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NICOTINE PERRIGO 2MG LOZENGES

Active substance(s): NICOTINE RESINATE

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1.3.1

PRODUCT INFORMATION.

PACKAGE LEAFLET: INFORMATION FOR THE USER
Nicotine Perrigo
2 mg & 4 mg Lozenges
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 Perrigo 2mg
and 4mg Lozenges carefully to get the best results from them.
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 your symptoms worsen or do not improve after 6 months
If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet,
please tell your healthcare professional.
IN THIS LEAFLET:
1. What this medicine is and what it is used for
2. Before you use this medicine
3. How to take this medicine
4. Possible side effects
5. How to store your medicine
6. Further information

1. WHAT THIS MEDICINE IS AND WHAT IS IT USED FOR?
Nicotine Perrigo 2mg and 4mg Lozenges are used to help people stop smoking. This type of treatment
is called Nicotine Replacement Therapy (NRT).
Nicotine Perrigo 2mg and 4mg Lozenges can reduce your urge to smoke by providing some of the
nicotine previously inhaled from cigarettes and helps you resist cigarettes. Nicotine Perrigo 2mg and
4mg Lozenges do not have the health dangers of tobacco because they do not contain the tar or
carbon monoxide of cigarette smoke.
This medicine contains:
• nicotine resin which when sucked, nicotine is released slowly from the resin and absorbed
through the lining of the mouth. This nicotine relieves some of the cravings and unpleasant
withdrawal symptoms, such as feeling ill or irritable, that smokers frequently feel when they try
to give up.
If possible, when giving up smoking these lozenges should be used with a stop smoking behavioural
support programme. For further information talk to your healthcare professional.
2. BEFORE YOU USE THIS MEDICINE
Do not take this medicine if you:
• are allergic to nicotine or any of the other ingredients
• are a non-smoker
• are under 12 years of age.
• suffer from phenylketonuria, a rare inherited metabolic disorder
• have recently suffered from a heart attack, severe heart rhythm disturbances or a stroke
• have unstable or worsening angina or Prinzmetals angina
Nicotine 2mg Lozenges / Module 1.3.1 / January 2015

1.3.1

PRODUCT INFORMATION.

Take special care with Nicotine Perrigo 2mg and 4mg Lozenges if you:
• have heart or circulation problems including heart failure or stable angina (episodes of chest
discomfort that are usually predictable)
• have high blood pressure
• have occlusive peripheral artery disease - which is a narrowing of the blood vessels outside of
your heart
• have serious liver or kidney disease
• have a stomach ulcer
• have inflammation of the oesophagus (oesophagitis), which is the tube leading from the mouth
to the stomach
• have an uncontrolled, over active thyroid gland
• are diabetic, as diabetic patients need to monitor blood sugar levels more closely as nicotine from
smoking or from taking these lozenges may vary them more than usual
• have been diagnosed as having a tumour of the adrenal glands (phaeochromocytoma)
• have had allergic reactions (see also section 4 “Possible side effects”).
Other important information:
When you stop smoking your metabolism slows down and this may alter the way your body responds
to certain medicines.
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.
Using this medicine with food and drink
Do not eat or drink while a lozenge is in the mouth. Avoid liquids which lower the pH in the mouth such
as coffee, juices and soft drinks, for up to 15 minutes before the lozenge is used.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding it is best if you can give up smoking without the use of NRT.
However, if you have tried and this has not worked, NRT may be recommended by a healthcare
professional to help you stop smoking.
Smoking during pregnancy has risks for the baby. These include poor growth before birth, premature
birth or stillbirth. Stopping smoking is the best way to improve both your health and that of your baby.
The earlier you stop smoking the better.
The decision to use NRT should be made as early on in your pregnancy as possible. Aim to use NRT
for only 2 to 3 months.
If you are breast-feeding tobacco smoke causes breathing difficulties and other problems in babies
and children. If you need to use NRT, the amount of nicotine your baby may get is smaller and less
harmful than breathing in second-hand smoke. It is better to breastfeed just before you take the
product – this helps your baby to get the smallest amount of nicotine possible.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
There are no known effects of these lozenges on your ability to drive or use machines. However, you
should be aware that giving up smoking can cause behavioural changes that could affect you in this
way.

