BUPRENORFINA 2 mg /0,5 Mg Sublingual Tablet

Зміст інструкції

1. BUPRENORFINA E NALOXONE ETHYPHARM 2 mg/0.5 mg sublingual tablets
   1. What is BUPRENORPHINE AND NALOXONE ETHYPHARM and what it is used for
   2. What you need to know before you take BUPRENORPHINE AND NALOXONE
   3. How to take BUPRENORPHINE AND NALOXONE ETHYPHARM
   4. Possible side effects
2. BUPRENORPHINE AND NALOXONE ETHYPHARM following the use of opioids
   1. How to store BUPRENORFINA E NALOXONE ETHYPHARM
   2. Package contents and other information
3. BUPRENORFINA E NALOXONE ETHYPHARM 8 mg/2 mg sublingual tablets
   1. What is BUPRENORPHINE AND NALOXONE ETHYPHARM and what is it used for
   2. What you need to know before you take
   3. How to take BUPRENORPHINE AND NALOXONE ETHYPHARM
   4. Possible side effects
   5. How to store BUPRENORFINA E NALOXONE ETHYPHARM
   6. Package contents and other information

BUPRENORFINA E NALOXONE ETHYPHARM 2 mg/0.5 mg sublingual tablets

buprenorfina / naloxone

Generic medicine

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, 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 BUPRENORFINA E NALOXONE ETHYPHARM is and what it is used for
• 2. What you need to know before you take BUPRENORFINA E NALOXONE ETHYPHARM
• 3. How to take BUPRENORFINA E NALOXONE ETHYPHARM
• 4. Possible side effects 5 How to store BUPRENORFINA E NALOXONE ETHYPHARM
• 6. Contents of the pack and other information

1. What is BUPRENORPHINE AND NALOXONE ETHYPHARM and what it is used for

BUPRENORPHINE AND NALOXONE ETHYPHARM is used to treat opioid
(narcotic) dependence such as heroin or morphine in drug addicts who have agreed to be treated for
their dependence. BUPRENORPHINE AND NALOXONE ETHYPHARM is used in adults and
adolescents over 15 years of age, who are also receiving medical and psychosocial support.

2. What you need to know before you take BUPRENORPHINE AND NALOXONE

ETHYPHARM
Do not take BUPRENORPHINE AND NALOXONE ETHYPHARM

• if you are allergic 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 an intoxication due to alcohol or 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 ETHYPHARM in
case of:

• asthma or other respiratory problems
• any liver disease such as hepatitis
• low blood pressure
• recent head trauma or brain disease
• urinary pathology (especially related to prostate enlargement in men)
• any kidney disease
• thyroid problems
• adrenal pathology (e.g. Addison's disease)
• depression or other conditions that are being treated with antidepressants.

The use of these medicines together with BUPRENORPHINE AND NALOXONE ETHYPHARM may
lead to serotonin syndrome, a condition that can be fatal (see “Other
medicines and BUPRENORPHINE AND NALOXONE ETHYPHARM”).
Never open the blister pack early.
In case of accidental ingestion or suspected ingestion, call the emergency services immediately.

Important notes to be aware of:

• Further monitoringYou may be subject to increased monitoring by your doctor if you are under 18 or over 65 years of age. This medicine should not be taken by people under 15 years of age.
• Improper use and abuseThis medicine may be tempting to people who abuse prescription drugs, and should be kept in a safe place to protect it from theft. Do not givethis medicine to other people. It could be fatal or otherwise harmful.
• Breathing problemsSome people have died from respiratory failure (inability to breathe) due to improper use of the medicine, or due to 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
intentional 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.

In addition, BUPRENORPHINE AND NALOXONE ETHYPHARM can cause withdrawal symptoms
if suddenly stopped.

• Liver damage

Liver damage has been reported after taking BUPRENORPHINE AND NALOXONE
ETHYPHARM, 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). Your doctor mayhave you undergo regular blood tests to monitor your liver condition.
Tell your doctor if you have liver problems before starting treatment with
BUPRENORPHINE AND NALOXONE ETHYPHARM.

• 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.

