100 mg tablets 
phenytoin

1. What Fenantoin RPH Pharma is and what it is used for

Fenantoin RPH Pharma contains phenytoin which counteracts seizures and shortens seizures that occur by limiting the spread of irritation to the brain.

Fenantoin RPH Pharma is used for epilepsy, in so-called generalized tonic-clonic epileptic seizures ( grand mal ), and for seizures where only parts of the brain are affected ( partial seizures ).

What you need to know before using Fenantoin RPH Pharma 

Do not use Fenantoin RPH Pharma 

  • if you have a disease that involves the formation of porphyrins in the liver ( acute intermittent porphyria ).
  • if you are allergic to phenytoin or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

Talk to your doctor or pharmacist before using Fenantoin RPH Pharma.

Skin reactions, which may be life-threatening ( Stevens-Johnson syndrome and toxic epidermal necrolysis ), have been reported with the use of Fenantoin. 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 had Stevens-Johnson syndrome or toxic epidermal necrolysis while using Fenantoin, you must never use Fenantoin again.

If you get a rash or signs of these skin reactions, contact your doctor immediately and tell them you are taking this medicine. If you stop taking Fenantoin RPH Pharma too quickly, there is a risk of an increased number and possibly more severe seizures. If the medical treatment is to be terminated, it is therefore very important that the phasing out takes place slowly, often over the course of 3-12 months. However, never change your treatment yourself without consulting a doctor.

Those with hepatic or renal impairment should consult a physician before starting treatment with Fenantoin RPH Pharma.

Fenantoin RPH Pharma can in rare cases affect the white blood cells so that the defense against infection deteriorates. Therefore, contact your doctor if you get a sudden fever, sore throat, and/or sore mouth.

Thorough cleaning of the teeth with fluoride toothpaste twice daily is essential to counteract swelling of the gums and tooth damage.

If you get a rash, fever, joint pain, jaundice (whites of the eyes and skin turn yellow), enlarged lymph nodes, you should contact a doctor as soon as possible. This may be a sign of hypersensitivity syndrome.

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

In rare cases, severe skin and mucosal changes may occur during treatment with Fenantoin RPH Pharma. This risk 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 Fenantoin RPH Pharma. 

Other medicines and Fenantoin RPH Pharma 

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

Some drugs used in the acidic stomach and peptic ulcers (cimetidine), some anticoagulant ( warfarin ), the remedies containing St. John’s wort (Hypericum perforatum), drugs used for myocardial infarction or unstable angina (ticagrelor), drugs for epilepsy (midazolam), P -pills as well as several other drugs may affect or be affected by treatment with Fenantoin RPH Pharma.

The treating physician, therefore, needs to know about all other concomitant medications.

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.

There is a risk of fetal harm effects. Do not use Fenantoin RPH Pharma during pregnancy except on certain prescriptions from the doctor.

Fenantoin RPH Pharma passes into breast milk but is unlikely to affect breastfed infants. However, consult a physician if more than temporary use of Fenantoin RPH Pharma during breast-feeding.

Driving and using machines

During treatment with Fenantoin RPH Pharma, the reactivity may be reduced. This should be taken into account when sharper attention is required, e.g. while driving. 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.

Fenantoin RPH Pharma contains lactose

Fenantoin RPH Pharma contains lactose . If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to use Fenantoin RPH Pharma 

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

Dose one is determined by the doctor, who adjusts it individually for you. Dosage one of Fenantoin RPH Pharma varies greatly from person to person. The doctor adjusts the size of the dose about the level of Fenantoin RPH Pharma in the blood, how the medicine affects the disease, and how the patient feels.

If you take more Fenantoin RPH Pharma then you should 

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

4. Possible side effects

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

Contact a doctor if the side effects are bothersome or long-lasting.

Common (affects more than one patient in 100): Drowsiness, dizziness, inability to coordinate muscle movements, tremors, involuntary eye movements, and visual disturbances. Growth of the gums, especially in the front of the mouth, this side effect occurs mainly in children and adolescents. Skin rash, hives, and increased body hair. Blood tests may show elevated liver values ​​(transaminase elevation).

Uncommon: Digestive disorders, nausea, and vomiting. Lymph node changes with fever, rash, and enlargement of lymph nodes.

Rare (affects less than one in 1000 people): Confusion. The disease SLE (an autoimmune disease that can affect many organs and which often gives a typical rash over the back of the nose and cheeks). Decreased number of certain red and white blood cells and platelets. Cardiac effects, hepatitis, elevated blood sugar, and calcification of the skeleton. Skin and mucous membrane changes (sometimes severe). Severe widespread skin damage (skin detachment).

Very rare (affects less than 1 in 10,000 people): Skin reactions, which may be life-threatening ( Stevens-Johnson syndrome and toxic epidermal necrolysis ) have been reported (see section 2).

Hypersensitivity symptoms may occur, usually, within the first 2 months of treatment, see “What to think about before and when using Fenantoin RPH Pharma”.

There have been reports of bone diseases e.g. decreased bone density in the skeleton, osteoporosis, and bone fractures. Contact a 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.

5. How to store Fenantoin RPH Pharma

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. The expiration date is the last day of the specified month.

The medicine 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

One tablet contains: Active substance: Phenytoin 100 mg

Other ingredients:  Lactose monohydrate 50 mg, corn starch, povidone, microcrystalline cellulose, colloidal silica, magnesium stearate.

What the medicine looks like and the contents of the pack

Fenantoin RPH Pharma 100 mg tablet is a white, flat tablet, about 8 mm in diameter, with a notch, marked FT in frames.

Pack sizes: 100 and 250 tablets in a plastic jar.

Holder of the marketing authorization / Information is provided by

RPH Pharmaceuticals AB

Box 603

101 32 Stockholm

Local representative

Astimex Pharma AB

Isafjordsgatan 36 
164 40 Kista

Tel. 08-5151 1535

info@astimex.se

Muhammad Nadeem

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