VARENICLINE CINFA 0.5 mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet

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 leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Leaflet

1. What is Varenicline Cinfa and what is it used for
2. What you need to know before taking Varenicline Cinfa
3. How to take Varenicline Cinfa
4. Possible side effects
5. Storage of Varenicline Cinfa
6. Packaging contents and additional information

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

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

Varenicline can help alleviate anxiety and withdrawal symptoms associated with quitting smoking.

Varenicline may also reduce the pleasure caused by cigarettes if you smoke during treatment.

2. What you need to know before taking Varenicline Cinfa

Do not take Varenicline Cinfa

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Varenicline Cinfa.

There have been reports of depression, suicidal ideation and behavior, and attempted suicide in patients taking varenicline. If you are taking this medication and experience agitation, depressed mood, changes in behavior that concern you or your family, or develop suicidal thoughts or behavior, you should stop taking varenicline and contact your doctor immediately for a treatment evaluation.

Effects of quitting smoking

The effects of changes in your body as a result of quitting smoking, with or without varenicline treatment, may alter the action of other medications. Consequently, in some cases, a dose adjustment may be necessary. See below for more details in "Other medications and Varenicline Cinfa".

Quitting smoking, with or without treatment, has been associated in some people with an increased risk of experiencing changes in thinking or behavior, feelings of depression and anxiety, 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. Inform your doctor if you experience any changes in symptoms during treatment with this medication. If you experience symptoms of a heart attack or stroke, seek emergency medical help immediately.

Seizures

Before starting treatment with varenicline Cinfa, inform your doctor if you have had seizures or if you are epileptic. Some people have observed seizures during treatment with this medication.

Hypersensitivity reactions

Stop taking varenicline and inform 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 rashes (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 medication and seek urgent medical attention.

Children and adolescents

The use of varenicline is not recommended in pediatric patients, as its efficacy has not been demonstrated.

Other medications and Varenicline Cinfa

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

In some cases, as a result of quitting smoking, with or without varenicline Cinfa, a dose adjustment of other medications may be necessary. Examples include theophylline (a medication for respiratory problems), warfarin (a medication to reduce blood clotting), and insulin (a medication for diabetes). If you have any doubts, consult your doctor or pharmacist.

If you have severe kidney disease, you should avoid taking cimetidine (a medication for stomach problems) at the same time as this medication, 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 medication 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 medication increases the effects of alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

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

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

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 perform any other potentially hazardous activity until you know whether this medication affects your ability to perform these activities.

3. How to take Varenicline Cinfa

Follow the administration instructions for this medication exactly as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

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

Normally, before starting treatment with Varenicline Cinfa, you should decide on a date during the second week of treatment (between day 8 and day 14) to quit smoking. If you do not wish to or cannot set a date to quit smoking within these 2 weeks, you can choose your quit date within the following 5 weeks after starting treatment. You should write this date on the packaging 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 switch to the 1 mg tablets. See below for the usual administration instructions to follow from Day 1.

If you have quit 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 cannot or are not willing to quit smoking immediately, you should reduce your tobacco consumption during the first 12 weeks of treatment and quit at the end of this period. Then, you should continue taking Varenicline Cinfa 1 mg film-coated tablets twice a day for another 12 weeks, for a total of 24 weeks of treatment.

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

If you have kidney problems, you should consult your doctor before taking this medication. You may need a lower dose.

Varenicline Cinfa is administered orally.

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

If you take more Varenicline Cinfa than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Varenicline Cinfa

Do not take a double dose to make up for forgotten doses. It is important to 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 3-4 hours before your next dose, do not take the missed tablet.

If you interrupt treatment with Varenicline Cinfa

It has been shown in clinical trials that if you take all the doses of your medication at the right times and during the recommended treatment period, your chances of quitting smoking will increase. Therefore, unless your doctor instructs you to stop treatment, it is essential to continue taking varenicline as described in the table above.

In smoking cessation therapy, the risk of relapse may be high in the period immediately following 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 other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Quitting smoking, with or without treatment, can cause various symptoms, including mood changes (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 behavior during an attempt to quit smoking with or without varenicline, and you should contact a doctor or pharmacist if you experience these symptoms.

Serious side effects have occurred rarely in people trying to quit smoking with this medication: seizures, stroke, heart attack, suicidal thoughts, loss of contact with reality, and inability to think or judge clearly (psychosis), changes in thinking or behavior (such as aggressive behavior), 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:

• Nasal and throat inflammation, abnormal dreams, difficulty sleeping, headache
• Nausea

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

• Chest infection, nasal sinus inflammation
• Weight gain, decreased appetite, increased appetite
• Sleepiness, dizziness, changes in taste
• Difficulty breathing, cough
• Acid reflux, vomiting, constipation, diarrhea, feeling bloated, abdominal pain, toothache, indigestion, flatulence, dry mouth
• Skin rash, itching
• Joint pain, muscle pain, back pain
• Chest pain, fatigue

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

• Fungal infection, viral infection
• Panic sensation, difficulty thinking, restlessness, mood changes, depression, anxiety, hallucinations, changes in sexual impulse
• Seizures, tremor, feeling of lethargy, decreased sensitivity to touch
• Conjunctivitis, eye pain
• Ringing in the ears
• Angina, rapid heart rate, palpitations, increased heart rate
• Increased blood pressure, hot flushes
• Nasal, sinus, and throat inflammation, nasal congestion, throat and chest congestion, hoarseness, hay fever, throat irritation, nasal sinus congestion, excessive nasal mucus production with cough, rhinorrhea
• Red 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
• Abnormal urination frequency, nocturia
• Increased menstrual flow
• Chest discomfort, flu-like illness, fever, feeling of weakness or discomfort
• High blood sugar levels
• Heart attack
• Suicidal thoughts
• Changes in thinking or behavior (such as aggression)

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

• Excessive thirst
• Malaise or feeling of unhappiness, slow thinking
• Stroke
• Increased muscle tension, speech difficulties, coordination difficulties, decreased sense of taste, sleep pattern changes
• Visual disturbances, eye discoloration, dilated pupils, sensitivity to light, myopia, tearing
• Irregular heartbeat or changes in heart rhythm
• Sore throat, snoring
• Blood in vomit, abnormal stools, furry tongue
• Stiff joints, back pain
• Glucose in urine, increased urine volume and frequency
• Vaginal discharge, changes in sexual ability
• Feeling of cold, cyst
• Diabetes
• Sleepwalking
• Loss of contact with reality and inability to think or judge clearly (psychosis)
• Abnormal behavior
• 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 available data

• Transient loss of consciousness

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Varenicline Cinfa

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date stated on the packaging after "EXP". The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Packaging Content and Additional Information

Varenicline Cinfa Composition

• 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).

Product Appearance and Packaging Content

Varenicline Cinfa 0.5 mg film-coated tablets EFG:

White to off-white, round, and biconvex 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:

White to off-white, capsule-shaped, and biconvex 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 package 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 packages 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 package) 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 package 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 packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/90477/P_90477.html

QR code to: https://cima.aemps.es/cima/dochtml/p/90477/P_90477.html