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

• Sedative drugs such as benzodiazepines(used to treat anxiety or sleep disorders, such as diazepam, temazepam, alprazolam) or similar drugs: The concomitant use of BUPRENORPHINE AND NALOXONE ETHYPHARM and sedative drugs such as benzodiazepines or similar drugs 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 therapeutic options are not possible. However, if your doctor prescribes BUPRENORPHINE AND NALOXONE ETHYPHARM together with sedative drugs, your doctor should limit the dose and duration of concomitant treatment. Tell your doctor if you are taking sedative drugs and take exactly the dose recommended by your doctor. It may be helpful to inform friends or relatives so that they are aware of the above signs and symptoms. See your doctor when these symptoms occur.
• Other medicines that can induce 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. 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 isocarboxazide, phenelzine, selegiline, tranylcypromine and valproate may increase the effects of the medicine;
• antidepressants such as moclobemide, tranylcypromine, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, duloxetine, venlafaxine, amitriptyline, doxepin or trimipramine. These medicines may interact with BUPRENORPHINE AND NALOXONE ETHYPHARM and symptoms such as involuntary and rhythmic muscle contractions, including muscles that control eye movement, agitation, hallucinations, coma, excessive sweating, tremor, increased muscle contraction, fever above 38 °C may occur. Contact your doctor if you experience these symptoms.
• 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) may prolong the effects of the 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 BUPRENORPHINE AND NALOXONE ETHYPHARM. These include medicines for treating epilepsy (such as carbamazepine and phenytoin) and medicines for treating tuberculosis (rifampicin).
• Naltrexone and nalmefene (drugs used for the treatment of addictions) can prevent the therapeutic effects of BUPRENORPHINE AND NALOXONE ETHYPHARM. They should not be taken during treatment with BUPRENORPHINE AND NALOXONE ETHYPHARM because they can cause a sudden onset of intense and prolonged withdrawal symptoms.

BUPRENORPHINE AND NALOXONE ETHYPHARM with food, drinks and alcohol
Alcohol can increase drowsiness and the risk of respiratory failure if taken with
BUPRENORPHINE AND NALOXONE ETHYPHARM. Do not take BUPRENORPHINE AND
NALOXONE ETHYPHARM together 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, ask your doctor or
pharmacist for advice before taking this medicine.
The risks associated with the use of BUPRENORPHINE AND NALOXONE ETHYPHARM 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 an alternative medicine
Medicines like BUPRENORPHINE AND NALOXONE ETHYPHARM, when taken
during pregnancy and especially in the late stages, 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 BUPRENORPHINE AND
NALOXONE ETHYPHARM passes into breast milk.

Driving and using machines
BUPRENORPHINE AND NALOXONE ETHYPHARM 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 sedative medicines together with BUPRENORPHINE AND
NALOXONE ETHYPHARM. Do not drive, use tools or machinery and do not perform
dangerous activities until you know how this medicine affects you.

BUPRENORPHINE AND NALOXONE ETHYPHARM contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking
this medicine.

BUPRENORPHINE AND NALOXONE ETHYPHARM contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
‘sodium-free’

3. How to take BUPRENORPHINE AND NALOXONE ETHYPHARM

Your treatment is prescribed and monitored by doctors experienced in the treatment of drug dependence.
The doctor will determine the optimal dose for you. During the 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 any 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 tablets of BUPRENORPHINE AND NALOXONE ETHYPHARM 2 mg/0.5 mg. On day 1, it is
possible to administer two further tablets of BUPRENORPHINE AND NALOXONE
ETHYPHARM 2 mg/0.5 mg according to your needs.
Before taking the first dose of BUPRENORPHINE AND NALOXONE ETHYPHARM it is advisable
that there are clear and evident signs of withdrawal. A medical assessment of your readiness for
treatment will indicate the most appropriate time to take the first dose of
BUPRENORPHINE AND NALOXONE ETHYPHARM.

