CUITVAR 0.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Cuitvar 0.5 mg Film-Coated Tablets EFG

varenicline

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

• Keep this 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 signs of illness 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 leaflet. See section 4.

Contents of the Pack

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

1. What Cuitvar is and what it is used for

Cuitvar contains the active substance varenicline. Varenicline is a medicine used

in adults to help them stop smoking.

Varenicline can help to relieve the 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 Cuitvar

Do not takeCuitvar

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

Warnings and Precautions

Consult your doctor or pharmacist before starting Cuitvar.

There have been reports of depression, suicidal thoughts and behaviour, and attempted suicide in patients taking varenicline. If you are taking varenicline 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 evaluation of treatment.

Stopping smoking effects

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. Consequently, in some cases, it may be necessary to adjust the dose of other medicines. See below for more details in “Other medicines and Cuitvar”.

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. Inform your doctor if you experience any changes in symptoms during treatment with varenicline. If you experience symptoms of a heart attack or stroke, seek emergency medical help immediately.

Seizures

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

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 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 varenicline 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 Cuitvar

Inform 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, consult 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 varenicline, as this may cause increased levels of varenicline in the blood.

Useof Cuitvar with other smoking cessation therapies

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

TakingCuitvarwith alcohol

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

Pregnancy and breast-feeding

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.

It is preferable to avoid the use of varenicline while pregnant. 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 varenicline.

Driving and using machines

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

3. How to take Cuitvar

Follow exactly the administration instructions of this medicine given by your doctor. In case of doubt, consult 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 starting your treatment with varenicline, 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.

Cuitvar is available as white (0.5 mg) and light blue (1 mg) film-coated tablets. You will start with the white tablets and normally switch to the light blue ones. See below the table with the usual administration 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 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 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 the dose temporarily or permanently to 0.5 mg twice a day.

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

Cuitvar is administered orally.

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

If you take moreCuitvar than you should

If you have taken too much varenicline, contact your doctor immediately, go to the nearest hospital, or call the Poison Information Service on 91 562 04 20, stating the medicine and the amount taken. Take the carton with you.

If you forget to take Cuitvar

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 Cuitvar

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, you will increase your chances of stopping smoking. Therefore, unless your doctor tells you to stop treatment, it is important 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, urge 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 can cause various symptoms. These may 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 serious 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 varenicline: 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). 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, coughing
• Acid reflux, vomiting, constipation, diarrhoea, bloating, 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 attacks, difficulty thinking, restlessness, mood changes, depression, anxiety, hallucinations, changes in sexual impulse
• Seizures, tremors, feeling lethargic, 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, sore throat, hoarseness, hay fever, throat irritation, nasal congestion, excessive nasal mucus production with cough, runny nose
• Blood in stools, stomach upset, 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 tension, speech difficulties, coordination difficulties, decreased sense of taste, sleep pattern changes
• Visual disturbances, eye discolouration, 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

• 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 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. Storing Cuitvar

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, blister, or label 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. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Container Content and Additional Information

Cuitvar Composition

• The active ingredient is varenicline. Each film-coated tablet contains 0.5 mg of varenicline (as citrate).

• The other components are:

Tablet core: microcrystalline cellulose, pregelatinized starch (from corn), propyl gallate, magnesium stearate, and anhydrous citric acid.

Coating: hypromellose (E-464) and titanium dioxide (E-171).

Product Appearance and Container Content

Cuitvar 0.5 mg film-coated tablets EFG are white, capsule-shaped, film-coated tablets with "0.5" serigraphed on one side.

Cuitvar 0.5 mg film-coated tablets EFG are available in the following presentations:

• PVC/PE/PVdC//Al blisters containing 28 or 56 film-coated tablets or unit-dose PVC/PE/PVdC//Al blisters containing 28 x 1 or 56 x 1 film-coated tablets.

• HDPE bottles (with child-resistant closure): bottle of 56 film-coated tablets of 0.5 mg.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva B.V.

Swensweg 5,

2031GA Haarlem,

Netherlands

Manufacturer

Delorbis Pharmaceuticals Ltd.

17 Athinon Str., Ergates Industrial Area

2643 Ergates, Lefkosia

Cyprus

or

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park,

Paola, PLA 3000,

Malta

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1ª planta

28108, Alcobendas, Madrid (Spain)

Date of the last revision of this prospectus: February 2024

Other Sources of Information

You can access detailed and updated information about this medication by scanning the QR code included in the packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/89490/P_89490.html.