CONVULEX CAPSULES 300 MG - patient leaflet, side effects, dosage

Convulex® 150 mg capsules

Active substance: Valproic acid

▼ 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

Convulex (sodium valproate) can seriously harm an unborn child when taken during pregnancy. If you are a female able to have a baby you must use effective method of birth control (contraception) without interruptions during your entire treatment with Convulex. 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 Convulex unless your doctor tells you to as your condition may become worse.

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, ask your doctor or pharmacist.

• – This medicine has been prescribed for you only. 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.

In this leaflet:

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

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

• 3. How to take Convulex

• 4. Possible side effects

• 5. How to store Convulex

• 6. Contents of the pack and other information

1. what convulex is and what it is used for

Convulex is an antiepileptic, i.e. a medicine which is used to treat epilepsy (fits). Its active ingredient is valproic acid.

2. What you need to know before you take Convulex

Do not take Convulex

– if you are allergic (hypersensitive) to valproic acid or any of the other ingredients of Convulex (see section 6. “Further information”).

• – if you have liver problems (e.g. hepatitis).

• – if you have a family history of liver problems.

• – if you suffer from porphyria (a rare metabolic condition).

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

• – if you suffer from urea cycle disorders (a metabolic condition).

• – For epilepsy, you must not use Convulex if you are pregnant, unless nothing else works for you.

• – For epilepsy, if you are a woman able to have a baby, you must not take Convulex unless you use effective method of birth control (contraception) during your entire treatment with Convulex. Do not stop taking Convulex or your contraception, until you have discussed this with your doctor. Your doctor will advise you further (see below under “Pregnancy, breast-feeding and fertility -Important advice for women”).

Warnings and precautions

Talk to your doctor or pharmacist before taking Convulex.

Take special care with Convulex

• – if you experience abdominal pain, nausea and/or vomiting: Contact your doctor immediately , as these may be symptoms of pancreatitis (inflammation of the pancreas). The risk of this potentially life-threatening condition is especially high in young children, in patients receiving combination treatment and in those with severe liver function disorder.

• – Convulex may cause marked and progressive weight gain. This is a very common side effect. Consult your doctor about appropriate strategies to minimize this risk.

Tell your doctor before starting Convulex

• – if you have lupus (an immune system condition affecting skin, bones and joints, lungs, kidneys).

• – if you are diabetic. Valproic acid may give an indication that ketones are present in the urine when this is not the case.

• – if you have kidney problems. You may need a lower dose.

• – if you suffer from urea cycle enzymatic deficiency (a rare metabolic disorder).

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

• – if you know that you have a carnitine-palmitoyl transferase (CPT-)II deficiency because there is an increased risk of rhabdomyolysis developing with valproate therapy.

• – if you have a history of bone marrow damage.

Talk to your doctor even if you no longer have these conditions, but have had them in the past.

Your doctor may advise blood tests before you start taking Convulex and during the first six months of treatment.

A small number of people being treated with anti-epileptics such as valproic acid have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.

Other medicines and Convulex

Tell your doctor if you are taking, have recently taken or might take any other medicines.

If taken with some other medicines, the effects of Convulex or the effects of the other medicines may be changed.

Please tell your doctor if you are taking any of the following:

• – salicylates, e.g. aspirin.

• – antidepressants including monoamine oxidase inhibitors, fluoxetine or quetiapine.

• – olanzapine, used to treat psychosis.

• – anticoagulants, used to thin the blood (e.g. warfarin).

• – benzodiazepines, used as sleeping tablets and to treat anxiety.

• – other antiepileptics, e.g. phenytoin, carbamazepine, phenobarbital, lamotrigine, primidone, felbamate, rufinamide. Concomitant use of Convulex with topiramate and acetazolamide has been associated with encephalopathy and/or hyperammonaemia.

• – cholestyramine, used to treat high blood lipid (fat) levels.

• – cimetidine, used to treat stomach ulcers.

• – antibiotics, e.g. erythromycin, carbapenem, imipenem, rifampicin, panipenem and meropenem.

• – medicines to prevent and treat malaria, e.g. mefloquine and chloroquine. They may increase the likelihood of a fit. Before travelling to a high-risk malaria area, seek advice from your doctor or pharmacist on the most appropriate prevention medicines.

• – zidovudine, used to treat HIV and AIDS.

• – protease inhibitors such as lopinavir and ritonavir, used in the treatment of HIV infections.

• – temozolomide, used to treat cancer.

In particular, tell your doctor or nurse if you are taking any of the following medicines:

Carbapenem agents (antibiotic used to treat bacterial infections). The combination of valproic acid and carba-penems should be avoided because it may decrease the effect of sodium valproate.

