VARENICLINE CINFA 0.5 mg + 1 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Varenicline Cinfa 0.5 mg film-coated tablets EFG

Varenicline Cinfa 1 mg film-coated tablets EFG

Varenicline Cinfa 0.5 mg + 1 mg film-coated tablets EFG

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What is Varenicline Cinfa and what is it used for
2. What you need to know before you take Varenicline Cinfa
3. How to take Varenicline Cinfa
4. Possible side effects
5. Storage of Varenicline Cinfa
6. Contents of the pack and further information

1. What is Varenicline Cinfa and what is it used for

This medicine contains the active substance varenicline. Varenicline Cinfa is a medicine used in adults to help them stop smoking.

Varenicline may help to alleviate anxiety and withdrawal symptoms associated with stopping smoking.

Varenicline may also reduce the pleasure you get from smoking if you smoke during treatment.

2. What you need to know before you take Varenicline Cinfa

Do not take Varenicline Cinfa

• If you are allergic to varenicline or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before you start taking Varenicline Cinfa.

There have been reports of depression, suicidal thoughts and behaviour, and attempted suicide in patients taking varenicline. If you are taking this medicine and experience agitation, depressed mood, changes in behaviour that concern you or your family, or if you develop suicidal thoughts or behaviour, you should stop taking varenicline and contact your doctor immediately for an assessment of your treatment.

Effects of stopping smoking

The effects of the changes in your body as a result of stopping smoking, with or without treatment with varenicline, may alter the action of other medicines. Therefore, in some cases, it may be necessary to adjust the dose of other medicines. See below for more details in “Other medicines and Varenicline Cinfa”.

Stopping smoking, with or without treatment, has been associated in some people with an increased risk of experiencing changes in thinking or behaviour, feeling depressed or anxious, and may be associated with worsening of a psychiatric disorder. If you have a history of psychiatric disorder, you should discuss this with your doctor.

Cardiac symptoms

There have been reports of worsening or new cases of heart or blood vessel problems (cardiovascular) mainly in people who already had cardiovascular problems. Tell your doctor if you experience any changes in symptoms during treatment with this medicine. If you experience symptoms of a heart attack or stroke, seek emergency medical help immediately.

Seizures

Before you start treatment with varenicline, tell your doctor if you have had seizures or if you are epileptic. Some people have observed seizures during treatment with this medicine.

Hypersensitivity reactions

Stop taking varenicline and tell your doctor immediately if you experience any of the following signs and symptoms that may indicate a severe allergic reaction: swelling of the face, lips, tongue, gums, throat, or body, or difficulty breathing, wheezing.

Skin reactions

There have been reports of potentially life-threatening skin rash (Stevens-Johnson syndrome and erythema multiforme) with the use of varenicline. If you develop a rash or blisters or your skin peels, you should stop taking this medicine and seek urgent medical attention.

Children and adolescents

Varenicline is not recommended for use in paediatric patients as its efficacy has not been demonstrated.

Other medicines and Varenicline Cinfa

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

In some cases, as a result of stopping smoking, with or without varenicline, it may be necessary to adjust the dose of other medicines. Examples include theophylline (a medicine for respiratory problems), warfarin (a medicine to reduce blood clotting), and insulin (a medicine for diabetes). If you are in doubt, talk to your doctor or pharmacist.

If you have severe kidney disease, you should avoid taking cimetidine (a medicine for stomach problems) at the same time as this medicine, as this may cause increased levels of varenicline in the blood.

Use of Varenicline Cinfa with other smoking cessation therapies

Consult your doctor before using this medicine in combination with other smoking cessation therapies.

Taking Varenicline Cinfa with food, drinks, and alcohol

There have been some reports of increased intoxicating effects of alcohol in patients taking varenicline. However, it is not known whether this medicine increases the effects of alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

It is preferable to avoid the use of varenicline during pregnancy. Talk to your doctor if you plan to become pregnant.

Although it has not been studied, varenicline may pass into human breast milk. You should talk to your doctor or pharmacist before taking this medicine.

Driving and using machines

Varenicline Cinfa may be associated with dizziness, somnolence, and transient loss of consciousness. You should not drive, operate complex machinery, or engage in any other potentially hazardous activity until you know whether this medicine affects your ability to perform these activities.

