Mabron

Mabron

tramadol

Manufacturer:

Medochemie

Distributor:

KTZ

Marketer:

Aung Paing Tun
Full Prescribing Info
Contents
Tramadol hydrochloride.
Description
Each 2 ml ampoule contains 100 mg tramadol hydrochloride.
Mabron 100 mg/2ml is a solution for injection or infusion.
Excipients/Inactive Ingredients: Sodium acetate and water for injection.
Action
Tramadol - the active substance in Mabron - is a painkiller belonging to the class of opioids that acts on the central nervous system. It relieves pain by acting on specific nerve cells of the spinal cord and brain.
Indications/Uses
Mabron is used for the treatment of moderate to severe pain.
Dosage/Direction for Use
Always use this medicine exactly as the doctor or pharmacist has told. Check with the doctor or pharmacist if the patient is not sure.
The dosage should be adjusted to the intensity of the pain and the individual pain sensitivity. In general the lowest pain-relieving dose should be received. Normally, daily doses up to 8 ml of Mabron solution for injection (equivalent to 400mg tramadol hydrochloride) will be sufficient. Exceptionally, if clinically required, the doctor may direct to use a higher daily dose.
Unless otherwise prescribed by the doctor, the usual dose is: Adults: Depending on the pain, the patient will receive 1-2 ml of Mabron (equivalent to 50 - 100 mg tramadol hydrochloride).
Depending on the pain, the effect lasts for about 4-8 hours.
The doctor may prescribe a different, more appropriate dosage of Mabron.
Use in children and adolescents: Adolescents from the age of 12 years: as for adults.
Children from the age of 1 year: the usual single dose is 1 - 2 mg tramadol hydrochloride per kg body weight. The lowest analgesically effective dose should generally be selected.
Daily doses of 8 mg tramadol hydrochloride per kg body weight or 400 mg tramadol hydrochloride, whichever is lower, should not be exceeded per day.
Elderly: In elderly patients (above 75 years) the excretion of tramadol may be delayed. If this applies to the patient, the doctor may recommend to prolong the dosage interval.
Severe liver or kidney disease (insufficiency)/dialysis patients: Patients with severe liver and/or kidney insufficiency should not take Mabron.
If in case the insufficiency is mild or moderate, the doctor may recommend prolonging the dosage interval.
How and when should the patient receive Mabron: Mabron will be injected slowly usually into a blood vessel under the surface of the arm or injected into muscle (usually the buttocks) or under the skin. Alternatively, Mabron will be diluted and infused into a vein.
How long should the patient take Mabron: The patient should not receive Mabron for longer than necessary.
If the patient needs to be treated for a longer period, the doctor will check at regular short intervals (if necessary with breaks in treatment) whether the patient should continue to receive Mabron and at what dose.
If the patient has the impression that the effect of Mabron is too strong or too weak, talk to the doctor or pharmacist.
If the patient uses more Mabron than they should: If the patient has received an additional dose by mistake, this will generally have no negative effects. The patient should receive the next dose as prescribed.
If the patient (or someone else) receives a very high dose of Mabron they should go to the hospital or call a doctor straight away.
Signs of an overdose include very small pupils, being sick, fall in blood pressure, fast heartbeat, collapse, unconsciousness, fits and breathing difficulties or shallow breathing.
If the patient forgets to use Mabron: If the patient does not receive Mabron, pain is likely to return. The patient should not receive a double dose to make up for forgotten individual doses, simply continue receiving Mabron as before.
If the patient stops using Mabron: If treatment with Mabron is interrupted or finished too soon, pain is likely to return. If the patient wishes to stop treatment on account of unpleasant effects, tell the nurse or doctor.
Generally there will be no after-effects when treatment with Mabron is stopped. However, on rare occasions, people who have been treated with Mabron for some time may feel unwell if the treatment is abruptly stopped. They may feel agitated, anxious, nervous or shaky. They may be hyperactive, have difficulty sleeping and have stomach or bowel disorders. Very few people may get panic attacks, hallucinations, unusual perceptions such as itching, tingling and numbness, and "ringing" in the ears (tinnitus).
