Vitaminum C Teva

Leaflet attached to the packaging: information for the user

VITAMINUM C TEVA 200 mg, coated tablets

Ascorbic acid

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor, pharmacist, or nurse.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

• 1. What is Vitaminum C Teva 200 mg and what is it used for
• 2. Important information before taking Vitaminum C Teva 200 mg
• 3. How to take Vitaminum C Teva 200 mg
• 4. Possible side effects
• 5. How to store Vitaminum C Teva 200 mg
• 6. Contents of the pack and other information

1. What is Vitaminum C Teva 200 mg and what is it used for

Vitaminum C Teva coated tablets contain 200 mg of ascorbic acid (vitamin C).
Vitamin C participates in oxidation and reduction processes in the body, contributes to the formation of collagen, affects the elasticity of blood vessels, is necessary for the proper development of cartilage and bones, and for the normal healing of wounds. It stimulates the production of prostacyclin, which has a protective effect on blood vessels, and inhibits the production of thromboxane, which promotes vasoconstriction and thrombosis. It has antioxidant properties, inhibits the formation of lipid peroxides (fats), and inactivates free radical peroxides. It is necessary for adrenal hormone metabolism. Indirectly, it participates in the metabolism of phenylalanine, tyrosine, norepinephrine, histamine, folic acid, as well as lipids, proteins, and carnitine. In the digestive tract, it increases iron absorption.
Signs of vitamin C deficiency include: poor well-being, irritability, joint pain, excessive keratinization of hair follicles, bleeding gums and nose, and petechiae.
Vitaminum C Teva 200 mg is indicated for the prevention and supplementation of vitamin C deficiency in the body during periods of convalescence after infectious diseases, wound healing after burns, and in smokers.
The drug can be used as an adjunct in the treatment of iron deficiency anemia, inflammatory skin conditions, and mucous membranes of the respiratory, digestive, and urinary tracts.

2. Important information before taking Vitaminum C Teva 200 mg

When not to take Vitaminum C Teva 200 mg

If the patient has been diagnosed with hypersensitivity (allergy) to the active substance or to any of the other ingredients of Vitaminum C Teva 200 mg.
Do not administer high doses (above 1 g per day) to patients with urinary tract stones or with excessive excretion of oxalates through the kidneys.

Warnings and precautions

If the patient has been diagnosed with hemochromatosis, sideroblastic anemia, and thalassemia (diseases accompanied by iron metabolism disorders), caution should be exercised due to the fact that ascorbic acid increases iron absorption.
In patients with a deficiency of erythrocyte glucose-6-phosphate dehydrogenase (a genetically determined lack of this enzyme in red blood cells), long-term administration may cause hemolytic anemia. Long-term administration of high doses of ascorbic acid in patients with urinary tract stones causes the formation and deposition of stones in the kidneys.
Ascorbic acid participates in oxidation-reduction reactions, high doses of the drug may affect the results of chemical oxidation and reduction reactions. Therefore, before performing blood and urine tests, it is recommended that the patient does not take drugs containing ascorbic acid for at least 1 day. This will avoid possible errors in diagnosis (e.g., masking the presence of hidden blood in the stool, increased bilirubin levels in blood serum, presence of sugar in urine, decreased activity in blood serum of enzymes such as ALAT, AspAT, LDH; decreased urine pH). The results of sugar level measurements in the urine of diabetic patients may be falsified when taking high doses of vitamin C. Before taking the drug, patients with renal impairment should consult their doctor.
Long-term administration of high doses of ascorbic acid may cause symptoms of poisoning.
Diagnosis is based on laboratory tests and clinical symptoms such as difficult and painful urination and hematuria.

Vitaminum C Teva 200 mg and other medicines

Tell your doctor about all the medicines you have taken recently, including those that are available without a prescription.
Ascorbic acid increases the absorption of iron compounds taken at the same time.
When ascorbic acid and acetylsalicylic acid are administered simultaneously, an increase in ascorbic acid excretion and a decrease in acetylsalicylic acid excretion are observed.
Ascorbic acid increases the rate of elimination of tricyclic antidepressants and amphetamines from the body, reduces the effectiveness of phenothiazine derivatives (antihistamines and psychiatric medications), aminoglycoside antibiotics (e.g., gentamicin, amikacin), and increases estrogen levels in blood serum (female hormones, including those found in oral contraceptives).

Taking Vitaminum C Teva 200 mg with food and drink

The drug should be taken during meals.

Pregnancy, breastfeeding, and fertility

Pregnancy

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before taking this medicine.
Before taking any medicine, consult your doctor or pharmacist.
Ascorbic acid passes through the placenta.
High doses of ascorbic acid are not recommended for pregnant women, as this may cause symptoms of vitamin C deficiency in newborns after the supply through the placenta stops.

Breastfeeding

Before taking any medicine, consult your doctor or pharmacist.
Ascorbic acid passes into breast milk.
Cautious use is recommended, and high doses should not be taken without medical advice.

Driving and using machines

No effect on the ability to drive vehicles or operate machinery.

Vitaminum C Teva 200 mg contains lactose

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Vitaminum C Teva 200 mg

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Oral administration.
Adults:
prophylactically: 100 mg per day;
as an adjunct in treatment: 100 mg to 500 mg per day.
Children over 5 years old:
as an adjunct in treatment: 100 mg to 200 mg per day.
The drug should be taken during meals.
To achieve a daily dose of 100 mg, 300 mg, 500 mg: oral pharmaceutical forms of 100 mg strength are available.

Taking a higher dose of Vitaminum C Teva 200 mg than recommended

In case of taking a significantly higher dose than recommended, consult your doctor or pharmacist. If you have any doubts about taking the medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Vitaminum C Teva 200 mg can cause side effects, although not everybody gets them.
The drug is generally well-tolerated. However, taking high doses of ascorbic acid (above 1 g per day) may cause side effects such as: nausea, vomiting, diarrhea, heartburn, skin rashes, headache, increased urination.
Long-term use of vitamin C in doses above 1 g per day causes increased excretion of oxalates in the urine, may also cause the formation of uric acid and cystine stones, especially in patients with urinary tract stones or those undergoing hemodialysis.
If any of the side effects worsen or if you experience any side effects not listed in the leaflet, inform your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, inform your doctor or pharmacist.
Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, e-mail: [email protected].
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Vitaminum C Teva 200 mg

Keep the medicine out of the sight and reach of children.
Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Vitaminum C Teva 200 mg contains

• The active substance is ascorbic acid.
• The other ingredients are: lactose monohydrate, povidone, talc, magnesium stearate, potato starch. Coating: hypromellose, titanium dioxide (E 171), glycerol, magnesium stearate, polysorbate 80, xylitol, lemon flavor, quinoline yellow lake (E 104).

What Vitaminum C Teva 200 mg looks like and contents of the pack

Coated tablets.
2 blisters of 10 tablets (20 tablets) in a cardboard box;
3 blisters of 10 tablets (30 tablets) in a cardboard box;
5 blisters of 10 tablets (50 tablets) in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, Poland

Manufacturer

Teva Operations Poland Sp. z o.o., ul. Mogilska 80, 31-546 Krakow, Poland

Date of last revision of the leaflet: July 2017