Buprenorphine and naloxone Mylan Pharma

Patient Information Leaflet

Buprenorphine and Naloxone Mylan Pharma 2 mg/0.5 mg sublingual tablets, 8 mg/2 mg sublingual tablets

Generic Medicine
Please read all of this leaflet carefully before taking this medicine because 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 side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Buprenorphine and Naloxone Mylan Pharma is and what it is used for

Buprenorphine and Naloxone Mylan Pharma is used to treat opioid dependence (narcotics) such as heroin or morphine in drug-dependent individuals who have agreed to be treated for their addiction.
Buprenorphine and Naloxone Mylan Pharma is used in adults and adolescents over 15 years of age who are also receiving medical and psychosocial support.

2. What you should know before taking Buprenorphine and Naloxone Mylan Pharma

Do not take Buprenorphine and Naloxone Mylan Pharma

• if you are allergic (hypersensitive) to buprenorphine, naloxone, or any of the excipients of this medicine (see section 6)
• if you have severe respiratory problems
• if you have severe liver problems
• if you have alcohol intoxication or are experiencing tremor, 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
Talk to your doctor before taking Buprenorphine and Naloxone Mylan Pharma if you have:

• asthma or other respiratory problems
• any liver disease such as hepatitis
• low blood pressure
• recent head trauma or brain disorder
• urinary problems (especially related to an enlarged prostate in men)
• any kidney disease
• thyroid problems
• adrenal cortical disorder (e.g., Addison's disease)

Important information to know:

• Additional monitoring You may be monitored more closely by your doctor if you are under 18 years of age or over 65 years of age. This medicine must not be taken by individuals under the age of 15.
• Misuse and abuse This medicine may be attractive to individuals who abuse prescription medicines and must be stored securely to prevent theft. Do not give this medicine to other people. It could cause death or otherwise harm them.
• Respiratory problems Some people have died from respiratory failure (inability to breathe) due to misuse of this medicine or from taking it together with other substances that depress the central nervous system, such as alcohol, benzodiazepines (tranquilizers), or other opioids. This medicine can cause severe respiratory depression (reduced ability to breathe), which can be fatal in children and non-dependent individuals in case of accidental or intentional ingestion.
• Dependence This medicine may lead to dependence.
• Withdrawal symptoms This medicine may cause withdrawal symptoms if taken less than six hours after using a short-acting opioid (e.g., morphine, heroin) or less than 24 hours after using a long-acting opioid such as methadone. Buprenorphine and Naloxone Mylan Pharma may also cause withdrawal symptoms if treatment is abruptly stopped.
• Liver damage Liver damage has been reported after taking Buprenorphine and Naloxone Mylan Pharma, especially with misuse of the medicine. This may also be due to viral infections (chronic hepatitis C), alcohol abuse, anorexia, or use of other medicines that can harm the liver (see section 4). Your doctor may regularly perform blood tests to monitor your liver function. Inform your doctor if you have liver problems before starting treatment with Buprenorphine and Naloxone Mylan Pharma.
• Blood pressure This medicine may cause a sudden drop in blood pressure, leading to dizziness when rising too quickly from a sitting or lying position.
• Diagnosis of unrelated medical conditions This medicine may mask painful symptoms that could help diagnose certain conditions. Remember to inform your doctor if you are taking this medicine.

For athletes: using this medicine without a therapeutic need constitutes doping and may result in a positive anti-doping test.
Other medicines and Buprenorphine and Naloxone Mylan Pharma
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
Some medicines may increase the side effects of Buprenorphine and Naloxone Mylan Pharma and may sometimes cause very serious reactions. Do not take other medicines during treatment with Buprenorphine and Naloxone Mylan Pharma without first consulting your doctor, especially:

• the concomitant use of Buprenorphine and Naloxone Mylan Pharma and sedative medicines such as benzodiazepines (used to treat anxiety or sleep disorders) or related drugs increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening.
  For this reason, concomitant use should only be considered when no other therapeutic options are available.
  If your doctor prescribes Buprenorphine and Naloxone Mylan Pharma together with sedative medicines, the dose and duration of concomitant treatment should be limited.
  Inform your doctor about all sedative medicines you are taking and carefully follow their dosage recommendations. It may be helpful to inform friends and family about the signs and symptoms mentioned. Contact your doctor if you experience such symptoms.

