Nicotine 2 Mg Compressed Lozenges
PACKAGE LEAFLET: INFORMATION FOR THE USER
Nicotine 2 mg Compressed Lozenge (Nicotine)
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to use Nicotine 2mg Lozenge carefully to get the best results from it.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- You must contact a doctor if you still need to use Nicotine Lozenge after 9 months.
- If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or your pharmacist.
- This medicine is available under the above products names but will be called Nicotine Lozenge throughout the package leaflet.
In this leaflet
1. What Nicotine Lozenge is and what it is used for
2. Before you take Nicotine Lozenge
3. How to take Nicotine Lozenge
4. Possible side effects
5. How to store Nicotine Lozenge
6. Further information
1. WHAT NICOTINE LOZENGE IS AND WHAT IT IS USED FOR
Nicotine Lozenge contains nicotine, which is one of the substances contained in tobacco.
This medicinal product belongs to a group of medicines which are used to help you stop smoking.
When sucked, nicotine is release slowly and absorbed through the lining of the mouth.
This medicinal product is used to relieve the nicotine withdrawal symptoms in nicotine dependency, as an aid to smoking cessation.
Patient counselling and support normally improve the success rate.
2. BEFORE YOU TAKE NICOTINE LOZENGE Do not take Nicotine Lozenge
- If you are allergic (hypersensitive) to nicotine or any of the other ingredients of Nicotine Lozenge.
- If you are a non-smoker.
Take special care with Nicotine Lozenge
Please check with your doctor or pharmacist before taking Nicotine Lozenge if you have:
- heart disease, e.g. heart attack, heart failure, angina, Prinzmetal’s angina or abnormalities in heart beat rhythm.
- had a ‘stroke’ (cerebrovascular accident).
- high blood pressure (uncontrolled hypertension).
- problems with your circulation.
- diabetes.
- overactive thyroid glands (hyperthyroidism).
- overactive adrenal glands (pheochromocytoma).
- kidney or liver disease.
- oesophagitis, inflammation in the mouth or throat, gastritis or peptic ulcer.
Even small quantities of nicotine are dangerous in children and may result in severe symptoms or death. It is therefore essential that you keep Nicotine Lozenge out of the sight and reach of children at all times.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. If you stop smoking and if you are using other medicines, your doctor may want to adjust the dose.
No information is available on interactions between Nicotine Lozenge and other medicines. However, apart from nicotine, other substances in cigarettes may have an effect on certain medicines.
Stopping smoking can affect the action of certain medicines, e.g.:
- theophyllin (a medicine used for the treatment of bronchial asthma)
- tacrine (medicine used to treat Alzheimers’ disease)
- olanzapine and clozapine (for the treatment of schizophrenia)
- insulin dose (medicine used for the treatment of diabetes) may need to be adjusted
Taking Nicotine Lozenge with food and drink
Coffee, acidic and soft drinks may decrease the absorption of nicotine and should be avoided for 15 minutes before sucking a lozenge.
Pregnancy and breast-feeding
It is very important to stop smoking during pregnancy because it can result in poor growth of your baby.
It can also lead to premature births and even stillbirths. Ideally you should try to give up smoking without the use of medicines. If you cannot manage this, Nicotine Lozenge may be recommended to help as the risk of developing baby is less than that expected from continued smoking. Nicotine in any form may cause harm to your unborn baby. Nicotine Lozenge should only be used after consulting the healthcare professional who is managing your pregnancy, or a doctor that is specialised in helping people quit smoking.
Nicotine Lozenge like smoking itself should be avoided during breast-feeding as it may be found in breast milk. If your doctor has recommended you to use Nicotine Lozenge during breast-feeding, the lozenge should be sucked just after breast-feeding and not during the two hours before breast-feeding.
Driving and using machines
There is no evidence of risk associated with driving or operating machinery if the lozenge is taken according to the recommended dose but remember that smoking cessation can cause behavioural changes.
Important information about some of the ingredients of Nicotine Lozenge.
Nicotine Lozenge contains sweeteners, including aspartame and maltitol.
Each Nicotine 2mg Lozenge contains aspartame (E951), a source of phenylalanine equivalent to 5 mg per piece and may be harmful for people with phenylketonuria. Because Nicotine 2mg Lozenge contains maltitol (E965), a source of fructose:
- If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine
- Patients may experience a mild laxative effect.
Calorific value 2.3 kcal/g maltitol. Nicotine Lozenge ingredients are suitable for diabetics. Nicotine 2mg Lozenge contains 9.8 mg of sodium per piece. To be taken into consideration by patients on a controlled sodium diet.
3. HOW TO TAKE NICOTINE LOZENGE
Always take Nicotine Lozenge exactly as stated in this package leaflet. You should check with your doctor or pharmacist if you are not sure.
To improve your changes of giving up smoking you should stop smoking completely when you start to use the lozenge and for the whole treatment period.
Nicotine Lozenge is available in two strengths: 1 mg and 2 mg. The appropriate dose will depend on your previous smoking habits.
You should use the 2 mg Nicotine Lozenge if:
- You are a smoker with a strong or very strong nicotine dependency.
- You have previously failed to stop smoking with the 1 mg lozenge.
