Prospecto: information for the user

Byteqi 0.5mg + 1 mg film-coated tablets EFG

varenicline

Read this prospectus carefully before starting to take this medication, as it contains important information for you.

-Keep this prospectus, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medication has been prescribed only to you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist,even if they are not listed in this prospectus.See section 4.

1.What is Byteqi and what it is used for

2.What you need to know before starting to take Byteqi

3.How to take Byteqi

4.Adverse effects

1. Storage of Byteqi

6.Contents of the package and additional information

Byteqi contains the active ingredient varenicline. Byteqi is a medication used in adults to help them stop smoking.

Varenicline may help alleviate anxiety and nicotine withdrawal symptoms associated with quitting smoking.

Varenicline also may reduce the pleasure that cigarettes cause if smoked during treatment.

Do not take Byteqi

-If you are allergic to varenicline or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Byteqi.

Cases of depression, ideation, and suicidal behavior, and suicide attempts have been reported in patients receiving varenicline. If you are taking varenicline and experience agitation, depressed mood, behavior changes that concern you or your family, or if you develop suicidal thoughts or behavior, stop taking varenicline and contact your doctor immediately for a treatment evaluation.

Effects of quitting smoking

The effects of changes in your body as a result of quitting smoking, with or without treatment with Byteqi, may alter the action of other medications. Consequently, in some cases, a dose adjustment may be necessary. See below for more details in “Other medications and Byteqi”.

Quitting smoking, with or without treatment, has been associated in some people with a higher risk of experiencing changes in thinking or behavior, feeling depressed and anxious, and may be associated with a worsening of a psychiatric disorder. If you have a history of psychiatric disorder, discuss it 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

Inform your doctor before starting treatment with varenicline if you have had seizures or are epileptic. Some people have experienced 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

Cases of potentially life-threatening skin rash (Stevens-Johnson syndrome and erythema multiforme) have been reported with the use of varenicline. If you develop a rash or if blisters or skin peeling occur, stop taking varenicline and seek urgent medical attention.

Children and adolescents

The use of varenicline in pediatric patients is not recommended as its efficacy has not been demonstrated.

Other medications and Byteqi

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

In some cases, as a result of quitting smoking, with or without varenicline, a dose adjustment of other medications may be necessary. Examples include theophylline (a medication for respiratory problems), warfarin (a medication to reduce blood clotting), and insulin (a medication for diabetes). If you have any doubts, consult your doctor or pharmacist.

If you have severe kidney disease, avoid taking cimetidine (a medication for gastrointestinal problems) at the same time as varenicline, as this may cause an increase in varenicline blood levels.

Use of Byteqi with other smoking cessation therapies

Consult your doctor before using varenicline in combination with other smoking cessation 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 unknown whether varenicline increases the effects of alcohol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

It is preferable to avoid using varenicline while pregnant. Consult your doctor if you plan to become pregnant.

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

Driving and operating machinery

Varenicline may be associated with dizziness, somnolence, and transient loss of consciousness. Do not drive, operate complex machinery, or perform any other potentially hazardous activity until you know if this medication affects your ability to perform these activities.

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

It is more likely that you will quit 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 quit 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) on which you will stop smoking. If you do not want or cannot set a date to stop smoking within those 2 weeks, you can choose your date to stop smoking within the 5 weeks following the start of treatment.You must write this date on the packaging as a reminder.

Byteqi is presented as white tablets (0.5 mg) and light blue tablets (1 mg). You will start with the white tablets and normally switch to the light blue ones. See the following 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 12 weeks of additional treatment with varenicline 1 mg film-coated tablets twice a day to help you not smoke again.

If you cannot or are not willing to stop smoking immediately, you must reduce tobacco consumption during the first 12 weeks of treatment and stop it at the end of that treatment period. You must then continue taking varenicline 1 mg film-coated tablets twice a day for another 12 weeks, totaling 24 weeks of treatment.

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

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

Byteqi is administered orally.

The tablets must 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, consult your doctor immediately, go to the nearest hospitalor call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken. Bring your packaging.

If you forget to take Byteqi

Do not take a double dose to compensate for the missed doses. It is essential to take varenicline regularly at the same hour each day. If you forget to take a dose, take it as soon as you can. However, if there are 3 to 4 hours left before your next dose, do not take the missed tablet.

