BUPRENORPHINE MOLTENI

Patient Information Leaflet

Buprenorphine Molteni 2 mg sublingual tablets, 8 mg sublingual tablets

Buprenorphine
Equivalent medicine
Please read this entire 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, 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 could be harmful.
• If any of the side effects worsen, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Buprenorfina Molteni is and what it is used for

Buprenorfina Molteni contains the active substance buprenorphine.
Buprenorfina Molteni is used:

• if you are dependent on opioids, for example heroin or morphine, as part of a medical, social, and psychological treatment programme.

The treatment is prescribed and monitored by doctors specialised in the treatment of opioid dependence.

2. What you need to know before taking Buprenorphine Molteni

Do not take Buprenorphine Molteni if:

• You are allergic to buprenorphine or to any of the other ingredients of this medicine (listed in section 6).
• You have severe difficulty breathing.
• You suffer from severe impairment of liver function.
• You suffer from alcoholism or delirium tremens.

Warnings and precautions
Talk to your doctor or pharmacist before taking Buprenorphine Molteni if:
You have taken morphine or heroin (opioids) less than 6 hours ago, as withdrawal symptoms may occur.
You have taken methadone less than 24 hours ago, as withdrawal symptoms may occur (if you are using methadone,
your dose may need to be adjusted before taking buprenorphine; see section 3).
You suffer from asthma or have difficulty breathing.
You suffer from reduced kidney or liver function. If you suffer from severe liver impairment,
you must not take buprenorphine.
You suffer from low blood pressure.
You have difficulty urinating (due to an enlarged prostate or urinary stenosis).
You have a head injury and increased intracranial pressure.
Please note that Buprenorphine Molteni may:

• Cause dependence.
• Cause a positive result in anti-doping tests. For individuals engaged in sports: using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.
• Cause a sudden drop in your blood pressure, which may make you feel dizzy, especially if you stand up quickly from a sitting or lying position.
• Mask other diseases where pain is a symptom, since buprenorphine has a pain-relieving effect.

Children and adolescents
Children and adolescents under 18 years of age must not take this medicine.
Other medicines and Buprenorphine Molteni
Buprenorphine Molteni may affect the effect of other medicines, and other medicines may affect the effect
of Buprenorphine Molteni.
It is therefore important that you inform your doctor if you are taking any of the following medicines:

• Medicines used to treat anxiety, restlessness, and difficulty falling asleep (benzodiazepines and other anxiolytics);
• Medicines used to treat scalp infections (ketoconazole, itraconazole);
• Medicines used to treat certain infections (rifampicin);
• Medicines used in the treatment of HIV (ritonavir, indinavir, nelfinavir);
• Certain types of medicines used to treat allergies;
• Certain types of medicines used to treat depression;
• Medicines used to treat headaches, hot flushes, and withdrawal symptoms due to drug abuse (clonidine);
• Cough medicines (dextromethorphan, noscapine);
• Strong painkillers (morphine and similar substances);
• Medicines containing alcohol;
• Medicines used to treat epilepsy (phenobarbital, phenytoin, carbamazepine);
• Medicines used to treat psychosis (neuroleptics);
• Medicines used as sedatives and for seizure control (barbiturates).

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any
other medicines.
Buprenorphine Molteni with food, drinks and alcohol
You may take Buprenorphine Molteni regardless of meals (see section 3).
Do not drink alcohol while being treated with Buprenorphine Molteni, as alcohol will increase the sedative effect of buprenorphine.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding,
please consult your doctor or pharmacist before taking this medicine.
Pregnancy
Buprenorphine Molteni should not be used during pregnancy. However, your doctor may make an exception during the first three months of pregnancy if considered necessary.
Breastfeeding
Do not take Buprenorphine Molteni while breastfeeding.
Driving and using machines
Buprenorphine Molteni may cause drowsiness, fainting, and dizziness, and therefore may reduce your ability to drive or operate machinery.
Do not drive or operate machinery if you feel confused or drowsy. This usually occurs at the beginning of treatment or when the dose is increased.
Buprenorphine Molteni contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.

3. How to take Buprenorphine Molteni

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

How to take Buprenorphine Molteni
A sublingual tablet is a tablet placed under the tongue. Keep the tablet under your tongue until it dissolves – this normally takes 5–10 minutes. Do not swallow, crush, or chew the tablet.
You may take Buprenorphine Molteni regardless of meals.

