Civarenix

PACKAGE LEAFLET

Package leaflet: information for the user

Civarenix 0.5 mg film-coated tablets, 1 mg film-coated tablets, 0.5 mg and 1 mg film-coated tablets

varenicline
Generic medicine
Please read all of this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet. 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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Civarenix is and what it is used for
2. What you need to know before taking Civarenix
3. How to take Civarenix
4. Possible side effects
5. How to store Civarenix
6. Contents of the pack and other information

1. What Civarenix is and what it is used for

Civarenix contains the active substance called varenicline. Civarenix is a medicine used in adults to help them stop smoking.
Civarenix can help relieve the symptoms of craving and withdrawal associated with stopping smoking.
Civarenix may also reduce the pleasure derived from smoking cigarettes if you smoke during treatment.

2. What you need to know before taking Civarenix

Do not take Civarenix

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Civarenix.
Cases of depression, suicidal thoughts and behaviours, and suicide attempts have been reported in patients taking varenicline. If you are taking Civarenix and develop agitation, depressed mood, or behavioural changes causing concern to you or your family, or if you develop suicidal thoughts or behaviours, stop taking Civarenix and contact your doctor immediately for treatment evaluation.

Effects of smoking cessation
Changes in your body resulting from stopping smoking, with or without treatment with Civarenix, may affect how other medicines work. Therefore, in some cases, a dose adjustment may be necessary. For further details, see the section below “Other medicines and Civarenix”.
In some individuals, stopping smoking, with or without treatment, has been associated with an increased risk of changes in thinking or behaviour, feelings of depression and anxiety, and may be associated with worsening of psychiatric illness. If you have a history of psychiatric illness, discuss this with your doctor.

Cardiac symptoms
New or worsening heart or blood vessel (cardiovascular) problems have been reported, especially in individuals who already have cardiovascular conditions. Inform your doctor if you experience any changes in symptoms during treatment with Civarenix. If you experience symptoms of a heart attack or stroke, seek immediate emergency medical help.

Seizures
Before starting treatment with Civarenix, inform your doctor if you have ever had seizures or suffer from epilepsy. During treatment with Civarenix, some people have experienced seizures.

Hypersensitivity reactions
Stop taking Civarenix and contact your doctor immediately if you experience any of the following signs or symptoms, which may indicate a severe allergic reaction: swelling of the face, lips, tongue, gums, throat or body and/or difficulty breathing, wheezing.

Skin reactions
Potentially life-threatening skin reactions (Stevens-Johnson syndrome and erythema multiforme) have been reported with the use of Civarenix. If you develop a skin rash, or if skin peeling or blistering occurs, stop treatment with Civarenix and seek urgent medical attention.

Children and adolescents
The use of Civarenix is not recommended in pediatric patients, as efficacy has not been demonstrated.

Other medicines and Civarenix
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In some cases, as a consequence of smoking cessation, with or without Civarenix, a dose adjustment of other medicines may be required. Examples include theophylline (a medicine used to treat respiratory problems), warfarin (a medicine used to reduce blood clot formation), and insulin (a medicine for diabetes). If in doubt, consult your doctor or pharmacist.
If you have severe kidney disease, you should avoid taking cimetidine (a medicine for gastric disorders) while taking Civarenix, as this could lead to increased levels of Civarenix in the blood.

Use of Civarenix with other smoking cessation therapies
Talk to your doctor before using Civarenix in combination with other smoking cessation therapies.

Civarenix with food and drink
Cases of increased effects of alcohol intoxication have been reported in patients taking Civarenix. However, it is not known whether Civarenix actually increases alcohol intoxication.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
It is preferable to avoid using Civarenix during pregnancy. Talk to your doctor if you are planning a pregnancy.
Although not studied, Civarenix may pass into breast milk. Consult your doctor or pharmacist before taking Civarenix.

Driving and using machines
Civarenix 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 these tasks.

Civarenix contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take Civarenix

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
You are more likely to succeed in quitting smoking if you are motivated. Your doctor or pharmacist can provide you with advice, support, and further information to help make your attempts to stop smoking successful.
Before starting treatment with Civarenix, you should usually set a quit date during the second week of treatment (between day 8 and day 14). If you are unable or do not wish to set a quit date within the first 2 weeks, you may choose your own individual quit date within 5 weeks from the start of treatment. You should write down this date on the pack to help you remember it.
Civarenix is available as white tablets (0.5 mg) and light blue tablets (1 mg). Treatment is started with the white tablet and then usually switched to the light blue tablet. See the table below for instructions on the usual dosing regimen to follow starting from day 1.

