0.3 mg/ml solution for injection
buprenorphine
What Temgesic solution for injection is and what it is used for
Temgesic injection solution is an injection solution that contains buprenorphine and belongs to the group of opioid analgesics.
Temgesic injection is a medicine that reduces the pain that occurs after surgery.
The buprenorphine contained in Temgesic solution for injection may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have further questions, and always follow their instructions.
What you need to know before you use Temgesic solution for injection
Do not use Temgesic solution for injection
If you are allergic to buprenorphine or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using Temgesic solution for injection if you have:
- Problems with breathing or decreased lung function as can worsen your difficulty breathing or if you are taking medicines that can slow or weaken your breathing.
- If you are or have been dependent on morphine-like painkillers or if you have previously received long-term treatment with this type of medicine because withdrawal symptoms may occur.
- Problems with the liver.
- Any kidney disease.
- Low blood pressure.
- Injured your head recently, or if you have a brain disease.
- Thyroid disorders.
- Adrenocortical disorders (eg Addison’s disease ).
- Problems in the urinary tract such as enlarged prostate or narrowing of the urethra.
- Depression or other conditions are treated with antidepressants. If these medicines are used together with a Temgesic solution for injection, this can lead to serotonin syndrome, a condition that can be life-threatening (see “Other medicines and Temgesic solution for injection”).
Important things to consider:
- Misuse and abuse
This drug may be desirable for patients who abuse prescription medications and should be kept in a safe place to protect it from theft. Never give the medicine to anyone else, it can lead to death or injury. - Respiratory problems
Patients have died from respiratory failure (inability to breathe) due to using this medicine incorrectly or taking it in combination with other CNS depressants such as alcohol, benzodiazepines (sedatives), or other opioids. - Sleep-related breathing problems
Temgesic solution for injection can cause sleep-related breathing problems such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). The symptoms can be breathing pauses during sleep, waking up at night due to shortness of breath, difficulty staying asleep, or pronounced fatigue during the day. Contact the doctor if you or anyone else observes these symptoms. The doctor may consider reducing the dose. - Addiction
This medicine can be addictive. - Withdrawal
symptoms This medicine can cause withdrawal symptoms if you also take other opioids such as heroin or methadone. - Diagnosis of unrelated medical conditions
This medicine may mask the pain which is a sign of certain diseases. Remember to inform the doctor that you are using this medicine.
Other medicines and Temgesic solutions for injection
Some medicines can increase the side effects of Temgesic solution for injection and in some cases can cause very serious reactions. Tell your doctor if you are taking, have recently taken, or might take any other medicines. Do not take any other medicines while using Temgesic solution for injection without first talking to your doctor, especially:
- 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 Temgesic solution for injection and you may have symptoms such as involuntary rhythmic muscle twitching, including in the muscles that control eye movements, agitation, hallucinations, coma, profuse sweating, tremors, increased reflexes, tense muscles and body temperature above 38°C. Contact the doctor if you experience such symptoms.
- Benzodiazepines (used to treat anxiety and sleep disorders), eg diazepam, temazepam, or alprazolam. If you use Temgesic solution for injection at the same time as sedatives such as benzodiazepines or similar medicines, it can increase the risk of drowsiness, breathing difficulties, and coma, and it can be life-threatening. Concurrent treatment should therefore only be considered if there are no other treatment options. However, if the doctor prescribes Temgesic together with sedative drugs, the doctor must limit the dose and the duration of treatment. Inform the doctor about all sedatives you are taking and follow the doctor’s prescription very carefully. It may be helpful to inform family and friends that they should be aware of the signs and symptoms described above. Contact the doctor if you experience any such symptoms.
- Other medicines that can make you feel sleepy are used to treat conditions such as anxiety, insomnia, convulsions/seizures, or pain. These types of drugs reduce your level of alertness, which can make it difficult to drive and use machines. They can also cause central nervous system depression, which is very serious. Below is a list of examples of these types of drugs:
- Other opioid-containing medications, e.g. methadone, certain pain relievers, and cough suppressants.
- Antidepressants (used to treat depression), e.g. isocarboxazid, phenelzine, selegiline, tranylcypromine, and valproate, may enhance the effects of this drug.
- Sedative H 1 -receptor antagonists (used to treat allergic reactions), eg 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.
- Clonidine (used to treat high blood pressure ) may prolong the effects of this medicine.
- Naltrexone can counteract the therapeutic effects of Temgesic solution for injection. If you take this medicine and then take naltrexone at the same time, you may experience a sudden onset of prolonged and intense withdrawal symptoms.
- Antiretroviral drugs (used against HIV infection ), e.g. ritonavir, nelfinavir, and indinavir, may increase the effects of this medicine.
- Some antifungals (used to treat fungal infections), e.g. ketoconazole, itraconazole, and certain antibiotics ( macrolides ), may prolong the effects of this medicine.
- Some medicines can reduce the effect of Temgesic solution for injection. These include drugs for the treatment of epilepsy (e.g. carbamazepine and phenytoin ), as well as drugs for the treatment of tuberculosis (rifampicin).
- Anesthetics (used in surgery such as halothane).
Temgesic solution for injection with food, drink, and alcohol
Alcohol can cause increased drowsiness and can increase the risk of respiratory failure if taken with a Temgesic solution for injection. Do not take Temgesic solution for injection with alcohol or with medicines that contain alcohol.
Pregnancy and breastfeeding
The risks for pregnant women of using Temgesic solution for injection are not known. Tell your doctor if you are pregnant or planning to have a baby. The doctor will decide whether the treatment should be continued with another medicine.
