MXL 30 mg, 60 mg, 90 mg, 120 mg, 150 mg and 200 mg prolonged-release capsules
Morphine sulphate
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 become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What MXL capsules are and what they are used for
2. Before you take MXL capsules
3. How to take MXL capsules
4. Possible side effects
5. How to store MXL capsules
6. Further information
What MXL capsules are and what they are used for
These capsules have been prescribed for you by your doctor to relieve severe pain over a period of 24 hours. They contain the active ingredient morphine which belongs to a group of medicines called strong analgesics or ‘painkillers’.
Before you take MXL capsules
Do not take MXL capsules if:
- you are allergic (hypersensitive) to morphine or any of the other ingredients of the capsules (see section 6 ‘Further Information’);
- you have breathing problems, such as obstructive airways disease or respiratory depression. Your doctor will have told you if you have these conditions. Symptoms may include breathlessness, coughing or breathing more slowly or weakly than expected;
- you have a head injury that causes a severe headache or makes you feel sick. This is because the capsules may make these symptoms worse or hide the extent of the head injury;
- you have a condition where the small bowel (part of your gut) does not work properly (paralytic ileus), your stomach empties more slowly than it should (delayed gastric emptying) or you have severe pain in your abdomen;
- you have recent onset liver disease;
- you are taking a type of medicine known as a monoamine oxidase inhibitor (examples include tranylcypromide, phenelzine, isocarboxazid, moclobemide and linezolid), or you have taken this type of medicine in the last two weeks;
- the patient is under one year of age.
If you are going to have an operation, please tell the doctor at the hospital that you are taking these capsules.
Take special care with MXL capsules
Before treatment with these capsules tell your doctor or pharmacist if you:
- have breathing problems, such as impaired lung function. Your doctor will have told you if you have this condition. Symptoms may include breathlessness and coughing;
- have an under-active thyroid gland (hypothyroidism), kidney or long-term liver problems as you may need a lower dose;
- have a severe headache or feel sick as this may indicate that the pressure in your skull is increased;
- suffer from seizures, fits or convulsions;
- have low blood pressure;
- have a severe heart problem after long-term lung disease (severe cor pulmonale);
- have inflammation of the pancreas (which causes severe pain in the abdomen and back) or problems with your gall bladder;
- have an inflammatory bowel disorder;
- have prostate problems;
- have poor adrenal gland function (your adrenal gland is not working properly which may cause symptoms including weakness, weight loss, dizziness, feeling or being sick);
- are or have ever been addicted to alcohol or drugs;
- have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, upon stopping taking alcohol or drugs.
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. If you take these capsules with some other medicines, the effect of the capsules or the other medicine may be changed.
These capsules must not be used together with a monoamine oxidase inhibitor, or if you have taken this type of medicine in the last two weeks (see section 2 ‘Do not take…’).
Tell your doctor or pharmacist if you are taking:
- medicines to help you sleep (for example tranquillisers, hypnotics or sedatives);
- medicines to treat psychiatric or mental disorders (such as phenothiazines);
- muscle relaxants;
- medicines to treat high blood pressure;
- cimetidine to treat stomach ulcers, indigestion or heartburn;
- other strong analgesics or ‘painkillers’ (such as buprenorphine, nalbuphine or pentazocine);
- rifampicin to treat tuberculosis;
- ritonavir to treat HIV.
Also tell your doctor if you have recently been given an anaesthetic.
Taking MXL capsules with alcohol
Drinking alcohol during your treatment with these capsules may make you sleepy. If you are affected you should avoid drinking alcohol.
Pregnancy and breastfeeding
Do not take these capsules if you are pregnant or breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
These capsules may cause a number of side effects such as drowsiness which could affect your ability to drive or use machinery (see section 4 for a full list of side effects). These are usually most noticeable when you first start taking the capsules, or when changing to a higher dose. If you are affected you should not drive or use machinery.
How to take MXL capsules
Always take the capsules exactly as your doctor has told you. The label on your medicine will tell you how many capsules to take and how often.
Swallow your capsules whole with a glass of water. If you prefer, you can open your capsules and sprinkle the contents on to cold soft food, such as yogurt. Do not crush, dissolve or chew the capsule contents.
MXL capsules are designed to work properly over 24 hours. If the capsule contents are crushed, dissolved or chewed, the entire 24-hour dose may be absorbed rapidly into your body. This can be dangerous, causing serious problems such as an overdose, which may be fatal.
You should take your capsules every 24 hours. For instance, if you take a capsule at 8 o’clock in the morning, you should take your next capsule at 8 o’clock the next morning.
You must only take the capsules by mouth.
Adults
The usual starting dose is one 60 mg capsule every 24 hours. However, the dose will depend on your age, weight and the severity of your pain. If you are elderly or weigh less that 70 kg your doctor may suggest a starting dose of one 30 mg capsule every 24 hours. Your doctor will decide how many capsules you should take.
Children over one year of age
Children over one year of age can take these capsules. The required dose will depend on their weight and severity of pain. This should be discussed with your doctor or pharmacist.
If you find that you are still in pain whilst taking these capsules discuss this with your doctor.
Do not exceed the dose recommended by your doctor. You should check with your doctor or pharmacist if you are not sure.
