Last Edit: 22 Apr 2015 by NW

Status: Issue 1 Final

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Module 1.3.1- Nicotine

0.45mg Inhaler Patient

Information Leaflet

novations

CONFIDENTIAL

NICOTINE 0.45 MG INHALER

nicotine

What you should know about the Nicotine Inhaler

Please read this leaflet carefully before you start using this medicine. It provides useful information on how to use it safely. Keep the leaflet, you might need it again. If you think you are having side-effects, have any questions or are not sure about anything, please ask your doctor, nurse, pharmacist.

In this leaflet:

1.    What Nicotine Inhaler    is and what it is used for

2.    Before using Nicotine    Inhaler

3.    How and when to use    Nicotine    Inhaler

4.    Possible side-effects

5.    How to clean, store and dispose of Nicotine Inhaler

6.    Further information

1. WHAT NICOTINE INHALER IS AND WHAT IT IS USED FOR

Nicotine Inhaler is a nicotine inhalation device that is used in a similar way to smoking and substitutes the nicotine that you normally get from cigarettes. Nicotine Inhaler is an alternative to smoking.

It is the toxins in cigarette smoke such as tar, lead, cyanide and ammonia that cause smoking related disease and death, not the nicotine.

By using this Nicotine Replacement Therapy, you and those around you, will not be exposed to the serious health risk associated with smoking.

For the full health benefits you should use Nicotine Inhaler to help you stop smoking completely. If you’re not ready to do this, it can also help you cut down. Alternatively you can use Nicotine Inhaler when you are unable to smoke or want to avoid causing harm to others e.g. children, friends or family.

When you use Nicotine Inhaler, nicotine is released and passes into your body, just like a cigarette but without the harmful chemicals in the smoke. You can use Nicotine Inhaler as you would a cigarette and inhale as much as desired.

For the best effect, ensure that you use your Nicotine Inhaler correctly - see “How and when to use Nicotine Inhaler’.

The benefits of stopping smoking far outweigh any potential risk from using nicotine from Nicotine Inhaler. There are no circumstances in which it is safer to smoke than to use Nicotine Inhaler.

Since the product replaces nicotine from smoking, it can help relieve nicotine withdrawal symptoms such as irritability, low mood, anxiety, restlessness and cravings when used in place of cigarettes.

2. BEFORE USING NICOTINE INHALER

Do not use Nicotine Inhaler:

-    if you have an allergy to nicotine or any of the other ingredients (see section 6).

-    if you are under 18 years of age.

Any risks associated with Nicotine Inhaler are less than those of continued smoking. However,

talk to your doctor, nurse or pharmacist:

-    if you are pregnant or breast-feeding - you may be able to use Nicotine Inhalerto help you give up smoking; but you should try to give up without it. See “If you are pregnant or breastfeeding’.

-    if you are in hospital because of heart disease (including heart attack, disorders of heart rate or rhythm, or stroke). In other heart conditions not requiring you to be in hospital, using Nicotine Inhaler is better than continuing to smoke.

-    if you have a stomach ulcer, duodenal ulcer, inflammation of the stomach or inflammation of the oesophagus (passage between the mouth and stomach).

-    if you have liver or kidney disease.

-    if you have a long-term throat disease or difficulty breathing due to bronchitis, emphysema or asthma. Nicotine Inhalermay not be suitable for you to use and you may be advised to use a different type of nicotine product.

-    if you have an overactive thyroid gland or have a phaeochromocytoma (a tumour of the adrenal gland that can affect blood pressure) - your doctor will have told you this.

-    if you have diabetes - monitor your blood sugar levels more often when starting to use Nicotine Inhaler as you may find your insulin or medication requirements alter.

-    if you are taking any other medicines such as theophylline, clozapine or ropinirole. Stopping smoking or cutting down may require the dose of these medicines to be adjusted.

If you are pregnant or breast-feeding:

-    Firstly, you should try to give up smoking without using a nicotine product. Stopping completely is by far the best option. The earlier and quicker you do this the better it is for you and your baby.