After 12 weeks of treatment, if you have stopped smoking, your doctor may recommend an additional 12-week treatment cycle with Civarenix 1 mg film-coated tablets twice daily to help prevent you from starting to smoke again.
If you are unable or unwilling to stop smoking immediately, you should reduce smoking during the first 12 weeks of treatment and stop completely by the end of this period. You should then continue taking Civarenix 1 mg film-coated tablets twice daily for another 12 weeks, for a total of 24 weeks of treatment.
If you experience adverse events that you cannot tolerate, your doctor may decide to temporarily or permanently reduce the dose to 0.5 mg twice daily.
If you have kidney problems, you must speak with your doctor before taking Civarenix. You may require a lower dose.
Civarenix is for oral use.
The tablets must be swallowed whole with water and may be taken with or without food.
If you take more Civarenix than you should
If you accidentally take more Civarenix than prescribed, you must contact your doctor or go to the nearest emergency department. Take the tablet pack with you.
If you forget to take Civarenix
Do not take a double dose to make up for a forgotten tablet. It is important to take your Civarenix tablet regularly every day at the same time. If you forget to take a dose, take it as soon as you remember. If less than 3–4 hours remain before your next scheduled dose, do not take the missed tablet.
If you stop taking Civarenix
Clinical studies have shown that taking all doses of the medicine at the correct times and for the recommended duration of treatment described above increases the likelihood of successfully quitting smoking. Therefore, unless your doctor has instructed you to stop treatment, it is important to continue taking Civarenix according to the instructions described in the table above.
During smoking cessation therapy, the risk of resuming smoking may be high in the period immediately following the end of treatment. When you stop treatment with Civarenix, you may temporarily experience increased irritability, strong urge to smoke, depression, and/or sleep disturbances. Your doctor may decide to gradually reduce the dose of Civarenix at the end of treatment.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Stopping smoking, with or without treatment, may cause various symptoms. These may include mood changes (such as feeling depressed, irritable, frustrated or anxious), insomnia,
reduced heart rate, and increased appetite or weight gain.
You should be aware of the possible onset of serious neuropsychiatric symptoms, such as agitation, depressed mood, or changes in behaviour during attempts to quit smoking, with or without Civarenix, and you should contact your doctor or pharmacist if such symptoms occur.
In people who have attempted to stop smoking using Civarenix, serious adverse reactions have occurred, with uncommon or rare frequency: seizures, stroke, heart attack, suicidal thoughts, loss of touch with reality, and inability to think or judge clearly (psychosis), changes in thought or behaviour (such as aggression or abnormal behaviour). Cases of severe skin reactions have also been reported, including erythema multiforme (a type of skin rash) and Stevens-Johnson syndrome (a serious illness characterized by blistering of the skin, mouth, around the eyes or genitals), and severe allergic reactions, including angioedema (swelling of the face, mouth or throat).

• Very common: may affect more than 1 in 10 people:

  o Inflammation of the nose and throat, altered dreams, sleep disturbances, headache
  o Nausea

• Common: may affect up to 1 in 10 people:

  o Chest infections, sinusitis
  o Weight gain, decreased appetite, increased appetite
  o Drowsiness, dizziness, altered taste
  o Shortness of breath, cough
  o Heartburn, vomiting, constipation, diarrhoea, bloating, abdominal pain, toothache, indigestion, flatulence, dry mouth
  o Rash, itching
  o Joint pain, muscle pain, back pain
  o Chest pain, fatigue

• Uncommon: may affect up to 1 in 100 people:

  o Fungal infection, viral infection
  o Panic sensation, difficulty in thinking, restlessness, mood swings, depression, anxiety, hallucinations, changes in sexual impulses
  o Seizures, tremors, feeling of apathy, loss of sensitivity to touch
  o Conjunctivitis, eye pain
  o Ringing in the ears
  o Angina, increased heart rate, palpitations, increased heart frequency
  o Increased blood pressure, hot flushes
  o Inflammation of the nose, sinuses and throat, nasal, throat and chest congestion, hoarse voice, hay fever, throat irritation, congested sinuses, excess mucus in the nose causing cough, runny nose
  o Presence of bright red blood in stools, stomach irritation, changes in bowel habits, belching, mouth ulcers, gum pain
  o Skin redness, acne, increased sweating, night sweats
  o Muscle spasms, chest wall pain
  o Abnormally frequent urination, nocturnal urination
  o Increased menstrual flow
  o Chest discomfort, flu-like syndrome, fever, feeling of weakness or malaise
  o High blood sugar levels
  o Heart attack
  o Suicidal thoughts
  o Changes in thought or behaviour (such as aggression)

