Package leaflet: Information for the user

Tradename® 120 mg and 200 mg prolonged-release capsules

Morphine sulfate

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 Tradename capsules are and what they are used for

2.    What you need to know before you take Tradename capsules

3.    How to take Tradename capsules

4.    Possible side effects

5.    How to store Tradename capsules

6.    Contents of the pack and other information

1. What Tradename 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’.

2. What you need to know before you take Tradename capsules

Do not take Tradename capsules if:

•    you are allergic to morphine or any of the other ingredients of this medicine (listed in section 6);

•    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.

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;

•    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.

Very rarely you may experience increased sensitivity to pain despite the fact that you are taking increasing doses of these capsules (hyperalgesia). Your doctor will decide whether you need a change in dose or a change in strong analgesic (‘painkiller’).

Other medicines and Tradename capsules

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.

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;

•    gabapentin to treat epilepsy or neuropathic pain (pain due to nerve problems).

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

Tradename capsules and alcohol

Drinking alcohol whilst taking Tradename 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’re taking Tradename capsules.

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.

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.

3.    How to take Tradename 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. Check with your doctor or pharmacist if you are not sure.

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.

Tradename 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 dose will depend on your age, weight and the severity of your pain. 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 Tradename 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 Tradename 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 Tradename 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.

4. 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.

Very common side effects (may affect more than 1 in 10 people taking these capsules)

•    Constipation (your doctor can prescribe a laxative to overcome this problem).

•    Feeling sick.

Common side effects (may affect up to 1 10 people taking these capsules)

•    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, abdominal pain or discomfort.

•    Vomiting (being sick). (This should normally wear off after a few days. However your doctor can prescribe an anti-vomiting medicine if it continues to be a problem).

•    Dizziness, headache, confusion, difficulty in sleeping.

•    A feeling of unusual weakness.

•    Involuntary muscle contractions.

•    Rash or itchy skin.

•    Sweating.

Uncommon side effects (may affect up to 1 in 100 people taking these capsules)

•    Difficulty in breathing (possibly due to fluid on the lungs) or wheezing.

•    A condition where the bowel does not work properly (ileus).

•    Changes in taste, indigestion.

•    A feeling of dizziness or ‘spinning’, fainting, seizures, fits or convulsions.

•    Agitation, mood changes, hallucinations, a feeling of extreme happiness.

•    Generally feeling unwell.

•    Unusual muscle stiffness.

•    Tingling or numbness.

•    Difficulty in passing urine.

•    Low blood pressure, facial flushing (redness of the face).

•    Palpitations.

•    Swelling of the hands, ankles or feet.

•    Hives.

•    A worsening in liver function tests (seen in a blood test).

•    Blurred vision.

•    Muscle spasms.

Frequency unknown (cannot be estimated from available data)

•    Unpleasant or uncomfortable mood, abnormal thoughts.

•    An increased sensitivity to pain.

•    Reduction in size of the pupils in the eye.

•    A fast or slow heartbeat.

•    High blood pressure.

•    Decreased cough reflex.

•    Colicky abdominal pain or discomfort, an increase in the severity of symptoms associated with inflammation of the pancreas (severe pain in the abdomen and back).

•    Impotence, decreased sexual drive, absence of menstrual periods.

•    Withdrawal symptoms (See section 3 “If you stop taking Tradename capsules”).

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 Tradename capsules

Keep this medicine out of the sight and reach of children.

Do not use any capsules after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month. EXP 08 2020 means that you should not take the capsules after the last day of August 2020.

Do not store your capsules above 25^oC.

Do not take your capsules if they are broken or crushed as this can be dangerous and can cause serious problems such as overdose.

Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information What Tradename capsules contain

The active ingredient is morphine sulfate. Each capsule contains 120 mg or 200 mg of morphine sulfate.

The other ingredients are:

•    Hydrogenated vegetable oil

•    Macrogol

•    Talc

•    Magnesium stearate

•    Gelatin

•    Sodium laurilsulfate

•    Shellac

•    Iron oxide (E172)

•    Propylene glycol

•    Titanium dioxide (E171)

The 120 mg capsules also contain Indigo carmine (E132)

What Tradename capsules look like and the contents of the pack

The capsules are marked MS OD followed by the strength (120, 200).

The capsules are coloured as follows: 120 mg - olive, 200 mg - rust.

In each box there are 28 capsules.

Marketing Authorisation Holder and Manufacturer

The capsules are made by Bard Pharmaceuticals Limited for the marketing authorisation holder Napp Pharmaceuticals Limited, both at Cambridge Science Park, Milton Road, Cambridge CB4 0GW, UK.