Patient leaflet - Metaperex 400 IU soft capsules
1. What Metaperex is and what it is used for 2. What you need to know before you take Metaperex 3. How to take Metaperex
- 4. Possible side effects
- 5. How to store Metaperex
- 6. Contents of the pack and other information
- 1. What Metaperex is and what it is used for
Metaperex contains 280 mg RRR-α-tocopherol (equivalent to 400 IU of Vitamin E)
Metaperex is indicated in the following conditions for adults:
- Vitamin E deficiency in patients diagnosed with ataxia with vitamin E deficiency (AVED).
2. What you need to know before you take Metaperex
Do not take Metaperex:
- If you are allergic to Vitamin E or any of the other ingredients of this medicine (listed in section 6). • Metaperex 400 IU soft capsules contains soya-bean oil. If you are allergic to peanut or soya, do not use this medicinal product.
- If you have Vitamin K deficiency (increased risk of bleeding).
Warnings and precautions
Talk to your doctor or pharmacist before taking Metaperex. In particular, tell your doctor if: • You lack vitamin K (involved in the blood clotting process). If you take doses of vitamin E above 560 mg per day (equivalent to 800 I.U), you may be more likely to bleed for longer than usual.
- You are being treated with blood thiners or the hormone oestrogen. A possible adjustment of the dose of blood thiner medication during and after treatment with Vitamin E may be required.
- Long term vitamin E supplements (400 IU daily) may increase the risk of prostate cancer in men. • You have impaired kidney function.
- If you have had or are known to be at high risk of developing prostate cancer.
Other medicines and Metaperex
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including
Anticoagulants (e.g., warfarin or phenprocoumon), inhibitors of platelet aggregation (e.g., acetylsalicylic
acid, clopidogrel, ticlopidine, dipyridamole, eptifibatide, tirofiban and abciximab), thrombolytics (e.g. recombinant tissue plasminogen activator) or ibrutinib. Taking vitamin E with these medicines may increase the risk of bleeding.
- Taking tripanavir alone may increase the risk of bleeding. These risks are increased when taking a high dose of vitamin E.
- Oestrogens, as it may increase the risk of thrombosis. • Agents that bind with vitamin E and reduce its absorption (e.g. Orlistat, Colestyramine and colestipol) or iron-containing medicines. Ensure there is a gap of at least 2 hours between taking vitamin E and the other medicine.
- Iron-containing medicines reduces activity of vitamin E. Therefore, an interval of at least 2 hours should be maintained between taking both medications. • High-dose vitamin E, either alone or in combination with other antioxidants, may change how your body processes ciclosporin and decrease its blood level. • Anticonvulsants (e.g., phenobarbital, phenytoin and carbamazepine) may lower blood vitamin E levels. • Vitamin E increases the absorption, utilisation, and storage of vitamin A.
- Vitamin E may be present in large amounts in other medicines, for example Selumetinib contains D-alpha-tocopheryl and should not be taken with vitamin E. • Vitamin E increases the expression of the cytochrome P450 enzyme CYP3A4, which may influence the metabolism of other medications.
Pregnancy, breast-feeding and fertility
No controlled studies have been conducted among pregnant women. Doses of vitamin E above the recommended daily allowance should not be used in women during pregnancy. Therefore, Metaperex should not be used in pregnancy.
No controlled studies have been conducted among breastfed infants. Vitamin E passes into breast milk. Doses of vitamin E above the recommended daily allowance of 28.5 IU (19 mg) should not be used in nursing mothers. Therefore, Metaperex should not be used during breastfeeding.
Driving and using machines
Metaperex has no or negligible influence on the ability to drive and use machines.
Metaperex contains:
Refined soya-bean oil (146 mg per capsule). If you are allergic to peanut or soya, do not use this medicinal product.
Components of capsule: gelatin and glycerol.
3. How to take Metaperex
Always take this medicine exactly as your doctor or pharmacist has told
you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is:
For adults (18 years and older) diagnosed with AVED the following doses should be administered:
- 800 IU (560 mg) vitamin E per day (2 capsules) divided into 2 doses.
Method of administration
Capsules for oral use.
Take Metaperex during or after a meal.
If you take more Metaperex than you should
If you have taken more of this medicine than directed or if a child accidentally has taken this medicine, immediately contact your doctor or local hospital casualty department for judgement of the risk and advice.
Long-term overdose with vitamin E is unknown.
The symptoms and signs of vitamin E overdose are general. Gastrointestinal disorders such as nausea, diarrhoea, flatulence have been reported with daily doses above 700 mg. Other symptoms may include tiredness, lack of energy, headache, blurred vision, and dermatitis. If an overdose is suspected, vitamin E treatment should be stopped.
If you forget to take Metaperex
Do not take a double dose to make up for the forgotten dose.
If you stop taking Metaperex
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.
If you experience any of the following side effects, stop treatment and tell your doctor:
Not known (frequency cannot be estimated with the available data):
- Unusual tiredness or weakness
- Nausea, diarrhoea, flatulence, abdominal pain and oral pain
- Headache and dizziness
- Rash
- Blurred vision
- Severe allergic reactions including rash, swelling, swelling of lips, breathlessness, redness and inflammation of the skin, and blisters
- Difficulty breathing
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 (see details below)
Great Britain
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 affects you can help provide more information on the safety of this medicine.
5. How to store Metaperex.
Keep this medicine out of the sight and reach of children.
Do not store above 25 °C.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
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 protect the environment.
6. Contents of the pack and other information
What Metaperex contains
- The active substance(s) is RRR-α-tocopherol. Each capsule contains 280 mg of RRR-α-tocopherol (the equivalent of 400 IU of vitamin E).
- The other ingredients are efined soya-bean oil (see section 2), gelatin and glycerol.
What Metaperex looks like and contents of the pack
Metaperex is presented as a soft gelatin capsule, with a length of about 1.6 cm and a width of about 0.9 cm. The soft capsules are contained in PVC-PVDC blister packs welded to a sheet of aluminium lacquered with PVDC.
It is available in packs of 60 capsules.
Marketing Authorisation Holder
Kora Corporation Ltd t/a Kora Healthcare
20 Harcourt Street
Dublin 2
D02 H364
Ireland
Manufacturer
CATALENT ITALY S.p.A.
Via Nettunense Km 20+100
04011 Aprilia (LT)
OR
ABIOGEN PHARMA S.p.A.
Via Meucci, 36 – Ospedaletto - Pisa
This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Belgium: Metaperex 400 IE zachte capsules/
UI capsules molles/ IE Weichkapseln Ireland: Metaperex 400 IU soft capsules Netherland: Metaperex 400 IE zachte capsules United Kingdom (Northern Ireland):
Metaperex 400 IU soft capsules
This leaflet was last revised in month YYYY
163800-00
257-01