• Rare: may affect up to 1 in 1,000 people:

  o Excessive thirst
  o Feeling of discomfort or unhappiness, slowed thinking
  o Stroke
  o Increased muscle tension, difficulty speaking, coordination problems, reduced sense of taste, changes in sleep rhythm
  o Vision disturbances, change in colour of the eyeball, dilated pupils, light sensitivity, myopia, excessive tearing
  o Irregular heartbeat or heart rhythm disturbances
  o Sore throat, snoring
  o Blood in vomit, altered stools, white tongue
  o Joint stiffness, rib pain
  o Glucose in urine, increased volume and frequency of urination
  o Vaginal discharge, changes in sexual performance
  o Feeling cold, cysts
  o Diabetes
  o Sleepwalking
  o Loss of touch with reality and inability to think or judge clearly (psychosis)
  o Abnormal behaviour
  o Severe skin reactions, including erythema multiforme (a type of skin rash) and Stevens-Johnson syndrome (a serious illness characterized by blistering of the skin, mouth, around the eyes or genitals)
  o Severe allergic reactions, including angioedema (swelling of the face, mouth or throat)

• Not known:

  o Transient loss of consciousness

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Civarenix

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging, carton, vial or blister after Exp. The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Civarenix contains

• The active substance is varenicline.
• Each 0.5 mg film-coated tablet contains varenicline tartrate equivalent to 0.5 mg of varenicline.
• Each 1 mg film-coated tablet contains varenicline tartrate equivalent to 1.0 mg of varenicline.
• The other components are:

Tablet core – Civarenix 0.5 mg and 1 mg film-coated tablets
Ascorbic acid
Microcrystalline cellulose
Calcium hydrogen phosphate
Sodium croscarmellose
Anhydrous colloidal silica
Magnesium stearate

Tablet coating – Civarenix 0.5 mg film-coated tablets
Hypromellose
Titanium dioxide (E171)
Macrogol 400

Tablet coating – Civarenix 1 mg film-coated tablets
Hypromellose
Titanium dioxide (E171)
Macrogol 400
Aluminium lake containing indigo carmine (E132)

Description of the appearance of Civarenix and contents of the pack

• Civarenix 0.5 mg film-coated tablets are white to off-white, capsule-shaped, biconvex tablets, 4 mm x 8 mm, with "0.5" engraved on one side and smooth on the other side.
• Civarenix 1 mg film-coated tablets are light blue, capsule-shaped, biconvex tablets, 5 mm x 10 mm, with "1.0" engraved on one side and smooth on the other side.

Civarenix is available in the following pack sizes:
Starter pack, 0.5 mg + 1 mg (to be used at the beginning of treatment)

• 2-week pack: 11 film-coated tablets of 0.5 mg and 14 film-coated tablets of 1 mg in a blister pack within a carton.
• 4-week pack: 11 film-coated tablets of 0.5 mg and 42 film-coated tablets of 1 mg in a blister pack within a carton.

0.5 mg

• Bottle with child-resistant closure containing 56 film-coated tablets.
• Blister packs in a cardboard box containing 56 film-coated tablets.

1 mg

• Bottle with child-resistant closure containing 56 film-coated tablets.
• Blister packs in a cardboard box or carton containing 28 film-coated tablets.
• Blister packs in a cardboard box containing 56 or 112 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder
G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach, Austria

Manufacturer
Combino Pharm Malta, Ltd
HF60 Hal Far Industrial Estate
Hal Far BBG3000
MALTA
G.L. Pharma GmbH
Industriestraße 1
8502 Lannach, Austria

Marketing Authorization Holder in Italy:
G.L. Pharma Italy S.r.l., [email protected]

This medicinal product is authorised in the European Economic Area countries under the following names:
Sweden Civarenix 0.5 mg film-coated tablets
Civarenix 1 mg film-coated tablets
Civarenix 0.5 mg + 1 mg film-coated tablets
Italy Civarenix
Austria Civarenix 0.5 mg Filmtabletten
Civarenix 1 mg Filmtabletten
Civarenix 0.5 mg + 1 mg Filmtabletten
Denmark Civarenix
Czech Republic Civarenix