3. How to take Varenicline Cinfa

Follow the instructions for administration of this medicine exactly as prescribed by your doctor. If you are in doubt, talk to your doctor or pharmacist again.

You are more likely to stop smoking if you are motivated to do so. Your doctor or pharmacist can provide you with advice, support, and additional information to help you ensure that your attempt to stop smoking is successful.

Normally, before you start treatment with Varenicline Cinfa, you should decide on a date during the second week of treatment (between day 8 and day 14) when you will stop smoking. If you do not wish to or cannot set a date to stop smoking within these 2 weeks, you can choose your quit date within the next 5 weeks after starting treatment. You should write this date on the pack as a reminder.

Varenicline Cinfa is available as 0.5 mg and 1 mg film-coated tablets. You will start with the 0.5 mg tablets and normally move to the 1 mg tablets. See below for the usual dosing instructions that you should follow from Day 1.

If you have stopped smoking after 12 weeks of treatment, your doctor may recommend an additional 12 weeks of treatment with Varenicline Cinfa 1 mg film-coated tablets twice a day to help you avoid relapse.

If you are unable or unwilling to stop smoking immediately, you should reduce your tobacco consumption during the first 12 weeks of treatment and stop at the end of this period. You should then continue to take Varenicline Cinfa 1 mg film-coated tablets twice a day for another 12 weeks, making a total treatment duration of 24 weeks.

If you experience side effects that you cannot tolerate, your doctor may decide to reduce your dose temporarily or permanently to 0.5 mg twice a day.

If you have kidney problems, you should talk to your doctor before taking this medicine. You may need a lower dose.

Varenicline Cinfa is taken by mouth.

The tablets should be swallowed whole with water or can be taken with or without food.

If you take more Varenicline Cinfa than you should

In case of overdose or accidental ingestion, talk to your doctor or pharmacist immediately or call the Toxicological Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Varenicline Cinfa

Do not take a double dose to make up for forgotten doses. It is important that you take varenicline regularly at the same time each day. If you forget to take a dose, take it as soon as you can. However, if it is almost time for your next dose, do not take the missed dose.

If you stop taking Varenicline Cinfa

It has been shown in clinical trials that if you take all the doses of your medicine at the right times and for the recommended treatment period, your chances of stopping smoking will increase. Therefore, unless your doctor tells you to stop treatment, it is important to keep taking varenicline as described in the table above.

In smoking cessation therapy, the risk of relapse may be high in the period immediately after the end of treatment. Temporarily, when you stop taking varenicline, you may experience increased irritability, need to smoke, depression, and/or sleep disturbances. Your doctor may decide to gradually reduce your dose of varenicline at the end of treatment.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stopping smoking, with or without treatment, may cause various symptoms, which can include changes in mood (such as feeling depressed, irritable, frustrated, or anxious), insomnia, difficulty concentrating, decreased heart rate, and increased appetite or weight gain.

You should be aware of the possible occurrence of severe neuropsychiatric symptoms, such as agitation, depressed mood, or changes in behaviour during an attempt to stop smoking with or without varenicline, and you should contact a doctor or pharmacist if you experience these symptoms.

Serious side effects have been reported rarely in people trying to stop smoking with this medicine: seizures, stroke, heart attack, suicidal thoughts, loss of contact with reality, and inability to think or judge clearly (psychosis), changes in thinking or behaviour (such as aggressive or abnormal behaviour), sleepwalking, diabetes, and high blood sugar levels. Serious skin reactions, including erythema multiforme (a type of rash) and Stevens-Johnson syndrome (a severe disease with blisters on the skin, mouth, and around the eyes and genitals), and severe allergic reactions, including angioedema (swelling of the face, mouth, or throat), have also been reported.

