Patient Information Leaflet

Buprenorphine/Naloxone Zentiva 2mg/0.5mg sublingual tablets EFG

Buprenorphine/Naloxone Zentiva 8mg/2mg sublingual tablets EFG

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

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as 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.

1.What is Buprenorphine/Naloxone Zentiva and what is it used for

2.What you need to know before you start taking Buprenorphine/Naloxone Zentiva

3.How to take Buprenorphine/Naloxone Zentiva

4.Possible side effects

5.Storage of Buprenorphine/Naloxone Zentiva

6.Contents of the pack and additional information

This medication is used to treat opioid drug dependence (narcotics), such as heroin and morphine, in individuals who have given their consent to be treated for their addiction. This medication is used in adults and older adolescents over 15 years of age who are also receiving medical, social, and psychological support.

Do not take Buprenorfina/Naloxona Zentiva

• If you are allergic (hypersensitive) to buprenorphine, naloxone or any of the other ingredients of this medicine (see section 6).
• If you have severe respiratory problems.
• If you have severe liver problems.
• If you are intoxicated due to alcohol, or if you have tremors, sweating, anxiety, confusion or hallucinations caused by alcohol.
• If you are taking naltrexone or nalmefene for the treatment of alcohol or opioid dependence.

Warnings and precautions

Consult your doctor before starting to take this medicine if you have:

• Asthma or other respiratory problems.
• Any liver disease, such as hepatitis.
• Low blood pressure.
• A recent head injury or brain disease.
• Any urinary tract problem (especially related to an enlarged prostate in men).
• Any kidney disease.
• Thyroid problems.
• Any adrenal gland disorder (e.g. Addison's disease).

Important aspects to be taken into account

• Additional monitoring

If you are under 18 years or over 65, your doctor may monitor you more closely.

Children under 15 years should not take this medicine.

• Abuse and misuse

This medicine may be a target for people who abuse prescription medicines.

Keep this medicine in a safe place to protect it from theft.Do not give this medicine to anyone else. It may cause death or other harm.

• Respiratory problems

Some people have died from respiratory failure (inability to breathe) because they have misused this medicine or taken it in combination with other central nervous system depressants, such as alcohol, benzodiazepines (tranquilizers) or other opioids.

This medicine may cause severe respiratory depression (difficulty breathing), possibly fatal, in children and non-dependent individuals if they ingest it accidentally or intentionally.

• Dependence

This medicine may cause dependence.

• Withdrawal symptoms

This medicine may cause withdrawal symptoms if you take it less than six hours after using a rapid-acting opioid (e.g. morphine, heroin) or less than 24 hours after using a long-acting opioid, such as methadone.

Buprenorfina/Naloxona Zentiva may also cause withdrawal symptoms if you stop taking it suddenly.

• Liver damage

Liver damage has been reported after taking buprenorphine/naloxone, especially when the medicine is used inappropriately. It may also be due to chronic hepatitis C infection, alcohol abuse, anorexia or the use of other medicines that can damage the liver (see section 4).Your doctor may order frequent blood tests to monitor your liver function.Inform your doctor if you have had any liver problems before starting treatment with this medicine.

• Blood pressure

This medicine may cause a sudden drop in blood pressure, making you feel dizzy if you get up too quickly after sitting or lying down.

• Diagnosis of unrelated medical conditions

This medicine may mask the symptoms of pain that could help in the diagnosis of some diseases. Do not forget to inform your doctor if you are taking this medicine.

Buprenorfina/Naloxona Zentiva may cause a positive reaction in drug tests performed during antidoping controls.

Other medicines and Buprenorfina/Naloxona Zentiva

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

Some medicines may increase the adverse effects of Buprenorfina/Naloxona Zentiva and, in some cases, cause severe reactions. If you are taking Buprenorfina/Naloxona Zentiva, do not take other medicines at the same time without consulting your doctor, especially:

• The concomitant use of Buprenorfina/Naloxona Zentiva and sedative medicines such as benzodiazepines or related medicines increases the risk of drowsiness, difficulty breathing (respiratory depression), coma and may put your life at risk. Therefore, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor prescribes Buprenorfina/Naloxona Zentiva along with sedative medicines, your doctor should limit the dose and duration of concomitant treatment.

