Savings set: Nicorette Entry for strong smokers, pcs

Important notes (compulsory information):

Nicorette TX patch 25 mg. Active substance: Nicotine. Areas of application: for the treatment of tobacco dependence by relieving the withdrawal symptoms.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


This set consists of:

• 2 x Nicorette TX patch 25 mg, 14 pcs

Leaflet: Information for the User
Nicorette TX patch 25 mg
Transdermal patch
For use in adults
Active substance: Nicotine

Read the entire leaflet carefully before starting using this medicine, because it contains important information. Always use this medicine as described in this leaflet or exactly as your doctor's or pharmacist instructions.
- Lift the package leaflet. You might want to read it again.
- Ask your pharmacist if you need more information or advice.
- If you notice side effects, contact your doctor or pharmacist. This also applies to side effects that are not indicated in this leaflet.

What is in this leaflet
1. What is Nicorette TX patch 25 mg and what is it applied for?
2. What should you prior to use Nicorette TX Patch 25 MG Note?
3. How to use Nicorette TX patch 25 mg?
4. Which side effects are possible?
5. How to keep Nicorette TX patch 25 mg?
6. Content of the pack and further information

1. What is Nicorette TX patch 25 mg and what is it applied for?

Nicorette TX patch 25 mg is a tobacco couping agent. Nicorette TX plaster 25 mg is used to treat the tobacco dependence by relieving the withdrawal symptoms. This supports Nicorette TX patch 25 mg of smoking cessation. By additional advice and supporting measures, the success rate can be increased.

2. What should you prior to use Nicorette TX Patch 25 MG Note?

Nicorette TX patch 25 mg must not be used:
- If you are non-smokers.
- If you are casual smoke and smoke a cigarette a day or rare.
- if you allergic against Nicotine or one of the section 6.1 other ingredients of this medicine are.
- If you suffer from dandruff, chronic skin inflammation or hives.
If you have questions about these application restrictions, please talk to your doctor.

Warnings and Precautions:
Please talk to your doctor or pharmacist before using Nicorette TX plaster 25 mg,
> If you have suffered a heavy cardiovascular incident within the last 4 weeks or treated for cardiovascular complaints, such as:
- Stroke
- Heart attack
- unstable or deteriorating constriction of coronary vessels (angina pectoris)
- Prinzmetal angina (a certain form of angina pectoris)
- Heart rhythmias
- Bypass operations
- Surgical procedures for exciting blood vessels (angioplastic interventions)
> if you suffer from insufficiently treated hypertension
In these cases, you should only use Nicorette TX patch 25 mg after consulting the doctor.

CAUTION When using Nicorette TX patch 25 mg is also required:
- if you suffer from moderate to heavy liver damage
- if you have heavy kidney weakness (renal insufficiency) To suffer
- if you suffer from acute duodenum and stomach ulcers
- if you suffer from diabetes (diabetes mellitus) (your doctor may need to reduce insulinosis)
- if you suffer from an insufficiently treated overfunction of thyroid gland
- If you have a tumor of the adrenal leaflet (pheochromeozytom) exists.
Your doctor will carefully weigh the risks of nicotine replacement therapy against non-smoking.

Hints:
During treatment with Nicorette TX patch 25 mg, you should not smoke or otherwise to take Nicotin as your body could otherwise be added too much nicotine. This could endanger stronger nicotin and endanger their attempt to give up smoking. In addition, overdoses can come. Nicotine is a highly toxic substance. Also in a dosage that is quite compatible for adult smokers, nicotine can lead to severe poisoning in small children, d. H. The use of Nicorette TX patch 25 mg can be life-threatening for children. Therefore, Nicorette TX plaster must be stored unreachable at any time for children. Since the patches also contain nicotine even after use, they must be eliminated so that they can under no circumstances get into the hand of a child.

Children and adolescents:
Apply Nicorette TX patch 25 mg in children and adolescents under 18 years only after consulting the doctor, as there are only limited experiences for a general recommendation for this age group.

Application of Nicorette TX patch 25 mg together with other medicines:
Inform your doctor or pharmacist if you take / use other medicines or recently taken / applied / applied, or intend to take / use other medicines. If you give up smoking, the effect of insulin can strengthen the effect of insulin. Your doctor will eventually reduce the insulin dose. Likewise, the effectiveness of the following drugs may be increased: theophylline, tacrin, clozapine, ropinirol, imipramine, olanzapine, clomipramine, fluvoxamine, flecainide, pentazocin, prazosin, propranolol. A dose increase, however, may be necessary for isoprenaline and salbutamol.

Application of Nicorette TX patch 25 mg together with food and drinks:
There is no impact of the effects of food and beverage.

