Vitamin c synteza
Poland
Table of Contents
Package leaflet: Information for the patient
Vitamina C Synteza, 500 mg, hard capsules
Acidum ascorbicum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
the doctor or pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you need advice or further information, consult your pharmacist.
- If you experience any adverse reactions, including any possible side effects not mentioned in this leaflet, inform your doctor or pharmacist. See section 4.
- If there is no improvement or if you feel worse, contact your doctor.
Table of contents
- What Vitamina C Synteza is and what it is used for
- Important information before taking Vitamina C Synteza
- How to take Vitamina C Synteza
- Possible side effects
- How to store Vitamina C Synteza
- Contents of the pack and other information
1. What Vitamina C Synteza is and what it is used for
Vitamina C Synteza contains ascorbic acid (vitamin C). Water-soluble vitamin C is essential for metabolic processes in humans. It participates in oxidation and reduction reactions occurring in body cells. It plays a role in collagen biosynthesis, a factor determining proper development of cartilage, bone, dentin, normal wound healing, and maintenance of healthy blood vessels. Vitamin C stimulates biosynthesis of numerous intercellular substances and prostacyclin synthesis. It inhibits thromboxane production. It participates in the absorption of iron ions from the gastrointestinal tract, in the metabolism of tyrosine, phenylalanine, folic acid, histamine, noradrenaline, carnitine, proteins and lipids, as well as in adrenal steroid and cholesterol metabolism. It inhibits lipid peroxidation and neutralizes superoxide free radicals.
Vitamina C Synteza is used:
- to correct vitamin C deficiency in the body;
- in the treatment of metabolic consequences of hypovitaminosis;
- in the treatment of iron-deficiency anemia;
- to accelerate wound healing and scar formation;
- as an adjunct in conditions of reduced body resistance;
- during infectious diseases and the convalescence period.
2. Important information before using Vitamina C Synteza
When not to use Vitamina C Synteza:
- if the patient is allergic to vitamin C or to any of the other ingredients of this medicine (listed in section 6).
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Warnings and precautions
Vitamina C Synteza should not be used in patients undergoing radiotherapy and/or chemotherapy.
Daily doses exceeding 1 g may interfere with blood and urine tests based on oxidation-reduction reactions.
Children
Vitamina C Synteza should not be used in children under 12 years of age.
Vitamina C Synteza and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Concomitant use of vitamin C with preparations containing metal salts or with oxidizing agents may reduce their mutual effectiveness.
Vitamina C Synteza administered together with cyanocobalamin (vitamin B_), may reduce its efficacy; therefore, a several-hour interval should be maintained between administration of these medicines. Salicylic acid and its derivatives reduce the plasma concentration of vitamin C. Vitamin C may reduce the effectiveness of tricyclic antidepressants and aminoglycosides, enhance the effect and toxicity of oral anticoagulants and sulfonamides, and increase serum concentrations of concurrently administered estrogens.
Taking Vitamina C Synteza with food and drink
Vitamina C Synteza may be taken regardless of meals.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine.
Pregnancy
During pregnancy, Vitamina C Synteza should be taken only at doses recommended by a doctor.
Breastfeeding
Ascorbic acid passes into breast milk; therefore, during breastfeeding, the medicine should be taken only at doses recommended by a doctor.
Driving and operating machinery
Vitamina C Synteza has no effect or has negligible effect on the ability to drive and operate machinery.
Use in elderly patients
Elderly individuals may safely use Vitamina C Synteza.
The medicine contains quinoline yellow (E 104) and sunset yellow (E 110)
This medicine may cause allergic reactions.
3. How to use Vitamina C Synteza
This medicine should always be taken exactly as described in this patient information leaflet, or as directed by a physician.
If in doubt, consult a doctor or pharmacist.
Oral administration.
Recommended dose: adults and children over 12 years of age - 1 capsule once or twice daily.
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Use of a higher than recommended dose of Vitamina C Synteza
Severe symptoms of vitamin C overdose have not been observed following oral administration. Excess vitamin C is effectively eliminated from the body by the kidneys; therefore, large amounts of fluids should be consumed in case of overdose. Adverse effects may occur following overdose (see section 4).
Missed dose of Vitamina C Synteza
Do not take a double dose to make up for a missed dose.
If you have any further doubts concerning the use of this medicine, consult a doctor or pharmacist.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Vitamin C is generally well tolerated. High doses exceeding 1 g per day used for prolonged periods may cause adverse reactions:
Gastrointestinal disorders:
Frequency not known: diarrhoea, heartburn.
Urinary system disorders:
Frequency not known: increased risk of formation of urate, cystine and oxalate stones.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, Phone: + 48 22 49 21 301,
Fax: + 48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions enables continuous monitoring of the medicine's safety and helps to identify new information regarding its safe use.
5. How to store Vitamina C Synteza
Store below 25°C.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.
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6. Contents of the pack and other information
What Vitamina C Synteza contains
- The active substance is ascorbic acid (Acidum ascorbicum). One capsule contains 500 mg of vitamin C.
- Other ingredients are: gelatin, magnesium stearate, colloidal anhydrous silica, titanium dioxide (E 171), quinoline yellow (E 104), sunset yellow (E 110).
What Vitamina C Synteza looks like and contents of the pack
Vitamina C Synteza is a hard, yellow capsule, packed in aluminium/PVC blisters with a cardboard box.
1 pack contains 10 capsules (1 blister with 10 pieces).
Marketing Authorisation Holder and Manufacturer
Przedsiębiorstwo Farmaceutyczno-Chemiczne „Synteza” Sp. z o.o.
ul. Św. Michała 67/71
61-005 Poznań
tel. 61 879-20-81
For more detailed information, please contact the local representative of the Marketing Authorisation Holder:
Poland
Przedsiębiorstwo Farmaceutyczno-Chemiczne „Synteza” Sp. z o.o.
ul. Św. Michała 67/71
61-005 Poznań
tel. 61 879-20-81
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