BUNAMOL 2 mg /0,5 Mg Tabletka Sublingwalna

Treść ulotki

1. Bunamol 2 mg/0.5 mg sublingual tablets, 4 mg/1 mg sublingual tablets, 8 mg/2 mg sublingual tablets
   1. What is Bunamol and what is it used for
   2. What you need to know before you take Bunamol
   3. How to take Bunamol
   4. Possible side effects
   5. How to store Bunamol
   6. Package Contents and Other Information

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

Buprenorphine/naloxone
Generic Medicine

Read this leaflet carefully before you start 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful. If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Bunamol and what is it used for

Bunamol is used to treat opioid (narcotic) dependence such as heroin or morphine in
drug addicts who have agreed to be treated 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 need to know before you take Bunamol

Do not take Bunamol

• if you are allergic (hypersensitive) to buprenorphine, naloxone or any of the other ingredients of this medicine (see section 6)
• if you have severe breathing problems
• if you have severe liver problems
• if you have alcohol intoxication or 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 trauma or brain disease
• urinary tract disease (especially related to prostate enlargement in men)
• any kidney disease
• thyroid problems
• adrenal cortex disease (e.g. Addison's disease)

Important things to know:

• Further monitoringYou may be monitored more closely by your doctor if you are under 18 or over 65 years of age. This medicine should not be taken by people under the age of 15.
• Improper use and abuseThis medicine may be a temptation for people who abuse prescription drugs, and should be kept in a safe place to protect it from theft. Do not give this medicine to others. It could be fatal or otherwise harmful to them.
• Breathing problemsSome people have died from respiratory failure (inability to breathe) due to improper use of the medicine, or by 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), potentially fatal, in children and non-dependent people in case of accidental or deliberate ingestion.
• DependenceThis medicine can cause dependence.
• Withdrawal symptomsThis medicine can 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 can cause withdrawal symptoms if suddenly stopped.

• Liver damageLiver damage has been reported after taking Bunamol, especially in cases of 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 to allow your doctor to monitor your liver condition. Tell your doctor if you have liver problems before starting treatment with Bunamol.
• Blood pressureThis medicine can cause a sudden drop in blood pressure, causing dizziness when getting up too quickly from a sitting or lying position.
• Diagnosis of unrelated medical conditionsThis medicine may mask painful symptoms that would help establish the diagnosis of some conditions. Do not forget to inform your doctor if you are taking this medicine. For those who play sports: the use of the drug without a therapeutic need constitutes doping and can still lead to positive doping tests.

Other medicines and Bunamol
Tell 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 can sometimes cause very serious reactions.

• Do not take other medicines during treatment with Bunamol without first consulting your
  doctor, especially:
• in the concomitant use of Bunamol and sedatives such as benzodiazepines(used for the treatment of anxiety or sleep disorders) or medicines related to them as it increases the risk of drowsiness, difficulty breathing (respiratory depression), coma and can be life-threatening. For this reason, concomitant use should only be considered when other treatment options are not possible. However, if your doctor prescribes Bunamol together with sedatives, the dose and duration of concomitant treatment must be limited by the doctor. Tell your doctor about all the sedatives you are taking and carefully follow your doctor's dosage recommendations. It may be helpful to inform friends or family members to pay attention to the above symptoms. See a doctor if you experience these symptoms.
• Other medicines that can cause drowsiness which areused to treat conditions such as anxiety, insomnia, seizures/convulsions, pain. These types of medicines reduce the level of attention making it difficult to drive and operate machinery. They can also cause central nervous system depression, a very serious condition. The following 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 can increase the effects of the medicine
• sedative antihistamine receptor antagonists (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) can prolong the effects of this medicine.
• Antiretrovirals (used to treat HIV) such as ritonavir, nelfinavir and indinavir can increase the effects of the medicine.
• Some antifungal agents (used to treat fungal infections) such as ketoconazole, itraconazole and some antibiotics can prolong the effects of the medicine.
• Some medicines can reduce the effect of Bunamol. These include medicines for treating epilepsy (such as carbamazepine and phenytoin) and medicines used to treat tuberculosis (rifampicin).
• Naltrexone and nalmefene (drugs used for the treatment of addictions) can prevent the therapeutic effects of Bunamol. They should not be taken during treatment with Bunamol as they can cause a sudden onset of intense and prolonged withdrawal symptoms.

Bunamolwith food, drinks and alcohol
Alcohol can increase drowsiness and the risk of respiratory failure if taken with Bunamol. Do
not take Bunamol with alcoholic beverages. Do not ingest or consume food or any beverage until
the tablet has completely dissolved.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your
doctor for advice before taking this medicine.
The risks of using Bunamol in pregnant women are not known. Tell your doctor if you are pregnant or
intend to become pregnant. The doctor will decide whether to continue your treatment with a
alternative medicine.
Medicines like Bunamol, when taken during pregnancy (especially at an advanced stage),
can cause symptoms associated with drug withdrawal, including respiratory problems, in the newborn. These
symptoms can occur several days after birth.
Do not breastfeed while taking the medicine as Bunamol passes into breast milk.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Bunamol can cause drowsiness. This may happen more often in the first few weeks of treatment, when
the dose is changed, but can also happen if you drink alcohol or take other sedatives in
conjunction with Bunamol. Do not drive, use tools or machinery, and do not engage in dangerous activities until
you know how this medicine affects you.

