Tramadol Hydrochloride/Paracetamol 37.5/325mg Film Coated Tablets
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
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.
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.
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.
Do not exceed the maximum daily doses of paracetamol or tramadol from this or other medicines.
Do not take Tramadol/Paracetamol Tablets with MAOIs (see section 2 'Do not take Tramadol/ Paracetamol Tablets').
Tramadol/Paracetamol Tablets are 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).
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').
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.
Ta lk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.
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.
Children under 12 years of age:
This medicine is not recommended for children under 12 years of age.
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.
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/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'.
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).
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.
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.
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.
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.
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