Skip to Content

UK Edition. Click here for US version.

MANEO 200 MG PROLONGED-RELEASE TABLETS

Active substance(s): TRAMADOL HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
MANEO 100 mg,
150 mg AND 200 mg
PROLONGED-RELEASE
TABLETS
(tramadol hydrochloride)

Maneo 100 mg, 150 mg and 200 mg Prolongedrelease tablets are referred to as Maneo Tablets
throughout this leaflet.
Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your
doctor, pharmacist or nurse.
• This medicine has been prescribed for you
only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same
as yours.
• If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Maneo Tablets are and what they are
used for
2. What you need to know before you take
Maneo Tablets
3. How to take Maneo Tablets
4. Possible side effects
5. How to store Maneo Tablets
6. Content of the pack and other information

1. What Maneo tablets are and what they
are used for
Maneo Tablets contain the active substance tramadol
hydrochloride. Tramadol hydrochloride is a painkiller
belonging to the class of opioids that act on the
central nervous system. It relieves pain by acting on
specific nerve cells of the spinal cord and brain.

The risk of side effects increases if:
• You take tranquillisers, sleeping pills, other pain
relievers such as morphine and codeine (also as
cough medicine), and alcohol while you are taking
this medicine. You may feel drowsier or feel that
you may faint. If this happens tell your doctor.
• You are taking medicines which may cause
convulsions (fits), such as certain antidepressants
(e.g. selective serotonin re-uptake inhibitors
(SSRIs), serotonin-norepinephrine reuptake
inhibitors (SNRIs), tricyclic anti-depressants)
or antipsychotics. The risk of having a fit may
increase if you take this medicine at the same
time. Your doctor will tell you whether Maneo
Tablets are suitable for you.
• You are taking certain antidepressants (e.g. selective
serotonin reuptake inhibitors (SSRIs), serotoninnorepinephrine reuptake inhibitors (SNRIs), tricyclic
antidepressants or mirtazapine). Maneo Tablets
may interact with these medicines and you 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.
• You take coumarin anticoagulants (medicines for
blood thinning), e.g. warfarin, together with this
medicine. The effect of these medicines on blood
clotting may be affected and bleeding may occur.

Maneo Tablets with food, drink and alcohol.

Do not drink alcohol during treatment with Maneo
Tablets as their effect may be intensified. Food
does not influence the effect of Maneo Tablets.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this
medicine. There is very little information regarding
the safety of tramadol in human pregnancy.
Therefore you should not use Maneo Tablets if you
are pregnant. Chronic use during pregnancy may
lead to withdrawal symptoms in newborns.

2. What you need to know before you
take Maneo Tablets

Generally, the use of tramadol hydrochloride is
not recommended during breast-feeding. Small
amounts of tramadol hydrochloride are excreted
into breast milk. With a single dose it is usually not
necessary to interrupt breast-feeding. Please ask
your doctor for advice.
Based on human experience, tramadol hydrochloride
is suggested not to influence female or male fertility.

Do not take Maneo Tablets:

Driving and using machines

Maneo Tablets are used for the treatment of
moderate to severe pain in adults and children
over 12 years of age.

• if you are allergic to tramadol or any of the other
ingredients of this medicine (listed in section 6).
An allergic reaction may include rash, itching,
difficulty breathing or swelling of the face, lips,
throat or tongue
• if you have drunk too much alcohol or taken too
many sleeping tablets, pain killers, opiates or
other psychotropic medicines (medicines that
affect mood and emotions)
• if you are also taking MAOIs (monoamine oxidase
inhibitors used to treat depression or Parkinson’s)
or have taken them in the last 14 days before
treatment with Maneo Tablets
• if you are an epileptic and your fits are not
adequately controlled by treatment
• as a substitute in drug withdrawal treatment.

Warnings and precautions

TBC
1122111

Talk to your doctor or pharmacist before taking
Maneo Tablets if you:
• think you are addicted to other pain
killers (opioids)
• suffer from an increased pressure in the brain,
causing symptoms such as headache and vomiting
(possibly after a head injury or brain disease)
• suffer from consciousness disorders (e.g. if you
feel that you are going to faint)
• are in a state of shock (cold sweat may be a sign
of this)
• have difficulty in breathing
• have a tendency towards epilepsy or fits,
because the risk of a fit may increase
• suffer from kidney or liver disease;
In such cases please consult your doctor before
taking the medicine.

During treatment

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 (400mg).
Please note that Maneo Tablets may lead to
physical and psychological addiction. When
Maneo Tablets are taken for a long time, their
effect may decrease so that higher doses have
to be taken (tolerance development). In patients
with a tendency to abuse medicines or who are
dependent on medicines, treatment with this
medicine should only be carried out for short
periods and under strict medical supervision.
Please also inform your doctor if one of these
problems occur during Maneo Tablets treatment
or if they applied to you in the past.

