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Valprotek Cr 300 Mg (Prolonged Release) Tablets

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Valprotek CR 300 mg (prolonged release) tablets Valprotek CR 500 mg (prolonged release) tablets

Active substances: sodium valproate and valproic acid

^BThis 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

Valproate can cause birth defects and problems with early development of the child if it is taken during pregnancy. If you are a female of childbearing age you should use an effective method of contraception throughout your treatment.

Your doctor will discuss this with you but you should also follow the advice in section 2 of this leaflet.

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


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. 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 Valprotek CR is and what it is used for

2.    Before you take Valprotek CR

3.    How to take Valprotek CR

4.    Possible side effects

5.    How to store Valprotek CR

6.    Further information

1. WHAT VALPROTEK CR IS AND WHAT IT IS USED FOR

Valprotek CR is a medicine for the treatment of seizures (antiepileptic agent) and a mood stabilising medicine for the treatment of acute mania.

Valprotek CR is used in the treatment of

-    seizures originating in both halves of the brain (generalised seizures, e.g. absences, myoclonic and tonic-clonic seizures)

-    seizures originating from a localised area of the brain (focal seizures) which may subsequently spread to both halves of the brain (secondary generalised seizures)

Valprotek CR can be used in other forms of seizure, e.g. seizures with mixed (complex) symptoms, and seizures which spread from a localised area of the brain to both brain halves (secondary generalised seizures), together with other medicines for treating seizures, if these forms of seizures do not respond to the usual antiepileptic treatment.

-    mania, where you may feel very excited, elated, agitated, enthusiasthic ot hyperactive. Mania occurs in an illness colled “bipolar disorder” Valprotek CR can be used when lithium can not be used.

2. BEFORE YOU TAKE VALPROTEK CR

Do not take Valprotek CR

-    if you are allergic (hypersensitive) to sodium valproate or valproic acid or any of the other ingredients of Valprotek CR

-    if you suffer from an impaired function of your liver or pancreas

-    if you or any of your dependants have a history of severe liver disease, especially drug related

-    if you suffer from a disease due to a disorder in the formation of red blood pigment (porphyria)

-    if you are susceptible to bleeding.

- if you suffer from enzyme disturbances of the urea cycle (see also Take special care with Valprotek CR)

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

Take special care with Valprotek CR

-    if there has been earlier damage to the bone marrow; in this case close medical supervision is necessary (blood count tests)

-    if you suffer from inflammation-like diseases of the skin and/or internals (SLE; systemic lupus erythematosus); this disorder can be made worse or be induced due to Valprotek CR.

-    if you develop complaints during treatment with Valprotek CR, such as physical or mental weakness, loss of appetite (anorexia), apathy, sleepiness, nausea, repeated vomiting, abdominal pain, aversion to foods normally eaten and/or to valproate/valproic acid, recurrence or worsening of seizures/convulsions, noticeably frequent bruising/nosebleeds and/or prolonged bleeding time, consult the attending doctor immediately. Inflammation of the liver or pancreas, or an increased level of ammonia in the blood may be the reason. Patients with suspected metabolic disturbances, especially enzyme disturbances of the urea cycle should therefore undergo metabolic investigation by the attending doctor before treatment is started (see also Do not take Valprotek CR).

-    if you suffer from a reduced renal function or protein deficiency in the blood; it may be necessary that your doctor reduces the dose in order to decrease the content of valproic acid in blood (see 3.)

-    before you have any surgical or dental procedure (e.g. a tooth extraction). As intake of Valprotek CR may be associated with an increased tendency to bleeding, the attending doctor must be informed that you are taking Valprotek CR, so that blood coagulation is checked.

-    if you are simultaneously taking any medicines which thin your blood (e.g. vitamin K antagonists), as you may be more prone to bleeding. Blood clotting (Quick’s value) must therefore be regularly checked.

-    if Valprotek CR is given to infants and children aged less than 3 years with a severe form of epilepsy (particularly those with anomalies regarding cerebrum, mental retardation, certain disorders caused by genes and/or known metabolic disorders); there is a higher risk of liver intoxication in the first 6 months of treatment, particularly in very young children. The risk of liver intoxication is higher particularly in combined treatment with other antiepileptics.

