Substitol 120 mg. 30 capsules
Substitol prolonged-release capsules are prescribed for maintenance treatment (replacement therapy) for opioid dependence.
Tain the treatment of persons with opioid dependence will be carried out under appropriate medical supervision as part of a comprehensive psychosocial program.
Substitol prolonged-release capsules contain granules or pellets, providing a sustained release of the active substance in the digestive tract. This ensures the effectiveness of the drug for 24 hours. Therefore Substitol prolonged-release capsules should be taken only once daily, preferably at an interval of 24 hours.
2. BEFORE YOU TAKE Substitol prolonged-release capsules
Do not take Substitol extended release capsules
• if you are allergic (hypersensitive) to morphine or any of the other ingredients of Substitol prolonged-release capsules
• If you have problems or difficulty breathing (respiratory depression)
• If you have a head injury
• If you have seizures (epilepsy) or increased tendency to bruise seizures
• if you are taking certain drugs for depression (monoamine oxidase inhibitors, eg, moclobemide) or have stopped taking them in the last two weeks.
• if you have narrowing of the airways
• if your clogged airways (eg. With secretions)
• if you have abdominal pain of unknown origin
• you have bowel obstruction or paralysis
• if you have delayed gastric emptying
• if you have active liver disease
• if you suffer from alcoholism or withdrawal symptoms of alcohol (delirium tremens)
• in children and adolescents under 18 years of age
• before the surgery or during the first 24 hours after surgery.
Use of Substitol prolonged-release capsules are not recommended during pregnancy.
Take special care with Substitol prolonged-release capsules at:
• diseases that affect breathing
• disturbance of consciousness
• increased intracranial pressure
• a history of alcohol dependence
• low blood pressure and hypovolemia
• cardiac disorders as a result of severe lung diseases (cor pulmonale)
• bowel diseases associated with narrowing and / or inflammation
• suspected intestinal paralysis (see below)
• underactive thyroid gland
• diseases of the biliary tract
• inflammation of the pancreas
• impaired renal function
• impaired liver function
• enlargement of the prostate gland with residual urine
• narrowing of the urinary tract or the renal colic
• adrenal insufficiency
• tumors of the adrenal glands (pheochromocytoma)
Substitol prolonged release capsules should not be used if there is a risk of obstruction of the bowel or paralysis (signs: abdominal pain, lack of a bowel movement, abdominal wall with bone density). The occurrence or suspected intestinal obstruction should be discontinued immediately taking Substitol prolonged-release capsules and as much as possible faster to consult a doctor.
Suspicion of another disease, usually accompanied by pain, should consult a doctor, even in the absence or the sudden appearance of only slight pain. Analgesic effects of Substitol prolonged-release capsules may mask the signs and symptoms of comorbidities.
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.
When you visit your doctor or go to hospital must always honestly define your need for administration of drug replacement therapy that conduct and the dose that you take. This information is necessary in order to avoid combinations of many drugs which could create hazardous situations.
You should never use any hypnotic medications or sedatives (eg. Benzodiazepines), painkillers, medicines used in states of agitation or depression or other drugs that act on the central nervous system, before checking with your doctor. The combination of such products with Substitol prolonged-release capsules can have life-threatening effects. If you can not stop taking these medicines, you should seek advice from your doctor or contact a specialized facility. Problems such as sleep disorders, depression or anxiety can be treated with targeted therapy.
Substitol prolonged-release capsules should not be used with certain medicines to treat depression (so-called monoamine oxidase inhibitors eg. Moclobemide) or within two weeks after discontinuation of their intake. Co-administration of Substitol prolonged-release capsules with the following medicinal products may lead to exaggeration of the effects:
• Drugs (before surgery, incl. Dental surgery)
• potent analgesics or painkillers, incl. opioids
• sedatives or tranquilizers
• muscle relaxants
• medicines to lower blood pressure
When co-administered with cimetidine (medicine against expressed heartburn), rifampicin (medicine to treat tuberculosis) and ritonavir (a medicine to stop the development of HIV) is possible to change the operation of Substitol prolonged-release capsules.