Further unusual CNS symptoms, i.e. confusion, delusions, change of perception of the own personality (depersonalisation), and change in perception of reality (derealisation) and delusion of persecution (paranoia) have been seen very rarely. If the patient experiences any of these complaints after stopping Mabron, tell the nurse or doctor.
If the patient has any further questions on the use of this medicine, ask the doctor or pharmacist.
Contraindications
Do not use Mabron: if the patient is allergic to tramadol hydrochloride, or any of the other ingredients of this medicine (listed in Description); in acute poisoning with alcohol, sleeping pills, pain relievers or other psychotropic medicines (medicines that affect mood and emotions); if the patient is also taking MAO inhibitors (certain medicines used for treatment of depression) or has taken them in the last 14 days before treatment with Mabron (see "Interactions"); if the patient is an epileptic and the fits are not adequately controlled by treatment; as a substitute in drug withdrawal.
Special Precautions
Talk to the doctor or pharmacist or nurse before using Mabron: if the patient thinks that they are addicted to other pain relievers (opioids); if the patient suffers from consciousness disorders (if they feel that they are going to faint); if the patient is in a state of shock (cold sweat may be a sign of this); if the patient suffers from increased pressure in the brain (possibly after a head injury or brain disease); if the patient has difficulty in breathing; if the patient has a tendency towards epilepsy or fits because the risk of a fit may increase; if the patient suffers from a liver or kidney disease.
Epileptic fits have been reported in patients taking tramadol at the recommended dose level. The risk may be increased when doses of tramadol exceed the recommended upper daily dose limit (400 mg). Note that Mabron may lead to physical and psychological addiction. When Mabron is used for a long time, its effect may decrease, so that higher doses have to be used (tolerance development). In patients with a tendency to abuse medicines or who are dependent on medicines, treatment with Mabron should only be carried out for short periods and under strict medical supervision.
Inform the doctor if one of these problems occurs during Mabron treatment or if they applied to the patient in the past.
Mabron contains sodium. This medicinal product contains less than 1 mmol sodium (23 mg) per ml, i.e. essentially 'sodium-free'.
Driving and using machines: Mabron may cause drowsiness, dizziness and blurred vision and therefore may impair the reactions. If the patient feels that their reactions are affected, do not drive a car or other vehicle, do not use electric tools or operate machinery.
Use In Pregnancy & Lactation
If the patient is pregnant or breast-feeding, thinks she may be pregnant or is planning to have a baby, ask the doctor or pharmacist for advice before using this medicine.
There is very little information regarding the safety of tramadol in human pregnancy. Therefore the patient should not receive tramadol if she is pregnant.
Chronic use during pregnancy may lead to withdrawal symptoms in newborns.
Generally, the use of tramadol is not recommended during breast-feeding. Small amounts of tramadol are excreted into breast milk. After a single dose it is usually not necessary to interrupt breast-feeding.
Based on human experience tramadol is suggested not to influence female or male fertility.
Side Effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The patient should see a doctor immediately if they experience symptoms of an allergic reaction such as swollen face, tongue and/or throat, and/or difficulty swallowing or hives together with difficulties in breathing.
The most common side effects during treatment with Mabron are nausea and dizziness, which occur in more than 1 in 10 people.
Very common: may affect more than 1 in 10 people: dizziness; feeling sick (nausea).
Common: may affect up to 1 in 10 people: headaches, drowsiness; fatigue; constipation, dry mouth, being sick (vomiting); sweating (hyperhidrosis).
Uncommon: may affect up to 1 in 100 people: effects on the heart and blood circulation (pounding of the heart, fast heartbeat, feeling faint or collapse). These adverse effects may particularly occur in patients in an upright position or under physical strain; urge to be sick (retching), stomach trouble (e.g. feeling of pressure in the stomach, bloating), diarrhoea; skin reactions (e.g. itching, urticaria).
