BYTEQI 0.5 mg + 1 mg FILM-COATED TABLETS

2. What you need to know before taking Byteqi

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.

There have been reports of depression, suicidal ideation and behavior, and attempted suicide in patients receiving varenicline. If you are taking varenicline and experience agitation, depressed mood, changes in behavior that concern you or your family, or develop suicidal thoughts or behavior, you should stop taking varenicline and contact your doctor immediately for a treatment assessment.

Quitting smoking effects

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, it may be necessary to adjust the dose of other medications. See below for more details in "Other medications and Byteqi".

Quitting smoking, with or without treatment, has been associated in some people with an increased risk of experiencing changes in thinking or behavior, feelings of depression and anxiety, 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. 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

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.

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

There have been reports of potentially life-threatening skin rashes (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

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

Other medications and Byteqi

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

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

If you have severe kidney disease, you should avoid taking cimetidine (a medication 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 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 not known whether varenicline increases the effects of alcohol.

Pregnancy and breastfeeding

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

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

Although it has not been studied, varenicline may pass into human breast milk. You should consult 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 medication affects your ability to perform these activities.

3. How to take Byteqi

Follow the administration instructions for this medication exactly as indicated by your doctor. If you have any doubts, consult your doctor or pharmacist again.

You are more likely to quit 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 quit smoking is successful.

Normally, before starting treatment with varenicline, you should decide on a date during the second week of treatment (between day 8 and day 14) when you will quit smoking. If you do not wish to or cannot set a date to quit 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 package as a reminder.

Byteqi is available 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 tablets. See the table below for the usual administration instructions to follow from Day 1.

If you have quit 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 avoid relapse.

If you cannot or are not willing to quit smoking immediately, you should reduce your tobacco consumption during the first 12 weeks of treatment and quit at the end of this period. Then, you should continue taking varenicline 1 mg film-coated tablets twice a day for another 12 weeks, for a total of 24 weeks of treatment.

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

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

Byteqi is administered orally.

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, consult your doctor immediately, go to the nearest hospital, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken. Bring your box of tablets.

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

If you interrupt treatment with Byteqi

It has been demonstrated in clinical trials that if you take all the doses of your medication at the right times and during the recommended treatment period, your chances of quitting smoking will increase. Therefore, unless your doctor instructs you to stop treatment, it is essential to continue taking varenicline as 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 disturbances. Your doctor may decide to gradually reduce your dose of varenicline at the end of treatment.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Quitting 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 behavior during an attempt to quit smoking with or without varenicline, and you should contact a doctor or pharmacist if you experience these symptoms.

Severe side effects have occurred rarely 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. Serious skin reactions, including erythema multiforme (a type of rash) and Stevens-Johnson syndrome (a severe 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, 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: may 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 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 nasal mucus with cough, rhinorrhea
• Blood in stools, stomach irritation, change in bowel habit, belching, mouth ulcers, gum pain
• Redness of the skin, acne, increased sweating, night sweats
• Muscle spasms, chest wall pain
• Abnormal urination, nocturia
• Increased menstrual flow
• Chest discomfort, flu-like illness, fever, feeling of weakness or malaise
• High blood sugar levels
• Heart attack
• Suicidal thoughts
• Changes in thinking or behavior (such as aggression)

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

• Excessive thirst
• Indisposition or feeling of unhappiness, slow thinking
• Stroke
• Increased muscle tension, speech difficulties, coordination difficulties, decreased sense of taste, sleep pattern changes
• Visual disturbances, discoloration of the eyeball, dilated pupils, sensitivity to light, myopia, tearing
• Irregular heartbeat or changes in heart rhythm
• Sore throat, snoring
• Blood in vomit, abnormal stools, coated tongue
• Stiff joints, rib pain
• Glucose in urine, increased urine volume and frequency
• Vaginal discharge, changes in sexual ability
• Feeling of 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 severe 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 side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines Monitoring System: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Byteqi

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

Do not use this medication after the expiration date stated on the carton and blister or on the label of the bottle after EXP. 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 via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medication. Deposit the packaging and unused medication in the SIGRE collection point at the pharmacy. This will help protect the environment.

6. Container Content 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 Container Content

• 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 perforated unit-dose 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 perforated unit-dose 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 Prospectus: 03/2024

Other Sources of Information

Detailed information about 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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