Rigentex
Italy
Table of Contents
Patient Information Leaflet
RIGENTEX 200 IU Soft Capsules, 400 IU Soft Capsules
Vitamin E (RRR-α-Tocopherol)
Please read this entire leaflet carefully before taking this medicine, as it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.
- Keep this leaflet. You may need to read it again.
- If you need further 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.
- Contact your doctor if you do not notice any improvement or if your symptoms worsen.
Contents of this leaflet:
- What RIGENTEX is and what it is used for
- What you need to know before taking RIGENTEX
- How to take RIGENTEX
- Possible side effects
- How to store RIGENTEX
- Contents of the pack and other information
1. What RIGENTEX is and what it is used for
RIGENTEX contains vitamin E.
RIGENTEX is indicated:
- in conditions characterized by vitamin E deficiency caused by inadequate absorption of nutrients from food during digestion;
- in conditions where prevention of excessive free radical production is required.
2. What you should know before taking RIGENTEX
Do not take RIGENTEX
- 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 RIGENTEX.
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 RIGENTEX”);
- you have a deficiency of vitamin K (involved in the blood clotting process). If you take vitamin E doses exceeding 560 mg per day (equivalent 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).
Other medicines and RIGENTEX
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
In particular, inform your doctor if you are taking:
- warfarin, anticoagulants, thrombolytics, or platelet aggregation or hemostasis inhibitors, which are medicines used to make the blood thinner. Vitamin E could 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), as high-dose vitamin E intake may reduce the absorption of these vitamins.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Take RIGENTEX only if clearly needed and only after your doctor has carefully evaluated your condition, adjusted the dosage according to your blood test results, and scheduled monitoring during treatment.
Driving and using machines
RIGENTEX has no effect on the ability to drive or operate machinery.
RIGENTEX contains soybean oil
This medicine contains soybean oil. If you are allergic to peanuts or soy, do not use this medicine.
3. How to take RIGENTEX
Take this medicine exactly as stated 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 140–280 mg per day (equivalent to 200–400 I.U.), divided into 1–2 doses, according to the physician's judgment.
If you take more RIGENTEX than you should
If you accidentally ingest/absorb an excessive dose of RIGENTEX, inform 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 700 mg, 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 RIGENTEX and inform your doctor immediately or go to the nearest hospital. Your doctor will provide appropriate treatment, if necessary.
It is not known whether ingestion/absorption of an excessive dose of RIGENTEX may cause chronic adverse effects.
If you forget to take RIGENTEX
Do not take a double dose to make up for the forgotten dose.
If you stop taking RIGENTEX
If you have any doubts about using 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: diarrhoea, abdominal and stomach pain, nausea, intestinal gas.
Effects related to the skin: skin rash, itching.
Effects related to the whole body: fatigue (following high-dose intake).
Effects related to muscles and bones: muscle weakness (following high-dose intake).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist.
You can also report side effects directly via the national reporting system at the website http://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 RIGENTEX
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 carton after EXP.
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.
6. Package contents and other information
What RIGENTEX contains
RIGENTEX 200 IU soft capsules
The active substance is
- RRR-α-Tocopherol 140 mg (equivalent to 200 IU of vitamin E).
The other ingredients are refined soybean oil (see section 2, “RIGENTEX contains soybean oil”), gelatin, glycerol.
RIGENTEX 400 IU soft capsules
The active substance is
- RRR-α-Tocopherol 280 mg (equivalent to 400 IU of vitamin E).
The other ingredients are refined soybean oil (see section 2, “RIGENTEX contains soybean oil”), gelatin, glycerol.
Description of the appearance of RIGENTEX and contents of the pack
RIGENTEX is presented as a soft gelatin capsule.
It is available in packs containing:
- 30 capsules of 400 IU
- 60 capsules of 200 IU
Not all pack sizes may be marketed.
Marketing Authorization Holder
SUBSTIPHARM
24 rue Erlanger, 75016 Paris - France
Marketing Licensee
SUBSTIPHARM S.r.l.
Via Felice Casati, 20 – 20124 Milano
Manufacturer
Catalent Italy S.p.A.
Via Nettunense Km 20+100, 04011 Aprilia (LT)
Abiogen Pharma S.p.A., Via Meucci, 36 - Ospedaletto (PI)