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NICOTINELL SUPPORT ICEMINT 2 MG MEDICATED CHEWING GUM, NICOTINELL ICEMINT 2 MG MEDICATED CHEWING-GUM - Patient leaflet, side effects, dosage

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Patient leaflet - NICOTINELL SUPPORT ICEMINT 2 MG MEDICATED CHEWING GUM, NICOTINELL ICEMINT 2 MG MEDICATED CHEWING-GUM

Nicotinell Icemint 4 mg

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 Nicotinell chewing gum carefully to get the best results from it.

  • Keep this leaflet. You may need to read it again.
  • Ask your doctor, nurse or pharmacist if you need more information or advice.
  • 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 pharmacist.

In this leaflet:

  • 1. What Nicotinell chewing-gum is and what it is used for

  • 2. Before you take Nicotinell chewing-gum

  • 3. How to take Nicotinell chewing-gum

  • 4. Possible side effects

  • 5. How to store Nicotinell chewing-gum

  • 6. Further information

1 what nicotinell chewing-gum is and what it is used for

Nicotinell medicated chewing-gum is a nicotine replacement therapy (NRT) which is used to help you to stop smoking. It is available in two strengths (2 mg and 4 mg) and five flavours (Fruit, Mint, Icemint, Liquorice and Classic). This leaflet is for Nicotinell Icemint 2mg and 4mg medicated chewing-gums.

The chewing-gum contains nicotine, which is one of the substances in tobacco. When chewed, nicotine is released slowly and absorbed through the lining of the mouth. Nicotinell chewing-gum does not contain the other harmful substances found in tobacco smoke such as tar and carbon monoxide.

Follow the chewing technique instructions in section 3 to get the best effect.

The gum contains a number of ingredients which help remove dental staining, chewing Nicotinell Gums will help improve the whiteness of your teeth.

Nicotinell 2mg and 4mg gums can be used to help you:

  • stop smoking completely
  • cut down the amount you smoke – perhaps before you go on to stop completely.

In addition, they may be used when you:

  • do not wish to smoke. For example in confined spaces (in the car: in the house) or where others (such as children) could be harmed by tobacco smoke
  • are unable to smoke
  • develop cravings once you have stopped smoking.

Reducing the number of cigarettes smoked can increase the chances that you will move on to quit completely.

Nicotinell 2 mg gum is for smokers smoking less than 20 cigarettes per day. It can also be used by smokers smoking between 20 and 30 cigarettes per day.

Smokers of more than 20 cigarettes per day, who are reducing their smoking prior to a quit attempt, should use Nicotinell 2mg gums once they have successfully reduced the number of cigarettes smoked per day.

If you smoke more than 30 cigarettes per day, you should use Nicotinell 4 mg medicated chewing-gum.

Nicotinell 2mg and 4mg gums can also be used to relieve breakthrough cravings of smokers attempting to quit by following a patch programme.

If you need advice before starting to use Nicotinell gum, talk to your doctor, nurse, pharmacist or trained counsellor.

To help quit smoking you should also try to use a behavioural support programme to increase your chances of success. Talk to your doctor, nurse, pharmacist or a trained counsellor about this.

  • 2 Before you take Nicotinell chewing-gum

Do NOT take Nicotinell chewing-gum if you are

  • allergic (hypersensitive) to nicotine or any of the other ingredients of the chewing-gum a non-smoker or occasional smoker
  • under 12 years of age, except on the advice of a doctor.

Take special care with Nicotinell chewing-gum

Please speak with your doctor, nurse or pharmacist before taking the chewing-gum if you:

  • have heart disease, (heart attack, worsening chest pain, disorders of the heart rate and/or rhythm)
  • have uncontrolled high blood pressure
  • have recently had a stroke
  • have serious liver or kidney disease
  • have or had a stomach ulcer
  • have persistent indigestion
  • have a severe sore throat or inflammation of the mouth
  • are diabetic (see next section)
  • have an overactive thyroid gland
  • have a tumour of the adrenal glands (pheochromocytoma)
  • are fructose intolerant
  • are on a low-sodium diet
  • are taking any other medicines (see next section)
  • are pregnant or breast-feeding (see Pregnancy/Breast-feeding sections).

People having problems with the jawbone and some denture wearers may experience difficulty in chewing the gum. If you do, it is recommended that you use a different form of nicotine replacement therapy, such as a patch or lozenge. Ask your doctor or pharmacist for advice. Using nicotine replacement therapy is better than continuing to smoke.

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.

The effect of some medicines can be altered when you stop smoking.

  • If you are already taking regular medication you should tell your doctor, nurse or pharmacist.
  • Diabetics should monitor their blood sugar levels more often than usual when taking chewing gum because your insulin/medication requirements may alter.

Taking Nicotinell chewing-gum with food and drink

Coffee, juices, acidic and fizzy drinks may reduce the absorption of nicotine and should not be taken for 15 minutes before chewing the gum.

