Ceel

INFORMATION ON INDIVIDUAL PACKAGING
CONTAINER

1. NAME OF THE MEDICINAL PRODUCT

CEEL
50 mg + 100 mg, coated tablets
Ascorbic acid + int-rac-α-Tocopheryl acetate

2. COMPOSITION OF ACTIVE SUBSTANCES

Composition:
1 tablet contains:

• active substances: 50 mg of ascorbic acid (vitamin C) and 0100 mg of all- rac - α -tocopheryl acetate (vitamin E).

3. LIST OF EXCIPIENTS

Excipients: povidone K 25, cellulose, magnesium stearate, sorbitol instant.
Coating composition: monohydrate lactose, hypromellose, triacetin, yellow iron oxide (E 172), titanium dioxide (E 171), quinoline yellow (E 104).

4. PHARMACEUTICAL FORM AND CONTENTS OF THE PACKAGE

50 tablets EAN.UCC Code: 5909990892464
60 tablets EAN.UCC Code: 5909990892471

5. METHOD AND ROUTE OF ADMINISTRATION

Method of administration and route of administration: oral administration. Children over 12 years of age and adults: 1 to 2 tablets per day. Children up to 12 years of age: according to physician's instructions.

6. WARNING ON STORAGE OF THE MEDICINAL PRODUCT

KEEP OUT OF SIGHT AND REACH OF CHILDREN
Store in a place inaccessible and not visible to children.

7. OTHER SPECIAL WARNINGS, IF NECESSARY

Warning: a desiccant is placed under the closure.
Contraindications:

• Hypersensitivity to the components of the preparation;
• Vitamin K deficiency (risk of bleeding);
• Disorders of intestinal absorption.

Precautions: use with caution in patients with a history of kidney stones, gout, cystinuria,
glucose-6-phosphate dehydrogenase deficiency, hemochromatosis, thalassemia, or
sideroblastic anemia. During prolonged concomitant use of this drug and oral anticoagulants due to
the risk of hypoprothrombinemia.
Do not increase the recommended dose without consulting a physician.
If the patient has previously experienced intolerance to certain sugars, the patient should
consult a physician before taking the medicine.
The drug may cause allergic reactions.
Pregnancy. Breast-feeding: consult a physician before use.
Driving and operating machinery: the drug does not affect psychophysical performance.
Interactions: vitamin E may enhance the effect of anticoagulant drugs. Cholestyramine and
colestipol may reduce the effectiveness of the drug. Vitamin E used simultaneously with iron
preparations may weaken their effect, especially in children with iron-deficiency anemia.

8. EXPIRY DATE

Expiry date:

9. STORAGE INSTRUCTIONS

Store below 25°C.

10. SPECIAL PRECAUTIONS FOR DISPOSAL

UNUSED MEDICINAL PRODUCT OR WASTE MATERIAL DERIVING FROM SUCH MEDICINAL PRODUCT, IF APPROPRIATE

11. NAME AND ADDRESS OF THE RESPONSIBLE ENTITY

Responsible entity:
PPF „GEMI” Grzegomp Nowakowski
Mickiewicza 36
05-480 Karczew

12. MARKETING AUTHORISATION NUMBER

Authorisation number 10624

13. BATCH NUMBER

Batch number:

14. GENERAL CATEGORY OF AVAILABILITY

Medicinal product available without a doctor's prescription – OTC.

15. INSTRUCTIONS FOR USE

Indications:

• treatment of vitamin C and E deficiency;
• supportive treatment in myocardial dysfunction, ischemic heart disease;
• in diseases associated with oxidative stress.

16. INFORMATION PROVIDED IN BRAILLE SYSTEM

ceel

17. OTHER INFORMATION

Action:
The combination of vitamins C and E allows utilization of their synergistic effects, as well as the protective action of vitamin C on vitamin E. Vitamin E protects other vitamins, especially vitamin A, as well as hormones and enzymes, against oxidation. It prevents excessive oxidation of lipids and unsaturated fatty acids, thus exerting a protective effect on body cells. It also modulates prostaglandin biosynthesis and platelet aggregation. Vitamin E is also attributed an important role in protecting the body against the harmful effects of free radicals and lipid peroxides.
Vitamin C is a compound essential for redox processes, synthesis of catecholamines, and other metabolic transformations occurring in body cells.
C may have a supportive effect in the treatment of patients with elevated LDL cholesterol levels, especially after myocardial infarction.

Undesirable effects: Tolerance of vitamin E is good. When recommended doses are exceeded, the following may occur: feeling of fatigue, weakness, headache, nausea, diarrhea, flatulence, rash.
Vitamin C is present in the CEEL medicinal product at a dose twice lower than the recommended daily intake, and therefore adverse effects related to its content are unlikely.
If any adverse reactions occur, including any adverse reactions not listed in this package leaflet, please inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 4921 301
Fax: +48 22 4921 309
e-mail: [email protected]
Reporting of adverse reactions enables collection of further information on the safety of the medicinal product.

MINIMUM INFORMATION TO BE DISPLAYED ON SMALL IMMEDIATE PACKAGING
BLISTER

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION

Ceel
50 mg + 100 mg, coated tablets
Acidum ascorbicum + int-rac-α-Tocopherylis acetas
2. ROUTE OF ADMINISTRATION
3. EXPIRY DATE
4. BATCH NUMBER, DONATION CODES AND PRODUCT CODES
Batch number and expiry date: on the blister

5. CONTENTS OF THE PACKAGE WITH QUANTITY, VOLUME OR NUMBER OF UNITS

UNITS

6. OTHER

Pharmaceutical Production Enterprise "GEMI" Grzegorz Nowakowski
Mickiewicza 36, 05-480 Karczew