• Other medicines that may cause drowsiness used to treat conditions such as anxiety, insomnia, seizures/epileptic fits, or pain. These types of medicines reduce alertness, making driving and operating machinery difficult. They may also cause central nervous system depression, a very serious condition. Below is an illustrative list of these types of medicines:

• other opioid-containing medicines such as methadone, certain painkillers, and cough suppressants

• antidepressants (used to treat depression) such as isocarboxazid, phenelzine, selegiline, tranylcypromine, and valproate, which may increase the effects of this medicine

• H₁-receptor antagonist sedatives (used to treat allergic reactions) such as diphenhydramine and chlorphenamine

• barbiturates (used to induce sleep or sedation) such as phenobarbital and secobarbital

• tranquilizers (used to induce sleep or sedation) such as chloral hydrate.

• Clonidine (used to treat high blood pressure) may prolong the effects of this medicine.

• Antiretrovirals (used to treat HIV) such as ritonavir, nelfinavir, and indinavir may increase the effects of this medicine.

• Some antifungal agents (used to treat fungal infections) such as ketoconazole, itraconazole, and certain antibiotics may prolong the effects of this medicine.

• Some medicines may reduce the effect of Buprenorphine and Naloxone Mylan Pharma. These include medicines used to treat epilepsy (such as carbamazepine and phenytoin) and medicines used to treat tuberculosis (rifampicin).

• Naltrexone and nalmefene (medicines used to treat addictions) may block the therapeutic effects of Buprenorphine and Naloxone Mylan Pharma. They must not be taken during treatment with Buprenorphine and Naloxone Mylan Pharma, as they may cause a sudden onset of severe and prolonged withdrawal symptoms.

Buprenorphine and Naloxone Mylan Pharma with food, drinks, and alcohol
Alcohol may increase drowsiness and the risk of respiratory failure when taken with Buprenorphine and Naloxone Mylan Pharma. Do not take Buprenorphine and Naloxone Mylan Pharma with alcoholic beverages. Do not ingest or consume food or any drink until the tablet is completely dissolved.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before taking this medicine.
The risks of using Buprenorphine and Naloxone Mylan Pharma in pregnant women are not known. Inform your doctor if you are pregnant or intend to become pregnant. Your doctor will decide whether to continue your treatment with an alternative medicine.
Medicines such as Buprenorphine and Naloxone Mylan Pharma, when taken during pregnancy (especially in the later stages), may cause drug withdrawal symptoms in the newborn, including breathing problems. These symptoms may appear several days after birth.
Do not breastfeed while taking this medicine, as Buprenorphine and Naloxone Mylan Pharma passes into breast milk.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Buprenorphine and Naloxone Mylan Pharma may cause drowsiness. This is more likely during the first weeks of treatment or when the dose is adjusted, but may also occur if alcohol or other sedative medicines are taken together with Buprenorphine and Naloxone Mylan Pharma. Do not drive, operate tools or machinery, or perform hazardous activities until you know how this medicine affects you.
Buprenorphine and Naloxone Mylan Pharma contains lactose and sodium
If your doctor has diagnosed an intolerance to certain sugars, consult your doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., it is essentially “sodium-free”.

3. How to take Buprenorphine and Naloxone Mylan Pharma

Your treatment is prescribed and monitored by doctors experienced in treating drug addiction.
Your doctor will determine the optimal dose for you. During treatment, your doctor may adjust the dose based on your response.
Always take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Starting treatment

The recommended starting dose for adults and adolescents over 15 years of age is one or two tablets of Buprenorphine and Naloxone Mylan Pharma 2 mg/0.5 mg. On day 1, up to two additional tablets of Buprenorphine and Naloxone Mylan Pharma 2 mg/0.5 mg may be administered, depending on your needs.
Before taking the first dose of Buprenorphine and Naloxone Mylan Pharma, clear and evident withdrawal symptoms should be present. A medical assessment of your suitability for treatment will determine the most appropriate time for taking the first dose of Buprenorphine and Naloxone Mylan Pharma.

