Buprenorfin Alkaloid 2 mg and 8 mg sublingual tablets – treatment of opioid dependence

Buprenorfin Alkaloid are sublingual tablets (placed under the tongue) containing buprenorphine hydrochloride equivalent to 2 mg or 8 mg buprenorphine. Buprenorphine is an opioid used as substitution treatment in dependence on opioids such as heroin or morphine.

The medicine is intended for adults and adolescents over 16 years who have agreed to be treated for dependence, as part of medical, social and psychological treatment. It is classed as a narcotic and is dispensed only on a prescription in duplicate.

How does Buprenorfin Alkaloid work and how is it used correctly in the treatment of opioid dependence?

Key facts about the medicine

What is Buprenorfin Alkaloid used for?

Buprenorfin Alkaloid is used to treat dependence on opioids (narcotics) such as heroin or morphine in drug users who have agreed to be treated. It is used in adults and adolescents over 16 years as part of comprehensive medical, social and psychological treatment.

How is it used and dosed?

• The tablet is placed under the tongue and kept there until it has completely dissolved (about 5–10 minutes). This is the only way to take it – the tablets must not be chewed or swallowed whole, as they will then not work.
• Do not eat or drink until the tablet has completely dissolved.
• Treatment is started when clear signs of withdrawal are already present, so as not to trigger withdrawal.

This is the general dosage from the package leaflet – your doctor sets and monitors your dose.

Special patient groups

• Children and adolescents under 16 years: the medicine must not be used.
• Over 65 years: safety and efficacy have not been established; opioids should be used with caution in elderly and debilitated patients.
• Liver impairment: contraindicated in severe liver problems; the doctor may request regular blood tests.
• Kidney impairment: caution when dosing in severe impairment (creatinine clearance below 30 mL/min).

Contraindications – when the medicine must not be used

• hypersensitivity to buprenorphine hydrochloride or the excipients
• age under 16 years
• severe breathing problems
• severe liver problems
• alcohol intoxication or delirium tremens
• breast-feeding

Warnings and precautions

• Tell your doctor if you have asthma or other breathing problems, liver or bile duct disease, low blood pressure, a recent head injury or epileptic seizures, difficulty passing urine (e.g. with an enlarged prostate), kidney, thyroid or adrenal disease (e.g. Addison's disease).
• Misuse (especially intravenous) can cause severe infections that may be fatal; keep the medicine in a safe place and do not give it to others.
• Fatal respiratory failure has occurred with misuse or in combination with alcohol, benzodiazepines or other opioids.
• The medicine can cause dependence, as well as withdrawal symptoms if taken too soon after another opioid or if stopped suddenly.
• Cases of liver damage have been reported, especially with misuse – the doctor may monitor liver function.
• A sudden drop in blood pressure on standing and masking of pain that points to other diseases are possible.
• The medicine contains lactose monohydrate.

Interactions with other medicines, food and drink

• benzodiazepines and other sedatives – risk of drowsiness, respiratory depression, coma and death; combine only if other treatment is not possible, with limited dose and duration
• other opioids (methadone, some painkillers and cough medicines), some antidepressants (MAO inhibitors), sedating antihistamines (diphenhydramine, chlorphenamine), barbiturates, chloral hydrate
• naltrexone – may block the effect and cause sudden, intense withdrawal
• clonidine, ritonavir, nelfinavir, indinavir, ketoconazole, itraconazole and some antibiotics (erythromycin, clarithromycin, azithromycin) – may increase or prolong the effect
• carbamazepine, phenytoin and rifampicin – may reduce the effect
• Alcohol: do not drink during treatment – it increases drowsiness and the risk of respiratory arrest.

Pregnancy and breast-feeding

If you are pregnant or planning a pregnancy, consult your doctor before use. Use in pregnancy, especially in the last trimester, can cause withdrawal syndrome in the newborn (breathing problems, muscle tension, trembling, spasms, convulsions), which may appear several days after birth. You must not breast-feed during treatment, as the medicine passes into breast milk.

Driving and using machines

Buprenorphine may cause drowsiness, dizziness and impaired thinking, especially with alcohol or tranquillisers. The medicine is a narcotic and has a strong effect on psychophysical abilities – driving motor vehicles and operating machinery are not allowed during treatment.

