hair colour changes, nail and nail bed disorders
• swelling of the feet and legs (oedema)
• kidney problems, bedwetting or increased need to pass urine
• passing a lot of urine and feeling thirsty (Fanconi syndrome)
• abnormal behaviour, restlessness/hyperactivity and learning disorder
• impairment of fertility
• decrease in body temperature
• 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 anti-epileptic medication, have a history of osteoporosis, or take steroids
• double vision.

Children: The safety profile of EPILIZINE INTRAVENOUS 400 in children is comparable to adults, but some adverse reactions are more severe or more often observed in children. There is a particular risk of severe liver damage in infants and young children especially under the age of 3 years. Young children are also at particular risk of pancreatitis. These risks decrease with increasing age (see Warnings and precautions). Psychiatric disorders such as aggression, agitation, disturbance in attention, abnormal behaviour, psychomotor hyperactivity and learning disorder are mainly observed in children.

If you notice any side effects not mentioned in this leaflet, please inform your doctor, pharmacist or other health care provider.

Reporting of side effects If you get side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can report side effects directly to Sanofi’s Pharmacovigilance Unit at [email protected] (email) or 011 256 3700 (tel). You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form” found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of EPILIZINE.

STORE ALL MEDICINES OUT OF REACH OF CHILDREN. EPILIZINE INTRAVENOUS 400 will be kept by your doctor or pharmacist in a safe place. EPILIZINE INTRAVENOUS 400 should be stored at or below 30 °C in the original package until required for use. Protect from light. The reconstituted solution should be used immediately, and any unused portion thrown away (see section 6 for reconstitution information). If the reconstituted solution is further diluted for infusion and prepared aseptically it may be kept for up to 24 hours at 2 – 8 °C. Any remaining solution should be thrown away after 24 hours. EPILIZINE INTRAVENOUS 400 must not be given after the expiry date stated on the pack. Your health care provider administering EPILIZINE INTRAVENOUS 400 will dispose of any unused medicine.