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TRAMADOL 50 MG CAPSULES

Active substance(s): TRAMADOL HYDROCHLORIDE

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Tramadol 50 mg capsules, hard
Tramadol hydrochloride
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 is and what it is used for
2. What you need to know before you take Tramadol
3. How to take Tramadol
4. Possible side effects
5. How to store Tramadol
6. Contents of the pack and other information
1. What Tramadol is and what it is used for
Tramadol hydrochloride - the active substance in Tramadol - 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 is used for the treatment of moderate to severe pain.
You must talk to a doctor if you do not feel better or if you feel
worse after number of days.
2. What you need to know before you take Tramadol
Do not take Tramadol
- if you are allergic to active substance or any of the other
ingredients of this medicine (listed in section 6).
- if you are under the influence of alcohol or sedative drugs
including sleeping pills, other pain-killers or tranquiliser
medicines
- if you are taking, or have taken in the last two weeks, certain
medicines called “monoamine oxidase inhibitors” or MAOIs
(used to treat e.g. depression, and the antibiotic linezolid). The
combination could result in a serious, potentially life threatening
interaction
- if you have epilepsy that is not controlled with your current
medicine;
- as a substitute in drug withdrawal.
Warnings and precautions
Talk to your doctor or pharmacist before taking Tramadol

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if you suffer from epilepsy or seizures (fits) or have had them in
the past because tramadol could increase the risk of you having
further fits
if you have liver or kidney problems.

As with all painkillers of this type (opioid analgesics), tramadol
should be used with caution, and only under medical supervision in
seriously ill patients including those with breathing difficulties,
excessively low blood pressure (shock), decreased consciousness,
serious head injury or brain diseases that may cause elevated
pressure in the skull.
As with all medicines of this type, tramadol may lead to
psychological and physical dependence or addiction in some
people, especially with long term use. The dose needed to achieve
the desired effect may increase with time. Tramadol should be used
with caution, and only for short periods, in patients who are
addicted to other opioid pain-killers.
Other medicines and Tramadol
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines.
Do not take Tramadol at the same time as medicines called
“monoamine oxidase inhibitors” or MAOIs (which are used to treat
e.g. depression), or if you have taken MAOIs in the past 2 weeks.

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Tramadol 50 mg

Package leaflet: Information for the user

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Tramadol 50 mg

Pharmacode position may change as per Supplier's m/c requirement &additional
small pharma code may appear on the front / back panel

The pain-relieving effect of Tramadol may be weakened and/or
shortened if you also take medicines containing:
- carbamazepine (used to treat epilepsy)
- pentazocine, nalbuphine or buprenorphine (pain killers)
- ondansetron (used to stop you feeling sick).
The risk of side effects increases if you take Tramadol at the same
time as:
- 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 at the same time.
Your doctor will tell you whether Tramadol is suitable for you.
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if you are taking certain antidepressants. Tramadol 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.
sedative medicines such as tranquillizers, sleeping pills,
antidepressants and other pain relievers (morphine, codeine);
you may feel excessively drowsy or feel that you might faint
medicines that prevent blood clotting, such as warfarin; the
dose of these medicines may need to be reduced, otherwise
there could be an increased risk of potentially serious bleeding.

Tramadol with food and drink and alcohol
You should not drink alcohol during treament with Tramadol, as its
effect may be intensified.
Pregnancy, breast-feeding and fertility
Always take use this medicine exactly as your doctor or pharmacist
has told you. Check with your doctor or pharmacist if you are not
sure.
There is very little information regarding the safety of tramadol
during pregnancy. Tramadol should therefore not be used during
pregnancy. If you become pregnant you should inform your doctor
as soon as possible.
Generally, the use of tramadol is not recommended during breastfeeding as small amounts of tramadol are excreted into breast milk.
On a single dose it is usually not necessary to interrupt breastfeeding. Ask your doctor for advice.
Driving and using machines
Tramadol may cause side effects such as sleepiness and
dizziness. If this happens, do not drive or operate machinery.
3. How to take Tramadol
Always take use this medicine exactly as your doctor or pharmacist
has told you. Check with your doctor or pharmacist if you are not
sure.
The capsules should be swallowed whole with a glass of water.
The capsules can be taken with or without food and should not be
chewed.
The usual doses are given below. Your doctor may gradually
increase or decrease your dose depending on how you respond to
the treatment.
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.
Adults and adolescents aged 12 and over
The usual dose is 50 mg or 100 mg (1 or 2 capsules) every 4-6
hours, according to severity of pain. You should normally not take
more than 400 mg (8 capsules) a day.
Children below 12 years of age
Tramadol is not recommended for use in children below age 12.
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. If in your case the insufficiency is mild or moderate,
your doctor may recommend prolonging the dosage interval.

