Vitamin E 400 IU Soft Capsules – patient leaflet, side effects, dosage

1. What Vitamin E Soft Capsules are and what they are used for

Vitamin E Soft Capsules contain 400 mg of DL-alpha-tocopheryl acetate, equivalent to 400 IU. Although the exact role of Vitamin E has not yet been worked out, it is known to play an important part in metabolism – the chemical reactions that are taking place in the body all the time.

Vitamin E Soft Capsules are used to prevent and treat vitamin E deficiency, including that occurring in abetalipoproteinaemia, and for the prevention and treatment of vitamin E deficiency arising from cystic fibrosis in adults. By taking extra vitamin E in the form of Vitamin E Soft Capsules, the body gets all it needs.

2. What you need to know before you take Vitamin E Soft Capsules

Do not take Vitamin E Soft Capsules:

! If you are allergic to Vitamin E (DL-alpha-

tocopheryl acetate) or any of the other ingredients of this medicine (listed in section 6). ! If you have Vitamin K deficiency (increased risk

of bleeding).

! If you are pregnant or breast-feeding

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Vitamin E Soft Capsules. In particular, tell your doctor if:

! You lack Vitamin K (involved in the blood

clotting process). If you take doses of vitamin E

above 800 IU per day, you may be more likely to bleed for longer than usual.

! You are being treated with blood thinners or the

hormone oestrogen. A possible adjustment of the dose of blood thinner medication during and after treatment with vitamin E may be required.

! You have impaired kidney function.

! If you have had or are known to be at high risk

of developing prostate cancer. Long term vitamin E supplementation may increase the risk of prostate cancer in men.

Other medicines and Vitamin E Soft Capsules:

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 tipranavir 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 reduce the 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 and therefore patients should check if other medicines contain vitamin E and discuss with your doctor before taking together with Vitamin E Soft Capsules.

! 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, this medicine 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 (28.5 mg) should not be used in nursing mothers. Therefore, this medicine should not be used during breastfeeding.

Driving and using machines:

Vitamin E Soft Capsules should not affect your ability to drive or use machinery.

3. How to take Vitamin E Soft Capsules

Always take this medicine exactly as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure. Vitamin E Soft Capsules are for oral use. Preferably you should take this medicine during or after a meal.

The capsule should be swallowed whole, do not chew.

Adults (including the elderly)

The recommended dose for vitamin E deficiency is one 400 IU capsule per day. Vitamin E should be taken with food.

If you take more Vitamin E Soft Capsules than you should

If you or anyone else takes a large amount (greater than 2 capsules (800 IU)) of Vitamin E Soft Capsules, or if a child has accidentally taken this medicine, immediately contact your doctor or local hospital casualty department for assessment of the risk and advice.

The symptoms and signs of vitamin E overdose are general. Gastrointestinal disorders such as nausea, diarrhoea and flatulence have been reported with daily doses above 800 IU (2 capsules). 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 Vitamin E Soft Capsules

Do not take a double dose to make up for a forgotten dose.

If you stop taking Vitamin E Soft Capsules

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

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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the MHRA 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 Vitamin E Soft 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 label. The expiry date refers to the last day of that month.

Store below 25°C. Store in the original package in order to protect from light and moisture. Do not freeze.

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 Vitamin E Soft Capsules contain

The active substance is DL-alpha-tocopheryl acetate.

Each Vitamin E 400 IU soft capsule contains 400mg DL-alpha-tocopheryl acetate.

The other ingredients are:

! Capsule fill: olive oil.

! Capsule shell: gelatin, glycerol, purified water.

What Vitamin E Soft Capsules look like and contents of the pack

Transparent, yellow, round soft gelatin capsules containing a transparent, light yellow liquid. Each pack contains 30 soft capsules.

Marketing Authorisation Holder

Ennogen IP Ltd,

Unit G4, Riverside Industrial Estate, Riverside Way, Dartford, DA1 5BS, UK.

Manufacturer

Ennogen Healthcare Ltd, Unit G4, Riverside Industrial Estate, Riverside Way, Dartford, Kent, DA1 5BS, UK.

This leaflet was last revised in June 2025.

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