Varenicline Aurobindo

Package leaflet: Information for the user

Vareniclina Aurobindo 1 mg film-coated tablets, 0.5 mg + 1 mg film-coated tablets

Generic medicine
Please 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 other people, 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, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

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

2. What you need to know before taking Vareniclina Aurobindo

Do not take Vareniclina Aurobindo
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 or pharmacist before taking Vareniclina Aurobindo.

Cases of depression, suicidal thoughts and behaviour, and suicide attempts have been reported in patients taking Vareniclina Aurobindo. If you are taking Vareniclina Aurobindo and develop agitation, depressed mood, or behavioural changes that concern you, your family, or your doctor, or if you experience suicidal thoughts or behaviours, stop taking Vareniclina Aurobindo 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 Aurobindo, 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 Aurobindo”.

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 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, especially in people who already have cardiovascular disease. Inform your doctor if you notice any change in symptoms during treatment with Vareniclina Aurobindo. If you experience symptoms of a heart attack or stroke, seek emergency medical help immediately.

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

Hypersensitivity reactions
Stop taking Vareniclina Aurobindo and contact your doctor immediately if you develop any of the following signs or symptoms, which may 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 Aurobindo. If you develop a skin rash, or if skin peeling or blistering occurs, stop treatment with Vareniclina Aurobindo and seek urgent medical attention.

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

Other medicines and Vareniclina Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

In some cases, as a consequence of smoking cessation, with or without Vareniclina Aurobindo, a dose adjustment of other medicines may be required. 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, avoid taking cimetidine (a medicine for gastric disorders) while taking Vareniclina Aurobindo, as this could lead to increased levels of Vareniclina Aurobindo in the blood.

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

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

Pregnancy and breastfeeding
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 preferable to avoid using Vareniclina Aurobindo during pregnancy. Talk to your doctor if you are planning a pregnancy.

Although not studied, Vareniclina Aurobindo may pass into breast milk. Consult your doctor or pharmacist before taking Vareniclina Aurobindo.

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

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

3. How to take Vareniclina Aurobindo

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 stop smoking successful.
Before starting treatment with Vareniclina Aurobindo, 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 Aurobindo is available as white tablets (0.5 mg) and light blue tablets (1 mg). Treatment is started with the white tablet, and you will usually switch later to the light blue tablet. See the table below for instructions on the usual dosing regimen to follow starting from day 1.

After 12 weeks of treatment, if you have stopped smoking, your doctor may recommend an additional 12-week course of treatment with Varenicline Aurobindo 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 Varenicline Aurobindo 1 mg film-coated tablets twice daily for another 12 weeks, for a total treatment duration of 24 weeks.

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 Varenicline Aurobindo. You may require a lower dose.

Varenicline Aurobindo is for oral use.

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

If you take more Varenicline Aurobindo than you should

If you accidentally take more Varenicline Aurobindo than prescribed, you must contact your doctor immediately or go to the nearest emergency room. Take the tablet packaging with you.

If you forget to take Varenicline Aurobindo

Do not take a double dose to make up for a missed tablet. It is important to take your Varenicline Aurobindo tablet 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 dose, do not take the missed tablet.

If you stop taking Varenicline Aurobindo

Clinical studies have shown that taking all doses of the medicine at the correct times and for the recommended treatment duration described above increases your chances of successfully quitting smoking. Therefore, unless your doctor has instructed you otherwise, it is important to continue taking Varenicline Aurobindo 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 Varenicline Aurobindo, you may temporarily experience increased irritability, a strong urge to smoke, depression, and/or sleep disturbances. Your doctor may decide to gradually reduce your dose of Varenicline Aurobindo at the end of treatment.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Stopping smoking, with or without treatment, may cause a number of 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 stop smoking with or without Vareniclina Aurobindo, and you should contact your doctor or pharmacist if such symptoms occur.

