2 mg, 4 mg and 8 mg resoriblett, sublingual 
buprenorphine

What Buprenorphine GL Pharma is and what it is used for

Buprenorphine GL Pharma contains the active substance Buprenorphine which is an opiate-like narcotic drug ( opioid ) and also has analgesic properties.

Buprenorphine is used only as voluntary replacement therapy in patients aged 18 years or older who are addicted to opiate-like drugs (eg heroin) and who have agreed to treatment for their addiction.

Buprenorphine is part of a comprehensive and supervised medical, social and psychological treatment program.

Buprenorphine contained in Buprenorphine GL Pharma may also be approved for the treatment of other conditions not mentioned in this leaflet. 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 GL Pharma

Do not take Buprenorphine GL Pharma

  • if you are allergic to buprenorphine or any of the other ingredients of this medicine (listed in section 6).
  • if you are taking monoamine oxidase (MAO) inhibitors (medicines used to treat depression) or have been taking them for the last 2 weeks
  • if you have severe breathing problems
  • if you have serious problems with your liver
  • if you are an alcoholic and / or have delirium tremens .

Warnings and cautions

You can start treatment with Buprenorphine only if you have discussed the treatment conditions in detail with a specially trained doctor or if you have evidently agreed to them (if you have signed a replacement treatment agreement).

Tell your doctor if you have any of the following diseases or if you develop them during treatment with Buprenorphine:

  • head injuries and increased pressure in the skull
  • seizures ( epilepsy )
  • low blood pressure
  • enlarged prostate and narrowing of the ureter
  • asthma or severe breathing problems
  • kidney failure
  • liver failure
  • depression or other conditions treated with antidepressants.If these medicines are used together with Buprenorphine GL, this may lead to serotonergic syndrome, a condition which can be life threatening (see “Other medicines and Buprenorphine GL”).

If necessary, your doctor will reduce the dose of Buprenorphine or start appropriate treatment for this disease. Your doctor will decide what type of adjustment is necessary.

If pain develops during treatment, consult your doctor. He / she will take appropriate action.

Get regular check- ups recommended by your doctor (eg urine tests). They benefit your own safety and ensure effective treatment.

Buprenorphine can cause addiction . Buprenorphine does not eliminate residual dependence on other addictive drugs.

Athletes should be aware that this drug may give positive results in doping tests .

Other medicines and Buprenorphine GL Pharma

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

Interaction can occur with:

  • benzodiazepines (medicines used to treat anxiety and sleep disorders). Intake with Buprenorphine can lead to respiratory failure and can also be fatal , especially with concomitant alcohol consumption.
  • MAO inhibitors . Taking MAO inhibitors within 14 days of taking Buprenorphine may lead to life-threatening breathing difficulties and circulatory disorders.
  • other sedatives and hypnotics as well as anti- anxiety drugs
  • medicines for cough
  • antidepressants (antidepressants) such as moclobemide, tranylcypromine, citalopram , escitalopram, fluoxetine , fluvoxamine, paroxetine , sertraline , duloxetine, venlafaxine , amitriptyline, doxepine or trimipramine. These medicines can affect or be affected by Buprenorphine GL 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, intensified reflexes, tense muscles and body temperature above 38 ° C. . Contact your doctor if you experience such symptoms.
  • medicines for high blood pressure
  • strong painkillers. Buprenorphine may reduce their effect.
  • blood-thinning drugs
  • substances that are metabolised via special enzymes (CYP) in the liver. This is especially medicines for the treatment of fungal diseases or HIV – infection .

Concomitant use of Buprenorphine GL Pharma and sedatives or medicines for insomnia 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 GL Pharma at the same time as sedatives, dose one 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 recommendations. It may be helpful to inform friends or relatives about paying attention to the signs and symptoms described above. Contact a doctor if you experience any of these symptoms.

If you have been treated with methadone or other medicines as a replacement therapy before switching to Buprenorphine, your doctor will give you appropriate dosing recommendations for both medicines.

Buprenorphine GL Pharma with alcohol

During treatment with Buprenorphine you must not drink alcoholic beverages or take medicines that contain alcohol.

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 or pharmacist for advice before taking this medicine.

There are not enough data available to evaluate the harmful effects of Buprenorphine during pregnancy. High doses at the end of pregnancy can cause breathing problems in the newborn baby.

Prolonged intake of Buprenorphine during the last three months of pregnancy may cause withdrawal symptoms in the newborn. Therefore , Buprenorphine is not recommended during pregnancy.

The baby ingests Buprenorphine via breast milk. You should not take Buprenorphine if you are breast-feeding .

Driving and using machines

This medicine may impair your ability to react and your ability to drive. Discuss with your doctor if you can drive or use machines.

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 GL Pharma contains lactose . If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How to take Buprenorphine GL Pharma

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

This medicine should only be taken by mouth, and should not be injected.

DOSAGE

Your doctor will determine the appropriate dose for you.

For this purpose, there are different strengths of the drug. Your doctor will adjust the dose to suit your individual needs during treatment. You must not change the doseon your own.

The effect of this treatment depends on the dose one and the accompanying medical, psychological and social support.

Talk to your doctor if you think the effect of Buprenorphine is too strong or too weak.

METHOD OF ADMINISTRATION

Place the tablet under the tongue until it has dissolved. This is the only way to take Buprenorphine. You must not swallow the tablet, as it will lose its effect if you do. Hold the tablet under the tongue until it has completely dissolved  (5 to 10 minutes).

