Buprenorphine 2 mg. 7 tablets
Buprenorphine Actavis is a medicinal product used in opioid dependence (drugs).
Actavis buprenorphine sublingual tablets are used as part of the medical, social and psychological treatment of patients addicted to opiates (drugs). Sublingual tablet is a tablet which should be placed under the tongue and allow to dissolve.
Treatment is appointed and supervised by a physician experienced in the treatment of drug dependence.
Treatment with Buprenorphine sublingual tablets Actavis is intended for adults and adolescents over 15 years.
2. BEFORE YOU TAKE buprenorphine Actavis
Do not take Buprenorphine Actavis
if you are allergic (hypersensitive) to buprenorphine or any of the other ingredients of Buprenorphine Actavis (see. section 6 for a list of excipients);
If you have severe breathing problems;
If you have severe liver problems;
if you suffer from alcohol intoxication or have delirium tremens (tremors and hallucinations).
Tell your doctor if you have any of the following conditions before starting treatment or if you develop them during treatment, as may be necessary for your doctor to reduce the dose of Buprenorphine Actavis or you may need additional treatment to control them :
Asthma or other breathing problems;
Problems with liver or kidneys. If you suffer from severe liver disease should not take buprenorphine;
Head injury or brain disease;
Low blood pressure;
Prostatic enlargement, which may make it difficult urination;
Difficulty urinating due to narrowing of the urethra (urethral stenosis).
Misuse and abuse
Abuse, especially by injection at high doses is dangerous and can be fatal.
Have been reported deaths from respiratory failure (breathing stops) because they misused buprenorphine or took it in combination with depressing effect on the central nervous system such as alcohol, benzodiazepines (medicines used to treat anxiety or sleep disorders) or other opiates.
Cases of acute hepatic injury (liver problems) by misuse, especially by intravenous route and at high doses. Damage may be in connection with certain diseases such as viral infections (chronic C hepatitis), alcohol abuse, anorexia, or in connection with the intake of drugs (eg antiretroviral nucleoside analogues, acetylsalicylic acid (aspirin), amiodarone, isoniazid, valproate ). If you experience symptoms of severe fatigue, no appetite, itching or yellowing of the skin and eyes, immediately tell your doctor, to appropriate treatment.
This medicine can cause:
development of withdrawal symptoms if you take more than 6 hours after the last dose of drug (eg. morphine, heroin or other similar products) or more than 24 hours after administration of methadone;
drowsiness, which may be increased by alcohol or drugs, anti-anxiety. If you are drowsy, do not drive or operate machinery;
a sharp drop in blood pressure, resulting in feel dizzy upon standing;
positive reaction to "anti-doping tests" (athletes need to know).
Buprenorphine Actavis may mask the accompanying pain in some diseases. If you are taking this product, be sure to consult with your doctor.
The risk of serious side effects is greater if you take drugs, alcohol, sedatives and sleeping drugs, particularly benzodiazepines.
Discontinuation of treatment may result in a withdrawal syndrome.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Before taking Buprenorphine Actavis, you should inform your doctor if you are taking any of the following medications:
benzodiazepines and other medicines used to treat anxiety or sleep disorders. If your doctor prescribes benzodiazepines, you must not take a dose higher than prescribed. Buprenorphine Actavis with benzodiazepines may cause death due to respiratory failure;
other drugs with sedative properties, including sedating antihistamines, some antidepressants and clonidine (for the treatment of high blood pressure, migraine, menopausal flushing);
strong painkillers (opioid analgesics) and cough medicines containing similar opioid substances such as methadone, dextropropoxyphene, codeine, dextromethorphan and noscapine;
barbiturates and other medicines used to treat sleep disorders, anxiety, or exemption from convulsions;
monoamine oxidase inhibitors (a type of antidepressant);
gestodene (oral contraceptives);
drugs for the treatment of HIV / AIDS (protease inhibitors), including indinavir, ritonavir, nelfinavir, and saquinavir;
antiepileptic (anticonvulsant) drugs including phenobarbital, carbamazepine and phenytoin;
antibiotic medicines, including rifampicin, erythromycin and troleandomycin;
antifungals including ketoconazole and itraconazole.
Buprenorphine Actavis with food and drink
Do not drink alcohol while being treated with buprenorphine. Alcohol increases the sedative effect of buprenorphine, which can make driving and operating machinery dangerous.
Pregnancy and lactation
Ask your doctor or pharmacist before taking any medicine.
Before taking Buprenorphine Actavis, tell your doctor if you are pregnant or intend to become pregnant. If during treatment with Buprenorphine Actavis pregnant, contact your doctor immediately.
Buprenorphine Actavis should be used during pregnancy only if the benefits outweigh the possible risks.
There was neonatal abstinence, including respiratory depression after treatment of mothers in the latter part of pregnancy. Your doctor will decide whether you should be treated with Buprenorphine Actavis.
Since this product will pass into breast milk and may lead to the development of adverse reactions in nursing infants, you should stop breastfeeding while taking Buprenorphine Actavis.
Driving and using machines
Buprenorphine can cause drowsiness. If you feel tired, do not drive or operate machinery.
Important information about some of the ingredients of Buprenorphine Actavis
Buprenorphine Actavis contains lactose (a type of sugar). If your doctor has said that you have an intolerance to some sugars, before you start taking this medicine, contact your doctor.
Actavis 2 mg buprenorphine and buprenorphine Actavis 8 mg sublingual tablets also contain the colorant sunset yellow (E110) which may cause allergic reactions.