Other medicines and Maneo Tablets

Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines, including medicines obtained without
a prescription, herbal medicines or any of
the following:
• Do not take Maneo Tablets at the same
time, or within 14 days of taking MAOIs (e.g.
moclobemide or phenelzine for depression,
selegiline for Parkinson’s disease).
The pain relieving effect of Maneo Tablets may
be weakened or shortened if you also take
medicines containing:
• carbamazepine (used to treat epilepsy)
• buprenorphine, nabulphine or pentazocine
(pain killers)
• ondansetron (prevents nausea)

Maneo Tablets may cause drowsiness, dizziness
and blurred vision and therefore may impair
your reactions. If you feel that your reactions are
affected, do not drive a car or other vehicle, and
do not use electric tools or operate machinery.
The medicine can affect your ability to drive as it
may make you sleepy or dizzy.
• Do not drive while taking this medicine until you
know how it affects you.
• It is an offence to drive if this medicine affects
your ability to drive.
• However, you would not be committing an
offence if:
* The medicine has been prescribed to treat a
medical or dental problem and
* You have taken it according to the instructions
given by the prescriber or in the information
provided with the medicine and
* It was not affecting your ability to drive safely.
Talk to your doctor or pharmacist if you are not
sure whether it is safe for you to drive while taking
this medicine.

Maneo Tablets contain lactose

This medicine contains lactose, a type of sugar.
If you have been told by your doctor that you
have an intolerance to some sugars, contact your
doctor before taking this medicine.

3. How to take Maneo Tablets
Dosage

Always take 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 children over 12 years of age:

Maneo 100 mg Tablets: one tablet (100 mg
tramadol hydrochloride) twice a day, preferably in
the morning and evening.
If this is not sufficient to kill the pain the dose can
be increased to:
Maneo 150 mg Tablets: one tablet (150 mg
tramadol hydrochloride) twice a day, preferably in
the morning and evening.
or:
Maneo 200 mg Tablets: one tablet (200 mg
tramadol hydrochloride) twice a day, preferably in
the morning and evening.
Your doctor may prescribe a different, more
appropriate dosage strength of Maneo Tablets
if necessary.
Do not take more than 400 mg of tramadol
hydrochloride daily, except if your doctor has
instructed you to do so.

Use in children:

Do not give Maneo Tablets to children below the
age of 12 years.

Elderly patients:

In elderly patients (over 75 years) the excretion
of tramadol hydrochloride may be delayed. If
this applies to you, your doctor may recommend
prolonging the dosage interval.

Date: 25 May 2015
Description Tramadol Hydrochloride 200/100/150mg 60
Component Type Leaflet

Pharma Code TBC

Affiliate Item Code 609161

SAP No. N/A

Superceded Affiliate Item Code 484306
TrackWise PR No. 609161
MA No. 04569/1406 - 1408

Vendor Job No. 251553
Proof No. 3
Client Market UK

Packing Site/Printer N/A

Keyline/Drawing No. N/A

Supplier Code N/A

Barcode Info N/A

Sign-offs

TBC
1122111

Package leaflet: Information for the patient

No. of colours
Colours

1

Time: 13:56
Page Count

1/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro

Body Text Size 9.5 pt

Dimensions 170 x 480mm

Min Text Size used 9.5 pt

Severe liver and/or kidney disease
(insufficiency) / dialysis patients:

Patients with severe liver and/or kidney
insufficiency should not take Maneo Tablets. If in
your case the insufficiency is mild or moderate,
your doctor may recommend prolonging the
dosage interval.

Method of administration

Always swallow the tablets whole with a glass of
water, preferably in the morning and evening. Do
not break, chew or crush them. You can take the
tablets on an empty stomach or with food.

Duration of treatment

Your doctor will tell you how long you should use
Maneo Tablets. This depends on the cause of the
pain. You should not take Maneo Tablets for longer
than necessary. If you need to be treated for a longer
period, your doctor will check at regular short
intervals whether you should continue to take Maneo
Tablets and at what dose. If necessary you may have
breaks in your treatment. If you have the impression
that the effect of this medicine is too strong or too
weak, talk to your doctor or pharmacist.

If you take more Maneo Tablets than you should

If you (or someone else) take more Maneo Tablets
than you should talk to your doctor or go to
your nearest hospital emergency department
immediately. You may feel sick, notice small
(constricted) pupils, feel dizzy due to a fall in blood
pressure, lose consciousness, fall into a coma,
experience fits (convulsions) or have difficulty
breathing which may be severe.

If you forget to take Maneo Tablets

If you forget to take your tablets, pain is likely to
return. Take your dose as soon as you remember
unless it is almost time for your next dose. Do not
take a double dose to make up for a forgotten dose.

If you stop taking Maneo Tablets

If you interrupt or finish treatment with this
medicine 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 Maneo Tablets is stopped.
However, on rare occasions, people who have
been taking Maneo 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 rarely, people may experience confusion,
panic attacks, delusions of persecution (paranoia),
hallucinations, change in perception of reality
(derealisation) or feeling a loss of identity
(depersonalization). They may experience
unusual perceptions such as itching, tingling and
numbness, and “ringing” in the ears (tinnitus).
If you experience any of these complaints after
stopping Maneo 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.
If you get any of the following contact your
doctor straight away or seek emergency
help immediately:
Rare: may affect up to 1 in 1,000 people
• allergic reactions e.g. difficulty breathing,
wheezing or swelling of skin,
• swollen face, tongue and/or throat and/or
difficulty to swallow or hives together with
difficulties in breathing,
• shock/sudden circulation failure,
• fits (seizures).