Pregnancy and breast feeding period:
If you are pregnant or breastfeeding, ask your doctor or pharmacist for advice before taking / application of all medicines. Smoking can harm the fetus and infant heavy damage and should therefore be terminated. Pregnant smokers should perform smoking cessation without support of nicotine-containing medicines. The use of Nicorette TX patch 25 mg should only be considered after consultation with the doctor if there is a risk of smoking. In this case, the doctor must weigh the risks of roll-up (possibly higher nicotine plasma levels, harmful substances from tobacco smoke) against the risk of nicotine replacement treatment. Nicotine goes into breast milk. When using Nicorette TX patches 25 mg in therapeutic dosages, nicotin levels can be achieved in breast milk, which exert an effect on the child. Should a Nicotine replacement treatment with Nicorette TX plaster 25 MG will be required during breast-feeding, the infant must be switched to bottle food.

Fertility:
Smoking can have adverse effects on female and male fertility (fertility). It is not known which specific share Nicotine has on these effects. Women with a desire for children should neither smoke nor a nicotiter replacement therapy if possible. Although smoking can have negative effects on male procilability, there is no evidence that special contraceptive measures would be required in men under Nicotiter replacement therapy.

Driving and ability to operate machines:
Effects on the ability to drive and the use of machines are unknown.

3. How to use Nicorette TX patch 25 mg?

Always use this medicine as in this leaflet
described or exactly according to the one with your doctor or pharmacist
Agreement. Ask your doctor or pharmacist if you are
are not safe.
The patches are available in 3 dose levels (the specified dose thickness relates
to those within 16 Hours issued Nicotin quantity):
- Nicorette TX patch 25 mg,
- Nicorette TX patch 15 mg and
- Nicorette TX patch 10 mg.

The recommended dose is:

Adult:
The dosage should be based on the smoker's tobacco dependence.
> Smokers who are strong tobacco (more than 20 cigarettes a day):
Dosage Scheme: Strong smoker (more than 20 cigarettes per day)
Duration of application:
Phase 1 Nicorette TX patch 25 mg 8 weeks
Phase 2 Nicorette TX patch 15 mg 2 weeks
Phase 3 Nicorette TX patch 10 mg 2 weeks

> Smokers who are less high tobacco (up to 20 Cigarettes a day):
Dosage Scheme: Weak smoker (up to 20 cigarettes per day)
Duration of application:
Phase 1 Nicorette TX patch 15 mg: 8 weeks
Phase 2 Nicorette TX patch 10 mg: 4 weeks

Application in children and adolescents:
Apply Nicorette TX patch 25 mg in children and adolescents under 18 years only after consulting the doctor, as there are only limited experiences for a general recommendation for this age group.

Older people:
Limited experiences are available for smokers over 65 years, but the effectiveness and compatibility in this age group seem to be unproblematic.

Type of application:
Every day, a pavement will be glued in the morning immediately after getting up after removal of the protective film on a clean, dry, uninvested and unhurt skin point on the upper body, upper arm or the hip. To do this, press the patch fixed for 10 - 15 seconds against the skin.

1. Before applying the pavement, you should wash your hands.
2. Cut the bag with a scissor along the line pre-drawn and remove the pavement.
3. Pull a part of the silvery aluminum protective layer. Avoid touching the adhesive part of the patch with your fingers to not reduce the adhesive properties of the patch.
4. The adhesive side of the patch is carefully glued to a clean, dry, unknown and unhurt skinage on the upper body, upper arm or on the hip. Then remove the second part of the silvery aluminum protection layer.
5. Push the patch with the palm or fingertips on the skin.
6. Stroke with your fingers again on the edges of the patch to ensure that the pavement sticks firmly.

After that, you should thoroughly wash your hands so that not accidentally arrested at the fingers nicotine into the eyes. The maximum nicotin levels in the blood will be reached in the afternoon (about 9 hours after sticking the patch) if the risk of relapsing is greatest. In the evening before sleeping, the pavement will be removed again (i.e., the patch remains on the skin for 16 hours). As a result, the treatment with the 16 hour pavement mimics the change in the nicotin mirror according to the wake / sleep change in smokers. Also, do not take any nicotine during sleep. In patients who react with sleep disorders on nicotine administration during sleep, this side effect can be avoided. The next morning you glue a fresh pavement to another skin point. The same skin office should be glued again after a few days.

Duration of application:
A treatment lasting longer than 6 months with Nicorette TX patch 25 mg is generally not recommended. For some former smokers, a longer treatment may be necessary to prevent relapse in their smoking habits. Please talk to your doctor or pharmacist if you have the impression that the effect of Nicorette TX patch is 25 mg too strong or too weak.

