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Document: Nicorette Pepparmint oromucosal spray ENG PL change

• Nicorette Pepparmint oromucosal spray PL
• Nicorette Pepparmint oromucosal spray ENG PL

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Package leaflet: information for the user

Nicorette Pepparmint 1 mg/spray oromucosal spray, solution

Nicotine

Read all of this leaflet carefullybefore you start using this medicine because it contains important information for you.

• Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.Keep this leaflet. You may need to read it again.

• Ask your pharmacist if you need more information or advice.

• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

• You must talk to a doctor if you have not been able to stop smoking after 6 months of treatment with Nicorette Pepparmint.

What is in this leaflet

1. What Nicorette Pepparmint is and what it is used for

2. What you need to know before you use Nicorette Pepparmint

3. How to use Nicorette Pepparmint

4. Possible side effects

5. How to store Nicorette Pepparmint

6. Contents of the pack and other information

1. What Nicorette Pepparmint is and what it is used for

Nicorette Pepparmint is used to help you stop smoking when you want to quit. This is a type of treatment called Nicotine Replacement Therapy (NRT).

Nicorette Pepparmint relieves nicotine withdrawal symptoms including cravings, symptoms you get when stopping smoking. When you suddenly stop providing nicotine from tobacco to your body, you get hit by different kinds of unpleasant feelings called withdrawal symptoms. By using Nicorette Pepparmint you can prevent or reduce these unpleasant feelings and cravings for smoking. This is because you continue to provide a small amount of nicotine to your body for a short period of time. Nicorette Pepparmint does not contain the tar, carbon monoxide or other toxins in cigarette smoke.

To improve the chances of helping you to stop smoking, you should also seek counselling advice and support, if you can.

Do not use Nicorette Pepparmint

Warnings and precautions

Talk to your doctor before if you suffer from the following. You may be able to have Nicorette Pepparmint, but need to discuss with your doctor first if you have:

• Recently (within 3 months) had a heart attack or stroke

• Chest pain (unstable angina), or resting angina

• A heart condition that effects your heart rate or rhythm

• High blood pressure which is not being controlled by medicines

• Ever had allergic reactions that involve swelling of the lips, face and throat (angioedema) or itchy skin rash (urticaria). Using NRT can sometimes trigger this type of reaction.

• Severe or moderate liver disease

• Severe kidney disease

• Diabetes

• An overactive thyroid gland

• A tumour of the adrenal gland (phaeochromocytoma)

• Stomach or duodenal ulcer

• Oesophagitis

Nicorette Pepparmint should not be used by non-smokers.

Other medicines and Nicorette Pepparmint

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is especially important if you take medicines containing:

theophylline to treat asthma

tacrine for Alzheimer’s disease

clozapine for schizophrenia

ropinirole to treat Parkinson’s disease

Nicorette Pepparmint with food and drink

Do not eat or drink when administering the oromucosal spray.

Pregnancy,breast-feeding and fertility

It is very important to stop smoking during pregnancybecause it can result in poor growth of your baby. It can also lead to premature births or stillbirths. It is best if you can give up smoking without the use of medicines containing nicotine. If you cannot manage this, Nicorette Pepparmint should only be usedafter consulting the healthcare professional who is managing your pregnancy, your family doctor, or a doctor in a centre that is specialised in helping people quit smoking.

Nicorette Pepparmint should be avoided during breast-feedingas nicotine is found in breast milk and may affect your child. If your doctor has recommended you to use Nicorette Pepparmint, the spray should be taken just after breast-feeding and not during the 2 hours before breast-feeding.

Smoking increases the risk of infertility in women and men. The effects of nicotine on fertility is unknown.

Driving and using machines

No effects on the ability to drive cars or use machines have been observed.

Nicorette Pepparmint contains small amounts of ethanol (alcohol), less than 100 mg per spray.

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure.

People under 18 years of age should not use Nicorette Pepparmint.