• Starting treatment with Buprenorphine and Naloxone Mylan Pharma during heroin dependence. If you are dependent on heroin or another short-acting opioid, the first dose of Buprenorphine and Naloxone Mylan Pharma should be taken when early signs of withdrawal appear, but not less than 6 hours after the last opioid use.
• Starting treatment with Buprenorphine and Naloxone Mylan Pharma during methadone dependence. If you are taking methadone or another long-acting opioid, the methadone dose should be reduced to less than 30 mg/day before starting treatment with Buprenorphine and Naloxone Mylan Pharma. The first dose of Buprenorphine and Naloxone Mylan Pharma should be taken only when early withdrawal signs appear, but not less than 24 hours after the last methadone use.

Taking Buprenorphine and Naloxone Mylan Pharma

• Take your dose once daily by placing the tablet under the tongue.
• Keep the tablet under the tongue until it is completely dissolved. This will take 5–10 minutes.
• Do not chew or swallow the tablet, as the medicine will not work and you may experience withdrawal symptoms.
• Do not eat or drink anything until the tablet is completely dissolved.

Dose adjustment and maintenance therapy
In the days following the start of treatment, your doctor may increase your dose of Buprenorphine and Naloxone Mylan Pharma according to your needs.
If you feel that the effect of Buprenorphine and Naloxone Mylan Pharma is too strong or too weak, discuss this with your doctor or pharmacist. The maximum daily dose is 24 mg.
After completing a treatment period, you may agree with your doctor to gradually reduce the dose to a lower maintenance dose.

Stopping treatment
Depending on your condition, the dose of Buprenorphine and Naloxone Mylan Pharma may continue to be reduced under close medical supervision until treatment is discontinued.
Do not change or stop your treatment in any way without the consent of your treating doctor.

If you take more Buprenorphine and Naloxone Mylan Pharma than you should
If you or someone else takes an excessive dose of this medicine, you must go or be taken immediately to the emergency department or hospital for treatment, as overdose of Buprenorphine and Naloxone Mylan Pharma can cause severe breathing problems, potentially fatal.
Symptoms of overdose include drowsiness, lack of coordination with slowed reflexes, blurred vision and/or speech difficulties. You may lose consciousness and have slower-than-normal breathing.

If you forget to take Buprenorphine and Naloxone Mylan Pharma
Inform your doctor as soon as possible if you have missed a dose.

If you stop taking Buprenorphine and Naloxone Mylan Pharma
Do not change or stop your treatment in any way without the consent of your treating doctor.
Sudden discontinuation of treatment may cause withdrawal symptoms.
If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately or seek emergency medical help if any of the following side effects occur:

• swelling of the face, lips, tongue or throat, which may cause difficulty swallowing or breathing, hives/severe skin rash. These could be signs of a life-threatening allergic reaction
• drowsiness and lack of coordination, blurred vision, slurred speech, confusion, or if breathing becomes much slower than normal

Also contact your doctor immediately if any of the following side effects occur:

• severe tiredness, itching sensation with yellowing of the skin or eyes. These could be symptoms of liver damage
• Seeing or hearing things that do not exist (hallucinations)

Side effects associated with Buprenorfina e Naloxone Mylan Pharma
Very common side effects (may affect more than 1 in 10 people):
Insomnia, constipation, nausea, excessive sweating, headache, withdrawal syndrome.
Common side effects (may affect up to 1 in 10 people):
Weight loss, swelling (of the 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, migraine, runny nose, sore throat and painful swallowing, increased cough, stomach discomfort or other stomach disturbances, diarrhoea, abnormal liver function, flatulence, vomiting, rash, itching sensation, urticaria, pain, joint pain, muscle pain, leg cramps (muscle spasm), difficulty achieving or maintaining an erection, changes in urine, abdominal pain, back pain, weakness, infection, chills, chest pain, fever, flu-like symptoms, general discomfort, accidental injury due to loss of attention or coordination, malaise and dizziness.
Uncommon side effects (may affect up to 1 in 100 people):
Enlargement of glands (lymph nodes), agitation, tremor, abnormal dreams, excessive muscle activity, depersonalization (feeling detached from oneself), drug dependence, amnesia (memory disorder), loss of interest, exaggerated sense of well-being, seizures (epileptic fits), speech disorder, reduced pupil size, difficulty urinating, eye inflammation or infection, rapid or slow heartbeat, low blood pressure, palpitations, myocardial infarction (heart attack), chest tightness, shortness of breath, asthma, yawning, mouth pain and sores, changes in tongue colour, acne, skin nodules, hair loss, dry or scaly skin, joint inflammation, urinary tract infection, abnormal blood tests, blood in urine, abnormal ejaculation, menstrual or vaginal problems, kidney stones, protein in urine, pain or difficulty urinating, sensitivity to heat or cold, heat stroke, loss of appetite, feelings of hostility.
Frequency not known (frequency cannot be estimated from the available data):
Sudden withdrawal syndrome caused by taking Buprenorfina e Naloxone Mylan Pharma too soon after using illicit opioids, neonatal opioid withdrawal syndrome.
Difficulty or slow breathing, liver injury with or without jaundice, hallucinations, facial and throat swelling or allergic reactions that may be fatal, low blood pressure when standing up from a sitting or lying position. Misusing this medicine by 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 side effect, including those not listed in this leaflet, talk to your doctor. You can also report side effects directly via the national reporting system at: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Buprenorphine and Naloxone Mylan Pharma

