Niquitin Mini Citrus

Package Leaflet: Information for the User

NiQuitin MINI Citrus, 2 mg, lozenges

Nicotine

Read all of this leaflet carefully before using this medicine because it contains important information for you.

This medicine is to be used only as described in this leaflet or as directed by a healthcare professional.

• You should keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
• If you are not able to stop smoking or cut down on smoking after using NiQuitin MINI Citrus, you should talk to your doctor.

Contents of the pack

• 1. What NiQuitin MINI Citrus is and what it is used for
• 2. Important information before using NiQuitin MINI Citrus
• 3. How to use NiQuitin MINI Citrus
• 4. Possible side effects
• 5. How to store NiQuitin MINI Citrus
• 6. Contents of the pack and other information

1. What NiQuitin MINI Citrus is and what it is used for

NiQuitin MINI Citrus lozenges help you stop smoking by reducing your craving for nicotine and the withdrawal symptoms that you may experience when you stop smoking. This type of treatment is called Nicotine Replacement Therapy (NRT). NiQuitin MINI Citrus is used to help adults and children over 12 years of age to stop smoking. The 2 mg lozenges are suitable for smokers who smoke less than 20 cigarettes a day.

• Nicotine in tobacco causes physical addiction to smoking. NiQuitin MINI Citrus lozenges help you to stop smoking by replacing some of the nicotine you get from cigarettes. The nicotine in the lozenges helps to relieve some of the unpleasant symptoms that you may experience when you stop smoking, such as irritability and anxiety. The nicotine also helps to reduce your craving for cigarettes.

NiQuitin MINI Citrus lozenges do not contain the tar, carbon monoxide, and other harmful chemicals found in tobacco smoke. Some people may be concerned about becoming addicted to lozenges containing nicotine. This is unlikely, and even if it does happen, it is less harmful than smoking.

2. Important information before using NiQuitin MINI Citrus

When not to use NiQuitin MINI Citrus

• If you are allergic to nicotine or any of the other ingredients listed in section 6.
• In children under 12 years of age.
• In non-smokers.

Warnings and precautions

Before you start using NiQuitin MINI Citrus, tell your doctor or pharmacist:

• If you have any heart problems, or have had a stroke, or you have a severe blood vessel disease.
• If you have diabetes.
• If you have an overactive thyroid gland.
• If you have a tumor of the adrenal gland (such as a pheochromocytoma).
• If you have stomach or duodenal ulcers or inflammation of the stomach (gastritis) or the esophagus (esophagitis).

Do not use NiQuitin MINI Citrus lozenges if you are pregnant or breastfeeding unless your doctor tells you that you can.

Children and adolescents

Do not use NiQuitin MINI Citrus in children under 12 years of age. The typical dose of nicotine for an adult smoker can cause severe poisoning in a child. Always keep NiQuitin MINI Citrus out of the reach of children.

Other medicines and NiQuitin MINI Citrus

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.

Eating and drinking while using NiQuitin MINI Citrus

Do not eat or drink while using NiQuitin MINI Citrus lozenges. Acidic drinks like coffee, soda, or fruit juices may decrease the absorption of nicotine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, you should try to stop smoking without using NiQuitin MINI Citrus. However, if you are unable to stop smoking without help, your doctor may recommend using NiQuitin MINI Citrus.

Driving and using machines

There is no information to suggest that NiQuitin MINI Citrus affects your ability to drive or use machines.

NiQuitin MINI Citrus contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per lozenge, that is to say essentially 'sodium-free'.

3. How to use NiQuitin MINI Citrus

Always use NiQuitin MINI Citrus exactly as described in this leaflet or as directed by your doctor or pharmacist.

NiQuitin MINI Citrus lozenges are designed to be sucked, allowing the nicotine to be released and absorbed through the mouth tissue.

Suck one lozenge until it dissolves (about 10 minutes). Do not chew or swallow the lozenge whole.

Adults (18 years and over)

Monotherapy:

• Stopping smoking immediately
• Use one lozenge when you have the urge to smoke (use 8-12 lozenges per day for up to 6 weeks).
• Gradually reduce the number of lozenges used per day.

Reducing smoking before quitting

• Use one lozenge when you have the urge to smoke instead of smoking a cigarette.
• Try to reduce the number of cigarettes you smoke per day.

Combination therapy

Combination therapy is for smokers who have failed monotherapy or for those who are heavily addicted to nicotine.

Patch and lozenge combination: Use a nicotine patch in combination with NiQuitin MINI Citrus lozenges.

Children and adolescents

NiQuitin MINI Citrus is not recommended for children under 12 years of age.

If you use more NiQuitin MINI Citrus than you should

If you use too many lozenges, you may experience nausea, dizziness, and headaches. Stop using the lozenges and talk to a doctor or pharmacist.

4. Possible side effects

Like all medicines, NiQuitin MINI Citrus can cause side effects, although not everybody gets them.

Stop using NiQuitin MINI Citrus and tell your doctor or pharmacist if you experience any of the following side effects:

• Severe allergic reaction, with symptoms such as difficulty breathing, swelling of the face, lips, tongue, or throat.
• Skin rash or redness, itching, or swelling.

Other side effects that may occur:

• Common (affects less than 1 in 10 people): nausea, vomiting, headache, dizziness.
• Uncommon (affects less than 1 in 100 people): palpitations, increased heart rate.
• Rare (affects less than 1 in 1,000 people): hypersensitivity, seizures.

5. How to store NiQuitin MINI Citrus

Keep NiQuitin MINI Citrus out of the reach of children.

Do not use NiQuitin MINI Citrus after the expiry date which is stated on the carton.

Store in the original package to protect from moisture.

6. Contents of the pack and other information

Each lozenge contains 2 mg of nicotine.

The other ingredients are mannitol, sodium alginate, xanthan gum, potassium bicarbonate, calcium polycarbophil, sodium carbonate, acesulfame potassium, citrus flavor, magnesium stearate, and sucralose.

NiQuitin MINI Citrus lozenges are white or off-white, oval-shaped, and have the letters "CIT2" embossed on one side.

The pack contains 1, 3, or 5 containers, each containing 20, 60, or 100 lozenges, respectively.