3. HOW TO TAKE buprenorphine Actavis
Method of administration
Always take Buprenorphine Actavis exactly as your doctor has told your doctor or pharmacist. You should consult with your doctor or pharmacist if you are unsure.
Tablets are administered sublingually. This means that you need to place the tablet under your tongue and let it dissolve. This is the only way that the tablets should be taken. Do not chew or break the tablets, do not swallow whole, as they will not operate properly and may experience withdrawal symptoms.
Take the dose once a day, unless otherwise prescribed by your doctor.
Your doctor will determine the best dose for you. During treatment, your doctor may adjust your dose depending on how you respond to treatment. To maximize the benefits of buprenorphine Actavis, you should tell your doctor about all medicines you are taking, including alcohol, medicines containing alcohol, drugs, and any other drugs that are not prescribed by your doctor .
After the first dose Buprenorphine Actavis is possible to develop opiate withdrawal symptoms, see section 4 'POSSIBLE SIDE EFFECTS'.
Reduced renal or hepatic function:
If you have problems with your kidneys or liver, you may need your dosage to be reduced. Discuss with your doctor. If you suffer from severe liver disease should not take Buprenorphine Actavis.
[Only for blister packs, protected from children:]
Instructions for use of blister packs, protected children:
1. Do not attempt to remove the tablet by direct pressing.
2. Separate one blister cell from the strip following the perforations.
3. Carefully peel off the top with the arrow.
4. Remove the tablet as drill foil.
5. Place the tablet under your tongue.
Duration of treatment
The duration of treatment will be determined individually by your doctor. After a period of retention of successful treatment, your doctor may gradually reduce your dose to a lower maintenance dose. Depending on your condition, reducing the dose of Buprenorphine Actavis can continue close monitoring until eventually it may be stopped.
Do not change the treatment in any way or stop treatment without the consent of the doctor who is treating you.
The effectiveness of this treatment depends on the dose of the joint implementation of medical, psychological and social treatment.
If you have the impression that the effect of Buprenorphine Actavis is too strong or too weak, talk to your doctor or pharmacist.
Use in children and adolescents
Buprenorphine Actavis should not be used in children and adolescents below 15 years due to lack of data on safety and efficacy.
If you take more dose Buprenorphine Actavis
In case of overdose of buprenorphine Actavis must go or be taken immediately to an emergency room or hospital to be treated. Immediately consult your doctor or pharmacist. Symptoms of overdose may include difficulty in breathing, slow breathing or cardiac symptoms. After misuse (overdose or wrong administration) had toxic poisoning, it can result in the worst case, to respiratory arrest, heart failure and / or liver damage.
If you forget to take Buprenorphine Actavis
Contact your doctor if you forget to take Buprenorphine Actavis.
Do not take a double dose to make up for a missed dose unless your doctor instructs you to do so.
If you stop taking Buprenorphine Actavis
Should not suddenly stop taking Buprenorphine Actavis, as this may cause withdrawal symptoms (sweating, anxiety and restlessness). Do not stop the treatment yourself and talk to your doctor about how it can be stopped.
If you have other questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Buprenorphine Actavis can cause side effects, although not everybody gets them.
If you develop symptoms of severe allergic reactions (such as difficulty breathing, wheezing and swelling of the eyes, lips, throat, tongue or hands), seek medical advice immediately.
Abuse by injection, this drug can cause withdrawal symptoms, infections, other skin reactions and potentially serious liver problems - see "Take special care when taking Buprenorphine Actavis".
After the first dose Buprenorphine Actavis can develop opiate withdrawal symptoms, see section 3 "HOW TO TAKE buprenorphine Actavis".
The frequency of adverse reactions listed below is defined using the following convention:
Very common: affects more than 1 in 10;
Common: affects 1 to 10 patients in 100;
Uncommon: affects 1 to 10 patients in 1000;
Rare: affects 1 to 10 patients in 10,000;
Very rare: affects less than 1 in 10,000;
Not known: frequency can not be estimated from the available data.
Very common side effects:
general feeling of weakness;
Common side effects:
drop in blood pressure when standing up from a sitting or lying down;
Uncommon side effects:
severe breathing difficulties (respiratory depression);
liver problems with or without jaundice;
death of liver cells (liver necrosis).
Very rare side effects:
Reported allergic hypersensitivity reactions. Symptoms may include skin rash, urticaria and pruritus.
If any of the side effects gets serious, or if you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE buprenorphine Actavis
Keep out of reach of children.
Do not use Buprenorphine Actavis after the expiry date stated on the carton, blister pack and label after "EXP". The expiry date refers to the last day of that month.
Blister packs: Do not store above 25 ° C. Store in the original package in order to protect from moisture.
Packaging for tablets: Do not store above 30 ° C. Keep container tightly closed in order to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unused medicine. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Buprenorphine Actavis
The active substance is buprenorphine (as buprenorphine hydrochloride).
Each tablet contains 0,4 mg, 2 mg or 8 mg buprenorphine.
Excipients are: magnesium stearate, sodium citrate, povidone, anhydrous citric acid, pregelatinized starch (maize) and lactose monohydrate.
Actavis 2 mg buprenorphine and buprenorphine Actavis 8 mg sublingual tablets also contain crospovidone, mannitol and sunset yellow (E110).
Buprenorphine Actavis looks like and contents of the pack
Actavis 0,4 mg buprenorphine sublingual tablets are uncoated, white or almost white, 6 mm round and flat labeled "B" on one side.
Buprenorphine Actavis 2 mg sublingual tablets are uncoated, pale orange, 5x8 mm oval biconvex and marked "B" on one side.