Inform your doctor about all sedative medicines you are taking and follow your doctor's recommendation closely. It may be helpful to inform friends or family members to be aware of the symptoms mentioned above. Contact your doctor when you experience these symptoms.

• Other medicines that may cause drowsiness and are usedfor the treatment of diseases such as anxiety, insomnia, seizures/epileptic crises or pain. This type of medicine will reduce your level of alertness, making it difficult to drive and use machines. They may also cause central nervous system depression, which is very severe. The following is a list of examples of this type of medicine:

• Other medicines that contain opioids, such as methadone, some analgesics or antitussives.
• Antidepressants (used for the treatment of depression) such as isocarboxazid, phenelzine, selegiline, tranylcypromine and valproate, may potentiate the effects of this medicine.
• Antihistamines (used for the treatment of allergic reactions) such as
• diphenhydramine and chlorphenamine.
• Barbiturates (used to produce sleep or sedation) such as phenobarbital or secobarbital.
• Tranquilizers (used to produce sleep or sedation) como chloral hydrate.

• Clonidine (used for the treatment of high blood pressure) may potentiate the effects of this medicine.
• Antiretrovirals (used for the treatment of HIV) such as ritonavir, nelfinavir or indinavir may potentiate the effects of this medicine.
• Determined antifungals (for the treatment of fungal infections) such as ketoconazole, itraconazole or certain antibiotics may prolong the effects of this medicine.
• Some medicines may decrease the effect of Buprenorfina/Naloxona Zentiva, such as for example the medicines used for the treatment of epilepsy (carbamazepine and phenytoin) and medicines used to treat tuberculosis (rifampicin).
• Naltrexone and nalmefene (medicines used to treat addictive disorders) may prevent the therapeutic effects of Buprenorfina/Naloxona Zentiva. Do not take them at the same time as the treatment with Buprenorfina/Naloxona Zentiva, as you may experience a sudden onset of prolonged and intense withdrawal symptoms.

Use of Buprenorfina/Naloxona Zentiva with food, drinks and alcohol

Alcohol may increase drowsiness and the risk of respiratory failure if combined with this medicine.Do not takeBuprenorfina/NaloxonaZentivawith alcoholic beverages. Do not swallow or consume food or drinks until the tablet has completely dissolved.

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 medicine.

No risks have been identified for using Buprenorfina/Naloxona Zentiva in pregnant women. Inform your doctor if you are pregnant or if you plan to become pregnant. Your doctor will decide whether your treatment should continue with another medicine.

During pregnancy, especially in the last months, medicines like Buprenorfina/Naloxona Zentiva may cause withdrawal symptoms in the newborn, including respiratory problems. This may occur several days after birth.

This medicine cannot be used during breastfeeding, as Buprenorfina/Naloxona Zentiva passes into breast milk.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

This medicine may cause drowsiness. This may occur more frequently in the first weeks of treatment, when the dose is being changed, but it may also occur if you drink alcohol or take other sedative medicines when taking Buprenorfina/Naloxona Zentiva. Do not drive or use tools or machines, or perform hazardous activities, until you know how this medicine affects you.

Buprenorfina/Naloxona Zentiva contains lactose.

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Buprenorfina/Naloxona Zentiva contains sodium

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

Your treatment is prescribed and monitored by doctors who have experience in treating drug dependence.

Your doctor will decide what is the best dose for you. During your treatment, the doctor may adjust the dose based on your response.

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

Start of treatment

The recommended initial dose in adults and adolescents over 15 years old is one to two tablets of Buprenorfina/Naloxona Zentiva 2 mg/0.5 mg. Additional one to two tablets of this medication may be administered on day 1, as needed.

Before taking your first dose of Buprenorfina/Naloxona Zentiva, clear symptoms of withdrawal must be evident. A doctor's evaluation of your readiness for treatment will guide the appropriate time for your first dose of Buprenorfina/Naloxona Zentiva.

• Start of treatment with Buprenorfina/Naloxona Zentiva if you are dependent on heroin:

If you are dependent on heroin or a rapid-acting opioid, your first dose of Buprenorfina/Naloxona Zentiva should be taken when withdrawal symptoms appear, but not less than 6 hours after your last opioid consumption.