If you require a blood test to have your thyroid function checked, please inform your doctor about this, because treatment with Convulex may lead to a false diagnosis of hypothyroidism (insufficient production of thyroid hormone).

If you have to undergo any type of surgery, including dental procedures where anaesthesia is required, tell the doctor that you are taking Convulex.

Convulex does not appear to influence the effect of oral contraceptives.

Convulex with food, drink and alcohol

Convulex may be taken with food and drink.

The capsules are usually taken after meals.

Convulex may enhance the effects of alcohol. Therefore the consumption of alcohol should be avoided during Convulex therapy.

Pregnancy, breast-feeding and fertility

Pregnancy

Important advice for women

Epilepsy

• – For epilepsy, you must not use Convulex if you are pregnant, unless nothing else works for you.

• – For epilepsy, if you are a woman able to have a baby, you must not take Convulex unless you use effective method of birth control (contraception) during your entire treatment with Convulex. Do not stop taking Convulex or your contraception, until you have discussed this with your doctor. Your doctor will advise you further.

The risks of valproate when taken during pregnancy (irrespective of the disease for which valproate is used) – 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.

• – 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 to 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).

• – 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 baby you must not stop taking your medicine or your method of contraception until you have discussed this with your doctor.

• – If you are a parent or a caregiver of a female child treated with valproate, you should contact the doctor once your child using valproate experiences menarche.

• – 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.

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

o I AM STARTING TREATMENT WITH CONVULEX

o I AM TAKING CONVULEX AND NOT PLANNING TO HAVE A BABY

o I AM TAKING CONVULEX AND PLANNING TO HAVE A BABY

o I AM PREGNANT AND I AM TAKING CONVULEX

I AM STARTING TREATMENT WITH CONVULEX

If this is the first time you have been prescribed Convulex your doctor will have explained the risks to an unborn child if you become pregnant. Once you are able to have a baby, you will need to make sure you use an effective method of contraception without interruption throughout your treatment with Convulex. Talk to your doctor or family planning clinic if you need advice on contraception.

Key messages:

• – Pregnancy must be excluded before start of treatment with Convulex with the result of a pregnancy test, confirmed by your doctor.

• – You must use an effective method of birth control (contraception) during your entire treatment with Convulex.

• – You must discuss the appropriate 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.

• – You must get regular (at least annual) appointments with a specialist experienced in the management of epilepsy. During this visit your doctor will make sure you are well aware and have understood all the risks and advices 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 CONVULEX AND NOT PLANNING TO HAVE A BABY

If you are continuing treatment with Convulex but you are not planning to have a baby make sure you are using an effective method of contraception without interruption during your entire treatment with Convulex. Talk to your doctor or family planning clinic if you need advice on contraception.

Key messages:

• – You must use an effective method of birth control (contraception) during your entire treatment with Convulex.

• – You must discuss contraception (birth control) with your doctor. Your doctor will give you information on preventing pregnancy, and may refer you to a specialist for advice on birth control.

• – You must get regular (at least annual) appointments with a specialist experienced in the management of epilepsy. During this visit your doctor will make sure you are well aware and have understood all the risks and advices 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 CONVULEX 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 Convulex or your contraception, until you have discussed this with your doctor. 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 which can be seriously debilitating. Your doctor will refer you to a specialist experienced in the management of epilepsy, so that alternative treatment options can be 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 Convulex or switch you to another medicine, or stop treatment with Convulex, 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 Convulex unless your doctor tells you to.

• – Do not stop using your methods of birth control (contraception) before you have talked to your doctor and worked together on a plan to ensure your condition is controlled and the risks to your baby are reduced.

• – First schedule an appointment with your doctor. During this visit your doctor will make sure you are well aware and have understood all the risks and advices related to the use of valproate during pregnancy.

• – Your doctor will try to switch you to another medicine, or stop treatment with Convulex 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 USING CONVULEX

Do not stop taking Convulex, unless your doctor 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 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 Convulex 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 could 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.

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

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

• – Make sure you are referred to a specialist experienced in the treatment of epilepsy to evaluate the need for alternative treatment options.

• – You must get thorough counselling on the risks of Convulex during pregnancy, including teratogenicity and developmental effects in children.

• – Make sure you are referred to a specialist for prenatal monitoring in order to detect possible occurrences of malformations.

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.

Breast-feeding

Very little valproate gets into the breast milk. Your doctor will decide if it is necessary to discontinue breast-feeding.

Driving and using machines

When you first start taking Convulex, or if you are taking it with other medicines, you may notice some drowsiness.

Do not drive or use any tools or machines until you know if you are affected by the intake of Convulex.

3. how to take convulex

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

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

Swallow the capsules whole, after meals, with a drink of water, unless your doctor advises differently. Do not crush or chew the capsules.