-    if you notice that you gain weight, particularly at the beginning of treatment. This can be attributed to an increased appetite (see 4.). You should monitor your weight and limit a possible weight gain to a minimum. -You know that there is a genetic problem causing a mitochondrial disorder in your family.

A small number of people being treated with anti-epileptics such as Valprotek CR 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:

Valprotek CR should not be used in children and adolescents under 18 years of age for the treatment of mania.

Taking other medicines

The effect and sometimes the side effects of Valprotek CR are increased by:

-    felbamate (used to treat seizures)

-    cimetidine (used to treat stomach ulcers)

-    erythromycin (used to treat bacterial infections)

-    acetylsalicylic acid (“ASA”, used to reduce pain and fever). Simultaneous administration of Valprotek CR and acetylsalicylic acid should particularly be avoided in infants and children, as the tendency to bleeding may be increased.

The effect of Valprotek CR is reduced by:

-    other medicines to treat seizures such as phenobarbital, primidone, phenytoin and carbamazepine

-    mefloquine (used to treat malaria) which increases the breakdown of valproic acid and also has the potential to trigger seizures

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 carbapenems should be avoided because it may decrease the effect of sodium valproate.

The effect of Valprotek CR may be increased or reduced by:

-    fluoxetine (used to treat depression)

Valprotek CR increases the effect and sometimes the side effects of:

-    other antiepileptic therapy e.g. carbamazepine, clonazepam, felbamate, lamotrigine phenobarbital, phenytoin, primidone; following concurrent treatment with valproic acid and clonazepam, absence status (long-lasting seizure) occurred in patients with a history of absence seizures (special type of seizure); there is some evidence that a combination of lamotrigine and valproic acid causes an increased risk of skin reactions

, especially in children.

-    neuroleptic agents (used to treat psychological disorders)

-    benzodiazepines (used to relieve anxiety and tension), such as diazepam and lorazepam

-    barbiturates (tranquillisers)

-    monoamine oxidase (MAO) inhibitors (used to treat depression) and other medicines used to treat depression

-    codeine (used, among other things, in cough remedies)

-    zidovudine (used to treat HIV infections)

-    anticoagulants (e.g. vitamin K antagonists), so that the tendency to bleeding may be increased

In one female patient with a schizoaffective disorder (a psychological disorder), catatonia (a condition of persistent immobility which cannot be ended by external stimuli) occurred following simultaneous treatment with valproic acid, sertraline (an antidepressant) and risperidone (a neuroleptic agent).

Other interactions:

-    acetylsalicylic acid (“ASA”, used to reduce pain and fever) can increase the tendency to bleeding

-    in diabetic patients, a test for ketone bodies in the urine may have a false result

-    other medicines which put a strain on liver metabolism can increase the risk of liver damage

-    concomitant administration of Valprotek CR and topiramate (used to treat seizures) has been associated with signs of brain damage (encephalopathy) and/or increased blood levels of ammonia (hyperammonia)

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

Taking Valprotek CR with food and drink

Alcohol consumption can affect the activity of Valprotek CR and increase its side effects. You should thus avoid alcohol during treatment.

You should preferably avoid intake of acidic beverages or chilled foods at the same time as Valprotek CR. Pregnancy

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.

•    There have been case reports of bleeding problems occurring in the newborns of mothers treated with valproic acid during pregnancy.

•    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 ever 100 bom 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

will have explained the risks to an you will need to make sure you use to your doctor or family planning


If this is the first time you have been prescribed valproate your doctor unborn child if you become pregnant. Once you are of childbearing age, an effective method of contraception throughout your treatment. Talk 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 it 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.

Breast-feeding

Do not breast-feed while taking valproate and ask your doctor for advice. Valproate passes into the breast milk. Blood disorders have been shown in breastfed newborns/infants of women taking valproate.

Driving and using machines

Do not drive and do not use any tools or machines without consulting your doctor or pharmacist.

Especially at the beginning of treatment, if higher doses are taken or if you are simultaneously taking other medicinal products which also affect the central nervous system, such as drowsiness or confusion may occur. These may so alter your responsiveness that your ability to drive a vehicle or operate tools and machinery is impaired, regardless of your underlying disease. This effect is more pronounced in combination with alcohol.

