Depakine 500 mg. 40 tablets

What is Depakine 500 mg and what is it used?

The active substance in Depakine 500 mg with valproate.

Depakine 500 mg belongs to a group of medicines used to treat epilepsy and mania.

Depakine 500 mg is used in the treatment of:

In adults: Epilepsy

• Primary generalized epilepsy and seizures

• Types of attacks:

absence seizures (petit mal), generalized tonic-clonic (grand mal), tonic and atonic seizures, myoclonic seizures, infantile spasms.

• generalized epilepsy and epileptic syndromes:

absence epilepsy, juvenile myoclonic epilepsy (syndrome Janz), epilepsy with generalized tonic-clonic seizures on awakening, photosensitive epilepsies.

• Lennox- Gastaut Syndrome

• Syndrome West

• Focal (partial) epilepsy and seizures with or without secondary generalization.

Mania, where you may feel very excited, elated, excited, enthusiastic or hyperactive. Mania occurs in an illness called "bipolar disorder". Valproate 500 mg can be used, when lithium can not be attached.

In children: as monotherapy or in combination with other antiepileptic drugs:

Treatment of generalized epilepsy: clonic, tonic, tonic-clonic seizures, absence seizures, myoclonic seizures, atonic seizures; Treatment of partial epilepsy: partial seizures with or without secondary generalized seizures.
2. Before you take 500 mg of Depakine

Do not take Depakine 500 mg of

• If you are allergic to sodium valproate (Depakine active substance of 500 mg) or any of the ingredients of Valproate 500 mg of
• If you have active hepatitis or active liver disease
• If you (or someone in your immediate family) have data for the past spent in severe hepatitis, especially one caused by drugs
• If you suffer from hepatic porphyria (a very rare metabolic disease)

If you think you have any of these problems, or if you have any doubt, consult with your doctor before taking Depakine 500 mg.

Take special care with Depakine 500 mg of

• If you or your child develop a sudden illness, especially if this occurs within the first 6 months of treatment, especially if it involves repeated vomiting, extreme fatigue, abdominal pain, drowsiness, weakness, loss of appetite, stomach pain, nausea, jaundice (yellowing of the skin or whites of the eyes), swelling of the legs or worsening epilepsy or a general feeling of ill health, you should immediately tell your doctor. In a very small number of patients Valproate 500 mg may damage the liver (rarely pancreas).
• If Valproate 500 mg is considered a child under 3 years, while taking other anti-epileptic drugs or have other neurological or metabolic disease and severe form of epilepsy
• Especially if the child is under 3 years of Valproate 500 mg, it should be administered with acetylsalicylic acid (aspirin)
• If you have systemic lupus erythematosus (a rare type of disease)
• If you have any metabolic disorders, particularly hereditary enzyme deficiency as a violation of the urea cycle, due to the risk of increased levels of ammonia in the blood
• If you have impaired kidney function. Your doctor may want to monitor the level of valproate or adjust the dose,
• If you put some weight because of increased appetite.
• A small number of persons treated with anti-epileptics have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.
• A small number of people being treated with antiepileptic drugs such as sodium valproate have had thoughts of harming or killing themselves. If you experience such thoughts at any time, immediately contact your doctor.

Children and adolescents

Children and adolescents under the age of 18:

Depakine 500 mg should not be given to children and adolescents under 18 years of age for the treatment of mania.

Other medicines and Valproate 500 mg of

Tell your doctor or pharmacist if you are taking, you have recently taken or might take any other medicines, even those obtained without a prescription.

Some medicines may influence the use of Valproate 500 mg or vice versa. These are:

• neuroleptics (used to treat psychiatric disorders)

• drugs for the treatment of depression,
benzodiazepines used as sedatives or for the treatment of anxiety
• other medicines used to treat epilepsy, including phenobarbital, phenytoin, primidone, lamotrigine, carbamazepine, topiramate

• zidovudine (used to treat HIV infection and AIDS)

• mefloquine (used for the treatment and prevention of malaria),

• salicylates (aspirin); see. also children under 3 years. "Before take Valproate 500

mg. "),

• anticoagulants (used to prevent blood clots)

• cimetidine (used to treat stomach ulcers)

• erythromycin, rifampicin, carbapenems such as imipenem, meropenem and panipenem (antibiotics). Concomitant administration of valproic acid and carbapenem should be avoided to reduce the effect of sodium valproate.