You should stop smoking completely during treatment with Nicorette Pepparmint.

The following chart shows the recommended step by step process for Nicorette Pepparmint.

Step 1: Weeks 1-6 Use 1 or 2 sprays when you would normally smoke a cigarette or have cravings to smoke. Use one spray first and if your cravings do not disappear within a few minutes use the second spray. If 2 sprays are required, future doses may be delivered as 2 consecutive sprays. For most smokers this means about 1 or 2 sprays every 30 minutes to 1 hour. For example, if you smoke an average of 15 cigarettes per day, you should use 1 or 2 sprays at least 15 times during the day. Do not use more than 2 sprays at a time or 4 sprays per hour for 16 hours. The maximum dose is 64 sprays over 16 hours in any 24-hour period. Step 2: Weeks 7-9 Start reducing the number of sprays per day. By the end of week 9 you should be using HALF the average number of sprays per day that you used in Step 1. Step 3: Weeks 10-12 Continue reducing the number of sprays per day so that you are not using more than 4 sprays per day during week 12. When you have reduced to 2-4 sprays per day, you should stop using Nicorette Pepparmint.

You may be tempted to smoke again after treatment has stopped. Save any remaining doses of the spray, as craving for smoking may suddenly occur. If you have a craving use one or two sprays if one spray does not help within a few minutes.

Normally you should take Nicorette Pepparmint for 3 months, though no longer than 6 months.

Consult your doctor if you need to use Nicorette Pepparmint for longer than 6 months.

Follow these instructions carefully and use the pictures to guide you

To unlock nozzle

How to open the dispenser

How to load the dispenser

When you use the oromucosal spray for the first time you must first load the spray pump. Point the spray nozzle safely away from you, any other adults, children or pets near you. Press the top of the dispenser with your index finger 3 times until a fine spray appears. If you do not use the spray for 2 days, this loading procedure will need to be repeated.

How to use the dispenser

To retract nozzle

How to close the dispenser

To take another dose repeat the steps above.

Close the dispenser every time after use to prevent use of the spray by children and accidental spraying.

Care should be taken not to spray the eyes whilst administering the oromucosal spray. If you get spray in your eye, rinse thoroughly with water.

If you use more Nicorette Pepparmint than you should

Overdosing of nicotine may occur if you smoke at the same time as you take Nicorette Pepparmint.

If a child takes Nicorette Pepparmint or if you have used more Nicorette Pepparmint than you should, contact your doctor or go to the nearest hospital immediately. Doses of nicotine that are tolerated by adult smokers during treatment may produce severe symptoms of poisoning in children and may prove fatal.

The symptoms of overdose are feeling sick (nausea), vomiting, too much saliva, stomach pain, diarrhoea, sweating, headache, dizziness, changed hearing, and feeling very weak. At high doses, these symptoms may be followed by low blood pressure, weak and irregular pulse, difficulty breathing, extreme tiredness, circulatory collapse and general convulsions.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Nicorette Pepparmint can give the same side effects as other forms of nicotine. The side effects generally depend on the dose you take.

Effects related to stopping smoking (nicotine withdrawal)

Some of the unwanted effects that you experience when stopping smoking can be withdrawal symptoms due to decreases in nicotine intake.

These effects include:

• Irritability, aggression, impatience or frustration

• Feeling anxious, restless or having difficulty concentrating

• Night time awakening or sleep disturbance

• Increased appetite or weight gain

• Feeling low

• Urges to smoke (craving)

• Lowering of heart rate

• Bleeding gums or mouth ulcers

• Dizziness or light-headedness

• Cough, sore throat, stuffy or runny nose

• Constipation

If you notice any of the following serious rare side effects, stop taking Nicorette Pepparmint and contact a doctor immediately (signs of angioedema):

• Swollen face, tongue or pharynx

• Difficulty to swallow

• Hives and difficulties to breath

Very common: may affect more than 1 in 10 people:

• Hiccups (these are particularly common)

• Headache, nausea (feeling sick)

• Throat irritation

Common: may affect up to 1 in 10 people:

• Local effects such as burning sensation, inflammation in the mouth, changes in taste perception

• Dry mouth or increased amounts of saliva

• Feelings of dyspepsia

• Pain or discomfort in tummy (abdomen)

• Vomiting, flatulence or diarrhoea

• Feeling tired (fatigue)

• Hypersensitivity (allergy)

• Tingling

Uncommon: may affect up to 1 in 100 people:

• Effects on the nose such as stuffiness, sneezing

• Wheezing (bronchospasm), or feeling like breathing requires more effort than usual (dyspnoea), throat tightness

• Skin flushing (blushing), or increased sweating

• Oral effects such as mouth tingling, inflammation of the tongue, mouth ulcers, damage to the lining of the mouth, or changes in the sound of your voice, pain in the mouth and throat, belching

• Palpitations (an unusual awareness of your heart beating), increase of heart rate, hypertension

• Rash and/or itching (pruritus, urticaria) of the skin

• Abnormal dream

• Chest discomfort and pain

• Weakness, feeling unwell

• abnormal heart rhythm

• bleeding gums

• Runny nose

Rare: may affect up to 1 in 1,000 people

• Difficulty swallowing, reduced sensations in the mouth

• Retching

Not known: frequency cannot be estimated from the available data:

• Blurred vision, increased tear production (lacrimation)

• Dry throat, stomach discomfort, pain in the lips

• Redness of the skin

• Allergic reactions including swelling of the face and mouth (angioedema or anaphylaxis)

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side efects you can help provide more information on the safety of this medicine.

5. How to store Nicorette Pepparmint

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the dispenser and on the blister card. The expiry date refers to the last day of that month.

Do not store above 25C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Nicorette Pepparmint contains

• The active substance is nicotine. One spray delivers 1 mg of nicotine.

• The other ingredients are: propylene glycol, anhydrous ethanol, trometamol, poloxamer 407, glycerol, sodium hydrogen carbonate, levomenthol, mint flavour, cooling flavour, sucralose, acesulfame potassium, hydrochloric acid (for pH adjustment) and purified water.

What Nicorette Pepparmint looks like and contents of the pack

Nicorette Pepparmint consists of a plastic bottle of solution held in a dispenser with a mechanical spray pump. The dispenser has a child resistant feature.

Each bottle contains 13.2 ml of solution which provides 150 sprays.

Nicorette Pepparmint is supplied in packs of either 1 or 2 dispensers.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Company name + Address

Phone/Web address

Manufacturer:

McNeil AB, P.O. Box 941, Norrbroplatsen 2, SE-251 09 Helsingborg, Sweden

And

Batch Release Site (alternative):

Johnson & Johnson Consumer NV/SA,

Antwerpseweg 15-17

B- 2340 Beerse

Belgium

This medicinal product is authorised in the Member States of the EEA under the following names:

Sweden	Nicorette Pepparmint
Denmark Iceland, Ireland	Nicorette QuickMist
Austria, Czech Republic, Germany, Poland, Slovak Republic	Nicorette Spray
Belgium, Bulgaria, Finland, Luxembourg, Romania	Nicorette Freshmint
Cyprus, Greece, Hungary	Nicorette Quickspray
Estonia, Latvia, Lithuania	Nicorette Coolmint
Norway, Slovenia	Nicorette
France	Nicorettespray
Italy	Nicorettequick
Netherlands	Nicorette Menthol Mint Mondspray
Spain	Nicorette Bucomist

This leaflet was last revised in 2016-07-28

<Detailed and updated information on this product is available by scanning the QR code included in the PL with a smartphone. The same information is also available on the following URL: [URL to be included] <and the <NCA> website>>.

[To be completed nationally – if QR code is used]