Medicines such as Temgesic solution for injection, if taken during, especially advanced, pregnancy can cause withdrawal symptoms and breathing problems in the newborn baby. These problems can occur several days after birth.
Do not breastfeed while taking this medicine because the Temgesic solution for injection passes into breast milk.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving ability and use of machinery
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. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
During treatment with a Temgesic solution for injection, the ability to react may be prolonged because a Temgesic solution for injection can cause drowsiness. Do not drive or operate machinery, or perform any hazardous activity until you know how this medicine affects you.
Temgesic solution for injection contains glucose.
If your doctor has told you that you have an intolerance to some sugars, consult your doctor before using this medicine.
How to use Temgesic solution for injection
Always use Temgesic solution for injection as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure. Do not inject more than the dose your doctor has prescribed for you.
The recommended dose is 0.3-0.6 mg (1-2 ml) given intramuscularly or slowly intravenously. Dose one can be given every 6-8 hours or as needed according to the doctor’s prescription.
If you have used too much Temgesic solution for injection
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
If you or someone else accidentally injects too much Temgesic solution for injection, you must seek medical attention immediately for treatment as an overdose of Temgesic solution for injection can cause serious and life-threatening breathing problems.
Symptoms of overdose may include feeling tired, sleepy, dizzy, sweating, dilated pupils (characterized by blurred vision and difficulty focusing), dry mouth, euphoria, hallucinations, shallow breathing, possibly slower heart rate, low blood pressure ( hypotension ), nausea, vomiting or constipation.
If you forget to take Temgesic solution for injection
Your doctor or nurse will tell you what to do if you miss a dose.
Do not take a double dose to make up for a missed dose.
If you stop taking Temgesic solution for injection
If you have previously received long-term treatment with this type of medicine and if you stop taking Temgesic injection, withdrawal symptoms may occur. Tell your doctor if you think this is happening to you. Do not change the dosage or stop taking Temgesic solution for injection without the consent of your attending physician.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor or seek medical attention immediately if you experience any of the following symptoms after taking this medicine. These symptoms can be serious and Temgesic solution for injection can cause serious and life-threatening breathing problems:
- If you start to breathe more slowly or more weakly than usual. This may occur with respiratory depression caused by Temgesic solution for injection (occurs in an unknown number of patients).
- If you suddenly experience wheezing, difficulty breathing, swelling of the eyelids, face, or lips, rash or itching especially if it covers the whole body. It may be a sign of an allergic reaction (a rare side effect that may occur in up to 1 in 1000 patients).
- If you feel dizzy, this may be a sign of low blood pressure (a very common side effect that may affect more than 1 in 10 patients).
- If you experience sudden constriction of the airways ( bronchospasm ) (which occurs in an unknown number of patients).
- If you have a hypersensitivity reaction with fever, rash, swelling, and sometimes a drop in blood pressure (anaphylactic shock ) (occurs in an unknown number of patients).
- If you experience swelling of the face, tongue, or throat or difficulty swallowing, hives, and difficulty breathing ( angioedema ) (occurs in an unknown number of patients).
Other side effects:
Very common side effects (may affect more than 1 in 10 patients)
Sedation, dizziness, nausea
Common side effects (may affect up to 1 in 10 patients):
Headache, miosis (reduced pupils ), hypoventilation (shallow or slow breathing), vomiting, hyperhidrosis (increased sweating).
Uncommon side effects (may affect up to 1 in 100 patients):
Confusion, euphoria (exaggerated feeling of well-being), nervousness, depression, psychotic illness (mental illness causing abnormal thinking and perception), hallucinations, personality change (not feeling like yourself), dysarthria (difficulty speaking), paresthesia (numbness and tingling), coma, tremors, blurred vision, diplopia (double vision), visual impairment, conjunctivitis (eye inflammation or infection), tinnitus (ringing in the ears), tachycardia (fast heartbeat), bradycardia (slow heartbeat), cyanosis (blue discoloration of the skin), another degree atrioventricular block (heart rhythm disturbances), hypertension(high blood pressure ), pallor (pallor), dyspnea (shortness of breath), apnea (stopping breathing), dry mouth, constipation, dyspepsia (indigestion), flatulence, pruritus ( itching ), rash, difficulty urinating, asthenia (fatigue), fatigue, malaise.
Rare side effects (may affect up to 1 in 1,000 patients):
Decreased appetite, dysphoria (depressed mood), aggressiveness, convulsions, coordination difficulties, diarrhea, urticaria ( hives ).
Frequency not known (cannot be estimated from available data):
Drug dependence, drowsiness, lack of effect, drug interactions.
How to store Temgesic solution for injection
Keep this medicine out of the sight and reach of children.
Store at a maximum of 30°C. Store in the original packaging. Light sensitive.
Use before the expiry date stated on the carton after “EXP”. The expiration date is the last day of the specified month.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to deal with medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
The active substance is buprenorphine (as buprenorphine hydrochloride). Each ampoule contains 300 micrograms of buprenorphine.
Other ingredients are glucose monohydrate, hydrochloric acid, and water for injection.
Appearance and package sizes of the medicine
Temgesic solution for injection is a clear solution packaged in 1 ml glass ampoules and cartons containing a plastic tray of 5 ampoules.
Indivior Europe Limited,
27 Windsor Place,
Dublin 2,
D02 DK44,
Ireland
For further information on this medicine, please contact the marketing authorization holder
Telephone: 020791680
Email: PatientSafetyRoW@indivior.com