Patient leaflet - BUPRENORPHINE/NALOXONE 4 MG / 1 MG SUBLINGUAL TABLETS
What is in this leaflet
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1. What Buprenorphine/Naloxone is and what it is used for
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2. What you need to know before you take Buprenorphine/Naloxone
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3. How to take Buprenorphine/Naloxone
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4. Possible side effects
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5. How to store Buprenorphine/Naloxone
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6. Contents of the pack and other information
1. what buprenorphine/naloxone is and what it is used for
Buprenorphine/Naloxone is used to treat dependence on opioid (narcotic) drugs such as heroin or morphine in drug addicts who have agreed to be treated for their addiction. Buprenorphine/Naloxone is used in adults and adolescents over 15 years of age, who are also receiving medical, social and psychological support.
2. what you need to know before you take buprenorphine/naloxone
Do not take Buprenorphine/Naloxone
- if you are allergic (hypersensitive) to buprenorphine, naloxone or any of the other ingredients of this medicine (see section 6)
- if you have serious breathing problems if you have serious liver problems
- if you are intoxicated due to alcohol or have trembling, 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/ Naloxone if you have:
- asthma or other breathing problems
- any liver disease such as hepatitis
- low blood pressure
- recently suffered a head injury or brain disease a urinary disorder (especially linked to enlarged prostrate in men)
- any kidney disease
- thyroid problems
- adrenocortical disorder (e.g. Addison’s disease)
- Depression or other conditions that are treated with antidepressants.
The use of these medicines together with Buprenorphine/Naloxone can lead to serotonin syndrome, a potentially lifethreatening condition (see “Other medicines and Buprenorphine/Naloxone”).
- Important things to be aware of: Additional monitoring
You may be more closely monitored by your doctor if you are below the age of 18 or over the age of 65. This medicine should not be taken by those under 15 years of age.
- Misuse and abuse
This medicine can be a target for people who abuse prescription medicines, and should be kept in a safe place to protect it from theft. Do not give this medicine to anyone else. It can cause death or otherwise harm them.
- Breathing problems
Some people have died from respiratory failure (inability to breathe) because they misused this medicine or took it in combination with other central nervous system depressants, such as alcohol, benzodiazepines (tranquilisers), or other opioids.
This medicine may cause severe, possibly fatal, respiratory depression (reduced ability to breathe) in children and non-dependent people who accidentally or deliberately take it.
- Dependence
This product can cause dependence.
- Withdrawal symptoms
This medicine can cause withdrawal symptoms if you take it less than six hours after you use a short-acting opioid (e.g. morphine, heroin) or less than 24 hours after you use a long-acting opioid such as methadone.
Buprenorphine/Naloxone can also cause withdrawal symptoms if you stop taking it abruptly.
- Liver damage
Liver damage has been reported after taking Buprenorphine/Naloxone, especially when the medicine is misused. This could also be due to viral infections (chronic hepatitis C), alcohol abuse, anorexia or use of other medicines with the ability to harm your liver (see section 4). Regular blood tests may be conducted by your doctor to monitor the condition of your liver. Tell your doctor if you have any liver problems before you start treatment with Buprenorphine/ Naloxone.
- Blood pressure
This product may cause your blood pressure to drop suddenly, causing you to feel dizzy if you get up too quickly from sitting or lying down.
- Diagnosis of unrelated medical conditions This medicine may mask pain symptoms that could assist in the diagnosis of some diseases. Do not forget to advise your doctor if you take this medicine.
Please note that Buprenorphine/Naloxone contains buprenorphine, which may give
Other medicines and Buprenorphine/ Naloxone
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Some medicines may increase the side effects of Buprenorphine/Naloxone and may sometimes cause very serious reactions. Do not take any other medicines whilst taking Buprenorphine/ Naloxone without first talking to your doctor, especially:
- Concomitant use of Buprenorphine/Naloxone and sedative medicines such as benzodiazepines (used to treat anxiety or sleep disorders) or related drugs increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible.
However if your doctor does prescribe Buprenorphine/Naloxone together with sedative medicines the dose and duration of concomitant treatment should be limited by your doctor.
Please tell your doctor about all sedative medicines you are taking, and follow your doctor’s dose recommendation closely. If could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.