Pregnancy

Smoking during pregnancy is associated with risks such as poor growth of the baby before birth, premature birth or still birth. Stopping smoking is the single most effective way to improve both your health and that of your baby. The earlier smoking stops, the better. Ideally, stopping smoking during pregnancy should be done without nicotine replacement therapy. However, if you have tried and this is not possible, nicotine replacement therapy may be used because the risk to the developing baby is less than that expected from continued smoking. The decision to use nicotine replacement therapy should be made as early on in the pregnancy as possible with the aim of discontinuing use after 2–3 months.

Ask your doctor for advice before taking any medicine.

Breast-feeding

It is better to use nicotine replacement therapy products that can be taken intermittently (not patches). Try to breast-feed at a time just before you take the product to ensure that the baby gets the smallest amount of nicotine possible. If you need to use nicotine replacement therapy to help you give up smoking, the amount of nicotine that the baby may receive is considerably smaller and less harmful than the second-hand smoke they would otherwise be breathing in.

Driving and using machines

The chewing gum is unlikely to affect your ability to drive or operate machinery.

Important information about some of the ingredients of Nicotinell Medicated chewing gum

These chewing-gums contain some ingredients of which you may need to be aware of:

  • sorbitol: if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine

Each piece of Ice mint flavour gum contains 0.1g, a source of 0.02 g fructose.

  • sodium: Each piece of Icemint flavour gum contains 11.44 mg per piece. To be taken into consideration by those on a controlled sodium diet
  • butylhydroxytoluene (E321): an ingredient of the gum base of Nicotinell Icemint flavour gums which may cause local irritation to the lining of the mouth.

For other ingredients see Section 6.

3 how to take nicotinell chewing-gum

Chew one piece of gum when you feel the urge to smoke. It is important to chew the gum correctly, not like ordinary chewing-gum. Follow the instructions below and do NOT swallow the gum: Chewing technique:

  • 1. Chew one piece of gum slowly until the taste becomes strong.

  • 2. Rest between your gum and cheek.

  • 3. Chew again when taste has faded.

  • 4. Repeat this chewing routine for about 30 minutes.

Most people use 8 – 12 pieces of 2 mg or 4 mg gum a day.

Do NOT use more than 1 piece of gum at a time, more than 25 pieces of 2 mg gum a day or more than 15 pieces of 4 mg gum a day.

Remember not to drink certain drinks 15 minutes before chewing the gum (see Section 2).

The gum can stick to and very rarely damage dentures or other dental work. You may prefer to use a patch or lozenge.

After 3 months, you should try to gradually reduce the number of pieces of gum chewed each day. You should stop using the gum when you are only taking 1–2 pieces of gum per day.

For the relief of breakthrough cravings:

If you are attempting to quit smoking using a patch programme, you can use these gums to relieve any breakthrough cravings you may experience. Chew one piece of gum if you feel the need to smoke. Counselling may improve your chances of giving up smoking.

Children and adolescents (12 –18 years) should only use the gum for 12 weeks. If longer is required then talk to your doctor, nurse or pharmacist.

Children under 12 years should not use the gum unless advised by a doctor.

If you take more Nicotinell chewing-gums than you should

If you accidentally take too many, or if a child has eaten any, contact your doctor or nearest hospital casualty department immediately, take the pack or leaflet with you if possible.

Nicotine ingestion by a child may result in severe poisoning.

The general symptoms of nicotine overdose include:

  • weakness, sweating, increased production of saliva, throat burn, headache, sickness, diarrhoea stomach pains, disturbed hearing and vision, disturbance in heartbeat, shortness of breath and circulatory problems

If you forget to use Nicotinell chewing-gums

Only chew the gum when you need to. Do NOT use more than 1 piece of gum at a time or more than 25 pieces of 2 mg gum a day, or 15 pieces of 4 mg gum a day.

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

4 possible side effects

Like all medicines, Nicotinell chewing-gums can cause side effects, although not everybody gets them.

STOP using the gum and seek medical help immediately if you have any of the following which may be signs of an allergic reaction:

  • difficulty breathing or swallowing, swelling of the mouth, face, lips, tongue or throat.
  • severe itching of the skin, with a red rash or raised lumps.

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 (occur in 1 to 10 users in 100)

  • dizziness and headache.
  • Hiccups, stomach trouble such as nausea, flatulence, vomiting, heartburn, increased saliva production, irritation of the mouth and throat and jaw muscle ache may also occur, especially as a result of intense chewing. Check that you are following the correct chewing technique if you experience these effects.

Uncommon side effects (occur in 1 to 10 users in 1,000)

  • palpitations.
  • red skin rash (erythema) and itching of raised bumps of the skin (urticaria).

Rare side effects (occur in 1 to 10 users in 10,000)

  • disturbances in heart beat rhythm and allergic reactions.

Mouth ulcers may be related to quitting smoking and not to your treatment.

The chewing-gum can stick to and very rarely damage dentures or other dental work.

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.

Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at. Alternatively you can call Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available from your local pharmacy.

5 how to store nicotinell chewing-gum

Keep out of the reach and sight of children.

Do not use Nicotinell gums after the expiry date which is stated on the blister pack and box after “EXP”. The expiry date refers to the last day of that month.

Do not store above 25°C.

To dispose of used gum, wrap in paper before putting into a waste bin. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

  • 6 Further information

What Nicotinell chewing-gum contains

The active substance is nicotine.

