Varenicline Zentiva

Package leaflet: Information for the user

Vareniclina Zentiva 0.5 mg film-coated tablets, 1 mg film-coated tablets

Equivalent medicine
Read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor. See section 4.

Contents of this leaflet

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

1. What Vareniclina Zentiva is and what it is used for

Vareniclina Zentiva contains the active substance varenicline. Vareniclina Zentiva is a medicine used in adults to help them stop smoking.
Vareniclina Zentiva can help relieve the symptoms of craving and withdrawal associated with smoking cessation.
Vareniclina Zentiva may also reduce the pleasure derived from smoking cigarettes if you smoke while being treated.

2. What you need to know before taking Vareniclina Zentiva

Do not take Vareniclina Zentiva

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

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Vareniclina Zentiva.
Cases of depression, suicidal ideation and behaviour, and suicide attempts have been reported in patients taking Vareniclina Zentiva. If you are taking Vareniclina Zentiva and develop agitation, depressed mood, or behavioural changes causing concern to you, your family, or your doctor, or if you develop suicidal thoughts or behaviour, stop taking Vareniclina Zentiva and contact your doctor immediately for a treatment evaluation.

Effects of smoking cessation
Changes in your body resulting from stopping smoking, with or without treatment with Vareniclina Zentiva, may affect how other medicines work. Therefore, in some cases, a dose adjustment may be necessary. For further details, see the section below “Other medicines and Vareniclina Zentiva”.
In some individuals, stopping smoking, with or without treatment, has been associated with an increased risk of changes in thinking or behaviour, feelings of depression and anxiety, and may be associated with a worsening of psychiatric illness. If you have a history of psychiatric illness, discuss this with your doctor.

Cardiac symptoms
New cardiovascular problems or worsening of existing heart or blood vessel (cardiovascular) conditions have been reported, particularly in individuals who already have cardiovascular disease. Inform your doctor if you experience any changes in symptoms during treatment with Vareniclina Zentiva. If you experience symptoms of a heart attack or stroke, seek immediate emergency medical help.

Seizures
Before starting treatment with Vareniclina Zentiva, inform your doctor if you have ever had seizures or suffer from epilepsy. Some people have experienced seizures during treatment with Vareniclina Zentiva.

Hypersensitivity reactions
Stop taking Vareniclina Zentiva and contact your doctor immediately if you experience any of the following signs or symptoms that could indicate a severe allergic reaction: swelling of the face, lips, tongue, gums, throat, or body, and/or difficulty breathing, wheezing.

Skin reactions
Potentially life-threatening skin reactions (Stevens-Johnson syndrome and erythema multiforme) have been reported with the use of Vareniclina Zentiva. If you develop a skin rash, or if skin peeling or blistering occurs, stop treatment with Vareniclina Zentiva and seek urgent medical assistance.

Children and adolescents
The use of Vareniclina Zentiva is not recommended in pediatric patients, as efficacy has not been demonstrated.

Other medicines and Vareniclina Zentiva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. These include theophylline (a medicine used to treat respiratory problems), warfarin (a medicine used to reduce blood clot formation), and insulin (a medicine for diabetes). If in doubt, consult your doctor or pharmacist.
If you have severe kidney disease, you should avoid taking cimetidine (a medicine for gastric disorders) while taking Vareniclina Zentiva, as this could lead to increased levels of Vareniclina Zentiva in the blood.

Use of Vareniclina Zentiva with other smoking cessation therapies
Talk to your doctor before using Vareniclina Zentiva in combination with other smoking cessation therapies.

Vareniclina Zentiva with food and drink
Cases of increased alcohol intoxication effects have been reported in patients taking Vareniclina Zentiva. However, it is not known whether Vareniclina Zentiva actually increases alcohol intoxication.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
It is advisable to avoid using Vareniclina Zentiva during pregnancy. Talk to your doctor if you are planning a pregnancy.
Although not studied, Vareniclina Zentiva may pass into breast milk. Consult your doctor or pharmacist before taking Vareniclina Zentiva.

Driving and using machines
Vareniclina Zentiva may be associated with dizziness, somnolence, and transient loss of consciousness. Do not drive, operate heavy machinery, or engage in any other potentially hazardous activities until you know how this medicine affects your ability to perform these tasks.

