100 mg hard phenytoin sodium capsules
Phenytoin

1. What Epanutin is and what it is used for

Epanutin reduces the risk of seizures by limiting the spread of the electrical discharges in the brain that occur in epilepsy.

2. What you need to know before you use Epanutin

Do not take Epanutin

  • if you are allergic to phenytoin sodium or any of the other ingredients of this medicine (listed in section 6).
  • if you have acute intermittent porphyria (hereditary metabolic disease).
  • if you are also taking delavirdine (a medicine used to treat HIV ) or telaprevir (a medicine used to treat chronic hepatitis C).

Warnings and cautions

Talk to your doctor before taking Epanutin:

  • if you have impaired liver and/or kidney function.

Women of childbearing potential should use effective contraception during treatment with Epanutin (see “Contraceptives for women, pregnancy and lactation” for more information).

If you get an infection with symptoms such as fever with severe general deterioration or fever with local infection symptoms such as sore throat/pharynx/mouth or urination problems, you should see a doctor as soon as possible so that blood tests can rule out a lack of white blood cells ( agranulocytosis ). It is important that you then information about your medication.

If you get any of the following symptoms, you should contact a doctor as soon as possible: rash, blisters, fever, itching, joint pain, jaundice (whites of the eyes and skin turn a yellowish color), enlarged lymph nodes, or effects on internal organs such as liver, kidney, heart or lungs. This may be a sign of severe hypersensitivity reaction such as hypersensitivity syndrome or drug-induced rash with eosinophilia and systemic symptoms (DRESS).

Skin reactions, which may be life-threatening (eg Stevens-Johnson syndrome and toxic epidermal necrolysis ), have been reported with the use of phenytoin sodium. It can start as red-violet target-like or round spots with blistering in the middle, often symmetrically spread, on the torso. Additional signs to be aware of are sores in the mouth, throat, nose, genitals, or eye inflammation (red and swollen eyes). The skin reactions, which can be life-threatening, are often followed by flu-like symptoms. The rash can develop into blisters over large areas of skin detachment. The risk of serious skin reactions is greatest during the first weeks of treatment. If you have Stevens-Johnson syndrome or toxic Epidermal Necrolysis When using Phenytoin Sodium Epanutin, never use medicines containing Phenytoin Sodium again. If you get a rash or signs of these skin reactions, contact your doctor immediately and tell them you are taking this medicine. Talk to your doctor before stopping Epanutin medication.

The risk of getting these serious skin and mucous membrane changes may be related to a gene variant in people of Chinese or Thai origin. If you are of such origin and have previously been shown to have this genetic variant (HLA-B * 1502), talk to your doctor before taking Epanutin. The risk of suffering from hypersensitivity reactions has also been shown to be increased among people with the black skin color of African origin.

Cases of swelling of the face, mouth (lips, gums, tongue) or throat that can lead to life-threatening breathing difficulties have been reported in people treated with phenytoin. If you get these signs or symptoms, contact your doctor immediately.

A small number of people who are treated with antiepileptic drugs such as Epanutin have also had thoughts of harming themselves or committing suicide. If you ever get these thoughts, contact your doctor immediately.

Epanutin can cause heart problems, including a slow heartbeat. Tell your doctor immediately if you get such symptoms.

Prolonged elevated levels of phenytoin in the blood and/or prolonged use of phenytoin may confuse or, in rare cases, cause permanent damage and/or wasting of the cerebellum. In case of signs of acute poisoning, you should contact a doctor immediately. Such signs can e.g. be balance disorders, difficulty coordinating movements, involuntary movements including eye movements, or speech difficulties. If blood levels are too high, the dose of phenytoin should be reduced. If signs of poisoning persist, it is recommended that phenytoin treatment be discontinued.

You must clean your teeth thoroughly with fluoride toothpaste twice a day, to prevent swelling of the gums and tooth damage.

Other medicines and Epanutin

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

Epanutin can be affected by or affect the effect of many other medicines. The attending physician must therefore be aware of any other medication. This applies to both prescription and over-the-counter medicines as well as dietary supplements, (traditional) herbal medicines, and herbal medicines.

Hormonal contraceptives (eg birth control pills ) may be less effective (see “Contraceptives for women, pregnancy and lactation” for more information).

(Traditional) herbal medicines containing St. John’s wort ( Hypericum perforatum ) should not be used during medication with Epanutin. If you are already taking a St. John’s wort preparation, consult your doctor before stopping this preparation.

Always tell Epanutin to the doctor who prescribes another medicine for you.

Epanutin with food and drink

Epanutin can be taken with or without food.

Talk to your doctor if you are receiving or will receive tube feeding at the same time as this may affect the effect of Epanutin.

Frequent (chronic) consumption of alcohol can affect the effect of Epanutin. Consult your doctor.

Pregnancy, breastfeeding, and fertility

Contraceptives for women

Women of childbearing potential should use effective contraception during treatment with Epanutin. Hormonal contraceptives may be less effective with Epanutin. Talk to your doctor about which contraceptive to use. Your doctor may ask you to take a pregnancy test before you start taking this medicine.

Pregnancy

If Epanutin is used during pregnancy, there is a risk of birth defects.