You can take the tablets at any time of the day.

To reduce the risk of addiction, it is recommended that the daily intake be monitored at the doctor’s surgery or at the pharmacy .

You must not dissolve and inject the tablets, as this can lead to severe side effects with a risk of fatal outcome (breathing problems, severe liver damage) and severe reactions, as well as infection at the injection site.

DURATION OF TREATMENT

The duration of treatment is determined individually by your doctor.

After a period of successful treatment, your doctor may gradually reduce the dose to a lower maintenance dose . Depending on your condition, the dose of Buprenorphine may continue to be reduced under close medical supervision until it can eventually be discontinued.

If you take more Buprenorphine GL Pharma than you should

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital or poison information center (tel. 112) for risk assessment and advice.

Buprenorphine overdose requires immediate medical attention in hospital. Therefore, contact a doctor or ask someone to contact a doctor immediately.

The main sign of buprenorphine overdose is very heavy breathing ( respiratory depression ), which can even lead to respiratory arrest and death.

If you forget to take Buprenorphine GL Pharma

Do not take a double dose to make up for a forgotten dose, but contact your doctor.

If you stop taking Buprenorphine GL Pharma

Do not change the treatment on your own and do not stop the treatment without your doctor’s consent. If you stop treatment, you may experience 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.

Contact a doctor immediately if you get the following symptoms:

  • severe fatigue
  • yellowing of eyes and / or skin.

This can be a sign of severe liver disorders that can occur in particular in connection with addiction, viral infections, low food intake, alcohol abuse and intake of drugs that can damage the liver (such as acetylsalicylic acid ).

Other side effects ar

Common (may affect up to 1 in 10 people):

headache, fainting, dizziness, constipation, nausea, vomiting, drop in blood pressure after getting up quickly from a sitting or lying position, insomnia, feeling weak, drowsiness, sweating.

Rare (may affect up to 1 in 1,000 people):

severe allergic reactions such as painful swelling of the skin and mucous membranes or shock , hallucinations, severe breathing problems (see also section “Warnings and precautions”), liver damage (see also section “Warnings and precautions”), hepatitis, allergic reactions such as skin rash, hives and itching .

Withdrawal symptoms may occur after the first dose , but also if you have taken Buprenorphine less than 4 hours after taking addictive drugs (morphine, heroin, etc.) or less than 24 hours after the last dose of methadone, as Buprenorphine may partially cancel out the effect. of these substances. Buprenorphine does not eliminate persistent opiate dependence.

Buprenorphine can also cause addiction .

Abuse in the form of intravenous injection can cause reactions and sometimes even infection at the injection site as well as severe acute hepatitis.

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. Postal address

5. How to store Buprenorphine GL Pharma

Keep this medicine out of the sight and reach of children.

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

Do not store above 30 ° C.

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

Buprenorphine GL Pharma 2 mg resoriblett, sublingual:

The active substance is buprenorphine. 

Each travel tablet contains 2.16 mg of buprenorphine hydrochloride equivalent to 2 mg of buprenorphine.

The other ingredients are lactose monohydrate , mannitol, corn starch, povidone (K = 27.0‑32.4), citric acid monohydrate, sodium citrate, magnesium stearate.  

Buprenorphine GL Pharma 4 mg resoriblett, sublingual:

Each travel tablet contains 4.32 mg buprenorphine hydrochloride equivalent to 4 mg buprenorphine.

The other ingredients are lactose monohydrate , mannitol, corn starch, povidone (K = 27.0‑32.4), citric acid monohydrate, sodium citrate, magnesium stearate.  

Buprenorphine GL Pharma 8 mg resoriblett, sublingual:

One travel tablet contains 8.64 mg buprenorphine hydrochloride equivalent to 8 mg buprenorphine.

The other ingredients are lactose monohydrate , mannitol, corn starch, povidone (K = 27.0-32.4), citric acid monohydrate, sodium citrate, magnesium stearate.  

What the medicine looks like and contents of the pack

Buprenorphine GL Pharma 2 mg resoriblett, sublingual , is a white, oval, flat tablet with bevelled edges, 10 mm long and 5 mm wide.

Buprenorphine GL Pharma 4 mg travel tablet, sublingual are white, oval, flat tablets with bevelled edges and a notch on both sides, 12 mm long and 6 mm wide.

The notch is not intended to break the tablet.

Buprenorphine GL Pharma 8 mg travel tablet, sublingual are white, oval, flat tablets with bevelled edges and a notch on both sides, 14 mm long and 7 mm wide.

The notch is not intended to break the tablet.

Buprenorphine GL Pharma travel tablet, sublingual , is available in blister packs of 7, 10, 28, 30 and 49 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

GL Pharma GmbH, Schlossplatz 1, 8502 Lannach, Austria

Local representative

Nordic Drugs AB

Box 300 35

200 61 Limhamn

Sweden

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

Germany: Buprenorphine GL 2/4/8 mg Sublingual tablet

Bulgaria: Buprenorphine GL 2/4/8 mg tablet tablet

Estonia: Buprenorphine GL Pharma

Latvia: Buprenorphine GL Pharma 2/4/8 mg tablet tablets

Lithuania: Buprenorphine GL Pharma 2/4/8 mg tablets

Sweden: Buprenorphine GL Pharma 2/4/8 mg resoriblett, sublingual

Muhammad Nadeem

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