2 mg / 0.5 mg, 4 mg / 1 mg, 8 mg / 2 mg resoriblett, sublingual 
buprenorphine / naloxone

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor or pharmacist.

– This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Buprenorphine / Naloxone GL Pharma is and what it is used for 
2. What you need to know before taking Buprenorphine / Naloxone GL Pharma 
3. How to take Buprenorphine / Naloxone GL Pharma 
4. Possible side effects 
5. How to store Buprenorphine / Naloxone GL Pharma 
6. Contents of the packaging and other information 

1. What Buprenorphine / Naloxone GL Pharma is and what it is used for

Buprenorphine / Naloxone GL Pharma is used to treat drug addicts, addicted to opiate drugs (narcotics) such as heroin or morphine, who have given their consent to be treated for their addiction. Treatment with Buprenorphine / Naloxone GL Pharma is intended for adults and adolescents over the age of 15 who also receive medical, social and psychological support.

Buprenorphine and naloxone contained in Buprenorphine / Naloxone GL Pharma may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions and always follow their instructions.

What you need to know before you take Buprenorphine / Naloxone GL Pharma

Do not take Buprenorphine / Naloxone GL Pharma

  • if you are allergic (hypersensitive) to buprenorphine, naloxone or any of the other ingredients of this medicine (listed in section 6).
  • if you have severe breathing problems 
  • if you have severe liver problems 
  • if you are under the influence of alcohol or suffer from 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 cautions

Talk to your doctor before taking Buprenorphine / Naloxone GL Pharma if you have:

  • asthma or other respiratory problems
  • a liver disease, e.g. hepatitis
  • low blood pressure
  • a recent head injury or brain disease
  • urinary tract problems (mainly associated with an enlarged prostate in men)
  • a kidney disease
  • thyroid problems
  • adrenocortical disorders (eg Addison’s disease )
  • depression or other conditions treated with antidepressants.If these medicines are used together with Buprenorphine / Naloxone GL Pharma ”, this can lead to serotonergic syndrome, a condition that can be life-threatening (see“ Other medicines and Buprenorphine / Naloxone GL Pharma ”).

Important things to keep in mind:

  • Extra follow-up 
    Your doctor can follow you up more closely if you are under 18 or over 65. People under the age of 15 must not take this medicine.
  • Misuse and abuse of this medicine may be desirable for people abusing prescription drugs, and should be stored in a safe place to protect against theft. Never give the medicine to anyone else, it could lead to death or injury.
  • Respiratory problems some people have died of respiratory depression (severe difficulty breathing) due to misuse of this drug or that they took it along with other drugs that affect the central nervous system such as. alcohol, benzodiazepines (sedatives), or other opioids. This medicine can cause severe, possibly fatal respiratory paralysis (difficulty breathing) in children and in people who do not have an addiction and who take the medicine intentionally or unintentionally.
  • DependentThis medicine may be addictive.
  • Withdrawal symptoms this medicine may cause withdrawal symptoms if you take it earlier than 6 hours after using a short-acting opioid (eg morphine or heroin) or earlier than 24 hours after using a long-acting opioid such as methadone .

Buprenorphine / Naloxone GL Pharma can also cause withdrawal symptoms if you stop taking them suddenly.

  • Liver damage has been reported with the use of Buprenorphine / Naloxone GL, especially if the medicine is used incorrectly. These liver damage can also be due to viral infections ( chronic hepatitis C), alcohol abuse, anorexia or the use of other drugs that can damage the liver (listed in section 4). Doctors may perform regular blood tests to monitor the condition of your liver. Tell your doctor if you have liver problems before starting treatment with Buprenorphine / Naloxone GL Pharma
  • Blood pressure this medicine may cause your blood pressure to drop rapidly, making you feel dizzy if you get up quickly from a sitting or lying position.
  • Diagnosis of unrelated medical conditions this medicine can hide pain which is a sign of certain diseases. Remember to tell your doctor that you are taking this medicine.

Other medicines and Buprenorphine / Naloxone GL Pharma

Tell your doctor if you are taking, have recently taken, or might take any other medicines.