• Start of treatment with Buprenorfina/Naloxona Zentiva if you are dependent on methadone:

If you have been taking methadone or a long-acting opioid, it is recommended that the dose be reduced to less than 30 mg/day before starting treatment with Buprenorfina/Naloxona Zentiva. Your first dose of Buprenorfina/Naloxona Zentiva should be taken when withdrawal symptoms appear, but not less than 24 hours after your last methadone consumption.

How to take Buprenorfina/Naloxona Zentiva

• Take the dose once a day by placing the tablet under the tongue.
• Hold the tablet under the tongue until it has completely dissolved. This may take 5-10 minutes.
• Do not chew or swallow the tablets, as the medication will not work and you will experience withdrawal symptoms.
• Do not consume food or drinks until the tablets have completely dissolved.

Dose adjustment and maintenance treatment

During the days following the start of treatment, your doctor may increase the dose of Buprenorfina/Naloxona Zentiva you take, as needed. If you feel that the effect of Buprenorfina/Naloxona Zentiva is too intense or too weak, inform your doctor or pharmacist. The maximum daily dose is 24 mg.

After a satisfactory period of treatment, you may agree with your doctor to gradually reduce the dose to a lower maintenance dose.

Discontinuation of treatment

Under medical supervision, the dose of Buprenorfina/Naloxona Zentiva may continue to decrease, until it can be discontinued.

Do not change the treatment in any way or discontinue it without the authorization of the doctor treating you.

If you take more Buprenorfina/Naloxona Zentiva than you should

If you or someone else takes too much of this medication, go or have them taken immediately to an emergency service or hospital for treatment, as an overdose of Buprenorfina/Naloxona Zentiva can cause severe and potentially fatal respiratory problems.

The symptoms of an overdose may include drowsiness and discoordination with slow reflexes, blurred vision, and/or difficulty speaking. You may not be able to think clearly and breathe more slowly than normal for you.

If you think you have taken more buprenorfina/naloxona than you should, or if someone has taken one of your tablets, inform your doctor immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Buprenorfina/Naloxona Zentiva

If you forget to take a dose, inform your doctor immediately.

If you interrupt treatment with Buprenorfina/Naloxona Zentiva

Do not change the treatment in any way or discontinue it without the authorization of the doctor treating you.

The sudden interruption of treatment may cause withdrawal symptoms.

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.

Inform your doctor or seek urgent medical attentionif you experience side effects such as:

• Swelling of the face, lips, tongue, or throat, which may cause difficulty swallowing or breathing; rashes or intense eruptions. These may be signs of a potentially fatal allergic reaction.
• Drowsiness and discoordination, blurred vision, difficulty speaking, unable to think clearly, or your breathing is much slower than normal for you.

Also, inform your doctorif you experience side effects such as:

• Intense fatigue, itching with yellowish discoloration of the skin or eyes. These may be signs of liver damage.
• Seeing or hearing things that do not exist (hallucinations).

Side effects reported with Buprenorfina/Naloxona Zentiva

Very common side effects (may affect more than 1 in 10 people):

• insomnia (inability to sleep),

• constipation,
• nausea,
• excessive sweating,
• headache,
• opioid withdrawal syndrome.

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

• weight loss,
• swelling (of hands and feet),
• drowsiness,
• anxiety,
• nervousness,
• tingling,
• depression,
• decreased libido,
• increased muscle tension,
• abnormal thinking,
• increased tearing (watery eyes) or other tear disorders,
• blurred vision,
• flushing,
• increased blood pressure,
• migraines,
• nasal secretion,
• throat pain and difficulty swallowing,
• increased coughing,
• stomach discomfort or other stomach upset,
• diarrhea,
• liver function abnormalities,
• flatulence,
• vomiting,
• skin rash,
• itching,
• hives,
• pain,
• joint pain,
• muscle pain,
• leg cramps (muscle spasms),
• difficulty achieving or maintaining an erection,
• urinary abnormalities,
• abdominal pain,
• lower back pain,
• weakness,
• infection,
• chills,
• chest pain,
• fever,
• flu-like symptoms,
• general feeling of discomfort,
• accidental injury due to loss of alertness or coordination,
• syncope and dizziness.