Vareniclina Zentiva contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e., it is essentially “sodium-free”.

3. How to take Vareniclina Zentiva

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Your chances of successfully quitting smoking are higher if you are motivated. Your doctor or pharmacist can
provide you with advice, support, and further information to help make your attempts to quit smoking successful.
Before starting treatment with Vareniclina Zentiva, you should usually set a quit date during the second week of treatment (between day 8 and day 14). If you are unable or prefer not to set a quit date within the first 2 weeks, you may choose your own individual quit date within 5 weeks of starting treatment. You should write this date on the pack to help you remember it.
Vareniclina Zentiva is available as white tablets (0.5 mg) and light blue tablets (1 mg). You start with the white tablet and then usually switch to the light blue tablet. See the table below for instructions on the usual dosing schedule to follow starting from day 1.

After 12 weeks of treatment, if you have stopped smoking, your doctor may recommend an additional 12-week treatment cycle with Vareniclina Zentiva 1 mg film-coated tablets twice daily to help prevent you from starting to smoke again.

If you are unable or unwilling to stop smoking immediately, you should reduce your smoking during the first 12 weeks of treatment and stop completely by the end of this period. You should then continue taking Vareniclina Zentiva 1 mg film-coated tablets twice daily for another 12 weeks, for a total of 24 weeks of treatment.

If you experience adverse events that you cannot tolerate, your doctor may decide to temporarily or permanently reduce your dose to 0.5 mg twice daily.

If you have kidney problems, you must speak with your doctor before taking Vareniclina Zentiva. You may require a lower dose.

Vareniclina Zentiva is for oral use.

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

If you take more Vareniclina Zentiva than you should

If you accidentally take more Vareniclina Zentiva than prescribed, you must contact your doctor or go to the nearest emergency department. Take the medicine packaging with you.

If you forget to take Vareniclina Zentiva

Do not take a double dose to make up for a missed tablet. It is important to take Vareniclina Zentiva tablets regularly every day at the same time. If you forget to take a dose, take it as soon as you remember. If less than 3–4 hours remain before your next scheduled dose, do not take the missed tablet.

If you stop taking Vareniclina Zentiva

Clinical studies have shown that taking all doses of the medicine correctly and for the recommended duration described above increases the likelihood of successfully quitting smoking. Therefore, unless your doctor has instructed you to stop treatment, it is important to continue taking Vareniclina Zentiva as directed in the table above.

During smoking cessation therapy, the risk of resuming smoking may be high in the period immediately following the end of treatment. When you stop taking Vareniclina Zentiva, you may temporarily experience increased irritability, strong urge to smoke, depression, and/or sleep disturbances. Your doctor may decide to gradually reduce the dose of Vareniclina Zentiva at the end of treatment.

If you have any doubts about how to use this medicine, consult 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. These may include mood changes (such as feeling depressed, irritable, frustrated or anxious), insomnia, difficulty concentrating, reduced 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 while trying to quit smoking, with or without Vareniclina Zentiva, and you should contact your doctor or pharmacist if such symptoms occur.

In people who have tried to stop smoking using Vareniclina Zentiva, serious side effects have been observed, occurring uncommonly or rarely: seizures, stroke, heart attack, suicidal thoughts, loss of contact with reality and inability to think or judge clearly (psychosis), changes in thought or behaviour (such as aggression or abnormal behaviour). Cases of serious skin reactions have also been reported, including erythema multiforme (a type of skin rash) and Stevens-Johnson syndrome (a serious illness causing blisters on the skin, mouth, around the eyes or genitals), and serious allergic reactions, including angioedema (swelling of the face, mouth or throat).

Very common: may affect more than 1 in 10 people

• Inflammation of the nose and throat, altered dreams, sleep difficulties, headache
• Nausea

Common: may affect up to 1 in 10 people

• Chest infections, sinusitis
• Weight gain, decreased appetite, increased appetite
• Drowsiness, dizziness, altered taste
• Shortness of breath, cough
• Heartburn, vomiting, constipation, diarrhoea, bloating, abdominal pain, toothache, indigestion, flatulence, dry mouth
• Rash, itching
• Joint pain, muscle pain, back pain
• Chest pain, fatigue