Possible side effects

• Very common: withdrawal syndrome, headache, increased sweating, insomnia, nausea, pain.
• Common: abdominal pain, agitation, anxiety, joint, back, bone and muscle pain, weakness, bronchitis, chest pain, chills, constipation, cough, reduced appetite, depression, diarrhoea, dizziness, dry mouth, painful periods, indigestion, shortness of breath, bloating, nervousness, watery eyes, swollen lymph nodes, migraine, muscle cramps, dilated pupils, palpitations, paranoia, tingling in the hands and feet, swelling, sore throat, fever, rash, drowsiness, fainting, abnormal thinking, flushing, vomiting, yawning.
• Not known: drug dependence, neonatal withdrawal syndrome; hallucinations, a fall in blood pressure on standing up quickly and difficulty passing urine have also been reported.
• Contact your doctor immediately with severe exhaustion, loss of appetite or yellowing of the skin and eyes (possible liver damage).

Report suspected side effects to your doctor, pharmacist or ALIMS.

Overdose, missed dose and stopping treatment

• In case of overdose go to hospital or emergency services immediately – serious, life-threatening breathing problems, extreme drowsiness, reduced vision, pinpoint pupils, low blood pressure, nausea, vomiting and slurred speech may occur.
• Missed dose: tell your doctor as soon as possible and follow their instructions; do not take a double dose.
• Do not change treatment or stop without your doctor's agreement – stopping suddenly causes withdrawal.

Related information

We do not list a product category for this medicine: treatment of opioid dependence is carried out only under medical supervision, and calming and sleep products may increase drowsiness and the risk of breathing problems with buprenorphine. Please ask your doctor or pharmacist with any questions.

Composition, pack and manufacturer

• Active substance: buprenorphine 2 mg or 8 mg (as buprenorphine hydrochloride) per sublingual tablet.
• Excipients: lactose monohydrate, mannitol, maize starch, anhydrous citric acid, sodium citrate, povidone K30, sodium stearyl fumarate.
• Pack: Al/PVC blisters of 7 tablets; carton with 1 blister (7 tablets) or 4 blisters (28 tablets) and package leaflet.
• Marketing authorisation holder: ALKALOID D.O.O. BEOGRAD, Prahovska 3, Belgrade. Manufacturer: Alkaloid AD Skopje, Bulevar Aleksandar Makedonski 12, Skopje, North Macedonia.

Storage

• No special temperature storage conditions; store in the original package to protect from light and moisture.
• Shelf life: 2 years.
• Store in a safe place, out of the sight and reach of children and protected from theft. Return unused medicine to a pharmacy that collects unused medicines.

Frequently asked questions

Why must the tablet not be swallowed?

Buprenorfin Alkaloid is absorbed through the lining under the tongue. If the tablet is chewed or swallowed it will not work – so keep it under the tongue until it has completely dissolved.

When is the first dose taken?

When clear signs of withdrawal are already present – no earlier than 6 hours after the last use of a short-acting opioid, or at least 24 hours after the last methadone dose.

Can I drink alcohol or take tranquillisers?

Not alcohol – it increases drowsiness and the risk of respiratory arrest. Tranquillisers (e.g. benzodiazepines) only if prescribed by a doctor who knows you take buprenorphine, with limited dose and duration.

What if I stop taking the medicine suddenly?

Stopping suddenly can cause withdrawal. The doctor reduces the dose gradually, under medical supervision, until treatment is stopped completely.

Sources

• ALIMS – Summary of Product Characteristics Buprenorfin Alkaloid®, 2 mg and 8 mg, sublingual tablets (2 mg document, Serbian)
• ALIMS – Package leaflet Buprenorfin Alkaloid®, 2 mg and 8 mg, sublingual tablets (August 2020, Serbian)
• ALIMS – Summary of Product Characteristics Buprenorfin Alkaloid®, 8 mg, sublingual tablets (Serbian)
• ALIMS – Package leaflet Buprenorfin Alkaloid®, 8 mg, sublingual tablets (August 2020, Serbian)

Sources checked on: 24 October 2026.