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MABRON 150MG PROLONGED RELEASE TABLETS

Active substance(s): TRAMADOL HYDROCHLORIDE

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231-30-87190-E LEA TRAMADOL HCL (MABRON) A/S PR TAB TUK XMOR

TEVA UK Ref:

Version:

1

20 June 2014

Mabron 100 mg, 150 mg and 200 mg
Prolonged Release Tablets

suitable for you.
• if you are taking certain antidepressants. Mabron
Tablets may interact with these medicines and you
Tramadol Hydrochloride
may experience symptoms such as involuntary,
rhythmic contractions of muscles, including the
Package leaflet: Information for the user
muscles that control movement of the eye, agitation,
Read all of this leaflet carefully before you start
excessive sweating, tremor, exaggeration of reflexes,
taking this medicine because it contains important
increased muscle tension and body temperature
information for you.
above 38°C.
• Keep this leaflet. You may need to read it again.
• if you take coumarin anticoagulants (medicines for
• If you have any further questions, ask your doctor
blood thinning), such as warfarin, together with
or pharmacist.
Mabron Tablets. The effect of these medicines on blood
• This medicine has been prescribed for you only. Do
clotting may be affected and bleeding may occur.
not pass it on to others. It may harm them, even if
• if you take tranquillizers, sleeping pills, other pain
their signs of illness are the same as yours.
relievers such as morphine and codeine (also as
• If you get any side effects talk to your doctor or
cough medicine), and alcohol while you are taking
pharmacist. This includes any possible side effects
Mabron Tablets. You may feel drowsier or feel that
not listed in the leaflet. See section 4.
you might faint. If this happens tell your doctor.
What is in this leaflet:
Taking Mabron Tablets with food and alcohol:
1. What Mabron Tablets are and what they are used for Do not drink alcohol during treatment with Mabron
Tablets as its effect may be intensified. Food does not
2. What you need to know before you take Mabron
influence the effect of Mabron Tablets.
Tablets
3. How to take Mabron Tablets
Pregnancy, breast-feeding and fertility:
4. Possible side effects
If you are pregnant or breast-feeding, think you may
5. How to store Mabron Tablets
be pregnant or are planning to have a baby, ask your
6. Contents of the pack and other information
doctor or pharmacist for advice before taking this
medicine.
Mabron Tablets are and what they are There is very little information regarding the safety of
1 What
used for
tramadol in human pregnancy. Therefore you should
Tramadol – the active substance in Mabron Tablets is not use Mabron Tablets if you are pregnant. Chronic
a pain killer belonging to the class of opioids that acts use during pregnancy may lead to withdrawal
on the central nervous system. Mabron Tablets relieve symptoms in newborns.
pain by acting on specific nerve cells of the brain and Generally, the use of Mabron Tablets is not
spinal cord.
recommended during breast-feeding. Small amounts
Mabron Tablets are used for the treatment of moderate of tramadol are excreted into breast milk. On a single
dose it is usually not necessary to interrupt
to severe pain.
breast-feeding. Please ask your doctor for advice.

