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Morphine Sulphate Suppositories 10mg

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PACKAGE LEAFLET: INFORMATION FOR THE USER_D03157

Morphine Sulfate Suppositories 10mg

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In this leaflet:

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

2.    Before you use Morphine Sulfate Suppositories

3.    How to use Morphine Sulfate Suppositories

4.    Possible side effects

5.    How to store Morphine Sulfate Suppositories

6.    Further information

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

Morphine is an alkaloid with pain relieving properties.

Morphine Sulfate Suppositories are used or the relief of severe pain.

2.    Before you use Morphine Sulfate Suppositories

You should not use Morphine Sulfate Suppositories if you:

•    are allergic (hypersensitive) to Morphine Sulfate 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 suffering from severe stomach pains

•    suffer from problems with your liver

•    suffer from alcoholism

•    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

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

•    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

•    suffer from severe heart and lung problems

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

Take special care with Morphine Sulfate Suppositories if you:

•    are about to have an operation to reduce your pain

•    sufferfrom problems with your adrenal glands (adrenocortical insufficiency)

•    suffer from thyroid problems

•    have low blood pressure

•    suffer from liver or kidney disease

•    suffer from problems with your bowel

•    suffer from problems with your prostate

•    suffer from a disorder that causes muscle weakness known as myasthenia gravis

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

•    suffer from fits

•    suffer from problems with your pancreas

•    suffer from an irregular heartbeat

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

f you are elderly you should take special care when using morphine sulfate suppositories.

f you have any concerns about your treatment with this medicine please discuss this with your doctor.

Taking other medicines

Please tell your doctor, nurse 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

•    medicines used to treat mental disorders (antipsychotics) such as chlorpromazine and haloperidol

•    medicines used to reduce anxiety (anxiolytics) such as diazepam and buspirone

•    medicines used to help you to sleep (hypnotics) such as temazepam and zopiclone

•    CNS depressants (drugs that act on the brain and make you feel drowsy or faint). These include sleeping pills, anti-histamines (medicines used to treat allergies) that make you drowsy, medicines used to treat certain mental disorders, other pain killers or a general anaesthetic.

•    medicines used to treat depression (tricyclic antidepressants) such as amitriptyline and imipramine

•    cimetidine, a medicine used to treat stomach ulcers

•    ciprofloxacin, a medicine used to treat bacterial infections

•    medicines used to treat acid reflux and heartburn e.g. domperidone and metoclopramide

•    esmolol, a medicine used to treat high blood pressure

•    mexiletine, a medicine used to treat an irregular heartbeat

•    ritonavir, a medicine used to treat HIV Using Morphine Sulfate Suppositories with food and drink

You are advised not to drink alcohol during your treatment with this medicine Pregnancy and breast-feeding:

Morphine Sulfate 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.

This medicine can affect your ability to drive and operate machinery 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 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 or 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.

Contin ued overleaf


3.    How to use Morphine Sulfate Suppositories

Always use Morphine Sulfate 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 Sulfate Suppositories should

not be swallowed

Adults

Your doctor will determine the correct dose for you. The usual initial dose is one 10mg suppository inserted into the back passage (rectum) every 4 hours. In certain circumstances you may be given a larger dose of 20mg or 30mg.

The elderly

A reduced dose is recommended

Children under 12 years

Not recommended for children under 12 years

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

If you forget to use Morphine Sulfate 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 Sulfate 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 Sulfate Suppositories

You should not stop using Morphine Sulfate 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 Sulfate Suppositories.

4.    Possible Side Effects

Like all medicines Morphine Sulfate 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:

•    constipation

•    drowsiness

•    feeling or being sick

•    feeling faint on standing up from a seated position

•    slowed breathing

•    difficulty passing urine

•    a fast or slow heartbeat

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

•    dry mouth

•    facial flushing

•    feeling your heart beat (palpitations)

•    itching



•    a red rash

•    a feeling of spinning (vertigo)

•    spasms in the lower abdomen

•    reduced sex drive

•    difficulty achieving or maintaining an erection

•    sweating

•    feeling restless or exited

•    feeling nervous or worried

•    mood changes

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

•    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)

•    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.

Reporting of side effects If you get any side effects, talk to your doctor or 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 Website:

http://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 Morphine Sulfate Suppositories

Keep out of the sight and reach of children.

Do not use Morphine Sulfate 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 Sulfate Suppositories contain

The active ingredient in Morphine Suppositories 10mg is morphine sulfate BP 10mg equivalent to morphine base 7.5mg.

The other ingredient is adeps solidus EP What Morphine Sulfate Suppositories look like and contents of the pack:

Morphine Sulfate Suppositories are smooth, white suppositories supplied in plastic wrapping. Packs contain 6, 12, 24 or 48 suppositories.

Marketing Authorisation Holder:

Aurum Pharmaceuticals Ltd.,

Bampton Road, Harold Hill, Romford,

RM3 8UG, UK.

Manufacturer:

Lannacher Heilmittel GBMH,

Schlossplatz 1, A-8502, Lannach, Austria. Product Licence Number:

PL 12064/0005

This leaflet was last revised in:

December 2015


3157-A


M


100mm Measurement Verification Bar


MARTJNDALE PHARMA

DEVELOPMENT ARTWORK

Component Code: D03157

MORPHINE SULFATE SUPPOSITORIES 10MG Paper size: 330 x 120mm


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