250 mg soft capsules 
etosuximide

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor, pharmacist, or nurse.

– This medicine has been prescribed for you only. Do not give it to others. It may harm them, even if they show symptoms similar to yours.

– If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Ethosuximide Orifarm is and what it is used for 
2. What you need to know before you take Ethosuximide Orifarm 
2. How to take Ethosuximide Orifarm 
4. Possible side effects 
5. How to store Ethosuximide Orifarm 
6. Contents of the packaging and other information 

1. What Ethosuximide Orifarm is and what it is used for

Ethosuximide Orifarm is a medicine used to treat epileptic seizures ( antiepileptic drugs ).

Ethosuximide Orifarm is given to adults, elderly patients, and children over 6 years of age to treat:

  • Pycnoleptic absences and complex and atypical absences.
  • Myoclonic atonic petit mal and myoclonic seizures in adolescents (impulsive petit mal ), if other drugs are not effective and/or not tolerated.

Ethosuximide Orifarm may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you take Ethosuximide Orifarm

Do not take Ethosuximide Orifarm

– if you are allergic to ethosuximide, succinimides (the group of medicines to which ethosuximide belongs), or any of the other ingredients of this medicine (listed in section 6)

– if you suffer from the metabolic disease porphyria.

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before taking Ethosuximide Orifarm.

If movement disorders occur, do not continue to take Ethosuximide Orifarm. In case of significant disturbance, you should consult a doctor who can then give you the medicine diphenhydramine intravenously as an antidote (see section 4).

Pay special attention to symptoms of bone marrow depression such as fever, inflammation of the throat or polyps behind the nose, and bleeding tendency. Consult your doctor if any of these symptoms occur. Your blood status will be checked regularly (initially every month and after one year every six months) to identify any bone marrow damage. Your liver enzymes will also be checked regularly.

Mental side effects (anxiety, illusion) may occur, especially in patients with a history of mental disorders. The physician will pay special attention to this when administering Ethosuximide Orifarm to this patient group.

A small number of patients treated with antiepileptic drugs such as ethosuximide have developed thoughts of self-harm or suicidal ideation. Contact a doctor immediately if you experience such thoughts at any time during treatment.

Note!

To prevent tonic-clonic seizures ( grand mal ), which are often associated with complex and atypical absences, ethosuximide can be combined with effective antiepileptic drugs (eg primidone or phenobarbital). Additional prophylaxis against tonic-clonic seizures ( grand mal ) can only be prescribed in epilepsy with psycholeptics absences in school-age children.

Other medicines and Ethosuximide Orifarm

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

The effect of Ethosuximide Orifarm may be affected by other antiepileptic drugs(carbamazepine, valproate ).

It can not be ruled out that sedative drugs and Ethosuximide Orifarm enhance each other’s sedative (sedative and sleep-inducing) effects

Ethosuximide Orifarm with food, drink, and alcohol

Ethosuximide Orifarm can be taken during or after a meal with half a glass of water.

Alcohol can alter and potentiate the effects of Ethosuximide Orifarm in an unpredictable way. Do not drink alcohol or consume foods containing alcohol while taking Ethosuximide Orifarm.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy 

If you are of childbearing potential, your doctor should inform you of the need to plan and monitor any pregnancy before starting treatment with Ethosuximide Orifarm. Do not stop taking Ethosuximide Orifarm without first consulting your doctor as epileptic seizures may recur, which may harm you and/or your unborn baby.

No specific malformations are known in infants that have been caused by treatment with ethosuximide, the active substance in Ethosuximide Orifarm. However, the risk of developing fetal malformations is generally higher for women treated with antiepileptic drugs than for other women. The most commonly reported malformations are cleft lip, cardiovascular malformation, and neural tube defects (spina bifida). This risk is even higher in patients treated with more than one antiepileptic drug, and therefore combination therapy should be avoided during pregnancy.

The minimum effective dose of ethosuximide to ensure seizure control should not be exceeded, especially between day 20 and day 40 of pregnancy. Your concentration of ethosuximide in the blood must be checked regularly and you should take extra folic acid ( folic acid substitution) if you are planning to have a baby or are pregnant.

To prevent vitamin K1 deficiency in the baby and bleeding caused by this deficiency, you should receive vitamin K1 during the last month of pregnancy.

Breast-feeding

Ethosuximide is converted to breast milk. Do not breast-feed while you are being treated with ethosuximide.

Fertility

The effects of ethosuximide on fertility have not been studied.

Driving and using machines

Ethosuximide Orifarm may impair the ability to react. For this reason, throughout the treatment period, especially during the adjustment phase, keep in mind that you do not react quickly and purposefully to unexpected and sudden events. Do not drive or use any vehicles. Do not use dangerous power tools or machines. Do not work without a secure grip.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Ethosuximide Orifarm contains sorbitol

This medicine contains 13.7 mg sorbitol in each capsule.