If you forget to take Tramadol
If you forget to take Tramadol take it as soon as you remember and
then carry on as before.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Tramadol
If you stop taking Tramadol, your pain may return.
If you would like to stop treatment because you have unpleasant
side effects, please talk to your doctor. If you have been taking this
medicine for a very long time, you may get the following side
effects if you suddenly stop treatment: restlessness, anxiety,
nervousness, shaking or an upset stomach. If you get any of these
effects after stopping treatment with Tramadol please talk to 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.
Tramadol can occasionally cause allergic reactions although
serious allergic reactions (including anaphylaxis and
angioedema) are rare. Contact a doctor or emergency unit
immediately if you experience any sudden wheeziness,
difficulty in breathing, swelling of the eyelids, face or lips, rash
or itching (especially affecting your whole body). The same
applies in case of seizures (“fits”).
The frequency of side effects is classified as follows:
Common:
affects 1 to 10 users in 100
Uncommon: affects 1 to 10 users in 1,000
Rare:
affects 1 to 10 users in 10,000
Very rare:
affects less than 1 user in 10,000
Not known:
frequency cannot be estimated from the available
data
The following side effects may occur:
Very common:

nausea; dizziness.

Common:

headache, sleepiness; vomiting (being sick),
constipation, dry mouth; sweating.

Uncommon:

Irregular, rapid beating or pulsation of the
heart, increased heartbeat, low blood
pressure (especially when standing upright),
this may lead to collapse. Diarrhoea,
retching, gastrointestinal irritation (a feeling
of pressure in the stomach, bloating); skin
disorders (e.g. itchiness, rash, sudden onset
of skin redness).

Rare:

Slow heartbeat, rise in blood pressure;
sleepiness, change in appetite, tingling skin
sensation (e.g. pins and needles); trembling,
breathing difficulties, epileptic-like seizures
(“fits”), uncoordinated movement, muscle
twitches, fainting; blurred vision; difficulty in
passing urine and urinary retention. Muscle
weakness. Generalized allergic reactions
(e.g. anaphylaxis and angioedema, see
below). Hallucinations, confusion, anxiety,
sleep disturbance and nightmares, changes
in mood (high or low spirits), 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.

Frequency not known: Increased levels of liver enzymes.
Worsening of asthma has been reported,
however it has not been established whether
it was caused by tramadol. Speech
disorders, decrease in blood sugar level.

During use of Tramadol, dependence, abuse and addiction may
occur. When treatment is stopped, symptoms of withdrawal
reactions may occur, such as agitation, anxiety, nervousness,
sleeplessness, uncontrolled muscular action (hyperkinesia), tremor
and gastrointestinal symptoms. Other symptoms that have very
rarely been seen with tramadol discontinuation e.g., panic attacks,
severe anxiety, hallucinations, tingling skin sensation, hearing
sounds e.g. ringing or buzzing, without an external cause (tinnitus).
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,
Website: 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
Keep 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, 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 Tramadol contains
The active substance is tramadol hydrochloride. Each hard capsule
contains 50 mg tramadol hydrochloride.
The other ingredients are:
Capsule contents:
Cellulose, microcrystalline, silica colloidal
anhydrous, sodium starch glycolate (Type
A), magnesium stearate.
Capsule shell:

Gelatin, sodium lauryl sulphate, indigo
carmine, iron oxide yellow (E172) and
titanium dioxide (E171).

Printing ink:

Shellac and black iron oxide (E172).

What Tramadol looks like and contents of the pack
Green /Yellow, size '4' hard gelatin capsules filled with white to offwhite powder and imprinted with 'T' on green cap and '02' on yellow
body with black ink.
PVC/PVDC/Aluminium foil blister: 10, 20, 30, 50, 60, 90, 100 and
500 Capsules
HDPE bottle pack with polypropyle closure: 30, 200 and 500
Capsules
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Milpharm Limited
Ares Block
Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, BBG 3000
Malta
or
Milpharm Limited
Ares Block
Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
This leaflet was last revised in 04/2015.

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If you take more Tramadol than you should
If you have taken more capsules than you have been told to take,
contact your doctor immediately or go to your nearest hospital
casualty department. A number of symptoms may occur, which
might include: vomiting (being sick), a fall in blood pressure, a fast
heartbeat, collapse, fainting or even coma, epileptic fits and
difficulties in breathing.

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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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