PATIENT INFORMATION LEAFLET
Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.
Always take this medicine exactly as described in the information leaflet or as your doctor or pharmacist advises.
- Please keep this patient information leaflet because you might need the information in it later.
- For further information or advice, contact your pharmacist.
- If you notice any side effects, tell your doctor or pharmacist. This also refers to any possible side effects not listed in this leaflet.
- You must contact your doctor if your symptoms do not improve or worsen.
In this leaflet:
1. What Béres Vitamin C 500 mg retard film-coated tablets is and what it is used for?
2. What you need to know before you take Béres Vitamin C 500 mg retard film-coated tablets
3. How to take Béres Vitamin C 500 mg retard film-coated tablets
4. Possible side effects
5. How to store Béres Vitamin C 500 mg retard film-coated tablets
6. Further information
1. WHAT Béres Vitamin C 500 mg retard film-coated tablets IS AND WHAT IT IS USED FOR
The active substance of Béres Vitamin C 500 mg retard film-coated tablets is ascorbic acid (vitamin C), which is a water-soluble vitamin with antioxidant characteristics. Ascorbic acid is essential for a number basic physiological processes (e.g. hormone production, iron absorption, bones, teeth and cartilage formation, wound healing and the maintenance of adequate capillary patency).
It can also be used to prevent and treat vitamin C deficiencies (scurvy, Möller-Barlow’s disease).
2. Before you take Béres Vitamin C 500 mg retard film-coated tablets
• you are allergic to the active substance or any of the other ingredients of this medicine;
• you had or have kidney stones
• if you are allergic to soy or peanuts;
• if you are breast-feeding (See the “Pregnancy, breast-feeding and fertility” part).
Warnings and precautions
You may need to take smaller doses if you suffer from a tumour disease or if you have any kind of kidney disease in your medical history. Talk to you doctor if this refers to you.
Too high doses of ascorbic acid may cause hemolytic anemia in patients having certain inborn enzyme deficient diseases (glucose-6-phosphate dehyrogenase) deficiency.
Ascorbic acid helps absorption of iron, therefore ascorbic acid - when taken in higher doses - may increase the risk of developing iron storage disorder (hemochromatosis) and hemolytic anemia of various origins (siderblastic anemia, thalassemia).
When abruptly stopping long-term administration of high doses of ascorbic acid, more intense symptoms of deficiency may appear than initially.
Residues of the tablet may appear in the faeces. You need not worry about it because while the preparation was passing through the gastro-intestinal system, the active ingredient was released from the preparation and had its effect.
This preparation is not recommended for children.
Other medicines and Béres Vitamin C 500 mg retard film-coated tablets
You must tell your doctor or pharmacist about the medicines you are currently taking or have recently taken or are planning to take.
When you take these tablets together with other medicines, take into account that if the total daily intake of vitamin C exceeds 1000 mg, the effect of certain medicines may change.
You can take these tablets with care together with medicines containing the following active ingredients:
- preparations containing iron, copper and selenium
- deferoxamine (used for treating iron overdose)
- mexiletine (used for treating heart rhythm disorders)
- coumarin and indandione derivatives (anticoagulant medicines)
- salycilic acid derivatives (analgesic, antipyretic and anti-inflammatory medicines)
- disulfiram (used for treating alcoholism)
A high dose of ascorbic acid may reduce the pH of urine, which may increase the re-absorption of active ingredients of acidic type and may decrease the re-absorption of those of alkaline type.
Vitamin C may change the result of certain laboratory tests, so tell the doctor ordering the laboratory test if you take medicines with vitamin C content.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding or you may be pregnant or would like a child, talk to your doctor or pharmacist before you take this preparation.
Pregnant women can safely take 100 mg of vitamin C per day. Intake of vitamin C largely exceeding the required amount (above a dose of 1000 mg) is not recommended for pregnant women and women of child-bearing age living without contraception. Taking 1000 mg of vitamin C from the 3rd month of pregnancy until the delivery increases the risk of the newborn baby having a small body weight. During pregnancy the daily dose should not exceed 1 retard film-coated tablet per day.
Vitamin C is excreted into human milk. During breast-feeding the need for vitamin C is more intense but it is not recommended to administer a higher dose than the recommended daily dose of 100 mg. This preparation must not be administered during breast-feeding.