2

What you need to know before you take
Mabron Tablets

Driving and using machines:
Mabron Tablets can cause drowsiness, dizziness, and
blurred vision and therefore may impair your
Do not take Mabron Tablets:
• If you are allergic to tramadol hydrochloride or any reactions. If you feel that your reactions are affected,
do not drive a car or other vehicle, do not use electric
of the other ingredients of this medicine (listed in
tools or operate machinery.
section 6)
• In acute poisoning with alcohol, sleeping pills, pain This medicine can affect your ability to drive as it may
make you sleepy or dizzy.
relievers, or other psychotropic medicines
• Do not drive while taking this medicine until you
(medicines that affect mood and emotions)
know how it affects you.
• If you are also taking MAO-inhibitors (certain
medicines used for treatment of depression) or have • It is an offence to drive if this medicine affects your
ability to drive.
taken them in the last 14 days before treatment with
• However you would not be committing an offence if:
Mabron Tablets (see “Other medicines and Mabron
• The medicine has been prescribed to treat a
Tablets”)
medical or dental problem and
• If you are epileptic and your fits are not adequately
• You have taken it according to the instructions
controlled by treatment
given by the prescriber or in the information
• As a substitute in drug withdrawal.
provided with the medicine and
Warnings and precautions:
• It was not affecting your ability to drive safely.
Talk to your doctor or pharmacist before taking
Talk to you doctor or pharmacist if you are not sure
Mabron Tablets if:
whether it is safe to drive while taking this medicine.
• You think that you are addicted to other pain
relievers (opioids);
How to take Mabron Tablets
• You suffer from consciousness disorders (if you feel 3
that you are going to faint);
Always use this medicine exactly as your doctor or
• You are in a state of shock (cold sweat may be a
pharmacist has told you. Check with your doctor or
sign of this);
pharmacist if you are not sure.
• You suffer from increased pressure in the brain
The dosage should be adjusted to the intensity of your
(possibly after a head injury or brain disease);
pain and your individual pain sensitivity. In general
• You suffer from a liver or kidney disease;
the lowest pain-relieving dose should be taken.
• You have difficulty in breathing;
Unless otherwise prescribed by your doctor, the
• You have a tendency towards epilepsy or fits
recommended dose is:
because the risk of a fit may increase.
Adults and adolescents from the age of 12 years:
Epileptic fits have been reported in patients taking
One Mabron 100 mg Tablet twice daily (equivalent to
tramadol at the recommended dose level. The risk
200 mg tramadol hydrochloride per day), preferably
may be increased when doses of tramadol exceed the in the morning and evening.
recommended upper daily dose limit (400 mg).
One Mabron 150 mg Tablet twice daily (equivalent to
Please note that Mabron Tablets may lead to physical 300 mg tramadol hydrochloride per day), preferably
and psychological addiction. When Mabron Tablets are in the morning and evening.
taken for a long time, its effect may decrease, so that One Mabron 200 mg Tablet twice daily (equivalent to
higher doses have to be taken (tolerance development). 400 mg tramadol hydrochloride per day), preferably
In patients with a tendency to abuse medicines or who in the morning and evening.
are dependent on medicines, treatment with Mabron Your doctor may prescribe a different, more appropriate
Tablets should only be carried out for short periods and dosage strength of Mabron Tablets if necessary.
Do not take more than 400 mg tramadol hydrochloride
under strict medical supervision.
Please also inform your doctor if one of these problems daily, except if your doctor has instructed you to do so.
occurs during treatment with Mabron Tablets or if they Use in children
applied in the past.
Mabron Tablets are not suitable for children below the
age of 12 years.
Other medicines and Mabron Tablets:
Tell your doctor or pharmacist if you are taking, or
Elderly patients
have recently taken, any other medicines.
In elderly patients (above 75 years) the excretion of
Mabron Tablets should not be taken together with MAO tramadol may be delayed. If this applies to you, your
doctor may recommend prolonging the dosage
inhibitors (certain medicines for the treatment of
interval.
depression).
Severe liver or kidney disease (insufficiency)/dialysis
The pain relieving effect of Mabron Tablets may be
patients
reduced and the length of time it acts may be
Patients with severe liver and/or kidney insufficiency
shortened, if you also take medicines containing:
should not take Mabron Tablets. If in your case the
• Carbamazepine (for epileptic fits)
insufficiency is mild or moderate, your doctor may
• Buprenorphine, nalbuphine, or pentazocine (pain
recommend prolonging the dosage interval.
killers)
• Ondansetron (prevents nausea).
How and when you should take Mabron Tablets:
Your doctor will tell you whether you should take
Mabron Tablets are for oral use.
Mabron Tablets and what dose.
Always swallow Mabron Tablets whole, not divided or
The risk of side effects increases:
chewed, with sufficient liquid, preferably in the
• if you are taking medicines which may cause
morning and evening. You may take the tablets on an
convulsions (fits). Such as certain antidepressants or empty stomach or with meals.
antipsychotics. The risk of having a fit may increase
How long should you take Mabron Tablets:
if you take Mabron Tablets at the same time. Your
You should not take Mabron Tablets for longer than
doctor will tell you whether Mabron Tablets are

TEVA UK Ref:

231-30-87190-E LEA TRAMADOL HCL (MABRON) A/S PR TAB TUK XMOR

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
If you interrupt or finish treatment with Mabron
Tablets too soon, pain is likely to return. If you wish to
stop treatment on account of unpleasant effects,
please tell your doctor.
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 out of 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 judgement.
Dependence may occur.
Eye disorders
Rare: blurred vision.

Version:

1

20 June 2014

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.
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.
If Mabron Tablets are 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 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:
www.mhra.gov.uk/yellowcard. 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 100 mg Tablets are off white, round biconvex
tablets
Mabron 150 mg Tablets are off white, capsule shaped
tablets
Mabron 200 mg Tablets are off white, capsule shaped
tablets
Mabron 100 mg Tablets: packs of 10, 20, 30, 50, 60, 90,
100, 120, 180 or 500 white tablets in blisters or in
plastic tablet containers.
Mabron 150 mg Tablets: packs of 10, 20, 30, 50, 60, 90,
100, 120, 180 or 500 white tablets in blisters or in
plastic tablet containers.
Mabron 200 mg 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 Limited,
115 Narborough Road,
Leicester, LE3 0PA, 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 June 2014
87190-E
180 x 400

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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