Adults

The usual dose of Convulex is between 1000 and 2000 mg per day but may be increased to 2500 mg per day. Usually, this quantity is evenly divided and taken in 2 separate doses, e.g. half in the morning and half in the evening.

Use in children and adolescents

Children over 20 kg

The usual dose of Convulex is based on the child’s weight. The usual dose is between 20 and 30 mg for each kg of body weight but may be increased to 35 mg for each kg of body weight per day. Usually, this quantity is evenly divided and taken in 2 separate doses, e.g. half in the morning and half in the evening.

Children under 20 kg

The usual dose of Convulex is based on the child’s weight. The usual dose is 20 mg for each kg of body weight. Usually, this quantity is evenly divided and taken in 2 separate doses, e.g. half in the morning and half in the evening.

When Convulex is first commenced , you may be prescribed a lower dose. This is because some patients need less Convulex than others to control their fits. Your doctor will increase the dosage until your condition is controlled. As a result of this it is very important that you follow the instructions your doctor has given you about how much to take. Blood tests may be needed.

If you have a kidney disease , your doctor may prescribe a lower dose.

If you are taking other medicines to control your epilepsy at the same time as Convulex, your doctor may gradually reduce the dose of these antiepileptics while increasing the dose of Convulex in small units per day, based on your body weight.

Make sure you keep your regular check up appointments with your doctor. They are very important as your dosage may need to be changed.

If you take more Convulex than you should

An overdose of this medicine may be dangerous. If you think you have taken more Convulex than you should, talk to a doctor or pharmacist, or go to the nearest hospital casualty department immediately.

If you forget to take Convulex

If you forget to take a dose at the right time, take it as soon as you remember, unless it is nearly time for your next dose. Then go on as before. Do not take a double dose to make up for a forgotten dose.

If you stop taking Convulex

If you wish to stop taking Convulex, talk to your doctor first. Do not stop taking Convulex just because you feel better, as this may lead to an immediate relapse and your condition may get worse.

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

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Please note that the following list includes all reported side effects – even those that occur very rarely.

It is very important that you immediately contact your doctor if you develop any of the following symptoms, because urgent medical measures may be necessary:

• – Certain changes in the blood, which may lead to an increased risk of weakness, bleeding or bruising, and can make infections more likely.

• – Severe or persisting abdominal pain, nausea and/ or vomiting (these may be symptoms of severe liver damage or of an inflammation of the pancreas, which may take a life-threatening course).

• – Vomiting, disturbed coordination of movements and progressive clouding of consciousness (these may be signs of increased ammonia levels in the blood).

• – Serious (sometimes life-threatening) skin reactions with blistering of the skin, mouth, eyes or genitals.

Tell your doctor or pharmacist, if you develop any of the following side effects:

Very common (may affect more than 1 in 10 people):

• – uncontrolled trembling or shaking movements in one or more parts of your body (tremor)

• – nausea

Common (may affect up to 1 in 10 people):

• – isolated, moderate hyperammonaemia (increased levels of ammonia in the blood without abnormal liver test values)

• – especially in case of excessively high doses, treatment with valproate may cause transitory anomalies of the blood count or blood clotting disturbances

• – lack of enough red blood cells (anaemia)

• – increased appetite

• – weight gain

• – decreased sodium levels in the blood (hyponatraemia)

• – loss of appetite (anorexia)

• – irritability

• – seeing or sensing things that aren‘t there while a person is awake and conscious (such as hearing voices)

• – confusional state

• – aggression

• – agitation

• – disturbance in attention

• – tickling/tingling sensation or numbness, trembling

• – movement disorders due to impaired regulation of muscle coordination in the brain (so-called extra-pyramidal symptoms; stupor)

• – dizziness

• – sleepiness, the state of feeling drowsy, ready to fall asleep

• – trouble with memory

• – convulsions (fits)

• – headache

• – twitching of the eyes (nystagmus)

• – partly reversible tinnitus and partly reversible impairment of hearing

• – increased bleeding

• – vomiting, diarrhoea, lack of appetite or constipation may occur at the beginning of treatment

• – gingival disorder, especially gingival hyperplasia

• – upper abdominal pain

• – hypersensitivity reactions

• – nail and nail bed disorders

• – transient hair loss

• – severe abdominal cramps during a women‘s period

Uncommon (may affect up to 1 in 100 people):

• – reduced number of blood platelets (especially in children), transitorily severely reduced number of white blood cells (leucopenia)

• – severe reduction in all blood cells which can cause weakness, bruising or make infections more likely (pancytopenia)

• – increased formation of “antidiuretic” hormone (leading to increased build-up of fluid in tissue) (Syndrome of inappropriate antidiuretic hormone secretion (SIADH))

• – excessive levels of androgens in the female body (hyperandroge­naemia)

