Buprenorphine / Naloxone Mylan 2 mg / 0.5 mg sublingual resorblets Buprenorphine / Naloxone Mylan 8 mg / 2 mg sublingual resorablets 
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: 
1. What Buprenorphine / Naloxone Mylan is and what it is used for 
2. What you need to know before you take Buprenorphine / Naloxone Mylan 
3. How to take Buprenorphine / Naloxone Mylan 
4. Possible side effects 
5. How to take it Buprenorphine / Naloxone Mylan to be stored 
6. Contents of the pack and other information 

What Buprenorphine / Naloxone Mylan is and what it is used for

Buprenorphine / Naloxone Mylan 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 Mylan 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 Mylan 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 Mylan

Do not take Buprenorphine / Naloxone Mylan:

  • 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 opiate dependence.

Warnings and cautions

Talk to your doctor before taking Buprenorphine / Naloxone Mylan 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.
    • The use of these medicines together with Buprenorphine / Naloxone Mylan can lead to the serotonergic syndrome, a potentially life-threatening condition (see “Other medicines and Buprenorphine / Naloxone Mylan”).

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.
  • The respiratory problem some people have died of respiratory depression (severe difficulty breathing) due to misuse of this drug or that they took it together with 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 Mylan can also cause withdrawal symptoms if you stop taking it suddenly.

  • Liver damage has been reported with the use of Buprenorphine / Naloxone Mylan, especially if the medicine is used incorrectly. These liver damages can also be due to viral infections ( chronic hepatitis C), alcohol abuse, anorexia, or the use of other drugs that can damage the liver (see 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 Mylan.
  • 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 Mylan

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 Mylan and may in some cases cause very serious reactions. Do not take other medicines while taking Buprenorphine / Naloxone Mylan without first talking to a doctor, especially:

  • Concomitant use of Buprenorphine / Naloxone Mylan with sedatives, such as benzodiazepines (used to treat anxiety or sleep disorders) 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 by your doctor when other treatment options are not possible. If your doctor prescribes Buprenorphine / Naloxone Mylan at the same time as sedatives, the dose should be limited and the treatment time should be limited by your doctor. Tell your doctor about all sedative medications you are taking and carefully follow your doctor’s dose recommendations. It can be good to inform friends or relatives about the risks described above. Contact a doctor if you experience any of these symptoms.
  • Other medications that can make you feel sleepy are used to treat illnesses such as anxiety, insomnia, seizures, or pain. These types of medications reduce your alertness, which can make driving vehicles and using machines 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 Mylan. They 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 Mylan. They should not be taken with Buprenorphine / Naloxone Mylan treatment 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, doxepine, or trimipramine. These medicines can interact with Buprenorphine / Naloxone Mylan and you may experience symptoms such as involuntary, rhythmic contractions of muscles, including muscles that control eye movements, agitation, hallucinations, coma, excessive sweating, tremors, exaggeration of reflexes, increased muscle temperature, 38 ° C. Contact your doctor when you experience such symptoms.

Buprenorphine / Naloxone Mylan with food, drink, and alcohol

Alcohol may increase drowsiness and increase the risk of respiratory depression if ingested with Buprenorphine / Naloxone Mylan. Do not take Buprenorphine / Naloxone Mylan 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 Mylan 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 Mylan 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 Mylan passes into breast milk.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Buprenorphine / Naloxone Mylan 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 Mylan. Do not drive, use tools or machines, or perform dangerous activities until 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 attention. 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 Mylan 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 (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.

How to take Buprenorphine / Naloxone Mylan

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 15 years of age is one to two buprenorphine / Naloxone Mylan 2 mg / 0.5 mg resoriblets. One or more buprenorphine / Naloxone Mylan 2 mg / 0.5 mg resoriblets may be given on the first day, depending on your needs.

Clear signs of abstinence should be apparent before taking the first dose of Buprenorphine / Naloxone Mylan. The doctor’s assessment of how ready you are for treatment determines when you should receive the first dose of one with Buprenorphine / Naloxone Mylan.

  • Initial treatment with Buprenorphine / Naloxone Mylan under heroin addiction you are addicted to heroin or a short-acting opioid, the first dose of Buprenorphine / Naloxone Mylan should be taken when signs of abstinence occur, but not earlier than 6 hours after the last opioid use.
  • Initial treatment with Buprenorphine / Naloxone Mylan under methadone dependence you have taken methadone or a long-acting opioid, the methadone dose should preferably be reduced to below 30 mg/day before starting treatment with Buprenorphine / Naloxone Mylan. The first dose of Buprenorphine / Naloxone Mylan 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 Mylan

  • 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 Mylan according to your needs. If you have the impression that the effect of Buprenorphine / Naloxone Mylan 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 can agree with your doctor to gradually reduce the dose to a lower maintenance dose.

End of treatment

Depending on your condition, you can continue to reduce the dose of Buprenorphine / Naloxone Mylan under close medical supervision until it can be completely 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 Mylan 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 an overdose of Buprenorphine / Naloxone Mylan can cause serious and life-threatening breathing problems.

If you forget to take Buprenorphine / Naloxone Mylan

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

If you stop taking Buprenorphine / Naloxone Mylan

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).

Side effects have been reported for Buprenorphine / Naloxone Mylan

Very common (may affect more than 1 user in 10):

Insomnia (inability to sleep), constipation, nausea, heavy 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 sex drive, increased muscle tension, abnormal thoughts, increased tear flow (watery eyes) or other disturbance of tear flow, blurred vision, hot flashes, high blood pressure, migraine, running nose, sore throat and pain when swallowing, increased cough, upset stomach or other stomach problems, diarrhea, hepatic impairment, flatulence, vomiting, rash, itching, hives, aches, 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 (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 lumps, hair loss, dry or scaly skin, joint inflammation, urinary tract infection, abnormal blood test results, 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 the unknown number of users):

Sudden withdrawal syndrome caused by the Buprenorphine / Naloxone Mylan taken early after use of unauthorized opioid s, drug withdrawal syndrome of the newborn. Slow breathing or difficulty breathing, liver damage 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 Mylan

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 Mylan 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 sublingual resoriblett contains 2 mg buprenorphine (as hydrochloride) and 0.5 mg naloxone (as hydrochloride dihydrate).Each 8 mg / 2 mg sublingual resorblett 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), citric acid monohydrate, sodium citrate, magnesium stearate, acesulfame potassium, lemon flavor (contains: flavors, maltodextrin, acacia gum), lime acacia, lime acacia.

What the medicine looks like and the contents of the pack

Buprenorphine / Naloxone Mylan are white to off-white, round and biconvex tablets, with a notch on one side. The tablet can be divided into two equal doses.

The tablets are packaged in blister packs in cartons containing 7 or 28 tablets or in single-dose blisters containing 7 x 1 tablets or 28 x 1 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan AB

Box 23033

104 35 Stockholm

Manufacturer

GL Pharma GmbH 
Schlossplatz 1, 8502 Lannach, Austria

Muhammad Nadeem

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