Each piece of Nicotinell 2mg medicated chewing-gum contains 2 mg of nicotine in a resin complex (as 10 mg nicotine polacrillin).

Each piece of Nicotinell 4mg medicated chewing-gum contains 4mg of nicotine in a resin complex (as 20 mg nicotine polarcrillin).

The other ingredients of Nicotinell Icemint flavour gums are:

  • gum base (containing butylhydroxytoluene (E321)), calcium carbonate (E170), sorbitol (E420), sodium carbonate anhydrous, sodium hydrogen carbonate (E500), polacrilin, glycerol (E422), purified water, levomenthol, sucralose (E955), acesulfame potassium (E950), xylitol (E967), mannitol (E421), gelatin, titanium dioxide (E171), carnauba wax (E903) and talc (E553b). (see also Section 2 for further ingredient information).

Flavours:

  • Icemint 2 mg and 4 mg Gum contains natural mint flavouring and mint millicaps Nicotinell gum is sugar-free.

What Nicotinell chewing-gum looks like and contents of the pack

Each piece of chewing-gum is off-white in colour and rectangular in shape.

The Icemint 2 mg and 4 mg Gums are packed in blisters inside boxes containing 12, 24, 36, 72, 96, 120 and 204 pieces of gum. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

GlaxoSmithKline Consumer Healthcare (UK) Trading Limited, Brentford, TW8 9GS, U.K. Manufacturer

FAMAR S.A. 48th km Athens-Lamia, 19011, Avlona,

Greece.

Help/Advice

You can also find additional information and support

@ or by calling the NHS helpline on 0800 0224322.

This leaflet was last approved in February 2016.

<logo – GSK>

Frequently Asked Questions

What is Nicotinell Support Icemint 2 mg Medicated Chewing Gum used for?

Nicotinell Support Icemint 2 mg Medicated Chewing Gum is used to help people quit smoking by reducing withdrawal symptoms and cravings for nicotine.

How does Nicotinell Icemint chewing gum work?

The gum releases a small amount of nicotine as you chew, which helps to satisfy your body's craving for nicotine without the harmful effects of smoking.

Can anyone use Nicotinell gum to quit smoking?

Nicotinell gum is designed for adult smokers who want to quit. It's not recommended for non-smokers or young individuals under 18.

How often can I chew Nicotinell Icemint gum?

You can chew up to 15 pieces of Nicotinell Icemint gum per day, but it's best to follow your healthcare provider's advice on the frequency.

Is it safe to use Nicotinell chewing gum during pregnancy?

It's important to consult your doctor before using any nicotine replacement products during pregnancy or breastfeeding.

What are the side effects of using Nicotinell Support gum?

Some common side effects may include mouth irritation, hiccups, and jaw discomfort. Most side effects are mild and temporary.

Can I get addicted to Nicotinell chewing gum?

While Nicotinell contains nicotine, it's meant as a temporary aid to help you quit smoking. If used as directed, it should not lead to long-term dependence.

How long should I use Nicotinell Icemint gum while trying to quit smoking?

Most people should aim to gradually reduce their use over 8-12 weeks; however, follow your healthcare provider's plan that fits your needs.

Can I smoke while using Nicotinell chewing gum?

No, you should not smoke while using the gum as this can lead to excessive nicotine intake and increase side effects.

What flavor does Nicotinell Support Icemint gum come in?

Nicotinell Support Icemint gum has a cool minty flavor that helps freshen your breath while aiding in smoking cessation.

Do I need a prescription for Nicotinell chewing gum?

No, you can buy Nicotinell Support Icemint chewing gum over-the-counter at pharmacies without a prescription.

What if I forget to chew my Nicotinell gum at the scheduled time?

If you miss a dose, simply resume your normal schedule. Do not double up on doses if you miss one!

Can children use Nicotinell chewing gum?

No, this product is intended for adults only and should be kept out of reach of children.

Is it safe to use other medications with Nicotinell Support gum?

Always consult with your doctor or pharmacist before combining any medications with Nicotinell chewing gum.

Will using Nicotinell Icemint help stop weight gain after quitting smoking?

While some people worry about weight gain when quitting smoking, using nicotine replacement therapy like Nicotinell can help manage cravings and reduce stress eating.

How long does it take for the effects of Nicotinell chewing gum to kick in?

Most users feel relief from cravings within a few minutes after chewing the gum, as nicotine is absorbed quickly through the lining of the mouth.

Can I chew more than one piece at a time for quicker relief from cravings?

No, it's not recommended to chew more than one piece at once as this can lead to increased side effects like nausea and dizziness.

How should I store my Nicotinell chewing gum?

Store the chewing gum in a cool, dry place away from direct sunlight and keep it in its original packaging until you're ready to use it.

Is there an age limit for purchasing Nicotinell products?

Yes, customers must be over 18 years old to purchase Nicotinell products without parental consent or guidance from healthcare providers.

Where can I buy Nicotinell Support Icemint 2 mg Medicated Chewing Gum?

Nicotinell Support Icemint can be found at most pharmacies and supermarkets or purchased online from authorized retailers.