– Anti-depressants such as moclobemide, tranylcypromine, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, duloxetine, venlafaxine, amitriptyline, doxepine, or trimipramine. These medicines may interact with Buprenorphine/Naloxone and you may experience symptoms such as involuntary, rhythmic contractions of muscles, including the muscles that control movement of the eye, agitation, hallucinations, coma, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor when experiencing such symptoms.
- Other medicines that may make you feel sleepy which are used to treat illnesses such as anxiety, sleeplessness, convulsions/ seizures, pain. These types of medicines will reduce your alertness levels making it difficult for you to drive and use machines. They may also cause central nervous system depression, which is very serious. Below is a list of examples of these types of medicines: – other opioid containing medicines such as methadone, certain pain killers and cough suppressants
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– anti-depressants (used to treat depression) such as isocarboxazid, phenelzine, selegiline, tranylcypromine and valproate may increase the effects of this medicine.
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– sedative Hi receptor antagonists (used to treat allergic reactions) such as diphenhydramine and chlorphenamine.
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– barbiturates (used to cause sleep or sedation) such as Phenobarbital, secobarbital
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– tranquilisers (used to cause sleep or sedation) such as chloral hydrate.
- clonidine (used to treat high blood pressure) may extend the effects of this medicine.
- anti-retrovirals (used to treat HIV) such as ritonavir, nelfinavir, indinavir may increase the effects of this medicine.
- some antifungal agents (used to treat fungal infections) such as ketoconazole, itraconazole, certain antibiotics, may extend the effects of this medicine.
- some medicines may decrease the effect of Buprenorphine/Naloxone. These include medicines used to treat epilepsy (such as carbamazepine and phenytoin), and medicines used to treat tuberculosis (rifampicin).
- Naltrexone and nalmefene (drugs used to treat addiction disorders) may prevent the therapeutic effects of Buprenorphine/ Naloxone. They should not be taken at the same time as Buprenorphine/Naloxone treatment because you may experience a sudden onset of prolonged and intense withdrawal.
Buprenorphine/Naloxone with food, drink and alcohol
Alcohol may increase drowsiness and may increase the risk of respiratory failure if taken with Buprenorphine/Naloxone. Do not take Buprenorphine/Naloxone together with alcohol. Do not swallow or consume food or any drink until the tablet is completely dissolved.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
The risks of using Buprenorphine/Naloxone in pregnant women are not known. Tell your doctor if you are pregnant or intend to become pregnant. Your doctor will decide if your treatment should be continued with an alternative medicine.
When taken during pregnancy, particularly late pregnancy, medicines like Buprenorphine/ Naloxone may cause drug withdrawal symptoms including problems with breathing in your newborn baby. This may appear several days after birth.
Do not breast-feed whilst taking this medicine, since Buprenorphine/Naloxone passes into breast milk.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Buprenorphine/Naloxone may cause drowsiness. This may happen more often in the first few weeks of treatment when your dose is being changed, but can also happen if you drink alcohol or take other sedative medicines when you take Buprenorphine/ Naloxone. Do not drive, use any tools or machines, or perform dangerous activities until
RETRO
Buprenorphine/Naloxone contains lactose and sodium
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
3. how to take buprenorphine/naloxone
Your treatment is prescribed and monitored by doctors who are experienced in the treatment of drug dependence.
Your doctor will determine the best dose for you. During your treatment, the doctor may adjust the dose, depending upon your response.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Starting treatment
The recommended starting dose for adults and adolescents over the age of 15 years is one to two tablets of Buprenorphine/Naloxone 2 mg/0.5 mg. An additional one to two tablets of the Buprenorphine/Naloxone 2 mg/0.5 mg may be administered on day 1 depending on your needs.
Clear signs of withdrawal should be evident before taking your first dose of Buprenorphine/ Naloxone. A doctor’s assessment of your readiness for treatment will guide the timing of your first Buprenorphine/Naloxone dose.
- Starting treatment of Buprenorphine/ Naloxone whilst dependent on heroin.
If you are dependent upon heroin or a short acting opioid, your first dose of Buprenorphine/Naloxone should be taken when signs of withdrawal appear, but not less than 6 hours after you last used opioids.
- Starting treatment of Buprenorphine/ Naloxone whilst dependent on methadone If you have been taking methadone or a long acting opioid, the dose of methadone should ideally be reduced to below 30 mg/ day before beginning Buprenorphine/ Naloxone therapy. The first dose of Buprenorphine/Naloxone should be taken when signs of withdrawal appear, but not less than 24 hours after you last used methadone.