Some medicines may aggravate the side effects of Buprenorphine / Naloxone GL Pharma and may in some cases cause very serious reactions. Do not take other medicines while taking Buprenorphine / Naloxone GL Pharma without first talking to a doctor, especially:

  • Concomitant use of Buprenorphine / Naloxone GL Pharma and sedatives such as benzodiazepines or similar medicines increases the risk of drowsiness, difficulty breathing ( respiratory depression ), coma and may be life-threatening. Due to this, concomitant use should only be considered when other treatment options are not possible. If your doctor prescribes Buprenorphine / Naloxone GL Pharma together with sedatives, the dose should be limited and the treatment time should be limited by your doctor.
  • Tell your doctor if you are taking any sedatives and carefully follow your doctor’s dose recommendation. It may be helpful to inform friends or relatives about paying attention to the signs and symptoms listed above. Contact your doctor if you experience such symptoms.
  • Other medications that can make you feel sleepy are used to treat diseases such as anxiety, insomnia, seizures or pain. These types of drugs reduce your alertness, which can lead to vehicle driving and the use of machines become risky. They can also cause depression of the CNS, which is very serious. Below is a list of examples of these types of drugs:
    other opioid-containing medicines, e.g. methadone , some painkillers and antitussives- antidepressants (used to treat depression), e.g. isocarboxazid, phenelzine, selegiline , tranylcypromine and valproate , may potentiate the effects of this medicine.- sedatives Hi-receptor antagonists (used to treat allergic reactions), e.g. diphenhydramine and chlorphenamine.- barbiturate s (used to induce sleep or sedation ), e.g. phenobarbital and secobarbital. sedatives (used to induce sleep or sedation ), e.g. chloral hydrate.
  • Clonidine (used to treat high blood pressure ) may prolong the effects of this medicine
  • antiretroviral agents (used to treat HIV ), e.g. ritonavir, nelfinavir and indinavir, may prolong the effects of this medicine.
  • certain antifungals (used to treat fungal infections), e.g. ketoconazole, itraconazole, and certain antibiotics , may prolong the effects of this medicine.
  • Some medicines may reduce the effect of Buprenorphine / Naloxone GL Pharma These include medicines to treat epilepsy (eg carbamazepine and phenytoin ), as well as medicines to treat tuberculosis (rifampicin).
  • naltrexone and nalmefene (medicines used to treat addiction) may counteract the therapeutic effects of Buprenorphine / Naloxone GL Pharma They should not be taken with Buprenorphine / Naloxone GL Pharma because you may then experience a sudden onset of prolonged and intense withdrawal symptoms .
  • antidepressant drugs such as moclobemide, tranylcypromine, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, duloxetine, venlafaxine, amitriptyline, doxepin, or trimipramine. These medicines can affect or be affected by Buprenorphine / Naloxone GL Pharma and you may experience symptoms such as involuntary rhythmic muscle twitching, even in the muscles that control eye movements, agitation, hallucinations, coma , heavy sweating, tremors, increased reflexes, tense muscles and body temperature. 38 ° C. Contact your doctor if you experience such symptoms.

Buprenorphine / Naloxone GL Pharma with food, drink, and alcohol

Alcohol may increase drowsiness and increase the risk of respiratory depression if swallowed with Buprenorphine / Naloxone GL Pharma Do not take Buprenorphine / Naloxone GL  with alcoholic beverages . Do not swallow or consume food or drink of any kind until the travel tablet has completely dissolved.

Pregnancy and breastfeeding

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 using this medicine.

The risks for pregnant women using Buprenorphine / Naloxone GL Pharma are not known. Tell your doctor if you are pregnant or planning to become pregnant. Your doctor will decide if you should continue treatment with another medicine.

Medicines such as Buprenorphine / Naloxone GL Pharma can, if taken during – especially advanced – pregnancy cause withdrawal symptoms and also breathing problems in the newborn baby. These problems can occur several days after birth.

Do not breast-feed while taking this medicine as Buprenorphine / Naloxone GL Pharma passes into breast milk. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Buprenorphine / Naloxone GL Pharma may cause drowsiness. It can happen more often during the first weeks of treatment when the dose is changed, but it can also happen if you drink alcohol or take other sedatives while taking Buprenorphine / Naloxone GL Pharma Do not drive, use tools or machines, or perform dangerous activities before you know how this medicine affects you.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Buprenorphine / Naloxone GL Pharma 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, ie essentially ‘sodium-free’.

How to take Buprenorphine / Naloxone GL Pharma

The treatment is prescribed and monitored by a doctor with experience in the treatment of drug addiction.

Your doctor will decide which dose is best for you. During your treatment, your doctor may adjust your dose depending on how you react.

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Initial treatment

The recommended starting dose for adults and adolescents over the age of 15 is one to two Buprenorphine / Naloxone GL Pharma 2 mg / 0.5 mg tablets. One or more buprenorphine / Naloxone GL Pharma 2 mg / 0.5 mg resorablets may be administered on the first day, depending on your needs.

