Pentinimid syrup 50 mg. / ml. 250 ml.
If you suffer from a mixed type of epileptic seizures, your doctor may prescribe Pentinimid with other anti-seizure medications.
Pentinimid syrup 50 mg. / ml. 250 ml.
What Pentinimid is and what it is used for
Etosuximide, the active substance of Peptinid syrup, is used to treat abscess (small seizures (Petitmal) with absences).
If you suffer from a mixed type of epileptic seizures, your doctor may prescribe Peptinid with other anti-seizure medications.
2. What you need to know before taking Pentinimid
Do not take Pethinimide:
if you are allergic to etosuximide or to other substances in the same pharmaceutical group (succinimides) or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Take special care with Petinimid
if you have or have suffered from liver or kidney disease in the past, your doctor should be informed before you start treatment with Petinimide and can regularly carry out blood or urine tests to detect disease of these organs;
if you suffer from porphyria (a rare metabolic disorder). Please tell your doctor;
if you suffer or have suffered in the past from a mental / mental illness. In this case, treatment with Peptinid may lead to side effects such as irritability, agitation, anxiety, anxiety, aggression, difficulty concentrating or other psychiatric changes such as depression;
if you notice symptoms suggestive of infection (such as sore throat, fever). Immediately consult a doctor. These may be signs of a serious, sometimes life-threatening, hemorrhagic disorder, and a blood test should be performed immediately.
if you experience severe allergic skin reactions and changes in the blood picture (for early symptoms see "Possible side effects"), you should consult a doctor immediately. Your doctor may change your treatment with a medicinal product that contains a different active substance;
if you are planning to become pregnant while you are taking Penitinimide or are pregnant or think you may be pregnant, talk to your doctor immediately (see also section "Pregnancy and breast-feeding" below);
Only patients with mixed type epileptic seizures may experience generalized tonic-clonic (Grand mal) seizures when treatment is conducted with only Petidinide. It may be necessary to administer an additional drug against seizures. It is therefore important for you to follow the advice of your doctor;
During treatment, your doctor will appoint regular blood, urine and liver tests. All clinical and laboratory tests should be performed exactly as prescribed by your doctor;
Usually treatment for seizures is prolonged. The use of anti-epileptics may lead to impairment in some patients (eg children and adolescents may be worse at school). This effect has not been established with Pethinimide but can not be completely excluded;
Few patients treated with anti-epileptics had thoughts of self-harm or suicide. So far, this effect has not been seen with Petinimide treatment but can not be completely excluded. If you ever have such thoughts, contact your doctor immediately. If the patient treated with this medicine is a child you are caring for, please observe it for any signs of these effects and contact your doctor immediately.
Other Drugs and Petinimid
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
The effects of drugs and other substances may interfere with each other.
This also applies to other antiepileptic medicines used together with Peptide. Additional anti-epileptic medication may be necessary, for example, if you suffer from a mixed type of seizure. Your doctor will closely monitor your treatment and may prescribe regular laboratory tests for some therapeutic combinations.
For example, valproic acid or sodium valproate may lead to an increase or decrease in the effect of Petinimide. Carbamazepine may reduce the effect of Pethinimide. The use of Peptinamide may enhance the effect of phenytoin.
During the treatment with Petinimide, the use of sleeping and sedating agents should be avoided, as these may result in increased sedative effects.
For the same reason, you should not consume alcohol during treatment with Petiminide.
The effect of hormonal contraceptives (tablets, transdermal patches, etc.) can be reduced by Petinimide. For this reason other methods of pregnancy prevention should be used.
Petinimid with food, beverages and alcohol
Pentinimid should be taken during meals.
During treatment with Petinimide alcohol consumption should be avoided.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine. During pregnancy
Driving and using machines
The use of this medicine may affect your ability to drive and drive.
Therefore, when starting treatment, you should not drive, operate machinery or perform other potentially hazardous activities. Depending on the response to treatment, your doctor will consider whether you can drive or operate machines.
Peptinimide syrup contains methyl-4-hydroxybenzoate. This preservative may cause allergic reactions (may be delayed).
Peptinid syrup contains sucrose and sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this product.
Advice for patients with diabetes mellitus:
Account must be taken of the sucrose content of 300 mg / ml and sorbitol 325.5 mg / ml. 5 ml Peptinimide syrup corresponds to 0.26 HE.
(HE = Bread units = standardized carbohydrate units, 1 HP = 20 g white bread).
3. How to take Pethinimide
Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Adults, elderly (> 65 years) and children over 6 years old
The required dose of Pethinimide varies from individual to individual. Most adults and children over 6 years start with a low dose of 500 mg (10 ml) a day and increase to 1000-1500 mg (20-30 ml) with an increase of 250 mg (5 ml) every 5 to 7 days in dependence on tolerance.
Sometimes, you may need to administer 2000 mg (40 ml) a day divided into several doses.