• carbapenem agents, such as imipenem, meropenem and panipenem (antibiotics used to treat bacterial infections). Concomitant administration of valproic acid and carbapenem should be avoided to reduce the effect of sodium valproate.

These medicinal products, and some others may be affected by Valproate 500 mg or they affect its operation. It may need a different dose of your medicine or take any other medicines. You'll get advice from your doctor or pharmacist.

More information on medicinal products which can caution or who should avoid while taking Depakine 500 mg of you will get from your doctor or pharmacist.

Depakine 500 mg with food, drinks and alcohol

It is not recommended to drink alcohol during treatment

Pregnancy, lactation and fertility

You should not take this medicine if you are pregnant or you are a woman of childbearing age, unless specifically recommended by your doctor. If you are a woman of childbearing potential must use effective contraception during treatment.

Information for women who could become pregnant unplanned pregnancy is undesirable in women treated with Depakine 500 mg. You should use an effective method of contraception and consult your doctor before planning pregnancy.

Depakine 500 mg did not influence the effectiveness of oral contraceptive pills.

It is important to discuss pregnancy and epilepsy with your doctor if you have one, with its specialist epilepsy. This is done to ensure that if you become pregnant, you and your doctor agree to take Valproate 500 mg.

Babies born to mothers who took Valproate 500 mg were more likely to have problems. With appropriate planning, the likelihood of such events can be reduced. Valproate 500 mg may increase the risk of birth defects in the developing baby, such as spina bifida (a condition in which the bones of the spine are not developed properly), craniofacial defects, malformations of the lower limbs, cardiovascular malformations, hypospadias ( malformation of the urethra) and multiple abnormalities including various organ systems.

Intrauterine fetal disorders, however, can usually be opened in the first part of pregnancy by simple controls.

Children born to mothers who received 500 mg of Valproate during pregnancy may have impaired development or autistic disorders.

Immediately tell your doctor if you are pregnant or think you may be pregnant and taking or you are prescribed Valproate 500 mg. Your doctor may adjust your treatment and / or prescribe supplemental folic acid. You should not stop taking Valproate 500 mg, unless your doctor decides to stop treatment, because there are serious dangers for you and the developing baby due to untreated epilepsy. In newborns whose mothers took Valproate 500 mg during pregnancy may be problems with blood clotting, hypoglycemia (decrease levels of sugar in the blood) and hypothyroidism (underactive thyroid gland which can cause tiredness or rise weight.

Information for women planning to become pregnant (see. Information for women who could become pregnant)

Unplanned pregnancy is not desirable in women receiving anti-epileptic drugs. Consult your doctor before planning a pregnancy, to get proper consultation and allow your doctor to adjust your treatment and / or dose and adequate to track your pregnancy. Immediately contact your doctor as soon as you know you are pregnant.

Information for women who are pregnant at the time of adoption of Valproate 500 mg (see. Information for women who could become pregnant)

If you become pregnant while taking Valproate 500 mg, immediately contact your doctor. Breastfeeding

Since only a very small amount of Depakine 500 mg passes into breast milk does not generally pose a danger to the child and is not usually necessary to stop breastfeeding. However, discuss with your doctor whether you can breastfeed your baby.

Driving and using machines

Depakine 500 mg may cause drowsiness or dizziness in some people, especially early in treatment or in combination with other antiepileptic drugs or benzodiazepines. Check how you react to Valproate 500 mg before the driving, operating machinery, or performing other activities where danger can occur if you are sleepy or dizzy.

3. How to take Depakine 500 mg?

Regularly attend their control reviews. They are very important change in your dose.

Always take Depakine 500 mg exactly as instructed unsure, ask your doctor or pharmacist.

Dosage:

Medium dose 24 hours:

- Adolescents and adults: from 20 to 30 mg / kg (preferably using a tablet, a tablet or granule chrono prolonged-release formulation).

The daily dose should be divided into two or three doses, preferably during meals. This form is not suitable for children under 6 years (risk of choking).

Route of administration

Valproate 500 mg taken orally. Do not crush the tablet, if not scored for breaking.

Epilepsy
In children:

Of oral formulations, these formulations are suitable for use in children under the age of 11 years (syrup, oral solution and granules).

Craze

The daily dose should be individually determined and controlled by your doctor.