Clear signs of abstinence should be obvious before taking the first dose of Buprenorphine / Naloxone GL Pharma Your doctor’s assessment of your readiness for treatment will determine when you should receive the first dose of Buprenorphine / Naloxone GL Pharma.

  • Initial treatment with Buprenorphine / Naloxone GL Pharma during heroin addiction you are addicted to heroin or a short-acting opioid, the first dose of Buprenorphine / Naloxone GL Pharma should be taken when signs of abstinenceoccur, but not earlier than 6 hours before the last time you used opioids.
  • Initial treatment with Buprenorphine / Naloxone GL Pharma under methadone dependence

If you have taken methadone or a long-acting opioid, the methadone dose should preferably be reduced to less than 30 mg/day before starting treatment with Buprenorphine / Naloxone GL Pharma. The first dose of Buprenorphine / Naloxone GL Pharma should be taken when signs of abstinence occur, but not earlier than 24 hours after the last use of methadone.

How to take Buprenorphine / Naloxone GL Pharma

  • Take a dose once a day by placing the resoriblets under the tongue.
  • Hold the travel tablet under the tongue until it is completely dissolved . This may take 5-10 minutes.
  • Do not chew or swallow the resoriblets. The drug will then not work and it can lead to withdrawal symptoms.
  • Do not consume food or drink until the resoriblet has completely dissolved.

Dose adjustment and maintenance treatment:

During the first few days after starting treatment, your doctor may increase the dose of Buprenorphine / Naloxone GL Pharma according to your needs. Talk to your doctor or pharmacist if you feel that the effect of

Buprenorphine / Naloxone GL Pharma is too strong or too weak. The maximum daily dose is 24 mg.

After a period of successful treatment, you can agree with your doctor to gradually reduce the dose to a lower maintenance dose .

End of treatment

Depending on your condition, you may continue to reduce the dose of Buprenorphine / Naloxone GL Pharma under close medical supervision until it can be stopped.

Do not change the treatment in any way or discontinue it without the consent of the doctor who gives you the treatment.

If you take more Buprenorphine / Naloxone GL Pharma than you should

If you or anyone else takes too much of this medicine, you must immediately go to an emergency room or hospital for treatment as overdose of Buprenorphine / Naloxone GL Pharma can cause serious and life-threatening breathing problems.

Symptoms of overdose may include feelings of drowsiness and incoherence with slow reflexes, blurred vision and / or slurred speech. You may have difficulty thinking clearly and your breathing may be much slower than normal.


If you forget to take Buprenorphine / Naloxone GL Pharma

Tell your doctor as soon as possible if you miss a dose .

If you stop taking Buprenorphine / Naloxone GL Pharma

Do not change the treatment in any way or discontinue it without the consent of the doctor who gives you the treatment. Sudden discontinuation of treatment may lead to withdrawal symptoms.

If you have any further questions on the use of this product, 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 emergency care if you experience side effects, such as:

  • swollen face, lips, tongue or throat that may make it difficult to swallow or breathe, severe hives / rash. This may be a sign of a life-threatening allergic reaction.
  • a feeling of drowsiness and clumsiness, foggy vision, slurred speech, difficulty clear thinking, or that breathing becomes much slower than normal.

Also tell your doctor immediately if you experience any side effects , such as:

  • severe fatigue, or itching with yellowing skin or eyes. It may be a sign of liver damage.
  • see or hear things that do not exist (hallucinations).

Adverse reactions have been reported for Buprenorphine / Naloxone GL Pharma
Very common side effects (may affect more than 1 user in 10):
Insomnia (inability to sleep), constipation, nausea, heavy sweating, headache, drug withdrawal syndrome.
Common side effects (may affect up to 1 in 10 people):
Weight loss, swelling (hands and feet), drowsiness, anxiety, nervousness, tingling, depression, decreased sex drive, muscle twitching, abnormal thoughts, increased tear flow (watery eyes) or other disturbance of tear flow, blurred vision, hot flashes, high blood pressure , migraine , runny nose , sore throat and pain when swallowing, increased cough, upset stomach or other stomach problems, diarrhea, impaired liver function, flatulence, vomiting, rash, itching , hives , pain, joint pain, muscle aches, leg cramps, impotence , urinary problems, abdominal pain, back pain, weakness , infection, chills, chest pain, fever, flu-like symptoms, general malaise, accidental injury caused by decreased consciousness or coordination, lethargy and dizziness.
Uncommon side effects (may affect up to 1 in 100 people):
Swollen glands ( lymph nodes ), agitation, tremors, abnormal dreams, excessive muscle activity, personality change (not feeling like oneself), drug addiction, memory loss, disinterest, excessive feeling of well-being, seizures, speech difficulties, small pupils , binding memory, problems with in the eye, rapid or slow heartbeat, low blood pressure, palpitations, heart attack, chest tightness, shortness of breath, asthma , yawning, pain and sores in the mouth, discoloration of the tongue, acne , skin nodules, hair loss, dry or scaly skin, joint inflammation, urinary tract infection, blood in the urine, abnormal ejaculation, menstrual or vaginal problems,kidney stones , protein in the urine, pain when urinating or difficulty urinating, sensitivity to heat or cold, heat stroke, loss of appetite and feelings of hostility.
Has been reported (occurs in an unknown number of users):
Sudden withdrawal syndrome caused by the Buprenorphine / Naloxone GL Pharma taken early after use of unauthorized opioid s, drug withdrawal syndrome of the newborn. Slow breathing or difficulty breathing, liver problems with or without jaundice, hallucinations, swelling of the face and throat or life-threatening allergic reactions, drop in blood pressure when changing position from sitting or lying to standing. Misuse of the drug by injection may 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information