Nicotine 2mg Lozenges / Module 1.3.1 / January 2015

1.3.1

PRODUCT INFORMATION.

Important information about some of the ingredients in this medicine:
Each lozenge contains about 15 mg of sodium and the maximum daily dose of these lozenges (15
lozenges) contains 225 mg sodium. To be taken into consideration if you are on a controlled sodium
diet.
Contains aspartame (E951) which is a source of phenylalanine. May be harmful for people with
phenylketonuria.
Your lozenges are sugar free.
3. HOW TO USE THIS MEDICINE
Important: Nicotine Perrigo 4mg Lozenges are suitable for smokers who smoke within 30 minutes of
waking. Nicotine Perrigo 2mg Lozenges are suitable for smokers who have their first cigarette of the
day more than 30 minutes after waking up.
Always use Nicotine Lozenges exactly as stated in this package leaflet. You should check with your
pharmacist if you are not sure.
The product is for oromucosal use. That means that the nicotine in the lozenge is released slowly into
the mouth from where it is absorbed into the body.
In all cases you should use Nicotine Lozenges by putting one lozenge in your mouth and from time to
time move it from one side of your mouth to the other, until it is completely dissolved. This should take
around 20-30 minutes. Do not chew the lozenge or swallow it whole. Do not use more than 15
lozenges a day.
Adults (aged 18 years and over):
The recommended treatment schedule is:
Step 1
Step 2
Step 3
Weeks 1 to 6
Weeks 7 to 9
Weeks 10 to 12
Initial treatment period
Step down treatment period
Step down treatment period
1 lozenge every 1 to 2 hours
1 lozenge every 2 to 4 hours
1 lozenge every 4 to 8 hours
During weeks 1-6 it is recommended that you take at least 9 lozenges per day.
After you have given up you may sometimes feel a sudden craving for a cigarette. You can use a
lozenge again if this happens.
Adolescents (aged 12-17 years inclusive):
You should only use Nicotine Lozenges following advice from a healthcare professional
If you feel the need to use Nicotine Lozenges for longer than 6 months in total, you should ask
a healthcare professional for advice.
Do not exceed the stated dose. Follow the instructions carefully and do not use more than 15
lozenges in one day (24 hours).
Children under 12 years of age should not use Nicotine Lozenges.
Information: You are more likely to quit smoking when using this product with help from your
pharmacist, doctor, a trained counsellor, or a support programme.

Nicotine 2mg Lozenges / Module 1.3.1 / January 2015

1.3.1

PRODUCT INFORMATION.

