VARENICLINE TEVA 0.5 mg + 1 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

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

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

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

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

Varenicline can help to reduce the craving for smoking and the withdrawal symptoms, such as irritability, anxiety, and difficulty concentrating.

Varenicline may also reduce the pleasure associated with smoking if you smoke while taking the treatment.

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

Do not takeVarenicline Teva

• 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 taking Varenicline Teva.

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

Quit-smoking effects

The effects of the changes in your body as a result of quitting 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 Teva".

Quitting smoking, with or without treatment, has been associated with an increased risk of experiencing changes in thinking or behavior, 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 pediatric patients as its efficacy has not been demonstrated.

Other medicines and Varenicline Teva

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 quitting 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 have any doubts, 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 Varenicline Teva with other quit-smoking therapies

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

TakingVarenicline Tevawith 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 breastfeeding

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 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 Varenicline Teva

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.

Varenicline Teva 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 tablets. See below for 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, for a total of 24 weeks of treatment.

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.

Varenicline Teva is taken orally.

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

If you take moreVarenicline Teva 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 Varenicline Teva

Do not take a double dose to make up for a forgotten dose. 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 Teva

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.

During the period immediately after stopping treatment, the risk of relapse to smoking may be high. 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 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 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 behavior 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 behavior (such as aggressive or 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), 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
• Heartburn, vomiting, constipation, diarrhea, 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 desire
• 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, throat irritation, hoarseness, hay fever, throat irritation, nasal sinus congestion, excess mucus production with coughing, runny nose
• Blood in stool, 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 behavior (such as aggression)

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

• Excessive thirst
• Feeling unwell or unhappy, slow thinking
• Stroke
• Increased muscle tension, difficulty speaking, difficulty coordinating, decreased sense of taste, altered sleep pattern
• Visual disturbances, discoloration 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 stool, furry tongue
• Stiff joints, back 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 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

• 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: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Varenicline Teva

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 is 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 your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help to protect the environment.

6. Packaging Contents and Additional Information

Varenicline Teva Composition

• The active ingredient is varenicline.
• Each 0.5 mg film-coated tablet contains 0.5 mg of varenicline (as citrate).
• Each 1 mg film-coated tablet contains 1 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 - Varenicline Teva 0.5 mg film-coated tablets EFG: hypromellose (E-464) and titanium dioxide (E-171).

Coating - Varenicline Teva 1 mg film-coated tablets EFG: hypromellose (E-464), titanium dioxide (E-171), and indigo carmine, blue FD&C 2 (E-132).

Product Appearance and Packaging Contents

• Varenicline Teva 0.5 mg film-coated tablets EFG are white, capsule-shaped, film-coated tablets engraved with "0.5" on one side.

• Varenicline Teva 1 mg film-coated tablets EFG are light blue, capsule-shaped, film-coated tablets engraved with "1.0" on one side.

Varenicline Teva is available in the following presentations:

As starter treatment packs:

PVC/PE/PVdC//Al blister:

Package of 25 film-coated tablets:

Each package contains 25 film-coated tablets for a two-week treatment program that includes 11 film-coated tablets of 0.5 mg and 14 film-coated tablets of 1 mg.

Package of 53 film-coated tablets:

Each package contains 53 film-coated tablets for a four-week treatment program that includes 11 film-coated tablets of 0.5 mg and 42 film-coated tablets of 1 mg.

Package of 165 film-coated tablets:

Each package contains 165 film-coated tablets for an eight-week treatment program that includes 11 film-coated tablets of 0.5 mg and 154 film-coated tablets of 1 mg.

PVC/PE/PVdC//Al unit-dose blister:

Package of 165 x 1 film-coated tablets:

Each package contains 165 x 1 film-coated tablets for an eight-week treatment program that includes 11 x 1 film-coated tablets of 0.5 mg and 154 x 1 film-coated tablets of 1 mg.

Only some package 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/89492/P_89492.html.

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