In the event that you need to take any of these medicines, ask your doctor, as you may need dosage adjustments of Substitol prolonged-release capsules.
Taking Substitol prolonged-release capsule with food and drink
Drinking alcohol while taking Substitol prolonged-release capsules may make you feel sleepy or increase the risk of serious side effects such as shallow breathing with a risk of stopping breathing and loss of consciousness. It is recommended not to drink alcohol while taking Substitol prolonged-release capsules.
If you have a problem with avoiding alcohol intake, please consult your doctor!
Taking Substitol prolonged-release capsules with food has no significant influence on its effectiveness.
Pregnancy and lactation
Ask your doctor or pharmacist before taking any medicine. If you become pregnant, tell your doctor immediately. Please consult your doctor if you intend to become pregnant. Substitol prolonged-release capsules should not be used during pregnancy.
During pregnancy you will be provided medical care in a specialized hospital.
Substitol prolonged-release capsules should not be used during breastfeeding, because morphine passes into breast milk.
Driving and using machines
Warning: This product can affect your reactions and ability to drive.
This applies particularly when initiating treatment with Substitol prolonged-release capsules, increasing the dose or modification of therapy, and when taken together with alcohol or other substances depressant effect brain function. Please consult your doctor if you drive or operate machinery.
Must first observe that affected your perception and reactions.
Then you should consult with your doctor whether you can drive or operate machinery.
3. HOW TO TAKE Substitol prolonged-release capsules?
Always take Substitol prolonged-release capsules exactly as your doctor tells you. If you are not sure, Touch your doctor or pharmacist.
The capsules should be swallowed whole with a sufficient amount of liquid, the whole daily dose is taken once.
Upon specific instructions from your doctor, pharmacist will pour the contents of the capsule into a glass of water and you give it to accept it.
The dose will be determined by your doctor carefully. Please make sure that you follow his / her instructions carefully and strictly. Substitol prolonged-release capsules are available in two concentrations of 120 and 200 mg. Your doctor will prescribe a daily dose, you should take, so you will have to take a single capsule or a few capsules of the same or different concentrations. To prevent withdrawal symptoms, prescribed daily dose should be taken at intervals of 24 hours.
In the event that the medicated hunger is not enough depressed or feel withdrawal symptoms, please contact your doctor.
A suitable dose is one in which there is no occurrence of withdrawal symptoms. Please tell your doctor honestly what dose Substitol prolonged-release capsules will certainly suppress your symptoms of withdrawal. Drowsiness or depression using very high doses are not therapeutic purpose!
Substitol prolonged-release capsules has been prescribed for you. Do not pass it on to others. Assignment of Substitol prolonged-release capsules of other people is prohibited, as this may endanger their lives.
As with other opioids, when conducting replacement with regular use of the product, reducing the sensitivity to Substitol prolonged-release capsules, and requires the use of higher doses than the initial to achieve similar effects. Often, a similar dose can be fatal to have little people who accept it for the first time!
Providing Substitol prolonged-release capsules of other people also may jeopardize the continuation of your replacement therapy as it would violate the basic point of the treatment contract concluded with your doctor.
Only permissible ingesting Substitol prolonged-release capsules. The contents of the capsules must not be dissolved or injected (abuse injected). In such misuse, morphine will not only be released very quickly, leading to a lethal poison, but the excipients contained in the capsule will enter in the blood (e. Talc).
Abuse by injection of the reconstituted contents of the capsule can be life threatening. Reported the following potential effects:
• severe side effects fatal (death due to respiratory arrest)
• hypersensitivity reactions (reduction of peripheral blood pressure, progressing to circulatory shock)
• occlusion and inflammation of the blood vessels, invasion of bacteria into the bloodstream by subsequent sepsis and inflammation of the heart valves
• blood clots possible clot in the lung blood vessels
• deposition of the inorganic auxiliary substances in the body, for example. in the lungs (by the appearance of shortness of breath, high blood pressure in the pulmonary circulation with potentially fatal outcomes), eyes (accompanied with ocular lesions and partial detachment of the retina and loss of vision), in the liver and kidneys (with persistent inflammatory processes authorities).