In people who have attempted to stop smoking using Vareniclina Aurobindo, serious side effects have been observed, with uncommon or rare frequency: seizures, stroke, heart attack, suicidal thoughts, loss of touch with reality, and inability to think or judge clearly (psychosis), changes in thought or behaviour (such as aggression or abnormal behaviour).

Serious skin reactions have also been reported, including erythema multiforme (a type of skin rash) and Stevens-Johnson syndrome (a serious illness causing blistering of the skin, mouth, around the eyes or genitals), as well as severe 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, abnormal dreams, sleep disturbances, 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.
• Panic sensation, difficulty thinking, restlessness, mood swings, depression, anxiety, hallucinations, changes in sexual desire.
• Seizures, tremors, feeling of apathy, loss of sensitivity to touch.
• Conjunctivitis, eye pain.
• Ringing in the ears.
• Angina, increased heart rate, palpitations, increased heart frequency.
• Increased blood pressure, hot flushes.
• Inflammation of the nose, paranasal sinuses and throat, nasal congestion, throat and 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 syndrome, 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, slowed thinking.
• Stroke.
• Increased muscle tension, difficulty speaking, coordination problems, reduced sense of taste, changes in sleep rhythm.
• Vision disturbances, change in eye colour, dilated pupils, light sensitivity, myopia, excessive tearing.
• Irregular heartbeat or cardiac rhythm disorders.
• 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, changes in sexual performance.
• Feeling cold, cysts.
• Diabetes.
• Sleepwalking.
• Loss of touch with reality and inability to think or judge clearly (psychosis).
• Abnormal behaviour.
• Severe skin reactions, including erythema multiforme (a type of skin rash) and Stevens-Johnson syndrome (a serious illness causing blistering of the skin, mouth, around the eyes or genitals).
• Severe 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 or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Varenicline Aurobindo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP".
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how
to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Vareniclina Aurobindo contains

• The active substance is varenicline tartrate. Each film-coated tablet contains 0.855 mg of varenicline tartrate (equivalent to 0.5 mg of varenicline). Each 1 mg film-coated tablet contains 1.710 mg of varenicline tartrate (equivalent to 1 mg of varenicline).
• The other components are: Tablet core: Microcrystalline cellulose (Grade 101 and Grade 102), calcium hydrogen phosphate, croscarmellose sodium, anhydrous colloidal silica, magnesium stearate.

Tablet coating: Hypromellose 2910 (6 mPa·s) (E464), titanium dioxide (E171), indigo
carmine (FD&C Blue 2) aluminium lake (E132) ( for 1 mg) .
Description of the appearance of Vareniclina Aurobindo and contents of the pack
Film-coated tablet.
Vareniclina Aurobindo 0.5 mg film-coated tablets
Film-coated tablets, white, capsule-shaped, biconvex, marked with “VA” on one side and
“0.5” on the other side.
Vareniclina Aurobindo 1 mg film-coated tablets
Film-coated tablets, light blue in colour, capsule-shaped, biconvex, marked with “VA” on
one side and “1” on the other side.
Vareniclina Aurobindo film-coated tablets are available in blister packs.
Packs:
Blister packs: 28 and 56 film-coated tablets.
Starter packs:
Pack containing 25 film-coated tablets:
Each pack of 25 film-coated tablets contains 11 film-coated tablets of
Vareniclina Aurobindo 0.5 mg and 14 film-coated tablets of Vareniclina Aurobindo 1 mg.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Aurobindo Pharma (Italia) Srl
Via San Giuseppe, 102 - 21047 Saronno (VA), Italy
Manufacturer
APL Swift Services (Malta) Ltd
HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG3000, Malta
Generis Farmacêutica SA
Rua João de Deus, n. 19, Venda Nova, 2700-487 Amadora, Portugal
This medicinal product is authorised in the European Economic Area countries under the
following names:
Italy: Vareniclina Aurobindo
Portugal: Vareniclina Aurobindo