5. How to store Buprenorphine / Naloxone GL Pharma

Keep this medicine out of the reach and sight of children and other members of the household.

Do not use this medicine after the expiry date which is stated on the blister and the carton. The expiration date is the last day of the specified month.

Do not store above 30 ° C.

Buprenorphine / Naloxone GL Pharma may be desirable for people abusing prescription drugs. Store this medicine in a safe place to protect it from theft.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substances are buprenorphine and naloxone. 
    Each 2 mg / 0.5 mg mg resoriblett contains 2 mg buprenorphine (as hydrochloride) and 0.5 mg naloxone (as hydrochloride dihydrate).Each 4 mg / 1 mg resoriblett contains 4 mg buprenorphine (as hydrochloride) and 1 mg naloxone (as hydrochloride dihydrate).Each 8 mg / 2 mg resoriblet contains 8 mg buprenorphine (as hydrochloride) and 2 mg naloxone (as hydrochloride dihydrate).

The other ingredients are lactose monohydrate, mannitol, corn starch, povidone (K = 29.7), anhydrous citric acid, sodium citrate, magnesium stearate, acesulfame potassium, lemon flavor (contains: flavors, maltodextrin, stabilizer E 414 (acacia gum), acacia gum, stabilizer E 414 (acacia rubber)).

What the medicine looks like and the contents of the pack

Buprenorphine / Naloxone GL Pharma resoriblets are white or off-white, round and biconvex resorablets, scored on one side.

The tablet can be divided into two equal parts.

Tablets are packaged in cardboard boxes containing blister packs of 7, 28, 49 or 56 tablets or in single-dose blister packs of 7×1, 28×1, 49×1 56×1 tablets.

Not all packaging may be marketed.

Marketing Authorization Holder and Manufacturer

GL Pharma GmbH

Schlossplatz 1

8502 Lannach

Austria

This medicinal product is authorized under the European Economic Area under the names:

Denmark

Buprenorphine / Naloxone GL Pharma. 2 mg / 0.5 mg resoriblet, sublingual

Buprenorphine / Naloxone GL Pharma 4 mg / 1 mg resoriblet, sublingual

Buprenorphine / Naloxone GL Pharma 8 mg / 2 mg resoriblet, sublingual

Finland

Buprenorphine / Naloxone GL Pharma 2 mg / 0.5 mg resoribletti

Buprenorphine / Naloxone GL Pharma 4 mg / 1 mg resoribletti

Buprenorphine / Naloxone GL Pharma 8 mg / 2 mg resoribletti

Germany

Buprenorphine / Naloxone GL Pharma 2 mg / 0.5 mg Sublingual tablets

Buprenorphine / Naloxone GL Pharma 4 mg / 1 mg Sublingual tablets

Buprenorphine / Naloxone GL Pharma 8 mg / 2 mg Sublingual tablets

Buprenorphine / Naloxone GL Pharma 2 mg / 0.5 mg resoriblett, sublingual

Buprenorphine / Naloxone GL Pharma 4 mg / 1 mg resoriblett, sublingual

Buprenorphine / Naloxone GL Pharma 8 mg / 2 mg resoriblett, sublingual

UK

Buprenorphine / Naloxone GL Pharma 2 mg / 0.5 mg sublingual tablet

Buprenorphine / Naloxone GL Pharma 4 mg / 1 mg sublingual tablet

Buprenorphine / Naloxone GL Pharma 8 mg / 2 mg sublingual tablet

Muhammad Nadeem

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