2. How to take Ethosuximide Orifarm

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

The recommended dose is:

Adults, elderly patients, and children over 6 years of age: Treatment should be initiated with a low daily dose of 500 mg (2 capsules). Depending on the patient’s tolerance, dose one may be increased every five to seven days in increments of up to 250 mg until seizure control is achieved with a daily dose of 1,000-1,500 mg (4-6 capsules). In some cases, a daily dose of 2,000 mg (8 capsules) may be needed, divided into several doses.

This dosage form is not suitable for small children (0-6 years) or for people who cannot swallow capsules.

Hemodialysis patients

Ethosuximide disappears from the body during dialysis. Hemodialysis patients, therefore, need an additional dose or a modified dosing regimen. During four-hour dialysis, 39–52% of the dose taken disappears.

How long to take Ethosuximide Orifarm

The treatment of epileptic seizures is essentially a long-term treatment. The size of dose one and how it should be distributed throughout the day, and when and how you should stop taking Ethosuximide Orifarm are determined by a specialist experienced in epilepsy treatment.

If you have the impression that the effect of Ethosuximide Orifarm is too strong or too weak, talk to your doctor or pharmacist.

If you take more Ethosuximide Orifarm then you should

If you’ve taken the double dose of Ethosuximide Orifarm accidentally, do not change the dosage regimen, but continue to take Ethosuximide Orifarm exactly as your doctor’s prescription.

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

Symptoms of overdose are fatigue, lethargy (listlessness, apathy ), depressive states and anxiety, in some cases also irritability. The symptoms of overdose are exacerbated by alcohol and other drugs that affect the central nervous system .

If you forget to take Ethosuximide Orifarm

Do not take a double dose to make up for a forgotten dose . Normally no symptoms occur if you forget to take a single dose . Continue to take the medicine as your doctor prescribed . You should therefore not take the missed dose at a later time. Keep in mind that Ethosuximide Orifarm only controls your epilepsy safely if you take the medicine regularly.

If you stop taking Ethosuximide Orifarm

If you want to stop treatment, talk to your doctor first. Follow your doctor’s treatment recommendations carefully, as you may have epileptic seizures again. Contact your doctor if you think you may not tolerate Ethosuximide Orifarm.

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

4. Possible side effects

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

Common (may affect up to 1 in 10 users) to very common (may affect more than 1 in 10 users):

  • Nausea, vomiting, abdominal pain
  • Hiccup
  • Drowsiness, dizziness
  • Rash, hives

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

  • Severe headache, lethargy (listlessness, apathy ), ataxia (movement disorders), concentration problems
  • Withdrawal syndrome, anxiety, sleep disorders, psychosis , suicidal thoughts
  • Decreased appetite, weight loss
  • Diarrhea, constipation
  • Swollen gums, swollen tongue
  • Fatigue

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

  • Paranoia and hallucinations that develop over days and weeks (illusion, persecution mania)
  • Lupus erythematodes * of varying degrees (skin disease that may involve internal organs)
  • Leukopenia * (lack of white blood cells ), eosinophilia * (increase in a certain type of white blood cell ), thrombocytopenia * (lack of platelets ) or agranulocytosis * (lack of certain defense cells)
  • Nearsightedness
  • Blood in the urine

Has been reported (occurs in an unknown number of users):

  • In rare cases, dyskinesia (movement disorders, see section 2) may occur during the first 12 hours of treatment
  • Allergic skin reactions * such as rash, Stevens-Johnson syndrome (very severe allergic skin reaction)
  • In rare cases, aplastic anemia * (lack of red blood cells due to the body not producing new cells) and pancytopenia * (lack of all blood cells ) may occur (see section 2).

* Side effects that are independent of the drug dose.

Note!

Long-term treatment can affect the patient’s performance ability, for example school results for children and adolescents.

The risk of dose-dependent side effects is reduced if a low starting dose of Ethosuximide Orifarm is used, which is then gradually increased to an optimal dose(the amount should be increased slowly from day to day), and by taking the medicine during or after a meal. If side effects occur that are independent of the dose taken, the drug is normally discontinued and the side effects disappear. They may return when Ethosuximide Orifarm starts taking again.

Talk to your doctor if you get one or more of the above side effects so that he or she can determine their severity and what action to take.

5. How to store Ethosuximide Orifarm

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.

Store below 30 ° C.

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. Contents of the packaging and other information

Content declaration

  • The active substance is ethosuximide.
  • The other ingredients are: macrogol; gelatine; glycerol (E422); partially dehydrated liquid sorbitol (E420); purified water; titanium dioxide (E171); yellow iron oxide (E172).

What the medicine looks like and the contents of the pack

Oval, yellow and opaque soft capsules. The capsule size is about 14 × 8 mm.

Blister: 50, 100 or 200 soft capsules.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Orifarm Generics A / S

Energivej 15

5260 Odense S

Denmark

Local representative

Orifarm Generics AB

Box 56048

102 17 Stockholm 

info@orifarm.com

Muhammad Nadeem

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