Source: Health Products Regulatory Authority (IE) Revision Year: 2019 Publisher: Aflofarm Farmacja Polska Sp. z o.o., Partyzancka 133/151, Pabianice 95-200, Poland
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.
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 | Recommended dosing | Maximum daily dose |
|---|---|---|
| From the 1st to the 3rd day | 1 tablet every 2 hours | 6 tablets. |
| From the 4th to the 12th day | 1 tablet every 2.5 hours | 5 tablets. |
| From the 13th to the 16th day | 1 tablet every 3 hours | 4 tablets. |
| From the 17th to the 20th day | 1 tablet every 5 hours | 3 tablets. |
| From the 21st to the 25th day | 1-2 tablets a day | to 2 tablets. |
Smoking should be stopped no later than on the 5th day of treatment. Smoking should not be continued during treatment as this may aggravate adverse reactions (see section 4.4). In case of treatment failure, the treatment should be discontinued and may be resumed after 2 to 3 months.
There is no clinical experience of Asmoken in patients with renal or hepatic impairment, therefore the drug product is not recommended for use in this patient population.
Due to limited clinical experience, Asmoken is not recommended for use in elderly patients over 65 years of age.
The safety and efficacy of Asmoken in persons under 18 years of age have not been established. Asmoken is not recommended for use in persons under 18 years of age.
Asmoken should be taken orally with a suitable amount of water.
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 disturbances, clonic convulsions. In all cases of overdose, standard procedure should be taken as in acute poisoning; gastric lavage should be performedand the diuresis should be controlled with infusion fluids and diuretics. The anti-epileptic drugs, acting on the cardiovascular system and stimulating the respiration may be used, if necessary. Breathing, blood pressure and heart rate should be monitored.
18 months.
Store at temperatures below 25°C. Store in the original package in order to protect from moisture and light.
PVC/PCTFE/Aluminium blisters placed into cardboard box containing 100 tablets.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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