Active ingredients: Vitamin E (RRR -? - Tocopherol)
RIGENTEX 200 I.U. soft capsules
RIGENTEX 400 I.U. soft capsules
Why is Rigentex used? What is it for?
RIGENTEX contains vitamin E.
RIGENTEX is indicated:
- in conditions characterized by vitamin E deficiency, caused by insufficient absorption of nutrients from food during digestion;
- in the conditions in which it is necessary to prevent an "excessive production of free radicals.
Contraindications When Rigentex should not be used
Do not take RIGENTEX if you are allergic to vitamin E or any of the other ingredients of this medicine (listed in section 6).
Precautions for use What you need to know before taking Rigentex
Talk to your doctor or pharmacist before taking RIGENTEX.
In particular, tell your doctor if:
- you are already being treated with digitalis (a medicine to treat heart disease) or insulin (a medicine to treat diabetes). In such cases, your doctor may carry out blood tests (see section 2 "Other medicines and RIGENTEX");
- suffer from a lack of vitamin K (involved in the blood clotting process). If you take vitamin E doses higher than 800 mg per day (equal to 800 I.U.), for a prolonged time, you may be more prone to bleeding.
Therapeutic use of tocopherol is associated with an increased risk of lack of blood supply to the brain caused by a "haemorrhage" (hemorrhagic stroke).
Interactions Which drugs or foods may change the effect of Rigentex
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, tell your doctor if you are taking:
- warfarin, anticoagulants, thrombolytics or inhibitors of platelet aggregation or haemostasis, which are medicines to thin the blood. Vitamin E could increase the risk of bleeding
- digitalis, a medicine to treat heart disease
- insulin, a medicine to treat diabetes
as vitamin E can increase the action of these drugs.
- Vitamin A
- vitamin K (involved in blood clotting processes)
as vitamin E taken in high doses can reduce the absorption of these vitamins.
Warnings It is important to know that:
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Take RIGENTEX only when clearly needed and only after your doctor has carefully assessed your condition and adjusted the doses based on your blood test values. It will also carry out checks during the treatment.
Driving and using machines
RIGENTEX has no effect on the ability to drive and use machines.
RIGENTEX contains soybean oil
This medicine contains soybean oil. If you are allergic to peanuts or soy, do not use this medicine.
Dose, Method and Time of Administration How to use Rigentex: Posology
Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose is 200-400 mg per day (equal to 200-400 I.U.), divided into 1-2 administrations, according to the doctor's judgment.
If you forget to take RIGENTEX
Do not take a double dose to make up for a forgotten dose.
If you stop taking RIGENTEX
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Overdose What to do if you have taken too much Rigentex
In case of accidental ingestion / intake of an overdose of RIGENTEX, notify your doctor immediately or go to the nearest hospital.
Symptoms
You may experience the following symptoms: nausea, diarrhea, fatigue, muscle weakness.
In case of daily dosages greater than 1 g, you may experience transient complaints such as nausea, diarrhea, gas emission from the intestine. Other symptoms you may experience include: tiredness, a sense of weakness, headache, blurred vision and inflammation of the skin. .
Treatment
Stop taking RIGENTEX and contact your doctor immediately or go to the nearest hospital. Your doctor will give you appropriate treatment, if necessary.
Ingestion / intake of an excessive dose of RIGENTEX is not known to cause chronic side effects.
Side Effects What are the side effects of Rigentex
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following side effects, stop the treatment and tell your doctor:
- allergic reactions, even severe ones, symptoms of which may include hives, swelling caused by allergy, difficulty in breathing, redness of the skin, skin rash and blisters.
The side effects reported with the use of vitamin E are the following:
Effects affecting the mouth, stomach and intestines:
diarrhea, pain in the belly and stomach, nausea, gas emissions from the intestine
Effects affecting the skin:
skin rash, itching
Effects affecting the whole organism:
tiredness (after taking high dosages)
Effects affecting the muscles and bones:
muscle weakness (after taking high dosages)
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 national reporting system at http://www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Store at a temperature not exceeding 30 ° C.
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 after EXP.
The expiry date refers to the last day of that month.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Deadline "> Other information
What RIGENTEX contains
RIGENTEX 200 I.U. soft capsules
The active ingredient is RRR-α-Tocopherol oil solution 200 mg (equal to 200 I.U. of vitamin E).
The other ingredients are refined soybean oil (see paragraph 2. "RIGENTEX contains soybean oil"), gelatin, glycerol.
RIGENTEX 400 I.U. soft capsules
The active ingredient is RRR-α-Tocopherol oil solution 400 mg (equal to 400 I.U. of vitamin E).
The other ingredients are refined soybean oil (see paragraph 2. "RIGENTEX contains soybean oil"), gelatin, glycerol.
What RIGENTEX looks like and contents of the pack
RIGENTEX comes as a soft gelatin capsule.
It is available in packs of
- 30 capsules of 400 I.U.
- 60 capsules of 200 I.U.
Not all pack sizes may be marketed.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT -
RIGENTEX SOFT CAPSULES
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -
RIGENTEX 200 I.U. soft capsules
1 capsule contains:
Active principle : RRR- α - Tocopherol oil solution mg 200 (equal to 200 I.U. of vitamin E).
RIGENTEX 400 I.U. soft capsules
1 capsule contains:
Active principle: RRR- α - Tocopherol oil solution 400 mg (equal to 400 I.U. of vitamin E).
For the full list of excipients, see section 6.1
03.0 PHARMACEUTICAL FORM -
Soft capsules.