-    Secondly, if you can’t manage this, you can use Nicotine Inhaler as a safer alternative to smoking. However, you should talk to your doctor, nurse or pharmacist for advice.

-    If breast-feeding, try to do so before using Nicotine Inhaler to ensure the baby gets the smallest amount of nicotine possible. If you do need to use Nicotine Inhaler, the amount of nicotine that the baby may receive is considerably smaller and less harmful than the second-hand smoke they would have inhaled if you smoked. Tobacco smoke produces breathing and other problems in babies and children.

Nicotine Inhaler contains ethanol (alcohol).

This medicinal product contains small amounts of ethanol (alcohol), less than 10mg per charged stick.

3. HOW AND WHEN TO USE NICOTINE INHALER

Method of administration

Charging the Nicotine Inhalerstick:

•    Tear away the strip on the pack and remove the cellophane outer wrap completely.

•    Peel away the foil strip at the bottom of the pack.

•    Click open the side door and remove the Nicotine Inhaler stick.

•    Hold the pack upright and away from you.

•    Insert the arrowed end of the stick into the base of the pack and push firmly for five seconds to charge.

•    The first time you charge a Nicotine Inhaler stick, you need to repeat this charging step and shake well before use.

•    If you have not used Nicotine Inhaler for more than two days, repeat this charging step.

• You should only fill the stick before you intend to use it.

If spray comes into contact with skin or eyes, rinse gently with water.

Using the Nicotine Inhalerstick:

•    Inhale through the filter end of the stick as you would with a cigarette ensuring you don’t cover the air inlet holes at the filter end of the stick.

•    On average each charge apart from the first one provides a comparable number of puffs to a conventional cigarette.

•    The stick is empty when you no longer feel the flavoured spray in your mouth.

•    Put the Nicotine Inhaler stick back in the pack when not in use.

•    On normal use, you are unlikely to see any vapour. Whether you see it or not, the vapour is harmless to you and to those around you.

•    As with most inhaled medications, the therapeutic effect of this medication may decrease when the pack is cold.

Recharging the Nicotine Inhalerstick:

•    To recharge the stick follow the relevant instructions in “Charging the Nicotine Inhaler stick”.

•    The stick can be charged up to twenty times, sometimes more if the stick is only partially emptied between charges.

When to use Nicotine Inhaler

For the full health benefits you should use Nicotine Inhaler to help you stop smoking completely. When ready, which may be after many months, you should aim to reduce the number of packs until you have stopped using them completely. However, it is safer to remain on Nicotine Inhaler longterm than to re-start smoking.

If you’re not ready to stop smoking completely, Nicotine Inhaler can also help you cut down. You should replace as many cigarettes as possible with Nicotine Inhaler as reducing the number of cigarettes may also help you to become more motivated to stop smoking.

Alternatively you can use Nicotine Inhaler when you are unable to smoke or want to avoid causing harm to others e.g. children, friends or family.

Dosage

Adults aged over 18 years: as needed; up to a maximum of 2 full packs per day.

Module 1.3.1- Nicotine 0.45mg Inhaler Patient Information Leaflet

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The frequency with which you use Nicotine Inhaler and the length of time it lasts will depend on how many cigarettes you previously smoked and how strong they were.

If you use more Nicotine Inhalerthan you should

If you have used more than the recommended number of packs, you may experience feeling sick (nausea), salivation, pain in your abdomen, diarrhoea, sweating, headache, dizziness, hearing disturbance or weakness. If you get any of these effects, contact a doctor or your nearest hospital Accident and Emergency department. Take this leaflet and the pack with you.

If a child under 12 uses Nicotine Inhaler

Do not be alarmed, but contact a doctor or your nearest hospital Accident and Emergency department immediately. Take this leaflet and the pack with you. Nicotine inhalation or ingestion by a child may result in severe poisoning.

