VARENICLINE STADA 0.5 mg + 1 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Varenicline Stada 0.5 mg film-coated tablets EFG

Varenicline Stada 1 mg film-coated tablets EFG

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

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

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

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

Varenicline may also reduce the pleasure you get from smoking if you smoke during treatment.

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

Do not take Varenicline Stada

• 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 you start taking Varenicline Stada.

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 your treatment.

Effects of stopping smoking

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. 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 Stada”.

In some people, stopping smoking, with or without treatment, has been associated with an increased risk of changes in thinking or behaviour, feeling depressed or anxious, and may be associated with worsening of pre-existing psychiatric disorders. 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 them. Inform your doctor if you experience any change 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.

Allergic 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, and/or difficulty breathing, wheezing.

Skin reactions

There have been reports of potentially life-threatening skin reactions (Stevens-Johnson syndrome and erythema multiforme) with the use of varenicline. If you develop a rash or your skin starts to peel or you get blisters, you should stop taking varenicline and seek emergency medical help.

Children and adolescents

Varenicline is not recommended for patients under 18 years of age as its efficacy has not been demonstrated in this age group.

Other medicines and Varenicline Stada

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 the treatment of respiratory problems)
• Warfarin (a medicine to reduce blood clotting)
• Insulin (a medicine for the treatment of 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.

Use of varenicline with other therapies to stop smoking

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

Taking Varenicline Stada with food, drinks, and 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.

Pregnancy

You should avoid using varenicline while pregnant. Consult your doctor if you plan to become pregnant.

Breastfeeding

Although it has not been studied, varenicline may pass into breast milk. You should consult your doctor or pharmacist before taking varenicline.

Driving and using machines

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

3. How to take Varenicline Stada

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

It is more likely that you will stop smoking if you are motivated to do so. Your doctor or pharmacist can provide you with advice, support, and additional information to help ensure that your attempt to stop smoking is successful.

Quit date

Before starting your treatment with varenicline, you should choose a date during the second week of treatment (between day 8 and day 14) when you will stop smoking. This is your target quit date. If you do not want to or cannot set a quit date 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.

Dose

Varenicline is available as white tablets (0.5 mg) and light blue tablets (1 mg). You will start with the white tablets and normally move to the light blue tablets. 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 not to start smoking again.

If you cannot or are not willing 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. Then, you should continue taking varenicline 1 mg film-coated tablets twice a day for another 12 weeks, which makes 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.

People with kidney problems

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

Method of administration

Varenicline is administered orally.

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

If you take more Varenicline Stada than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, telephone: 91 562 04 20, indicating the medicine and the amount ingested. Bring your pack of tablets.

If you forget to take Varenicline Stada

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 between 3 and 4 hours before your next dose, do not take the missed tablet.

If you stop taking Varenicline Stada

It has been shown in clinical trials that if you take all the doses of your medicine at the right times and during the recommended treatment period and as described above, 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 indicated 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, you may experience increased irritability, need to smoke, depression, and/or sleep disturbances when you stop taking varenicline. 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 may produce various symptoms, which can 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 possibility of severe 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.

There have been reports of serious side effects 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 and abnormal behaviour). Serious 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 swelling of the face, mouth, or throat (angioedema), 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 or increased appetite
• Sleepiness, dizziness, changes in taste
• Difficulty breathing, cough
• Heartburn, vomiting, constipation, diarrhoea, feeling bloated, 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, difficulty thinking, restlessness, mood changes, depression, anxiety, hallucinations, changes in sexual impulse
• Seizures, tremor, feeling of lethargy, 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 and chest congestion, hoarseness, hay fever, throat irritation, nasal sinus congestion, excess mucus production with cough, runny nose
• Blood in stools, irritated stomach, 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 of weakness or discomfort
• 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
• Illness or feeling of unhappiness, 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/disorders in sexual function
• Feeling of 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 serious disease with blisters on the skin, mouth, and around the eyes and genitals)
• Severe allergic reactions, including swelling of the face, mouth, or throat (angioedema)

Frequency not known(cannot be estimated from the available data)

• Temporary loss of consciousness

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly to 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. Storage of Varenicline Stada

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 or blister pack 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 protect the environment.

6. Package Contents and Additional Information

Composition of Varenicline Stada

The active ingredient is varenicline.

Varenicline Stada 0.5 mg film-coated tablets EFG:

Each tablet contains varenicline tartrate equivalent to 0.5 mg of varenicline.

Varenicline Stada 1 mg film-coated tablets EFG:

Each tablet contains varenicline tartrate equivalent to 1 mg of varenicline.