Taking Buprenorphine/Naloxone
- Take the dose once a day by placing the tablets under the tongue.
- Keep the tablets in place under the tongue until they have completely dissolved. This may take 5–10 minutes.
- Do not chew or swallow the tablets, as the medicine will not work and you may get withdrawal symptoms.
- Do not consume any food or drink until the tablets have completely dissolved.
Dosage adjustment and maintenance therapy:
During the days after you start treatment, your doctor may increase the dose of Buprenorphine/ Naloxone you take according to your needs. If you have the impression that the effect of Buprenorphine/Naloxone is too strong or too weak, talk to your doctor or pharmacist. The maximum daily dose is 24 mg.
After a time of successful treatment, you may agree with your doctor to reduce the dose gradually to a lower maintenance dose.
Stopping treatment
Depending on your condition, the dose of Buprenorphine/Naloxone may continue to be reduced under careful medical supervision, until eventually it may be stopped.
Do not change the treatment in any way or stop treatment without the agreement of the doctor who is treating you.
If you take more Buprenorphine/Naloxone than you should
If you or someone else takes too much of this medicine, you must go or be taken immediately to an emergency centre or hospital for treatment as overdose with Buprenorphine/ Naloxone may cause serious and lifethreatening breathing problems.
Symptoms of overdose may include feeling sleepy and uncoordinated with slowed reflexes, blurred vision, and/or slurred speech. You may be unable to think clearly, and may breathe much slower than is normal for you.
If you forget to take Buprenorphine/ Naloxone
Tell your doctor as soon as possible if you miss a dose.
If you stop taking Buprenorphine/Naloxone Do not change the treatment in any way or stop treatment without the agreement of the doctor who is treating you. Stopping treatment suddenly may cause withdrawal symptoms.
If you have any further questions on 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 attention if you experience side effects, such as:
- swelling of the face, lips, tongue or throat which may cause difficulty in swallowing or breathing, severe hives/nettle rash. These may be signs of a life-threatening allergic reaction.
- feeling sleepy and uncoordinated, have blurred vision, have slurred speech, cannot think well or clearly, or your breathing gets much slower than is normal for you.
Also tell your doctor immediately if you experience side effects such as:
- severe tiredness, itching with yellowing of skin or eyes. These may be symptoms of liver damage.
- seeing or hearing things that are not there (hallucinations).
5. how to store buprenorphine/naloxone keep this medicine out of the sight and reach of children and other household members.
Do not use this medicine after the expiry date which is stated on the blister and carton. The expiry date refers to the last day of that month. Do not store above 30°C.
Buprenorphine/Naloxone can be a target for people who abuse prescription medicine. Keep this medicine in a safe place to protect it from theft.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. contents of the pack and other information what buprenorphine/naloxone contains
– The active substances are buprenorphine and naloxone.
Each 4 mg/1 mg sublingual tablet contains 4 mg buprenorphine (as hydrochloride) and 1 mg naloxone (as hydrochloride dihydrate). – The other ingredients are lactose monohydrate, mannitol, maize starch, povidone (K = 29.7), citric acid monohydrate, sodium citrate, magnesium stearate, acesulfame potassium, lemon flavour (contains: flavouring preparations, maltodextrin, Acacia), lime flavour (contains: flavouring preparations, maltodextrin, Acacia).
What Buprenorphine/Naloxone looks like and contents of the pack
Buprenorphine/Naloxone are white to off-white, round and biconvex sublingual tablets, with score line on one side. The tablet can be divided into equal doses.
The tablets are packaged in blisters in cardboard boxes containing 7 or 28 tablets or in unit-dose blisters of 7×1 or 28×1 tabletes. Not all pack sizes may be marketed.
Marketing Authorisation Holder
L. Molteni & C. dei Flli Alitti Societa di Esercizio SpA
Strada Statale 67, Fraz. Granatieri 50018 Scandicci (Firenze) – Italy
Manufacturer
G.L. Pharma GmbH – Schlossplatz 1, A-8502 Lannach – Austria
This medicinal product is authorised in the Member States of the EEA under the following names:
Germany: Buprenorphin/Naloxon
MOLTENI 4 mg/1 mg Sublingualtabletten
Italy Bunamol
United Kingdom Buprenorphine/Naloxone 4 mg/1 mg sublingual tablet
This leaflet was last revised in 08/2020
M MOLTENf FARMAC EUTICI
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