Skip to Content

TRAMADOL HYDROCHLORIDE 50 MG CAPSULES

Active substance(s): TRAMADOL HYDROCHLORIDE / TRAMADOL HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

• Drug dependence may occur. If Tramadol hydrochloride 50 mg
capsules 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 you stop
taking Tramadol hydrochloride 50 mg capsules”).
• 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
Reporting of side effects
If you get any 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 Tramadol hydrochloride 50 mg capsules
Keep this medicine out of the sight and reach of children.
Store below 30ºC.
Do not use this medicine after the expiry date which is stated on the
carton, blister and the bottle. 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 Tramadol hydrochloride 50 mg capsules contains
- The active substance is tramadol hydrochloride. Each capsule
contains 50 mg tramadol hydrochloride.
- The other ingredients are:
Capsule powder: Microcrystalline cellulose, sodium starch
glycolate (Type A), colloidal anhydrous silica and magnesium
stearate.
Capsule shell: gelatin, iron oxide yellow (E172) and titanium
dioxide (E171)
Printing ink: Shellac glaze, iron oxide black (E172) and
propylene glycol.
What Tramadol hydrochloride 50 mg capsules looks like and
contents of the pack
Tramadol hydrochloride 50 mg capsules are hard gelatin capsules
with yellow opaque cap and yellow opaque body marked as ‘T50’
with black ink on cap containing a white to off white powder.
Tramadol hydrochloride 50 mg capsules are supplied in following
pack sizes:
Alu/PVC/PVdC blister (60 g/m²) in packs of 10, 30 and 100 capsules
Alu/PVC/PVdC blister (120 g/m²) in packs of 10, 30 and 100 capsules
Alu/PVC/PE/PVdC blister (90 g/m²) in packs of 10, 30 and 100
capsules
HDPE containers of 500 capsules
HDPE containers of 1000 capsules
Not all pack sizes may be marketed.

POM
0167/O/PIL/001/I-3
Marketing Authorisation Holder and Manufacturer
MEDREICH PLC
Warwick House, Plane Tree Crescent,
Feltham TW13 7HF, UK
E-mail : info@medreich.co.uk

To listen to or request a copy of this leaflet in
Braille, large print or audio please call,
02088311580 (UK only)
Please be ready to give the following information:
Product name
Tramadol 50mg Capsules

Reference number
PL 21880/0167

This leaflet was last revised in March 2017

4

121XXXX - V1

Package leaflet: Information for the patient

Tramadol Hydrochloride 50 mg Capsules
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 or pharmacist.
• 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 or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.
What is in this leaflet
1. What Tramadol hydrochloride 50 mg capsules is and what it is
used for
2. What you need to know before you take Tramadol
hydrochloride 50 mg capsules
3. How to take Tramadol hydrochloride 50 mg capsules
4. Possible side effects
5. How to store Tramadol hydrochloride 50 mg capsules
6. Contents of the pack and other information
1. What Tramadol hydrochloride 50 mg capsules is and what it
is used for
Tramadol hydrochloride 50 mg capsules contain the active
ingredient tramadol hydrochloride and it 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.
Tramadol hydrochloride 50 mg capsules are used for the treatment of
moderate to severe pain.
2. What you need to know before you take Tramadol
hydrochloride 50 mg capsules
Do not take Tramadol hydrochloride 50 mg capsules:
- if you are allergic to tramadol 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 Tramadol hydrochloride 50 mg capsules (see
“Other medicines and Tramadol hydrochloride 50 mg capsules”);
- if you are an epileptic and your fits are not adequately controlled
by treatment
- as a substitute in drug withdrawal
Warnings and precautions
Talk to your doctor before taking Tramadol hydrochloride 50
mg capsules
- if you think that you are addicted to other pain relievers
(opioids);
- if you suffer from consciousness disorders (if you feel that you
are going to faint);
- if you are in a state of shock (cold sweat may be a sign of this);
- if you suffer from increased pressure in the brain (possibly after
a head injury or brain disease);
- if you have difficulty in breathing;
- if you have a tendency towards epilepsy or fits because the risk
of a fit may increase;
- if you suffer 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).
Please note that Tramadol hydrochloride 50 mg capsules may lead to
physical and psychological addiction. When Tramadol hydrochloride
50 mg capsules are taken for a long time, its 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 Tramadol hydrochloride 50 mg capsules should only be
carried out for short periods and under strict medical supervision.
Please also inform your doctor if one of these problems occurs
during Tramadol hydrochloride 50 mg capsules treatment or if they
applied to you in the past.
Other medicines and Tramadol hydrochloride 50 mg capsules
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines.
Tramadol hydrochloride 50 mg capsules should not be taken
together with MAO inhibitors (certain medicines for the treatment
of depression).
The pain-relieving effect of Tramadol hydrochloride 50 mg
capsules may be reduced and the length of time it acts may be
shortened, if you take medicines which contain
- carbamazepine (for epileptic fits);
- ondansetron (prevents nausea).
Your doctor will tell you whether you should take Tramadol
hydrochloride 50 mg capsules, and which dose.
The risk of side effects increases,
• if you are taking tranquillizers, sleeping pills, other pain
relievers such as morphine and codeine (also as cough
medicine), and alcohol while you are taking Tramadol
hydrochloride 50 mg capsules. You may feel drowsier or feel
that you might faint. If this happens tell your doctor.
1