Bunamol contains lactose and sodium
If your doctor has told you that you have an intolerance to some sugars, contact him before taking this
medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, therefore it is essentially “sodium-free”.

3. How to take Bunamol

Your treatment is prescribed and monitored by doctors experienced in the treatment of drug dependence.
The doctor will establish the optimal dose for you. During treatment, the doctor may adjust the dose, based on
your response.
Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.

Start of treatment
The recommended starting dose in adults and adolescents over 15 years of age corresponds to one or two
Bunamol 2 mg/0.5 mg tablets.
On day 1, one or two additional Bunamol 2 mg/0.5 mg tablets may be administered according to your
needs.
Before taking the first dose of Bunamol, clear signs of withdrawal must be evident. A
medical assessment of your readiness to receive treatment will indicate the time to take your
first dose of Bunamol.

• Start of treatment with Bunamol 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 less than 6 hours after the last opioid use.
• Start of treatment with Bunamol in case of methadone dependenceIf you are taking methadone or a long-acting opioid, the dose of methadone should be reduced to less than 30 mg/day before starting therapy with Bunamol. The first dose of Bunamol should be taken when withdrawal symptoms appear and no less than 24 hours after the last methadone use.

How to take Bunamol

• Take the dose once a day, placing the tablet under the tongue.
• Keep the tablet under the tongue until complete dissolution. This will take 5-10 minutes.
• Do not chew or swallow the tablet, as the medicine will not be effective and you may experience withdrawal symptoms.
• Do not consume food or beverages until the tablet is completely dissolved.

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

Discontinuation of treatment
Based on your condition, the dose of Bunamol may be further reduced, under close medical
supervision, until possible discontinuation.
Do not modify the treatment in any way or discontinue the treatment without the consent of the doctor
who is following you.

If you take more Bunamol than you should
If you or others take an excessive dose of this medicine, you must go to or be taken
immediately to the Emergency Room or hospital to receive treatment for cases of

overdosefrom Bunamol, as it is a medicine that can cause serious respiratory problems,
potentially fatal.
Symptoms of overdose include drowsiness and lack of coordination with slowed reflexes, blurred vision and/or speech problems. You may lose consciousness and have a slower breathing rate than
normal.

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

If you stop taking Bunamol
Do not modify or stop treatment without the consent of your doctor.

Sudden discontinuation of treatment can cause withdrawal symptoms.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
manifest.

Immediately 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, hives/severe skin rash. These could be signs of a life-threatening allergic reaction
• drowsiness and loss of coordination, blurred vision, slurred speech, confusion, or if breathing becomes much slower than normal Also, immediately inform your doctorif you experience side effects such as:
• severe fatigue, itchy skin with 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 (difficulty sleeping), 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 disorder, blurred vision, flushing, increased blood
pressure, migraine, runny nose, sore throat and painful swallowing, increased cough, stomach discomfort or other stomach upset, diarrhea, abnormal liver function, flatulence, vomiting, rash,
itchy skin, hives, pain, joint pain, muscle pain, leg cramps
(muscle spasm), difficulty getting or maintaining an erection, altered urine, abdominal pain,
back pain, weakness, infection, chills, chest pain, fever, flu-like symptoms, feeling of
general discomfort, accidental injury caused by loss of attention or coordination, feeling unwell and dizziness.

Uncommon side effects (may affect up to 1 in 100 people):
Enlargement of the glands (lymph nodes), agitation, tremor, abnormal dreams, excessive muscle activity,
depersonalization (not feeling like yourself), drug dependence, amnesia (memory disorder),
loss of interest, exaggerated sense of well-being, seizures (fits), speech disorder,
reduced pupil size, difficulty urinating, inflammation or infection of the eye, fast or slow heartbeat, low blood pressure, palpitations, myocardial infarction (heart
attack), tightness in the chest, shortness of breath, asthma, yawning, pain and sores in the mouth, altered color
of the tongue, acne, skin nodule, dry or scaly skin, inflammation of the
joints, urinary tract infection, altered 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, heatstroke, loss of appetite, feelings of hostility.

Not known (frequency cannot be estimated from the available data):
Sudden withdrawal syndrome caused by taking Bunamoltoo early
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
can be fatal, low blood pressure when standing up from a sitting or lying position. Improper use for injection of this medicine can cause withdrawal symptoms,
infections, other skin reactions and potentially serious liver problems (see “Warnings and
precautions”).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through 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 any other member of the household.
Do not use this medicine after the expiry date which is reported on the blister and on the packaging. The expiry
date refers to the last day of that month.
Do not store at a temperature above 30°C.

Bunamolmay be a temptation for people who abuse prescription medicines.
Store the medicine in a safe place to protect it from theft.
Do not dispose of any medicine in the drain or in 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 Bunamol contains

• The active ingredients 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 buprenorphine (as hydrochloride) and 2 mg of naloxone (as dihydrate hydrochloride).
• The other ingredients are lactose monohydrate, mannitol, corn starch, povidone (K = 29.7), citric acid monohydrate, sodium citrate, magnesium stearate, acesulfame potassium, lemon aroma (contains: aromatic preparations, maltodextrins, acacia), lime aroma (contains: aromatic preparations, maltodextrins, acacia).

Description of the appearance of Bunamol and package contents
Bunamol sublingual tablets are white to off-white, round and biconvex, with a fracture 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 single-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 (Firenze)

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

This medicinal product is authorised in the Member States of the European Economic Area 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