Varenicline Normon 0.5 mg + 1 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Vareniclina Normon 0.5 mg film-coated tablets EFG

Vareniclina Normon 1 mg film-coated tablets EFG

Read the entire 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Package leaflet contents

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

2. What you need to know before taking Vareniclina Normon

3. How to take Vareniclina Normon

4. Possible side effects

5. Storage of Vareniclina Normon

6. Contents of the pack and other information

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

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

Vareniclina can help relieve the anxiety and withdrawal symptoms associated with quitting smoking.

Vareniclina may also reduce the pleasure derived from cigarettes if you smoke while on treatment.

2. What you need to know before starting to take Vareniclina Normon

Do not take Vareniclina Normon

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Varenicline Normon.

Cases of depression, suicidal ideation 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 develop thoughts or behaviors related to suicide, you must stop taking varenicline and contact your doctor immediately for treatment evaluation.

Effects of quitting smoking

The effects of changes in your body resulting from quitting smoking, with or without treatment with varenicline, may alter the action of other medicines. Therefore, in some cases, a dosage adjustment may be necessary. See further details below under “Other medicines and Varenicline Normon”.

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, you should discuss this with your doctor.

Cardiac symptoms

Worsening or new onset of heart or blood vessel (cardiovascular) problems has been reported, primarily in individuals who already had cardiovascular conditions. 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 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 develop 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 its efficacy has not been demonstrated.

Other medicines and Vareniclina Normon

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 stopping 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 used 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 gastric problems) at the same time as varenicline, as this may cause increased blood levels of varenicline.

Use of Vareniclina Normon with other smoking cessation therapies

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

Use of Vareniclina Normon with alcohol

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 operating machinery

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.

Vareniclina 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 Vareniclina Normon

Follow exactly the instructions for use of this medicine as given by your doctor. If 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 your attempt to quit smoking is successful.

Normally, before starting treatment with varenicline, you should choose 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.

Vareniclina Normon is available as white tablets (0.5 mg) and light blue tablets (1 mg). You will start with the white tablets and normally progress to the light blue ones. 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 stop smoking immediately, you should reduce your tobacco consumption during the first 12 weeks of treatment and quit completely by the end of this treatment period. Afterwards, you should continue taking varenicline 1 mg film-coated tablets twice daily for another 12 weeks, resulting in a total treatment duration of 24 weeks.

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.

Vareniclina Normon is administered orally.

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

If you take more Vareniclina Normon 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 telephone number 91 562 04 20, stating the medication and the amount taken. Bring your tablet pack with you.

If you forget to take Vareniclina Normon

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 3–4 hours or less until your next scheduled dose, do not take the missed tablet.

If you stop taking Vareniclina Normon

Clinical trials have shown that taking all doses of your medication at the correct times and for the recommended treatment period, as previously described, 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 in the period immediately following the end of treatment. 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, which may include mood changes (such as feeling depressed, irritable, frustrated, or anxious), insomnia, difficulty concentrating, slowed 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 adverse effects have occurred rarely or very rarely in people trying to quit smoking with varenicline: seizures, stroke, heart attack, suicidal thoughts, loss of touch with reality, and inability to think or judge clearly (psychosis), changes in thinking or behavior (such as aggressive or abnormal behavior), 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, diarrhea, bloating, 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 heartbeat, palpitations, increased heart rate.
• Increased blood pressure, flushing.
• Inflammation of the nose, sinuses, and throat, nasal congestion, throat and chest congestion, hoarseness, hay fever, throat irritation, congested sinuses, excess nasal mucus with cough, rhinorrhea.
• Red blood in the stools, irritated stomach, change in bowel habits, burping, 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 malaise.
• High blood sugar levels.
• Heart attack.
• Suicidal thoughts.
• Changes in thinking or behavior (such as aggression).

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

• Excessive thirst.
• Malaise or feeling of unhappiness, slowed thinking.
• Stroke.
• Increased muscle tension, speech difficulties, coordination difficulties, decreased sense of taste, changes in sleep pattern.
• Vision disturbances, discoloration of the eyeball, dilated pupils, light sensitivity, myopia, watery eyes.
• Irregular heartbeat or changes in heart rhythm.
• Sore throat, snoring.
• Blood in vomit, abnormal stools, coated tongue.
• Numb joints, rib pain.
• Glucose in urine, increased volume and frequency of urine.
• Vaginal discharge, changes in sexual ability.
• Feeling cold, cyst.
• Diabetes.
• Sleepwalking.
• Loss of touch 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 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 reactions

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

5. Storage of Varenicline Normon

This medicine does not require special storage conditions.

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. Deposit unused medicines and their packaging at the SIGRE Point in your pharmacy. This way, you will help protect the environment.

6. Contents of the container and additional information

Composition of Vareniclina Normon

The active substance 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

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

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

Coating

Vareniclina Normon 0.5 mg film-coated tablets EFG:

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

Vareniclina 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 contents of the pack

Varenicline Normon 0.5 mg film-coated tablets EFG

Film-coated tablets, white or almost white, capsule-shaped and biconvex, 8 mm in length and 4 mm in width, printed with "C2" on one side and plain on the other.

Varenicline Normon 1 mg film-coated tablets EFG

Film-coated tablets, light blue, capsule-shaped and biconvex, 10 mm in length and 5 mm in width, printed with "C1" on one side and plain on the other.

Varenicline Normon is available in the following pack sizes:

PVDC/PVC/PE/PVDC blister with an aluminium foil lid, containing 56 x 0.5 mg film-coated tablets in a cardboard box.

PVDC/PVC/PE/PVDC blister with an aluminium foil lid, containing 56 x 1 mg film-coated tablets in a cardboard box.

PVDC/PVC/PE/PVDC blister with an aluminium foil lid, containing 112 x 1 mg film-coated tablets in a cardboard box.

PVDC/PVC/PE/PVDC blister with an aluminium foil lid, 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 a sealed cardboard outer packaging.

Only certain 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 review of this leaflet:

October 2023

Detailed information about this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/89220/P_89220.html