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TRAMADOL HYDROCHLORIDE 50MG CAPSULES

Active substance(s): TRAMADOL HYDROCHLORIDE

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Tramadol Packinsert front side
Size - 148x350 mm

40gsm Bible paper,
folded to size: 148mm x 37mm

Tramadol Packinsert Back side
Size - 148x350 mm

Please read this leaflet carefully before you start taking your medicine.
• Keep this leaflet; you may need to read it again.
• If you have further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally and you should not pass it on to
others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this
leaflet please tell your doctor or pharmacist.

2.

BEFORE YOU TAKE YOUR MEDICINE

Do not take your medicine if you:
• have previously suffered an allergic reaction to
a medicine containing tramadol hydrochloride
or other opioids
• are allergic to any of the other ingredients in
this medicine (see section 6, More information)
• are taking or have taken monoamine oxidase
inhibitors (MAOIs, medicines used to treat
depression) in the last 2 weeks
• are suffering from uncontrolled epilepsy
• drink large amounts of alcohol regularly or are
dependent/addicted to other drugs
• are undergoing treatment for drug or alcohol
withdrawal
• are pregnant, planning to become pregnant or
are breast-feeding
If the answer is yes to any of the above, please
tell your doctor.
Take special care with your medicine
Always tell your doctor before using this medicine
if you:
• have been or are presently addicted to alcohol
or any other drug
• have a head injury
• are in a state of shock
• experience dizziness while taking this medicine
as it may increase the risk of falling
• have a history of epilepsy or are susceptible to
seizures or convulsions
• have severe liver or kidney problems
• suffer from or have a history of suffering from
peptic (stomach) ulcers – tramadol
hydrochloride may mask the effects of
perforated ulcers
• have any problem with your breathing
If the answer is yes to any of the above, you must
tell your doctor, he may decide to alter your
treatment.

Pharmacode

Taking other medicines
You should consult your doctor BEFORE taking
any other medicine particularly any of the
following:
• Monoamine oxidase inhibitors (MAOIs,
medicines used to treat depression) now or
within the last two weeks, or any other
medicines used for depression (e.g.
amitriptyline, fluoxetine and lithium)
• Selective serotonin reuptake inhibitors (SSRIs)
taken with tramadol hydrochloride may cause
confusion, agitation, fever, sweating,
unsteadiness, muscle rigidity or spasms and
diarrhoea. These symptoms may be an
indication of a serious disorder called serotonin
syndrome. If you experience any of these
symptoms contact your doctor immediately.
• Other medicines which act on the central
nervous system including hypnotics (drugs
used to aid sleeping), painkillers and
anaesthetics
• Carbamazepine (used to treat epilepsy)
• Anticoagulants (drugs used to thin the blood)
for example warfarin
• Ondansetron (prevents nausea)

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

The risk of side effects increases if you are taking:
• medicines which may cause convulsions (fits),
such as certain antidepressants or
antipsychotics. The risk of having a fit may
increase if you take Tramadol Hydrochloride
50mg Capsules at the same time. Your doctor
will tell you whether Tramadol Hydrochloride
50mg Capsules is suitable for you.
• certain antidepressants. Tramadol
Hydrochloride 50mg Capsules 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.

Children
This medicine is not recommended for children
under 12 years.
Patients with kidney or liver complaints
Your doctor may advise you to take the medicine
every 12 hours.
Severe liver or kidney disease (insufficiency)/
dialysis patients
Patients with severe liver and/or kidney
insufficiency should not take Tramadol
Hydrochloride 50mg Capsules. If in your case the
insufficiency is mild or moderate, your doctor may
recommend prolonging the dosage interval.
If you take more of your medicine than you
should
If you or anyone else has swallowed a lot of the
capsules all together contact your nearest hospital
casualty department or doctor immediately. Signs
of an overdose may include narrowed pupils,
being sick, heart problems, sleepiness, coma, fits
and breathing difficulties.

If you are to undergo surgery you should inform
the anaesthetist of your treatment with Tramadol
Hydrochloride 50mg Capsules.
Taking this medicine with food and drink
Do not drink alcohol while taking Tramadol
Hydrochloride 50mg Capsules without first asking
your doctor.

If you forget to take your medicine
If you forget to take a dose, take it as soon as you
remember, then go on as before. Do not take two
doses within approximately two hours of each
other.

Pregnancy and breast-feeding
Do not take this medicine without first consulting
with your doctor if you are pregnant, planning to
become pregnant or are breast-feeding.

If you stop taking your medicine
Always ask your doctor first before you stop taking
your medicine.
In very rare cases, withdrawal symptoms may be
experienced when your treatment is stopped (see
section 4, Possible Side Effects).

Chronic use during pregnancy may lead to
withdrawal symptoms in the newborn baby.
Driving and using machines
This medicine may make you sleepy, confused,
forgetful, unsteady, or affect your concentration or
co-ordination. This may affect your performance
at skilled tasks, e.g. driving or operating
machinery. DO NOT drive or operate machinery if
you are affected.
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

4.

Tell your doctor if you notice any of the
following side effects:

Talk to your doctor or pharmacist if you are not
sure whether it is safe for you to drive while taking
this medicine.

Very common (more than 1 in 10 people)
• dizziness, nausea
Common (more than 1 in 100 people)
• headache, drowsiness, tiredness
• vomiting, constipation, dry mouth
• sweating

Important information about some of the
ingredients of your medicine
This medicine contains lactose monohydrate. If
you have been told by your doctor that you have
an intolerance to some sugars, contact your
doctor before taking this medicinal product.