Initial dose

The recommended initial daily dose is 750 mg. Average daily dose

The recommended daily dose range between 1000 mg and 2000 mg

Bipolar disorder
In children and adolescents:

The safety and efficacy of Depakine 500 mg for the treatment of manic episodes in bipolar disorder have not been evaluated in patients aged less than 18 years.

Duration of treatment

Take Depakine 500 mg, as long as your doctor continues to prescribe it.

If ste take more dose of 500 mg of Depakine

If you take Depakine 500 mg, more than it should, they should take the following measures in hospital: gastric lavage, maintenance of effective diuresis and monitoring of cardiac and respiratory function. If needed, many severe cases dialysis.

Depakine overdose of 500 mg may be dangerous. Immediately contact your doctor or the nearest emergency unit.

If you forget to take Depakine 500 mg.

Do not take a double dose to make up the missed dose. Just continue taking your medicine as directed by your doctor.

If you forget to take several doses, contact your doctor. If stop treatment with Depakine 500 mg.

Do not stop taking Depakine 500 mg, or change the dose without consulting your doctor. If you stop taking the tablets without instructions from your doctor, your disease may get worse.

4. POSSIBLE SIDE EFFECTS

Like all medicines Depakine 500 mg may have side effects in a small number of persons. They are rarely severe, and in most cases are not serious. Usually reversible. If you experience any of the side effects you may need to get medical help, nausea or stomach pain, diarrhea, especially when starting treatment headache, shaking (tremor), drowsiness, unsteadiness in walking, aggression, agitation (emotion), impaired attention, abnormal behavior and psychomotor hyperactivity tingling or numbness in the hands and feet skin reactions such as rashes, transient hair loss, changes in the menstrual cycle, hearing problems, rapid, uncontrollable eye movements

• allergic reactions

• swelling of the feet and legs (edema)

• weight gain

• kidney problems, dropping in little need or urinary urgency

• infertility in men

• memory impairment and cognitive impairment (cognitive impairment)

• impaired learning

There have been reports of abnormal bone structure, including osteopenia and osteoporosis (loss of bone density). Check with your doctor or pharmacist if you have long-term antiepileptic treatment, you have a past disease osteoporosis or taking steroids.

Tell your doctor if you notice any of the following serious side effects. You may need to get emergency medical help:

• Change in level of consciousness, abnormal behavior whether or not associated with more frequent or more severe seizures, loss of interest in the outside world, particularly when taken together with phenobarbital and topiramate, or if the dose of Valproate 500 mg of a sudden be increased.

• Repeatedly vomiting, extreme fatigue, abdominal pain, drowsiness, weakness, loss of appetite, pain in the upper abdomen, nausea, jaundice (yellowing of the skin or whites of the eyes), swelling of the legs or worsening epilepsy or a general feeling impaired health.

• Problems with blood clotting

• Spontaneous bruising or bleeding

• Blisters with peeling skin

• Profound reduction in white blood cells or bone marrow failure that sometimes occurs with a high temperature and difficulty in breathing

• confusion, which may be due to decreased levels of sodium in the blood.

• allergy-induced painful itchy bumps with seals (most commonly around the eyes, lips, throat and sometimes on the palms and soles)

• syndrome with drug rash, fever, lymph node enlargement and possibly other organs disorders

• Reduced function of the thyroid gland, which may cause fatigue and weight gain (hypothyroidism)

• Allergic reactions, which causes joint pain, skin rashes and fever (systemic lupus erythematosus)

• extrapyramidal disorder

• Difficulty in breathing and inflammation due to the lining of the kidney (pleural effusion)

Depakine 500 mg may also cause reduction in the number of platelets or red blood cells.

If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. How to store Depakine 500 mg?

Keep out of reach of children.

Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of that month.

Medicines should not be disposed of in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment
This medicinal product does not require any special storage conditions. Keep out of reach of children.

6. Contents of the pack and further information
What Depakin 500 mg?

The active substance is 500 mg sodium valproate (sodium valproate) - The other ingredients are; tovidon 90 K, calcium silicate, talc, magnesium stearate,

polyethylene glycol, corn starch, povidion R 30, titanium dioxide, yellow iron oxide, cellulose acetate phthalate, ethyl phthalate.

Looks Depakine 500 mg and contents of the pack?

Gastro-resistant tablets

Depakine 500 mg tablets are placed in a polypropylene tube of 40 tablets.