- Your withdrawal symptoms remain so strong as to threated relapse.
Otherwise 1mg Nicotine Lozenge should be used.
Do not swallow.
Select your optimal dosage from the following table:
|
Low in inoderate dependency |
Moderate to strong dependency |
Strong io very strong dependency | ||||
|
, MII ---1| | | |
Low dosage forms acceptable |
r— — _ | ||||
|
High dosage forms acceptable | ||||||
|
-. I-J> | ||||||
|
Less than Z.n curettes 1 day |
From 20 » 30 cigarettes , day |
Over M cigarettes ; day | ||||
|
Low dose forms are preferable (i mg lozenge) |
Low [ 1 fTTH lozenge i or high (2 mg lozenge * OQse forms am acceptable depend; ng: on patient enjructensrcs and preference. |
High dose forms are preferable P mg lozengei | ||||
If an adverse event occurs with the use of the high dose (2 mg lozenge), use of the low dose (1 mg lozenge) should be considered.
Instruction for use:
1. Suck a lozenge until the taste becomes strong.
2. Allow the lozenge to rest between your gum and cheek.
3. Suck again when the taste has faded.
4. Repeat this routine until the lozenge dissolves completely (about 30 minutes).
Dosage for adult over 18 years:
Suck one lozenge when you feel the urge to smoke. In general one lozenge should be taken every one or two hours. Normally 8-12 lozenges per day are sufficient. If you still experience an urge to smoke, you can suck additional lozenges. Do not exceed 15 lozenges per day of the 2 mg strength.
The treatment duration is individual. Normally, treatment should continue for at least 3 months. After 3 months you should gradually reduce the number of lozenges used each day. Treatment should be stopped when you have reduced your use of lozenge to 1-2 lozenges per day. It is generally not recommend to use
Nicotine Lozenge for longer than 6 months, however, some ex-smokers may need treatment with the lozenge longer to avoid returning to smoking. If you are still using the lozenge after 9 months, you should speak to you doctor or pharmacist.
Counselling may improve your changes of giving up smoking.
Children and adolescents (<18 years)
Nicotine Lozenge should not be used by people under 18 years of age without recommendation from a doctor.
If you take more Nicotine Lozenge than you should
Sucking too many lozenges can result in the same symptoms as smoking too much. The general symptoms of nicotine overdose include weakness, sweating, increased production of saliva, throat burn, nausea, vomiting, diarrhoea, pain in the abdomen, disturbance of hearing and vision, headache, fast or other disturbance in heartbeat, shortness of breath an circulatory problems.
You should consult your doctor or pharmacist if you experience any problems.
If poisoning is suspected in a child, a doctor must be consulted immediately. Even small quantities of nicotine are dangerous in children and may result in severe symptoms or death.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECT
Like all medicines, Nicotine Lozenge can cause side effects, although not everybody gets them.
Some effects you may notice in the first few days are dizziness, headache and sleep disturbances. These may be withdrawal symptoms in connection with smoking cessation and may be caused by insufficient administration of nicotine.
Common side effects
(affects 1 to 10 users in 100)
- dizziness and headache.
- dryness of the mouth, hiccups, stomach trouble such as nausea, flatulence, heartburn, increased saliva production and irritation of the mouth and throat may also occur, especially as a result of intense sucking. Slower sucking will usually overcome this problem.
Less common side effects
(affects 1 to 10 users in 1,000)
- palpitations.
Rare side effects
(affects 1 to 10 users in 10,000)
- disturbances in heart beat rhythm and allergic reactions. These reactions may in very few cases be serious. You should see your doctor immediately if you experience symptoms such as swollen face, tongue and/or pharynx and/or difficulty to swallow or hives together with difficult breathing (angioedema).
Mouth ulcers may occur when trying to quit smoking, but the relationship to the nicotine treatment is not clear.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE NICOTINE LOZENGE
Keep out of sight and reach of children.
Do not use Nicotine Lozenges after the expiry date which is stated on the label of the package after “EXP”.
The expiry date refers to the last date of that month.
Do not store above 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Nicotine 2mg Compressed Lozenge contains The active substance is nicotine.
Each lozenge contains 2 mg of nicotine (as 6.144 mg nicotine bitartrate dihydrate).
The other ingredients are:
- maltitol (E965), sodium carbonate anhydrous, sodium hydrogen carbonate, polyacrylate, xanthan gum, colloidal anhydrous silica, levomenthol, peppermint oil, aspartame (E951), magnesium stearate.
What Nicotine Lozenge looks like and content of the pack
Nicotine Lozenge is a white, mint flavoured, round biconvex compressed lozenge.
Nicotine Lozenge is available in two strengths: 1mg and 2mg. This package deals with both Nicotine 2mg lozenge. The blisters are packed in boxes containing 12, 36, 72, 96, 144 or 24 lozenges.
Not all pack sizes may be marketed.
Marketing authorization holder
GlaxoSmithKline Consumer Healthcare (UK) Trading Limited,
Brentford,
TW8 9GS,
U.K.
Manufacturer
Novartis Consumer Health GmbH Zielstattstrasse 40 81379 Munich Germany
This leaflet was last revised June 2016.