Abuse by injection of the reconstituted contents of the capsule will jeopardize the continuation of your replacement therapy as it would violate the basic point of the treatment contract concluded with your doctor.
If you take more dose Substitol prolonged-release capsules, it is possible to occur drowsiness, pinpoint pupils and respiratory depression, as possible signs of overdose.
These symptoms may progress to circulatory collapse, coma and life-threatening damage to breathing. This may be associated with acute risk of death due to respiratory arrest.
Please seek medical attention from the first doctor that you can connect immediately after symptoms of overdose!
The same applies in suspicion of taking Substitol prolonged-release capsules of children. Even a small amount of active substance can be fatal for children. For this reason you should not wait for the signs of intoxication and immediately seek medical care from the first doctor that you can contact.
If you forget to take Substitol prolonged-release capsules, do not take a double dose to make up for a missed dose. Take the prescribed dose and continue to take 24 hours or consult your doctor.
If you stop taking Substitol prolonged-release capsules in you will experience symptoms of withdrawal.
After a short period of time (several days), decreased sensitivity to Substitol prolonged-release capsules subsides, which could be very dangerous, as tolerated dose before discontinuation now can be deadly. After discontinuation should never be taken previous daily dose without correct! This applies to any relapse after discontinuation, even in multi dependence. Stopping the drug should be performed only under medical supervision.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Substitol prolonged-release capsules can cause side effects, although not everybody gets them.
The occurrence of adverse reactions depends on the degree of patient tolerance to opioids. The most commonly reported side effects include constipation, nausea, vomiting and drowsiness. Constipation should be treated prophylactically with the use of laxatives. For nausea and vomiting, your doctor may prescribe medicine to prevent nausea.
The frequency of adverse reactions, the following definitions: Very common: occurring in more than 1 in 10 patients
Common: occur in more than 1 in 100 but less than 1 in 10 patients
Uncommon: occurring in more than 1 in 1000, but less than 1 in 100 patients
Rare: occurring in more than 1 in 10 000 but less than 1 in 1000 patients
Very rare: occur in less than 1 in 10,000 patients Not known (from the available data can not be estimated)
In patients treated with Substitol prolonged-release capsules are reported to occur following adverse reactions:
Uncommon low or high blood pressure and heart rate (pulse), palpitations, malaise with nausea and heart failure.
Common: headache, somnolence, dizziness.
Uncommon: increased muscle tension, numbness, nausea.
Very rare: muscle twitching, seizures.
Uncommon: constriction of pupils
Very rare: tremor of the eyes, visual disturbances (blurred vision, double vision)
Respiratory, thoracic and mediastinal disorders
Rare: spasm of the respiratory tract, reduced cough
Very rare: dyspnea, pulmonary edema, respiratory depression
Common: anorexia, constipation, dry mouth, nausea, vomiting, indigestion
Rare: elevation of pancreatic enzymes, inflammation of the pancreas
Very rare: gastrointestinal disorders, intestinal obstruction, impaired sense of taste, abdominal pain
Renal and urinary tract
Common: urinary retention
Rare: renal colic
Skin and subcutaneous tissue disorders
Common: sweating, urticaria, pruritus
Very rare: rash, fluid retention in the upper and lower limbs
Disorders of the musculoskeletal system and connective tissue
Very rare: muscle cramps, muscle rigidity
Uncommon: low blood pressure, high blood pressure, flushing
General disorders and administration site conditions
Uncommon: drug intolerance
Rare: withdrawal symptoms
Very rare: fatigue, malaise, fever
Uncommon: allergic reactions, hypersensitivity reactions
Rare: elevated liver enzymes
Very rarely, pain of the gall bladder, biliary colic
Reproductive system and breast disorders
Very rare: lack of menstruation, decreased sex drive, impotence
Very common: depressed mood, euphoric mood
Common: confusion, sleep disorders, abnormal thinking, agitation, hallucinations, mood changes Very rare: drug addiction
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 Substitol prolonged-release capsules?
Keep out of the reach and sight of children.