The usual dose if you are:

• Adults or elderly: Your doctor will determine your initial dose and will increase your dose according to your response to treatment until a stable dose is reached. A daily dose of 16 mg is normally sufficient. The maximum daily dose is 24 mg. Your doctor will individually determine the duration of your treatment and will gradually reduce your dose. Do not change your treatment in any way or stop treatment without consulting your doctor.
• Children and adolescents (under 18 years of age): Buprenorphine Molteni must not be used in children and adolescents under 18 years of age.
• Reduced kidney or liver function: If you have kidney or liver problems, your dose may need to be reduced. Discuss this with your doctor. If you suffer from severe liver impairment, you must not take Buprenorphine Molteni.
• Concomitant treatment with methadone: Your methadone dose must be reduced to a maximum of 30 mg per day before starting treatment with Buprenorphine Molteni. Contact your doctor if you experience withdrawal symptoms (sweating, anxiety, or restlessness).

If you take more Buprenorphine Molteni than you should
If you take too much buprenorphine, go or have someone take you immediately to the nearest emergency room or hospital.
Signs of overdose include difficulty breathing, slow breathing, or cardiac symptoms.
Toxic poisoning has been observed following misuse (overdose or incorrect administration) and, in the worst cases, may lead to respiratory or cardiac arrest and/or liver damage.

If you forget to take Buprenorphine Molteni
Do not take a double dose to make up for the forgotten dose.

If you stop taking Buprenorphine Molteni
Do not stop treatment on your own; consult your doctor for advice.
Sudden discontinuation may cause withdrawal symptoms (sweating, anxiety, or restlessness).

If you have any doubts about how to use 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.
You must stop treatment with Buprenorphine Molteni and contact your doctor immediately if you experience the following symptoms of angioedema (a rare side effect):

• swelling of the face, tongue or pharynx
• difficulty swallowing
• urticaria and breathing difficulties

Dependence on Buprenorphine Molteni
Buprenorphine Molteni may lead to dependence.
Common side effects (occur in more than 1 but in fewer than 10 out of 100 patients):

• Headache, fainting, dizziness
• Constipation, nausea, vomiting
• Insomnia, somnolence, feeling of weakness
• Sudden drop in blood pressure when standing up from a sitting or lying position
• Sweating

With long-term buprenorphine treatment, common side effects gradually decrease.
However, constipation and sweating often persist.
Rare side effects (occur in more than 1 but in fewer than 10 out of 10,000 patients):

• Hallucinations
• Respiratory depression, bronchospasm
• Liver damage, hepatitis
• Severe allergic reactions (anaphylactic shock), swelling of the face, tongue or pharynx (angioedema)
• Difficulty urinating

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You may also report side effects directly via the national reporting system at:
http://www.agenziafarmaco.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 Buprenorfina Molteni

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the blister after "Exp.".
The expiry date refers to the last day of that month.
Buprenorfina Molteni does not require any special storage conditions.
Do not dispose of medicines 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 Buprenorfina Molteni contains

• The active substance is buprenorphine in the form of buprenorphine hydrochloride.
• Each 2 mg sublingual tablet contains 2 mg of buprenorphine.
• Each 8 mg sublingual tablet contains 8 mg of buprenorphine.
• The other components are monohydrate lactose, mannitol (E421), maize starch, citric acid (E330), sodium citrate (E331), povidone (E1201), magnesium stearate (E470b).

Description of the appearance of Buprenorfina Molteni and contents of the pack
Buprenorfina Molteni 2 mg is a white, oval, biconvex sublingual tablet with a "2" imprinted on one side.
Buprenorfina Molteni 8 mg is a white, oval, biconvex sublingual tablet with an "8" imprinted on one side.
Buprenorfina Molteni is packaged in strips in packs of 7, 14 and 28 tablets and in a multiple pack of 140 (5x28) sublingual tablets. Not all pack sizes may be marketed.

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

Manufacturer
L. Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A.
Strada Statale 67
Fraz. Granatieri
50018 Scandicci (Florence)
Italy

Fine Foods & Pharmaceuticals N.T.M. S.p.A.
Via Follereau 25
24027 Nembro, Bergamo
Italy

This medicinal product is authorised in the European Economic Area countries under the following names:
Italy: Buprenorfina Molteni
Poland and Spain: Bunorfin
Sweden: Molterfin