Patient leaflet - MABRON 200 MG PROLONGED-RELEASE TABLETS
2. What you need to know before you take Mabron Tablets.
3. How to take Mabron Tablets.
4. Possible side effects.
5. How to store Mabron Tablets.
6. Contents of the pack and other information.
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1. What Mabron Tablets are and what they are used for
Tramadol – the active substance in Mabron Tablets is a pain killer belonging to the class of opioids that acts on the central nervous system. Mabron Tablets relieve pain by acting on specific nerve cells of the brain and spinal cord.
Mabron Tablets are used for the treatment of moderate to severe pain.
2. what you need to know before you take mabron tablets
Do not take Mabron Tablets:
! If you are allergic to tramadol hydrochloride or any of the other ingredients of this medicine (listed in section 6).
! In acute poisoning with alcohol, sleeping pills, pain relievers, or other psychotropic medicines (medicines that affect mood and emotions).
! If you are also taking MAO-inhibitors (certain medicines used for treatment of depression) or have taken them in the last 14 days before treatment with Mabron Tablets (see “Other medicines and Mabron Tablets”).
! If you are epileptic and your fits are not adequately controlled by treatment.
! As a substitute in drug withdrawal.
Warnings and precautions:
Talk to your doctor or pharmacist before taking Mabron Tablets if:
! You think that you are addicted to other pain relievers (opioids);
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! You suffer from consciousness disorders (if you feel that you are going to faint);
3. how to take mabron tablets
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The dosage should be adjusted to the intensity of your pain and your individual pain sensitivity. In general the lowest pain-relieving dose should be taken.
Unless otherwise prescribed by your doctor, the recommended dose is:
Adults and adolescents from the age of 12 years:
One Mabron 100mg Tablet twice daily (equivalent to 200 mg tramadol hydrochloride per day), preferably in the morning and evening.
One Mabron 150mg Tablet twice daily (equivalent to 300 mg tramadol hydrochloride per day), preferably in the morning and evening.
One Mabron 200mg Tablet twice daily (equivalent to 400 mg tramadol hydrochloride per day), preferably in the morning and evening.
Your doctor may prescribe a different, more appropriate dosage strength of Mabron Tablets if necessary.
Do not take more than 400 mg tramadol hydrochloride daily, except if your doctor has instructed you to do so.
Use in children
Mabron Tablets are not suitable for children below the age of 12 years.
Elderly patients
In elderly patients (above 75 years) the excretion of tramadol may be delayed. If this applies to you, your doctor may recommend prolonging the dosage interval.
Severe liver or kidney disease (insufficiency)/dialysis patients Patients with severe liver and/or kidney insufficiency should not take Mabron Tablets. If in your case the insufficiency is mild or moderate, your doctor may recommend prolonging the dosage interval.
How and when you should take Mabron Tablets: Mabron Tablets are for oral use.
Always swallow Mabron Tablets whole, not divided or chewed, with sufficient liquid, preferably in the morning and evening. You may take the tablets on an empty stomach or with meals.
How long should you take Mabron Tablets:
You should not take Mabron Tablets for longer than necessary. If you need to be treated for a longer period, your doctor will check at regular short intervals (if necessary with breaks in treatment) whether you should continue to take Mabron Tablets and at what dose.
If you have the impression that the effect of Mabron Tablets is too strong or too weak, talk to your doctor or pharmacist.
If you take more Mabron Tablets than you should:
If you have taken an additional dose by mistake, this will generally have no negative effects. You should take your next dose as prescribed.
After taking very high doses, pin-point pupils, vomiting, fall in blood pressure, fast heart beat, collapse, disturbed consciousness up to coma (deep unconsciousness), epileptic fits, and difficulty in breathing up to cessation of breathing may occur. In such cases a doctor should be called immediately!
If you forget to take Mabron Tablets
If you forgot to take the tablets, pain is likely to return. Do not take a double dose to make up for forgotten individual doses, simply continue taking tablets as before.
If you stop taking Mabron Tablets
You should not suddenly stop taking this medicine unless your doctor tells you to. If you want to stop taking your medicine, discuss this with your doctor first, particularly if you have been taking it for a long time. Your doctor will advise you when and how to stop, which may be by lowering the dose gradually to reduce the chance of developing unnecessary side effects (withdrawal symptoms).