Other side effects:
Very common: may affect more than 1 in
10 people
• dizziness
• feeling sick
Common: may affect up to 1 in 10 people
• headache, drowsiness
• being sick, constipation, dry mouth
• tiredness
• sweating
Uncommon: may affect up to 1 in 100 people
• 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
• urge to be sick (retching), stomach trouble
(e.g. feeling of pressure in the stomach,
bloating), diarrhoea
• skin reactions (e.g. itching, rash)
Rare: may affect up to 1 in 1,000 people
• slow heart beat, increase in blood pressure
• slow breathing and shortness of
breath (dyspnoea)
• changes in appetite, abnormal sensations (e.g.
itching, tingling, numbness), trembling
• muscle twitches, weak muscles,
uncoordinated movement
• fainting (syncope)
• speech disorders
• blurred vision, small (constricted) pupil,
dilated pupils
• difficulty or pain when passing water, less urine
than normal
• hallucinations (seeing, feeling or hearing things
that are not real), confusion, sleep disorders,
anxiety, change in mood and attention (delirium)
and nightmares

Psychological complaints may appear after treatment
with Maneo 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.
Very rare: may affect up to 1 in 10,000 people
• increase in liver enzyme values
Not known (frequency cannot be estimated from
the available data):
• low sugar levels in the blood (hypoglycaemia)
• worsening of asthma, however it has not
been established whether it was caused by
tramadol hydrochloride.
If the recommended doses are exceeded, or if
other medicines that depress brain function are
taken at the same time, breathing may slow down.
If Maneo 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 Maneo Tablets’).

Reporting of side effects

If you get any side effects, talk to your doctor,
pharmacist or nurse. 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 Maneo Tablets
Keep this medicine out of the sight and reach
of children.
This medicine does not require any special
storage conditions.
Do not use this medicine if you notice the tablets
become discoloured or show any other signs of
deterioration and talk to your pharmacist who will
tell you what to do.
Do not use this medicine after the expiry date
which is stated on the carton or bottle after EXP.
The expiry date refers to the last day of that month.
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 protect the environment.

6. Contents of the pack and
other information
What Maneo Tablets contain

• The active substance is tramadol (as hydrochloride).
Each prolonged- release tablet contains: 100 mg,
150 mg or 200 mg of the active substance.
• The other ingredients are microcrystalline
cellulose, hypromellose, colloidal anhydrous
silica, magnesium stearate
• The tablet coating contains the following:
hypromellose, lactose monohydrate, talc,
macrogol, propylene glycol, titanium dioxide.
Maneo 150 mg and 200 mg Prolonged-release
tablets also contain iron oxide red (E172) and
lake quinoline yellow (E104). Maneo 150 mg
Prolonged-release tablets in addition contain
iron oxide brown (E172).

What Maneo Tablets look like and contents of
the pack

Maneo 100 mg Prolonged-release tablets are
white to off white, round, film coated tablet
debossed with “M” on one side and “TM1” on
other side.
Maneo 150 mg Prolonged-release tablets are pale
orange coloured, oval-shaped, film coated tablet,
debossed with “M” on one side and “TM2” on other
side.
Maneo 200 mg Prolonged-release tablets are
brownish orange coloured, capsule shaped, film
coated tablet debossed with “M” on one side and
“TM3” on other side.
Maneo Tablets are packed in:
• blisters and are supplied in cardboard cartons
containing 10, 20, 28, 30, 50, 56, 60, 90 and
100 prolonged-release tablets.
• HDPE Bottles with polypropylene child-resistant
closures containing 100 prolonged-release tablets.
• HDPE Bottles with polypropylene screw closures
containing 500 and 1000 prolonged-release
tablets (dispensing package).
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan
Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom

Manufacturer

Generics [UK] Ltd.
Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom
Gerard Laboratories
35/36 Baldoyle Industrial Estate,
Grange Road, Dublin 13,
Ireland
Mylan Hungary Kft.
H-2900 Komárom,
Mylan utca 1,
Hungary

This leaflet was last revised in 05/2015

Date: 25 May 2015
Description Tramadol Hydrochloride 200/100/150mg 60
Component Type Leaflet

Pharma Code TBC

Affiliate Item Code 609161

SAP No. N/A

Superceded Affiliate Item Code 484306
TrackWise PR No. 609161
MA No. 04569/1406 - 1408

Vendor Job No. 251553
Proof No. 3
Client Market UK

Packing Site/Printer N/A

Keyline/Drawing No. N/A

Supplier Code N/A

Barcode Info N/A

Sign-offs

No. of colours
Colours

1

609161

Time: 13:56
Page Count

2/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro

Body Text Size 9.5 pt

Dimensions 170 x 480mm

Min Text Size used 9.5 pt

Expand view ⇕

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.

Hide