• Start of treatment with BUPRENORPHINE AND NALOXONE ETHYPHARM during heroin dependence In case of heroin dependence, or dependence on another short-acting opioid, your first dose of BUPRENORPHINE AND NALOXONE ETHYPHARM should be taken when the first symptoms of withdrawal appear, but no less than 6 hours after the last opioid use.
• Start of treatment with BUPRENORPHINE AND NALOXONE ETHYPHARM during methadone dependence If 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 BUPRENORPHINE AND NALOXONE ETHYPHARM. The first dose of BUPRENORPHINE AND NALOXONE ETHYPHARM should be taken only when the first signs of withdrawal appear, but no less than 24 hours after the last methadone use.

Taking BUPRENORPHINE AND NALOXONE ETHYPHARM
Take the dose once a day by placing the tablets under your tongue.

• Keep the tablets under your tongue until complete dissolution. This will take 5-10 minutes.
• Do not chew or swallow the tablets, as the medicine will not be effective and you may experience withdrawal symptoms.
• Do not consume any food or drink until the tablets have completely dissolved.

How to remove the tablet from the blister

• 1 – Do not press the tablet through the foil

• 2 – Remove only one portion of the blister, tearing along the perforated line

• 3 - Starting from the edge where the seal is lifted, pull the foil to remove the tablet

If the blister is damaged, do not use the tablet.

Dosage adjustment and maintenance therapy:
In the days following the start of treatment, the doctor may increase the dose of
BUPRENORPHINE AND NALOXONE ETHYPHARM you are taking according to your needs. If you
feel that the effect of BUPRENORPHINE AND NALOXONE ETHYPHARM is too strong
or too weak, talk to your doctor or pharmacist. The maximum daily dose is 24 mg.
After a period of successful treatment, you may agree with your doctor to gradually reduce
the dose to a lower maintenance dose.

Discontinuation of treatment
Depending on your condition, the dose of BUPRENORPHINE AND NALOXONE ETHYPHARM may
continue to be reduced under close medical supervision, until it is stopped.
Do not change the treatment in any way and do not stop the treatment without the consent of
the doctor treating you.

If you take more BUPRENORPHINE AND NALOXONE ETHYPHARM than you should
If you or someone else takes an excessive dose of the medicine, it is necessary to go to or be
taken immediately to the emergency room or hospital to receive treatment for
overdoseof BUPRENORPHINE AND NALOXONE ETHYPHARM, as it is a
medicine capable of causing serious breathing problems that can lead to death.
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
respiratory rate slower than normal.

If you forget to take BUPRENORPHINE AND NALOXONE ETHYPHARM
Inform your doctor as soon as possible if you have forgotten to take a dose.

If you stop taking BUPRENORPHINE AND NALOXONE ETHYPHARM
Do not change the treatment in any way or stop the treatment without the consent of the doctor treating you. Sudden discontinuation of treatment may 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.

Seek immediate medical attention or emergency medical careif 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 potentially life-threatening allergic reaction.
• drowsiness and loss of coordination, blurred vision, speech problems, inability to think clearly or lucidly, or if breathing becomes much slower than normal.

Also, seek immediate medical attentionif 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 reported in association with BUPRENORPHINE AND NALOXONE
ETHYPHARM
Very common(may affect more than 1 in 10 people):

• insomnia (difficulty sleeping),
• constipation,
• nausea,
• excessive sweating,
• headache,
• drug withdrawal syndrome. Common(may affect up to 1 in 10 people):
• weight loss,
• swelling (hands and feet),
• drowsiness,
• anxiety,
• nervousness,
• tingling,
• depression,
• decreased libido,
• increased muscle tension,
• abnormal thinking,
• increased tear production (watery eyes) or other tear disturbance,
• blurred vision,
• hot flushes,
• increased blood pressure,
• migraine,
• runny nose,
• sore throat and painful swallowing,
• increased cough,
• stomach discomfort and other stomach upset,
• diarrhoea,
• abnormal liver function,
• flatulence,
• vomiting,
• rash,
• itching,
• urticaria,
• pain,
• joint pain,
• muscle pain,
• leg cramps (muscle spasms),
• difficulty achieving or maintaining an erection,
• altered urination,
• abdominal pain,
• back pain,
• weakness,
• infection,
• chills,
• chest pain,
• fever,
• flu-like symptoms,
• general feeling of discomfort,
• accidental injury caused by loss of attention or coordination,
• feeling unwell and dizziness. Uncommon(may affect up to 1 in 100 people):
• swollen 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 wellbeing,
• convulsion (seizure),
• speech disorder,
• reduced pupil size,
• difficulty urinating,
• eye inflammation or infection,
• fast or slow heartbeat,
• low blood pressure,
• palpitations,
• myocardial infarction (heart attack),
• chest tightness,
• dyspnea,
• asthma,
• yawning,
• pain and ulcers in the mouth,
• altered tongue color,
• acne,
• skin nodule,
• dry or scaly skin,
• joint inflammation,
• urinary tract infection,
• blood test abnormalities,
• blood in urine,
• ejaculation disorders,
• menstrual or vaginal problems,
• kidney stones,
• protein in urine,
• painful or difficult urination,
• 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 it too early