Varenicline Stada 0.5 mg + 1 mg film-coated tablets EFG:

Each 0.5 mg tablet contains varenicline tartrate equivalent to 0.5 mg of varenicline.

Each 1 mg tablet contains varenicline tartrate equivalent to 1 mg of varenicline.

The other ingredients are:

Tablet core

Microcrystalline cellulose (E468), maltodextrin (E1400), sodium croscarmellose (E468), stearic acid (E570).

Tablet coating

Varenicline Stada 0.5 mg film-coated tablets EFG: hypromellose (E464), hydroxypropylcellulose (E463), titanium dioxide (E171), talc (E553b).

Varenicline Stada 1 mg film-coated tablets EFG: hypromellose (E464), titanium dioxide (E171), hydroxypropylcellulose (E463), talc (E553b), indigo carmine (E132).

Varenicline Stada 0.5 mg + 1 mg film-coated tablets EFG:

Varenicline Stada 0.5 mg film-coated tablets EFG: hypromellose (E464), titanium dioxide (E171), hydroxypropylcellulose (E463), talc (E553b).

Varenicline Stada 1 mg film-coated tablets EFG: hypromellose (E464), titanium dioxide (E171), hydroxypropylcellulose (E463), talc (E553b), indigo carmine (E132).

Product Appearance and Package Contents

Varenicline Stada 0.5 mg are film-coated tablets, biconvex, white to off-white, capsule-shaped, engraved with "C2" on one side and smooth on the other.

Varenicline Stada 1 mg are film-coated tablets, biconvex, light blue, capsule-shaped, engraved with "C1" on one side and smooth on the other.

Varenicline Stada 0.5 mg + 1 mg film-coated tablets EFG:

Varenicline Stada 0.5 mg are film-coated tablets, biconvex, white to off-white, capsule-shaped, engraved with "C2" on one side and smooth on the other.

Varenicline Stada 1 mg are film-coated tablets, biconvex, light blue, capsule-shaped, engraved with "C1" on one side and smooth on the other.

Package Sizes

Varenicline Stada 0.5 mg film-coated tablets are available in:

• packs containing 56 film-coated tablets in blisters or 56x1 film-coated tablets in unit-dose blisters.
• HDPE bottles containing 56 film-coated tablets.

Varenicline Stada 1 mg film-coated tablets are available in:

• packs containing 28, 56, 112, or 140 film-coated tablets in blisters or 28x1, 56x1, 112x1, or 140x1 film-coated tablets in unit-dose blisters.
• HDPE bottles containing 56 film-coated tablets.

Varenicline Stada 0.5 mg + 1 mg film-coated tablets are available in:

• packs containing 11 tablets of 0.5 mg and 14 or 42 tablets of 1 mg in blisters or 11x1 tablets of 0.5 mg and 14x1 or 42x1 tablets of 1 mg in unit-dose blisters.
• HDPE bottles containing 56 film-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

info@stada.es

Manufacturer

Stada Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

or

Centrafarm Services B.V.

Van de Reijstraat 31-E

4814 NE Breda

Netherlands

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Netherlands Varenicline CF 0.5 mg, film-coated tablets

Varenicline CF 1 mg, film-coated tablets

Varenicline CF 0.5 mg + 1 mg, film-coated tablets

Belgium Varenicline EG 0.5 mg film-coated tablets

Varenicline EG 1 mg film-coated tablets

Varenicline EG 0.5 mg + 1 mg film-coated tablets

Denmark Vareniclin Stada

Vareniclin Stada

Spain Vareniclina Stada 0.5 mg film-coated tablets EFG

Vareniclina Stada 1 mg film-coated tablets EFG

Vareniclina Stada 0.5 mg + 1 mg film-coated tablets EFG

Finland Varenicline Stada 0.5 mg film-coated tablets

Varenicline Stada 1 mg film-coated tablets

Varenicline Stada 0.5 mg + 1 mg film-coated tablets

France Varénicline EG 0.5 mg film-coated tablets

Varénicline EG 1 mg film-coated tablets

Varénicline EG 0.5 mg film-coated tablets

Varénicline EG 1 mg film-coated tablets

Luxembourg Varenicline EG 0.5 mg film-coated tablets

Varenicline EG 1 mg film-coated tablets

Varenicline EG 0.5 mg + 1 mg film-coated tablets

Sweden Varenicline Stada 0.5 mg film-coated tablets

Varenicline Stada 1 mg film-coated tablets

Varenicline Stada 0.5 mg + 1 mg film-coated tablets

Date of the Last Revision of this Leaflet:January 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es.