Package leaflet: Information for the patient

CERUTIN, 100 mg + 25 mg, coated tablets
Acidum ascorbicum + Rutosidum trihydricum
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
the doctor or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, please consult your pharmacist.
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after several days, or if the patient feels worse, consult a doctor.

Contents of the leaflet

What Cerutin is and what it is used for
Important information before taking Cerutin
How to take Cerutin
Possible side effects
How to store Cerutin
Contents of the pack and other information

1. What Cerutin is and what it is used for

Rutin and ascorbic acid (vitamin C) reduce permeability and strengthen the walls of blood vessels.
Rutosid prolongs the action of vitamin C by delaying its oxidation.
The medicine is indicated for:
conditions of deficiency of vitamin C and rutin – supporting the body's immunity;
strengthening capillary walls – preventing colds and alleviating flu symptoms.

2. Important information before using Cerutin

When not to use Cerutin:

if the patient is allergic to the active substances or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Cerutin, consult a doctor or pharmacist.
This medicine should be used with caution in patients with disorders of hemoglobin synthesis and in those with hemochromatosis. Do not use simultaneously with sulfathiazole. High doses of vitamin C may increase excretion of oxalic acid, and may lead to gout, uric acid stones, cystinuria, hypokalemia, and hypercalcemia.
Cerutin with other medicines
Inform your doctor or pharmacist about all medicines currently used or recently taken, as well as any medicines you plan to take.
Enhanced effect and toxicity of oral anticoagulants of the warfarin type and sulfonamides (including risk of crystalluria). Vitamin C in doses exceeding 1 g per day may reduce the effectiveness of tricyclic antidepressants and aminoglycosides. Long-term use of rutin may enhance the effect of non-steroidal anti-inflammatory drugs. Vitamin C increases intestinal absorption of iron.
High doses of acetylsalicylic acid reduce the concentration of ascorbic acid in platelets and plasma.
Pregnancy and breastfeeding
During pregnancy or breastfeeding, or if pregnancy is suspected or planned, consult a doctor or pharmacist before using this medicine.
Safety of use of this medicine in pregnant women has not been established.
Driving and operating machinery
This medicine does not impair psycho-physical performance, ability to drive or operate machinery.
Cerutin contains lactose
This medicine contains lactose (one coated tablet contains 1.90 mg of lactose). If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Cerutin

Orally.
This medicine should always be taken according to the instructions in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Adults
Prophylactically: 1 to 2 tablets per day
In vitamin C deficiency states: 1 to 2 tablets 2 to 4 times per day
Children and adolescents
Prophylactically: up to 12 years of age: 1 tablet per day
from 12 to 18 years of age: 1 to 2 tablets per day
In vitamin C deficiency states: up to 12 years of age: 1 to 2 tablets twice per day
from 12 to 18 years of age: 1 to 2 tablets 2 to 4 times per day
Should be used only in children who are able to swallow a tablet.
Use of a higher than recommended dose of Cerutin
No cases of overdose with rutin and ascorbic acid have been reported.
Missed dose of Cerutin
Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine may cause adverse reactions, although not everybody gets them.

High doses of vitamin C (more than 500 mg per day) have a diuretic effect and may
cause acidification of urine, leading to crystallization of calcium oxalates, urates,
and calcium citrates in the urinary tract. After using high doses of vitamin C, the following may also occur:
nausea; vomiting; indigestion; diarrhea; rash; headache.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: 22 49-21-301,
Fax: 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting of adverse reactions enables continuous monitoring of the benefit-risk balance of the medicinal product.

5. How to store Cerutin

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 and blister pack following the
"EXP" label. The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Cerutin contains
The active substances in Cerutin are ascorbic acid and trihydrated rutin. Each tablet contains 100 mg of ascorbic acid and 25 mg of trihydrated rutin.
The other ingredients are: microcrystalline cellulose, maize starch, povidone, magnesium stearate.
Coating: monohydrate lactose, hypromellose, titanium dioxide (E 171), macrogol 6000, yellow iron oxide (E 172).
What Cerutin looks like and contents of the pack
Cerutin is in the form of film-coated tablets. The tablets are yellow, round, and biconvex.
The pack contains 25, 100, 125 or 150 tablets in blisters.
Marketing authorisation holder and manufacturer
Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Tel.: (24) 357 44 44
Fax: (24) 357 45 45
e-mail: [email protected]