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Brand Names: Tidigesic, Zonor, Suboxone, Subutex,
Generic name: Buprenorphine
Manufacturer: Sun Pharma
Each Tidigesic tablet contains: Buprenorphine Hydrochloride USP 0.2 mg
How does Tidigesic work?
Tidigesic tablets contain the active ingredient buprenorphine, which is a type of medicine called an opioid.
Opioids are painkillers such as codeine, morphine and diamorphine (heroin) that work by mimicking the action of naturally occurring pain-reducing chemicals called endorphins. Endorphins are found in the brain and spinal cord and reduce pain by combining with opioid receptors. However, opioids also act in the brain to cause feelings of euphoria and hallucinations. They can be addictive and people taking them long-term can become dependent on them.
Buprenorphine is an opioid that is used to wean people off their addiction to stronger opioids such as morphine, diamorphine (heroin) and methadone. It is prescribed as a substitute for such drugs. By acting on the same opioid receptors as other opioids, buprenorphine prevents the physical withdrawal symptoms that occur when these drugs are stopped. This prevents physical cravings. Over time, the dose of buprenorhpine is gradually reduced until it can be stopped completely.
Buprenorphine is only suitable as an opioid substitute in people who are moderately dependent on other opioids. This is because in addition to stimulating opioid receptors, buprenorphine also blocks them. In people who are dependent on high doses of opioids, this can cause withdrawal symptoms when the buprenorphine is started. For this reason, in people highly addicted to opioids, the daily opioid dose should be reduced gradually before therapy with buprenorphine is started.
For people taking methadone, the methadone dose should be reduced before this medicine is started. However, buprenorphine may still cause symptoms of withdrawal in people dependent upon methadone.
For drug addicts who have not undergone withdrawal, the first dose of this medicine should be taken at least 4 hours after the last use of the opioid, or when the first signs of craving appear. If it is taken earlier than this it can actually cause withdrawal symptoms.
Buprenorphine substitution therapy for opioid addiction must be used in combination with other medical, social and psychological treatment.
What is it used for?
• Opioid (eg heroin) addiction
• This medicine may cause drowsiness. If affected do not drive or operate machinery. Drowsiness will be made worse by alcohol, tranquilisers, sedatives and sleeping tablets such as benzodiazepines. Taking these in combination with buprenorphine can also cause potentially dangerous problems with breathing and so should be avoided while you are taking this medicine.
• Your liver function should be regularly monitored while you are receiving treatment with this medicine.
Use with caution in
• Decreased liver function
• Decreased kidney function
• People with breathing problems, eg asthma.
Not to be used in
• Children under 16 years of age
• Severely decreased liver function
• Severe breathing problems
• Alcohol intoxication (acute alcoholism)
• Serious medical condition caused by withdrawal from alcohol (delirium tremens)
This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.
If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.
Pregnancy and Breastfeeding
Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.
• The safety of this medicine during pregnancy has not been established. It is not recommended for use during pregnancy as it may be harmful to the developing baby, particularly in the third trimester, when it may cause breathing problems or a withdrawal syndrome in the baby after birth. Seek medical advice from your doctor.
• This medicine passes into breast milk. It may also inhibit the production of breast milk. Mothers who need to take this medicine should not breastfeed during treatment. Seek medical advice from your doctor.
• This medication is to be dissolved under the tongue.
• This medication may cause drowsiness. If affected do not drive or operate machinery. Avoid alcoholic drink.
Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.
• Difficulty sleeping (insomnia)
• Feeling weak
• Nausea and vomiting
• Slow, shallow breathing (respiratory depression)
• Inflammation of the liver (hepatitis)
• Withdrawal symptoms in people addicted to high doses of opioids.
The side effects listed above may not include all of the side effects reported by the drug's manufacturer.
For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.
How can this medicine affect other medicines?
It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to ensure that the combination is safe.
There may be an increased risk of side effects such as drowsiness, sedation, low blood pressure and slow, shallow breathing that can potentially be fatal, if this medicine is used with other medicines that have a sedative effect on the central nervous system. These include the following and should be avoided while taking this medicine:
• antipsychotics, eg haloperidol
• barbiturates, eg phenobarbital, amobarbital
• benzodiazepines, eg diazepam, temazepam
• other opioid painkillers, eg codeine, morphine
• sedating antihistamines, eg chlorphenamine, hydroxyzine
• sleeping tablets, eg zopiclone
• tricyclic antidepressants, eg amitriptyline.
In people who are dependent on high doses of other opioids, eg morphine, diamorphine, methadone, this medicine may cause some withdrawal symptoms. This is because buprenorphine can block some of the effects of other opioids. People highly dependent on other opioids should have their daily opioid dose reduced before starting treatment with this medicine.
The antifungal medicine ketoconazole increases the blood level of this medicine. Your dose of buprenorphine should be reduced if you start treatment with ketoconazole.