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TRAMADOL HYDROCHLORIDE 50MG CAPSULES HARD

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Package leaflet: Information for the user
Tramadol Hydrochloride 50mg 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 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, or pharmacist or nurse. This includes any
possible side effects not listed in this leaflet
What is in this leaflet:
1. What Tramadol Hydrochloride 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 Hydrochloride is and what it is used for
Tramadol Hydrochloride capsules contain Tramadol hydrochloride. Tramadol hydrochloride
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 is used for the treatment of moderate to severe pain.

2. What do you need to know before you take Tramadol
Do not take Tramadol Hydrochloride
-

-

if you are allergic to tramadol hydrochloride 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 or nurse before taking Tramadol Hydrochloride
- 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.

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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 Hydrochloride
Please tell your doctor or pharmacist if you are taking or have recently taken or might take
any other medicines.
Do not take Tramadol Hydrochloride 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.
The pain-relieving effect of Tramadol Hydrochloride 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 Hydrochloride 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 Hydrochloride is suitable
for you.
- if you are taking certain antidepressants, tramadol may interact with these medicines and
you may experience symptoms such as involuntary rhythmic contraction 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 Hydrochloride with food and drink and alcohol
You should not drink alcohol during treatment with Tramadol, as its effect may be intensified.
Pregnancy and 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.

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Generally, the use of tramadol is not recommended during breast-feeding as small amounts of
tramadol are excreted into breast milk. On a single dose it is usually not necessary to interrupt
breast-feeding. Ask your doctor for advice.
Driving and using machines
Tramadol Hydrochloride may cause side effects such as sleepiness and dizziness. If this
happens, do not drive or operate machinery.

3. How to take Tramadol HYDROCHLORIDE
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 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 Hydrochloride 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)s/ 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.
In less severe cases of kidney problems or in case you have liver problems; your doctor may
increase the length of time between each dose of medicine and/or decrease the dose.
If you take more Tramadol Hydrochloride 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.
If you forget to take Tramadol Hydrochloride
If you forget to take Tramadol Hydrochloride 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 Hydrochloride
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
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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 Hydrochloride please talk to your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist
or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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
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 following side effects may occur:
Very common (affects more than 1 user in 10):
Nausea; dizziness.
Common (affects 1 to 10 users in 100):
Headache, sleepiness; vomiting (being sick), constipation, dry mouth; sweating.
Uncommon (affects 1 to 10 users in 1,000):
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 (affects 1 to 10 users in 10,000):
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.
Not known (frequency cannot be estimated from the available data):
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.
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
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discontinuation e.g., panic attacks, severe anxiety, hallucinations, tingling skin sensation,
hearing sounds e.g. ringing or buzzing, without an external cause (tinnitus).
If you get any side effects, talk to your doctor or, pharmacist or nurse. This includes any side
effects not listed in this leaflet.
5. How to store Tramadol HYDROCHLORIDE
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date (“EXP”) which is stated on the blister and
carton or label. The expiry date refers to the last day of that month.
Store below 30ºC.
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 contains
Capsule content
The active substance is tramadol hydrochloride. Each capsule contains 50mg of tramadol
hydrochloride.
The other ingredients are: Cellulose, microcrystalline, Silica, colloidal anhydrous, Sodium
starch glycolate (Type A), Magnesium stearate.
Capsule shell
Gelatin, Sodium lauryl sulphate, Indigo carmine, Iron oxide yellow (E172), Titanium dioxide
(E171).
Printing ink (TEK print SW-9008 Black):
Shellac, Black iron oxide (E172).
What Tramadol Hydrochloride looks like and contents of the pack
Tramadol Hydrochloride Capsules are Green / Yellow, size ‘4’ hard gelatin capsules filled
with white to off-white powder and imprinted with ‘T’ on green cap and ‘02’ on yellow body
with black ink.
The Tramadol Hydrochloride Capsules are available in PVC/PVDC/Aluminium foil blister
packs and HDPE bottle packs with polypropylene closures.
Blister packs: 10, 14, 20, 28, 30, 40, 50, 56, 60, 98, 100, 112, 250 or 500 capsules.
HDPE bottle packs: 30 or 500 capsules.
Not all pack sizes may be marketed.

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Marketing Authorisation Holder and Manufacturer

Amneal Pharma Europe Limited
70 Sir John Rogerson’s Quay
Dublin 2
Ireland
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate,
Hal Far, Birzebbugia, BBG 3000
Malta
This leaflet was last revised in 06/2014

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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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