If you have used a larger quantity Nicorette TX patch 25 mg than you should:
An overdose with Nicotin can occur: in non-smokers, for smokers, which before treatment with Nicorette TX pavement 25 Mg smoked very few cigarettes, or if, during the use of Nicorette TX plaster, 25 mg is additionally supplied to other ways nicotine. The symptoms of overdose of Nicorette TX patch 25 mg correspond to those of acute nicotine poisoning, nausea, increased salivation, abdominal paincase, welding outbreaks, headaches, dizziness, hearing disturbances and matters. For heavy overdose, this symptoms of blood pressure drop, weak and irregular pulse, respiratory difficulties, exhaustion states (prostonation) can Circulatory collapses and generalized convulsions follow. Dosages that are well tolerated by adult smokers during treatment can cause severe poisoning symptoms with potential life-threatening history.

Treatment of overdose:
For poisoning phenomena, the nicotine feed must be stopped immediately. A doctor must be informed immediately. It will, if necessary, symptomatically treat.

If you forget the application of Nicorette TX Patch 25 mg:
Do not apply two patches if you forget the previous application. If you have further questions about the application of the medicine, ask your doctor or pharmacist.

4. Which side effects are possible?

Like all medicines, this medicine can also have side effects, but they do not have to occur each other. The side effects are dose-dependent. In principle, such as smoking also under Nicorette TX patches can occur 25 mg of nicotine side effects (headache, dizziness and nausea, increase in heart attack, temporary light blood pressure increase). However, one can assume that when adhering to the recommended dosage, the side effects under treatment with Nicorette TX patch 25 mg are less pronounced due to lower nicotine tension concentrations in the blood than smoking. In addition to the Nicotin effects, smoking adds additional risks through the known damaging influences of ingredients of tobacco smoke such as carbon monoxide and tar. Some phenomena, such as dizziness, headache, insomnia, can be withdrawal symptoms associated with smoking cessation. After adjusting smoking, more aphthene (rash on the oral mucosa) may occur, with the relationship being unclear.

Significant side effects or characters to which you should pay attention and measures if they are affected by:
At about 20% of the users of Nicorette TX pavement 25 mg occurred slight local skin reactions such as the first weeks of treatment. As itching, rash and / or burning. If you know that you react hypersensitive to stickers, you should carefully pay attention to the appearance of skin phenomena during the first day of treatment.

Other possible side effects:
The frequency information on side effects is based on the following categories:
Very common: More than 1 treated from 10
Frequently: 1 to 10 treated from 100
Occasionally: 1 to 10 treated from 1,000
Rarely: 1 to 10 treated from 10,000
Very rare: less than 1 treated from 10,000
Unknown: Frequency on the basis of the available data is not estimable

Nervous system:
Often: headache, dizziness

Heart Circulation System:
Occasionally: palpitations
Very rare: Heart rhythmism of the pre-chamber

Gastrointestinal system:
Often: complaints in the gastrointestinal area, nausea, vomiting

Skin and subcutaneous tissue:
Occasionally: Hives

General diseases and complaints at the administration site:
Very common: Light local skin reactions such. As rash, itching and / or burning
Frequently: skin withdrawals

If you worry about side effects, talk to your doctor or pharmacist. If you notice side effects, contact your doctor or pharmacist. This also applies to side effects that are not indicated in this leaflet.

5. How to keep Nicorette TX patch 25 mg?

Keep this medicine inaccessible to children. Since Nicorette TX patches contain 25 mg even after use nicotine, they must be eliminated so that they can under no circumstances in the hands of a child. You may not use this medicine after the expiration date specifiable to "usable up to" or "exp". The expiration date refers to the last day of the specified month. Do not store over 25 ºC. The disposal Von medicines should be carried out in accordance with the respective regional requirements. Ask your pharmacist how to dispose of the medicine if you do not apply it anymore. You help to protect our environment.

6. Content of the pack and further information

What Nicorette TX Plaster contains 25 mg:
The active ingredient is: Nicotine.
1 transdermal patch contains with 22.5 cm² adsorption surface 39.4 mg Nicotin (1.75 mg / cm²).
Average active ingredient approval: 25 mg Nicotin / 16 hours.

The other ingredients are:
Medium-chain triglycerides, basic butyl methacrylate copolymer (Ph.eur.), Poly acrylic acid co-butyl acrylate-co-(2-ethylhexyl) acrylate-co-vinyl acetate (5: 15: 75: 5), potassium hydroxide, croscarmello sodium, aluminum tris (acetylacetonate), poly (ethylene terephthalate) film.

Like Nicorette TX patches 25 mg looks and content of the pack:
Nicorette TX patch 25 mg is in packs with 7 and 14 Transdermal patches available. Each patch is individually packed in a heat sealed bag.

Pharmaceutic entrepreneur:
McNeil Consumer HealthCare GmbH
Mailbox 210551
41431 Neuss
Tel.: 00800 260 260 00 (free of charge)

Manufacturer:
LTS Lohmann Therapy-Systeme AG
Lohmannstr. 2
56626 Andernach

This leaflet was recently revised in March 2012.

Source: Information of the leaflet
Status: 06/2013