• – acne and excessive growth of facial or body hair

• – hair disorder (e.g. altered hair texture, change of hair colour, abnormal hair growth), transient hair loss

• – unconscious state

• – continual tightening and contraction of certain muscles resulting in problems walking and talking

• – loss of muscle coordination; awkward, uncoordinated walking unsteadiness when walking

• – abnormal brain function

• – lethargy (occasionally followed by disturbed consciousness and sometimes associated with hallucinations or convulsions)

• – reversible parkinsonism (tremor, stiffness and shuffling)

• – aggravated convulsions

• – pain, reddening or itching of the skin, which may be signs of an inflammation of the blood vessels (vasculitis)

• – collection of fluid around the lungs in the chest cavity, which can cause shortness of breath and may require treatment

• – increased formation of saliva (hypersalivation)

• – inflammation of the pancreas, which may take a lifethreatening course (see section 2. under “Other things you should know before taking Convulex”)

• – severe liver damage, sometimes taking a fatal course (see section 2. “Other things you should know before taking Convulex”)

• – rash

• – 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.

• – kidney disorder (renal insufficiency)

• – absence of menstrual period in women

• – low body temperature

• – peripheral oedema (accumulation of fluid in tissue)

Rare (may affect up to 1 in 1,000 people):

• – tissue damage when valproate was inadvertently injected into an artery or in the area around a vein; inflammation at the injection site, pain

• – decreased production of blood cells by the bone marrow (including pure red cell aplasia, agranulocytosis, macrocytic anaemia, macrocytosis)

• – allergic reactions (ranging from rash to hypersensitivity reactions)

• – abnormally low level of thyroid gland hormone

• – elevation of testosterone levels

• – vomiting, disturbed coordination of movements and progressive clouding of consciousness may be signs of increased ammonia levels in the blood. If such symptoms occur, consult a doctor immediately.

• – obesity

• – hyperactivity

• – abnormal behavior

• – learning disorder

• – chronic abnormal brain function

• – reversible dementia

• – loss of neurons and the connections between them

• – cognitive impairment

• – double vision

• – potentially life-threatening condition affecting less than 10% of the skin in which cell death causes the epidermis (outer layer) to separate from the dermis (middle layer; Stevens-Johnson syndrome)

• – life-threatening condition affecting greater than 30% of the skin in which cell death causes the epidermis (outer layer) to separate from the dermis (middle layer; Toxic Epidermal Necrolysis)

• – severe reaction of the skin and gut lining that may include rash and shedding or death of tissue (erythema multiforme)

• – Drug Rash with Eosinophilia and Systemic Symptoms (DRESS syndrome)

• – systemic lupus erythematosus (a rare immune disorder)

• – allergic painful swelling of skin and mucous membranes, particularly in the face

• – breakdown of damaged skeletal muscle (rhabdomyolysis)

• – enuresis (involuntary discharge of urine)

• – inflammation of the spaces between renal tubules (tubulo-interstitial nephritis)

• – reversible failure of the tubules in the kidney to reabsorb small molecules (Fanconi syndrome)

• – male infertility

• – changes on the ovaries and menstrual irregularities in women (polycystic ovarian syndrome)

• – abnormal blood clotting

• – abnormal coagulation tests

• – biotin deficiency/bi­otinidase deficiency (a rare nutritional disorder)

• – porphyria (a rare metabolic disease)

Very rare (may affect up to 1 in 10,000 people):

• – increased breast growth in men

• – transient brain affection or loss of consciousness; if you notice any of these or similar symptoms, contact a doctor as quickly as possible.

Not known (frequency cannot be estimated from the available data):

• – depressed states

• – increase in alertness

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 the national reporting system:

Yellow Card Scheme

Website:

By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store convulex

Keep out of the sight and reach of children.

Do not store above 25 °C.

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

Do not use Convulex after the expiry date which is stated on the blister and on the carton after “use before”. The expiry date refers to the last day of that month.

Do not throw away 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 informationwhat convulex contains- the active substance is valproic acid.

One Convulex capsule 150 contains 150 mg valproic acid. One Convulex capsule 300 contains 300 mg valproic acid. One Convulex capsule 500 contains 500 mg valproic acid.

• – The other ingredients are gelatine, glycerol 85%, dry substance of Karion 83, titanium dioxide (E 171), red ferric oxide (E 172), hydrochloric acid, methacrylic acid-ethylacrylate copolymer (1:1)-dispersion 30%, triethyl citrate, macrogol 6000 and glycerol monostearate 44–55 Type II.

What Convulex looks like and contents of the pack

Convulex capsules are oval, old-rose coloured gastro-resistant soft-gelatine capsules in blister packs and are supplied in cartons of 30 and 100.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

Leaflet revised January 2020.