Rutinoscorbin plus

Patient Information Leaflet

Rutinoscorbin Plus
coated tablets
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet for future reference.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement or if you feel worse, consult your doctor.

Table of Contents

1. What Rutinoscorbin Plus is and what it is used for
2. What you need to know before taking Rutinoscorbin Plus
3. How to take Rutinoscorbin Plus
4. Possible side effects
5. How to store Rutinoscorbin Plus
6. Contents of the pack and other information

1. What Rutinoscorbin Plus is and what it is used for

Rutinoscorbin Plus is a combined preparation containing vitamin C, rutoside, zinc, and selenium.
These substances have, among others, antioxidant properties, helping to protect cells against the harmful effects of free radicals.
Indications
Conditions associated with deficiency or increased requirement for vitamin C, rutin, zinc, and selenium:

• prevention of colds and relief of flu symptoms;
• supporting the body's immune system;
• strengthening and preventing fragility of capillary blood vessels.

2. Important information before using Rutinoscorbin Plus

When not to use Rutinoscorbin Plus
Do not use Rutinoscorbin Plus if the patient has:

• hypersensitivity to the active substances or any of the other components of this medicine (listed in section 6);
• oxalate kidney stones (a condition characterized by formation of deposits, so-called "stones" in the kidneys) or a history of oxalate kidney stones;
• disorders associated with excessive iron accumulation (thalassemia, hemochromatosis, sideroblastic anemia) or other conditions that may cause excess iron in the body.

Warnings and precautions
Do not use higher than recommended doses.
Before starting to use Rutinoscorbin Plus, consult a doctor or pharmacist if the patient:

• has a rare metabolic disorder (glucose-6-phosphate dehydrogenase deficiency), which may lead to breakdown of red blood cells and anemia;
• has impaired kidney function. Do not take more than 5 tablets (corresponding to 500 mg of vitamin C) per day;
• is taking sulfonamides (antibacterial agents).

High doses of vitamin C (above 1 g) are not recommended if the patient has:

• excessive excretion of oxalic acid;
• gout (a chronic disease associated with impaired metabolism of uric acid);
• uric acid kidney stones (a condition characterized by formation of deposits, so-called "stones" in the urinary tract);
• cystinuria (a disorder characterized by increased excretion of an amino acid called cystine in urine);
• hypokalemia (reduced potassium concentration in blood);
• hypercalcemia (increased calcium concentration in blood).

Effect on laboratory test results
Vitamin C may affect test results for glucose in urine and occult blood in stool.
If such tests are necessary, inform the doctor about the use of Rutinoscorbin Plus and follow his or her instructions.

Rutinoscorbin Plus and other medicines
Inform the doctor or pharmacist about all medicines currently used, recently used, or planned to be used.
In particular, inform the doctor about taking the following medicines:

• coumarin anticoagulants (e.g. acenocoumarol) and paracetamol, as Rutinoscorbin Plus enhances their effect;
• iron-containing preparations and other metals, as Rutinoscorbin Plus may increase their absorption;
• acetylsalicylic acid-containing preparations (aspirin), as Rutinoscorbin Plus may intensify the adverse effects of acetylsalicylic acid on the stomach. Conversely, acetylsalicylic acid may impair the absorption of ascorbic acid;
• deferoxamine, as Rutinoscorbin Plus reduces its effect and may increase iron toxicity to the heart muscle;
• disulfiram, as Rutinoscorbin Plus reduces its efficacy in alcoholism treatment;
• acidic or basic drugs (e.g. tricyclic antidepressants), as Rutinoscorbin Plus may affect their action;
• antacids containing aluminium, as Rutinoscorbin Plus may increase aluminium absorption;
• sulfonamides, which when used together with Rutinoscorbin Plus may lead to crystallization of sulfonamides in urine.

Rutinoscorbin Plus with food and drink
Consumption of dairy products may reduce the absorption of the medicine (significantly decrease selenium and zinc ion uptake). Therefore, the medicine should be taken one hour before or two hours after consuming milk or milk products.

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 or pharmacist before using this medicine.
Vitamin C passes into breast milk and crosses the placental barrier.
The safety of use during pregnancy and breastfeeding has not been established.

Driving and operating machinery
This medicine does not affect the ability to drive vehicles or operate machinery.

Rutinoscorbin Plus contains lactose and sorbitol. If the patient has previously been diagnosed with intolerance to certain sugars, he or she should consult a doctor before taking this medicine.

Rutinoscorbin Plus contains quinoline yellow, which may cause allergic reactions.

3. How to use Rutinoscorbin Plus

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Do not take higher doses than recommended.
The medicine should be taken orally, preferably during a meal (see section 2: "Rutinoscorbin Plus with food and drink").

Recommended dose:
Adults and adolescents over 12 years of age:

• for prophylaxis: 1 to 2 tablets per day;
• in deficiency states: 1 to 2 tablets, 2 to 4 times per day.

Patients with kidney disease should not take more than 5 tablets per day (corresponding to 500 mg of vitamin C, see Warnings and precautions in section 2).

Taking more Rutinoscorbin Plus than recommended
If you have taken more medicine than recommended, consult a doctor or pharmacist immediately.
After taking very large doses, diarrhoea may occur. There is a risk of haemolysis (breakdown of red blood cells), kidney stone formation, water and electrolyte imbalances, and significant reduction in the activity of cobalamin (vitamin B12).

Missing a dose of Rutinoscorbin Plus
Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
Very rare adverse reactions (occurring in no more than 1 in 10,000 patients):

• allergic reactions, including hypersensitivity reactions (shortness of breath, swelling of the face, lips, tongue or throat, skin rash, itching);
• headache, dizziness;
• vomiting, nausea, diarrhoea, indigestion, abdominal pain;
• fatigue.

Other adverse reactions
Other adverse reactions may occur in a small number of patients, but their frequency is unknown.

• skin redness;
• increased urination, kidney stones.

Very high doses of vitamin C (more than 10 g per day) may cause water and electrolyte disturbances, haemolysis (breakdown of red blood cells), and significant reduction in the activity of cobalamin (vitamin B12).
If any of the following symptoms occur: nausea, vomiting, diarrhoea, headache, skin redness or increased urination, use of Rutinoscorbin should be stopped immediately and a doctor should be consulted.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, e-mail: [email protected].
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Rutinoscorbin Plus

Keep the medicine out of sight and reach of children.
Store below 25°C.
Keep in the original packaging to protect from light and moisture.
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 the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Rutinoscorbin Plus contains

• The active substances in the medicine are: rutoside (25 mg), ascorbic acid (100 mg), zinc (2 mg), and selenium (8 micrograms).
• Other ingredients of the medicine are: lactose monohydrate, potato starch, sorbitol, crospovidone, talc, povidone K30, magnesium stearate, colloidal anhydrous silica.
• The coating contains: hypromellose, titanium dioxide (E 171), talc, macrogol 6000, acesulfame K, quinoline yellow (E 104), indigo carmine (E 132).

What Rutinoscorbin Plus looks like and contents of the pack
Rutinoscorbin Plus is in the form of green, biconvex tablets. It is available in packs containing 30 or 60 tablets.
Marketing Authorisation Holder:
GlaxoSmithKline Consumer Healthcare sp. z o.o.
Rzymowskiego 53 Street
02-697 Warsaw
Manufacturer:
GlaxoSmithKline Pharmaceuticals Spółka Akcyjna
Grunwaldzka 189 Street, 60-322 Poznań
For further information, please contact the local representative of the Marketing Authorisation Holder.