Maxitram Sr 100mg Prolonged-Release Capsules
GChiesi
Package Leaflet: Information for the user
MAXITRAM SR 50 mg, 100 mg, 150 mg and 200 mg prolonged-release capsule, hard
Tramadol hydrochloride
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, pharmacist or nurse.
• 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
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:
• if you are allergic to tramadol or any of the other ingredients of this medicine (listed in section 6)
• if you are intoxicated with alcohol or with sedative drugs including sleeping pills, other painkillers or tranquiliser medicines
• if you are taking, or have taken in the last two weeks, certain medicines called “monoamine oxidase inhibitors” or MAOIs (used to treat depression). The combination could result in a serious, potentially life threatening interaction.
• if you have epilepsy that is not controlled with your current medicine
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:
• if you suffer from epilepsy or seizures (fits) or have had them in the past, because tramadol could increase the risk of you having further fits.
• if you have liver or kidney problems.
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.
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:
• carbamazepine (used to treat epilepsy)
• pentazocine, nalbuphine or buprenorphine (pain killers)
• ondansetron (used to stop you feeling sick)
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 MAXITRAM SR at the same time. Your doctor will tell you whether MAXITRAM SR is suitable for you.
• if you are taking certain antidepressants. MAXITRAM SR 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 oC.
• if you take MAXITRAM SR at the same time as sedative medicines such as tranquilisers, or sleeping pills, and other pain relievers (morphine, codeine). You may feel excessively drowsy or feel that you might faint.
• if you take MAXITRAM SR at the same time as alcohol. Tramadol may increase the intoxicating effect of alcohol and therefore you should be cautious if you wish to drink alcohol during treatment with MAXITRAM SR.
• if you take MAXITRAM SR at the same time as medicines that inhibit blood clotting, such as warfarin. The dose of these medicines may need to be reduced, otherwise there could be an increased risk of potentially serious bleeding.
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 and is present in breast milk. Therefore it should not be taken during pregnancy or breast-feeding.
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.
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.
• 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.
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.
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 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, 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.
If you would like to stop treatment because you have unpleasant side effects, please talk to your doctor. 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 10people
Dizziness
Common: affects up to 1 in 10 people
Drowsiness Dry mouth Sweating
• Fatigue (tiredness)
Uncommon: affects up to 1 in 100people
Retching Diarrhoea Stomach bloating
Skin disorders (e.g. itchiness, rash, sudden onset of skin redness)
• Palpitations (quicker or irregular heartbeat) •
• Low blood pressure, especially when •
standing upright
Rare: affects up to 1 in 1,000 people
Mood changes
Hallucinations
Confusion
Difficulty sleeping
Anxiety
Nightmares
Blurred vision
Reduced muscle strength
Urinary disorders e.g. producing less urine
than normal
Drug dependance (addiction)
Generalised allergic reactions (see above)
• Slow heartbeat (bradycardia) •
• Abnormal skin sensations (e.g. pins and •
• Epileptic-like seizures (“fits”) •
• Fainting
Very rare: affects up to 1 in 10,000people
• Increased level of liver enzymes
Not known: Frequency cannot be estimated from the available data
• Decrease in blood sugar level (hypoglycaemia)
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:
• Sugar spheres (maize starch and sucrose)
• Macrogol 4000
• Polyacrylate dispersion 30% (ethyl acrylate, methyl methacrylate, nonoxynol)
• Dimeticone emulsion (dimeticone, (t-octylphenoxy) polyethoxyethanol, Macrogol 600, polyethylene-sorbitan-monolaurate, sodium benzoate, propyl-4-hydroxybenzoate (E216), methyl-4-hydroxybenzoate (E218), propylene glycol, sorbic acid)
• Hypromellose • Talc • Gelatin
• Titanium dioxide (E 171)
• Yellow iron oxide (E172) [100 mg, 150 mg, 200 mg capsules only]
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
Chiesi Limited, Cheadle Royal Business Park, Highfield, Cheadle, SK8 3GY, UK.
Is this leaflet hard to see or read? Phone 0161 488 5555 for help.
This leaflet was last revised in: 02/2014 CP0033/7