Rutinoscorbin Plus

Leaflet attached to the packaging: patient information

Rutinoscorbin Plus

coated tablets

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 or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. 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 Rutinoscorbin Plus and what is it used for
• 2. Important information before taking Rutinoscorbin Plus
• 3. How to take Rutinoscorbin Plus
• 4. Possible side effects
• 5. How to store Rutinoscorbin Plus
• 6. Package contents and other information

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

Rutinoscorbin Plus is a medicine with a combined action of vitamin C, rutin, zinc, and selenium.
These substances have, among other things, antioxidant properties, which help protect cells from the harmful effects of free radicals.

Indications for use

States of deficiency or increased demand for vitamin C, rutin, zinc, and selenium:

• prevention of colds and alleviation of flu symptoms;
• supporting the body's immunity;
• sealing and preventing the fragility of blood vessels.

2. Important information before taking Rutinoscorbin Plus

When not to take Rutinoscorbin Plus

Rutinoscorbin Plus should not be taken if the patient has:

• an allergy to the active substances or any of the other ingredients of this medicine (listed in section 6);
• kidney stones (a disease characterized by the formation of stones in the kidneys) or has had them in the past;
• diseases related to excessive iron accumulation (thalassemia, hemochromatosis, sideroblastic anemia) or other diseases that may cause an excess of iron in the body.

Warnings and precautions

Doses larger than recommended should not be taken.
Before starting to take Rutinoscorbin Plus, the patient should discuss it with their doctor or pharmacist:

• if the patient has a rare metabolic disease (erythrocyte glucose-6-phosphate dehydrogenase deficiency), which may lead to the breakdown of red blood cells and anemia;

6. if the patient has kidney function disorders. No more than 5 tablets (equivalent to 500 mg of vitamin C) should be taken per day;

• if the patient is taking sulfonamides (antibacterial drugs).

It is not recommended to take large doses of vitamin C (over 1 g) if the patient has:

• excessive excretion of oxalic acid;
• gout (a chronic disease related to uric acid metabolism disorder);
• uric acid stones (a disease characterized by the formation of stones in the urinary system);
• cystinuria (a disease characterized by the excretion of an increased amount of the amino acid cystine in the urine);
• hypokalemia (decreased potassium levels in the blood);
• hypercalcemia (elevated calcium levels in the blood).

Effect on laboratory test results

Vitamin C may affect the results of tests for sugar in urine and blood in the stool.
If such tests need to be performed, the patient should inform their doctor about taking Rutinoscorbin Plus and follow their instructions.

Rutinoscorbin Plus with food and drink

Taking dairy products may limit the absorption of the medicine (significantly reduce the absorption of selenium and zinc ions), so the medicine should be taken an hour before or two hours after consuming milk or its products.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking 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

The medicine does not affect the ability to drive or operate machinery.
Rutinoscorbin Plus contains lactose and sorbitol.If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
Rutinoscorbin Plus contains quinoline yellow,which may cause allergic reactions.

3. How to take Rutinoscorbin Plus

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
Doses larger than recommended should not be taken.
The medicine is taken orally, preferably during a meal (see section 2: "Rutinoscorbin Plus with food and drink").
The recommended dose is:

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

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

Taking a higher dose of Rutinoscorbin Plus than recommended

In case of taking a higher dose of the medicine than recommended, the patient should consult their doctor or pharmacist.
After taking very large doses, diarrhea may occur, and there is a risk of hemolysis (breakdown of red blood cells), kidney stones, water and electrolyte disorders, and significant weakening of the action of cobalamin (vitamin B12).

Missing a dose of Rutinoscorbin Plus

A double dose should not be taken to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very rare side effects(occurring in less 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, diarrhea, indigestion, abdominal pain;
• fatigue.

Other side effects

Other side effects may occur in a small number of patients, but their frequency is not known.

• skin redness;
• increased urination, kidney stones.

Very large doses of vitamin C (over 10 g per day) may cause water and electrolyte disorders, lysis (breakdown) of red blood cells, and significant weakening of the action of cobalamin (vitamin B12).
If the following symptoms are observed: nausea, vomiting, diarrhea, headache, skin redness, or increased urination, the patient should stop taking Rutinoscorbin and consult their doctor.

Reporting side effects

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

5. How to store Rutinoscorbin Plus

The medicine should be stored out of sight and reach of children.
Store at a temperature below 25°C.
Store in the original packaging to protect from light and moisture.
The medicine should not be taken after the expiry date stated on the box. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Rutinoscorbin Plus contains

• The active substances of the medicine are: rutin (25 mg), ascorbic acid (100 mg), zinc (2 mg), and selenium (8 micrograms).
• The other ingredients of the medicine are: lactose monohydrate, potato starch, sorbitol, crospovidone, talc, povidone K30, magnesium stearate, anhydrous colloidal 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 what the package contains

Rutinoscorbin Plus is a green, biconvex tablet. The medicine is available in packages containing 30 or 60 tablets.

Responsible entity:

GlaxoSmithKline Consumer Healthcare sp. z o.o.
Ul. Rzymowskiego 53
02-697 Warszawa

Manufacturer:

GlaxoSmithKline Pharmaceuticals Spółka Akcyjna
ul. Grunwaldzka 189, 60-322 Poznań
To obtain more detailed information, the patient should contact the local representative of the responsible entity.

Date of the last update of the leaflet: