Patient Leaflet Updated 21-Nov-2019 | Ethypharm UK Ltd
Maxitram SR 50mg, 100mg, 150mg and 200mg prolonged-release capsule, hard
Package leaﬂet: Information for the user
MAXITRAM SR 50 mg, 100 mg, 150 mg and 200 mg prolonged-release capsule, hard
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet
1. What MAXITRAM SR is and what it is used for
2. What you need to know before you take MAXITRAM SR
3. How to take MAXITRAM SR
4. Possible side effects
5. How to store MAXITRAM SR
6. Contents of the pack and other information
1. WHAT MAXITRAM SR IS AND WHAT IT IS USED FOR
Tramadol hydrochloride — the active substance of MAXITRAM SR —belongs to a group of medicines known as opioid analgesics or painkillers. Its pain-relieving action is due to its effect on specific nerve cells in the spinal cord and brain.
MAXITRAM SR is used in the treatment of moderate to severe pain.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MAXITRAM SR
Do not take MAXITRAM SR:
MAXITRAM SR is not suitable as a drug substitute for the treatment of drug addiction.
MAXITRAM SR is not suitable for use in children under 25 kg body weight.
MAXITRAM SR is contraindicated in children below 12 years of age.
Warnings and Precautions
Talk to your doctor, pharmacist or nurse before taking MAXITRAM SR:
Tramadol is transformed in the liver by an enzyme. Some people have a variation of this enzyme and this can affect people in different ways.
In some people, they may not get enough pain relief but other people are more likely to get serious side effects. If you notice any of the following side effects, you must stop taking this medicine and seek immediate medical advice: slow or shallow breathing, confusion, sleepiness, small pupils, feeling or being sick, constipation, lack of appetite.
Epileptic fits have been reported in patients taking tramadol at the recommended dose level. The risk may be increased when doses of tramadol exceed the recommended upper daily dose limit (400 mg).
As with all opioids, tramadol should be used with caution, and only under medical supervision in seriously ill patients including those with impaired breathing, excessively low blood pressure (shock), serious head injury or brain diseases that may cause elevated pressure in the skull.
As with all opioids, tramadol may lead to psychological and physical dependence or addiction in some people, especially with long term use. The dose needed to achieve the desired effect may increase with time. Tramadol should be used with caution, and only for short periods, in patients who are addicted to other opioid pain-killers.
Children and adolescents
Use in children with breathing problems:
Tramadol is not recommended in children with breathing problems, since the symptoms of tramadol toxicity may be worse in these children.
Other medicines and MAXITRAM SR
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
The pain-relieving effect of MAXITRAM SR may be weakened and/or shortened if you also take medicines containing:
Your doctor will tell you whether you should take MAXITRAM SR, and which dose.
The risk of side effects increases,
Do not take MAXITRAM SR at the same time as medicines called “monoamine oxidase inhibitors" (which are used to treat depression), or if you have taken one in the past 2 weeks.
Concomitant use of MAXITRAM SR and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible.
However if your doctor does prescribe MAXITRAM SR together with sedative medicines the dose and duration of concomitant treatment should be limited by your doctor.
Please tell your doctor about all sedative medicines you are taking, and follow your doctor's dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.
MAXITRAM SR with food and alcohol
Do not drink alcohol during treatment with MAXITRAM SR as its effect may be intensified.
Food does not influence the effect of MAXITRAM SR.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
MAXITRAM SR may affect an unborn child. Therefore, it should not be taken during pregnancy.
Tramadol is excreted into breast milk. For this reason, you should not take MAXITRAM SR more than once during breast-feeding, or alternatively, if you take MAXITRAM SR more than once, you should stop breast-feeding.
Based on human experience tramadol is suggested not to influence female or male fertility.
Driving and using machines
MAXITRAM SR may cause side effects such as drowsiness and blurred vision. If this happens, do not drive or use any tools/machines and do not perform any hazardous tasks.
The medicine can affect your ability to drive as it may make you sleepy or dizzy.
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.
MAXITRAM SR contains benzoates and sucrose
This medicine contains methyl parahydroxybenzoate and propyl parahydroxybenzoate which may cause allergic reactions, some of which may be delayed.
This medicine contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
MAXITRAM SR contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per prolonged-release capsule, that is to say essentially ‘sodium-free‘.
3. HOW TO TAKE MAXITRAM SR
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.
Always take MAXITRAM SR exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The usual doses are given below. Your doctor may gradually increase or decrease your dose depending on how you respond to the treatment.
