Rutinoscorbin

Package Leaflet: Information for the Patient

Rutinoscorbin

25 mg + 100 mg coated tablets

Rutoside trihydrate + Ascorbic acid

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

This medicine should always be used exactly as described in the package leaflet for the patient 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 and what is it used for
• 2. Important information before using Rutinoscorbin
• 3. How to use Rutinoscorbin
• 4. Possible side effects
• 5. How to store Rutinoscorbin
• 6. Package contents and other information

1. What is Rutinoscorbin and what is it used for

Rutinoscorbin is a medicine with a combined action of rutoside and vitamin C (ascorbic acid).
Rutoside strengthens blood vessels and reduces their permeability. It also protects vitamin C from oxidation, allowing it to retain its properties for longer.
Vitamin C has an antioxidant effect. It is essential in many metabolic processes, including the formation of collagen and hemoglobin, and facilitates iron absorption.

Indications for use:

• in cases of vitamin C deficiency and increased demand (colds, viral infections, including flu);
• as an auxiliary agent in cases of excessive vascular permeability.

2. Important information before using Rutinoscorbin

When not to use Rutinoscorbin

Rutinoscorbin should not be used if the patient has:

• an allergy (hypersensitivity) to rutoside and ascorbic acid (vitamin C) or any other component of this medicine (listed in section 6);
• oxalate kidney stones (a disease characterized by the formation of stones in the kidneys) or a history of such condition;
• 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 higher than recommended should not be used.
Before starting to use Rutinoscorbin, the patient should discuss it with their doctor or pharmacist:

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

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

• excessive oxalate excretion;
• uric acid kidney stones (a disease characterized by the formation of stones in the urinary system);
• gout (a chronic disease related to uric acid metabolism disorders);
• cystinuria (a metabolic disorder);
• hypokalemia (low potassium levels in the blood);
• hypercalcemia (high calcium levels in the blood).

Children

In children under 6 years of age, Rutinoscorbin should be used as directed by a doctor.

Effect on laboratory test results

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

Rutinoscorbin and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those available without a prescription.
The vitamin C contained in the medicine:

• increases the absorption of metal compounds (mainly iron);
• increases the absorption of aluminum (a component of antacids, used, for example, in the treatment of heartburn and indigestion). If the patient is taking vitamin C, they should not use antacids, especially if they have kidney disease;
• when used with deferoxamine (a medicine used in iron overdose, helping to remove excess iron from the body), it may have an adverse effect on the heart at an early stage of treatment;
• may enhance the adverse effect of acetylsalicylic acid (aspirin) on the stomach. In turn, acetylsalicylic acid may disrupt the absorption of ascorbic acid;
• enhances the effect of paracetamol and coumarin anticoagulant medicines (e.g., acenocoumarol);
• reduces the effectiveness of disulfiram (a medicine used in the treatment of alcoholism);
• when used with sulfonamides (antibacterial medicines), it may cause the formation of their crystals in urine;
• when used for a long time in high doses, it may affect the excretion of certain medicines (e.g., tricyclic antidepressants, such as imipramine, amitriptyline).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their 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 using machines

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

3. How to use Rutinoscorbin

This medicine should always be used exactly as described in the package leaflet for the patient or as directed by a doctor or pharmacist.
In case of doubt, the patient should consult their doctor or pharmacist.
Doses higher than recommended should not be used.
The medicine is taken orally. The recommended dose is:

• prophylactically: 1 to 2 tablets per day;
• in cases of vitamin C deficiency: 1 to 2 tablets 2 to 4 times a day.

Use in children

In children under 6 years of age, Rutinoscorbin should be used as directed by a doctor.
Patients with kidney diseasesshould not take more than 5 tablets per day (equivalent to 500 mg of vitamin C, see Warnings and precautionsin section 2).

Using a higher than recommended dose of Rutinoscorbin

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

Missing a dose of Rutinoscorbin

A double dose should not be used 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.
When using doses of vitamin C higher than 600 mg per day, side effects may occur:
Very rare side effects(less than 1 in 10,000 patients):

• allergic reactions, including hypersensitivity reactions (shortness of breath, face, lip, tongue, or throat swelling, 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 high doses of vitamin C (over 10 g per day) may cause electrolyte disorders, hemolysis (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 using Rutinoscorbin and consult their doctor.

Reporting side effects

If any side effects occur, including any possible side effects not listed in the leaflet, the patient should inform their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the 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. Website: https://smz.ezdrowie.gov.pl
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 Rutinoscorbin

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C.
Store in the original packaging to protect from light and moisture.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste containers. 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 contains

• The active substances of the medicine are: rutoside and ascorbic acid (vitamin C). One tablet contains 25 mg of rutoside and 100 mg of ascorbic acid.
• The other ingredients of the medicine are: lactose monohydrate, potato starch, sucrose, polyvinyl alcohol, talc, magnesium stearate. The tablet coating contains: Opadry II 85F32876 Yellow (polyvinyl alcohol, macrogol 4000, titanium dioxide (E171), talc, quinoline yellow aluminum lake).

What Rutinoscorbin looks like and what the package contains

Rutinoscorbin is a yellow, round, biconvex tablet.
Packages containing 20, 30, 60, 90, 120, 150, 180, or 210 tablets are available.

Marketing authorization holder

Haleon Poland Sp. z o.o.
ul. Rzymowskiego 53
02-697 Warsaw
tel. 800 702 849

Manufacturer

Delpharm Poznań S.A.
ul. Grunwaldzka 189
60-322 Poznań
To obtain more detailed information, the patient should contact the representative of the marketing authorization holder.

Date of the last update of the leaflet: November 2023