This section is continued overleaf

• if you are taking medicines which may cause convulsions (fits),
such as certain antidepressants or antipsychotics. The risk
having a fit may increase if you take Tramadol hydrochloride 50
mg capsules at the same time. Your doctor will tell you whether
Tramadol hydrochloride 50 mg capsules are suitable for you.
• if you are taking certain antidepressants Tramadol
hydrochloride 50 mg 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.
• if you are taking coumarin anticoagulants (medicines for blood
thinning), e.g. warfarin, together with Tramadol hydrochloride
50 mg capsule. The effect of these medicines on blood clotting
may be affected and bleeding may occur.
Tramadol hydrochloride 50 mg capsules with food and alcohol
Do not drink alcohol during treatment with Tramadol
hydrochloride 50 mg capsules as its effect may be intensified.
Food does not influence the effect of Tramadol hydrochloride 50 mg
capsules.
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 Tramadol
hydrochloride 50 mg capsules if you are 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.
Driving and using machines
Tramadol hydrochloride 50 mg capsules 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, 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.
3. How to take Tramadol hydrochloride 50 mg capsules
Always take this medicine exactly as your doctor 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 painrelieving dose should be taken. Do not take more than 400 mg
tramadol hydrochloride daily, except if your doctor has instructed
you to do so.
Unless otherwise prescribed by your doctor, the usual dose is:
Adults and adolescents from the age of 12 years
One or two Tramadol hydrochloride 50 mg capsules (equivalent to
50 mg-100 mg tramadol hydrochloride)
Depending on the pain the effect lasts for about 4-8 hours.
Your doctor may prescribe a different, more appropriate dosage of
Tramadol hydrochloride 50 mg capsules if necessary.
Children
Tramadol hydrochloride 50 mg capsules 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 Tramadol hydrochloride 50 mg capsules. If in your case the
insufficiency is mild or moderate, your doctor may recommend
prolonging the dosage interval.
How and when should you take Tramadol hydrochloride 50 mg
capsules?
Tramadol hydrochloride 50 mg capsules are for oral use.
Always swallow Tramadol hydrochloride 50 mg capsules whole,
not divided or chewed, with sufficient liquid, preferably in the
morning and evening. You may take the capsule on an empty
stomach or with meals.
2

121XXXX - V1

How long should you take Tramadol hydrochloride 50 mg capsules?
You should not take Tramadol hydrochloride 50 mg capsules 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 Tramadol
hydrochloride 50 mg capsules and at what dose.
If you have the impression that the effect of Tramadol
hydrochloride 50 mg capsules is too strong or too weak, talk to your
doctor or pharmacist.
If you take more Tramadol hydrochloride 50 mg capsules 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.
If you (or someone else) swallow a lot of Tramadol hydrochloride 50 mg
capsules at the same time you should go to 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 you forget to take Tramadol hydrochloride 50 mg capsules
If you forget to take the capsule, pain is likely to return. Do not take
a double dose to make up for forgotten individual doses, simply
continue taking the capsule as before.
If you stop taking Tramadol hydrochloride 50 mg capsules
If you interrupt or finish treatment with Tramadol hydrochloride 50
mg capsules 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
Tramadol hydrochloride 50 mg capsules is stopped. However, on
rare occasions, people who have been taking Tramadol
hydrochloride 50 mg capsules for some time may feel unwell if
they abruptly stop taking them. 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 you
experience any of these complaints after stopping Tramadol
hydrochloride 50 mg capsules, 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 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 stop
taking and see your doctor immediately:
The most common side effects during treatment with Tramadol
hydrochloride 50 mg capsules 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 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
• 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
Tramadol hydrochloride 50 mg capsules. 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 (usually
suppression, occasionally increase) and decreased cognitive and
sensory perception (being less aware and less able to make
decisions, which may lead to errors in judgement)
This section is continued overleaf
3

Expand Transcript

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