0.5 mg and 1 mg film-coated tablets
varenicline
1. What CHAMPIX is and what it is used for
CHAMPIX contains the active substance varenicline. CHAMPIX is a medicine used by adults to quit smoking.
CHAMPIX can help relieve cravings and other symptoms that may occur when trying to quit smoking.
CHAMPIX can also reduce the pleasure of cigarettes if you smoke during treatment.
2. What you need to know before using CHAMPIX
Do not use CHAMPIX
- If you are allergic to varenicline or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor or pharmacist before taking CHAMPIX.
There have been cases of depression, suicidal ideation, suicidal behavior, and suicide attempts in patients taking CHAMPIX. If you are taking CHAMPIX and develop anxiety, depression, changes in your behavior that worry you or your loved ones, or if you experience suicidal thoughts or behavior, stop taking CHAMPIX and contact your doctor immediately for an assessment of treatment.
The effects of smoking cessation
The changes that occur in your body when you stop smoking, regardless of whether you are treated with CHAMPIX or not, can affect the effectiveness of other medicines. In some cases, therefore, a dose may need to be adjusted. For more information, see below under “Other medicines and CHAMPIX”.
Some people who have tried to quit smoking, with or without treatment, have experienced an increased degree of mental symptoms such as changes in mindset or behavior, depression or anxiety, and may lead to worsening of mental illness. If you have previously had a mental illness, discuss this with your doctor.
Heart symptoms
New or worsening symptoms from the heart or blood vessels (cardiovascular) have been reported mainly in patients who already have cardiovascular disease. Tell your doctor if your symptoms change during treatment with CHAMPIX. Seek emergencymedical attention immediately if you experience symptoms of a heart attack or stroke .
Cramps
Tell your doctor if you have had seizures or are suffering from epilepsy before starting your treatment with CHAMPIX. Some patients have reported seizures during treatment with CHAMPIX.
Hypersensitivity s
Stop taking CHAMPIX and contact your doctor immediately if you get any of the following signs and symptoms that may indicate a severe allergic reaction: swelling of the face, lips, tongue, palate, throat, or body and/or difficulty breathing and wheezing.
Skin reactions
Potential life-threatening rash ( Stevens-Johnson syndrome and multiforme erythema) has been reported with the use of CHAMPIX. If you get a rash or if your skin starts to flake or if you get blisters, stop taking CHAMPIX and seek emergencymedical help immediately .
Children and young people
CHAMPIX is not recommended for the treatment of children or adolescents under 18 years of age as no effect has been demonstrated.
Other medicines and CHAMPIX
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
As a result of quitting smoking with or without CHAMPIX, in some cases, the dose ofone of the other medicines may need to be adjusted. Examples are theophylline (a medicine used for breathing difficulties), warfarin (a medicine to reduce the risk of blood clots), and insulin (a medicine for diabetes ). If you are not sure, talk to your doctor or pharmacist.
If you have severe kidney disease, you should avoid taking cimetidine (a medicine used to treat stomach problems) at the same time as CHAMPIX as this may cause high blood levels of CHAMPIX.
Use of CHAMPIX with other smoking cessation treatments
Talk to your doctor before using CHAMPIX in combination with other smoking cessation treatments.
CHAMPIX with food, drink and alcohol
There have been some reports of increased alcohol intoxication in patients taking CHAMPIX. However, it is not known whether CHAMPIX actually increases the poisoning effect of alcohol.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
You should not take CHAMPIX if you are pregnant. Talk to your doctor if you are planning to have a baby.
Although not studied, CHAMPIX may pass into breast milk. You should consult your doctor or pharmacist before taking CHAMPIX.
Driving and using machines
CHAMPIX may be associated with dizziness, drowsiness and transient loss of consciousness. You should not drive, use advanced machines, or engage in any other potentially hazardous activities until you know if this medicine affects your ability to perform these activities.
CHAMPIX contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.
3. How to use CHAMPIX
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
It is easier for you to quit smoking if you are motivated. Doctors and pharmacists can give you advice and support as well as information brochures, which can help you succeed in quitting smoking.
Before starting treatment with CHAMPIX, you should usually decide on a day during the second week of treatment (between Day 8 and Day 14) when you want to stop smoking. If you do not want or can set a goal end date within 2 weeks, you can choose your own goal end date within 5 weeks after starting treatment. Write this date on the package as a reminder.
CHAMPIX is a white tablet (0.5 mg) and a light blue tablet (1 mg). You start with the white tablet and then usually switch to the light blue tablet.