If you interrupt the treatment with Byteqi

It has been demonstrated in clinical trials that if you take all your medication doses at the right times and during the recommended treatment period and previously described, your chances of quitting smoking will increase. Therefore, unless your doctor gives you instructions to suspend treatment, it is essential to continue taking varenicline according to the instructions described 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, when you stop taking varenicline, you may experience increased irritability, need to smoke, depression, and/or sleep disorders. Your doctor may decide to gradually reduce your varenicline dose at the end of treatment.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

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

Stopping smoking with or without treatment can produce different 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 appearance of severe neuropsychiatric symptoms, such as agitation, depressive mood, or changes in behavior during an attempt to quit smoking with or without varenicline, and should contact a doctor or pharmacist if you experience these symptoms.

Severe side effects have occurred with low or rare frequency in people trying to quit 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 and abnormal behavior), sleepwalking, diabetes, and high blood sugar levels. Also, severe skin reactions have been reported, 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).

• Very common side effects: that can affect more than 1 in 10 people:

• Nasal and throat inflammation, abnormal dreams, difficulty sleeping, headache
• Nausea

• Common side effects: that can affect up to 1 in 10 people:

• Chest infection, nasal sinus inflammation
• Weight gain, decreased appetite, increased appetite
• Dreams, dizziness, changes in taste
• Difficulty breathing, cough
• Acid reflux, vomiting, constipation, diarrhea, feeling bloated, abdominal pain, toothache, indigestion, flatulence, dry mouth
• Skin rash, itching
• Joint pain, muscle pain, back pain
• Chest pain, fatigue

• Uncommon side effects: that can affect up to 1 in 100 people:

• Fungal infection, viral infection
• Panic sensation, difficulty thinking, restlessness, mood changes, depression, anxiety, hallucinations, changes in sexual impulse
• Seizures, tremor, feeling of apathy, decreased sensitivity to touch
• Conjunctivitis, eye pain,
• Tinnitus
• Angina, rapid heart rate, palpitations, increased heart rate
• Increased blood pressure, heat sensation
• Nasal and throat inflammation, nasal congestion, throat congestion, hoarseness, hay fever, throat irritation, nasal congestion with cough, rhinorrhea
• Bloody stools, irritated stomach, change in bowel habit, belching, mouth ulcers, toothache
• Redness of the skin, acne, increased sweating, night sweats
• Muscle spasms, chest wall pain
• Abnormal urination frequency, 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: that can affect up to 1 in 1,000 people:

• Excessive thirst
• Discomfort or feeling unhappy, slow thinking
• Stroke
• Increased muscle tension, speech difficulties, coordination difficulties, decreased sense of taste, altered sleep pattern
• Eye changes, discoloration of the eyeball, dilated pupils, light sensitivity, myopia, watery eyes
• Irregular heartbeat or changes in heart rhythm
• Throat pain, hoarseness
• Blood in vomit, abnormal stools, tongue soreness
• Joint numbness, chest 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
• Severe 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)

• Unknown frequency

• Transient loss of consciousness

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and blister pack or on the bottle label after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of empty containers and unused medications. Dispose of empty containers and unused medications at the SIGRE drop-off point at the pharmacy. This will help protect the environment.

Byteqi Composition

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

Core tablet:microcrystalline cellulose, pregelatinized cornstarch, 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).

Appearance of the product and contents of the package

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

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

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

• Blister of PVC/PE/PVdC//Al in a package containing 28 or 56 film-coated tablets or blister perforated for single-dose packaging in a package 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:

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

Only some package sizes may be marketed.

Marketing authorization holder and responsible for manufacturing

Marketing authorization holder

Neuraxpharm Spain, S.L.

Avda. Barcelona, 69

08970 – Sant Joan Despí

Barcelona – Spain

Responsible for manufacturing

Delorbis Pharmaceuticals Ltd.

17 Athinon Str.

Ergates Industrial Area

2643 Ergates, Lefkosia

Cyprus

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park

Paola, PLA 3000

Malta

Last review date of this leaflet: 03/2024

Other sources of information

The detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.

You can access detailed information about this medicine by scanning the QR code included in the packaging with your smartphone.

You can also access this information at the following internet address:

.