Package Insert: Information for the Patient

Cuitvar 0.5 mg Film-Coated Tablets

varenicline

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

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

1. What isCuitvarand for what it is used

2. What you need to know before starting to takeCuitvar

3. How to takeCuitvar

4. Possible adverse effects

5. Storage ofCuitvar

6. Contents of the package and additional information

Cuitvarcontains the active ingredient varenicline. Varenicline is a medication that is used

in adults to help them stop smoking.

Varenicline may help alleviate anxiety and withdrawal syndrome associated with quitting smoking.

Varenicline also may reduce the pleasure that cigarettes cause if smoked during treatment.

Do not takeCuitvar

• 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 takeCuitvar.

Cases of depression, ideation, and suicidal behavior and attempts have been reported in patients receiving varenicline. If you are taking varenicline and experience agitation, depressive mood, changes in behavior that concern you or your family, or if you develop suicidal thoughts or behavior, stop taking varenicline and immediately contact your doctor for an evaluation of your treatment.

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 andCuitvar”.

Quitting smoking, with or without treatment, has been associated in some people with a greater risk of experiencing changes in thinking or behavior, feelings of depression and anxiety, and may be associated with a worsening of a psychiatric disorder. If you have a history of psychiatric disorder, discuss it with your doctor.

Cardiac symptoms

Reports of worsening or new cases of heart or blood vessel problems (cardiovascular) have been communicated, mainly in people who already had cardiovascular problems. Inform your doctor if you experience any changes in symptoms during varenicline treatment. If you experience symptoms of a heart attack or stroke, seek immediate emergency medical help.

Seizures

Inform your doctor before starting varenicline treatment if you have had seizures or are epileptic. Some people have observed seizures during varenicline treatment.

Hypersensitivity reactions

Stop taking varenicline and immediately inform your doctor 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

Cases of potentially life-threatening skin rash (Stevens-Johnson syndrome and erythema multiforme) have been reported with varenicline use. If you develop a rash or if blisters or skin peeling occur, stop taking varenicline and seek urgent medical attention.

Children and adolescents

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

Other medications and Cuitvar

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

In some cases, as a result of quitting smoking, with or without varenicline, 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 treatment). If you have any doubts, consult your doctor or pharmacist.

If you have severe kidney disease, avoid taking cimetidine (a medication for gastrointestinal problems) at the same time as varenicline, as this may cause an increase in varenicline blood levels.

UseofCuitvarwith other smoking cessation therapies

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

Use ofCuitvarwith alcohol

Some reports have indicated an increase in the intoxicating effects of alcohol in patients taking varenicline. However, it is unknown whether varenicline increases the effects of alcohol.

Pregnancy and breastfeeding

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

It is preferable to avoid using varenicline while pregnant. Consult your doctor if you plan to become pregnant.

Varenicline may pass into human breast milk. Consult your doctor or pharmacist before taking varenicline.

Driving and operating machinery

Varenicline may be associated with dizziness, somnolence, and transient loss of consciousness. Do not drive, operate complex machinery, or perform any other potentially hazardous activity until you know if this medication affects your ability to perform these activities.

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

It is more likely that you will quit 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 quit 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) on which you will quit smoking. If you do not want or are unable to set a date to quit smoking within those 2 weeks, you can choose your quit date within the 5 weeks following the start of treatment. You should write this date on the packaging as a reminder.

Cuitvaris presented as white tablets (0.5 mg) and light blue tablets (1 mg). You will start with the white tablets and normally switch to the light blue ones. See the following table with the usual administration instructions that you should 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 1 mg tablets coated twice a day to help you not smoke again.

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 that treatment period. You should then continue taking varenicline 1 mg tablets coated twice a day for another 12 weeks, totaling 24 weeks of treatment.

If you experience adverse effects that you cannot tolerate, your doctor may decide to temporarily or permanently reduce your dose 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 or can be taken with or without food.

If you take moreCuitvar than you should

If you have accidentally taken more varenicline than your doctor prescribed, consult your doctor immediately, go to the nearest hospital, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken. Bring your packaging.

If you forgot to take Cuitvar

Do not take a double dose to compensate for the missed doses. It is essential to take varenicline regularly at the same hour each day. If you forget to take a dose, take it as soon as you can. However, if 3-4 hours have passed since your next dose, do not take the missed tablet.

