Buprenorphine 2 mg. 7 tablets

WHAT buprenorphine Actavis IS AND WHAT IT IS USED
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 that you need to put 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 ingredients);
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 these 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;
Enlarged prostate gland, which may make it difficult urination;
Difficulty urinating due to narrowing of the urethra (urethral stenosis).
Misuse and abuse
Abuse, especially by injecting at high doses is dangerous and can be fatal.
There have been reports of 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.
There have been reports of acute hepatic injury (liver problems) if misused, especially when administered intravenously and in high doses. Damage may be in connection with certain diseases such as viral infections (chronic hepatitis C), alcohol abuse, anorexia, and in conjunction with medications (eg antiretroviral nucleoside analogues, acetylsalicylic acid (aspirin), amiodarone, isoniazid, valproate ). If you experience symptoms such as severe fatigue, no appetite, itching or yellowing of the skin and eyes, immediately tell your doctor about to start 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 taking methadone;
drowsiness, which can be reinforced when alcohol intake or medications, anti-anxiety. If you are drowsy, do not drive or operate machinery;
a sharp drop in blood pressure, resulting in feel dizzy upon standing;
drug addiction;
positive reaction to "anti" tests (athletes must know).
Buprenorphine Actavis may mask the accompanying pain in some diseases. If you are taking this medicine, be sure to consult with your doctor.
The risk of serious side effects is greater if you take drugs, alcohol, tranquilizers and sleeping medications, especially 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 drugs used to treat anxiety or sleep disorders. If your doctor prescribes benzodiazepines, you should not take a dose higher than prescribed. Actavis buprenorphine 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);
antipsychotic drugs;
gestodene (oral contraceptive);
medicines to treat 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;
including antifungal drugs ketoconazole and itraconazole.
Taking Buprenorphine Actavis with food and drink
Do not drink alcohol while being treated with buprenorphine. Alcohol enhances 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.

pregnancy
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 withdrawal symptoms, 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.

breastfeeding
Since this product passes 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 told you have an intolerance to some sugars before you start taking this medicine, contact your doctor.
Buprenorphine Actavis 2 mg and buprenorphine Actavis 8 mg sublingual tablets also contain the colourant 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 check with your doctor or pharmacist if you are unsure.
Tablets are administered sublingually. This means that you should 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 crush the tablets, swallow them whole, because they will not work correctly and you may get withdrawal symptoms.
Take the dose once a day, unless otherwise prescribed by your doctor.
Your doctor will determine the best dose for you. During your treatment, your doctor may adjust your dose depending on how you respond to treatment. To maximize the benefits of taking 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 may develop symptoms of 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 dose should be reduced. Discuss with your doctor. If you suffer from severe liver disease should not take Buprenorphine Actavis.

[For blister packs, protected children:]
Instructions for use of blister packs protect children:
1. Do not attempt to remove the tablet by direct touch.
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 holding period 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 careful monitoring until it may be stopped.
Do not change your treatment in any way or stop treatment without the consent of the doctor who is treating you.
The efficacy of this treatment depends on the dose, the joint conduct 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 where you are being treated. Immediately consult your doctor or pharmacist. Symptoms of overdose may include breathing difficulties, slow breathing or heart 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 this.

If you stop taking Buprenorphine Actavis
Should not suddenly stop taking Buprenorphine Actavis, as this can cause withdrawal symptoms (sweating, anxiety and restlessness). Do not stop treatment on their own, but consult your doctor 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 may develop symptoms of opiate withdrawal symptoms, see section 3 'HOW TO TAKE buprenorphine Actavis. "

The incidence 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:
insomnia;
general feeling of weakness;
withdrawal.
Common side effects:
headache;
fainting;
dizziness;
anxiety;
nervousness;
constipation;
nausea;
vomiting;
diarrhea;
tummy ache;
fever;
drowsiness;
drop in blood pressure when standing up from a sitting or lying position;
sweating;
back pains;
chills;
abnormal electrocardiogram.
Uncommon side effects:
hallucinations;
severe difficulty in breathing (respiratory depression);
liver problem, with or without jaundice;
death of liver cells (liver necrosis).
Very rare side effects:
Reported allergic hypersensitivity reactions. Symptoms may include skin rash, hives and itching.
If any of the side effects gets serious, or 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 container 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 in 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.
Buprenorphine Actavis 2 mg and buprenorphine Actavis 8 mg sublingual tablets also contain crospovidone, mannitol and sunset yellow (E110).