Generally there will be no after-effects when treatment with Mabron Tablets is stopped. However, on rare occasions, people who have been taking Mabron Tablets for some time may feel unwell if they abruptly stop taking them. They may feel agitated, anxious, nervous or shaky. They may be confused, hyperactive, have difficulty sleeping and have stomach or bowel disorders. Very few people may get panic attacks, hallucinations, delusions, paranoia or feeling a loss of identity. They may experience 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 their own personality (depersonalisation), and change in perception of reality (derealisation) and delusion of persecution (paranoia) have been seen very rarely. If you experience any of these complaints after stopping Mabron Tablets, please consult your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Usually the frequency of side effects is classified as follows:
! very common (may affect more than 1 in 10 people),
! common (may affect up to 1 in 10 people),
! uncommon (may affect up to 1 in 100 people),
! rare (may affect up to 1 in 1,000 people)
! very rare (may affect up to 1 user in 10,000)
! not known (frequency cannot be estimated from the available data).
You should see a doctor immediately if you 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 Tablets are nausea and dizziness, which occur in more than in 1 in 10 patients.
Heart and blood circulation disorders
Uncommon: effects on the heart and blood circulation (pounding of the heart, fast heart beat, feeling faint or collapse). These adverse effects may particularly occur in patients in an upright position or under physical strain.
Rare: slow heart beat, increase in blood pressure.
Metabolism and nutrition disorders
Not known: decrease in blood sugar level
Nervous system disorders
Very common: dizziness.
Common: headaches, drowsiness.
Rare: changes in appetite, abnormal sensations (e.g. itching, tingling, numbness), trembling, slow breathing, epileptic fits, muscle twitches, uncoordinated movement, transient loss of consciousness (syncope).
If the recommended doses are exceeded, or if other medicines that depress brain function are taken at the same time, breathing may slow down.
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.
Not known: speech disorders
Psychiatric disorders
Rare: hallucinations, confusion, sleep disorders, anxiety and nightmares.
Psychological complaints may appear after treatment with Mabron Tablets. 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 being less aware and less able to make decisions, which may lead to errors in judgment.
Dependence may occur.
Eye disorders
Rare: blurred vision.
Not known: extreme pupil dilation (mydriasis).
Respiratory disorders
Rare: shortness of breath (dyspnoea).
Worsening of asthma has been reported, however it has not been established whether it was caused by tramadol.
Not known: hiccups
Stomach and bowel disorders
Very common: feeling sick.
Common: being sick, constipation, dry mouth.
Uncommon: urge to vomit (retching), stomach trouble (e.g. feeling of pressure in the stomach, bloating), diarrhoea.
Skin disorders
Common: sweating.
Uncommon: skin reactions (e.g. itching, rash).
Muscle disorders
Rare: weak muscles.
Liver and biliary disorders
Very rare: increase in liver enzyme values.
Urinary disorders
Rare: passing urine with difficulty or pain, passing less urine than normal
General disorders
Common: fatigue.
Rare: allergic reactions (e.g. difficulty breathing, wheezing, swelling of the skin) and shock (sudden circulatory failure) come in very rare cases.
When treatment is stopped abruptly signs of withdrawal may appear (see “If you stop taking Mabron Tablets”).
Reporting of side effects
If you get any of the side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. how to store mabron tablets
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and / or bottle and the carton after “EXP”. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. contents of the pack and other information
What Mabron Tablets contain :
The active substance is: tramadol hydrochloride
! 1 Mabron 100 mg tablet contains 100 mg tramadol
hydrochloride
! 1 Mabron 150 mg tablet contains 150 mg tramadol
hydrochloride
! 1 Mabron 200 mg tablet contains 200 mg tramadol
hydrochloride
The other ingredients are: calcium hydrogen phosphate dihydrate (E341), hydroxypropyl cellulose (E463), colloidal anhydrous silica (E551), and magnesium stearate (E470b).
What Mabron Tablets look like and contents of the pack
Mabron 100mg Tablets are off white, round biconvex tablets
Mabron 150mg Tablets are off white, capsule shaped tablets
Mabron 200mg Tablets are off white, capsule shaped tablets
Mabron 100mg Tablets: packs of 10, 20, 30, 50, 60, 90, 100, 120, 180 or 500 white tablets in blisters or in plastic tablet containers.
Mabron 150mg Tablets: packs of 10, 20, 30, 50, 60, 90, 100, 120, 180 or 500 white tablets in blisters or in plastic tablet containers.
Mabron 200mg Tablets: packs of 10, 20, 30, 50, 60, 90, 100, 120, 180 or 500 white tablets in blisters or in plastic tablet containers.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Morningside Healthcare Ltd.
Unit C, Harcourt Way
Leicester, LE19 1WP, UK
Manufacturers:
Farmaceutisch Analytisch Laboratorium Duiven BV,
Dijkgraaf 30, 6921 RL Duiven, The Netherlands.
Medochemie Ltd
Facility A-Z, Ayios Athanassios Industrial St, Limassol,
Cyprus
This leaflet was last revised in April 2021.