BYTEQI 0.5 mg FILM-COATED TABLETS

2. What you need to know before you take Byteqi

Do not take Byteqi

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

Warnings and precautions

Talk to your doctor or pharmacist before you start taking Byteqi.

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 an assessment 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 Byteqi, may alter the action of other medicines. Consequently, in some cases it may be necessary to adjust the dose of other medicines. See below for more details in “Other medicines and Byteqi”.

Stopping smoking, with or without treatment, has been associated in some people with an increased risk of experiencing changes in thinking or behaviour, 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. Tell 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, tell 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 tell 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 paediatric patients as its efficacy has not been demonstrated.

Other medicines and Byteqi

Tell your doctor or pharmacist if you are using, have recently used, or might use 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 respiratory problems), warfarin (a medicine to reduce blood clotting), and insulin (a medicine for diabetes). If you are in doubt, talk to 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 Byteqi with other stop-smoking therapies

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

Use of Byteqi 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.

It is recommended to avoid the use of varenicline while pregnant. Talk to your doctor if you plan to become pregnant.

Although it has not been studied, varenicline may pass into human breast milk. You should talk to 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 potentially hazardous activity until you know whether this medicine affects your ability to perform these activities.

3. How to take Byteqi

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.

Byteqi 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 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 start smoking again.

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, making a total treatment duration of 24 weeks.

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 talk to your doctor before taking varenicline. You may need a lower dose.

Byteqi is taken by mouth.

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

If you take more Byteqi than you should

If you have accidentally taken more varenicline than your doctor prescribed, talk to your doctor immediately, go to the nearest hospital, or call the Toxicology Information Service, telephone 91 562 04 20, stating the medicine and the amount taken. Take the pack with you.

If you forget to take Byteqi

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 Byteqi

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, 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 keep taking varenicline as directed.

In smoking cessation therapy, the risk of relapse to smoking may be high in the period immediately after the end of treatment. Temporarily, when you stop taking varenicline, you may experience increased irritability, need to smoke, depression, and/or sleep disturbance. 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, can cause various symptoms, which 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 occurrence of serious neuropsychiatric symptoms, such as agitation, depressed mood, or changes in behaviour during an attempt to stop smoking with or without varenicline, and 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 or abnormal behaviour), sleepwalking, diabetes, and high blood sugar levels. 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 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, diarrhoea, feeling bloated, abdominal pain, toothache, indigestion, flatulence, dry mouth
• Skin rash, itching
• Joint pain, muscle pain, back pain
• Chest pain, tiredness

• 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 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 cough, runny nose
• Blood in stools, 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 behaviour (such as aggression)

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

• Excessive thirst
• Illness or feeling unhappy, slow thinking
• Stroke
• Increased muscle tension, speech difficulties, coordination difficulties, decreased sense of taste, sleep pattern changes
• Visual disturbances, discolouration 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 stools, furry tongue
• Numbed joints, rib 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 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 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 package leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Byteqi

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 and blister or on the label of the bottle 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. Ask your pharmacist how to dispose of medicines no longer required. Dispose of the packaging and any unused medicine in the SIGRE collection point at your pharmacy. This will help protect the environment.

6. Packaging Contents and Additional Information

Byteqi Composition

• The active ingredient is varenicline.
• Each 0.5 mg film-coated tablet contains 0.5 mg of varenicline (as tartrate)
• Each 1 mg film-coated tablet contains 1 mg of varenicline (as tartrate)
• The other components are:

Tablet core: microcrystalline cellulose, pregelatinized corn starch, propyl gallate, magnesium stearate, and anhydrous citric acid.

Coating:

Byteqi 0.5 mg film-coated tablets EFG

Hypromellose (E464), titanium dioxide (E171).

Byteqi 1 mg film-coated tablets EFG

Hypromellose (E464), titanium dioxide (E171), indigo carmine (E132).

Product Appearance and Packaging Contents

• Byteqi 0.5 mg are film-coated tablets with a capsule shape and white color, marked with “0.5” on one face.

• Byteqi 1 mg are film-coated tablets with a capsule shape and light blue color, marked with “1.0” on one face.

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

• PVC/PE/PVdC//Al blister pack in a container containing 28 or 56 film-coated tablets or a single-dose perforated blister pack in a container containing 28 or 56 film-coated tablets.
• HDPE bottle (with child-resistant closure): bottle of 56 film-coated tablets

Byteqi 1 mg film-coated tablets EFG are available in the following presentations:

• PVC/PE/PVdC//Al blister pack in a container containing 28, 56, 112, 140, or 168 film-coated tablets or a single-dose perforated blister pack in a container containing 28, 56, or 112 film-coated tablets.
• HDPE bottle (with child-resistant closure): bottle of 56 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Neuraxpharm Spain, S.L.

Avda. Barcelona, 69

08970 – Sant Joan Despí

Barcelona – Spain

Manufacturer

Delorbis Pharmaceuticals Ltd.

17 Athinon Str.

Ergates Industrial Area

2643 Ergates, Lefkosia

Cyprus

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park

Paola, PLA 3000

Malta

Date of the Last Revision of this Leaflet: 03/2024

Other Sources of Information

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/.

You can access detailed information about this medicinal product 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:

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