Marol 100mg Prolonged-Release Tablets
TEVA UK Ref: 231-30-87197-X LEA TRAMADOL (MAROL) A/S TAB TUK XMOR Version: 1 5 June 2014
MAROL 100 mg, 150 mg and 200 mg PROLONGED RELEASE TABLETS
(Tramadol hydrochloride)
PACKAGE LEAFLET: INFORMATION FOR THE USER
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, 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Marol Tablets are and what they are used for
2. Before you take Marol Tablets
3. How to take Marol Tablets
4. Possible side effects
5. How to store Marol Tablets
6. Further information
OWHAT MAROL TABLETS ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Marol 100 mg, 150 mg or 200 mg Prolonged-release Tablets.
Each prolonged release tablet contains 100 mg, 150 mg or 200 mg of tramadol hydrochloride. Tramadol, the active substance, is a centrally acting opioid analgesic that is used for the treatment of moderate to severe pain.
Marol Prolonged-release tablets are referred to as Marol tablets below.
Do not take Marol Tablets
• if you are allergic (hypersensitive) to tramadol hydrochloride or any of the other ingredients of Marol Tablets
• if you are pregnant (see Pregnancy and breast-feeding below)
• if you have recently drunk too much alcohol or taken too many sleeping tablets, other pain killers or any medicines that affect your mood such as antidepressant medicines
• if you are, or have taken in the last two weeks, an antidepressant medicine called a monoamine oxidase inhibitor (MAOI), such as phenelzine or moclobemide.
Take special care with Marol Tablets if
• you have recently had any head injuries, suffered from any severe headaches or felt sleepy for no reason (especially after an accident)
• you have recently had an accident where you may still be in shock
• you find it difficult to breathe, or your breathing is a lot slower than normal
• you have, or have had, an addiction to opioid analgesics (such as morphine, diamorphine or codeine)
• you have epilepsy.
tablets, antidepressants, some other pain killers);
• other opioid pain killers (analgesics) (such as buprenorphine, nalbuphine or pentazocine);
• carbamazepine (for epilepsy);
• antidepressant or antipsychotic medicines (such as fluoxetine, citalopram, amitriptyline, imipramine, chlorpromazine, haloperidol or sulpiride);
• medicines to thin the blood (such as warfarin);
• ketoconazole (a medicine for treating fungal infections);
• erythromycin (an antibiotic for treating infections).
The risk of side effects increases,
• if you are taking medicines which may cause convulsions (fits), such as certain antidepressants or antipsychotics. The risk of having a fit may increase if you take Marol tablets at the same time. Your doctor will tell you whether Marol tablets are suitable for you.
• if you are taking certain antidepressants. Marol 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.
Taking with food and drink
Marol tablets can be taken before, with or after food. You should NOT drink alcohol whilst taking these tablets.
Pregnancy and breast-feeding
Marol tablets should not be taken during pregnancy as it may affect the unborn child. If you become pregnant while taking Marol you should talk to your doctor immediately.
It is also not advised to take the tablets whilst breast-feeding. However, if your doctor feels it necessary, you do not have to stop breast-feeding for a once only dose of Marol Tablets.
Driving and using machines
Marol tablets can affect your ability to drive and operate machinery, particularly when combined with other medicines that can cause drowsiness. Therefore, driving and operating machinery is not advised whilst taking these tablets.
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.
If any of the above apply to you, please talk to your doctor or pharmacist for advice if you have not already done so.
Always take Marol tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The tablets should be swallowed whole, without breaking or chewing, with a glass of water. The usual dose is:-
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.
In particular, you should talk to your doctor before taking Marol if you are taking any of the following:
• a monoamine oxidase inhibitor (MAOI) (such as isocarboxazid, phenelzine or tranylcypromine)
• alcohol;
• medicines that cause drowsiness (such as sleeping
Adults:
The usual starting dose is one 100 mg tablet twice a day (in the morning and evening). If this is not sufficient to kill the pain, your doctor may give you either one 150 mg tablet or one 200 mg tablet twice a day.
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. This is usually no more than 400 mg (two 200 mg tablets) a day except in special circumstances.
|
teva UK Ref: 231-30-87197-X LEA TRAMADOL (MAROL) A/S TAB TUK XMOR |
Version: 1 |
5 June 2014 |
Marol tablets should not be used for any longer than is absolutely necessary. If you need to take these tablets for a long period your doctor will monitor you regularly. Children (under 12 years old):
Marol tablets are not suitable for children under 12 years old. 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 Marol tablets. If in your case the insufficiency is mild or moderate, your doctor may recommend prolonging the dosage interval.
