Cytisine Adamed
Italy
Table of Contents
Package leaflet: Information for the user
Citisiniclina Adamed 1.5 mg film-coated tablets
cytisine
Equivalent medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
- If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What Citisiniclina Adamed is and what it is used for
- What you need to know before taking Citisiniclina Adamed
- How to take Citisiniclina Adamed
- Possible side effects
- How to store Citisiniclina Adamed
- Contents of the pack and other information
1. What Citisiniclina Adamed is and what it is used for
Citisiniclina Adamed contains the active substance citisiniclina.
This medicinal product is used to stop smoking and to reduce nicotine craving in smokers who decide to quit smoking. The aim of treatment with Citisiniclina Adamed is the permanent discontinuation of nicotine-containing products.
The use of Citisiniclina Adamed helps gradually reduce nicotine dependence without experiencing nicotine withdrawal symptoms (e.g. depressed mood, irritability, anxiety, difficulty concentrating, insomnia, increased appetite).
2. What you need to know before using Citisiniclina Adamed
Do not use Citisiniclina Adamed:
- if you are allergic to cytisine or to any of the other ingredients of this medicine (listed in section 6);
- if you have unstable angina;
- if you have recently had a myocardial infarction;
- if you suffer from clinically significant cardiac arrhythmias;
- if you have recently had a stroke;
- if you are pregnant or breastfeeding.
Warnings and precautions
Citisiniclina Adamed should be used with caution if you have:
ischaemic heart disease,
heart failure,
hypertension,
pheochromocytoma (a tumour of the adrenal gland),
atherosclerosis (hardening of the arteries) or other peripheral vascular diseases,
gastric or duodenal ulcer,
gastro-oesophageal reflux disease,
hyperthyroidism (overactive thyroid),
diabetes,
schizophrenia,
renal or hepatic impairment.
Citisiniclina Adamed should only be taken by individuals who are seriously intending to quit nicotine. Continuing to smoke while taking Citisiniclina Adamed may lead to aggravated nicotine-related adverse effects.
If you are a woman of childbearing potential, you must use effective contraceptive methods. See also section “Pregnancy and breastfeeding”.
Children and adolescents
Due to limited clinical experience, the use of Citisiniclina Adamed is not recommended in individuals under 18 years of age.
Elderly population
Due to limited clinical experience, the use of Citisiniclina Adamed is not recommended in individuals over 65 years of age.
Patients with renal or hepatic impairment
There is no clinical experience with Citisiniclina Adamed in patients with renal or hepatic impairment; therefore, use of this product is not recommended in these patients.
Other medicines and Citisiniclina Adamed
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Citisiniclina Adamed with anti-tuberculosis drugs.
In some cases, when stopping smoking, with or without Citisiniclina Adamed, a dose adjustment of other medicines may be necessary. This is particularly important if you are taking other medicines containing theophylline (for the treatment of asthma), tacrine (for Alzheimer's disease), clozapine (for schizophrenia), or ropinirole (for the treatment of Parkinson's disease). If in doubt, consult your doctor or pharmacist.
It is currently unknown whether Citisiniclina Adamed may reduce the effectiveness of systemic hormonal contraceptives. If you are using systemic hormonal contraceptives, you must add a second barrier contraceptive method (e.g. condom).
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Contraception in women
If you are a woman of childbearing potential, you must use effective contraceptive methods.
It is currently unknown whether Citisiniclina Adamed may reduce the effectiveness of systemic hormonal contraceptives. If you are using systemic hormonal contraceptives, you must add a second barrier contraceptive method (e.g. condom).
Please consult your doctor.
Pregnancy and breastfeeding
Citisiniclina Adamed must not be used during pregnancy or breastfeeding.
Driving and use of machinery
Citisiniclina Adamed does not affect the ability to drive vehicles or operate machinery.
Stopping smoking
The effects of changes in your body when stopping smoking, with or without Citisiniclina Adamed, may alter the action of other medicines. Therefore, in some cases a dose adjustment may be necessary. See section “Other medicines and Citisiniclina Adamed” for further details.
For some people, quitting smoking, with or without treatment, has been associated with an increased risk of experiencing changes in thinking or behaviour, feelings of depression and anxiety (including, rarely, suicidal ideation and suicide attempts), and may be associated with a worsening of psychiatric disorders. If you have a history of psychiatric disorders, you should discuss this with your doctor.
Citisiniclina Adamed contains aspartame
This medicine contains 0.12 mg of aspartame per film-coated tablet. Aspartame is a source of phenylalanine. It may be harmful if you suffer from phenylketonuria, a rare genetic disorder causing accumulation of phenylalanine because the body cannot properly eliminate it.
