CHAMPIX 0.5mg./1mg. 14 tablets

WHAT CHAMPIX IS AND WHAT IT IS USED FOR

CHAMPIX is a non-narcotic medicine that is used to help you stop smoking. CHAMPIX can help alleviate the symptoms of irreversible desire and withdrawal associated with stopping smoking.
Although it is not recommended to smoke while you are on treatment, CHAMPIX may also reduce the pleasure of smoking if you smoke during treatment.

2. BEFORE YOU TAKE CHAMPIX
Do not take CHAMPIX
- If you are allergic (hypersensitive) to varenicline tartrate or any of the other ingredients of CHAMPIX.
Take special care with CHAMPIX

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.

Effects of stopping smoking
The effects of changes in your body resulting from stopping smoking with or without treatment with CHAMPIX can change the way other medicines work. Therefore, in some cases dose adjustment may be necessary. Examples include theophylline (a medicine to treat breathing problems), warfarin (a medicine to suppress clotting) and insulin (a medicine to treat diabetes). If you have any fluctuations, you should consult your doctor or pharmacist.
In some people, stopping smoking is associated with an increased likelihood of experiencing feelings such as depression and anxiety.
You may temporarily experience increased irritability, a desire to smoke, depression and / or sleep disturbances when you stop taking CHAMPIX. Your doctor may decide to gradually reduce your CHAMPIX dose at the end of treatment.

Effects of CHAMPIX on other medicines
CHAMPIX is not expected to affect the effects of other medicines.

Effects of other medicines on CHAMPIX
Due to the way varenicline tartrate is removed from the body, no other medication is expected to affect the way CHAMPIX works.
Using CHAMPIX with other means of stopping smoking The safety and benefits of taking CHAMPIX in combination with other medicines to stop smoking have not been studied. Therefore, the use of CHAMPIX in combination with other means of stopping smoking is not recommended. CHAMPIX is not recommended for use in children or adolescents under 18 years of age.

Take CHAMPIX with food and drink
CHAMPIX can be taken with or without food.

Pregnancy
You should not take CHAMPIX during pregnancy.
Tell your doctor if you plan to become pregnant. If you want to start treatment with CHAMPIX, your treatment should be scheduled in time so that you have completed the course before you become pregnant.

Breastfeeding
Although not studied, CHAMPIX may pass into breast milk. You should talk to your doctor or pharmacist before using CHAMPIX.

Driving and using machines
CHAMPIX can cause dizziness and drowsiness. You should not drive, operate complicated equipment, or engage in any other risky activity until you know whether this medicine affects your ability to do so.

3. HOW TO TAKE CHAMPIX
You are more likely to stop smoking if you are motivated to stop. Your doctor and pharmacist can provide advice, support, and sources of additional information to ensure success in your attempt to stop smoking.
Always take CHAMPIX exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Before starting your CHAMPIX course, you must specify a date from the second treatment week (between day 8 and day 14) when you stop smoking. You must write this date on the Reminder Pack.
CHAMPIX tablets should be swallowed whole with water.
If you experience side effects that you can not tolerate, your doctor may decide to temporarily or permanently reduce your dose to 0.5 mg twice a day.
After 12 weeks of treatment, if you stop smoking, your doctor may recommend an additional 12 weeks of treatment with CHAMPIX 1 mg film-coated tablets twice daily.
In the smoking cessation treatment, the risk of smoking resumption is increased in the period immediately after the end of the treatment. Your doctor may decide to gradually reduce your CHAMPIX dose at the end of the treatment.
If you have kidney problems, you should consult your doctor before taking CHAMPIX. You may need a lower dose.

If you take more CHAMPIX than you should
If you accidentally take more CHAMPIX tablets than your doctor prescribed, you should immediately seek medical advice or go to the nearest emergency department. Take your tablet box with you. If you forget to take CHAMPIX, do not take a double dose to make up for the forgotten tablet. It is more important to take CHAMPIX regularly at the same time each day. If you forget to take a dose, take it as soon as you remember the missed dose. If time for the next dose has almost come, do not take the tablet you missed.

If you stop taking CHAMPIX
In clinical trials, it has been proven that taking all the doses of your medicine at the appropriate time and the recommended duration of treatment described above will increase your chances of stopping smoking. Therefore, it is important that you continue to take CHAMPIX as directed in the above table unless your doctor tells you to stop treatment. If you have any further questions on the use of this product, please ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Quitting smoking with or without treatment can cause various symptoms. These may include mood swings (such as feeling depressed, irritable, discouraged, or anxious), insomnia, difficulty concentrating, decreased heart rate and increased appetite or weight gain.
Like all medicines, CHAMPIX can cause side effects, although not everybody gets them.
- Very common side effects that may affect more than 1 in 10 people are listed below:
O Headache, difficulty falling asleep, strange dreams
O Nausea
- Common side effects that may affect more than 1 in 100 people are listed below:
O Increased appetite, taste changes, dry mouth
O Drowsiness, tiredness, dizziness
O Vomiting, constipation, diarrhea, feeling swollen, stomach discomfort, indigestion, increased gas formation
- Uncommon side effects that may affect more than 1 in every 1,000 people are listed below:
O Infection of the airways, discomfort or pain, inflammation of the sinuses
O Fever, feeling cold, feeling weak or unwell, viral infection, shortness of breath, cough, hoarse voice, sore throat and soreness, blocked sinuses, nasal discharge. Snoring
O Loss of appetite, feeling thirsty, increased weight
O Feeling of panic, difficulty thinking, mood swings
O Trembling, difficulty in coordination, impaired speech, decreased sensitivity to touch, increased muscle tone, anxiety
O Heart rhythm abnormal, increased blood pressure, increased heart rate
O Disturbed vision, eye color changes, eye pain, enlarged pupils, myopia, light sensitivity, eye watery,
O Tearing in your ears
O Blood in the vomiting, irritable stomach and "heartburn", abdominal pain, changes in the stools, clear blood in the stool, belching, mouth ulceration, gum ache,
O Skin rash, cyst, fungal infection, skin redness, itching, acne, increased sweating
O Chest pains and ribs, stiffness of joints, muscle spasms
O Sugar in the urine, increased urine volume and urination frequency
O Increased menstrual bleeding, vaginal discharge, changes in sexual desire and abilities
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.

5. HOW TO STORE CHAMPIX
Keep out of the reach and sight of children.
Do not use CHAMPIX after the expiry date which is stated on the package card or carton. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unnecessary medicines. These measures will help to protect the environment.

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