Package Leaflet: Information for the User_

Oramorph® Oral Solution 10 mg/5 ml

(morphine sulfate)

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, ask your doctor or pharmacist.

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

In this leaflet:

1.    What ORAMORPH Oral Solution is and what it is used for

2.    Before you take ORAMORPH Oral Solution

3.    How to take ORAMORPH Oral Solution

4.    Possible side effects

5.    How to store ORAMORPH Oral Solution

6.    Further information

1. WHAT ORAMORPH ORAL SOLUTION IS AND WHAT IT IS USED FOR

The name of your medicine is ORAMORPH Oral Solution 10 mg/5 ml

(called ORAMORPH in this leaflet).

•    It contains a medicine called morphine sulfate. This belongs to a group of medicines called ‘opioid analgesics’

•    It is used to relieve severe pain

2. BEFORE YOU TAKE ORAMORPH ORAL SOLUTION

Do not take ORAMORPH if:

•    You are allergic (hypersensitive) to morphine sulfate or any of the other ingredients of ORAMORPH (listed in Section 6 below)

•    You have problems with your lungs or breathing such as ‘hypoventilation’ or ‘Chronic Obstructive Pulmonary Disease’ (COPD)

•    You are having an asthma attack

•    You have sudden or recent liver problems

•    You have recently had a head injury

•    You have something called ‘phaeochromocytoma’. This is a rare tumour which is not malignant

•    You have fits (convulsions) or increased pressure inside your skull

•    The person taking the medicine is in a deep and prolonged unconscious state (coma)

•    You are addicted to alcohol or have recently consumed large amounts of alcohol

•    You are taking or have in the last two weeks taken medication to treat depression such as monoamine-oxidase inhibitors (MAOIs)

•    You have paralytic ileus (loss of intestinal movement)

Do not take this medicine if any of the above apply to you. If you

are not sure, talk to your doctor or pharmacist.

Take special care with ORAMORPH

Check with your doctor or pharmacist before taking your medicine if:

•    You are pregnant, trying to become pregnant or if you are breast-feeding

•    You have had an operation within the last 24 hours

•    You have a particular lung problem that causes shortness of breath called emphysema or you have heart failure

•    You have shock (circulatory failure)

•    You have asthma

•    You have gall bladder problems

•    You have long term (chronic) liver or kidney problems

•    You are a man who has prostate problems

•    You have an under-active thyroid gland or swelling of your skin (myxoedema)

•    Your spine is unusually curved (kyphoscoliosis)

•    You have bowel problems

•    You have an under-active adrenal gland (adrenocortical insufficiency)

•    You are very overweight

If you are not sure if any of the above apply to you, talk to your

doctor or pharmacist before taking OrAmOrPH.

■jjTN Boehringer |

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because ORAMORPH can affect the way some other medicines work. Also some other medicines can affect the way ORAMORPH works.

In particular tell your doctor or pharmacist if you are taking any of the following medicines:

•    Medicines to help you sleep, make you feel less anxious or calm you down such as tranquilisers, hypnotics, sedatives, antipsychotics or tricyclic antidepressants

•    Anaesthetics - used during operations

•    Domperidone, metoclopramide or phenothiazine - medicines for feeling sick (nausea) and being sick (vomiting)

•    Mexiletine and esmolol - for controlling heart rhythm

•    Ritonavir - for HIV infections

•    Cimetidine - for stomach ulcers, indigestion or heartburn

•    Monoamine oxidase inhibitors (MAOIs) - for depression

•    Rifampicin - used to treat tuberculosis and other infections

•    Gabapentin - for epilepsy and long lasting pain caused by damage to the nerves

Taking ORAMORPH with food and drink

You should avoid alcohol whilst taking this medicine.

Pregnancy and breast-feeding

Talk to your doctor before taking this medicine if you are pregnant, trying to become pregnant or if you are breast-feeding. If you take this medicine during pregnancy or while breast-feeding, it may slow down the baby’s breathing. If you take this medicine for a long time whilst pregnant, it may mean that the baby will be born showing signs of withdrawal.

Operations and anaesthetics

Tell your doctor or pharmacist if you are due to have an operation or an anaesthetic or if you have had an operation or an anaesthetic within the last 24 hours.

Driving and using machines

You may feel drowsy while taking this medicine. If this happens, do not drive or use any tools or machines.

Additional information for patients in the UK:

•    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.

Important information about some of the ingredients of ORAMORPH

This medicine contains:

•    Ethanol (Alcohol): This product contains 10 volume % ethanol (alcohol). Each dose contains up to 0.81 g of alcohol which is equivalent to 20 ml beer or 8.3 ml wine. This medicine is harmful if you are addicted to alcohol. The amount of alcohol should also be considered if you are pregnant or breast-feeding, have long term (chronic) liver problems or epilepsy, or you are a child

•    Sucrose: This product contains 30 g of sucrose in the 100 ml bottle, 90 g of sucrose in the 300 ml bottle, and 150 g of sucrose in the 500 ml bottle. When taken according to the dosage recommendations each dose supplies up to 3 g of sucrose. You should not take this product if you have a bowel condition that makes you intolerant to some sugars such as fructose, glucose, galactose or sucrose

•    Methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) - These may cause allergic reactions in some people that could occur some time after taking this medicine. The signs may include swelling of the mouth and face, sudden breathing difficulties and your blood pressure being lower than normal

3.    HOW TO TAKE ORAMORPH ORAL SOLUTION

Always take this medicine exactly as your doctor has told you.

