Tramadol Hydrochloride And Paracetamol 37.5 Mg/325 Mg Film-Coated Tablets
Packaging Development Department Packaging Material Specification
Item: Leaflet
A/W Code No.: xxxxxxxxxxx Open Size: 297 X 210 mm
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Reason for Preparation: New Development
Pharma Code : 844
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Tramadol hydrochloride and Paracetamol 37.5 mg/325 mg 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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
What is in this leaflet
1. What Tramadol hydrochloride and Paracetamol tablet is and what it is used for
2. What you need to know before you take Tramadol hydrochloride and Paracetamol tablets
3. How to take Tramadol hydrochloride and Paracetamol tablets
4. Possible side effects
5. How to store Tramadol hydrochloride and Paracetamol tablets
6. Contents of the pack and other information
1. What Tramadol hydrochloride and Paracetamol tablet is and what it is used for
Tramadol hydrochloride and Paracetamol tablet is a combination of two pain killers - paracetamol and tramadol hydrochloride. It 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 tablets
Do not take Tramadol hydrochloride and Paracetamol tablets
• if you are hypersensitive or have had an allergic reaction (for instance skin rash, swelling of the face, wheezing or difficulty breathing) to tramadol, paracetamol or any of the other ingredients in Tramadol hydrochloride and Paracetamol tablets (see 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 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 hydrochloride and Paracetamol tablets if you:
• take other medicines containing tramadol or paracetamol
• have liver problems or disease where 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 such as chronic obstructive pulmonary disorder (COPD)
• 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, heroin etc.)
• 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 tablets).
Other medicines and Tramadol hydrochloride and Paracetamol Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. Your doctor will tell you which medicines are safe to take with Tramadol hydrochloride and Paracetamol tablets.
Do not exceed the maximum daily doses of paracetamol or tramadol from this or other medicines.
Do not take Tramadol hydrochloride and Paracetamol tablets with MAOIs (see section 'Do not take Tramadol hydrochloride and Paracetamol tablet').
Tramadol hydrochloride and Paracetamol tablet 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 (opioid-type pain relievers)
Tramadol hydrochloride and Paracetamol tablets may increase the risk of
side effects if you also take 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 a 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 hydrochloride and Paracetamol tablets 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 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 hydrochloride and Paracetamol tablets with food and drink
Do not drink alcohol while you are taking Tramadol hydrochloride and Paracetamol tablets, as you may feel drowsy.
Pregnancy and breast-feeding
Do not take Tramadol hydrochloride and Paracetamol tablets while you are pregnant.
Check with your doctor if you become pregnant during treatment with Tramadol hydrochloride and Paracetamol tablets and before taking any further tablets. Do not take Tramadol hydrochloride and Paracetamol tablets while you are breast-feeding, as small amounts of tramadol may pass into the breast-milk.
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 hydrochloride and 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:
o The medicine has been prescribed to treat a medical or dental problem and
o You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and o 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 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 hydrochloride and Paracetamol tablets for as short a time as possible and no longer than your doctor has told you.
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.
Date: 17.12.15
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Your doctor may increase the time between doses if: |
Uncommon side effects (may affect up to 1 in 100 people) |
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• you are older than 75 years |
• increase in pulse or blood pressure, heart rate or heart rhythm |
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• you have kidney problems |
disorders |
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• you have liver problems. |
• difficulty or pain on passing water • skin reactions (for example rashes, hives) tingling, numbness or feeling |
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Children under 12 years of age |
of pins and needles in the limbs, ringing in the ears, involuntary muscle |
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NOT RECOMMENDED |
twitching • depression, nightmares, hallucinations (hearing, seeing or sensing |
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If you think that the effect of Tramadol hydrochloride and Paracetamol |
things that are not really there), memory lapses |
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tablet is too strong (you feel very drowsy or have difficulty breathing) or too |
• difficulty swallowing, blood in the stools |
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weak (you do not have enough pain relief), contact your doctor. |
• shivering, hot flushes, pain in the chest • difficulty breathing. |
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If you take more Tramadol hydrochloride and Paracetamol tablets than you should |
Rare side effects (affecting less than 1 in 1,000 but more than 1 in |
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Immediate medical advice should be sought in the event of an overdose, |
10,000 people treated) |
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even if you feel well, because of the risk of delayed, serious liver damage. |
• fits, uncoordinated movements • addiction |
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If you forget to take Tramadol hydrochloride and Paracetamol tablets |
• blurred vision. |
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If you forget to take the tablets, pain is likely to return. |
In addition, the following side effects have been reported by people using |
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Do not take a double dose to make up for a forgotten dose, simply continue |
medicines that contain only tramadol or only paracetamol: |
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taking the tablets as before. |
• feeling faint when getting up from a lying or sitting position, slow heart |