Effects of the preparation on capabilities required for driving and operating machines
Such effects are not known at the recommended dose.
Béres Vitamin C 500 mg retard film-coated tablets contain soy lecithin and orange FCF aluminium lacquer
Do not take this product if you are allergic to soy or peanuts.
The orange FCF aluminium lacquer may cause allergic reaction.
3. How to take Béres Vitamin C 500 mg retard film-coated tablets?
Always take this medicine exactly as described in the information leaflet or as your doctor or pharmacist advises. Consult your doctor or pharmacist if you are not sure about dosing.
To treat vitamin C deficiency for adults are recommended to take 1-2 film-coated retard tablet per day (500-1000mg).
Maximum daily dose: 1 film-coated tablet (1000 mg).
How to use the product for children?
It is not recommended for children.
It is recommended to take the product while the complaints persist. In case of a disease take the product as long as your doctor tells you to do so.
Take the film-coated tablet at the end of meals, without chewing it, with ample liquid.
The score on the tablet is not intended for breaking the tablet.
If you take more Béres Vitamin C 500 mg retard film-coated tablets than you should
Taking doses higher than recommended may cause a vitamin C overdose. Symptoms of a vitamin C overdose: heartburn, nausea, feeling sick, diarrhoea.
Ascorbic acid is a water soluble vitamin therefore the quantity exceeding needs is excreted in the urine and faeces. So, if you take too much of the preparation, drink lots of liquid.
If you forget to take Béres Vitamin C 500 mg retard film-coated tablets
Do not take a double dose the next time because you cannot make up for the missed quantity this way, but you may increase the likelihood of side effects. Continue as recommended.
If you stop taking Béres Vitamin C 500 mg retard film-coated tablets before the required period
Discontinuation of the treatment does not usually provoke any harmful effects but the symptoms of vitamin C deficiency may return.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Béres Vitamin C 500 mg retard film-coated tablets can cause side effects, although not everybody gets them.
When taking high doses for a long time, mainly if the daily vitamin C intake exceeds 1000 mg – heartburn, nausea, feeling sick, diarrhoea may occur, and the risk of kidney stone formation may increase.
If you notice any side effects, tell your doctor or pharmacist. This also refers to any possible side effects that are not listed in this patient information leaflet.
5. HOW TO STORE BÉRES VITAMIN C 500 MG FILM-COATED TABLETS
Store at or below 25 °C in the original packaging to protect from moisture.
Keep this medicine out of the sight and reach of children.
Do not take this medicine after the expiry date (Felhasználható:/Exp.) indicated on the box and the blister packaging. The expiry date refers to the last day of the relevant month.
Do not throw any medicines into waste water or household waste. Ask your pharmacist what to do with your medicines no longer required. These measures help protect the environment.
6. Content of packaging and other information
What do Béres Vitamin C 500 mg retard film-coated tablets contain?
- Active ingredient of the preparation: 500 mg vitamin C per retard film-coated tablet.
- Other ingredients:
- Tablet core: hypromellose, sodium alginate, microcrystalline cellulose, mannitol, anhydrous colloidal silicon dioxide, glyceryl dibehenate.
- Coating: partially hydrolysed poly(vinyl alcohol), talc, titanium dioxide (E171), makrogol/PEG 3350, soy lecithin, orange FCF aluminium lacquer (E110), yellow iron oxide (E172), quinoline yellow aluminium lacquer (E104).
What does the medicine look like and what does the packaging contain?
10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 120 orange-coloured, oblong film-coated tablets, convex on both sides and scored on one side, in colourless, transparent PVC/PVdC/PVC/AL blister packaging and box.
The score on the tablet is not intended for breaking the tablet.
Not all pack sizes may be marketed.
Marketing authorisation holder
Béres Gyógyszergyár Zrt., 1037 Budapest, Mikoviny u. 2-4.
E-mail: [email protected]
Béres Gyógyszergyár Zrt.,
5005 Szolnok, Nagysándor József út 39.
OGYI-T-22427/03 30x PVC/PVdC/PVC//Al in blister packaging
OGYI-T-22427/10 60x PVC/PVdC/PVC//Al in blister packaging
This leaflet was approved on: February, 2011.