Tramadol Hydrochloride/Paracetamol 37.5mg/325mg Film-Coated Tablets
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Package Leaflet: Information for the user
Tramadol Hydrochloride/Paracetamol 37.5mg/325mg 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. Y ou 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.
- The full name of this medicine is Tramadol Hydrochloride/Paracetamol 37.5mg/325mg Film-coated Tablets but within the leaflet it will be referred to as Tramadol Hydrochloride/ Paracetamol Tablets.
What is in this leaflet
1. What Tramadol Hydrochloride/Paracetamol Tablets are and what they are used for
2. What you need to know before you take Tramadol Hydrochloride/Paracetamol Tablets
3. How to take Tramadol Hydrochloride/Paracetamol Tablets
4. Possible side effects
5. How to store Tramadol Hydrochloride/Paracetamol Tablets
6. Contents of the pack and other information.
1. What Tramadol Hydrochloride/Paracetamol Tablets are and what they are used for
Tramadol Hydrochloride/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 Hydrochloride/Paracetamol Tablets Do not take Tramadol Hydrochloride/Paracetamol Tablets
• if you are allergic 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 Tramadol Hydrochloride/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/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 Hydrochloride/Paracetamol Tablets).
Other medicines and Tramadol Hydrochloride/Paracetamol Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not exceed the maximum daily doses of paracetamol or tramadol from this or other medicines.
Do not take Tramadol Hydrochloride/Paracetamol Tablets with MAOIs (see section ‘Do not take Tramadol Hydrochloride/Paracetamol Tablets).
Tramadol Hydrochloride/Paracetamol Tablets are not recommended with the following medicines, as they 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/Paracetamol Tablets 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 Hydrochloride/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/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/Paracetamol Tablets with food, drink and alcohol
Do not drink alcohol while you are taking Tramadol Hydrochloride/Paracetamol Tablets, 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.
Pregnancy
Do not take Tramadol Hydrochloride/Paracetamol Tablets while you are pregnant. Check with your doctor if you become pregnant during treatment with Tramadol Hydrochloride/Paracetamol Tablets and before taking any further tablets.
Breast-feeding
Tramadol is excreted into breast milk. For this reason, you should not take Tramadol Hydrochloride/Paracetamol Tablets more than once during breast-feeding, or alternatively, if you take Tramadol Hydrochloride/Paracetamol Tablets more than once, you should stop breast-feeding.
Driving and using machines
If you feel drowsy while taking Tramadol Hydrochloride/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
- Y ou 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.
Tramadol Hydrochloride/Paracetamol Tablets contain lactose monohydrate
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 Hydrochloride/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/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.
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 Hydrochloride/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.
The maximum daily dose is 8 tablets per day (equivalent to 300mg of tramadol and 2600mg of paracetamol). Do not exceed this dose from this or other medicines.
If you take more Tramadol Hydrochloride/Paracetamol Tablets 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 Hydrochloride/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 Hydrochloride/Paracetamol Tablets
Generally, there will be no after-effects when treatment with Tramadol Hydrochloride/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 Hydrochloride/Paracetamol Tablets for some time and want to stop, contact your doctor because your body may have become used to Tramadol Hydrochloride/Paracetamol 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 Tramadol Hydrochloride/Paracetamol Tablets, please contact your doctor. Other side effect information is listed in section 4.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
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 Hydrochloride/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 (may affect more than 1 in 10 people):
• nausea
• dizziness, drowsiness.
Common side effects (may affect up to 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 up to 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)
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tingling, numbness or feeling of pins and needles in the limbs, ringing in muscle twitching |
the ears, involuntary |
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depression, nightmares, hallucinations (hearing, seeing or sensing things there), memory lapses |
that are not really |
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difficulty swallowing, blood in the stools | |
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shivering, hot flushes, pain in the chest | |
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difficulty breathing | |
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raised liver enzymes (shown in blood tests). | |
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Rare |
side effects (may affect up to 1 in 1,000 people): | |
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fits, uncoordinated movements | |
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addiction | |
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blurred vision | |
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transient loss of consciousness (syncope). | |
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Very |
rare side effects (may affect up to 1 in 10,000 people): | |
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cases of serious skin reactions have been reported. | |
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Unknown frequency (frequency cannot be estimated from the available data): | ||
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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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. Y ou can also report side effects directly via the Y ellow 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 Hydrochloride/Paracetamol Tablets
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date (EXP) which is stated on the carton and the label or foil 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 Hydrochloride/Paracetamol Tablets contain
• The active substances are: 37.5mg tramadol hydrochloride and 325mg paracetamol.
• The other ingredients are:
Tablet core:
Pre-gelatinised Maize Starch
Stearic acid Crospovidone
Povidone (Plasdone K29-32)
Maize Starch Croscarmellose sodium Microcrystalline cellulose Magnesium stearate (vegetable)
Film-coating:
Opadry yellow II OYL 22903 (Lactose monohydrate, Hypromellose 15cP, Titanium dioxide, Macrogol/PEG 4000, Talc, Iron oxide yellow).
What Tramadol Hydrochloride/Paracetamol Tablets look like and contents of the pack
6.4 mm x 15.5mm, yellow, oblong, biconvex, film coated tablet with "T" on one side.
Tramadol Hydrochloride/Paracetamol Tablets is available in blister packs of 2, 10, 20, 30, 40, 50, 60, 70, 80, 90 or 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder Actavis Group PTC ehf.
Reykjavikurvegi 76-78 220 Hafnarfjordur Iceland
Manufacturers
Arrow Pharm (Malta) Ltd
HF62 Hal Far Industrial Estate, Birzebbugia
BBG3000
Malta
Actavis Ltd.
BLB016, Bulebel Industrial Estate, Zejtun
ZTN 3000
Malta
This leaflet was last revised in August2016.
If you would like a leaflet with larger text, please contact 01271 385257.
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