BUPRENORPHINE AND NALOXONE ETHYPHARM following the use of opioids

illicit, neonatal abstinence syndrome,

• difficult 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 getting up from a sitting or lying position,
• improper use of this medicine by injection can cause withdrawal symptoms, infections, other skin reactions and, potentially, serious liver problems (see “Warnings and precautions”).

Reporting of adverse reactions
If you experience any side effects, including those not listed in this leaflet, please inform
your doctor or pharmacist. You can also report side effects directly through the
national reporting system at https://www.aifa.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 E NALOXONE ETHYPHARM

Keep this medicine out of the sight and reach of children and any other family members.
Do not use this medicine after the expiry date which is stated on the blister and the box after
“Exp.”. The expiry date refers to the last day of that month.
Do not store at a temperature above 30°C.
Store in the original package, to protect the medicine from light. However,
BUPRENORFINA E NALOXONE ETHYPHARM may 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 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 E NALOXONE ETHYPHARM contains

• The active ingredients 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). The other components are lactose monohydrate, corn starch, mannitol (E421), povidone K30, anhydrous citric acid, sodium citrate, lime flavour, lemon flavour, acesulfame potassium and sodium stearyl fumarate.

Description of the appearance of BUPRENORFINA E NALOXONE ETHYPHARM and package contents
The sublingual tablets of BUPRENORFINA E NALOXONE ETHYPHARM 2 mg/0.5 mg are
uncoated, round tablets, white to off-white in colour, biconvex, with a diameter of 6.5 mm
with “N2” imprinted on one side and the “↑” logo on the other.
The packs contain divisible unit-dose blisters, with removable foil, child-resistant, with 7 x 1 tablets and 28 x 1 tablets.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Ethypharm
194 Bureaux de la Colline, Batiment D
92213 Saint-Cloud Cedex
France
Manufacturer
Ethypharm
Chemin de la Poudrière
76121 Le Grand
Quevilly Cedex
France
Ethypharm
Z.I. de Saint Arnoult
28170 Châteauneuf en
Thymerais
France

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Italy: BUPRENORFINA E NALOXONE
ETHYPHARM 2 mg/0.5 mg
More detailed information on this medicinal product is available on the website of
http://www.aifa.gov.it/.

BUPRENORFINA E NALOXONE ETHYPHARM 8 mg/2 mg sublingual tablets

buprenorfina / naloxone

Generic medicine

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, 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 BUPRENORFINA E NALOXONE ETHYPHARM is and what it is used for
• 2. What you need to know before you take BUPRENORFINA E NALOXONE ETHYPHARM
• 3. How to take BUPRENORFINA E NALOXONE ETHYPHARM
• 4. Possible side effects 5 How to store BUPRENORFINA E NALOXONE ETHYPHARM
• 6. Contents of the pack and other information

1. What is BUPRENORPHINE AND NALOXONE ETHYPHARM and what is it used for

BUPRENORPHINE AND NALOXONE ETHYPHARM is used to treat opioid
(narcotic) dependence such as heroin or morphine in drug addicts who have agreed to be treated for
their addiction. BUPRENORPHINE AND NALOXONE ETHYPHARM is used in adults and
adolescents over 15 years of age, who are also receiving medical and psychosocial support.