Adults and adolescents aged 12 and over:
50 mg capsules: The usual dose is two to four 50 mg capsules taken twice a day, equivalent to 200 to 400 mg per day.
100 mg capsules: The usual dose is one to two 100 mg capsules taken twice a day, equivalent to 200 to 400 mg per day.
150 mg capsules: The usual dose is one 150 mg capsule taken twice a day, equivalent to 300 mg per day.
200 mg capsules: The usual dose is one 200 mg capsule taken twice a day, equivalent to 400 mg per day.
The capsules should be taken in the morning and evening. You should not normally take more than 400 mg a day.
Use in children:
This medicinal product is not suitable for use in children below 25 kg body weight which in general does not allow for individualized dosage in children below 12 years of age. Other form(s) of this medicine may be more suitable for children; ask your doctor, pharmacist or nurse.
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 problems, should not take MAXITRAM SR.
If in your case the insufficiency is mild or moderate, your doctor may recommend prolonging the dosage interval.
Route and method of administration
For oral use.
The capsules should be swallowed whole with a glass of water.
The capsules can be taken with or without food. They should NOT be chewed, divided or crushed.
How long should you take MAXITRAM SR
You should not take MAXITRAM SR for longer than necessary. If you need to be treated for a longer period, your doctor will check at regular short intervals (if necessary with breaks in treatment) whether you should continue to take MAXITRAM SR and at what dose.
If you have the impression that the effect of MAXITRAM SR is too strong or too weak, talk to your doctor or pharmacist.
If you take more MAXITRAM SR than you should
If high doses are taken accidentally, you should contact your doctor immediately or go to your nearest hospital casualty department. A number of symptoms may occur. These might include: very small pupils, vomiting (being sick), a fall in blood pressure, a fast heartbeat, collapse, fainting or even coma, epileptic fits and difficulties in breathing or shallow breathing.
If you forget to take MAXITRAM SR, take it as soon as you remember and then carry on as before. Do not take a double dose to make up for a forgotten dose.
If you stop taking MAXITRAM SR, your pain may return.
You should not suddenly stop taking this medicine unless your doctor tells you to. If you want to stop taking your medicine, discuss this with your doctor first, particularly if you have been taking it for a long time. Your doctor will advise you when and how to stop, which may be by lowering the dose gradually to reduce the chance of developing unnecessary side effects (withdrawal symptoms).
If you have been taking this medicine for a very long time, you may get the following side effects if you suddenly stop treatment: restlessness, anxiety, nervousness, shaking or an upset stomach. Very few people may get panic attacks, hallucinations, unusual perceptions such as itching, tingling and numbness, and “ringing” in the ears (tinnitus). Further unusual CNS symptoms, i.e. confusion, delusions, change of perception of the own personality (depersonalisation), and change in perception of reality (derealisation) and delusion of persecution (paranoia) have been seen very rarely. If you get any of these effects after stopping treatment with MAXITRAM SR, please talk to your doctor.
If you have any further questions on the use of this product, ask your doctor, pharmacist or nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
MAXITRAM SR can occasionally cause allergic reactions although serious allergic reactions (including anaphylaxis and angioedema) are rare. Tell your doctor immediately if you get any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body).
The following side effects may occur:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1 000 people
Very rare: may affect up to 1 in 10 000 people
Not known: frequency cannot be estimated from the available data
When treatment is stopped abruptly, signs of withdrawal may appear (see “If you stop taking MAXITRAM SR").
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 Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App store. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE MAXITRAM SR
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 blister and the carton after EXP. The expiry date refers to the last day of that month. Do not store above 25°C. 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 to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What MAXITRAM SR contains
The active substance is tramadol hydrochloride. Each capsule contains 50 mg, 100 mg, 150 mg or 200 mg of tramadol hydrochloride equivalent to 43.91 mg, 87.82 mg, 131.73 mg or 175.64 mg tramadol.
The other ingredients are:
What MAXITRAM SR looks like and contents of the pack
All strengths of MAXITRAM SR capsules contain white spherical microgranules ("beads")
50 mg gelatin capsules are white opaque
100 mg gelatin capsules have an opaque yellow cap and natural transparent body
150 mg gelatin capsules are opaque yellow
200 mg gelatin capsules have an opaque yellow cap and opaque white body
Pack sizes: 10, 20, 28, 30, 50, 56,60, 100 capsules. Hospital packs: 500 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
For any information about this medicine, please contact 0161 488 5555.
This leaflet was last revised in: 07/2019
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