04.0 CLINICAL INFORMATION -
04.1 Therapeutic indications -
Vitamin E deficiencies linked to malabsorption. Conditions in which the prevention of excessive cellular lipid peroxidation is required.
04.2 Posology and method of administration -
200 - 400 mg per day, divided into 1 - 2 doses, according to the doctor's judgment.
04.3 Contraindications -
Known hypersensitivity to the active substance or to any of the excipients.
04.4 Special warnings and appropriate precautions for use -
Since vitamin E reduces the need for digitalis, in case of simultaneous intake of the two drugs, attention should be paid to "possible hyperdigitalization. Insulin dosages in diabetics treated with vitamin E must be carefully controlled, since vitamin E can considerably reduce the need for insulin (see also section 4.5).
Prolonged use of doses above 800 mg per day has been associated with an increased bleeding tendency in patients with vitamin K deficiency. Excessive use of vitamin E can antagonize vitamin K function and should be under close supervision. .
Therapeutic use of tocopherol is associated with an increased risk of hemorrhagic stroke.
04.5 Interactions with other medicinal products and other forms of interaction -
High doses of vitamin E (1200 I.U.) can interfere with warfarin, resulting in a transient increase in bleeding time. Vitamin E can enhance the action of digitalis and insulin.
Concomitant use of anticoagulants, thrombolytics, or inhibitors of platelet aggregation or haemostasis may increase the risk of bleeding.
High doses of α-tocopherol can reduce the absorption of vitamin A and vitamin K.
04.6 Pregnancy and breastfeeding -
During pregnancy and lactation the product should only be used under strict medical supervision due to the high dosage of alpha-tocopherol in the medicine.
In the event that the use of the medicinal product is necessary, the risk / benefit ratio for both the mother and the child must be considered, and the treatment must be adapted according to the serum tocopherol levels.
04.7 Effects on ability to drive and use machines -
The drug does not alter the state of alertness.
04.8 Undesirable effects -
After taking high dosages, fatigue and muscle weakness may appear.
Adverse reactions are derived from spontaneous reports and therefore it is not possible to establish their frequency.
Disorders of the immune system
Allergic reaction, anaphylactic reaction. Symptoms may include hives (secondary mechanism), allergic edema, dyspnoea, erythema, rash and boils. If an allergic reaction appears, stop treatment and consult a doctor.
Gastrointestinal disorders
Diarrhea, abdominal pain, epigastric pain, nausea, flatulence.
Skin and subcutaneous tissue disorders
Skin rash, itching.
04.9 Overdose -
In case of overdose it is possible the appearance of gastrointestinal disorders (nausea, diarrhea), fatigue, muscle weakness.
Chronic phenomena of hypervitaminosis are not known E.
Symptoms and signs of tocopherol overdose are non-specific. Transient gastrointestinal disturbances such as nausea, diarrhea, flatulence have been reported with daily dosages greater than 1 g. Other symptoms may include fatigue, asthenia, headache, blurred vision and dermatitis. If overdose is suspected, treatment should be discontinued. Where necessary, general supportive measures should be taken.
05.0 PHARMACOLOGICAL PROPERTIES -
05.1 "Pharmacodynamic properties -
Vitamin E carries out its main activity as a physiological antioxidant of lipid structures and as a stabilizer of cell membranes; it is therefore an adjuvant drug in the treatment of various clinical manifestations related to toxic-oxidative vulnerability of biomembranes.
Vitamin E, as a biological antioxidant, protects other substances, such as vitamin A, from oxidative inactivation.
05.2 "Pharmacokinetic properties -
Vitamin E is absorbed in the intestine following the same mechanisms as fat-soluble substances. Consequently, below normal tocopherolemia values were found in subjects with hepato-pancreatic disorders.
Bioavailability ranges from 20 to 40%. The vitamin circulates in the plasma bound to lipoproteins. It is found in all tissues, especially cell membranes.
Vitamin E is poorly metabolized. Its elimination occurs mainly via the biliary route.
In the urine some metabolites have been found consisting of glucuronidated compounds of tocopherolic acid and its gammalactone.
05.3 Preclinical safety data -
Acute toxicity studies found that the highest dose without toxic effects, administered orally in mice, rats and dogs, was 50,000 mg / kg, 5,000 mg / kg and 320 mg / kg, respectively. Repeated oral administration for 19 consecutive weeks was also well tolerated by the rat for doses up to 100 mg / day.
06.0 PHARMACEUTICAL INFORMATION -
06.1 Excipients -
Refined soybean oil.
Constituents of the capsule : gelatin, glycerol.
06.2 Incompatibility "-
None.
06.3 Period of validity "-
4 years
06.4 Special precautions for storage -
Do not store above 30 ° C.
06.5 Nature of the immediate packaging and contents of the package -
The soft capsules are contained in PVC-PVDC blisters welded to a sheet of lacquered aluminum
PVDC. Packaging:
RIGENTEX 200 I.U. 60 soft capsules
RIGENTEX 400 I.U. 30 soft capsules
06.6 Instructions for use and handling -
07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -
Bracco S.p.A. - Via E. Folli, 50 - MILAN
08.0 MARKETING AUTHORIZATION NUMBER -
RIGENTEX 200 I.U. soft capsules - 60 capsules n. AIC 034680013
RIGENTEX 400 I.U. soft capsules - 30 capsules n. AIC 034680025
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -
May 2001 / May 2011
10.0 DATE OF REVISION OF THE TEXT -
May 2012
