2 mg and 8 mg sublingual resoriblets
Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.
- Save this leaflet, you may need to read it again.
- If you have any further questions, ask your doctor, pharmacist or nurse.
- 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, pharmacist or nurse. This also applies to any side effects not mentioned in this information. See section 4.
In this leaflet:
1. What Buprenorphine Orifarm is and what it is used for
2. What you need to know before you take Buprenorphine Orifarm
3. How to take Buprenorphine Orifarm
4. Possible side effects
5. How to store Buprenorphine Orifarm
6. Package contents and other information
What Buprenorphine Orifarm is and what it is used for
Buprenorphine Orifarm is indicated for the treatment of drug addicts who are addicted to opiate drugs, such as heroin or morphine.
Buprenorphine Orifarm reduces withdrawal symptoms in patients addicted to opioids and reduces the craving for these drugs.
Buprenorphine Orifarm sublingual resoriblet is used to treat adults and adolescents over 15 years of age who also receive medical, social and psychological support for their treatment.
Buprenorphine contained in Buprenorphine Orifarm 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 Orifarm
Do not take Buprenorphine Orifarm
- if you are allergic to buprenorphine 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 have tremors, sweating, anxiety, confusion or hallucinations caused by alcohol.
- depression or other conditions treated with antidepressants. If these medicines are used in combination with Buprenorphine Orifarm, it can lead to serotonergic syndrome, a condition that can be life-threatening (see “Other medicines and Buprenorphine Orifarm”).
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before taking Buprenorphine Orifarm, if you have:
- asthma or other respiratory problems
- a kidney disease
- a liver disease, e.g. hepatitis
- a recent head injury or brain disease
- low blood pressure
- have some urinary incontinence (especially applies to problems associated with enlarged prostate in men or narrowing of the urethra)
- have a problem with the thyroid gland
- has any disturbance in the function of the adrenal cortex (eg Addison’s disease ).
V in ktiga things to consider:
- Misuse, abuse, and attempts to mislead healthcare professionals
Severe cases of infection, sometimes life-threatening, can occur with intravenous abuse of Buprenorphine Orifarm. 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.
- Respiratory problems
Some people have died of respiratory depression (inability to breathe) due to misuse of buprenorphine or taking it in combination with drugs that affect the central nervous system such as alcohol, benzodiazepines (sedatives), or other opioids.
Buprenorphine Orifarm can be addictive.
- Withdrawal symptoms
Buprenorphine Orifarm may cause withdrawal symptoms if you take it less than 6 hours after using a short-acting opioid (eg morphine, heroin) or less than 24 hours after using a long-acting opioid such as methadone.
Sudden discontinuation of treatment may result in a withdrawal syndrome.
- Liver damage
Cases of acute liver damage (liver problems) have been reported in connection with incorrect use, especially during intravenous use and at high doses. These injuries may be due to specific circumstances such as viral infections ( chronic hepatitis C), alcohol abuse, anorexia or are related to other drugs that can damage the liver (listed in section 4). Tell your doctor immediately if you have symptoms such as severe fatigue, itching or if your skin or eyes look yellow, so that you can receive appropriate treatment. 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 Orifarm.
- Blood pressure
Buprenorphine Orifarm can 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
Buprenorphine Orifarm can mask the pain that is a sign of certain diseases. Remember to tell your doctor that you are taking this medicine.
Other medicines and Buprenorphine Orifarm
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines may aggravate the side effects of Buprenorphine Orifarm and in some cases may cause very serious reactions. Do not take any other medicines while you are taking Buprenorphine Orifarm without first talking to your doctor, especially
- Benzodiazepines (used to treat anxiety or sleep disorders) such as diazepam, temazepam, alprazolam. Your doctor will prescribe the correct dose for you. An incorrect dose of benzodiazepines can lead to death due to respiratory depression (severe difficulty breathing).
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 have a calming effect on the central nervous system, which is very serious. Below is a list of examples of these types of drugs:
- other opioid-containing medications, e.g. methadone, some painkillers, and antitussives
- Some antidepressants used to treat depression may exacerbate the effects of this drug
- sedative H ı receptor antagonists (used to treat allergic reactions), e.g. diphenhydramine and chlorphenamine
- barbiturates (used to induce sleep or sedation ), e.g. phenobarbital and secobarbital
- sedatives (used to induce sleep or sedation ), e.g. chloral hydrate.
- Naltrexone (a drug used to treat addiction) may counteract the therapeutic effects of buprenorphine. It should not be taken with buprenorphine treatment because you may then experience a sudden onset of prolonged and intense withdrawal symptoms.
- 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 (called macrolides ) may prolong the effects of this medicine.
- Some medicines may reduce the effect of buprenorphine. These include medicines to treat epilepsy (eg carbamazepine and phenytoin ), as well as antibiotics to treat tuberculosis (rifampicin).
- Antidepressants such as moclobemide, tranylcypromine, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, duloxetine, venlafaxine, amitriptyline, doxepin, or trimipramine. These medicines can affect or be affected by Buprenorphine Orifarm 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, reflexes, tense muscles and body temperature above 38 ° C . Contact your doctor if you experience such symptoms.
To get the most out of your treatment with Buprenorphine Orifarm, you must tell your doctor all the other medicines you are taking, including the use of alcohol, medicines containing alcohol, illegal drugs, and prescription medicines that you may use without a doctor’s prescription.