Rare: may affect up to 1 in 1,000 people: allergic reactions (e.g. difficulty in breathing, wheezing, swelling of skin) and shock (sudden circulation failure) have occurred in very rare cases; slow heartbeat; increase in blood pressure; abnormal sensations (e.g. itching, tingling, numbness), trembling, epileptic fits, muscle twitches, uncoordinated movement, transient loss of consciousness (syncope), speech disorders; epileptic fits have occurred mainly at high doses of tramadol or when tramadol was taken at the same time as other medicines which may induce fits; changes in appetite; hallucination, confusional state, sleep disorders, delirium, anxiety and nightmares; psychological complaints may appear after treatment with Mabron. Their intensity and nature may vary (according to the patient's personality and length of therapy). These may appear as a change in mood (mostly high spirits, occasionally irritated mood), changes in activity (slowing down but sometimes an increase in activity) and decreased cognitive and sensory perception (being less aware and less able to make decisions, which may lead to errors in judgement); Drug dependence may occur. If Mabron is taken over a long period of time dependence may occur, although the risk is very low. When treatment is stopped abruptly, signs of withdrawal may appear (see "If the patient stops using Mabron under Dosage & Administration"); blurred vision, excessive dilation of the pupils (mydriasis), constriction of the pupil (miosis); slow breathing, shortness of breath (dyspnoea); worsening of asthma has been reported, however it has not been established whether it was caused by tramadol. If the recommended doses are exceeded, or if other medicines that depress brain function are taken at the same time, breathing may slow down; weak muscles; passing urine with difficulty or pain, passing less urine than normal (dysuria).
Very rare: may affect up to 1 in 10,000 people: hepatic enzyme increased.
Not known: frequency cannot be estimated from the available data: decrease in blood sugar level; low sodium concentration in the blood (hyponatremia).
Reporting of side effects: If the patient gets any side effects, talk to the doctor or pharmacist. This includes any possible side effects not listed in this monograph. The patient can also report side effects directly to the Pharmaceutical Services, Ministry of Health. By reporting side effects the patient can help provide more information on the safety of this medicine.
Drug Interactions
Tell the doctor or pharmacist or nurse if the patient is using, has recently used or might use any other medicines.
Mabron should not be used together with MAO inhibitors (certain medicines for the treatment of depression).
The pain-relieving effect of Mabron may be reduced and the length of time it acts may be shortened, if the patient takes medicines which contain: carbamazepine (for epileptic fits), ondansetron (prevents nausea).
The doctor will tell the patient whether they should take Mabron, and which dose.
The risk of side effects increases: if the patient is taking tranquillizers, sleeping pills, other pain relievers such as morphine and codeine (also as cough medicine), and alcohol while receiving Mabron. The patient may feel drowsier or feel that they might faint. If this happens tell the nurse or doctor.
If the patient is taking medicines which may cause convulsions (fits), such as certain antidepressants or antipsychotics. The risk having a fit may increase if the patient receives Mabron at the same time. The doctor will tell the patient whether Mabron is suitable for them.
If the patient is taking certain antidepressants. Mabron may interact with these medicines and the patient may experience symptoms such as involuntary, rhythmic contractions of muscles, including the muscles that control movement of the eye, agitation, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature above 38°C.
If the patient is taking coumarin anticoagulants (medicines for blood thinning), e.g. warfarin, during treatment with Mabron. The effect of these medicines on blood clotting may be affected and bleeding may occur.
Mabron with food and alcohol: Do not drink alcohol during treatment with Mabron as its effect may be intensified. Food does not influence the effect of tramadol.
Caution For Usage
Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines no longer used. These measures will help protect the environment.
Storage
Store below 25°C, in the original package. Do not refrigerate or freeze.
MIMS Class
Analgesics (Opioid)
Presentation/Packing
Inj (amp) 100 mg/2 mL (clear, colourless, sterile) x 10's.
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