See the table below for the usual dosing instructions that you should follow from Day 1.
| Week 1 | Dose |
| Day 1-3 | From Day 1 to Day 3, take a white CHAMPIX 0.5 mg film-coated tablet once a day. |
| Day 4-7 | From Day 4 to Day 7, take a white CHAMPIX 0.5 mg film-coated tablet twice a day, morning and evening, at approximately the same time each day. |
| Week 2 | |
| Day 8-14 | From Day 8 to Day 14, take a light blue CHAMPIX 1 mg film-coated tablet twice a day, morning and evening, at approximately the same time each day. |
| Week 3-12 | |
| Day 15- end of treatment | From Day 15 until the end of treatment, you should take a light blue CHAMPIX 1 mg film-coated tablet twice a day, morning and evening, at approximately the same time each day. |
If you have managed to quit smoking after 12 weeks of treatment, your doctor may recommend additional 12-week treatment with CHAMPIX 1 mg film-coated tablets twice a day to help you stop smoking again.
If you cannot or do not want to stop smoking immediately, you should reduce your smoking during the first 12 weeks of treatment and stop smoking completely when the treatment period is over. You should then continue to take CHAMPIX 1 mg film-coated tablets twice a day for a further 12 weeks, giving a total treatment duration of 24 weeks.
Should you experience side effects that you can not tolerate, your doctor may decide to reduce the dose to 0.5 mg twice a day temporarily or permanently.
If you have kidney problems, talk to your doctor before taking CHAMPIX. You may need a lower dose.
CHAMPIX is for oral use.
The tablets should be swallowed whole with water and can be taken with or without food.
If you use more CHAMPIX than you should
If you have accidentally taken more CHAMPIX than your doctor prescribed, talk to a doctor immediately or contact your nearest hospital emergency department. Bring the box of tablets.
If you forget to use CHAMPIX
Do not take a double dose to make up for a forgotten tablet. It is important that you take CHAMPIX regularly at the same time each day. If you forget to take a dose, take it as soon as you remember. If the next dose is to be taken within 3-4 hours, skip the tablet you missed.
If you stop using CHAMPIX
In clinical trials , it has been shown that your chances of succeeding in smoking increase if you take all doses of the drug at the right time and for as long as stated above. It is therefore important to continue taking CHAMPIX according to the instructions in the table above unless your doctor asks you to stop treatment.
During smoking cessation, the risk of resuming smoking is increased for a period immediately following the end of treatment. You may temporarily experience increased irritation, smoking, depression, and/or sleep disturbances when you stop taking CHAMPIX. Your doctor may decide to gradually lower your dose of CHAMPIX at the end of treatment.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Quitting smoking with or without treatment can cause various symptoms. These may include mood swings (such as feeling depressed, irritated, frustrated, or anxious), insomnia, difficulty concentrating, decreased heart rate, and increased appetite or weight gain.
You must be aware that severe neuropsychiatric symptoms, such as anxiety, depression, or behavioral changes, can develop when you try to quit smoking, whether you are treated with CHAMPIX or not. Contact your doctor or pharmacist if you experience such symptoms.
Serious side effects categorized as uncommon or rare have occurred in people who have tried to quit smoking CHAMPIX: seizures, strokes , heart attack, suicidal ideation, loss of contact with reality and inability to think clearly ( psychosis ), altered thinking or behavior (such as aggression and abnormal behavior). There have also been reports of severe skin reactions, including erythema multiforme (a type of rash) and Stevens-Johnson syndrome (a serious disease with blistering of the skin, mouth, around the eyes or genitals) and severe allergic reactions including angioedema(swelling of the face, mouth or throat).
