Bunamol

Patient Information Leaflet

Bunamol 2 mg/0.5 mg sublingual tablets, 4 mg/1 mg sublingual tablets, 8 mg/2 mg sublingual tablets

Buprenorphine/naloxone
Generic Medicine
Please read 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, 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, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Bunamol is and what it is used for

Bunamol is used to treat opioid dependence (narcotics) such as heroin or morphine in drug-dependent individuals who have agreed to undergo treatment for their addiction. Bunamol is used in adults and adolescents over the age of 15, who are also receiving medical and psychosocial support.

2. What you should know before taking Bunamol

Do not take Bunamol

• 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 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
Talk to your doctor before taking Bunamol if you have:

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

Important information:

• Additional monitoring You may be monitored more closely by your doctor if you are under 18 or over 65 years of age. This medicine must not be taken by individuals under 15 years of age.
• Misuse and abuse This medicine may be attractive to people who misuse prescription medicines and must be stored in a safe place to protect it from theft. Do not give this medicine to other people. It could cause death or be otherwise harmful to them.
• Respiratory problems Some people have died from respiratory failure (inability to breathe) due to misuse of the medicine or 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, potentially fatal respiratory depression (reduced ability to breathe) in children and non-dependent individuals in case of accidental or intentional ingestion.
• Dependence This medicine can cause 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.

Bunamol may cause withdrawal symptoms if treatment is abruptly stopped.

• Liver damage Liver damage has been reported after taking Bunamol, 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 damage the liver (see section 4). Regular blood tests may be performed so your doctor can monitor your liver function. Inform your doctor if you have liver problems before starting treatment with Bunamol.
• Blood pressure This medicine may cause a sudden drop in blood pressure, causing 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. Do not forget to inform your doctor if you are taking this medicine. For athletes: using the drug without therapeutic need constitutes doping and may result in a positive anti-doping test.

Other medicines and Bunamol
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
Some medicines can increase the side effects of Bunamol and may sometimes cause very serious reactions.
Do not take other medicines during treatment with Bunamol without first consulting your doctor, especially:

• when used concomitantly with Bunamol and sedative medicines such as benzodiazepines (used to treat anxiety or sleep disorders) or related medicines, as this increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. For this reason, concomitant use should only be considered when no other treatment options are possible. However, if your doctor prescribes Bunamol together with sedative medicines, the dose and duration of concomitant treatment must be limited by your doctor. Inform your doctor about all sedative medicines you are taking and follow your doctor’s dose recommendations carefully. It may be helpful to inform friends or family members to watch for the signs and symptoms listed above. 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 medicines containing opioids such as methadone, some painkillers, and cough suppressants
• antidepressants (used to treat depression) such as isocarboxazid, phenelzine, selegiline, tranylcypromine, and valproate, which may increase the effects of the medicine
• H\1-receptor antagonist sedatives (used to treat allergic reactions) such as diphenhydramine and chlorphenamine
• barbiturates (used to promote sleep or sedation) such as phenobarbital and secobarbital
• tranquilizers (used to promote 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 the medicine.
• Some antifungal agents (used to treat fungal infections) such as ketoconazole, itraconazole, and some antibiotics may prolong the effects of the medicine.
• Some medicines may reduce the effect of Bunamol. 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 Bunamol. They must not be taken during treatment with Bunamol because they may cause a sudden onset of severe and prolonged withdrawal symptoms.

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

3. How to take Bunamol

Your treatment must be prescribed and monitored by doctors experienced in the treatment of drug dependence.
Your doctor will determine the optimal dose for you. During treatment, your doctor may adjust the dose according to 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 initial dose for adults and adolescents over 15 years of age is one or two tablets of Bunamol 2 mg/0.5 mg.
On Day 1, one or two additional tablets of Bunamol 2 mg/0.5 mg may be administered, depending on your needs.
Before taking the first dose of Bunamol, clear signs of withdrawal must be present. A medical assessment of your readiness for treatment will determine the appropriate time to take your first dose of Bunamol.

• Starting Bunamol treatment in case of heroin dependence. If you are dependent on heroin or another short-acting opioid, your first dose of Bunamol should be taken when withdrawal symptoms appear and no sooner than 6 hours after the last opioid use.
• Starting Bunamol treatment in case of 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 Bunamol therapy. The first dose of Bunamol should be taken when withdrawal symptoms appear and no sooner than 24 hours after the last methadone use.