Uncommon side effects (may affect up to 1 in 100 people):

• inflammation of the lymph nodes,
• agitation,
• tremors,
• abnormal dreams,
• excessive muscle activity,
• depersonalization (not feeling like oneself),
• dependence on medication,
• amnesia (memory disorder),
• loss of interest,
• exaggerated feeling of well-being,
• convulsions (seizures),
• speech disorder,
• small pupils,
• difficulty urinating,
• inflammation or infection of the eyes,
• rapid or slow heart rate,
• low blood pressure,
• palpitations,
• myocardial infarction (heart attack),
• sensation of chest pressure,
• difficulty breathing,
• asthma, yawning,
• mouth pain and ulcers,
• lingual discoloration,
• acne,
• skin nodules,
• hair loss,
• dry or flaky skin,
• inflammation of the joints,
• urinary tract infection,
• abnormal blood test results,
• blood in the urine,
• abnormal ejaculation,
• menstrual or vaginal problems,
• kidney stones,
• protein in the urine,
• difficulty urinating or pain while urinating,
• sensitivity to heat or cold,
• heatstroke,
• loss of appetite,
• hostile feelings.

Frequency not known(cannot be estimated from available data):

• acute opioid withdrawal syndrome caused by taking Buprenorfina/Naloxona Zentivatoo soon after using illegal opioids,
• opioid withdrawal syndrome in newborns,
• slow breathing or difficulty breathing,
• liver damage with or without jaundice,
• hallucinations,
• swelling of the face and throat or potentially fatal allergic reactions,
• low blood pressure when changing from sitting or lying down to standing,
• abuse of this medication, injecting it, may cause withdrawal symptoms, infections, other skin reactions, and potentially serious liver problems (see Warnings and precautions).

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 Vigilance 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 medication.

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

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

Store below 30°C.

Buprenorfina/Naloxona Zentivamay be a target for individuals who abuse prescription medications. Keep this medication in a safe place to protect it from theft.

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

Composition of Buprenorphine/Naloxone Zentiva

• The active principles are buprenorphine and naloxone.

Each sublingual tablet of 2 mg/0.5 mg contains 2 mg of buprenorphine (as hydrochloride) and 0.5 mg of naloxone (as dihydrate hydrochloride).

Each sublingual tablet of 8 mg/2 mg contains 8 mg of buprenorphine (as hydrochloride) and 2 mg of naloxone (as dihydrate hydrochloride).

• The other components are: lactose monohydrate, mannitol, cornstarch, povidone (K = 29.7), citric acid monohydrate, sodium citrate, magnesium stearate, potassium acesulfame, and lemon flavor (contains: flavorings, maltodextrin, Acacia (E414)), and lime aroma (contains: flavorings, maltodextrin, Acacia (E414)).

Appearance of the product and contents of the package

Buprenorphine/Naloxone Zentiva 2 mg/0.5 mg

White to off-white, round, biconvex tablets with a notch on one face and a diameter of approximately 6.5 mm.

The tablet can be divided into equal doses.

Buprenorphine/Naloxone Zentiva 8 mg/2 mg

White to off-white, round, biconvex tablets with a notch on one face and a diameter of approximately 11.5 mm.

The tablet can be divided into equal doses.

The tablets are packaged in blisters within a cardboard box containing 7, 28, 49, or 56 tablets or in single-dose blisters of 7x1, 28x1, 49x1, or 56x1 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Zentiva, K.S.

U kabelovny 130,

Prague 10 – Dolní Mecholupy,

CZ - 102 37, Czech Republic

Responsible for Manufacturing

G.L. Pharma GmbH Schlossplatz 1, 8502 Lannach

Austria

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Zentiva Spain S.L.

Paseo Club Deportivo 1, Edificio 4

Pozuelo de Alarcón (Madrid)

28223 – Madrid, Spain

This medicinal product is authorized in the member states of the European Economic Area with the following trade names:

Last review date of this prospectus: October 2020

The detailed information about this medicinal product is available on the website of the {Spanish Agency of Medicines and Medical Devices (AEMPS)} ( http://www.aemps.gob.es/ )