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rate, fainting | |
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If you stop taking Tramadol hydrochloride and Paracetamol tablets |
• changes in appetite |
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Generally, there will be no after-effects when treatment with Tramadol |
• muscle weakness, slower or weaker breathing |
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hydrochloride and Paracetamol tablets is stopped. |
• mood changes, changes in activity, changes in perception • worsening of existing asthma |
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Rarely, people who have been using a medicine containing tramadol may |
• nose bleeds or bleeding gums, which may result from a low blood |
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become dependent on it, making it hard to stop taking it. If you have been |
platelet count. |
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taking Tramadol hydrochloride and Paracetamol tablets for some time and want to stop, contact your doctor because your body may have become |
Reporting of side effects |
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used to Tramadol hydrochloride and Paracetamol tablets. |
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also |
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People may: |
report side effects directly via the Yellow Card Scheme at: |
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• feel agitated, anxious, nervous or shaky |
www.mhra.gov.uk/yellowcard. By reporting side effects, you can help |
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• be over active • have difficulty sleeping |
provide more information on the safety of this medicine. |
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• have stomach or bowel disorders. |
5. How to store Tramadol hydrochloride and Paracetamol tablets Keep out of the sight and reach of children. |
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Very few people may also get: • panic attacks |
Do not use this medicine after the expiry date which is stated on the carton |
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• hallucinations, unusual perceptions such as itching, tingling and |
and blister after EXR The expiry date refers to the last day of that month. |
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numbness | |
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• ringing in the ears. |
This medicinal product does not require any special storage conditions. |
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If you experience any of these complaints after stopping Tramadol |
Do not throw away any medicines via wastewater or household waste. Ask |
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hydrochloride and Paracetamol tablets, please contact your doctor. Other |
your pharmacist how to throw away medicines you no longer use. These |
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side effect information is listed in section 4. |
measures will help protect the environment. |
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If you have any further questions on the use of this medicine, ask your |
6. Contents of the pack and other information |
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doctor or pharmacist. |
What Tramadol hydrochloride and Paracetamol tablets contain • The active substances are tramadol hydrochloride and paracetamol. |
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4. Possible side effects |
Each film-coated tablet contains 37.5 mg tramadol hydrochloride and |
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Like all medicines, this medicine can cause side effects, although not |
325 mg paracetamol. |
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everybody gets them. |
• The other ingredients are: |
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Tablet core: preqelatinised starch, sodium starch qlycolate (Type A). | |
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Some side effects could be serious. Contact your doctor immediately |
microcrystalline cellulose, magnesium stearate, purified water. |
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if any of the following occur: |
Film-coat: hypromellose (3cP), hypromellose (6cP), titanium dioxide |
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• rarely cases of skin rash, indicating an allergic reaction, may develop |
E171, macrogol 400, iron oxide yellow E172, polysorbate 80. |
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with sudden swelling of the face and neck, difficulties breathing or drop of blood pressure and fainting. If this happens to you, stop treatment. |
What Tramadol hydrochloride and Paracetamol tablets look like and |
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Do not take the medicine again. |
contents of the pack |
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• prolonged or unexpected bleeding, from the use of Tramadol |
Tramadol hydrochloride and Paracetamol tablets are yellow coloured, |
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hydrochloride and Paracetamol tablets with medicines used to thin the |
elongated, film-coated tablets with “325” debossed on one side and "37.5" |
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blood (e.g. warfarin, phenprocoumon). |
debossed on the other side. They are packed in blisters of 60 or 100 tablets in a carton. |
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Additionally, if any of the following side effects get serious, contact your doctor or pharmacist: |
Not all pack sizes may be marketed. |
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Very common side effects (may affect more than 1 in 10 people) |
Marketing Authorisation Holder |
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• nausea (feeling sick) |
Dawa Limited, 5 Sandridge Close, |
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• dizziness, drowsiness. |
Harrow, Middlesex, HA1 1XD, United kingdom |
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Common side effects (may affect up to 1 in 10 people) |
Manufacturer |
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• vomiting (being sick), digestion problems (constipation, flatulence, |
Drugsrus Limited, 5 Sandridge Close, |
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diarrhoea), stomach pain, dry mouth |
Harrow, Middlesex, HA1 1XD, United Kingdom |
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• itching, sweating • headache, shaking • confusion, sleep disorders, mood changes (anxiety, nervousness, |
This leaflet was last revised in 10/2015 |
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feeling of high spirits). |
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