Cefecon^® N (Suppositories) Instructions for Use

Marketing Authorization Holder

Nizhpharm JSC (Russia)

Contact Information

NIZHPHARM group of companies (Russia)

ATC Code

N02BA55 (Salicylamide in combination with other drugs, excluding psycholeptics)

Active Substances

Caffeine (Ph.Eur. European Pharmacopoeia)

Naproxen (Rec.INN WHO registered)

Salicylamide (Rec.INN WHO registered)

Dosage Form

Cefecon® N

Rectal suppositories: 10 pcs.

Dosage Form, Packaging, and Composition

Rectal suppositories white or white with a yellowish or creamy tint, torpedo-shaped; the appearance of a coating on the surface of the suppository and the presence of an air rod and a funnel-shaped depression on the cut are allowed.

Excipients: solid fat – to obtain a suppository weighing 2.2 g.

5 pcs. – contour cell packs (2) – cardboard packs.

Clinical-Pharmacological Group

NSAIDs of combined composition

Pharmacotherapeutic Group

Analgesics; other analgesics and antipyretics; salicylic acid and its derivatives

Pharmacological Action

Combined drug. It has analgesic, antipyretic and anti-inflammatory effects.

Naproxen and Salicylamide are NSAIDs, the mechanism of action of which is associated with the inhibition of prostaglandin synthesis and an effect on the thermoregulation center in the hypothalamus.

Caffeine has a psychostimulant, analeptic, antispasmodic effect on smooth muscles, reduces platelet aggregation and releases histamine from mast cells.

Pharmacokinetics

Data on the pharmacokinetics of the drug Cefecon^® N are not provided.

Indications

As an analgesic for mild to moderate pain syndrome

• Neuralgia;
• Myalgia;
• Sciatica;
• Lumbago;
• Degenerative-dystrophic diseases of the musculoskeletal system (osteochondrosis, osteoarthritis, ankylosing spondylitis);
• Headache, migraine;
• Toothache;
• Primary dysmenorrhea.

As an antipyretic

• Febrile syndrome in colds, infectious and inflammatory diseases.

ICD codes

Dosage Regimen

Administer the drug only after a spontaneous bowel movement or a cleansing enema.

Use one suppository rectally one to three times per day.

Insert the suppository deeply into the rectum.

Remain in a supine position for 30 to 40 minutes after insertion.

For analgesic purposes, the duration of treatment must not exceed 5 days.

For antipyretic purposes, the duration of treatment must not exceed 3 days.

Do not exceed the maximum daily dosage.

Discontinue use if symptoms persist or worsen.

This medication is contraindicated in patients under 16 years of age.

Consult a physician before use in patients with pre-existing medical conditions or those taking other medications.

Adverse Reactions

From the central nervous system dizziness, agitation, drowsiness, tinnitus, dizziness, slowing of psychomotor reactions.

From the hematopoietic system thrombocytopenia, granulocytopenia, aplastic anemia.

From the cardiovascular system rarely – tachycardia, increased blood pressure.

Local reactions itching and pain in the rectum.

Other allergic reactions, impaired liver function, impaired renal function.

Side effects are mild and do not require discontinuation of therapy or any medical manipulations.

Contraindications

• Gastric and duodenal ulcers in the acute phase;
• Bleeding tendency;
• Severe renal or hepatic impairment;
• Arterial hypertension;
• Organic diseases of the cardiovascular system;
• Chronic heart failure;
• Increased excitability;
• Insomnia;
• Closed-angle glaucoma;
• Bronchospasm (including that caused by taking NSAIDs);
• Old age;
• Children and adolescents under 16 years of age;
• Pregnancy;
• Lactation (breastfeeding);
• Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

Cefecon^® N is contraindicated for use during pregnancy and lactation.

Use in Hepatic Impairment

Contraindicated in severe hepatic impairment.

Use in Renal Impairment

Contraindicated in severe renal impairment.

Pediatric Use

The drug is contraindicated in children and adolescents under 16 years of age.

Geriatric Use

The drug is contraindicated in elderly patients.

Special Precautions

If itching and discomfort in the rectum appear during the use of the drug, warm sunflower oil in the amount of 1 tablespoon should be injected into the rectum in the form of an enema and the use of the drug should be temporarily stopped.

Overdose

Data on overdose of the drug Cefecon^® N are not provided.

Drug Interactions

With simultaneous use with Cefecon N, the hypotensive effect of beta-blockers and ACE inhibitors is reduced and the pharmacological effect of anticoagulants and sulfonylurea derivatives is enhanced.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 2 years.

Dispensing Status

The drug is approved for use as an over-the-counter product.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.