Package Leaflet: Information for the User

Varenicline Normon 0.5 mg Film-Coated Tablets

Varenicline Normon 1 mg Film-Coated Tablets

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as 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. Do not give it to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Vareniclina Normon contains the active ingredient vareniclina. Vareniclina is a medication used in adults to help them stop smoking.

Vareniclina may help alleviate anxiety and withdrawal syndrome associated with quitting smoking.

Vareniclina also may reduce the pleasure that cigarettes cause if smoked during treatment.

Do not take Vareniclina Normon

• If you are allergic to vareniclina 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 Vareniclina Normon.

Cases of depression, ideation, and suicidal behavior have been reported in patients receiving vareniclina. If you are taking vareniclina and experience agitation, depressive mood, changes in behavior that concern you or your family, or if you develop suicidal thoughts or behavior, stop taking vareniclina and immediately contact your doctor for an evaluation of your treatment.

Effects of quitting smoking

The effects of changes in your body as a result of quitting smoking, with or without vareniclina treatment, may alter the action of other medications. Consequently, in some cases, a dose adjustment may be necessary. See below for more details in “Other medications and Vareniclina Normon”.

Quitting smoking, with or without treatment, has been associated in some people with a higher risk of experiencing changes in thinking or behavior, feelings of depression and anxiety, and may be associated with a worsening of a psychiatric disorder. If you have a history of psychiatric disorder, discuss it with your doctor.

Cardiac symptoms

Reports of worsening or new cases of heart or blood vessel problems (cardiovascular) have been communicated, mainly in people who already had cardiovascular problems. Inform your doctor if you experience any changes in symptoms during treatment with vareniclina. If you experience symptoms of a heart attack or stroke, seek immediate emergency medical help.

Seizures

Inform your doctor before starting treatment with vareniclina if you have had seizures or are epileptic. Some people have experienced seizures during treatment with vareniclina.

Hypersensitivity reactions

Stop taking vareniclina and immediately inform your doctor 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

Cases of potentially life-threatening skin rash (Stevens-Johnson syndrome and erythema multiforme) have been reported with the use of vareniclina. If you develop a rash or if blisters or skin peeling occur, stop taking vareniclina and seek urgent medical attention.

Children and adolescents

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

Other medications and Vareniclina Normon

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

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

If you have severe kidney disease, avoid taking cimetidine (a medication for gastrointestinal problems) at the same time as vareniclina, as this may cause an increase in vareniclina blood levels.

Use of Vareniclina Normon with other smoking cessation therapies

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

Taking Vareniclina Normon with alcohol

There have been some reports of increased intoxicating effects of alcohol in patients taking vareniclina. However, it is unknown whether vareniclina increases the effects of alcohol.

Pregnancy and breastfeeding

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

It is preferable to avoid using vareniclina while pregnant. Consult your doctor if you plan to become pregnant.

Although not studied, vareniclina may pass into human breast milk. Consult your doctor or pharmacist before taking vareniclina.

Driving and operating machinery

Vareniclina may be associated with dizziness, drowsiness, and transient loss of consciousness. Do not drive, operate complex machinery, or perform any other potentially hazardous activity until you know if this medication affects your ability to perform these activities.

Vareniclina Normon contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

It is more likely that you will quit 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 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 quit smoking. If you do not want or are unable to set a date to quit smoking within those 2 weeks, you can choose your quit date within the 5 weeks following the start of treatment. You must write this date on the packaging as a reminder.

Varenicline Normon is presented 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 ones. See the following table with the usual administration instructions that you should 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 coated tablets twice a day to help you not smoke again.

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 that treatment period. Then, you should continue taking varenicline 1 mg coated tablets twice a day for another 12 weeks, totaling 24 weeks of treatment.

If you experience adverse 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.

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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken. Bring your packaging.

If you forgot to take Varenicline Normon

Do not take a double dose to compensate for the missed doses. It is essential to take varenicline regularly at the same hour each day. If you forget to take a dose, take it as soon as you can. However, if there are 3-4 hours until your next dose, do not take the missed tablet.

