- phenytoin sodium
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original can be viewed in PDF format using the link above.
The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet is: PL 20620/0105.
Phenytoin Sodium NRIM 100mg Capsules
PHENYTOIN SODIUM NRIM 100MG CAPSULES
PATIENT INFORMATION LEAFLET
Read all of this leaflet carefully before you start using this medicine.
In this leaflet:
1. What Phenytoin Capsules are and what they are used for
2. Before you take Phenytoin Capsules
3. How to take Phenytoin Capsules
4. Possible side effects
5. How to store Phenytoin Capsules
6. Further Information
1. WHAT PHENYTOIN CAPSULES ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Phenytoin sodium NRIM 100mg Capsules (referred to as Phenytoin Capsules or as Phenytoin throughout this leaflet). Phenytoin belongs to a group of medicines called anti-epileptic drugs; these medicines are used to treat epilepsy.
Phenytoin can be used to control a variety of epileptic conditions, to control or prevent seizures during or after brain surgery or severe head injury. Phenytoin can also be used to treat trigeminal neuralgia (facial nerve pain).
You should ask your doctor if you are unsure why you have been given Phenytoin capsules.
2. BEFORE YOU TAKE PHENYTOIN CAPSULES
You should not take Phenytoin until you are sure it is safe for you to do so.
Do not take Phenytoin
Take special care with Phenytoin
Medicines are not always suitable for everyone. Your doctor needs to know before you take phenytoin if you suffer from or have suffered in the past from any of the following conditions:
A small number of people being treated with antiepileptics such as phenytoin sodium have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.
Serious skin side effects can rarely occur during treatment with Phenytoin. This risk may be associated with a variant in genes in a subject with Chinese or Thai origin. If you are of such origin and have been tested previously carrying this genetic variant (HLA-B*1502), discuss this with your doctor before taking Phenytoin.
Taking other medicines
Some medicines can affect the way Phenytoin works, or Phenytoin itself can reduce the effectiveness of other medicines taken at the same time.
Your doctor may need to test the amount of Phenytoin in your blood to help decide if any of these medicines are affecting your treatment.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
The herbal preparation St John’s wort (Hypericum perforatum) should not be taken at the same time as this medicine. If you already take St John’s wort, consult your doctor before stopping the St John’s wort preparation.
Phenytoin capsules may also interfere with certain laboratory tests that you may be given.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Phenytoin.
Taking Phenytoin with food or drink
Phenytoin can be taken before or after food and drinks. Drinking a lot of alcohol can also affect the concentration of Phenytoin in your blood.
Pregnancy or breast-feeding
If you think you might be pregnant, or are planning to get pregnant, tell your doctor before you take Phenytoin.
You should not take phenytoin if you are breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Phenytoin may cause dizziness or drowsiness, especially during the first few weeks of treatment. If you experience these symptoms, do not drive or operate tools or machinery or carry out other hazardous activities.
Important information about some of the ingredients of Phenytoin
Phenytoin contains lactose, a type of sugar. If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. HOW TO TAKE PHENYTOIN CAPSULES
Always take Phenytoin exactly as your doctor has told you. You should check with your doctor if you are not sure.
It is best to take Phenytoin at the same time each day.
Swallow the capsules whole, with plenty of water.
The amount of Phenytoin needed varies from one person to another. Most adults need between 200mg and 500mg a day either as a single or divided dose. Occasionally higher doses are needed.
Infants and children usually start on a dose that depends on their weight (5mg per day for every kg they weigh) and is given as a divided dose, twice a day. The dose is then adjusted up to a maximum of 300mg a day.
The dose of Phenytoin for elderly patients who may be taking other medicines may also need careful consideration and adjustment by their doctor.
If you take more Phenytoin than you should
Phenytoin is dangerous in overdose. If you or someone else accidentally takes too much phenytoin contact your doctor at once or go to the nearest hospital casualty department. Always take the labelled medicine package with you, whether there is any Phenytoin left or not, as this will allow easier identification of the medicine.
If you forget to take Phenytoin
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 missed dose.
If you stop taking Phenytoin
Do not stop taking phenytoin unless your doctor tells you to. If you suddenly stop taking this medicine you may have a seizure. Should you need to stop taking phenytoin, your doctor will have decided which the best method is for you.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Phenytoin can cause side effects although not everybody gets them.
Tell your doctor immediately if you experience any of the following symptoms after taking this medicine. Although they are very rare, these symptoms can be serious.
Other side-effects that may occur are:
If any of the side effects get serious or lasts longer than a few days, or if you notice other unwanted effects, tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme (Website: www.mhra.gov.uk/yellowcard). By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE PHENYTOIN CAPSULES
6. FURTHER INFORMATION
What Phenytoin Capsules contain
The name of this medicine is Phenytoin sodium NRIM 100mg Capsules. The active substance in your capsules is phenytoin sodium. Each hard capsule contains 100mg of the active ingredient phenytoin sodium. Other ingredients include lactose monohydrate and magnesium stearate. The capsule shell is made of gelatin, water, erythrosine (E127), quinoline yellow (E104), titanium dioxide (E171), sodium lauryl sulfate and black edible printing ink, which contains shellac, propylene glycol, black iron oxide (E172) and potassium hydroxide.
What Phenytoin Capsules look like and contents of the pack
Phenytoin sodium NRIM 100mg Capsules are hard gelatin capsules with an orange transparent coloured cap printed with “146” and white coloured body, containing white granular powder. Phenytoin sodium NRIM 100mg Capsules are supplied in a HDPE capsule container with a child-resistant polypropylene cap. Each bottle contains 84 capsules.
Marketing Authorisation Holder
The Marketing Authorisation Holder of these capsules is
This leaflet was prepared in 05/2016
Mckenzie House, Bury Street, Ruislip, Middlesex, HA4 7TL
+44 (0)1895 627 480
+44 (0)895 627421
+44(0) 1271 385257