If you interrupt the treatment with Cuitvar

It has been demonstrated in clinical trials that if you take all your medication doses at the correct times and during the recommended treatment period and previously described, your chances of quitting smoking will increase. Therefore, unless your doctor gives you instructions to suspend treatment, it is essential to continue taking varenicline according to the instructions 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 disorders. Your doctor may decide to gradually reduce your varenicline dose at the end of treatment.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

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

Stopping smoking with or without treatment may produce different symptoms. These may include 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 appearance of severe neuropsychiatric symptoms, such as agitation, depressive mood, or changes in behavior during an attempt to quit smoking with or without varenicline, and contact a doctor or pharmacist if you experience these symptoms.

Severe side effects have occurred with low or rare frequency in people who were trying to quit 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 behavior (such as aggressive and abnormal behavior). Severe skin reactions, including erythema multiforme (a type of rash) and Stevens-Johnson syndrome (a serious 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: that can affect more than 1 in 10 people

• Pharyngitis and nasal congestion, abnormal dreams, difficulty sleeping, headache
• Nausea

Common side effects: that can affect up to 1 in 10 people

• Chest infection, nasal congestion
• Weight gain, decreased appetite, increased appetite
• Dreams, dizziness, changes in taste
• Difficulty breathing, cough
• Heartburn, vomiting, constipation, diarrhea, feeling bloated, abdominal pain, toothache, indigestion, flatulence, dry mouth
• Skin rash, itching
• Joint pain, myalgia, back pain
• Chest pain, fatigue

Rare side effects: that can 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 apathy, decreased sensitivity to touch
• Conjunctivitis, eye pain
• Tinnitus
• Angina, rapid heart rate, palpitations, increased heart rate
• Increased blood pressure, heat
• Nasal congestion, nasal and throat inflammation, congestion of the nose, throat, and chest, hoarseness, hay fever, throat irritation, nasal congestion with excessive mucus production and cough, rhinorrhea
• Blood in the stool, irritated stomach, change in bowel habit, belching, mouth ulcers, toothache
• 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 weak or unwell
• High blood sugar levels
• Heart attack
• Suicidal thoughts
• Changes in thinking or behavior (such as aggression)

Rare side effects: that can affect up to 1 in 1,000 people

• Excessive thirst
• Indisposition or feeling of unhappiness, slow thinking
• Stroke
• Increased muscle tension, speech difficulties, coordination difficulties, decreased sense of taste, altered sleep pattern
• Eye changes, discoloration of the eyeball, dilated pupils, light sensitivity, myopia, watery eyes
• Irregular heartbeat or changes in heart rhythm
• Throat pain, hoarseness
• Blood in the vomit, abnormal stools, tongue soreness
• Joint numbness, chest pain
• Glucose in the urine, increased urine volume and frequency
• Vaginal discharge, changes in sexual capacity
• Sensation of cold, cyst
• Diabetes
• Somnambulism
• Loss of contact with reality and inability to think or judge clearly (psychosis)
• Abnormal behavior
• Severe skin reactions, including erythema multiforme (a type of rash) and Stevens-Johnson syndrome (a serious 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)

Unknown frequency

• Transient loss of consciousness

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and blister or label of the bottle after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for preservation.

Medications should not be thrown down the drain or in the trash.Dispose of the packaging and medications that you no longer need at the SIGRE point of the pharmacy.Ask your pharmacist how to dispose of the packaging and medications that you no longer need.This will help protect the environment.

Composition of Cuitvar

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

• The other components are:

Core of the tablet: microcrystalline cellulose, pregelatinized maize starch, propyl gallate, magnesium stearate, and anhydrous citric acid.

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

Appearance of the product and contents of the package

Cuitvar 0.5 mg film-coated tablets EFG are white, capsule-shaped film-coated tablets, serigraphed with “0.5” on one face.

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

• PVC/PE/PVdC//Al blisterscontaining 28 or 56 film-coated tablets orpre-cut single-dose blisters of PVC/PE/PVdC//Alcontaining 28 x 1 or 56 x 1 film-coated tablets.

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

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Teva B.V.

Swensweg 5,

2031GA Haarlem,

Netherlands

Responsible 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 medicine by contacting the local representative of the marketing authorization holder:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor

28108, Alcobendas, Madrid (Spain)

Last review date of this leaflet: February 2024

Other sources of information

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