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TRAMADOL HYDROCHLORIDE AND PARACETAMOL 37.5 MG/325 MG FILM-COATED TABLETS

Active substance(s): TRAMADOL HYDROCHLORIDE

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Package leaflet: Information for the user



Tramadol hydrochloride and Paracetamol 37.5mg/325mg
film-coated tablets
Tramadol hydrochloride/Paracetamol
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 and Paracetamol is and what it is
used for
2. What you need to know before you take Tramadol
hydrochloride and Paracetamol
3. How to take Tramadol hydrochloride and Paracetamol
4. Possible side effects
5. How to store Tramadol hydrochloride and Paracetamol
6. Contents of the pack and other information
1. What Tramadol hydrochloride and Paracetamol is and what
it is used for
Tramadol hydrochloride and Paracetamol is used to treat moderate
to severe pain when your doctor recommends that a combination of
tramadol hydrochloride and paracetamol is needed.
2. What you need to know before you take Tramadol
hydrochloride and Paracetamol
Do not take Tramadol hydrochloride and Paracetamol:
• if you are hypersensitive or have had an allergic reaction (for
instance skin rash, swelling of the face, wheezing or difficulty
breathing) to tramadol hydrochloride, paracetamol or any of the
other ingredients of this medicine (listed in section 6)
• in cases of acute alcohol poisoning
• if you are taking sleeping pills, pain relievers or medicines that
affect mood and emotions
• if you are also taking medicines called monoamine oxidase
inhibitors (MAOIs) or have taken MAOIs in the last 14 days
before treatment with Tramadol hydrochloride and Paracetamol.
MAOIs are used in the treatment of depression or Parkinson's
disease.
• if you have a severe liver disorder
• if you have epilepsy that is not adequately controlled by your
current medicine.
Warnings and precautions
Talk to your doctor or pharmacist before taking Tramadol
hydrochloride and Paracetamol










take other medicines containing paracetamol or tramadol
have liver problems or disease as your eyes and skin may turn
yellow, which may suggest jaundice
have kidney problems
have severe difficulties in breathing, for example asthma or
severe lung problems
have epilepsy or have already experienced fits or seizures
have recently suffered from a head injury, shock or severe
headaches associated with vomiting (being sick)
are dependent on any medicine (for example morphine)
take other medicines to treat pain that contain buprenorphine,
nalbuphine or pentazocine
are going to have an anaesthetic (tell your doctor or dentist that
you are taking Tramadol hydrochloride and Paracetamol).

Other medicines and Tramadol hydrochloride and Paracetamol
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines. Your doctor will tell you which
medicines are safe to take with Tramadol hydrochloride and
Paracetamol.
Do not exceed the maximum daily doses of paracetamol or
tramadol from this or other medicines.
Do not take Tramadol hydrochloride and Paracetamol with MAOIs
(see section 'Do not take Tramadol hydrochloride and
Paracetamol').
Tramadol hydrochloride and Paracetamol is not recommended with
the following medicines, as it may affect how well they work:
• carbamazepine (a medicine used to treat epilepsy or some
types of pain)
• buprenorphine, nalbuphine or pentazocine (opioidtype pain
relievers).
Tramadol hydrochloride and Paracetamol may increase the risk of
side effects if you also take the following medicines:
• 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
and Paracetamol at the same time. Your doctor will tell you
whether Tramadol hydrochloride and Paracetamol is suitable for
you.

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Tramadol hydrochloride
and Paracetamol

Tramadol hydrochloride
and Paracetamol

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

If you are taking certain antidepressants. Tramadol
hydrochloride and Paracetamol 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.
tranquilizers, sleeping pills, other pain relievers such as
morphine and codeine (also as cough medicine), baclofen (a
muscle relaxant), medicines used to lower blood pressure,
antidepressants or medicines to treat allergies. Check with your
doctor if you feel drowsy or feel faint.
anaesthetics, medicines that affect the state of mind, or
bupropion (used to help stop smoking). The risk of having a fit
may increase. Your doctor will tell you whether Tramadol
hydrochloride and Paracetamol is suitable for you.
warfarin or phenprocoumon (for blood thinning). The
effectiveness of such medicines may be altered and bleeding
may occur (see section 4).

The effectiveness of Tramadol hydrochloride and Paracetamol may
be altered if you also take the following medicines:
• metoclopramide, domperidone or ondansetron (medicines used
to treat nausea and vomiting/being sick)
• cholestyramine (medicine used to reduce cholesterol in the
blood)
• ketoconazole or erythromycin (medicines used against
infections).
Tramadol hydrochloride and Paracetamol with food and drink
and alcohol
Do not drink alcohol while you are taking Tramadol hydrochloride
and Paracetamol, as you may feel drowsy.
Pregnancy and 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.
Do not take Tramadol hydrochloride and Paracetamol while you are
pregnant.
Do not take Tramadol hydrochloride and Paracetamol while you are
breastfeeding, as small amounts of tramadol may pass into the
breast-milk.
Driving and using machines
If you feel drowsy while taking Tramadol hydrochloride and
Paracetamol, do not drive, use tools or use 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 and Paracetamol
Always take this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.
Swallow the tablets whole with sufficient liquid.
Do not break or chew the tablets.
Take Tramadol hydrochloride and Paracetamol for as short a time
as possible and no longer than your doctor has told you.
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 over 12 years:
The recommended dosage is to start with 2 tablets, unless
otherwise prescribed by your doctor. If required, further doses may
be taken, as instructed by your doctor.
The shortest time between doses must be at least 6 hours.
Do not take more than 8 tablets in 24 hours.
Your doctor may increase the time between doses if:
• you are older than 75 years
• you have kidney problems
• you have liver problems.
Children under 12 years of age:
• not recommended.
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 and Paracetamol. If in your case the
insufficiency is mild or moderate, your doctor may recommend
prolonging the dosage interval.

