Active ingredient
- phenytoin sodium
Legal Category
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 leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 13621/0062.
Phenytoin Sodium Flynn Hard Capsules 50mg
Package leaflet: Information for the user
UNITED KINGDOM
Phenytoin Sodium Flynn 50mg Hard Capsules
Phenytoin Sodium
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet
1. What Phenytoin Sodium Flynn Hard Capsules are and what they are used for
2. What you need to know before you take Phenytoin Sodium Flynn Hard Capsules
3. How to take Phenytoin Sodium Flynn Hard Capsules
4. Possible side effects
5. How to store Phenytoin Sodium Flynn Hard Capsules
6. Contents of the pack and other information
1. What Phenytoin Sodium Flynn Hard Capsules are and what they are used for
Phenytoin Sodium Flynn Hard Capsules are one of a group of medicines called anti-epileptic drugs; these medicines are used to treat epilepsy.
Phenytoin Sodium Flynn Hard Capsules 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 Sodium Flynn Hard Capsules 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 Sodium Flynn Hard Capsules.
2. What you need to know before you take Phenytoin Sodium Flynn Hard Capsules
Do not take Phenytoin Sodium Flynn Hard Capsules
Warnings and precautions
Talk to your doctor or pharmacist before taking Phenytoin Sodium Flynn Hard Capsules.
Medicines are not always suitable for everyone.
Your doctor needs to know before you take Phenytoin Sodium Flynn Hard Capsules if you suffer from or have suffered in the past from any of the following conditions:
The following symptoms have been reported in some people treated with phenytoin at recommended doses:
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 Sodium Flynn Hard Capsules. 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 Sodium Flynn Hard Capsules.
There is a risk of harm to the unborn child if Phenytoin Sodium Flynn Hard Capsules are used during pregnancy. Women of childbearing age should use effective contraception with Phenytoin Sodium Flynn Hard Capsules (see Pregnancy, contraception in women, and breast-feeding).
Other medicines and Phenytoin Sodium Flynn Hard Capsules
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Some medicines can affect the way Phenytoin Sodium Flynn Hard Capsules work and Phenytoin Sodium Flynn Hard Capsules themselves can reduce the effectiveness of other medicines taken at the same time. These include:
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.
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 Sodium Flynn Hard Capsules may also interfere with certain laboratory tests that you may be given.
Phenytoin Sodium Flynn Hard Capsules with food, drink and alcohol
Phenytoin Sodium Flynn Hard Capsules 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, contraception in women and breast-feeding
Pregnancy
If you are pregnant consult your doctor promptly.
You should not stop taking your medicine until you have discussed this with your doctor. Stopping your medication without consulting your doctor could cause seizures which could be dangerous to you and the pregnancy. Your doctor may decide to change your treatment. Closer monitoring of your unborn child could also be considered.
Phenytoin Sodium Flynn Hard Capsules may cause birth defects. If you take Phenytoin Sodium Flynn Hard Capsule during pregnancy your baby has a higher risk of having a birth defect. Birth defects which have been reported include facial, skull, nail, finger and heart abnormalities.
If you are of childbearing age and plan to become pregnant, consult your doctor for a preconceptional visit. You should discuss your treatment options with your doctor.
If you take Phenytoin Sodium Flynn Hard Capsules during pregnancy, your baby is also at risk for bleeding problems right after birth. Your doctor may give you and your baby a medicine to prevent this. Moreover, your child should be closely monitored.
Contraception in women
If you are of childbearing age, you should discuss your treatment options and effective methods of birth control with your doctor. Phenytoin Sodium Flynn Hard Capsules may result in a failure of hormonal contraceptives, hence you should be counselled regarding the use of other effective contraceptive methods.
Breast-feeding
Phenytoin Sodium Flynn Hard Capsules passes into breast milk. You should not take Phenytoin Sodium Flynn Hard Capsules if you are breast-feeding.
Driving and using machines
Phenytoin Sodium Flynn Hard Capsules may cause dizziness or drowsiness, especially during the first few weeks of treatment. If you experience these symptoms, do not drive or use any tools or machinery.
Phenytoin Sodium Flynn Hard Capsules contain lactose, a type of sugar.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Phenytoin Sodium Flynn Hard Capsules
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
It is best to take Phenytoin Sodium Flynn Hard Capsules at the same time each day.
Swallow the capsules whole, with plenty of water.
Adults
The amount of Phenytoin Sodium Flynn Hard Capsules 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.
Use in children and adolescents
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.
Elderly and patients with kidney or liver disease
The dose of Phenytoin Sodium Flynn Hard Capsules for elderly patients, patients with kidney or liver disease, or those who may be taking other medicines may also need careful consideration and adjustment by their doctor.
If you take more Phenytoin Sodium Flynn Hard Capsules than you should
Phenytoin Sodium Flynn Hard Capsules are dangerous in overdose. If you accidentally take too much Phenytoin Sodium Flynn Hard Capsules contact your doctor at once or go to the nearest hospital casualty department.
Always take the labelled medicine package with you, whether there are any Phenytoin Sodium Flynn Hard Capsules left or not.
If you forget to take Phenytoin Sodium Flynn Hard Capsules
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 Phenytoin Sodium Flynn Hard Capsules
Do not stop taking Phenytoin Sodium Flynn Hard Capsules 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 Sodium Flynn Hard Capsules, your doctor will have decided which is the best method for you.
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 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:
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Phenytoin Sodium Flynn Hard Capsules
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 expiry date refers to the last day of that month.
Do not store above 25°C. Store in the original package in order to protect from light.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Phenytoin Sodium Flynn Hard Capsules contain
What Phenytoin Sodium Flynn Hard Capsules look like and contents of the pack
Phenytoin Sodium Flynn 50mg Hard Capsules are half white and half flesh-coloured hard capsules marked with “Epanutin 50” and available in packs containing 28, 50, 100 or 500 capsules. The capsules are packed in a plastic container which contains a desiccant. The desiccant should not be eaten.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
This leaflet was last revised in November 2020
Marine House, Clanwilliam Place, Dublin 2, Republic of Ireland
+44 (0)1438 727822
+44 (0)1438 727822
+44 (0)1773 510 123
+44 (0)1438 727805
+44 (0)1438 727805