3. HOW TO TAKE VALPROTEK CR

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

Seizures

Dosage

Always take Valprotek CR exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual average daily dose during long-term treatment is:

<Valprotek CR 300 mg (prolonged release) tablets>

Age

Body weight

Average dose in mg/day

Prolonged-

release

tablets/day

Children

3-6 years

approx. 15-25 kg

450-600

1/-2

7-14 years

approx. 25-40 kg

750-1200

2/-4

Adolescents from 14 years

approx. 40-60 kg

1000-1500

3-5

Adults

from approx. 60 kg

1200-2100

4-7

< Valprotek CR 500 mg (prolonged release) tablets>

Age

Body weight

Average dose in mg/day

Prolonged-

release

tablets/day

Children

3-6 years

approx. 15-25 kg

450-600

1

7-14 years

approx. 25-40 kg

750-1200

1/-2

Adolescents from 14 years

approx. 40-60 kg

1000-1500

2-3

Adults

from approx. 60 kg

1200-2100

2-4

In children up to 3 years dosage forms with a lower active substance content (e.g. solution) should preferably be used. For treatment in children > 3 years Valproate-ratiopharm chrono 300 mg Retardtabletten, which can be divided in equal halves, may be used.

Incremental (gradual) dose increases are recommended up to the optimal effective dose. In some cases, the full effect is not seen for 4-6 weeks. The daily dose should thus not be increased too rapidly above the average amounts.

If Valprotek CR is taken in combination with other medicines to treat seizures or to replace a medicine previously taken, the dose of the previously administered antiepileptic medication must be immediately reduced. If the previous medicine is to be discontinued, this must be tapered off gradually.

Other medicines used to treat seizures accelerate the breakdown of valproic acid. If these medicines are discontinued, the valproic acid concentration in the blood increases slowly, so that valproic acid concentrations should be checked over a period of 4-6 weeks. The daily dose of Valprotek CR should be reduced as required.

Pretreatment with non-prolonged release valproic acid products must be gradually replaced by Valprotek CR, until treatment can be continued with single doses of Valprotek CR.

Your doctor will determine the exact dose required on an individual basis.

Mania

The daily dosage should be established and controlled individually by your doctor.

Initial dose

The recommended initial dose is 750 mg.

Mean daily dose

Valprotek CR 300 mg prolonged-release tablets The recommended daily doses usually range between 1000 mg and 2000 mg.

Valprotek CR 500 mg prolonged-release tablets The recommended daily doses usually range between 1000 mg and 2000 mg.

Route of administration

For oral use. The prolonged-release tablets should be swallowed whole or in halves, not chewed, and taken with plenty of fluid (e.g. a glass of water).

Occasionally, the ingredients of the prolonged-release tablets may be visible as a white residue in the stool. This does not imply any impairment of the effect of the medicine, as the active substance dissolves completely from the tablet structure (matrix) while passing through the intestines.

Frequency of administration

The daily dose is given in 1-2 divided doses.

The prolonged-release tablets should preferably be taken 1 hour before meals (on an empty stomach in the morning). In case of gastrointestinal side-effects due to treatment, the prolonged-release tablets should be taken during or after a meal.

Duration of treatment

Treatment of seizures and bipolar disorder is principally a long-term therapy.

The specialist doctor (neurologist, neuropaediatrician) should decide upon dose titration, the duration of treatment, dosage and withdrawal of Valprotek CR on an individual basis, depending upon the individual course of disease.

Generally, in the treatment of seizures no dose reduction or withdrawal of the medicine should be attempted until the patient has been free of seizures for at least two to three years.

Special patient groups

In patients with reduced kidney function and protein deficiency in the blood, the effect of valproic acid may be increased. Your doctor will adjust or reduce the daily dose as appropriate.

If you take more Valprotek CR than you should

If you have used too much Valprotek CR, immediately contact your doctor. Symptoms of overdose can be: coma with elevated muscular tension, reduced reflexes, contracted pupils, confusion, sleepiness, metabolic acidosis, increased sodium in the blood and impaired respiratory or heart function.

Furthermore, high dosages caused abnormal neurological disturbances, such as an increased tendency to seizures and behavioural changes.

If you forget to take Valprotek CR

Do not take a double dose to make up for a forgotten tablet.

If you have forgotten to take a dose, you can do this afterwards unless it is almost time to take your following dose. In this case, follow the normal dosage scheme.

