VARENICLINE NORMON 0.5 mg FILM-COATED TABLETS

2. What you need to know before you take Varenicline Normon

Do not take Varenicline Normon

• 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 taking Varenicline Normon.

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 your treatment.

Quitting smoking

The effects of the changes in your body as a result of quitting 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 Normon”.

Quitting 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 change in symptoms during treatment with varenicline. If you experience symptoms of a heart attack or stroke, seek immediate medical help.

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 reactions (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 patients under 18 years of age, as its efficacy has not been demonstrated in this population.

Other medicines and Varenicline Normon

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 quitting 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 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.

Using Varenicline Normon with other stop-smoking therapies

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

Taking Varenicline Normon 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.

Varenicline should be used with caution during pregnancy. 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 activity that may be potentially dangerous until you know whether this medicine affects your ability to perform these activities.

Varenicline Normon contains sodium

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

3. How to take Varenicline Normon

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If you are in 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 Normon is available as white (0.5 mg) and light blue (1 mg) film-coated tablets. You will start with the white tablets and normally move to the light blue tablets. See the table below for the usual instructions for administration 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 avoid relapse.

If you are unable or unwilling to stop smoking immediately, you should reduce your smoking 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 a further 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 your 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 Normon is taken by mouth.

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

If you take more Varenicline Normon 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 Poison Information Service on 91 562 04 20, stating the medicine and the amount taken. Take the pack with you.

If you forget to take Varenicline Normon

Do not take a double dose to make up for a forgotten dose. 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 remember. However, if it is almost time for your next dose, do not take the missed dose.

If you stop taking Varenicline Normon

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, 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 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, urge 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 product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Quitting 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 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, sinusitis.
• Weight gain, decreased appetite, increased appetite.
• Somnolence, dizziness, changes in taste.
• Difficulty breathing, cough.
• Acid reflux, vomiting, constipation, diarrhoea, bloating, 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 attacks, 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.
• High blood pressure, hot flushes.
• Nasal, sinus, and throat inflammation, nasal congestion, throat irritation, hoarseness, hay fever, throat irritation, nasal discharge 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 of weakness or malaise.
• 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.
• Malaise or feeling of unhappiness, slow thinking.
• Stroke.
• Increased muscle tone, 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.
• Stiff joints, rib pain.
• Glucose in urine, increased urine volume and frequency.
• Vaginal discharge, changes in sexual ability.
• Feeling of coldness, 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 leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Varenicline Normon

This medicine does not require any special storage conditions.

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 stated.

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 unused medicine and empty containers in the pharmacy’s SIGRE collection point. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Varenicline Normon

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

Varenicline Normon 0.5 mg film-coated tablets EFG and Varenicline Normon 1 mg film-coated tablets EFG:

Microcrystalline cellulose, maltodextrin, sodium croscarmellose, and stearic acid.

Coating

Varenicline Normon 0.5 mg film-coated tablets EFG:

Hypromellose, hydroxypropyl-cellulose, titanium dioxide (E-171), and talc.

Varenicline Normon 1 mg film-coated tablets EFG:

Hypromellose, hydroxypropyl-cellulose, titanium dioxide (E-171), talc, and indigo carmine lake (E-132).

Appearance of the Product and Package Contents

Varenicline Normon 0.5 mg film-coated tablets EFG

White or almost white film-coated tablets, capsule-shaped and biconvex,

with a length of 8 mm and a width of 4 mm, serigraphed with “C2” on one face and smooth on the other.

Varenicline Normon 1 mg film-coated tablets EFG

Light blue film-coated tablets, capsule-shaped and biconvex, with a length of 10 mm and a width of 5 mm, serigraphed with “C1” on one face and smooth on the other.

Varenicline Normon is available in the following presentations:

PVDC/PVC/PE/PVDC blister pack with an aluminum foil sheet in a package containing 56 x 0.5 mg film-coated tablets in a cardboard box.

PVDC/PVC/PE/PVDC blister pack with an aluminum foil sheet in a package containing 56 x 1 mg film-coated tablets in a cardboard box.

PVDC/PVC/PE/PVDC blister pack with an aluminum foil sheet in a package containing 112 x 1 mg film-coated tablets in a cardboard box.

PVDC/PVC/PE/PVDC blister pack with an aluminum foil sheet in a package containing 1 transparent blister pack with 11 x 0.5 mg and 14 x 1 mg film-coated tablets; and 1 transparent blister pack with 28 x 1 mg or 2 transparent blister packs with 14 x 1 mg film-coated tablets, in a heat-sealed outer cardboard packaging.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the Last Revision of this Prospectus:

October 2023

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

You can access detailed and updated information about this medication by scanning the QR code included in the prospectus and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/89220/P_89220.html