Keep this medicine out of the sight and reach of children and all other household members.
Do not use this medicine after the expiry date stated on the blister and on the carton. The expiry date refers to the last day of that month.
Do not store above 30°C.
Buprenorphine and Naloxone Mylan Pharma may be attractive to individuals who abuse prescription medicines. Store the medicine in a secure place to protect it from theft.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Buprenorphine and Naloxone Mylan Pharma contains

• The active substances are buprenorphine and naloxone. Each 2 mg/0.5 mg sublingual tablet contains 2 mg of buprenorphine (as hydrochloride) and 0.5 mg of naloxone (as dihydrate hydrochloride). Each 8 mg/2 mg sublingual tablet contains 8 mg of buprenorphine (as hydrochloride) and 2 mg of naloxone (as dihydrate hydrochloride).
• The other components are monohydrate lactose, mannitol, maize starch, povidone (K = 29.7), monohydrate citric acid, sodium citrate, magnesium stearate, acesulfame potassium, lemon flavour (containing: flavouring preparations, maltodextrin, acacia) and lime flavour (containing: flavouring preparations, maltodextrin, acacia).

Description of the appearance of Buprenorphine and Naloxone Mylan Pharma and package contents
Buprenorphine and Naloxone Mylan Pharma are white to off-white, round, biconvex sublingual tablets with a score line on one side. The tablet may be divided into two equal doses.
The tablets are packaged in cardboard boxes containing blisters of 7 or 28 tablets, or unit-dose blisters of 7x1 or 28x1 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Mylan S.p.A
Via Vittor Pisani 20
20124 Milan, Italy

Manufacturer
G.L. Pharma GmbH
Schlossplatz 1, 8502 Lannach,
Austria

This medicinal product is authorised in the EEA Member States under the following names:
Croatia: Buprenorfin/Nalokson Mylan 2 mg/0.5 mg sublingvalne tablete
Buprenorfin/Nalokson Mylan 8 mg/2 mg sublingvalne tablete
Denmark: Buprenorfin/Naloxon Mylan 2 mg/0.5 mg resoriblet, sublingual
Buprenorfin/Naloxon Mylan 8 mg/2 mg resoriblet, sublingual
Finland: Buprenorphine/Naloxone Mylan 2 mg/0.5 mg resoribletti
Buprenorphine/Naloxone Mylan 8 mg/2 mg resoribletti
France: BUPRENORPHINE/NALOXONE MYLAN 2 mg/0.5 mg, comprimé sublingual
BUPRENORPHINE/NALOXONE MYLAN 8 mg/2 mg, comprimé sublingual
Germany: Buprenorphin/Naloxon Mylan 2 mg/0.5 mg Sublingualtabletten
Buprenorphin/Naloxon Mylan 8 mg/2 mg Sublingualtabletten
Italy: Buprenorfina e Naloxone Mylan Pharma
Netherlands: Buprenorfine/Naloxone Mylan 2 mg/0.5 mg, tabletten voor sublinguaal gebruik
Buprenorfine/Naloxone Mylan 8 mg/2 mg, tabletten voor sublinguaal gebruik
Sweden: Buprenorphine/Naloxone Mylan 2 mg/0.5 mg resoriblett, sublingual
Buprenorphine/Naloxone Mylan 8 mg/2 mg resoriblett, sublingual
United Kingdom: Buprenorphine/Naloxone Mylan 2 mg/0.5 mg sublingual tablet
Buprenorphine/Naloxone Mylan 8 mg/2 mg sublingual tablet