3.

Uncommon (more than 1 in 1,000 people)
• bloating, diarrhoea
• fast heart beat, feeling faint, low blood pressure
on standing

HOW TO TAKE YOUR MEDICINE

You should take your medicine as directed by
your doctor. The pharmacist’s label should tell you
how much to take and how often. If it does not or
you are not sure ask your doctor or pharmacist.
Your doctor will keep you under regular
supervision while you are taking this medicine,
and will advise you how long to keep taking it.
The capsules should be swallowed with a drink of
water.

CP.TDL.50C.OM.V1P1

POSSIBLE SIDE EFFECTS

This medicine, like most other medicines, may
cause side effects in some people.
STOP taking your medicine and contact your
doctor immediately if you experience:
• allergic reactions – these may include breathing
difficulties (or could make your asthma worse if
you already have asthma), angioedema
(swelling of the skin), itching or a skin rash. If
you experience any of these allergic reactions,
stop taking these capsules immediately and
contact your doctor.

Pharmacode

Tramadol Hydrochloride 50mg Capsules belong to
a group of drugs called opioid analgesics. They
work by acting on sites in the central nervous
system to block the transmission of pain signals.
Tramadol hydrochloride is used for the treatment
and prevention of moderate to severe pain.

The usual doses are as follows:
Adults and children aged 12 years and over
Take one or two capsules. Do not take more often
than every four hours.
Do not take more than eight capsules (400mg) per
day.
Do not take more than the doctor has prescribed.

IN THIS LEAFLET
1. What your medicine is and what it is used for
2. Before you take your medicine
3. How to take your medicine
4. Possible side effects
5. Storing your medicine
6. More information
WHAT YOUR MEDICINE IS AND WHAT
IT IS USED FOR

DOSAGE
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.

• change in mood, change in level of activity, less
able to make decisions
• dependence – see withdrawal symptoms below
• blurred vision
• difficulty passing urine
Not known (cannot be estimated from available
data)
• speech disorders
• shallow breathing – if recommended dose is
exceeded
In very rare cases long-term treatment with
tramadol hydrochloride may lead to dependence
and abuse, with withdrawal symptoms occurring
after stopping treatment. Your doctor will advise
you on this.
Withdrawal symptoms may include:
• agitation, anxiety, panic attacks, nervousness,
confusion, delusion
• sleeping difficulties, restlessness
• hallucinations, paranoia, personality change
• pins and needles, abnormal muscle
movements, shaking
• ringing in the ears
• abdominal pain
• outer body experience
If you experience any of the above or are
concerned about anything or you notice
anything unusual contact your doctor.

5.

STORING YOUR MEDICINE

This medicine should not be used after the expiry
date stated on the pack. The expiry date refers to
the last day of that month.
KEEP OUT OF THE SIGHT AND REACH OF
CHILDREN.
Store below 25°C, in a dry place.
Medicines should not be disposed of via
wastewater and household waste. Ask your
pharmacist how to dispose of medicines no longer
required. These measures will help to protect the
environment.

6.

MORE INFORMATION

What your medicine looks like
Tramadol Hydrochloride 50mg Capsules are green
and yellow in colour and printed with “TRA 50”.
Your medicine comes in pack sizes of 30, 50, 100,
250 and 500 capsules. Not all pack sizes may be
marketed.
What your medicine contains
Each capsule contains 50mg of tramadol
hydrochloride, the active ingredient.
The capsules also contain the inactive ingredients
microcrystalline cellulose, povidone, lactose
monohydrate, sodium starch glycolate and
magnesium stearate. The capsule shell contains
gelatin and the colours titanium dioxide (E171),
indigotin (E132), yellow iron oxide (E172) and
erythrosin (E127). The ink on the capsule shell
contains shellac, propylene glycol and the colour
black iron oxide (E172).
Marketing Authorisation Holder
Athlone Pharmaceuticals Limited, Ballymurray,
Co. Roscommon, Ireland.
Manufacturer responsible for batch release
Kent Pharmaceuticals Limited, Crowbridge Road,
Ashford, Kent, TN24 0GR, U.K.
Kent Pharmaceuticals Limited, Repton Road,
Measham, DE12 7DT, U.K.
Distributor
Kent Pharmaceuticals Limited, Repton Road,
Measham, DE12 7DT, U.K.
PL 30464/0037
This leaflet was last revised May 2015.

Rare (more than 1 in 10,000 people)
• change in appetite
• slow heart rate, high blood pressure
• tingling feeling on the skin
• muscle twitching, uncoordinated movement
• muscle weakness
• shortness of breath
• convulsions, fainting
• hallucinations, confusion, nightmares

CP.TDL.50C.OM.V1P1

Pharmacode

Pharmacode

Pharmacode
Pharmacode

TRAMADOL HYDROCHLORIDE 50mg CAPSULES

Pharmacode

Pharmacode
PATIENT INFORMATION LEAFLET

1.

non printing colour

Designer: TC

Colours

Product: Tramadol Hydrochloride 50mg Capsules PIL
Dimensions: 148mm x 350mm
Item Code: CP.TDL.50C.OM.V1P1
Proof No and Date: 1

21/05/2015

Revision:
ARTWORK FOR SUBMISSION
Supersedes: n/a

Pantone
280 C

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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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