Uncommon: may affect up to 1 in 100 people

• Fungal infection, viral infection
• Feeling of panic, difficulty thinking, restlessness, mood swings
• Depression, anxiety, hallucinations, changes in sexual impulses
• Seizures, tremors, feeling of apathy, loss of sensitivity to touch
• Conjunctivitis, eye pain
• Ringing in the ears
• Angina, rapid heartbeat, palpitations, increased heart rate
• Increased blood pressure, hot flushes
• Inflammation of the nose, sinuses and throat, nasal congestion, sore throat, chest congestion, hoarseness, hay fever, throat irritation, congested sinuses, excess mucus in the nose causing cough, runny nose
• Presence of red blood in stools, stomach irritation, changes in bowel habits, belching, mouth ulcers, gum pain
• Skin redness, acne, increased sweating, night sweats
• Muscle spasms, chest wall pain
• Abnormally frequent urination, nocturnal urination
• Increased menstrual flow
• Chest discomfort, flu-like illness, fever, feeling of weakness or malaise
• High blood sugar levels
• Heart attack
• Suicidal thoughts
• Changes in thought or behaviour (such as aggression)

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

• Excessive thirst
• Feeling of discomfort or unhappiness, slowness of thought
• Stroke
• Increased muscle tension, difficulty speaking, coordination difficulties, reduced sense of taste, changes in sleep rhythm
• Vision disorders, change in colour of the eyeball, dilated pupils, light sensitivity, myopia, excessive tearing
• Irregular heartbeat or disturbances in heart rhythm
• Sore throat, snoring
• Blood in vomit, altered stools, coated tongue
• Joint stiffness, rib pain
• Glucose in urine, increased volume and frequency of urine
• Vaginal discharge, altered sexual performance
• Feeling cold, cysts
• 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 skin rash) and Stevens-Johnson syndrome (a serious illness causing blisters on the skin, mouth, around the eyes or genitals)
• Serious allergic reactions, including angioedema (swelling of the face, mouth or throat)

Not known: frequency cannot be estimated from the available data

• Transient loss of consciousness

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Varenicline Zentiva

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 blister and carton after
"Exp.". The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Vareniclina Zentiva contains

• The active substance is varenicline. Each 0.5 mg film-coated tablet contains varenicline tartrate equivalent to 0.5 mg of varenicline. Each 1 mg film-coated tablet contains varenicline tartrate equivalent to 1 mg of varenicline.
• The other ingredients are: tablet core: microcrystalline cellulose (E460); anhydrous calcium hydrogen phosphate; hydroxypropylcellulose (E463); sodium croscarmellose (E468); anhydrous colloidal silica; magnesium stearate (E572).
  Film coating: hypromellose (E464); titanium dioxide (E171); triacetin; for Vareniclina Zentiva 1 mg film-coated tablets – indigo carmine AL (E132).

Description of the appearance of Vareniclina Zentiva and contents of the pack
Vareniclina Zentiva 0.5 mg film-coated tablets (tablet): film-coated tablets, white to almost white, capsule-shaped, biconvex with "S47" engraved on one side and flat on the other, approximately 8 x 4 mm in size.
Vareniclina Zentiva 1 mg film-coated tablets (tablet): film-coated tablets, blue, capsule-shaped, biconvex with "S48" engraved on one side and flat on the other, approximately 10 x 5 mm in size.
Packaged in OPA/Alu/PVC-Al and PVC/PCTFE-Al blisters.
Pack sizes:
Maintenance packs:
Vareniclina Zentiva 0.5 mg: 28, 56 film-coated tablets
Vareniclina Zentiva 1 mg: 28, 56, 112 film-coated tablets
Starting packs:
11 film-coated tablets of Vareniclina Zentiva 0.5 mg and 14 film-coated tablets of Vareniclina Zentiva 1 mg in a secondary cardboard packaging
11 film-coated tablets of Vareniclina Zentiva 0.5 mg and 42 film-coated tablets of Vareniclina Zentiva 1 mg in a secondary cardboard packaging
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Zentiva Italia S.r.l.
Via P. Paleocapa, 7
20121 Milano, Italy

Manufacturer
apis labor GmbH
Resslstraße 9
9065 Ebenthal in Kärnten,
Austria

This medicinal product is authorized in the European Economic Area countries under the following names:
Denmark, Sweden, Norway, France: Varenicline Zentiva
Spain, Italy, Portugal: Vareniclina Zentiva