2. What you need to know before you take

Do not take BUPRENORPHINE AND NALOXONE ETHYPHARM

• if you are allergic to buprenorphine, naloxone or any of the excipients of this medicine (see section 6)
• if you have serious breathing problems
• if you have serious liver problems
• if you have alcohol intoxication or 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 ETHYPHARM if you have:

• asthma or other respiratory problems
• any liver disease such as hepatitis
• low blood pressure
• recent head trauma or brain disease
• urinary pathology (especially related to enlarged prostate in men)
• any kidney disease
• thyroid problems
• adrenocortical disease (e.g. Addison's disease)
• depression or other conditions that are being treated with antidepressants.

The use of these medicines together with BUPRENORPHINE AND NALOXONE ETHYPHARM can
lead to serotonin syndrome, a condition that can be fatal (see “Other
medicines and BUPRENORPHINE AND NALOXONE ETHYPHARM”).
Never open the blister pack early.
In case of accidental ingestion or suspected ingestion, call the emergency room immediately.

Important notes to be aware of:

• Further monitoringYou may be subject to increased monitoring by your doctor if you are under 18 or over 65 years of age. This medicine should not be taken by people under 15 years of age.
• Misuse and abuseThis medicine may be tempting to people who abuse prescription drugs, and should be kept in a safe place to protect it from theft. Do not givethis medicine to others. It could be fatal or otherwise harmful.
• Breathing problemsSome people have died from respiratory failure (inability to breathe) due to misuse 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
intentional 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.

In addition, BUPRENORPHINE AND NALOXONE ETHYPHARM can cause withdrawal symptoms
if it is stopped abruptly.

• Liver damageLiver damage has been reported after taking BUPRENORPHINE AND NALOXONE ETHYPHARM, 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). Your doctor mayhave you undergo regular blood tests to monitor your liver condition.Tell your doctor if you have liver problems before starting treatment withBUPRENORPHINE AND NALOXONE ETHYPHARM.
• Blood pressure

This 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 diseases. Do not forget to inform your doctor if you are taking this medicine.

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

• Sedative drugs such as benzodiazepines(used to treat anxiety or sleep disorders, such as diazepam, temazepam, alprazolam) or similar drugs: Concomitant use of BUPRENORPHINE AND NALOXONE ETHYPHARM and sedative drugs such as benzodiazepines or similar drugs 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 therapeutic options are not possible. However, if your doctor prescribes BUPRENORPHINE AND NALOXONE ETHYPHARM together with sedative drugs, your doctor should limit the dose and duration of concomitant treatment. Tell your doctor if you are taking sedative drugs and take exactly the dose recommended by your doctor. It may be helpful to inform friends or family members so they are aware of the signs and symptoms above. Contact your doctor when these symptoms occur.
• Other medicines that can induce drowsiness that 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 may increase the effects of the medicine;
• antidepressants such as moclobemide, tranylcypromine, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, duloxetine, venlafaxine, amitriptyline, doxepin or trimipramine. These medicines may interact with BUPRENORPHINE AND NALOXONE ETHYPHARM and symptoms such as involuntary and rhythmic muscle contractions, including muscles that control eye movement, agitation, hallucinations, coma, excessive sweating, tremor, increased muscle contraction, fever above 38 °C may occur. Contact your doctor if you experience these symptoms.
• sedative antihistamines (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 the medicine.
• Antiretroviral agents (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 BUPRENORPHINE AND NALOXONE ETHYPHARM. These include medicines for treating epilepsy (such as carbamazepine and phenytoin) and medicines for treating tuberculosis (rifampicin).
• Naltrexone and nalmefene (drugs used for the treatment of dependencies) may prevent the therapeutic effects of BUPRENORPHINE AND NALOXONE ETHYPHARM. They should not be taken during treatment with BUPRENORPHINE AND NALOXONE ETHYPHARM because they can cause a sudden onset of intense and prolonged withdrawal symptoms.

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

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.
The risks of using BUPRENORPHINE AND NALOXONE ETHYPHARM 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 an alternative medicine.
Medicines like BUPRENORPHINE AND NALOXONE ETHYPHARM, when taken
during pregnancy and especially in the late stages, 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 BUPRENORPHINE AND
NALOXONE ETHYPHARM passes into breast milk.