How to take Bunamol

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

Dosage adjustment and maintenance therapy:
In the days following the start of treatment, your doctor may increase your Bunamol dose according to your needs.
If you feel that the effect of Bunamol is too strong or too weak, speak to your doctor or pharmacist. The maximum daily dose is 24 mg.
After successfully completing an initial treatment period, you may agree with your doctor to gradually reduce the dose to a lower maintenance dose.

Stopping treatment
Depending on your condition, your Bunamol dose may be further reduced under close medical supervision, eventually leading to discontinuation.
Do not change your treatment regimen or stop treatment without the approval of your supervising doctor.

If you take more Bunamol 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 Room or hospital for treatment of overdose with Bunamol, as this medicine can cause severe, potentially life-threatening respiratory problems.
Symptoms of overdose include drowsiness, lack of coordination with slowed reflexes, blurred vision and/or speech difficulties. You may lose consciousness and experience abnormally slow breathing.

If you forget to take Bunamol
Inform your doctor as soon as possible if you have missed a dose.

If you stop taking Bunamol
Do not change or stop your treatment in any way without your doctor’s consent.
Sudden discontinuation of treatment may cause withdrawal symptoms.
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 gets them.
Contact your doctor immediately or seek urgent medical attention 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 you experience side effects such as:

• severe tiredness, itching accompanied by yellowing of the skin or eyes. These could be symptoms of liver damage
• seeing or hearing things that are not there (hallucinations).

Side effects associated with Bunamol
Very common side effects (may affect more than 1 in 10 people):
Insomnia (inability to sleep), constipation, nausea, excessive sweating, headache, 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, migraine, runny nose, sore throat and painful swallowing, increased cough, stomach discomfort or other stomach upset, diarrhoea, abnormal liver function, flatulence, vomiting, rash, itching sensation, hives, pain, joint pain, muscle pain, leg cramps (muscle spasms), 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 feeling of well-being, seizures (fits), speech disorder, constricted pupils, difficulty urinating, inflammation or infection of the eye, rapid or slow heartbeat, low blood pressure, palpitations, myocardial infarction (heart attack), chest tightness, shortness of breath, asthma, yawning, mouth pain and sores, change in tongue colour, acne, skin nodule, hair loss, dry or scaly skin, joint inflammation, urinary tract infection, abnormal blood tests, blood in urine, abnormal ejaculation, menstrual or vaginal problems, kidney stone, 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 available data):
Sudden withdrawal syndrome caused by taking Bunamol too soon after using illicit opioids, neonatal drug withdrawal syndrome. Difficulty breathing or slow breathing, liver injury with or without jaundice, hallucinations, swelling of the face and throat or allergic reactions that may lead to death, drop in blood pressure upon standing up from sitting or lying down. Misuse by injection of this medicine may cause withdrawal symptoms, infections, other skin reactions, and potentially severe 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 Bunamol

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 pack and outer carton. The expiry date refers to the last day of that month.
Do not store above 30°C.
Bunamol 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 Bunamol 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 4 mg/1 mg sublingual tablet contains 4 mg of buprenorphine (as hydrochloride) and 1 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, potassium acesulfame, lemon flavour (containing: flavouring preparations, maltodextrins, acacia), lime flavour (containing: flavouring preparations, maltodextrins, acacia).

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

Marketing Authorisation Holder and Manufacturer
L. Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A., Strada Statale 67 – Fraz. Granatieri – 50018-
Scandicci (Florence)

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

This medicinal product is authorised in the European Economic Area Member States under the following names:
Germany: Buprenorphin/Naloxon MOLTENI 2 mg/0.5 mg Sublingualtabletten
Buprenorphin/Naloxon MOLTENI 4 mg/1 mg Sublingualtabletten
Buprenorphin/Naloxon MOLTENI 8 mg/2 mg Sublingualtabletten
Italy: Bunamol
United Kingdom: Buprenorphine/Naloxone MOLTENI 2 mg/0.5 mg sublingual tablet
Buprenorphine/Naloxone MOLTENI 4 mg/1 mg sublingual tablet
Buprenorphine/Naloxone MOLTENI 8 mg/2 mg sublingual tablet