If you become pregnant while taking Epanutin, tell your doctor immediately. However, do not stop taking your medicine, talk to your doctor who will inform you about the risks and your treatment options. Suddenly stopping your medication can cause seizures that can be dangerous for you and your unborn baby.

If you take Epanutin during pregnancy there is a risk:

  • for birth defects such as deformities of the face, skull, nail, finger, and heart.
  • that your baby has bleeding problems after birth. Your doctor may give you and your child medicine to prevent this. Also, your baby should be closely monitored after birth for other symptoms. Talk to your doctor if you are planning to become pregnant, to discuss risks and treatment options.

Breast-feeding

Epanutin passes into breast milk. If you are taking Epanutin, it is recommended that you refrain from breast-feeding, and discuss this with your doctor.

Driving and using machines

During treatment with Epanutin, the ability to react may be reduced. This should be taken into account when sharper attention is required, e.g. when driving a car or during precision work.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. 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.

Epanutin contains lactose

The capsules contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Epanutin contains sodium

This medicine contains 8.4 mg of sodium (the main ingredient in table salt/table salt) per capsule. This corresponds to 0.4% of the highest recommended daily intake of sodium for adults.

3. How to take Epanutin

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

Usual maintenance dose:

Adults: 2-5 capsules daily.

Children: The usual daily dose is 5-8 mg phenytoin per kilogram body weight.

The daily dose is usually divided into two doses (morning and evening).

To set the correct dosage, blood samples are taken to determine the level of the active substance phenytoin in the blood. Dose changes should be made in small steps and consultation with a doctor.

The capsules are swallowed whole.

Dosage for elderly patients

Elderly patients may need a lower dose of Epanutin. Dose one is determined by the doctor who adapts it for you.

Dosage for patients with liver or kidney disease

Patients with liver or kidney disease may need a lower dose of Epanutin. Dose one is determined by the doctor who adapts it for you.

If you take more Epanutin then you should

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

Symptoms of Epanutin overdose may include difficulty speaking, restlessness, anxiety, agitation, hallucinations, double vision, and flushing. Severe poisoning causes coma, involuntary movements, cramps, eye muscle paralysis, slow heart rhythm, and impaired breathing. For other symptoms, see Side Effects.

If you forget to take Epanutin

If you forget to take a dose, take it as soon as you remember unless it is time for your next dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Epanutin

If you abruptly stop taking the medicine, there is a risk that you will have more and more severe epileptic seizures. Change never dosage without a doctor’s prescription.

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

4. Possible side effects

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

Common side effects are (may affect up to  1 in 10): 

Drowsiness, dizziness, difficulty coordinating movements, visual disturbances, and involuntary eye movements, tremors, swelling of the gums, skin rash, hives, increased hair growth on the body, liver effects, folic acid deficiency.

Less common side effects are (may affect up to  1 in 100): 

Heartburn, nausea, vomiting, enlarged lymph nodes.

Rare side effects are (may affect up to  1 in 1000): 

Hypersensitivity Syndrome, allergic reactions such as fever, rash, swelling of the face, lips and/or throat, difficulty breathing or swallowing, SLE (severe connective tissue disease), a drug-induced rash with eosinophilia, and systemic symptoms (DRESS) (see section 2), effects on blood cell were bl .a. agranulocytosis (see section 2), effects on heart rhythm, jaundice ( hepatitis ), hypoglycemia, osteoporosis, joint pain, headache, confusion, and crawling, abnormal need for sleep, taste changes, skin reactions that may be life-threatening ( Stevens-Johnson syndrome and toxic epidermal ) see section 2).

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

Deviating test results regarding thyroid function. Breathing difficulties; swelling of the face, mouth, or throat ( angioedema ) (see section 2) and a life-threatening skin rash that causes blistering (this may affect the mouth and tongue) ( acute generalized exanthematous pustulosis (AGEP)).

Hypersensitivity syndrome can occur, usually within the first 2 months of treatment. Symptoms may include severe skin reactions, fever, swollen lips, and face. Contact a doctor or healthcare professional immediately if you experience any of these symptoms after taking Epanutin.

There have been reports of bone diseases e.g. decreased bone density in the skeleton, osteoporosis, and bone fractures. Contact your doctor or pharmacist if you are being treated with epilepsy medication for a long time, if you know you have osteoporosis or if you are on medication with steroids.

Displacement of the cerebellum (cerebellar atrophy ) has been reported and is likely to occur with elevated levels of phenytoin in the blood and/or long-term use of phenytoin.

Contact your treating physician for unusual symptoms and if side effects are bothersome or long-lasting.

5. How to store Epanutin

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.

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 phenytoin sodium.

Other ingredients:

Capsule content: 96 mg lactose monohydrate and magnesium stearate

Capsule shell: gelatin, sodium lauryl sulfate, dyes (titanium dioxide (E171), erythrosine (E127), quinoline yellow (E104))

Capsule ink: black iron oxide (E172), shellac, propylene glycol, potassium hydroxide

What the medicine looks like and the contents of the pack

Appearance:

The capsules are orange and white with EPANUTIN100 print

Pack sizes:

Jar of 100 pieces

Marketing Authorization Holder and Manufacturer

Pfizer AB

191 90 Sollentuna

Tel: 08-550 520 00

Email: eumedinfo@pfizer.com

Muhammad Nadeem

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