Box Please read this leaflet carefully before using this medicine. It contains important information for your treatment. If you have any further questions or doubts, ask your doctor or pharmacist for more information. - Keep this leaflet as you may need to read it again. - If you need more information or advice, ask your pharmacist. - If symptoms worsen or persist, consult your doctor. - If you notice any side effects not mentioned in this leaflet, or if you experience any of the effects mentioned as serious, please tell your doctor or pharmacist.
1. WHAT IS NICOTINELL TTS 7 mg/24 H, transdermal device AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: DRUGS USED IN NICOTINE DEPENDENCE.
Therapeutic indications
This medicine is indicated for the treatment of tobacco dependence in order to relieve the symptoms of nicotine withdrawal in subjects wishing to stop smoking.
2. WHAT DO YOU NEED TO KNOW BEFORE USING NICOTINELL TTS 7 mg/24 H, transdermal device?
List of information needed before taking the medicine Not applicable. Contraindications Never use NICOTINELL TTS 7 mg/24 h, transdermal device - if you do not smoke or if you are an occasional smoker, - if you are allergic (hypersensitive) to nicotine or to any of the components contained in this medicine, as mentioned in section 6. - if you suffer from a skin condition that may interfere with the use of a transdermal system. If in doubt, ask your doctor or pharmacist for advice. Precautions for use; special warnings To succeed in stopping smoking, it is essential to stop smoking completely. Read the health education advice carefully. You should consult a doctor before using NICOTINELL TTS 7 mg/24 h, transdermal device in case of recent myocardial infarction (heart attack), unstable or worsening angina pectoris, including Prinzmetal's angina, serious heart rhythm disorders, uncontrolled high blood pressure, recent stroke.
You should seek the advice of your doctor or healthcare professional before using NICOTINELL TTS, transdermal device: - in case of stable cardiovascular disease, severe arterial hypertension or heart failure, - in case of cerebrovascular disorder or arteritis of the lower limbs, - in case of diabetes, - in case of hyperthyroidism or pheochromocytoma (adrenal gland disease leading to severe arterial hypertension), - in case of severe liver or kidney disease, - in case of evolving stomach or duodenal ulcer, - in case of skin disease. The therapeutic dose intended for adults could cause serious or even fatal poisoning in children. This is why you should always keep the transdermal device out of the reach and sight of children before and after use. After use, it is advisable to fold the transdermal device onto itself before disposing of it. IF IN DOUBT, DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE. Interactions with other medicines Other medicines and NICOTINELL TTS 7 mg/24 h, transdermal device: Tell your doctor or pharmacist if you are using, have recently used or may use any other medicines. Interactions with food and drink Not applicable. Interactions with herbal products or alternative therapies Not applicable.
Pregnancy and breastfeeding
It is very important for you and your child to stop smoking during pregnancy. Stopping smoking during pregnancy requires medical advice and monitoring. You should therefore consult the doctor who is following your pregnancy or your usual doctor, or a doctor at a centre specialising in smoking cessation. Breast-feeding If you are a heavy smoker and do not intend to stop smoking, you should not breast-feed your child, but should resort to artificial breast-feeding. The use of this medicine is not recommended while breast-feeding. However, if you wish to stop smoking and breast-feed your child, seek the advice of your doctor or a doctor at a centre specialising in smoking cessation. Sportsmen and women Not applicable. Effects on ability to drive vehicles or use machines Not applicable.
List of excipients with a notable effect
Important information about the ingredients of Nicotinell TTS 7 mg/24 h, transdermal device The NICOTINELL TTS transdermal device contains aluminium. Therefore, you must remove it before any MRI (magnetic resonance imaging) scan.
3. HOW DO I USE NICOTINELL TTS 7 mg/24 H, transdermal device?
Dosage
For adults and adolescents over 15 years of age.
Treatment is divided into 3 periods: - Initial period: this lasts 3 to 4 weeks and will enable you to stop smoking. - Treatment follow-up: this period consolidates smoking cessation and begins nicotine withdrawal - Therapeutic withdrawal: this period should enable you to stop taking the treatment. The entire treatment lasts an average of 3 months.
Method of administration
TRANSDERMAL ROUTE - Open the sachet with a pair of scissors and remove the transdermal device. - Remove the pre-cut protective sheet. - Immediately after opening, apply NICOTINELL TTS to a dry area of skin, free from skin lesions and where there is little hair growth: trunk, upper arm, etc. - To ensure perfect adhesion, press firmly over the entire surface for approximately 10 seconds with the palm of the hand. - The device should remain in place for 24 hours. - The application site should be changed every day, if possible avoiding putting the device back in the same place for a few days. - It is essential to fold the device on itself after use before disposing of it in a safe place. - Any device, whether used or not, should be kept out of the reach of children. - During handling, avoid contact with the eyes and nose and wash your hands after application. - Do not cut the transdermal device. - If you are going to be in the sea or swimming pool for a prolonged period, you have 2 options: o Before bathing, remove the transdermal device and immediately replace it in its holder. It can then be re-adhered to well-dried skin. o Cover the transdermal device with a waterproof adhesive dressing for the duration of the bath. - In the event of a short shower, the transdermal device can be held in place by avoiding directing the shower jet at it.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of undesirable effects Like all medicines, this medicine may cause undesirable effects, but they do not occur systematically in everyone. Some side effects may be serious5. HOW DO I USE NICOTINELL TTS 7 mg/24 H, transdermal device?
Keep out of the reach and sight of children. Expiry date Do not use NICOTINELL TTS 7 mg/24 H, transdermal device after the expiry date stated on the box. Storage conditions Store at a temperature below 25°C, only in the sealed sachets. If necessary, warnings against certain visible signs of deterioration Medicines must not be disposed of down the drain or with household waste. Ask your pharmacist what to do with unused medicines. These measures will help to protect the environment.
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