MXL capsules 30 mg

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 or pharmacist.
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What MXL capsules are and what they are used for
2. What you need to know before you take MXL capsules
3. How to take MXL capsules
4. Possible side effects
5. How to store MXL capsules
6. Contents of the pack and other information

Do not take MXL capsules if:

• you are allergic to morphine or any of the other ingredients of the capsules (see section 6);
• you have breathing problems, such as obstructive airways disease, respiratory depression, or severe asthma. 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.

Warnings and precautions

Talk to your doctor or pharmacist before taking these capsules if you:

• have breathing problems, such as severe bronchial asthma or impaired lung function. Your doctor will have told you if you have these conditions. 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;
• you suffer from constipation;
• have prostate problems;
• have increased sensitivity to pain despite the fact that you are taking increasing doses (hyperalgesia). Your doctor will decide whether you will need a change in dose or a change in strong analgesic (“painkiller”), (see section 2);
• experience weakness, fatigue, lack of appetite, nausea, vomiting or low blood pressure. This may be a symptom of the adrenal glands producing too little of the hormone ‘cortisol’, and you may need to take a hormone supplement;
• have loss of libido, impotence, cessation of menstruation. This may be because of decreased sex hormone production;
• have previously been dependent on drugs or alcohol. Also tell your doctor if you feel that you are becoming dependent on this medicine while you are using it. You may have started to think a lot about when you can take the next dose, even if you do not need it for the pain;
• have withdrawal (abstinence) symptoms or dependence. The most common abstinence symptoms are mentioned in section 3. If this occurs, your doctor may change the type of medicine or the times between doses.

This medicine may cause breathing problems or worsen already existing problems while sleeping. These problems may include pauses in breathing during sleep, being awoken by shortness of breath, difficulty staying asleep or excessive daytime drowsiness. If you or someone else observes these symptoms contact your doctor. Your doctor may want to lower your dose.

You may experience hormonal changes while taking these capsules. Your doctor may want to monitor these changes.

Other medicines and MXL capsules

Concomitant use of MXL capsules 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 MXL capsules together with sedative medicines, the dosage 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 dosage recommendation closely. It could be helpful to inform friends or relatives to be aware of signs and symptoms stated above. Contact your doctor when experiencing such symptoms.

If you are taking or have recently taken any other medicines, or might take any other medicines please tell your doctor or pharmacist. 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 any of the medicines mentioned below:

• 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;
• Some medicines used to treat blood clots (e.g. clopidogrel, prasugrel, ticagrelor) may have delayed and decreased effect when taken together with morphine;
• 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;
• gabapentin to treat epilepsy or neuropathic pain (pain due to nerve problems).

Also tell your doctor if you have recently been given an anaesthetic.

Taking MXL capsules with alcohol

Drinking alcohol whilst taking MXL capsules may make you feel more sleepy or increase the risk of serious side effects such as shallow breathing with a risk of stopping breathing, and loss of consciousness. It is recommended not to drink alcohol while you are taking MXL capsules.

Pregnancy, breastfeeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Prolonged use of morphine during pregnancy may cause withdrawal symptoms in newborns, which should be treated by a doctor. Withdrawal (abstinence) symptoms in babies born to mothers who have used MXL capsules in pregnancy may include high-pitched crying, irritability and restlessness, shaking (tremor), feeding difficulties and sweating.

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.

This 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 while you have this medicine in your body over a specified limit unless you have a defence (called the ‘statutory defence’).
• This defence applies when:
  • 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 and in the information provided with the medicine.
• Please note that it is still an offence to drive if you are unfit because of the medicine (i.e. your ability to drive is being affected).

Details regarding a new driving offence concerning driving after drugs have been taken in the UK may be found here: https://www.gov.uk/drug-driving-law.

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

MXL capsules contain sodium

This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.

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 than 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 as you may need emergency treatment in hospital. People who have taken an overdose may feel very sleepy, sick, dizzy or get pneumonia from inhaling vomit or foreign matter (symptoms may include breathlessness, cough and fever). People who have taken an overdose may also have breathing difficulties leading to unconsciousness, or even death.

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

Do not stop treatment with these capsules unless agreed with your doctor. If you want to stop the treatment with these capsules, ask your doctor how to slowly decrease the dose so you avoid abstinence symptoms. Abstinence (withdrawal) symptoms may include body aches, tremors, diarrhoea, stomach pain, nausea, flu-like symptoms, fast heartbeat and large pupils. Psychological symptoms include an intense feeling of unsatisfaction, anxiety and irritability.

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 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.

What MXL capsules contain

The active ingredient is morphine sulfate. Each capsule contains 30 mg, 60 mg, 90 mg, 120 mg, 150 mg or 200 mg of morphine sulfate.

The other ingredients are:

• Hydrogenated vegetable oil
• Macrogol
• Talc
• Magnesium stearate
• Gelatin (contains Sodium dodecyl sulfate)
• 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 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