Tramadol Hydrochloride/Paracetamol 37.5mg/325 Mg Film-Coated Tablets
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8
24 mm
Package leaflet: Information for the user
Tramadol hydrochloride/ Paracetamol 37.5 mg/325 mg film-coated tablets
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.
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What is in this leaflet: | |
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1. |
What this medicine is and what it is used for |
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2. |
What you need to know before you take this medicine |
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3. |
How to take this medicine |
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4. |
Possible side effects |
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5. |
How to store this medicine |
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6. |
Contents of the pack and other information |
Tramadol hydrochloride and Paracetamol Tablets is a combination of two analgesics, tramadol and paracetamol, which act together to relieve your pain.
This medicine is intended for use in the treatment of moderate to severe pain when your doctor recommends that a combination of tramadol and paracetamol is needed.
2. What you need to know before you take this medicine
Do not take this medicine:
• 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 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 this medicine 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 this medicine 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 anesthetic (tell your doctor or dentist that you are taking medicine).
Taking other medicines
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 this medicine.
Do not exceed the maximum daily doses of paracetamol or tramadol from this or other medicines. Do not take this medicine with MAOIs (see section ‘Do not take this medicine’).
This medicine 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).
This medicine 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, anesthetics, 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 this medicine 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 this medicine 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 this medicine with food, drink and alcohol
Do not drink alcohol while you are taking this medicine, as you may feel drowsy.
Pregnancy and 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. Breast-feeding
Tramadol is excreted into breast milk. For this reason, you should not take this medicine more than once during breastfeeding, or alternatively, if you take this medicine more than once, you should stop breast-feeding.
Driving and using machines
If you feel drowsy while taking this medicine, 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.
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Always take this medicine exactly as your 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. 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. Take this medicine for as short a time as possible and no longer than your doctor has told you.
Adults and adolescents of 12 years and over:
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 this medicine is too strong (you feel very drowsy or have difficulty breathing) or too weak (you do not have enough pain relief), contact your doctor.
If you take more 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.
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If you forget to take this medicine
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 this medicine
Generally, there will be no after-effects when treatment with Tramadol and 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 this medicine for some time and want to stop, contact your doctor because your body may have become used to these tablets 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 this medicine, please contact your doctor. Other side effect information is listed in section 4.
If this happens to you, stop treatment and see a doctor immediately. You must not take the medicine again.
Reporting of side effects
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 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.
• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is printed on the carton and blister 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 waste water or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
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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. Very rare cases of serious skin reactions have been reported with paracetamol. If this happens to you, stop treatment. Do not take the medicine again.
• prolonged or unexpected bleeding, from the use of these 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 (may affect more than 1 in 10 people )
• nausea
• dizziness, drowsiness.
Common side effects (may affect more than 1 in 10 people )
• 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 (may affect more than 1 in 100 people)
• 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 (may affect more than 1 in 1,000 people)
• fits, uncoordinated movements
• addiction
• blurred vision
• transient loss of consciousness (syncope).
Not known side effects (frequency cannot be estimated from the available data)
• decrease in blood sugar level
The following are recognised side effects which 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.
What this medicine contains
• The active substances are Tramadol Hydrochloride and Paracetamol. Each tablet contains 37.5 mg tramadol hydrochloride and 325 mg paracetamol.
• The other ingredients are:
Tablet core: powdered cellulose, pregelatinised maize starch, sodium starch glycolate (type A), maize starch, magnesium stearate.
Film-coating: hypromellose, titanium dioxide (E171), macrogol 400, iron oxide yellow (E172), polysorbate 80.
What these tablets look like and contents of the pack
• These tablets are light yellow, capsule shaped, biconvex tablets embossed with ‘C8’ on one side and plain on other side.
• This medicine is available in packs of 2,10,20,30,40,50,60,70,80,90 and 100 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Bristol Laboratories Ltd,
Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire,
HP4 1EG, UK.
Telephone: 0044 (0) 1442 200922 Fax: 0044 (0) 1442 873717 Email: info@bristol-labs.co.uk
Tramadol hydrochloride/Paracetamol 37.5 mg/325 mg film-coated tablets;
PL 17907/0392
This leaflet was last revised in May 2016
To request a copy of this leaflet in Braille, large print or audio format, please contact the licence holder at address (or telephone, fax, e-mail) above.
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V5 31-05-16 D1 g
10 mm
SAME SIZE ARTWORK 130 x 480 mm Back
130 mm