If you interrupt the treatment with Varenicline Normon

It has been demonstrated in clinical trials that if you take all your medication doses at the right times and during the recommended treatment period and previously described, you will increase the chances of quitting smoking. Therefore, unless your doctor instructs you to discontinue 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 disorders. Your doctor may decide to gradually reduce your varenicline dose at the end of treatment.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Stopping smoking with or without treatment may produce different 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 severe neuropsychiatric symptoms, such as agitation, depressive mood, or changes in behavior during an attempt to quit smoking with or without varenicline, and should contact a doctor or pharmacist if you experience these symptoms.

Severe side effects have occurred in people who were 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. Severe 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: that may affect more than 1 in 10 people

• Pharyngitis and laryngitis, abnormal dreams, difficulty sleeping, headache.
• Nausea.

Common side effects: that may affect up to 1 in 10 people

• Chest infection, nasal congestion.
• Weight gain, decreased appetite, increased appetite.
• Dreams, dizziness, changes in taste.
• Difficulty breathing, cough.
• Heartburn, vomiting, constipation, diarrhea, feeling bloated, abdominal pain, toothache, indigestion, flatulence, dry mouth.
• Skin rash, itching.
• Joint pain, myalgia, back pain.
• Chest pain, fatigue.

Uncommon side effects: that 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 apathy, decreased sensitivity to touch.
• Conjunctivitis, eye pain.
• Tinnitus.
• Angina, rapid heart rate, palpitations, increased heart rate.
• High blood pressure, feeling hot.
• Nasal congestion, sinusitis and pharyngitis, congestion of the nose, throat and chest, hoarseness, hay fever, throat irritation, nasal congestion with cough, rhinorrhea.
• Blood in the stool, stomach irritation, change in bowel habit, belching, mouth ulcers, toothache.
• Redness of the skin, acne, increased sweating, night sweats.
• Muscle spasms, chest pain.
• Frequent urination, nocturia.
• Increased menstrual flow.
• Chest discomfort, flu-like illness, fever, feeling weak or unwell.
• High blood sugar levels.
• Heart attack.
• Suicidal thoughts.
• Changes in thinking or behavior (such as aggression).

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

• Excessive thirst.
• Discomfort or feeling unhappy, slow thinking.
• Stroke.
• Increased muscle tension, speech difficulties, coordination difficulties, decreased sense of taste, sleep pattern alteration.
• Vision changes, eye discoloration, dilated pupils, light sensitivity, myopia, watery eyes.
• Irregular heartbeat or heart rhythm changes.
• Throat pain, hoarseness.
• Blood in the vomit, abnormal stools, tongue soreness.
• Joint stiffness, chest pain.
• Glucose in the urine, increased urine volume and frequency.
• Vaginal discharge, changes in sexual capacity.
• Feeling 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 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).

Unknown frequency

• Transient loss of consciousness.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

This medicationdoes not require special storage conditions.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. Dispose of the packaging and medications that you no longer need at the SIGRE collection pointof the pharmacy. By doing so, you will help protect the environment.

Varenicline Normon Composition

The active ingredient is varenicline.

• Each film-coated tablet of 0.5 mg contains 0.5 mg of varenicline (as tartrate).
• Each film-coated tablet of 1 mg contains 1 mg of varenicline (as tartrate).

The other components are:

Core of the tablet

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

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

Coating

Varenicline Normon 0.5 mg film-coated tablets:

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

Varenicline Normon 1 mg film-coated tablets:

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

Appearance of the product and contents of the package

Varenicline Normon 0.5 mg film-coated tablets

White or almost white film-coated tablets, capsule-shaped and biconvex, with a length of 8 mm and a width of 4 mm, printed with “C2” on one side and smooth on the other.

Varenicline Normon 1 mg film-coated tablets

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

Varenicline Normon is available in the following presentations:

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

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

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

PVC/PVDC/PE/PVDC blister with an aluminum foil in a carton box containing 1 transparent blister with 11 x 0.5 mg and 14 x 1 mg film-coated tablets; and 1 transparent blister with 28 x 1 mg or 2 transparent blisters with 14 x 1 mg film-coated tablets, in an outer cardboard packaging.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

LABORATORIOS NORMON, S.A.

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

Last review date of this leaflet:

October 2023

For detailed information about this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/