Byteqi 1 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Byteqi 0.5 mg film-coated tablets EFG

Byteqi 1 mg film-coated tablets EFG

varenicline

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Byteqi is and what it is used for

2. What you need to know before taking Byteqi

3. How to take Byteqi

4. Possible side effects

   1. Storage of Byteqi

5. Contents of the pack and other information

1. What Byteqi is and what it is used for

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

Varenicline can help relieve the craving and withdrawal symptoms associated with quitting smoking.

Varenicline may also reduce the pleasure derived from cigarettes if you smoke during treatment.

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

Do not take Byteqi

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Byteqi.

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

Effects of quitting smoking

Changes in your body resulting from quitting smoking, with or without treatment with Byteqi, may alter the action of other medicines. Therefore, in some cases, a dose adjustment may be necessary. See below for further details in “Other medicines and Byteqi”.

Quitting smoking, with or without treatment, has been associated in some individuals 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, discuss this with your doctor.

Cardiac symptoms

Worsening or new cases of heart or blood vessel (cardiovascular) problems have been reported, mainly in people who already had cardiovascular conditions. Inform your doctor if you notice any change in your 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 ever had seizures or have epilepsy. Some people have experienced seizures during treatment with varenicline.

Hypersensitivity reactions

Stop taking varenicline and contact your doctor immediately if you experience any of the following signs or symptoms, which 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, blisters, or skin peeling, you must stop taking varenicline and seek urgent medical attention.

Children and adolescents

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

Other medicines and Byteqi

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

If you have severe renal impairment, you should avoid taking cimetidine (a medicine for stomach problems) at the same time as varenicline, as this may lead to increased blood levels of varenicline.

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, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

It is preferable to avoid using varenicline during pregnancy. Consult your doctor if you are planning to become pregnant.

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

Driving and use of 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 activities until you know whether this medicine affects your ability to perform such activities.

3. How to take Byteqi

Follow exactly the instructions for taking this medicine as given by your doctor. If you are unsure, 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 ensure 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 wish or are unable to set a quit date within those 2 weeks, you may choose your quit date within the following 5 weeks after starting treatment. You should write this date on the pack 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 dosing instructions to 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 daily to help you remain abstinent.

If you are unable or unwilling to quit smoking immediately, you should reduce your tobacco consumption during the first 12 weeks of treatment and stop smoking completely by the end of this treatment period. After that, you should continue taking varenicline 1 mg film-coated tablets twice daily for another 12 weeks, for a total of 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 daily.

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

Byteqi is administered orally.

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

If you take more Byteqi than you should

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

If you forget to take Byteqi

Do not take a double dose to make up for missed doses. It is important to take varenicline regularly at the same time each day. If you forget to take a dose, take it as soon as possible. However, if there are between 3 and 4 hours until your next scheduled dose, do not take the missed tablet.

If you stop taking Byteqi

Clinical trials have shown that taking all doses of your medicine at the correct times and for the recommended treatment period described above increases your chances of successfully quitting smoking. Therefore, unless your doctor instructs you otherwise, it is important to continue taking varenicline as directed in the table above.

In smoking cessation therapy, the risk of relapse may be high immediately after treatment ends. Temporarily, after stopping varenicline, you may experience increased irritability, craving for cigarettes, depression, and/or sleep disturbances. Your doctor may decide to gradually reduce your varenicline dose at the end of treatment.

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

4. Possible adverse effects

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

Stopping smoking, with or without treatment, may cause various symptoms, including 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 you should contact a doctor or pharmacist if you experience these symptoms.

Serious adverse effects have occurred infrequently or rarely 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 have also been reported, including erythema multiforme (a type of rash) and Stevens-Johnson syndrome (a serious illness with blisters on the skin, mouth, and around the eyes and genitals), as well as serious allergic reactions including angioedema (swelling of the face, mouth, or throat).

• Very common adverse effects: may affect more than 1 in 10 people:

• Inflammation of the nose and throat, abnormal dreams, difficulty sleeping, headache

• Nausea

• Common adverse effects: may affect up to 1 in 10 people:

• Chest infection, inflammation of the sinuses

• Weight gain, decreased appetite, increased appetite

• Drowsiness, dizziness, changes in taste sensation

• Difficulty breathing, cough

• Heartburn, vomiting, constipation, diarrhoea, feeling bloated, abdominal pain, toothache, indigestion, flatulence, dry mouth

• Skin rash, itching

• Joint pain, myalgia, back pain

• Chest pain, fatigue

• Uncommon adverse effects: may affect up to 1 in 100 people:

• Fungal infection, viral infection

• Feeling of panic, difficulty thinking, restlessness, mood changes, depression, anxiety, hallucinations, changes in sex drive

• Seizures, tremor, feeling of lethargy, reduced sensitivity to touch

• Conjunctivitis, eye pain

• Ringing in the ears

• Angina, rapid heart rate, palpitations, increased heart rate

• Increased blood pressure, hot flushes

• Inflammation of the nose, sinuses, and throat, nasal, throat, and chest congestion, hoarseness, hay fever, sore throat, congested sinuses, excess nasal mucus with cough, rhinorrhoea

• Red blood in stools, irritated stomach, change in bowel habit, 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 illness, fever, feeling of weakness or discomfort

• High blood sugar levels

• Heart attack

• Suicidal thoughts

• Changes in thinking or behaviour (such as aggression)

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

• Excessive thirst

• Malaise or feeling unwell, slowed thinking

• Stroke

• Increased muscle tension, speech difficulties, coordination difficulties, decreased sense of taste, sleep pattern disturbances

• Vision disorders, discoloration of the eyeball, dilated pupils, light sensitivity, myopia, watery eyes

• Irregular heartbeat or disturbances in heart rhythm

• Sore throat, snoring

• Blood in vomit, abnormal stools, coated tongue

• Numb 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 illness with blisters on the skin, mouth, and around the eyes and genitals)

• Serious allergic reactions including angioedema (swelling of the face, mouth, or throat)

• Frequency not known

• Transient loss of consciousness

Reporting of adverse effects

If you experience any kind of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Byteqi

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton, blister, or label of the bottle after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging no longer required. Dispose of unused medicines and their packaging at a SIGRE point in your pharmacy. This helps protect the environment.

6. Contents of the pack and other information

Composition of Byteqi

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

Tablet core: microcrystalline cellulose, pregelatinized maize 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).

Nature of the product and contents of the pack

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

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

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

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

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

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

Only certain 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 most recent 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 of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.

You can access detailed information about this medicine by scanning the QR code included on the packaging with your mobile phone (smartphone).

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