PACKAGE LEAFLET: INFORMATION FOR THE USER    C99732

Morphine Sulphate Suppositories BP 15mg and 30mg

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, please ask your doctor or nurse.

•    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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.

In this leaflet:

1.    What Morphine Sulphate Suppositories are and what they are used for

2.    Before you use Morphine Sulphate Suppositories

3.    How to use Morphine Sulphate Suppositories

4.    Possible side effects

5.    How to store Morphine Sulphate Suppositories

6.    Further information

1.    What Morphine Sulphate Suppositories are and what they are used for

Morphine is an alkaloid with pain relieving

properties.

This medicine is used for the relief of severe pain.

2.    Before you use Morphine Sulphate Suppositories

You should not use Morphine Sulphate

Suppositories if you:

•    are allergic (hypersensitive) to Morphine Sulphate or to any of the ingredients listed in section 6 of this leaflet

•    are currently suffering from breathing difficulties or you usually suffer from breathing problems such as asthma

•    are currently taking drugs used to treat depression known as monoamine oxidase inhibitors (MAOIs) or have taken them in the last 2 weeks

•    have suffered a head injury or are experiencing severe and undiagnosed headaches

•    suffer from alcoholism

•    suffer from heart problems

•    have been told you are suffering from a condition known as delayed gastric emptying, the symptoms of which include heartburn, feeling sick or being sick and feeling full quickly whilst eating

•    are suffering from severe stomach pains

•    suffer from severe heart and lung problems

•    suffer from a tumour of the adrenal gland known as phaeochromocytoma

•    suffer from severe problems with your liver

•    are unable to open your bowels due to a blockage in your intestines (paralytic ileus)

Take special care with Morphine Sulphate

Suppositories if you:

•    are elderly

•    suffer from liver or kidney disease

•    suffer from low blood pressure

•    suffer from problems with your pancreas

•    suffer from a muscle disorder known as myasthenia gravis

•    suffer from an irregular heartbeat

•    have been told you suffer from a severe heart problem known as cor pulmonale

•    suffer from bowel problems

•    suffer from problems with your adrenal glands (adrenocortical insufficiency)

•    suffer from thyroid problems

•    suffer from problems with your prostate

•    are in shock, the symptoms of which include sweating, a fast pulse and cold, clammy skin

•    suffer from fits

•    are about to have an operation to reduce your pain

This medicine is not recommended for children.

Taking other medicines

Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicine including medicines obtained without prescription.

Please tell your doctor if you are taking any of the following medicines:

•    medicines used to treat severe depression known as monoamine oxidase inhibitors (MAOIs) e.g. moclobemide. Tell your doctor even if you have stopped taking them within the last two weeks

Pregnancy and breast-feeding:

Morphine Sulphate Suppositories should not be used during pregnancy (especially during the first three months) as Morphine is known to cross the placenta.

This medicine should also not be used whilst breast-feeding as Morphine is known to be present in breast milk and it may cause respiratory problems in newborn babies.

Effects on the ability to drive and use machinery:

This medicine may cause drowsiness. If you are affected do not drive or use machines.

3. How to use Morphine Sulphate Suppositories

Always use Morphine Sulphate Suppositories exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

To remove a suppository, tear one from the strip along the perforations then peel it from the plastic wrapping by grasping the two halves of the wrapping at the tip of the suppository and pulling them gently apart. Morphine Sulphate Suppositories should not be swallowed

Adults

The usual dose is one or two suppositories inserted into the back passage (rectum) every four hours. The elderly

A reduced dose is recommended.

Prolonged use of Morphine Sulphate Suppositories is not recommended as it can lead to tolerance of and dependence on morphine.

Continued overleaf

Children

This medicine is not recommended for children.

If you forget to use Morphine Sulphate Suppositories

If you have missed a dose use it as soon as you remember unless it is nearly time for your next dose. Then continue your normal dose times. Do not use a double dose.

If you use more Morphine Sulphate Suppositories than you should If these suppositories are swallowed or if you have exceeded the stated dose of your medicine contact the nearest hospital or your doctor immediately, taking the carton, this leaflet and any suppositories with you. Symptoms of an overdose include:

•    pinpoint pupils

•    slowed breathing

•    feeling faint or light headed (low blood pressure)

If you stop using Morphine Sulphate Suppositories

You should not stop using Morphine Sulphate Suppositories until advised to do so by your doctor. If you stop treatment too suddenly you may experience symptoms of withdrawal such as stomach pains, feeling sick and feeling anxious. Your doctor will advise you how to stop your treatment with Morphine Sulphate Suppositories.

4. Possible Side Effects

Like all medicines Morphine Sulphate Suppositories can cause side effects, although not everybody gets them.

Repeated use of morphine can result in tolerance and addiction

If any of the following symptoms occur contact your doctor or nearest accident and emergency department immediately. These are symptoms of a serious allergic reaction.

•    sudden wheeziness and tightness of chest

•    swelling of eyelids, face or lips

•    skin lumps or hives

•    skin rash (red spots), itchiness, fever

•    collapse

Other side effects that may occur include:

•    feeling or being sick

•    drowsiness

•    confusion

•    dry mouth

•    sweating

•    facial flushing

•    slowed breathing

•    loss of appetite

•    indigestion

•    worsening of a condition that affects the pancreas known as pancreatitis. The symptoms of this include stomach pain and feeling or being sick.

•    changes in the way things taste

•    seizures (fits)

•    constipation

•    feeling faint on standing up from a seated position

•    difficulty passing urine

•    a fast or slow heart beat

•    hypothermia, the symptoms of which include shivering, drowsiness and feeling weak

•    facial flushing

•    feeling your heart beat (palpitations)

•    itching

•    a red rash

•    a feeling of spinning

•    spasms in the lower abdomen

•    reduced sex drive

•    difficulty achieving or maintaining an erection

•    sweating

•    mood changes

•    hallucinations (seeing or hearing things that aren't real)

•    fainting

•    tingling, pricking or numbness of the skin ('pins and needles')

•    feeling weak

•    a feeling of being unwell

•    feeling disoriented, confused or having problems concentrating

•    headaches

•    lack of menstruation (period)

•    involuntary muscle movement or twitching

•    a type of muscle damage known as rhabdomyolysis.

If any of these side effects get serious, or you notice any other side effects not listed in this leaflet, please tell your doctor or pharmacist.

5 How to Store Morphine Sulphate Suppositories

Keep out of the reach and sight of children.

Do not use Morphine Sulphate Suppositories after the expiry date on the carton label. The expiry date refers to the last day of that month. The doctor or nurse will check that the product has not passed this date.

Do not store above 25°C.

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.

6. Further Information

What Morphine Sulphate Suppositories contain

Active ingredient: Morphine Sulphate BP 15mg or 30mg per suppository Other ingredient: Suppocire Osil Base

What Morphine Sulphate Suppositories look like and contents of the pack:

Morphine Sulphate Suppositories are off-white, torpedo shaped suppositories supplied in plastic wrapping. Each pack contains 10 or 12 suppositories.

Marketing Authorisation Holder and Manufacturer:

Martindale Pharmaceuticals Ltd.

Bampton Road, Harold Hill,

Romford, RM3 8UG, United Kingdom.

Product Licence Numbers:

PL 01883/5890R PL 01883/5891R

This leaflet was last approved in: 09/2009

MARTINDALE

Pharmaceuticals

Bampton Road, Harold Hill Romford, RM3 8UG United Kingdom

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100mm Measurement Verification Bar