Driving and operating machinery
BUPRENORPHINE AND NALOXONE ETHYPHARM can cause drowsiness. This may happen
more often in the first weeks of treatment, when the dose is changed, but can also happen
if you drink alcohol or take other sedative medicines together with BUPRENORPHINE AND
NALOXONE ETHYPHARM. Do not drive, use tools or machinery and do not perform
dangerous activities until you know how this medicine affects you.

BUPRENORPHINE AND NALOXONE ETHYPHARM contains lactose
If your doctor has told you that you have an intolerance to some sugars, talk to your doctor before taking
this medicine.

BUPRENORPHINE AND NALOXONE ETHYPHARM contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
‘sodium-free’

3. How to take BUPRENORPHINE AND NALOXONE ETHYPHARM

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 the 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 initial dose in adults and adolescents over 15 years of age corresponds to one or
two tablets of BUPRENORPHINE AND NALOXONE ETHYPHARM 2 mg/0.5 mg. On day 1, it is
possible to administer two further tablets of BUPRENORPHINE AND NALOXONE
ETHYPHARM 2 mg/0.5 mg according to your needs.
Before taking the first dose of BUPRENORPHINE AND NALOXONE ETHYPHARM it is advisable
that there are evident and clear signs of withdrawal. A medical assessment of your readiness for
treatment will indicate the most appropriate time to take the first dose of
BUPRENORPHINE AND NALOXONE ETHYPHARM.

• Start of treatment with BUPRENORPHINE AND NALOXONE ETHYPHARM during heroin dependence

In case of heroin dependence, or dependence on another short-acting opioid, your first
dose of BUPRENORPHINE AND NALOXONE ETHYPHARM should be taken when the
first symptoms of withdrawal appear, but no less than 6 hours after the last opioid use.

• Start of treatment with BUPRENORPHINE AND NALOXONE ETHYPHARM during methadone dependence

If 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 BUPRENORPHINE AND
NALOXONE ETHYPHARM. The first dose of BUPRENORPHINE AND NALOXONE
ETHYPHARM should be taken only when the first signs of withdrawal appear, but not
less than 24 hours after the last methadone use.

Taking BUPRENORPHINE AND NALOXONE ETHYPHARM

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

How to remove the tablet from the blister

• 1 – Do not press on the tablet through the foil

• 2 – Remove only one portion of the blister, tearing along the perforated line

• 3 - Starting from the edge where the seal is lifted, pull the foil to remove the tablet

If the blister is damaged, do not use the tablet.

Dosage adjustment and maintenance therapy:
In the days following the start of treatment, the doctor may increase the dose of
BUPRENORPHINE AND NALOXONE ETHYPHARM you are taking according to your needs. If you
feel that the effect of BUPRENORPHINE AND NALOXONE ETHYPHARM is too strong
or too weak, talk to your doctor or pharmacist. The maximum daily dose is 24 mg.
After a period of successful treatment, you may agree with your doctor to gradually reduce
the dose to a lower maintenance dose.

Discontinuation of treatment
Depending on your condition, the dose of BUPRENORPHINE AND NALOXONE ETHYPHARM may
continue to be reduced under close medical supervision, until it is discontinued.
Do not modify the treatment in any way and do not discontinue the treatment without the consent of
the doctor treating you.

If you take more BUPRENORPHINE AND NALOXONE ETHYPHARM than you should
If you or someone else takes an excessive dose of the medicine, it is necessary to go to or be
accompanied immediately to the emergency room or hospital to receive treatment for
overdoseof BUPRENORPHINE AND NALOXONE ETHYPHARM, as it is a
medicine capable of causing serious respiratory problems that can lead to death.
The 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 BUPRENORPHINE AND NALOXONE ETHYPHARM
Inform your doctor as soon as possible if you have forgotten to take a dose.

If you stop taking BUPRENORPHINE AND NALOXONE ETHYPHARM
Do not modify in any way or discontinue the treatment without the consent of the doctor treating you. Sudden discontinuation of treatment may cause withdrawal symptoms.
If you have any doubts 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.