If you take more Marol Tablets than you should
Immediately contact your doctor or your nearest hospital casualty department immediately. Please take any remaining medicine with you in the carton in which it came so that staff will know what has been taken.
If you forget to take Marol Tablets
Take it as soon as you remember then continue as before. If it is nearly time for your next tablet, leave the missed dose and continue as before. Do not take any more tablets in one day than your doctor has prescribed. Do not take a double dose to make up for a forgotten dose.
If you stop taking Marol Tablets
You may suffer from the following withdrawal effects when you stop taking these tablets:
• agitation
• anxiety
• nervousness
• problems in sleeping
• feeling overactive
• shaking
• feeling sick or bloated, stomach pain or discomfort, and similar stomach problems.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
^ POSSIBLE SIDE EFFECTS
Like all medicines, Marol Tablets can cause side effects, although not everybody gets them.
Stop taking the tablets and tell your doctor immediately if you experience any of the following rare effects:
• A severe or itchy skin rash, especially if this shows blistering and there is soreness of the eyes, mouth or genital organs
• Swelling of the hands, face, lips or tongue
• Difficulty in breathing, or wheezing.
the skin.
Rare side effects (affecting less than 1 person in every 1000) include:
• slower heartbeat than normal;
• an increase in your blood pressure;
• changes in appetite;
• tingling of the hands and feet;
• shaking (tremor);
• breathing slower than normal;
• convulsions (fits);
• seeing or hearing things that are not there (hallucinations);
• confusion;
• sleep disturbances and nightmares;
• changes in your mood, such as feeling unusually cheerful, or sometimes emotional and moody;
• changes in activity levels, this is usually feeling slower but some people may feel more energetic;
• a change in how you see things (perception) or your ability to make decisions;
• blurred vision;
• muscle weakness;
• difficulty in passing water;
• allergic reactions (see first warning above), you should immediately stop taking the tablets and talk to your doctor.
There have been a few isolated reports of an increase in liver enzymes. This would only usually be seen after you have had a blood test. Your doctor may check you for this, if the doctor thinks it is necessary.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Keep out of the reach and sight of children.
Do not use Marol tablets after the expiry date which is stated on the carton and also on the blister.
This medicinal product does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
rg FURTHER INFORMATION
What Marol Tablets contain
• The active substance is Tramadol hydrochloride.
• The other ingredients are calcium hydrogen phosphate dihydrate (E341), hydroxypropylcellulose (E463), colloidal anhydrous silica (E551), and magnesium stearate (E470b).
These are all possible signs of a severe allergic reaction.
Very common side effects (affecting more than 10 people in every 100) are nausea and dizziness.
Common side effects (affecting 1 to 10 people in every 100) include:
• headache;
• drowsiness;
• being sick (vomiting);
• constipation;
• dry mouth;
• sweating.
Uncommon side effects (affecting less than 1 person in every 100) include:
• being aware of your heartbeat (heart palpitations);
• heart beating faster than normal;
• dizziness or fainting when standing from a sitting or lying position (hypotension);
• a collapse of the heart and blood supply;
• retching;
• a feeling of pressure or bloating in the stomach;
• skin reactions, such as itching or a rash, reddening of
What Marol Tablets look like and contents of the pack
Marol 100 mg tablets are round, biconvex, off white, prolonged release tablets.
Marol 150 mg and 200 mg tablets are capsule-shaped, off white, prolonged release tablets.
All the strengths are available in either clear or opaque coloured blister packs and pots of 10, 20, 30, 50, 60, 90, 100, 120, and 180 tablets but not all pack sizes may be marketed.
Marketing Authorisation Holder:
Morningside Healthcare Ltd.,
115 Narborough Road, Leicester, LE3 0PA, UK. Manufacturers:
FAL Duiven, Dijkgraaf, 6921, RK Duiven, The Netherlands. Medochemie Ltd, Facility A-Z, Ayios Athanassios, Industrial Street, Limassol, Cyprus.
Morningside Pharmaceuticals Ltd 5 Pavilion Way, Loughborough, LE11 5GW, UK.
This leaflet was last revised in June 2014
87197-X