3. How to use Citisiniclina Adamed
Use this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
One pack of Citisiniclina Adamed (100 tablets) is sufficient for a complete course of treatment. The duration of treatment is 25 days. Citisiniclina Adamed is for oral use and must be taken with an adequate amount of water according to the following schedule:
Days of treatment Recommended dose Maximum daily dose
Days 1 to 3 1 tablet every 2 hours 6 tablets
Days 4 to 12 1 tablet every 2.5 hours 5 tablets
Days 13 to 16 1 tablet every 3 hours 4 tablets
Days 17 to 20 1 tablet every 5 hours 3 tablets
Days 21 to 25 1-2 tablets per day up to 2 tablets
The blister pack is marked with consecutive days of Citisiniclina Adamed intake.
You must stop smoking no later than the 5th day of treatment. You must not continue smoking during treatment, as this could worsen adverse reactions. If the treatment fails, it must be discontinued and may be restarted after 2-3 months.
Use in children and adolescents
The use of Citisiniclina Adamed is not recommended in patients under 18 years of age.
If you take more Citisiniclina Adamed than you should
In case of overdose with Citisiniclina Adamed, symptoms of nicotine poisoning may occur. Symptoms of overdose include malaise, nausea, vomiting, increased heart rate, fluctuations in blood pressure, breathing difficulties, blurred vision, and seizures.
If you experience even one of the symptoms described, or any symptom not listed in this leaflet, stop taking Citisiniclina Adamed and contact your doctor immediately.
If you forget to take Citisiniclina Adamed
Do not take a double dose to make up for the forgotten dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody will experience them.
These side effects may occur with certain frequencies defined as follows:
Very common (may affect more than 1 in 10 users):
changes in appetite (especially increased appetite),
weight gain,
dizziness,
irritability,
mood changes,
anxiety,
increased blood pressure (hypertension),
dry mouth,
diarrhoea,
skin rash,
fatigue,
sleep disorders (insomnia, drowsiness, lethargy, abnormal dreams, nightmares),
headache,
increased heart rate,
nausea,
altered taste,
heartburn,
constipation,
vomiting,
abdominal pain (especially upper abdomen),
muscle pain.
Common (may affect from 1 to 10 in 100 users):
difficulty concentrating,
slow heart rate,
abdominal distension,
burning sensation of the tongue,
malaise.
Uncommon (may affect from 1 to 10 in 1,000 users):
feeling of heaviness in the head,
decreased libido,
lacrimation, dyspnoea,
increased sputum production,
excessive salivation,
sweating,
reduced skin elasticity,
tiredness,
increased serum transaminase levels.
The majority of the side effects listed above occur at the beginning of treatment and resolve during the course of treatment. These symptoms might also be due to smoking cessation (withdrawal symptoms), rather than treatment with Citisiniclina Adamed.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website: http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Citisiniclina Adamed
Keep this medicine out of the sight and reach of children.
Store in the original packaging to protect the medicine from light. This medicine does not require
any special storage temperature.
Do not use this medicine after the expiry date stated on the packaging and blister after Exp.. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What Citisiniclina Adamed contains
- The active substance is cytisine (previously used name: cytisine). Each film-coated tablet contains 1.5 mg of cytisine.
- The other components are: Tablet core: Hypromellose, mannitol, maize starch, magnesium aluminium metasilicate, colloidal anhydrous silica, magnesium stearate. Coating: Hypromellose (E464), microcrystalline cellulose (E460), talc (E553b), glycerol (E422), titanium dioxide (E171), quinoline yellow aluminium lake (E104), indigo carmine (blue 2) aluminium lake (E132), menthol flavour powder, aspartame (E951). See section 2 "Citisiniclina Adamed contains aspartame".
Description of the appearance of Citisiniclina Adamed and contents of the pack
Round, biconvex, film-coated tablets in light green or greenish colour, with a diameter of 5 mm.
Citisiniclina Adamed is available in blisters containing 100 film-coated tablets.
Marketing Authorization Holder
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland
Manufacturer
Adamed Pharma S.A.
ul. Marszałka J. Piłsudskiego 5
95-200 Pabianice, Poland
This medicinal product is authorized in the European Economic Area countries under the following names:
Germany: Cytisiniclin Adamed
Poland: Cytisinicline Adamed
Sweden: Belnifrem
Italy: Citisiniclina Adamed
Ireland: Cytisinicline Adamed Pharma 1.5 mg film-coated tablets
Spain: Belnifrem 1,5 mg comprimidos recubiertos con película EFG