ASMOKEN Tablet (2019)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Asmoken 1.5 mg tablets.

2. Qualitative and quantitative composition

Each tablet contains 1.5 mg of cytisine. For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Tablet. Round, biconvex, white tablet with diameter 6 mm.

4.1. Therapeutic indications

Smoking cessation and reduction of nicotine cravings in smokers who are willing to stop smoking. The treatment goal of Asmoken is the permanent cessation of the nicotine‑containing products use.

4.2. Posology and method of administration

Posology One package of Asmoken (100 tablets) is sufficient for a complete treatment course. The duration of therapy is 25 days. Asmoken should be taken according to the following schedule: Days of treatment ...

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, Unstable angina, A history of recent myocardial infarction, Clinically signific antarrhythmias, A history of ...

4.4. Special warnings and precautions for use

Asmoken should be taken only by those with a serious intention of weaning off nicotine. Patient should be aware, that the simultaneous administration of the drug and smoking or use of products containing ...

4.5. Interaction with other medicinal products and other forms of interaction

Asmoken should not be used with anti-tuberculosis drugs. No other clinical data on significant interaction with other drugs. Patient should be aware, that the simultaneous administration of the drug and ...

4.6. Fertility, pregnancy and lactation

Pregnancy There are no or limited amount of data from the use of cytisine in pregnant women. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). Asmoken is contraindicated ...

4.7. Effects on ability to drive and use machines

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

4.8. Undesirable effects

The clinical studies and previous experience with use of cytisine-containing product indicate a good tolerability of cytisine. The proportion of patients who discontinued treatment because adverse reactions ...

4.9. Overdose

Symptoms of nicotine intoxication are observed in Asmoken overdose. Symptoms of overdose include malaise, nausea, vomiting, increased heart rate, blood pressure fluctuations, breathing disorders, visual ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: drugs used in nicotine dependence ATC code: N07BA04 The use of Asmoken allows for a gradual reduction of nicotine dependence by relieving withdrawal symptoms. The ...

5.2. Pharmacokinetic properties

Pharmacokinetics in animals After oral administration of labeled cytisine in mice at a dose of 2 mg/kg, 42% of the administered dose was absorbed. The maximum concentration of cytisine in the blood was ...

5.3. Preclinical safety data

Non-clinical data reveal no special hazard for humans based on non-GLP studies of repeat dose toxicity, genotoxicity and toxicity to reproduction and development. Repeat dose toxicity studies in mice, ...

6.1. List of excipients

Mannitol Microcrystalline cellulose Magnesiumstearate Glycerol dibehenate Hypromellose

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

18 months.

6.4. Special precautions for storage

Store at temperatures below 25°C. Store in the original package in order to protect from moisture and light.

6.5. Nature and contents of container

PVC/PCTFE/Aluminium blisters placed into cardboard box containing 100 tablets.

6.6. Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7. Marketing authorization holder

Aflofarm Farmacja Polska Sp. z o.o., Partyzancka 133/151, Pabianice 95-200, Poland

8. Marketing authorization number(s)

PA22714/001/001

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 5th March 2018

10. Date of revision of the text

September 2019

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