If you use more Nicotine Perrigo 2mg and 4mg Lozenges than you should
If you take more than the recommended number of lozenges per day, you may suffer a nicotine
overdose and need to get advice from your doctor. Signs of overdose include headache, sickness,
stomach pains and diarrhoea.
In the event that a child has taken any lozenges or if an accidental overdose occurs, contact your
doctor or nearest hospital casualty department immediately as this could be fatal. If possible show
them the pack or this leaflet.
If you forget to take Nicotine Perrigo 2mg and 4mg Lozenges
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects although not everybody gets them. They are
similar to those you might get from the nicotine in cigarettes, and are more likely the more nicotine you
take..
Stopping smoking itself can cause symptoms such as dizziness, headache, sleep disturbance, cough
and cold-like symptoms, depression, irritability, anxiety and night-time awakening.
The following side effects have been reported in post marketing experience. The frequencies are
defined as: common: 1 patient out of 100 to 1 out of 10, uncommon: 1 out of 1,000 to 1 out of 100,
rare: 1 out of 10,000 to 1 out of 1,000, very rare: less than 1 out of 10,000, unknown: frequency cannot
be estimated from the available data.
Immune system disorders
Very rare: anaphylactic reactions (severe allergic reaction symptoms which include sudden heeziness
or tightness of the chest, rash and feeling faint. Stop taking the lozenges immediately and tell a
healthcare professional if you get these symptoms.
Platelet bleeding and clotting disorders
Uncommon: gingival bleeding (bleeding gums), nosebleed
Psychiatric disorders
Common: insomnia, anxiety, irritability, increased appetite
Uncommon: anger, aggravated anxiety, abnormal dreaming, abnormal hunger, mood swings,
wakefulness
Central and peripheral nervous system disorders
Common : headache
Uncommon: lightheaded feeling, localised numbness
Heart rate and rhythm disorders
Uncommon: palpitations, tachycardia (heart beating too fast)
Vascular disorders
Uncommon: vascular disorder, flushing
Respiratory system disorders
Common: pharyngitis (sore throat)
Uncommon : laryngismus (throat spasms), aggravated asthma, lower respiratory tract infection,
coughing, nasal irritation, throat irritation, nasal congestion
Gastrointestinal system disorders
Very common: nausea
Common: vomiting, heartburn, indigestion, hiccup, mouth irritation, mouth ulceration, tongue
ulceration, diarrhoea, belching, flatulence (wind)

Nicotine 2mg Lozenges / Module 1.3.1 / January 2015

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PRODUCT INFORMATION.

Uncommon: peptic ucler; dysphagia (difficulty swallowing), gastroesophageal reflux, hiatus hernia,
oesophagitis (inflammation of the oesophagus), borborygmus (rumbling stomach), dry lips, dry throat,
tongue disorder, tooth ache
Special senses other disorders
Uncommon: parageusia (bad taste in the mouth), metallic taste, taste perversion
Skin and appendages disorders
Uncommon: erythema (skin redness), itching, rash, localised skin reaction, increased sweating
Musculoskeletal system disorders
Uncommon: jaw pain
Urinary system disorders
Uncommon: nocturia (needing to urinate during the night)
Body as a whole - general disorders
Uncommon: overdose effect, pain, leg pain, build up of fluid in the legs
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in
this leaflet.
5. HOW TO STORE YOUR MEDICINE
Keep all medicines out of the sight and reach of children.
Do not use this medicine after the expiry date printed on the pack.
Do not store above 25°C and keep in the original carton.
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 this medicine contains
The active ingredient is nicotine. Each lozenge contains 2 mg or 4 mg (in the form of a resin complex
called nicotine resinate).
The other ingredients are: mannitol (E421), magnesium stearate, sodium alginate, xanthan gum,
potassium bicarbonate, sodium carbonate anhydrous, aspartame (E951) and peppermint flavour.
What your medicine looks like and contents of the pack:
Cream / white circular compressed lozenge with an odour of peppermint.
The 2 mg lozenge is embossed with L344 on one side.
The 4 mg lozenge is embossed with L873 on one side.
Your lozenges are available in pack sizes of 36 and 72’s.
Marketing Authorisation Holder and Manufacturer
Wrafton Laboratories Limited, Wrafton, Braunton, Devon, EX33 2DL, United Kingdom
This medicinal product is authorised in the Member States of the EEA under the following
names:
Czech Republic : Nicotine Perrigo 2mg and 4mg
Germany : Nicotin Perrigo 2mg and 4mg Lutschtabletten, gepresst
Hungary : Nicotine APC 2mg and 4mg
Italy : Nicotina Perrigo
The Netherlands : Nicotine ETOS 2mg and 4mg Zuigtabletten
Poland : Nicotine Perrigo
The leaflet was revised in: Jan 2013

Nicotine 2mg Lozenges / Module 1.3.1 / January 2015

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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