Very common side effects , which may affect more than 1 in 10 people:
- Inflammation of the nose and throat, abnormal dreams, difficulty sleeping, headache
- Nausea
Common side effects , which may affect up to 1 in 10 people:
- Respiratory tract infection, sinusitis
- Weight gain, decreased appetite, increased appetite
- Drowsiness, dizziness, altered sense of taste
- Shortness of breath, cough
- Heartburn, vomiting, constipation, diarrhea, bloating, abdominal pain, toothache, indigestion, gas, dry mouth
- Skin rash, itching
- Joint pain, muscle aches, back pain
- Chest pain, fatigue
Uncommon side effects , which may affect up to 1 in 100 people:
- Fungal infection, viral infection
- Panic disorder, difficulty thinking, restlessness, mood swings, depression, anxiety, hallucinations, altered sex drive
- Seizures, tremors, feeling of inertia, less sensitive to touch
- Conjunctivitis of the eye ( conjunctivitis ), eye pain
- Earrings
- Angina, fast heartbeat, palpitations, increased heart rate
- Increased blood pressure , hot flashes
- Inflammation of the nose, sinuses or throat, stuffy nose, throat and breast, hoarseness, hay fever, throat irritation, blocked sinuses, large mucus formation from the nose which causes cough, runny nose
- Red blood in the stool, stomach irritation, altered bowel habits, belching, cold sores, gum pain
- Reddening of the skin, acne, increased sweating, night sweats
- Muscle spasms, pain in the chest wall
- Need to urinate abnormally often, nocturnal urination
- Increased menstruation
- Chest discomfort, flu-like illness, fever, weakness or general malaise
- High blood sugar
- Heart attack
- Suicidal thoughts
- Changed mindset or behavior (such as aggression)
Rare side effects that may affect up to 1 in 1,000 users:
- Strong thirst
- Feeling sick or mood swings, slow thinking
- Stroke
- Increased muscle tension, speech difficulties, coordination problems, impaired sense of taste, altered sleep patterns
- Visual disturbances, discoloration of the eyes, enlarged pupils , photosensitivity, myopia, watery eyes
- Irregular heartbeat or disturbed heartbeat
- Sore throat, snoring
- Bloody vomiting, abnormal stools, tongue deposits
- Joint stiffness, pain in the ribs
- Sugar in the urine, increased urine volume and frequency of urination
- Vaginal discharge, altered sexual ability
- Feeling of freezing, cysts
- Diabetes
- Sleepwalking
- Lost contact with reality and inability to think clearly ( psychosis )
- Abnormal behavior
- Severe skin reactions, including erythema multiforme (a type of skin rash) and Stevens-Johnson syndrome (a serious disease with blistering of the skin, mouth, eyes or genitals)
- Severe allergic reactions including angioedema (swelling of the face, mouth or throat)
Has been reported (occurs in an unknown number of users):
- Transient loss of consciousness
Reporting of side effects
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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store CHAMPIX
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 carton after EXP. The expiration date is the last day of the specified month.
Blister: Do not store above 30 ° C.
Jar: No special storage instructions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substance is varenicline.
- Each 0.5 mg film-coated tablet contains 0.5 mg varenicline (as tartrate).
- Each 1 mg film-coated tablet contains 1 mg varenicline (as tartrate).
– The other ingredients are:
| Tablet core – CHAMPIX 0.5 mg and 1 mg film-coated tablets |
|---|
| Microcrystalline celluloseAnhydrous calcium hydrogen phosphateCroscarmellose sodium (see section 2 “CHAMPIX contains sodium”)Colloidal anhydrous silicaMagnesium stearate |
| Film-coating – CHAMPIX 0.5 mg film-coated tablets |
|---|
| HypromellosTitanium dioxide (E171)Macrogol 400Triacetin |
| Film-coating – CHAMPIX 1 mg film-coated tablets |
|---|
| HypromellosTitanium dioxide (E171)Macrogol 400Indigo carmine aluminum lake (E132)Triacetin |
What the medicine looks like and the contents of the pack
- CHAMPIX 0.5 mg film-coated tablets are white, film-coated, capsule-shaped tablets, labeled “Pfizer” and “CHX 0.5”.
- CHAMPIX 1 mg film-coated tablets are light blue, film-coated, capsule-shaped tablets, labeled “Pfizer” and “CHX 1.0”.
CHAMPIX is available in the following packages:
- Escalator package containing 2 blister packs; 1 clear blister pack of 11 CHAMPIX 0.5 mg film-coated tablets and 1 clear blister pack of 14 CHAMPIX 1 mg film-coated tablets in a foldable pocket pack.
- Escalator package containing 2 blister packs; 1 clear blister pack of 11 CHAMPIX 0.5 mg film-coated tablets and 14 CHAMPIX 1 mg film-coated tablets and 1 clear blister pack of 28 or 2 clear blister packs of 14 CHAMPIX 1 mg film-coated tablets in a foldable pocket pack.
- Escalation pack in an outer carton containing 1 pack of 1 clear blister pack of 11 CHAMPIX 0.5 mg and 14 CHAMPIX 1 mg film-coated tablets and 1 clear blister pack of 28 or 2 clear blister packs of 14 CHAMPIX 1 mg film-coated tablets in a foldable 2-pack package containing 2 clear blister packs of 28 or 4 clear blister packs of 14 CHAMPIX 1 mg film-coated tablets in a foldable pocket pack.