• Very common side effects: may affect more than 1 in 10 people:

• Inflammation of the nose and throat, abnormal dreams, difficulty sleeping, headache
• Nausea

• Common side effects: may affect up to 1 in 10 people:

• Chest infection, inflammation of the nasal passages
• Weight gain, decreased appetite, increased appetite
• Sleepiness, dizziness, changes in taste
• Difficulty breathing, coughing
• Heartburn, vomiting, constipation, diarrhoea, feeling bloated, abdominal pain, toothache, indigestion, flatulence, dry mouth
• Skin rash, itching
• Joint pain, muscle pain, back pain
• Chest pain, tiredness

• Uncommon side effects: may affect up to 1 in 100 people:

• Fungal infection, viral infection
• Panic, difficulty thinking, restlessness, mood changes, depression, anxiety, hallucinations, changes in sexual impulse
• Seizures, tremor, feeling lethargic, decreased sensitivity to touch
• Conjunctivitis, eye pain
• Ringing in the ears
• Angina, rapid heart rate, palpitations, increased heart rate
• High blood pressure, hot flushes
• Inflammation of the nose, nasal passages, and throat, nasal congestion, hoarseness, hay fever, sore throat, nasal passages congestion, excessive nasal mucus production with cough, runny nose
• Blood in stools, irritated stomach, change in bowel habit, belching, mouth ulcers, gum pain
• Redness of the skin, acne, increased sweating, night sweats
• Muscle spasms, chest wall pain
• Frequent urination, nocturia
• Increased menstrual flow
• Chest discomfort, flu-like illness, fever, feeling weak or unwell
• High blood sugar levels
• Heart attack
• Suicidal thoughts
• Changes in thinking or behaviour (such as aggression)

• Rare side effects: may affect up to 1 in 1,000 people:

• Excessive thirst
• Malaise or feeling unhappy, slow thinking
• Stroke
• Increased muscle tone, speech difficulties, coordination difficulties, decreased sense of taste, sleep pattern changes
• Visual disturbances, discolouration of the eyeball, dilated pupils, sensitivity to light, myopia, watery eyes
• Irregular heartbeat or changes in heart rhythm
• Sore throat, snoring
• Blood in vomit, abnormal stools, furry tongue
• Stiff joints, rib pain
• Glucose in urine, increased urine volume and frequency
• Vaginal discharge, changes in sexual ability
• Feeling cold, cyst
• Diabetes
• Sleepwalking
• Loss of contact with reality and inability to think or judge clearly (psychosis)
• Abnormal behaviour
• Serious skin reactions, including erythema multiforme (a type of rash) and Stevens-Johnson syndrome (a severe disease with blisters on the skin, mouth, and around the eyes and genitals)
• Severe allergic reactions, including angioedema (swelling of the face, mouth, or throat)

• Frequency not known: cannot be estimated from the available data

• Transient loss of consciousness

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Varenicline Cinfa

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 expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Packaging Content and Additional Information

Composition of Varenicline Cinfa

• The active ingredient is varenicline. Each film-coated tablet contains 0.5 mg or 1 mg of varenicline (as tartrate).
• The other components are:

Tablet core: microcrystalline cellulose, calcium hydrogen phosphate, and magnesium stearate.

Film coating: hypromellose, hydroxypropylcellulose, and titanium dioxide (E-171).

Appearance of the Product and Packaging Content

Varenicline Cinfa 0.5 mg film-coated tablets EFG:

Round, biconvex, white to off-white tablets, engraved with "M33" on one side and smooth on the other. Approximate diameter 6.1 mm.

Varenicline Cinfa 1 mg film-coated tablets EFG:

Capsule-shaped, biconvex, white to off-white tablets, engraved with "M34" on one side and smooth on the other. Approximate dimensions 10.2 x 5.2 mm.

Varenicline Cinfa 0.5 mg film-coated tablets EFG are available in the following packaging presentation:

• OPA/ALU/PVC-ALU blisters in a pack containing 56 film-coated tablets of 0.5 mg.

Varenicline Cinfa 1 mg film-coated tablets EFG are available in the following packaging presentations:

• OPA/ALU/PVC-ALU blisters in packs containing 56 and 112 film-coated tablets of 1 mg.

Varenicline Cinfa 0.5 mg + 1 mg film-coated tablets EFG (4-week treatment initiation pack) are available in the following packaging presentation:

• OPA/ALU/PVC-ALU blisters containing 1 blister with 11 film-coated tablets of 0.5 mg and 3 blisters with 14 film-coated tablets of 1 mg.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Date of the Last Revision of this Leaflet: July 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

You can access detailed and updated information on this medicinal product by scanning the QR code included in the leaflet and carton with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/90475/P_90475.html

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