MXL 120 mg prolonged release capsules

• 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.

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

• 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 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 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 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.

Tolerance, dependence, and addiction

This medicine contains morphine which is an opioid medicine. Repeated use of opioids can result in the drug being less effective (you become accustomed to it, known as tolerance). Repeated use of MXL capsules can also lead to dependence, abuse, and addiction, which may result in life-threatening overdose. The risk of these side effects can increase with a higher dose and longer duration of use.

Dependence or addiction can make you feel that you are no longer in control of how much medicine you need to take or how often you need to take it.

The risk of becoming dependent or addicted varies from person to person. You may have a greater risk of becoming dependent on or addicted to MXL capsules if:

• You or anyone in your family have ever abused or been dependent on alcohol, prescription medicines or illegal drugs (“addiction”).
• You are a smoker.
• You have ever had problems with your mood (depression, anxiety, or a personality disorder) or have been treated by a psychiatrist for other mental illnesses.

If you notice any of the following signs whilst taking MXL capsules, it could be a sign that you have become dependent or addicted:

• You need to take the medicine for longer than advised by your doctor
• You need to take more than the recommended dose
• You are using the medicine for reasons other than prescribed, for instance, ‘to stay calm’ or ‘help you sleep’
• You have made repeated, unsuccessful attempts to quit or control the use of the medicine
• When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again (‘withdrawal effects’)

If you notice any of these signs, speak to your doctor to discuss the best treatment pathway for you, including when it is appropriate to stop and how to stop safely (See section 3, If you stop taking MXL capsules).

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 a severe heart problem after long-term lung disease (severe cor pulmonale);
• have a breathing disorder where your breathing pauses during your sleep (sleep apnoea);
• are or have previously been dependent on opioids, alcohol, prescription medicines or illegal drugs. 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 previously suffered from withdrawal (abstinence) symptoms. The most common symptoms are mentioned in section 3. If this occurs, your doctor may change the type of medicine or the times between doses;
• 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);have a head injury or severe headache or feel sick as this may indicate that the pressure in your skull is increased;
• have low blood pressure;
• have an under-active thyroid gland (hypothyroidism);
• 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;
• suffer from seizures, fits or convulsions;
• have inflammation of the pancreas or have problems with your gall bladder due to gall stones;
• have prostate problems;
• have an inflammatory bowel disorder;
• have kidney or liver problems;
• you suffer from constipation;
• have sickle cell disease;
• have loss of libido, impotence or your menstrual cycle stops. This may be because of decreased sex hormone production.

Contact your doctor if you experience severe upper abdominal pain possibly radiating to the back, nausea, vomiting or fever as this could be symptoms associated with inflammation of the pancreas (pancreatitis) and the biliary tract system.

Taking this medicine regularly, particularly for a long time, can lead to addiction. Your doctor should have explained how long you will be using it for and when it is appropriate to stop, how to do this safely.

Rarely, increasing the dose of this medicine can make you more sensitive to pain. If this happens, you need to speak to your doctor about your treatment.

Addiction can cause withdrawal symptoms when you stop taking this medicine. Withdrawal symptoms can include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, loss of appetite, shaking, shivering or sweating. Your doctor will discuss with you how to gradually reduce your dose before stopping the medicine. It is important that you do not stop taking the medicine suddenly as you will be more likely to experience withdrawal symptoms.

Opioids should only be used by those they are prescribed for. Do not give your medicine to anyone else. Taking higher doses or more frequent doses of opioid may increase the risk of addiction. Overuse and misuse can lead to overdose and/or death.

Acute generalized exanthematous pustulosis (AGEP) has been reported in association with MXL capsules treatment. Symptoms usually occur within the first 10 days of treatment. Tell your doctor if you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking MXL capsules or other opioids. Stop using MXL capsules and seek medical attention immediately, if you notice any of the following symptoms: blistering, widespread scaly skin or pus-filled spots together with fever.

Sleep-related breathing disorders

MXL capsules can cause breathing disorders such as sleep apnoea (breathing pauses during sleep) and sleep related hypoxemia (low oxygen level in blood). These symptoms can include breathing pauses during sleep, night awakening due to shortness of breath, difficulties to maintain sleep or excessive drowsiness during the day. If you or another person observes these symptoms contact your doctor. A dose reduction may be considered by your doctor.

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

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.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. If you take these capsules with some other medicines, the effect of the capsules or the other medicine may be changed.

MXL 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. A large number of drugs can interact with morphine sulfate tablets which can significantly alter their effects. These drugs include:

• medicines to help you sleep (for example benzodiazepines, tranquillisers, hypnotics or sedatives);
• medicines to treat psychiatric or mental disorders (such as antidepressants or 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;
• certain types of medicines to stop you feeling or being sick;
• other strong analgesics or ‘painkillers’ (such as buprenorphine, nalbuphine or pentazocine);
• rifampicin to treat tuberculosis;
• ritonavir to treat HIV;
• gabapentin or pregabalin to treat epilepsy and pain due to nerve problems (neuropathic pain).

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

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.

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.

Do not take MXL capsules if you are pregnant or think you might be pregnant unless you have discussed this with your doctor and the benefits of treatment are considered to outweigh the potential harm to the baby. Prolonged use of morphine during pregnancy may cause withdrawal symptoms in newborns, which should be treated by a doctor. Withdrawal 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.

Do not take MXL capsules while you are breastfeeding as morphine passes into breast milk and will affect your baby.

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.

• 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 and 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.

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

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 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.

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.

An overdose may result in:

• A brain disorder (known as toxic leukoencephalopathy)

When seeking medical attention make sure that you take this leaflet and any remaining capsules with you to show to the doctor.

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.

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.

As with all strong painkillers, there is a risk that you may become addicted or reliant on these capsules.

If you notice any of the following signs whilst taking MXL capsules it could be a sign that you have become addicted.

• You need to take the medicine for longer than advised by your prescriber;
• You feel you need to use more than the recommended dose;
• You are using the medicine for reasons other than prescribed;
• When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again.

If you notice any of these signs it is important you talk to your doctor.

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.

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)

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.