VARENICLINE KERN PHARMA 0.5 mg FILM-COATED TABLETS

2. What you need to know before you take Varenicline Kern Pharma

Do not take Varenicline Kern Pharma

• 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 starting treatment with varenicline.

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 treatment.

Effects of stopping smoking

The effects of changes in your body as a result of stopping smoking, with or without treatment with varenicline, 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 Varenicline Kern Pharma”.

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. 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 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 Varenicline Kern Pharma

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), and insulin (a medicine for the treatment of diabetes). If you have any doubts, 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 Kern Pharma with other smoking cessation therapies

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

Taking Varenicline Kern Pharma with 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 preferable 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 medicine affects your ability to perform these activities.

Varenicline Kern Pharma contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially “sodium-free”.

3. How to take Varenicline Kern Pharma

Follow the instructions for administration of this medicine exactly as indicated 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 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.

Varenicline Kern Pharma 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 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 avoid relapse.

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, for 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.

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

Varenicline Kern Pharma is administered orally.

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

If you take more Varenicline Kern Pharma 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, telephone 91 562 04 20, indicating the medicine and the amount taken. Bring your pack of tablets.

If you forget to take Varenicline Kern Pharma

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 Kern Pharma

Clinical trials have shown that if you take all the doses of your medicine at the right times and for the recommended treatment period, your chances of stopping smoking will increase. Therefore, unless your doctor tells you to stop treatment, it is important to keep 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 further questions on the use of this product, 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 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 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 side effects have been reported 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, 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
• • 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 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 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
• Unhappiness 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 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 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 (cannot be estimated from the available data)

• 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 leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Varenicline Kern Pharma

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 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 a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Content and Additional Information

Composition of Varenicline Kern Pharma

The active ingredient is varenicline.

Each 0.5 mg film-coated tablet contains 0.5 mg of varenicline (as tartrate)

The other ingredients are:

• Tablet core: ascorbic acid, microcrystalline cellulose, calcium hydrogen phosphate, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate.
• Tablet coating: hypromellose, titanium dioxide (E-171), macrogol 400.

Each 1 mg film-coated tablet contains 1 mg of varenicline (as tartrate)

The other ingredients are:

• Tablet core: ascorbic acid, microcrystalline cellulose, calcium hydrogen phosphate, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate.
• Tablet coating: hypromellose, titanium dioxide (E-171), macrogol 400 and indigo carmine blue FD&C 2 (E-132).

Appearance of the Product and Container Content

Varenicline Kern Pharma 0.5 mg film-coated tablets EFG are biconvex, capsule-shaped, film-coated tablets, white or almost white in color, with one face marked with "0.5" and the other face plain.

Varenicline Kern Pharma 1 mg film-coated tablets EFG are biconvex, capsule-shaped, film-coated tablets, light blue in color, with one face marked with "1.0" and the other face plain.

Varenicline Kern Pharma 0.5 mg film-coated tablets EFG are available in the following packaging presentation:

• Al/Al blisters in a package containing 56 film-coated tablets of 0.5 mg.

Varenicline Kern Pharma 1 mg film-coated tablets EFG are available in the following packaging presentation:

• Al/Al blisters in a package containing 56 film-coated tablets of 1 mg.

Varenicline Kern Pharma 0.5 mg + 1 mg film-coated tablets EFG (4-week treatment initiation package) are available in the following packaging presentation:

• Al/Al blisters in a package containing 1 blister with 11 film-coated tablets of 0.5 mg and 3 blisters with 14 film-coated tablets of 1 mg.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Manufacturer

COMBINO PHARM MALTA, LTD

HF60 Hal Far Industrial Estate

Hal Far BBG3000

Malta

Date of the Last Revision of this Prospectus: October 2024

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