4. POSSIBLE SIDE-EFFECTS

Like all nicotine-containing products, Nicotine Inhaler can have side-effects. As many of the effects are due to nicotine, they can also occur when nicotine is obtained by smoking.

If you notice a fast, slow or irregular heartbeat, stop using the medicine, do not smoke and see your doctor as soon as possible.

Effects related to stopping smoking (nicotine withdrawal)

You may experience unwanted effects because by stopping smoking you have reduced the amount of nicotine you are taking. You may also experience these effects if you under use Nicotine Inhaler before you are ready to reduce your nicotine intake.

These effects include:

-    irritability or aggression

-    feeling low

-    anxiety

-    restlessness

-    poor concentration

-    increased appetite or weight gain

-    urges to smoke (craving)

-    night time awakening or sleep disturbance

-    lowering of heart rate

When you stop smoking you may also develop mouth ulcers. The reason why this happens is unknown.

Effects of too much nicotine

You may get the following effects if you are not used to inhaling tobacco smoke:

-    feeling faint

-    feeling sick (nausea)

-    headache

Side-effects for the Inhaler Very common side-effects:

(more than 1 in every 10 people are affected)

-    headache

-    cough

-    irritation of the mouth or throat

Common side-effects:

(less than 1 in every 10 people are affected)

-    dizziness

-    nasal congestion

-    stomach discomfort

-    hiccups

-    feeling sick (nausea)

-    vomiting (sickness)

Uncommon side-effects:

(less than 1 in every 100 people are affected)

-    chest palpitations

Very rare side-effects:

(less than 1 in 10,000 people are affected)

-    abnormal beating of the heart

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 CLEAN, STORE AND DISPOSE OF NICOTINE INHALER

Cleaning the Nicotine Inhaler stick:

Wipe the mouthpiece of the stick gently with a dry tissue.

Storing Nicotine Inhaler:

Keep out of the reach and sight of children and animals. Nicotine in high amounts can be very dangerous and sometimes fatal if used or swallowed by small children.

Pressurised container. Do not expose to temperatures higher than 50°C. Do not puncture, break or burn even when empty. Store below 25°C. Store away from heat or direct sunlight. Do not attempt to light the stick.

Once opened discard Nicotine Inhaler within 7 days and do not use Nicotine Inhaler after the ‘EXP’ date shown on the carton.

Disposal:

Because of residual nicotine and the potential choking hazard, used packs and sticks may be a hazard to children, animals and fish and so should never be left lying around. The stick should be kept in the pack and disposed of with household rubbish or an appropriate recycling facility.

6.    FURTHER INFORMATION

What Nicotine Inhalercontains:

The active substance is nicotine.

The other ingredients are propylene glycol, ethanol, saccharin, levomenthol and HFA134a (a CFC-free propellant).

What Nicotine Inhaler looks like and contents of the pack:

Nicotine Inhaler contains one cigarette-like inhaler stick and one pressurised aluminium aerosol canister (enclosed within the pack) containing 20 charges. Each charge contains 0.45mg nicotine equivalent to a delivered dose of 0.43mg nicotine, except for the first charge, which delivers less than 0.43 mg (range 0.10 - 0.30 mg) due to stick design.

Nicotine Inhaler is supplied in 1,2x1 or 5x1 pack sizes.

Not all pack sizes may be marketed.

Marketing Authorisation Holder: Nicovations Limited, Globe House, 1 Water Street, London, WC2R 3LA

Manufacturer: Bespak Europe Ltd, Bergen Way, Kings Lynn, PE30 2JJ.

This leaflet was last revised in 02/2015.

To request a copy of this leaflet in Braille, large print or audio format contact Nicovations on 0800 210 0110, or via email at info@nicovations.com.

Nicotine Inhaler is a registered trade mark of Nicovations Limited.**

{** text will be included on marketed pack when an appropriate tradename is approved by variation for ‘Nicotine Inhaler’ before placing the product on the market}