If you take more MXL capsules than you should or if someone accidentally swallows your capsules
Call your doctor or hospital straight away. People who have taken an overdose may feel very sleepy, sick or dizzy. They may also have breathing difficulties leading to unconsciousness or even death and may need emergency treatment in hospital. When seeking medical attention make sure that you take this leaflet and any remaining capsules with you to show to the doctor.
If you forget to take MXL capsules
If you remember within 16 hours of the time your capsule was due, take your capsule straight away. Take your next capsule at your normal time. If you are more than 16 hours late, please call your doctor for advice. Do not take a double dose to make up for a forgotten capsule.
If you stop taking MXL capsules
You should not suddenly stop taking these capsules unless your doctor tells you to. If you want to stop taking your capsules, discuss this with your doctor first. They will tell you how to do this, usually by reducing the dose gradually so you do not experience unpleasant effects. Withdrawal symptoms such as agitation, anxiety, shaking or sweating may occur if you suddenly stop taking these capsules.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, these capsules can cause side effects, although not everybody gets them.
All medicines can cause allergic reactions, although serious allergic reactions are uncommon. Tell your doctor immediately if you get any sudden wheeziness, difficulties in breathing, swelling of the eyelids, face or lips, rash or itching especially those covering your whole body.
The most serious side effect is a condition where you breathe more slowly or weakly than expected (respiratory depression).
As with all strong painkillers, there is a risk that you may become addicted or reliant on these capsules.
Common side effects (probably affecting more than 1 in 100 people taking these capsules)
- Constipation (your doctor can prescribe a laxative to overcome this problem).
- Feeling or being sick (this should normally wear off after a few days, however your doctor can prescribe an anti-sickness medicine if it continues to be a problem).
- Drowsiness (this is most likely when you first start taking your capsules or when your dose is increased, but it should wear off after a few days).
- Dry mouth, loss of appetite, indigestion, abdominal pain or discomfort.
- Headache, confusion, difficulty in sleeping, abnormal thoughts.
- A feeling of unusual weakness.
- Difficulty in breathing or wheezing, decreased cough reflex.
- Involuntary muscle contractions or spasms.
- An increase in the severity of symptoms associated with inflammation of the pancreas (severe pain in the abdomen and back).
- Rash or itchy skin.
- Sweating.
Uncommon side effects (probably affecting fewer than 1 in 100 people taking these capsules)
- Gastrointestinal disorders (e.g. upset stomach), changes in taste.
- A feeling of dizziness or ‘spinning’, fainting, seizures, fits or convulsions.
- Agitation, unpleasant or uncomfortable mood, mood changes, hallucinations, a feeling of extreme happiness.
- Generally feeling unwell.
- Tingling or numbness.
- Difficulty in passing urine.
- Impotence, decreased sexual drive, absence of menstrual periods.
- High or low blood pressure, facial flushing (redness of the face).
- A fast or slow heart beat, palpitations.
- Swelling of the hands, ankles or feet.
- Blurred vision, reduction in size of the pupils in the eye.
Uncommonly, these capsules may affect the results of blood tests to check that your liver is working properly.
If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How to store MXL capsules
Keep out of the reach and sight of children.
Do not use any capsules after the expiry date which is stated on the blister and carton. EXP 08 2010 means that you should not take the capsules after the last day of that month i.e. August 2010.
Do not store your capsules above 25°C.
Do not take your capsules if they are broken or crushed as this can be dangerous and can cause serious problems such as overdose.
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.
Further information
What MXL capsules contain
The active ingredient is morphine sulphate. Each capsule contains 30 mg, 60 mg, 90 mg, 120 mg, 150 mg or 200 mg of morphine sulphate.
The other ingredients are:
- Hydrogenated vegetable oil
- Macrogol
- Talc
- Magnesium stearate
- Gelatin
- Sodium dodecyl sulphate
- Shellac
- Iron oxide (E172)
- Propylene glycol
- Titanium dioxide (E171)
The capsules also contain the following colourants:
30 mg, 60 mg & 120 mg - Indigo carmine (E132)
90 mg - Erythrosine (E127)
150 mg - Erythrosine (E127) and indigo carmine (E132)
What MXL capsules look like and the contents of the pack
The capsules are marked MS OD followed by the strength (e.g. 30, 60 etc).
The capsules are coloured as follows: 30 mg - light blue, 60 mg - brown, 90 mg - pink, 120 mg - olive, 150 mg - blue, 200 mg - rust.
In each box there are 28 capsules.
Marketing Authorisation Holder and Manufacturer
The capsules are made by
for the marketing authorisation holder
This leaflet is also available in large print, Braille or as an audio CD. To request a copy, please call the RNIB Medicine Information line (free of charge) on:
0800 198 5000
You will need to give details of the product name and reference number.
These are as follows:
Product name: MXL prolonged-release capsules
Reference number: 16950/0042
This leaflet was last revised in 06/2009
MXL
capsules are protected by European Patent (UK) Nos. 0636370 and
0654263.
MXL and the NAPP device (logo) are Registered Trade Marks.
© 2009 Napp Pharmaceuticals Limited
P0072-A R1V7 UK AW 05-02-09
No comments:
Post a Comment