- tramadol hydrochloride
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original can be viewed in PDF format using the link above.
The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet are: PL08829/0165, PL08829/0163, PL08829/0162, PL08829/0164.
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.
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 dependance 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 painkillers.
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:
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.
Pregnancy and breast-feeding
MAXITRAM SR may affect an unborn child. Therefore it should not be taken during pregnancy.
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.
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.
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.
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 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 or crushed.
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: vomiting (being sick), a fall in blood pressure, a fast heartbeat, collapse, fainting or even coma, epileptic fits and difficulties in 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. 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: affects up to 1 in 10 people
Uncommon: affects up to 1 in 100 people
Rare: affects up to 1 in 1,000 people
Very rare: affects up to 1 in 10,000 people
Not known: Frequency cannot be estimated from the available data
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.
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 and Manufacturer
Is this leaflet hard to see or read? Phone 0161 488 5555 for help.
This leaflet was last revised in: 06/2018
FR02148.V7 / CP0033/9