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TRAMADOL HYDROCHLORIDE/PARACETAMOL 37.5/325MG FILM COATED TABLETS

Active substance(s): TRAMADOL HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Tramadol Hydrochloride/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/Paracetamol Tablets are and what they are used for
2. What you need to know before you take Tramadol/Paracetamol Tablets
3. How to take Tramadol/Paracetamol Tablets
4. Possible side effects
5. How to store Tramadol/Paracetamol Tablets
6. Contents of the pack and other information
1. What Tramadol/Paracetamol Tablets are and what they are used for
Tramadol/Paracetamol Tablets are 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/Paracetamol Tablets
Do not take Tramadol/Paracetamol Tablets
• if you are allergic to tramadol, paracetamol or any of the other ingredients 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/Paracetamol Tablets. 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/Paracetamol Tablets if you:
• 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/
Paracetamol Tablets);
Children
Tramadol/Paracetamol Tablets are not suitable for children under 12 years of age.

The effectiveness of Tramadol/Paracetamol Tablets 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/Paracetamol Tablets with food, drink and alcohol
Do not drink alcohol while you are taking Tramadol/Paracetamol Tablets, as you may feel drowsy.
Pregnancy and breast-feeding
Do not take Tramadol/Paracetamol Tablets while you are pregnant or breast-feeding.
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.
Driving and using machines
If you feel drowsy while taking Tramadol/Paracetamol Tablets, 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/Paracetamol Tablets
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/Paracetamol Tablets 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 per day.
Your doctor may increase the time between doses if:
• you are older than 75 years;
• you have kidney problems;
• you have liver problems.

Other medicines and Tramadol/Paracetamol Tablets
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/Paracetamol Tablets.

Children under 12 years of age:

Do not exceed the maximum daily doses of paracetamol or tramadol from this or other medicines.

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

Do not take Tramadol/Paracetamol Tablets with MAOIs (see section 2 ‘Do not take Tramadol/
Paracetamol Tablets’).

This medicine is not recommended for children under 12 years of age.

Elderly patients:

Tramadol/Paracetamol Tablets are not recommended with the following medicines, as it may affect
how well they work:

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.

• carbamazepine (a medicine used to treat epilepsy or some types of pain);
• buprenorphine, nalbuphine or pentazocine (opioid type pain relievers).

Severe liver or kidney disease (insufficiency)/dialysis patients:

The risk of side effects increases,
• 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/Paracetamol Tablets at
the same time. Your doctor will tell you whether Tramadol/Paracetamol Tablets is suitable for you;
• if you are taking certain antidepressants. Tramadol/Paracetamol Tablets 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.
Tramadol/Paracetamol Tablets may also increase the risk of side effects if you also take the following
medicines:
• triptans (used for migraine) or selective serotonin re-uptake inhibitors (SSRIs, used for depression).
Check with your doctor if you experience confusion, restlessness, fever, sweating, uncoordinated
movement of limbs or eyes, uncontrollable jerking of muscles or diarrhoea;
• 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;
• antidepressants, 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/
Paracetamol Tablets are suitable for you;
• warfarin or phenprocoumon (for blood thinning). The effectiveness of such medicines may be
altered and bleeding may occur (see section 4 ‘Possible side effects’).

Patients with severe liver and/or kidney insufficiency should not take Tramadol/Paracetamol Tablets.
If in your case the insufficiency is mild or moderate, your doctor may recommend prolonging the
dosage interval.
If you take more Tramadol/Paracetamol Tablets 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/Paracetamol Tablets
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 before.
If you stop taking Tramadol/Paracetamol Tablets
Generally, there will be no after-effects when treatment with Tramadol/Paracetamol Tablets is
stopped. 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/Paracetamol
Tablets for some time and want to stop, contact your doctor because your body may have become
used to Tramadol/Paracetamol Tablets.
You may:
• feel agitated, anxious, nervous or shaky;
• be over active;
• have difficulty sleeping;
• have stomach or bowel disorders.

Very few people may also get:
• panic attacks;
• hallucinations, unusual perceptions such as itching, tingling and numbness;
• ringing in the ears.
If you experience any of these symptoms after stopping Tramadol/Paracetamol Tablets, please
contact your doctor. Other side effect information is listed in section 4 ‘Possible side effects’.
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/Paracetamol Tablets with medicines
used to thin the blood (e.g. warfarin, phenprocoumon).

Marketing Authorisation Holder
Morningside Healthcare Ltd
115 Narborough Road
Leicester
LE3 0PA, UK
Manufacturer
Morningside Pharmaceuticals Ltd
5 Pavilion Way
Loughborough
LE11 5GW, UK
This leaflet was last revised in February 2016.

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 high spirits).
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.
In addition, the following side effects have been reported by people taking 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;
• 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. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via 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/Paracetamol Tablets
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry
date refers to the last day of that month.
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.
6. Contents of the pack and other information
What Tramadol/Paracetamol Tablets contain
- The active substances are tramadol hydrochloride and paracetamol.
One tablet contains 37.5 mg tramadol hydrochloride and 325 mg paracetamol.
- The other ingredients are:
• Tablet core: pregelatinised starch, sodium starch glycolate, microcrystalline cellulose and
magnesium stearate.
• Tablet coating: hypromellose, titanium dioxide (E171), macrogol 400, iron oxide yellow (E172)
and polysorbate 80.
What Tramadol/Paracetamol Tablets look like and contents of the pack
Tramadol Hydrochloride/Paracetamol Tablets are yellow coloured, elongated, film-coated tablets with
“325” debossed on one side and “37.5” debossed on other side.
Tramadol/Paracetamol Tablets are packed in white PVC/PVDC/aluminium blister packs of 10 tablets
and are available in boxes of 10, 20, 30, 40, 50, 60, 70, 80, 90 and 100 tablets. Not all pack sizes
may be marketed.

M0251LAMUKNAS-001

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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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