SURSUM

Patient Information Leaflet

SURSUM 200 IU Soft Capsules, 400 IU Soft Capsules

Vitamin E (RRR-α-Tocopherol)
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if your symptoms worsen.

Contents of this leaflet:

1. What SURSUM is and what it is used for
2. What you need to know before taking SURSUM
3. How to take SURSUM
4. Possible side effects
5. How to store SURSUM
6. Contents of the pack and other information

1. What SURSUM is and what it is used for

SURSUM contains vitamin E.
SURSUM is indicated:

• in conditions characterized by vitamin E deficiency due to inadequate absorption of nutrients from food during digestion;
• in conditions where prevention of excessive free radical production is required.

2. What you need to know before taking SURSUM

Do not take SURSUM

• if you are allergic to vitamin E or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking SURSUM.
In particular, inform your doctor if:

• you are already being treated with digitalis (a medicine used to treat heart diseases) or insulin (a medicine used to treat diabetes). In such cases, your doctor may carry out blood tests (see section 2 “Other medicines and SURSUM”);
• you suffer from vitamin K deficiency (vitamin K is involved in blood clotting). If you take doses of vitamin E exceeding 800 mg per day (equal to 800 IU) for a prolonged period, you may be more prone to bleeding. Therapeutic use of tocopherol is associated with an increased risk of hemorrhagic stroke (stroke caused by bleeding in the brain).

Other medicines and SURSUM
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking:

• warfarin, anticoagulants, thrombolytics, or platelet aggregation inhibitors or hemostasis inhibitors, which are medicines used to make the blood thinner. Vitamin E may increase the risk of bleeding;
• digitalis, a medicine used to treat heart diseases;
• insulin, a medicine used to treat diabetes, as vitamin E may enhance the effect of these drugs;
• vitamin A;
• vitamin K (involved in blood clotting processes).

Since high-dose vitamin E may reduce the absorption of these vitamins.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Take SURSUM only if strictly necessary and only after your doctor has carefully evaluated your condition and adjusted the dosage based on your blood test results. Your doctor will also carry out regular monitoring during treatment.
Driving and using machines
SURSUM has no effect on the ability to drive or operate machinery.
SURSUM contains soybean oil
This medicine contains soybean oil. If you are allergic to peanuts or soybeans, do not use this medicine.

3. How to take SURSUM

Take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 200–400 mg per day (equivalent to 200–400 I.U.), divided into 1–2 doses, according to the physician’s judgment.

If you take more SURSUM than you should
In case of accidental ingestion or overdose of SURSUM, contact your doctor immediately or go to the nearest hospital.

Symptoms
You may experience the following symptoms: nausea, diarrhoea, fatigue, muscle weakness.
If you take daily doses exceeding 1 g, you may experience transient disturbances such as nausea, diarrhoea, and intestinal gas. Other symptoms you may experience include fatigue, feeling of weakness, headache, blurred vision, and skin inflammation.

Treatment
Stop treatment with SURSUM immediately and contact your doctor or go to the nearest hospital. Your doctor will provide appropriate treatment, if necessary.
It is not known whether overdose of SURSUM may cause chronic adverse effects.

If you forget to take SURSUM
Do not take a double dose to make up for the forgotten dose.

If you stop taking SURSUM
If you have any questions about the use of this medicine, consult 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 taking the medicine and inform your doctor:

• allergic reactions, even severe ones, whose symptoms may include hives, swelling due to allergy, difficulty breathing, skin redness, skin rash, and blisters.

The side effects reported with vitamin E use are the following:
Effects related to the mouth, stomach, and intestine:
diarrhea, stomach and abdominal pain, nausea, intestinal gas
Effects related to the skin:
skin rash, itching
Effects related to the whole body:
tiredness (after taking high doses)
Effects related to muscles and bones:
muscle weakness (after taking high doses)
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at the website www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store SURSUM

Store below 30°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after EXP.
The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer in use. This will help protect the environment.

6. Pack contents and other information

What SURSUM contains
SURSUM 200 IU soft capsules
The active substance is

• RRR-α-Tocopherol oily solution 200 mg (equivalent to 200 IU of vitamin E).
  The other ingredients are refined soybean oil (see paragraph 2, "SURSUM contains soybean oil"), gelatin, glycerol.

SURSUM 400 IU soft capsules
The active substance is

• RRR-α-Tocopherol oily solution 400 mg (equivalent to 400 IU of vitamin E).
  The other ingredients are refined soybean oil (see paragraph 2, "SURSUM contains soybean oil"), gelatin, glycerol.

Description of the appearance of SURSUM and pack contents
SURSUM is presented as a soft gelatin capsule.
It is available in packs of

• 30 capsules of 400 IU
• 60 capsules of 200 IU
  Not all pack sizes may be marketed.

ABIOGEN PHARMA S.p.A. - Via Meucci, 36 – Ospedaletto – Pisa
Manufacturer
CATALENT ITALY S.p.A.
Via Nettunense Km 20+100
04011 Aprilia (LT)
ABIOGEN PHARMA S.p.A.
Via Meucci, 36 – Ospedaletto - Pisa