Tell your doctor immediately 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 potentially life-threatening allergic reaction.
• drowsiness and loss of coordination, blurred vision, speech problems, inability to think clearly or lucidly, or if breathing becomes very slow.

Also, tell your doctor immediatelyif 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 reported in association with BUPRENORPHINE AND NALOXONE
ETHYPHARM
Very common(may affect more than 1 in 10 people):

• insomnia (difficulty sleeping),
• constipation,
• nausea,
• excessive sweating,
• headache,
• drug withdrawal syndrome. Common(may affect up to 1 in 10 people):
• weight loss,
• swelling (hands and feet),
• drowsiness,
• anxiety,
• nervousness,
• tingling,
• depression,
• decreased libido,
• increased muscle tension,
• abnormal thinking,
• increased tearing (watery eyes) or other tear disturbance,
• blurred vision,
• hot flushes,
• increased blood pressure,
• migraine,
• runny nose,
• sore throat and painful swallowing,
• increased cough,
• stomach discomfort and other stomach upset,
• diarrhea,
• abnormal liver function,
• flatulence,
• vomiting,
• rash,
• itching,
• urticaria,
• pain,
• joint pain,
• muscle pain,
• leg cramps (muscle spasms),
• difficulty achieving or maintaining an erection,
• altered urination,
• abdominal pain,
• back pain,
• weakness,
• infection,
• chills,
• chest pain,
• fever,
• flu-like symptoms,
• general feeling of discomfort,
• accidental injury caused by loss of attention or coordination,
• feeling unwell and dizziness. Uncommon(may affect up to 1 in 100 people):
• swollen 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,
• convulsion (seizure),
• 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),
• chest tightness,
• dyspnea,
• asthma,
• yawning,
• pain and ulcers in the mouth,
• altered tongue color,
• acne,
• skin nodule,
• dry or scaly skin,
• inflammation of the joints,
• urinary tract infection,
• blood test abnormalities,
• blood in urine,
• ejaculation disorders,
• menstrual or vaginal problems,
• kidney stones,
• protein in urine,
• painful or difficult urination,
• 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 too early after using illicit opioids, neonatal abstinence 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 getting up from a sitting or lying position,
• improper use by 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. This includes any side effects not listed in this leaflet. You can also report side effects directly through the
national reporting system at https://www.aifa.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 E NALOXONE ETHYPHARM

Keep this medicine out of the sight and reach of children and any other family member.
Do not use this medicine after the expiry date which is stated on the blister and the box after
“Exp.”. The expiry date refers to the last day of that month.
Do not store at a temperature above 30°C.
Store in the original packaging, to protect the medicine from light. However,
BUPRENORFINA E NALOXONE ETHYPHARM may 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 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 E NALOXONE ETHYPHARM contains

• The active ingredients are buprenorphine and naloxone. Each 8 mg/2 mg tablet contains 8 mg of buprenorphine (as hydrochloride) and 2 mg of naloxone (as dihydrate hydrochloride).
• The excipients are lactose monohydrate, corn starch, mannitol (E421), povidone K30, anhydrous citric acid, sodium citrate, lime flavour, lemon flavour, acesulfame potassium and sodium stearyl fumarate.

Description of the appearance of BUPRENORFINA E NALOXONE ETHYPHARM and package contents
BUPRENORFINA E NALOXONE ETHYPHARM 8 mg/2 mg sublingual tablets are
round, uncoated tablets, white to off-white in colour, biconvex, with a diameter of 10.5 mm
with “N8” imprinted on one side and the “↑” logo on the other.
The packs contain unit-dose divisible blisters, with removable foil, child-resistant, with 7 x 1 tablet and 28 x 1 tablet.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Ethypharm
194 Bureaux de la Colline, Batiment D
92213 Saint-Cloud Cedex
France
Manufacturer
Ethypharm
Chemin de la Poudrière
76121 Le Grand
Quevilly Cedex
France
Ethypharm
Z.I. de Saint Arnoult
28170 Châteauneuf en
Thymerais
France

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Italy: BUPRENORFINA E NALOXONE ETHYPHARM 8 mg/2 mg
More detailed information on this medicinal product is available on the website of
http://www.aifa.gov.it.