VARENICLINE NORMON 1 mg FILM-COATED TABLETS

1. What is Varenicline Normon and what is it used for

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

Varenicline can help alleviate the anxiety and withdrawal syndrome associated with quitting smoking.

Varenicline may also reduce the pleasure caused by cigarettes if you smoke during treatment.

2. What you need to know before you start taking 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 starting to take Varenicline Normon.

There have been reports of depression, suicidal ideation and behavior, and suicide attempt in patients taking 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 must 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 varenicline treatment, 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 behavior, 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 must 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 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 treating respiratory problems), warfarin (a medicine for reducing blood clotting), and insulin (a medicine for treating 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 an increase in varenicline blood levels.

Use of Varenicline Normon with other smoking cessation therapies

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

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 Normon contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this 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 ensure that your attempt to stop 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) 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 date to stop smoking 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 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 not start smoking again.

If you cannot or are not willing to stop smoking immediately, you should reduce your tobacco consumption during the first 12 weeks of treatment and stop at the end of this treatment 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 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 Normon is administered orally.

The tablets should be swallowed whole with water or 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, telephone 91 562 04 20, indicating the medicine and the amount taken. Bring your pack of tablets.

If you forget to take Varenicline Normon

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

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 during the recommended treatment period and as described above, your chances of stopping smoking will increase. Therefore, unless your doctor gives you instructions to stop treatment, it is important to continue taking varenicline as indicated 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 about the use of this medicine, 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 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.

Serious side effects have been reported 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, coughing.
• Heartburn, vomiting, constipation, diarrhea, 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 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, excessive nasal mucus production with cough, runny nose.
• Red 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 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, 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 behavior.
• 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

• Transient loss of consciousness.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this package leaflet. You can also report side effects directly through 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 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 shown.

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 packaging and any unused medicine in the SIGRE collection point at your pharmacy. This will help protect the environment.

6. Container Content 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:

Core of the tablet

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, hydroxypropylcellulose, titanium dioxide (E-171), and talc.

Varenicline Normon 1 mg film-coated tablets EFG:

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

Appearance of the Product and Container Content

Varenicline Normon 0.5 mg film-coated tablets EFG

White or almost white film-coated tablets, capsule-shaped and biconvex, 8 mm in length and 4 mm in width, 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, 10 mm in length and 5 mm in width, 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 container 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 container 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 container 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 container 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 pack 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 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 and updated information about this medicinal product 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