Buprenorphine Orifarm with food, drink, and alcohol
Alcohol may increase drowsiness and increase the risk of respiratory depression if taken with Buprenorphine Orifarm. Do not take Buprenorphine Orifarm with alcoholic beverages. Do not swallow or consume food or drink of any kind until the travel tablet has completely dissolved.
Pregnancy, breastfeeding, and fertility
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.
The risks for pregnant women using buprenorphine 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 Orifarm 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 Buprenorhine Orifarm passes into breast milk.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Buprenorphine Orifarm 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 Orifarm. 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 Orifarm 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 Orifarm
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Buprenorphine Orifarm is a sublingual resoriblet. This means that the travel tablet should be placed and held under the tongue until it has dissolved (this normally takes 5-10 minutes).
The travel tablet must not be swallowed whole, crushed, or chewed. The medicine does not work in this way and you may experience withdrawal symptoms. Do not take Buprenorphine Orifarm with food and drink.
The effect of this treatment depends on the simultaneous medical, psychological, and social treatment.
Your doctor will decide which dose is best for you. During your treatment, your doctor may adjust your dose depending on how you react. The length of treatment is determined individually by your doctor.
If you have been stable for some time, your doctor will gradually reduce the dose one and it may be possible to stop treatment completely.
Take a dose once a day unless otherwise prescribed by your doctor.
Clear signs of abstinence should be apparent before taking the first dose of Buprenorphine Orifarm.
Opioid-dependent patients who have not yet received any other detoxification treatment: The first dose of Buprenorphine Orifarm should be taken when the first signs of abstinence occur, but not earlier than 6 hours before the last time you used opioids (drugs such as morphine or heroin). If you take this medicine less than 6 hours after using opioids, you may experience withdrawal symptoms.
Patients already taking methadone: Your doctor should reduce your methadone dose to a maximum of 30 mg / day before starting Buprenorphine Orifarm. Buprenorphine Orifarm can cause withdrawal symptoms in methadone-dependent patients, if taken earlier than 24 hours after the last dose of the methadone .
Do not change or stop treatment without consulting your doctor, as otherwise, you may experience withdrawal symptoms.
If you have the impression that the effect of Buprenorphine Orifarm is too strong or too weak, talk to your doctor or pharmacist.
If you have liver problems, it may be necessary to lower your dose. Talk to your doctor. If you have severe liver problems, do not take buprenorphine.
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 Orifarm may cause serious and life-threatening breathing problems.
If you forget to take Buprenorphine Orifarm
Contact your doctor if you forget to take Buprenorphine Orifarm. Do not take a double dose to make up for a forgotten dose unless your doctor tells you to.
If you stop taking Buprenorphine Orifarm
Do not suddenly stop taking Buprenorphine Orifarm as this may cause withdrawal symptoms. Do not stop the treatment yourself, but ask your doctor how to end the treatment.
If you have any further questions on the use of this product, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact a doctor immediately or seek emergency care if you experience side effects such as
- sudden wheezing breathing sounds, difficulty breathing, swollen eyelids; swelling of the face, tongue, lips, throat or hands; skin rash or itching – especially if these involve the whole body. Reactions of this type can be a sign of a life-threatening allergic reaction .
- slower or weaker / shallower breathing than normal (shortness of breath).
- feeling dizzy, as this may be a sign of low blood pressure.
Also consult a doctor if you experience side effects such as
- severe fatigue (tiredness), loss of appetite or yellowing of the skin or eyes. These symptoms may be signs of liver damage.
Improper use of this medicine by injecting it can cause withdrawal symptoms, infections, other skin reactions, and possibly serious liver problems – see “Important things to keep in mind”.
Very common side effect is (can occur in more than 1 in 10):
- sweating, insomnia, nausea, pain.
Common side effects are (may affect up to 1 in 10):
- joint pain, lethargy, back pain, skeletal pain, inflammation of the trachea ( bronchitis ), chest pain, chills, constipation, cough, decreased appetite, depression (depression), diarrhea, dizziness, dry mouth , menstrual pain, dyspepsia(indigestion), shortness of breath, shortness of breath, shortness of breath upset stomach or other stomach upset, hostile behavior, high blood pressure, infection , flu , nervousness, tear flow disorders, swollen glands ( lymph nodes ), general malaise, migraine , muscle twitching, muscle aches, dilated pupils, neck pain, palpitations, paranoia, tingling sensation in the skin, swelling of the skin (peripheral edema ), inflammation of the throat, fever, rashes, hay fever, fatigue, fainting, abnormal thinking, dental problems, trembling ( tremor ), dilated blood vessels, vomiting, yawning.
Has been reported (occurs in an unknown number of users):
- Drug addiction, withdrawal syndrome in newborns
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 Orifarm
Keep this medicine out of the sight and reach of children.
Store Buprenorphine Orifarm at a maximum of 30 ° C. Store in the original package. Sensitive to light and sensitive to moisture.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
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
- The active substance is buprenorphine. One travel tablet contains 2 mg or 8 mg of buprenorphine.
- The other ingredients are lactose monohydrate, mannitol (E421), corn starch, anhydrous citric acid, sodium citrate, povidone, magnesium stearate, ascorbic acid , edetic acid ( EDTA ).
What the medicine looks like and the contents of the pack
Buprenorphine Orifarm 2 mg and 8 mg are off-white, oval, biplane sublingual resoriblets.
Blister packs of 6, 7, 10, 28, and 30 sublingual resoriblets.
Not all packaging may be marketed.
Marketing Authorization Holder and Manufacturer
Orifarm Generics A / S
5260 Odense S
Orifarm Generics AB
102 17 Stockholm