What is DEPAKINE syrup and what is it used?
The active substance in DEPAKINE syrup is sodium valproate. DEPAKINE syrup belongs to a group of medicines to treat epilepsy.
In adults: Epilepsy
• Primary generalized epilepsy and seizures
• Types of seizures, absence seizures (petit mal), generalized tonic-clonic (grand mal), tonic and atonic seizures, myoclonic seizures, infantile spasms.
• Generalized epilepsies and epileptic syndromes: absence epilepsy, yuvenilnamioklonichna epilepsy (epilepsy syndrome with generalized tonic-clonic seizures on awakening, photosensitive epilepsies.
• Syndrome Lennox-Gastaut
• West Syndrome
• Focal (partial) epilepsy and seizures with or without secondary generalization.
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; Syndrome Lennox-Gastaut
Treatment of partial epilepsy: partial seizures with or without secondary generalized
seizures.
In children:
Prevention of febrile convulsions in fever, when prevention is considered urgent or risk factors for resumption of symptoms.
affective psychoses
Treatment and prevention of manic episodes in bipolar disorder.
2. BEFORE YOU TAKE DEPAKINE syrup
Do not take DEPAKINE syrup
• If you have a proven allergy to sodium valproate (the active ingredient of Depakine
syrup) or to any of the ingredients of Valproate syrup
• If you have active hepatitis or active liver disease
• If you know that you (or someone in your immediate family) have data for spent
past 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 syrup
Pay special attention to DEPAKINE syrup
• If you or your child develop a sudden illness, especially if this happens 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 item or a general feeling of ill health, you should immediately tell your doctor.
In a very small number of patients DEPAKINE syrup can damage the liver (and rarely the pancreas).
• If Valproate syrup is considered a child under H 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 DEPAKINE syrup should not be taken together with acetylsalicylic acid (aspirin)
• If you have systemic lupus erythematosus (a rare type of disease)
• If you suffer from any metabolic disorders, particularly hereditary enzyme deficiency as a violation of the urea cycle, as it may increase the level 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 antiepileptic agents have solved to harm or kill themselves. If at any time you have these thoughts, immediately contact your doctor.
pregnancy
Information for women who could become pregnant
Unplanned pregnancy is not desirable in women receiving DEPAKINE syrup. You must use effective contraception and should consult their doctor before planning pregnancy. DEPAKINE syrup does not affect the effectiveness of oral contraceptive tablets. It is important to discuss pregnancy and epilepsy with your doctor and if you have one, with its specialist epilepsy. This is done to ensure that you and your doctor agree to take Valproate syrup if you become pregnant. Babies born to mothers taking Valproate syrup are more likely to have problems. With appropriate planning, the likelihood of such events can be reduced.
Valproate syrup 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). Intrauterine fetal disorders, however, can usually be found in the first part of pregnancy by simple controls.
Children born to mothers taking DEPAKINE syrup during pregnancy may have impaired development or autistic disorders.
Immediately talk to your doctor if you are pregnant or think you may be pregnant and are taking or are you if DEPAKINE syrup. Your doctor may adjust your treatment and / or prescribe supplemental folic acid intake. You should not stop taking Valproate syrup, unless your doctor instructs, as there are serious hazards for BAE and developing baby due to untreated epilepsy. In women taking Valproate syrup during pregnancy may occur bleeding problems in the newborn child.
Information for women planning to become pregnant (see. Information about 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 dosage and to adequately monitor your pregnancy. As soon as you know you are pregnant, tell your doctor.
Information for women who became pregnant while taking Valproate syrup (see. Information about women who could become pregnant)
If you become pregnant while taking Valproate Table., Immediately contact your doctor.
breastfeeding
Since only a very small amount of syrup Valproate passes into breast milk, do not generally pose a danger to the child and is not usually necessary weaning. However, you should discuss with your doctor whether you can breastfeed your baby.
Driving and using machines
Valproate syrup can cause drowsiness or dizziness in some people, especially at the beginning of treatment or in combination with other antiepileptic drugs or benzodiazepines. Check
how you react to Valproate syrup before driving, operating machinery, or performing other activities where danger can occur if you are sleepy or dizzy.