If you stop taking Valprotek CR

On no account may you interrupt or prematurely end treatment with Valprotek CR on your own initiative, as this may endanger the success of your treatment and trigger epileptic seizures again. Please talk to your doctor beforehand if you experience any intolerance to your medicine or changes in your condition.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, Valprotek CR can cause side effects, although not everybody gets them.

The following frequency data are used in the evaluation of side effects:

very common

affects more than 1 user in 10

common

affects 1 to 10 users in 100

uncommon

affects 1 to 10 users in 1,000

rare

affects 1 to 10 users in 10,000

very rare

affects less than 1 user in 10,000

not known

frequency cannot be estimated from the available data

Blood and the lymphatic system disorders

A reduction in the number of blood platelets (thrombocytopenia) or the white blood corpuscles (leukopenia) is a common occurrence. These effects are often completely reversible if therapy is continued and always upon withdrawal of Valprotek CR.

Uncommon occurrences were increased accumulation of water in the tissues (oedema) and bleeding.

Rare: Valproate can cause reduced fibrinogen levels and inhibition of the platelet aggregation with prolonged bleeding time.

Very rarely, impairment of bone marrow function can lead to further disorders of the blood components (lymphopenia, neutropenia, pancytopenia), severe anaemia or agranulocytosis (symptoms: fever, sore throat).

Valproic acid can inhibit blood clotting (function of the blood platelets) thus causing a prolonged bleeding time.

Bleeding is an uncommon occurrence.

Immune system disorders

Rare: Reactions of the body’s defence system against its own connective tissue (lupus erythematosus). Frequency not known: Swelling with acing, itching wheals mostly affecting the eyes, lips, throat and sometimes hands and feet (angioedema). Syndrome with drug-induced rash, fever, swelling of lymph nodes and possible impairment of other organs (DRESS).

Metabolism and nutrition disorders

A very common occurrence is an isolated and moderate increase in serum ammonia levels without any change in liver function parameters, which does not necessitate withdrawal of therapy (see also sections 2 “Do not take Valprotek CR and “Take special care with Valprotek CR”).

Dose-dependently, weight increases or weight loss, increased appetite or loss of appetite are commonly observed.

A reduced biotinidase activity was observed during treatment with valproic acid. There have also been reports of biotin deficiency.

Very rare: Decreased sodium blood levels that may lead to fatigue and confusion.

Psychiatric disorders

Uncommon: Irritability, excessive activity or confusion, particularly at the beginning of treatment.

Hallucinations have been reported.

Nervous system disorders

Dose-dependent and common: drowsiness, trembling or disturbed sensations in the form of tingling or numbness of the skin.

Fatigue and somnolence, apathy and ataxia have been commonly observed during combined treatment with other antiepileptics.

Uncommon: Headache, muscle tension, uncertain gait, particularly at the beginning of treatment.

Uncommon: shortly after use of medicines containing valproic acid, irrespective of the dose, organic brain disease was observed. Its cause and developmental mechanism have not been established and it can resolve following discontinuation of the medicine. In some cases, elevated ammonia levels and, in combination therapy with phenobarbital (another medicine used to treat seizures), a rise in phenobarbital levels has been described.

Also uncommon were reported cases of physical rigidity while conscious (stupor) sometimes culminating in coma, which were partially associated with an increased frequency of seizures. The symptoms resolved following a dose reduction or withdrawal of the medicine. The majority of such cases occurred during combination therapy (particularly with phenobarbital) or following a rapid dose increase.

Rarely, particularly at higher doses or in combination therapy with other medicines to treat seizures, chronic brain disease (encephalopathy) with disorders of brain function, including mental performance capacity, have been reported. The developmental mechanism has not been sufficiently clarified.

Very rarely disturbed brain function, accompanied by shrinking of brain tissue, which resolved following discontinuation of Valprotek CR has been reported.

In long-term therapy with Valprotek CR, together with other medicines to treat seizures, particularly phenytoin, signs of brain damage (encephalopathy) may occur, accompanied by an increased occurrence of seizures, lack of drive, cases of physical rigidity while conscious (stupor), muscle weakness (muscular hypotension), movement disturbances (choreoid dyskinesias) and severe general changes in the electroencephalogram (EEG).

The occurrence of a reversible Parkinson syndrome has been reported.

Frequency not known: Sedation, uncontrollable movements (extrapyramidal disorders).

Ear disorders

Ringing in the ears has been observed.