Children under 6 years of age
Infants and children usually start with 250 mg (5 ml) a day, and the dose gradually increases with small increases every few days to achieve status control.
For most children, the optimal dose is 20 mg / kg per day. The maximum dose is 1000 mg (20 ml) per day.
Dose adjustment can only be done by the treating physician.
Method of administration in children
In children aged between 0 and 6 years and in subjects unable to swallow capsules, ethosuximide syrup should be given. Larger children and adults usually take etosuximide in the form of capsules.
In patients with severe renal impairment, the physician will prescribe a lower dose.
Etosuximide is dialysable. Hence, patients receiving hemodialysis treatment will need to take an additional dose or a different dosing regimen. Four-hour dialysis removes between 39 and 52% of the administered drug.
Patients with severe hepatic impairment
The use of this medicinal product in patients with severe hepatic impairment requires caution. Dose reduction may be necessary.
For oral use.
The prescribed daily dose is usually administered in two separate intakes. The syrup is taken during meals.
Duration of treatment
Generally, antiepileptic treatment is prolonged, usually more than several years. Your doctor will determine the appropriate dose, the necessary changes in the dosage, the duration of treatment and the appropriate time and method of discontinuing treatment.
As with all antiepileptic medicines, Petiminide should be taken regularly. Any change in dosage or the addition of other medicines should be gradual and never sudden.
Your doctor will tell you how to do it.
If you take more Pethidine than you should
Overdosage with Peptinamide results in severe fatigue, lethargy, mood swings or agitation, sometimes irritability. In addition, nausea, vomiting and suppression of the central nervous system (sometimes leading to coma and superficial / depressed breathing) may also occur. Immediate medical attention is required.
Information for doctors regarding treatment of overdose: see the end of the leaflet.
If you forget to take Petinimid
If you forget to take the dose, take it as soon as possible unless it is time to take the next dose.
Do not take a double dose to make up for the missed dose. Take the next dose at the usual time.
If you stop taking Petinimid
Do not stop taking Petinimide without consulting your doctor first, even if you have no more attacks. Suspension of the intake may lead to a recurrence of seizures.
Any dose modification, addition or discontinuation of other medicines, especially when stopping treatment, should be progressive for several weeks and always under medical supervision.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them:
Very common (> 1/10);
Common (> 1/100 to <1/10);
Uncommon (> 1 / 1,000 to <1/100);
Rare (> 1 / 10,000 to <1 / 1,000);
Immune system disorders
Allergic reactions, hives and other skin reactions including rashes accompanied by itching and systemic lupus erythematosus have been reported.
If you notice severe physical conditions such as fever, skin rashes, mucosal edema, blistering of the mouth and / or groin, you should contact your doctor immediately.
Metabolism and nutrition disorders
Sometimes, at high doses, appetite reduction and weight loss have been reported.
Irritability, nervousness, restlessness, aggression, inability to concentrate or other mental disorders (particularly in patients with a history of such disorders) have been reported.
The presence of nightmare dreams is definitely uncommon.
In some cases, libido, paranoid psychosis and increased depression with possible suicidal ideation have been reported.
Nervous system disorders
Sometimes dizziness, headache, vertigo, hyperactivity, euphoria, irritability, movement or gait disorder, and sleepiness or sleep disturbances.
There have been reports of parkinsonian-like symptoms and hypersensitivity to light.
General disorders and site disorders
Tiredness occurs abnormally.
Occasionally, when using high doses or in patients with a sensitive stomach, complaints such as stomach or abdominal pain, nausea, vomiting, hiccups, spasms and diarrhea appear. Swelling of the tongue and the palate has also been reported. These reactions are usually transient, rarely severe and usually do not require discontinuation of treatment. Hypertrophic cases of gums are considered uncommon.
There have been reports of changes in hepatic function.
A sudden onset of porphyria (a rare metabolic disorder, which in severe cases may cause liver damage), has been reported in association with the use of etosuximide.
Skin and subcutaneous tissue disorders
Isolated cases of scleroderma (skin thickening) and hirsutism (increased facial and body hair) have been reported. The frequency of hair loss is unknown.
Renal and urinary disorders
Changes in kidney function have been reported. The incidence of blood in the urine is considered uncommon.
Reproductive system and breast disorders
There have been reports of vaginal bleeding.
Possible changes in blood count, liver and kidney function.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
5. How to store Pentinimid
Store below 25 ° C. Store in the original package in order to protect from light.
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton.
The expiry date refers to the last day of that month.
Shelf life after first opening: 3 months.
Do not dispose of medicines in the sewer or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. Package Contents and Additional Information
What Pethinimid Syrup Contains
The active substance is ethosuximide. 1 ml of syrup contains 50 mg of ethosuximide.
The other ingredients are: sucrose, sorbitol (E 420), methyl-4-hydroxybenzoate (E 218), purified water.
What Petinimid looks like and what it contains
Clear, colorless liquid in a brown glass bottle with a measuring cup. Bottle content - 250 ml.