Tramadol Hydrochloride/Paracetamol 37.5mg/325mg Film-Coated Tablets
I
PACKAGE LEAFLET: INFORMATION FOR THE USER
Tramadol hydrochloride/Paracetamol 37.5 mg/325 mg Film-coated Tablets
(tramadol hydrochloride/paracetamol)
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms 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.
In this leaflet:
1. What Tramadol/Paracetamol is and what it is used for
2. Before you take Tramadol/Paracetamol
3. How to take Tramadol/Paracetamol
4. Possible side effects
5. How to store Tramadol/Paracetamol
6. Further information
1. What Tramadol/Paracetamol is and what it is used for
Tramadol/Paracetamol is used to treat moderate to severe pain when your doctor recommends that a combination of tramadol hydrochloride and paracetamol is needed.
2. Before you take Tramadol/Paracetamol
Do not take Tramadol/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, paracetamol or any of the other ingredients (see section 6) in Tramadol/Paracetamol
• 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. 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.
Before you take Tramadol/Paracetamol, check with your doctor or pharmacist 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).
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Your doctor will tell you which medicines are safe to take with Tramadol/Paracetamol.
Do not exceed the maximum daily doses of paracetamol or tramadol from this or other medicines.
Do not take Tramadol/Paracetamol with MAOIs (see section 'Do not take Tramadol/ Paracetamol').
Tramadol/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 (opioid-type pain relievers).
Tramadol/Paracetamol may 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 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/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).
Taking Tramadol/Paracetamol with food and drink
Do not drink alcohol while you are taking Tramadol/Paracetamol, as you may feel drowsy.
Pregnancy and breast-feeding
Do not take Tramadol/Paracetamol while you are pregnant.
Check with your doctor if you become pregnant during treatment with Tramadol/ Paracetamol and before taking any further tablets. Do not take Tramadol/Paracetamol while you are breast-feeding, as small amounts of tramadol may pass into the breast-milk.
Driving and using machines
If you feel drowsy while taking Tramadol/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.
Important information about some of the ingredients of Tramadol/Paracetamol
Lactose is an ingredient in these tablets.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Tramadol/Paracetamol
Take Tramadol/Paracetamol as you doctor 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 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.
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.
If you think that the effect of Tramadol/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.
I
If you take more Tramadol/Paracetamol than you should
Talk to a doctor at once if you take too much of this medicine, even if you feel well. This is because too much paracetamol can cause delayed, serious liver damage.
If you forget to take Tramadol/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 before.
If you stop taking Tramadol/Paracetamol
Generally, there will be no after-effects when treatment with Tramadol/Paracetamol 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 for some time and want to stop, contact your doctor because your body may have become used to Tramadol/Paracetamol.
People 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 complaints after stopping Tramadol/Paracetamol, please contact your doctor. Other side effect information is listed in section 4.
4. Possible side effects
Like all medicines, Tramadol/Paracetamol can cause side effects, however 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 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
• transient loss of consciousness (syncope).
Unknown frequency:
• 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
• 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 the Yellow Card Scheme, at 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
Keep out of the sight and reach of children.
Do not use Tramadol/Paracetamol after the expiry date which is printed on the carton and blister. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Further information
What Tramadol/Paracetamol contains
The active substances are tramadol hydrochloride and paracetamol.
One (1) tablet contains 37.5 mg tramadol hydrochloride and 325 mg paracetamol.
The other ingredients are:
• Tablet core: powdered cellulose, pregelatinised starch, sodium starch glycolate (type A), maize starch, magnesium stearate.
• Film-coating: hypromellose, lactose monohydrate, titanium dioxide (E 171), macrogol 6000, yellow iron oxide (E 172), propylene glycol, talc.
What Tramadol/Paracetamol looks like and contents of the pack
Tramadol/Paracetamol film-coated tablets are pale yellow film-coated tablets, marked with the manufacturer's logo d on one side, marked T5 on the other side.
Tramadol/Paracetamol film-coated tablets are packed in blister strips. Tramadol/Paracetamol comes in cartons of 2, 10, 20, 30, 40, 50, 60, 70, 80, 90 or 100 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:
Grunenthal Ltd, Regus Lakeside House, 1 Furzeground Way, Stockley Park East, Uxbridge, Middlesex UB11 1BD, United Kingdom.
Manufacturer:
Grunenthal GmbH, Zieglerstrasse 6, D-52078, Aachen, Germany.
Other formats of this leaflet
A service is available to listen to or request a copy of this leaflet in Braille, large print or audio.
• Please call free of charge: 0800 198 5000 (UK only)
Please be ready to give the following information:
• Product name: TRAMADOL/PARACETAMOL 37.5 mg/325 mg, film coated-tablets
• Reference number: PL 21727/0039
This leaflet was last revised in: April 2016
857649
93019152