You should check with your doctor or pharmacist if you are not sure.

Taking this medicine

•    Take this medicine by mouth only

•    Use a 5 ml plastic spoon to measure your dose

•    They are available from your pharmacist

How much to take

Your doctor will decide the amount of medicine to give you.

Adults

•    The most that should be taken is 5 to 10 ml (one to two teaspoons) every four hours

Paediatric population

Children 13 to 18 years

•    The most that should be taken is 2.5 to 10 ml (half to two teaspoons) every four hours

Children 6 to 12 years

•    The most that should be taken is 2.5 to 5 ml (half to one teaspoon) every four hours

Children 1 to 5 years

•    The most that should be taken is 2.5 ml (half a teaspoon) every four hours

Children under 1 year

•    Do not give this medicine to children under 1 year Being given more or less of this medicine

•    For some people, it may be necessary for the doctor to give a higher dose

•    For other people (for example the elderly, people with kidney or liver problems, an underactive adrenal or thyroid gland or prostate problems, and people that should not be sedated) the doctor

may decide to use a lower dose

Your body may get used to the medicine (tolerance)

•    Do not take more than your doctor has prescribed

•    If you have been taking your medicine for some time you may find that it does not seem to be working as well as it did. If this happens, talk to your doctor

If you take more ORAMORPH than you should

If you take more of this medicine than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you. This is so the doctor knows what you have taken.

If you take more than you should, the following effects may happen:

•    The black circle in the centre of your eyes (pupil) gets smaller

•    You breathe more slowly

•    You have low blood pressure

In more severe cases, very high doses could cause your blood circulation to slow down and cause unconsciousness for a long time, or even death. In children a high dose may cause fits (convulsions).

If you forget to take ORAMORPH

•    If you forget a dose, take it as soon as you remember it and take your next dose at the usual time

•    If it is nearly time for the next dose, skip the missed dose. This is because the time between doses should be at least 4 hours

•    Do not take a double dose to make up for a forgotten dose

If you stop taking ORAMORPH

It is important to talk to your doctor if you want to stop taking your medicine. Do not stop taking your medicine suddenly. This is because your body may have got used to it. Also, you may need to have your dose lowered slowly.

4.    POSSIBLE SIDE EFFECTS

Like all medicines, ORAMORPH can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:

Allergic reactions

If you have a severe allergic reaction, stop taking this medicine and see a doctor straight away. Signs may include swelling of the mouth and face, difficulty breathing, dizziness and skin reactions such as rash and itching.

Tell your doctor straight away if you notice the following side effects. You may need urgent medical treatment:

•    Having a headache. This could be a sign of increased pressure inside your skull

•    Feeling dizzy or unsteady when you stand up. This could be a sign of a temporary fall in blood pressure (orthostatic hypotension)

•    Shallow breathing, with a slow heartbeat (bradycardia) and cold clammy skin

•    Feeling restless, irritable or having changes in your mood

•    Stomach pain caused by spasm (cramps) of the tubes that carry urine to the bladder or bile to the intestines

•    Difficulty breathing (not linked to an allergic reaction)

Other side effects

•    Feeling sick (nausea) or being sick (vomiting)

•    Constipation, which can be treated with appropriate laxatives

•    Difficulty in passing water (urine)

•    Feeling drowsy

•    Dry mouth, sweating and flushing of your face

•    Your heart rate getting faster (tachycardia) or slower (bradycardia) or fast and uneven (palpitations)

•    Lower body temperature (hypothermia)

•    Lowered sex drive or erection problems

•    Seeing or hearing things that are not there (hallucinations) or feeling confused

•    Muscles feeling tense

•    The black circle in the centre of your eyes (pupil) getting smaller (miosis)

•    Dependence on ORAMORPH. This can happen with any morphine product

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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

Ireland

HPRA Pharmacovigilance Earlsfort Terrace IRL - Dublin 2 Tel: +353 1 6764971 Fax: +353 1 6762517 Website: www.hpra.ie e-mail: medsafety@hpra.ie

5.    HOW TO STORE ORAMORPH ORAL SOLUTION

Keep out of the reach and sight of children.

Do not use this medicine after the expiry date which is stated on the bottle label and the outer carton. The expiry date refers to the last day of the month.

Do not store ORAMORPH above 25°C. Store in the original container in order to protect from light.

Please return any remaining medicine to your pharmacist 3 months after first opening.

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 ORAMORPH contains

•    Each 5 ml contains 10 mg of morphine sulfate as the active ingredient

•    The other ingredients are alcohol (ethanol), corn syrup, sucrose, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216) and purified water

What ORAMORPH looks like and content of the pack

ORAMORPH is a solution and is available in bottles of 100, 250,

300 and 500 ml. The bottles come in cartons.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation for ORAMORPH is held by:

Boehringer Ingelheim Limited, Ellesfield Avenue,

Bracknell, Berkshire, RG12 8YS, United Kingdom

and the solution is manufactured by:

Istituto de Angeli S.r.l. at:

Localita Prulli Si Sotto n. 103/C, 50066 Reggello (FI), Italy This leaflet was revised in June 2015.

© Boehringer Ingelheim Limited 2015

437737/GB/15