There have been reports of temporary and permanent hearing loss, although no causal connection with intake of medicines containing valproic acid or sodium valproate has been established.

Vascular disorders

Rare: Inflammation of the blood vessels (vasculitis).

Gastrointestinal disorders

Uncommon occurrences were excessive saliva production and diarrhoea, particularly at the beginning of treatment.

Particularly at the beginning of therapy, there have been uncommon reports of mild gastrointestinal disturbances (nausea, stomach ache), which usually subsided after a few days even if therapy was continued. There have been rare cases of pancreatic damage, sometimes with fatal outcome.

Liver disorders

Uncommon: Dose-independent, severe (sometimes fatal) liver dysfunction can occur. In children, particularly in those simultaneously taking other medicines to treat seizures, the risk of liver damage is markedly increased (see 2.).

Skin disorders

Common: Dose-dependent, transient hair loss, thinning of the hair.

In rare cases, intake of medicines containing valproic acid leads to skin reactions (erythema multiforme). Very rarely severe skin reactions (Stevens-Johnson syndrome and toxic epidermal necrolysis or Lyell’s syndrome) have been reported.

See also “Disorders of the body’s defence system and hypersensitivity reactions”.

Musculoskeletal disorders

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.

Renal and urinary disorders

Rarely a certain type of kidney dysfunction (Fanconi’s syndrome) can occur. This resolves following discontinuation of the medicine.

Bedwetting has been observed in children.

Reproductive system disorders

Common: Irregular menstruation.

Rare: Irregular menstruation or failure to menstruate, painful menstruation, enlarged ovaries with cysts and increased levels of the male sex hormone, testosterone.

Congenital disorders

Frequency not known: Birth defects and developmental disorders when taken during pregnancy (see also section 2. “Important advice for women”).

General disorders

Very rarely a fall in body temperature (hypothermia) has been described. This resolved following discontinuation of the medicine.

If any dose-independent side effects occur, the medicine must be withdrawn by your treating physician. If severe liver function impairment or damage to the pancreas is suspected, the doctor must immediately withdraw Valprotek CR. Other medicines with the same metabolic breakdown, which could cause similar side effects, must be temporarily discontinued. In isolated cases, a clinical progression may still occur.

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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

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

5. HOW TO STORE VALPROTEK CR

Keep out of the reach and sight of children.

Do not use Valprotek CR after the expiry date which is stated on the <blister> <carton> <bottle> after {EXP}. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

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

6. FURTHER INFORMATION

What Valprotek CR 300 mg (prolonged release) tablets contain

The active substances are sodium valproate and valproic acid. 1 prolonged-release tablet contains 200 mg sodium valproate and 87 mg valproic acid (equivalent to a total of 300 mg sodium valproate).

The other ingredients are hypromellose 4000 mPas, hypromellose 15000 mPas, acesulfam potassium, silica colloidal hydrate, sodium laurilsulfate, dibutyl sebacate, basic butylated methacrylate copolymer, magnesium stearate, titanium dioxide.

What Valprotek CR 300 mg (prolonged release) tablets look like and contents of the pack

Valprotek CR 300 mg (prolonged release) tablets are white, oblong film coated prolonged-release tablets with break marks at both faces.

The tablet can be divided into equal halves.

Pack sizes:

20, 30, 50, 60, 90, 100, 200, 500 (hospital pack) prolonged-release tablets.

What Valprotek CR 500 mg (prolonged release) tablets contain

The active substances are sodium valproate and valproic acid. 1 prolonged-release tablet contains 333 mg sodium valproate and 145 mg valproic acid (equivalent to a total of 500 mg sodium valproate).

The other ingredients are hypromellose 4000 mPas, hypromellose 15000 mPas, acesulfam potassium, silica colloidal hydrate, sodium laurilsulfate, dibutyl sebacate, basic butylated methacrylate copolymer, magnesium stearate, titanium dioxide.

What Valprotek CR 500 mg (prolonged release) tablets look like and contents of the pack

Valprotek CR 500 mg (prolonged release) tablets are white, oblong film coated prolonged-release tablets with break marks at both faces.

The tablet can be divided into equal halves.

Pack sizes:

20, 28, 30, 50, 56, 60, 90, 100, 120, 200, 500 (hospital pack) prolonged-release tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm, Germany

This leaflet was last amended in March 2015

PL 15773/0609 PL 15773/0610