Taking other medicines
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
Some medicines can affect the effects of Valproate syrup or vice versa.
These are:
• neuroleptic agents (used to treat psychiatric disorders)
• Medicines to treat depression,
• Benzodiazepines used as sedatives or for the treatment of anxiety,
• Other medications used to treat epilepsy, including phenobarbital, phenytoin, primidone, lamotrigine, carbamazepine, topiramate
• Zidovudine (used to treat HIV infection and AIDS)
• Meflohin (used for treatment and prevention of malaria)
• Salicylates (aspirin); see. also children under S years. "Before you take Valproate 200 mg Table.")
• Anticoagulants (used to prevent blood clots)
• cimetidine (used to treat stomach ulcers)
• Erythromycin, rifampicin, carbapenems such as imipenem, meropenem and panipenem (antibiotics).
These drugs and some others can be influenced by Valproate syrup or they affect its validity. You may need to receive different amounts of your medicine or taking other medicines. You'll get advice from your doctor or pharmacist.
Your doctor or pharmacist can give you more information about medicines that use caution or avoid while taking Valproate syrup
3. How to take Valproate syrup
Be sure to regularly visit their control reviews. They are very important because you might need to change your dose.
• Always take Valproate syrup exactly as your doctor has told you. If you are unsure, ask your doctor or pharmacist.
Valproate syrup is taken orally Take Valproate syrup until your doctor continues to prescribe it.
Bottle syrup comes with an oral syringe (white piston) that is inserted into the adapter cup or spoon. Take the syrup just using in the package syringe or spoon.
To open the bottle, push down and turn the cap. After each use, the bottle must again be closed.
Frequency and time of administration of the drug Follow the prescription of your doctor.
Preferably daily dose should be taken with meals, usually:
• 2 taking in children under 1 year
• in 3 doses in children over 1 year.
Valproate If you take more syrup than you should, you should take the following measures in hospital: gastric lavage, maintaining an effective diuresis and monitoring of cardiac and respiratory function. If necessary, in very severe cases held dialysis.
Valproate syrup overdose can be dangerous. Immediately contact your doctor or the nearest emergency unit.
If you forget to take DEPAKINE syrup
Do not take a double dose to make up for missed doses. Just continue taking your medicine as directed by your doctor. If you forget to take several doses, contact your doctor. Effects when treatment with DEPAKINE syrup
Do not stop taking Valproate syrup or change the dose without consulting your doctor. If you stop taking the tablets without instructions from your doctor, your disease may worsen.
4. Possible side effects
Like all medicines DEPAKINE syrup can have side effects in a small number of persons. They rarely severe and most are not. 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
• shaking (tremor), drowsiness, unsteadiness when walking
• skin reactions such as rashes,
• transient hair loss,
• changes in menstrual cycle
• hearing problems,
• allergic reactions
• swelling of feet and legs (edema)
• weight gain
• kidney problems, dropping in little need or urinary urgency
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 syrup suddenly 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 of impaired health.
• Problems with blood clotting
• Spontaneous bruising or bleeding
• Blisters with peeling skin
• Severe reduction in white blood cells or bone marrow failure that sometimes occurs with fever and difficulty breathing
• confusion, which may be due to decreased levels of sodium in the blood.
• allergy-induced painful itchy bumps seals (most commonly around the eyes, lips, throat and sometimes on the palms and soles)
• syndrome with drug rash, fever, enlarged lymph nodes and suspected violations in other organs Valproate syrup may also cause reduced 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. Storing DEPAKINE syrup
Do not take this medicine after the expiry date indicated on the packaging.
Valproate syrup can be damaged if not stored properly (below 25 °)
Keep up to 1 month after first opening.
Keep out of reach of children.
6. FURTHER INFORMATION
Pharmaceutical form and content
What DEPAKINE syrup
Valproate syrup contains: Sodium valproate 57, 64mg / ml - 100 ml
Excipients: metilparahidroksiben zoat.propilparahidroksibenzoat, sucrose, sorbitol, glycerol, aroma of cherries, hydrochloric acid, concentrated sodium hydroxide or pH = 7,3- 7,7 purified water.