If you take more Tramadol hydrochloride and Paracetamol
than you should
Immediate medical advice should be sought in the event of an
overdose, even if you feel well, because of the risk of delayed,
serious liver damage.
If you forget to take Tramadol hydrochloride and Paracetamol
If you forget to take the tablets, pain is likely to return.
Do not take a double dose to make up for forgotten individual
doses; simply continue taking the tablets as usual.






muscle weakness, slower or weaker breathing
mood changes, changes in activity, changes in perception
worsening of existing asthma
nose bleeds or bleeding gums, which may result from a low
blood platelet count.

Reporting of side effects
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. You can also report side effects directly via the national
reporting system listed in 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 hydrochloride and Paracetamol

If you stop taking Tramadol hydrochloride and Paracetamol
Generally, there will be no after-effects when treatment with
Tramadol hydrochloride and Paracetamol is stopped.

Keep this medicine out of the sight and reach of children.

Rarely, people who have been using a medicine containing
tramadol may become dependent on it, making it hard to stop
taking it. If you have been taking Tramadol hydrochloride and
Paracetamol for some time and want to stop, contact your doctor
because your body may have become used to Tramadol
hydrochloride and Paracetamol.

Do not use this medicine after the expiry date which is stated on
the label, carton, and blister after EXP. The expiry date refers to
the last day of that month.

People may:
• feel agitated, anxious, nervous or shaky
• be over active
• have difficulty sleeping
• have stomach or bowel disorders.

6. Contents of the pack and other information

Very few people may also get:
• panic attacks
• hallucinations, unusual perceptions such as itching, tingling and
numbness
• ringing in the ears.

This medicinal product does not require any special storage
conditions.

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.

What Tramadol hydrochloride and Paracetamol contains
- The active substances are tramadol hydrochloride and
paracetamol. Each film-coated tablet contains 37.5 mg tramadol
hydrochloride and 325 mg paracetamol.
-

If you have any further questions on the use of this medicine, ask
your doctor or pharmacist. Other side effect information is listed in
section 4.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although
not everybody gets them.
Some side effects could be serious. Contact your doctor
immediately if any of the following occur:
• rarely cases of skin rash, indicating an allergic reaction, may
develop with sudden swelling of the face and neck, difficulties
breathing or drop of blood pressure and fainting. If this happens
to you, stop treatment. Do not take the medicine again.
• prolonged or unexpected bleeding, from the use of Tramadol
hydrochloride and Paracetamol with medicines used to thin the
blood (e.g. warfarin, phenprocoumon).
Additionally, if any of the following side effects get serious, contact
your doctor or pharmacist:
Very common side effects (affecting more than 1 in 10 people
treated)
• nausea
• dizziness, drowsiness.
Common side effects (affecting less than 1 in 10, but more
than 1 in 100 people treated)
• vomiting (being sick), digestion problems (constipation,
flatulence, diarrhoea), stomach pain, dry mouth
• itching, sweating
• headache, shaking
• confusion, sleep disorders, mood changes (anxiety,
nervousness, feeling of extreme happiness).
Uncommon side effects (affecting less than 1 in 100, but more
than 1 in 1,000 people treated)
• increase in pulse or blood pressure, heart rate or heart rhythm
disorders
• difficulty or pain on passing water
• skin reactions (for example rashes, hives)
• tingling, numbness or feeling of pins and needles in the limbs,
ringing in the ears, involuntary muscle twitching
• depression, nightmares, hallucinations (hearing, seeing or
sensing things that are not really there), memory lapses
• difficulty swallowing, blood in the stools
• shivering, hot flushes, pain in the chest
• difficulty breathing.
Rare side effects (affecting less than 1 in 1,000, but more than
1 in 10,000 people treated)
• fits, uncoordinated movements
• addiction
• blurred vision.
• transient loss of consciousness (syncope).
Unknown: (cannot be estimated from the available data)
• decrease in blood sugar level
In addition, the following side effects have been reported by people
using medicines that contain only tramadol or only paracetamol:



feeling faint when getting up from a lying or sitting position, slow
heart rate, fainting
changes in appetite

The other ingredients are
Tablet core: Maize starch, powdered cellulose, sodium starch
glycolate (Type A), starch, pregelatinized, Magnesium Stearate
Film-coating: Hypromellose, titanium dioxide (E171), macrogol
400, iron oxide yellow (E172), polysorbate 80

What Tramadol hydrochloride and Paracetamol looks like and
contents of the pack
Film-coated tablets
Light yellow, oblong shaped biconvex film coated tablets debossed
with “I 03” on one side and plain on the other side.
Tramadol hydrochloride and Paracetamol film-coated tablets are
available in PVC/PVdC – Aluminium foil blister pack and HDPE
container pack with polypropylene closure.
Pack sizes:
Blister pack: 10, 20, 30, 60 ,90 & 100 film-coated tablets
HDPE pack: 30, 250 & 1000 film-coated tablets
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 12/2015.

P15XXXXX

If you think that the effect of Tramadol hydrochloride and
Paracetamol is too strong (you feel very drowsy or have difficulty
breathing) or too weak (you do not have enough pain relief),
contact your doctor.

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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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