- Follow-up packs (for maintenance treatment) containing 2 or 4 clear blister packs of 14 or 2 clear blister packs of 28 CHAMPIX 1 mg film-coated tablets in a foldable pocket pack.
- Follow-up packs (for maintenance treatment) containing 2 or 4 clear blister packs of 14 or 2 clear blister packs of 28 CHAMPIX 0.5 mg film-coated tablets in a foldable pocket pack.
- Escalator package containing 2 blister packs; 1 clear blister pack of 11 CHAMPIX 0.5 mg film-coated tablets and 1 clear blister pack of 14 CHAMPIX 1 mg film-coated tablets in a carton.
- Follow-up packs (for maintenance treatment) containing 2, 4, 8, or 10 clear blister packs of 14 CHAMPIX 1 mg film-coated tablets in a carton.
- Sealed white jar in HDPE plastic with childproof screw cap, in a carton containing 56 CHAMPIX 1 mg film-coated tablets.
- Sealed white jar in HDPE plastic with childproof screw cap, in carton containing 56 CHAMPIX 0.5 mg film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium
Manufacturer
R-Pharm Germany GmbH
Heinrich-Mack-Str. 35, 89257 Illertissen
Germany
or
Pfizer Manufacturing Deutschland GmbH
Company Freiburg
Mooswaldallee 1
79090 Freiburg
Germany
or
Pfizer Italia Srl
Locality Marino del Tronto, 63100
Ascoli Piceno (AP)
Italy
Contact the representative of the marketing authorization holder to find out more about this medicineShow larger
| Belgium / Belgique / BelgienPfizer SA / NVTel: + 32 (0) 2 554 62 11 | LithuaniaPfizer Luxembourg SARL branches in LithuaniaTel. +3705 2514000 |
| BulgariaThe Pfizer of Luxembourg,Clone of BulgariaTel: +359 2 970 4333 | Luxembourg / LuxemburgPfizer SATel: + 32 (0) 2 554 62 11 |
| Czech RepublicPfizer, spol. s roTel: + 420 283 004 111 | HungaryPfizer Kft.Tel .: +36 1 488 37 00 |
| DenmarkPfizer ApSTel: + 45 44 20 11 00 | MaltaVivian Corporation Ltd.Tel: +356 21344610 |
| GermanyPfizer Pharma GmbHTel: + 49 (0) 30 550055-10000 | The NetherlandsPfizer bvTel: + 31 (0) 10 406 43 01 |
| EestiPfizer Luxembourg SARL Eesti subsidiaryTel: + 372 666 7500 | NorwayPfizer ASTel: +47 67 52 61 00 |
| GreecePFIZER ΕΛΛΑΣ Α.Ε..:Ηλ .: +30 210 67 85 800 | AustriaPfizer Corporation Austria Ges.mbHTel: + 43 (0) 1 521 15-0 |
| SpainPfizer SLTel: + 34 91 490 99 00 | PolandPfizer Polska Sp. z ooTel .: + 48 22 335 61 00 |
| FrancePfizerTel: + 33 (0) 1 58 07 34 40 | PortugalPfizer Lda Laboratories.Tel: +351 21 423 5500 |
| CroatiaPfizer Croatia dooTel: + 385 1 3908 777 | RomaniaPfizer România SRLTel: +40 (0) 21 207 28 00 |
| IrelandPfizer Healthcare IrelandTel: 1800 633 363 (tollfree)+44 (0) 1304 616161 | SloveniaPfizer Luxembourg SARL, Pfizer, manufacturing and manufacturing pharmaceutical services, LjubljanaTel: + 386 (0) 1 52 11 400 |
| IcelandIcepharma hf.Phone: + 354 540 8000 | Slovak RepublicPfizer Luxembourg SARL, organizerTel: + 421 2 3355 5500 |
| ItalyPfizer SrlTel: + 39 06 33 18 21 | Finland / FinlandPfizer OyPuh / Tel: + 358 (0) 9 43 00 40 |
| ΚύπροςPFIZER ΕΛΛΑΣ Α.Ε. (CYPRUS BRANCH):Ηλ: +357 22 817690 | |
| LatviaPfizer Luxembourg SARL subsidiary LatvijāTel: + 371 67035775 | United KingdomPfizer LimitedTel: + 44 (0) 1304 616161 |