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. See point 4.
- You must contact your doctor if your symptoms do not improve or worsen after 3-5 days.
In this leaflet:
1. What Béres Vitamin C 1000 mg film-coated tablets is and what it is used for?
2. What you need to know before you take Béres Vitamin C 1000 mg film-coated tablets
3. How to take Béres Vitamin C 1000 mg film-coated tablets
4. Possible side effects
5. How to store Béres Vitamin C 1000 mg film-coated tablets
6. Further information
1. WHAT BÉRES VITAMIN C 500 MG FILM-COATED TABLET IS AND WHAT IT IS USED FOR
The active substance of Béres Vitamin C 1000 mg 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 1000 mg film-coated tablets
Do not take Béres Vitamin C 1000 mg film-coated tablets if
• you are allergic to the active substance or any of the other ingredients of this medicine;
• you had or have kidney stones
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.
Long-term administration of high doses of ascorbic acid intensifies the risk of the production of kidney stones.
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.
Children and adolescents
It is not recommended to administer this preparation to children below 14 years of age.
Other medicines and Béres Vitamin C 1000 mg 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.
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.
During pregnancy and breast-feeding it is recommended to take a vitamin C preparation with low active ingredient content.
Effects of the preparation on capabilities required for driving and operating machines
Taking this medicine probably does not affect the capabilities required for driving and operating machines.
3. How to take Béres Vitamin C 1000 mg 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, adults and children over 14 years of age are recommended to take 1 film-coated tablet per day.
Maximum daily dose: 1 film-coated tablet (1000 mg).
Utilisation for children and adolescents
It is not recommended for children below the age of 14.
Take the film-coated tablet at the end of meals, without chewing it, with ample liquid.
If necessary, swallowing can be facilitated by breaking the tablet into two.
If you take more Béres Vitamin C 1000 mg 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 1000 mg 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 1000 mg 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 1000 mg 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.
Reporting side effects
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. You can report side effects directly to the authorities via the contact details included in Appendix V. By reporting the side effects you can also contribute to making as much information as possible available, regarding the safe use of this medicine.
5. HOW TO STORE BÉRES VITAMIN C 1000 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 that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Content of packaging and other information
What Béres Vitamin C 1000 mg film-coated tablets contain
The active substance: 1000 mg vitamin C in each film-coated tablet
Tablet core: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, hydroxypropyl cellulose, crospovidone, stearic acid, anhydrous colloidal silicon dioxide, talc, sodium stearyl fumarate.
Coating: “Aqua Polish D yellow 024.45 MS” [hypromellose, hydroxypropyl cellulose, talc, saturated medium-chain triglycerides, titanium dioxide (E 171), yellow iron oxide (E 172)]
What do Béres Vitamin C 1000 mg film-coated tablets look like and what does the packaging contain?
Yellow, oblong film-coated tablets, convex and scored on both sides. The score line is only there to help you break the tablet if you have difficulty swallowing it whole and not to divide the tablet into equal doses.
30, 60, 90, 100, 120, 150 or 200 film-coated tablets in colourless, transparent PVC/PVdC/PVC//Al or PVC/PVdC//Al blister packaging and box.
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-8344/13 30x PVC/PVdC/PVC//Al in blister packaging
OGYI-T-8344/14 60x PVC/PVdC/PVC//Al in blister packaging
OGYI-T-8344/15 90x PVC/PVdC/PVC//Al in blister packaging
OGYI-T-8344/16 100x PVC/PVdC/PVC//Al in blister packaging
OGYI-T-8344/17 120x PVC/PVdC/PVC//Al in blister packaging
OGYI-T-8344/18 150x PVC/PVdC/PVC//Al in blister packaging
OGYI-T-8344/19 200x PVC/PVdC/PVC//Al in blister packaging
OGYI-T-8344/20 30x PVC/PVdC//Al in blister packaging
OGYI-T-8344/21 60x PVC/PVdC//Al in blister packaging
OGYI-T-8344/22 90x PVC/PVdC//Al in blister packaging
OGYI-T-8344/23 100x PVC/PVdC//Al in blister packaging
OGYI-T-8344/24 120x PVC/PVdC//Al in blister packaging
OGYI-T-8344/25 150x PVC/PVdC//Al in blister packaging
OGYI-T-8344/26 200x PVC/PVdC//Al in blister packaging
This leaflet was approved on: January, 2016.