Defumoxan 1.5 mg, 100 tablets, Aflofarm

Defumoxan 1.5 mg, 100 tablets, Aflofarm

Smoking cessation and reduction of nicotine craving in smokers who wish to quit.

The goal of Defumoxan treatment is to permanently stop using products containing nicotine.

Composition:

• The active substance is cytisine
• One tablet contains 1.5 mg cytisine
• The other ingredients are: mannitol (E 421), microcrystalline cellulose, magnesium stearate, glycerol dibehenate, hypromellose 3 mPas.

Mode of administration:

• One package of Defumoxan (100 tablets) is enough for a complete treatment cycle
• The duration of the treatment is 25 days
• Defumoxan should be taken according to the following schedule:
• Days 1 to 3: 1 tablet every 2 hours 6 tablets
• Days 4 to 12: 1 tablet every 2.5 hours 5 tablets
• Days from 13 to 16: 1 tablet every 3 hours 4 tablets
• Days from 17 to 20: 1 tablet every 5 hours 3 tablets
• Days 21 to 25: 1 - 2 tablets per day Up to 2 tablets
• Smoking must be stopped on the 5th day of treatment at the latest
• Smoking should not be continued during treatment, as this may worsen adverse reactions (see section 4.4)
• In case of treatment failure, the treatment should be interrupted and can be resumed after 2 - 3 months
• Defumoxan should be taken orally with an adequate amount of water.

Contraindications:

Do not use Defumoxan:

• if you are allergic to cytisine or any of the other ingredients of this medicine
• if you have unstable angina
• if you have a history of recent myocardial infarction
• if you have a clinically significant irregular heartbeat
• if you have recently had a stroke
• if you are pregnant or breast-feeding.

Precautions:

• Special groups of patients (renal insufficiency, hepatic insufficiency) - There is no clinical experience regarding the use of Defumoxan in patients with renal or hepatic insufficiency, therefore it is not recommended to use the drug in these groups of patients
• Elderly - Due to limited clinical experience, the use of Defumoxan in elderly patients over 65 years of age is not recommended.
• Children and adolescents - The safety and effectiveness of Defumoxan in people under 18 years of age have not yet been established. It is not recommended to use Defumoxan in people under 18 years of age
• Defumoxan should be used with caution in case of ischemic heart disease, heart failure, high blood pressure, pheochromocytoma (a tumor of the adrenal gland), atherosclerosis (hardening of the arteries) and other peripheral vascular diseases, gastric and duodenal ulcers, gastroesophageal reflux disease, hyperthyroidism (thyroid hyperactive), diabetes, schizophrenia, kidney and liver failure
• Defumoxan should only be taken by people who have a serious intention of weaning themselves off nicotine
• Using Defumoxan and continuing to smoke may worsen the side effects of nicotine.

Pregnancy, breast-feeding and fertility:

• If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine
• If you are a woman of childbearing potential, you must use effective methods of contraception
• Ask your doctor for recommendations
• Defumoxan is contraindicated during pregnancy and breastfeeding.

Driving vehicles and using machines:

• Defumoxan has no influence on the ability to drive and use machines.

Presentation: 100 tablets