ORAMORPH CONCENTRATED ORAL SOLUTION 20 MG / ML - patient leaflet, side effects, dosage

Patient leaflet - ORAMORPH CONCENTRATED ORAL SOLUTION 20 MG / ML

1. what oramorph concentrated oral solution is and what it is used for

The name of your medicine is ORAMORPH Concentrated Oral Solution 20 mg/ml (called ORAMORPH Concentrated in this leaflet).

This medicine has been prescribed for you for relief of severe pain
It contains a medicine called morphine sulfate, which belongs to a class of medicines called opioids, which are ‘pain relievers’
This medicine has been prescribed for you and should not be given to anyone else
Opioids can cause addiction and you may get withdrawal symptoms if you stop taking it suddenly. Your prescriber should have explained how long you will be taking it for and when it is appropriate to stop, how to do this safely
2. BEFORE YOU TAKE ORAMORPH CONCENTRATED ORAL SOLUTION

Do not take ORAMORPH Concentrated if:

You are allergic (hypersensitive) to morphine sulfate or any of the other ingredients of ORAMORPH Concentrated (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 Concentrated Check with your doctor or pharmacist before taking your medicine if you:

Are pregnant, trying to become pregnant or if you are breast-feeding
Have had an operation within the last 24 hours
Have a particular lung problem that causes shortness of breath called emphysema or you have heart failure
Have shock (circulatory failure)
Have asthma
Have gall bladder problems
Have long term (chronic) liver or kidney problems
Are a man who has prostate problems
Have an under-active thyroid gland or swelling of your skin (myxoedema)
Have an unusually curved spine (kyphoscoliosis)
Have bowel problems
Have an under-active adrenal gland (adrenocortical insufficiency)
Are very overweight
Are or have ever been addicted to opioids, alcohol, prescription medicines, or illegal drugs.
Have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, when you have stopped taking alcohol or drugs.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking ORAMORPH Concentrated.

Warnings and precautions

Talk to your doctor, nurse or pharmacist if you experience any of the following symptoms while you are taking ORAMORPH Concentrated

Increased sensitivity to pain despite the fact that you are taking increasing doses (hyperalgesia). Your prescriber will decide whether you will need a change in dose or a change in strong analgesic (“painkiller”)
Weakness, fatigue, lack of appetite, nausea, vomiting or low blood pressure. This may be a symptom of your adrenal glands producing too little of a hormone called cortisol, and you may need to take a hormone supplement
Loss of libido (sex drive), difficulty getting an erection, menstrual periods stopping. This may be because of your body producing less sex hormones
You feel you need to take more of ORAMORPH Concentrated to get the same level of pain relief, this may mean you are becoming tolerant to the effects of this medicine or are becoming addicted to it. Speak to your prescriber who will discuss your treatment and may change your dose or switch you to an alternative pain reliever

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Taking this medicine regularly, particularly for a long time, can lead to addiction. Your prescriber should have explained how long you will be taking 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 prescriber 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 prescriber 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.

Other medicines and ORAMORPH Concentrated

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 Concentrated can affect the way some other medicines work. Also some other medicines can affect the way ORAMORPH Concentrated 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
– Taking ORAMORPH Concentrated together with sedative medicines such as benzodiazepines or related medicines increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, taking ORAMORPH Concentrated together with these types of medicines should only be considered when other treatment options are not possible. However if your doctor does prescribe ORAMORPH Concentrated together with sedative medicines the dose and duration of taking the treatments together should be limited by your doctor.
– Please tell your doctor about all sedative medicines you are taking, and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor if you experience these symptoms

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
Some medicines used to treat blood clots (e.g. clopidogrel, prasugrel, ticagrelor) may have delayed and decreased effect when taken together with ORAMORPH Concentrated

Taking ORAMORPH Concentrated with food and drink

You should avoid alcohol whilst taking this medicine.

Pregnancy and breast-feeding

Do not take ORAMORPH Concentrated if you are pregnant or think you might be pregnant unless you have discussed this with your prescriber and the benefits of treatment are considered to outweigh the potential harm to the baby. If you use ORAMORPH Concentrated during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.

Do not take ORAMORPH Concentrated while you are breast-feeding as morphine sulfate passes into breast milk and will affect your baby.

Operations and anaesthetics

Tell your doctor or pharmacist if you are due to have an operation or 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:

The 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 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 Concentrated

This medicine contains amaranth. This may cause allergic reactions including asthma. Allergy is more common in people who are allergic to aspirin. This medicine also contains 1 mg sodium benzoate (E211) in each 1 ml.

Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old). This medicine contains less than 1 mmol sodium (23 mg) per 1 ml, that is to say essentially ‘sodium-free’.

3. how to take oramorph concentrated 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. Your prescriber should have discussed with you how long the course of this medicine will last. They will arrange a plan for stopping treatment. This will outline how to gradually reduce the dose and stop taking the medicine.

Taking this medicine

Take this medicine by mouth only
Measure the exact dose using the supplied dosing syringe and adaptor
Open the bottle and put the adaptor onto the top of the open bottle neck by pressing. Make sure it is fixed well in place
Insert the syringe into the adaptor opening. Make sure the syringe is tightly inserted. Turn the bottle upside down and draw out the required amount of ORAMORPH Concentrated
You may prefer to add your dose to a soft drink. If you do this, it should be swallowed immediately after mixing

The plastic adaptor should remain in the bottle after first use. The bottle cap should be replaced after use.

Do not drink directly from the bottle as this may result in you taking the incorrect dose (too little or too much).

Taking too much may result in an overdose with potential for serious consequences including unconsciousness and even death.

How much to take

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

Adults

The most that should be taken is 0.5 to 1 ml (10–20 mg) every four hours

Paediatric population Children 13 to 18 years

The most that should be taken is 0.25 to 1 ml (5–20 mg) every four hours

Children 6 to 12 years

The most that should be taken is 0.25 to 0.5 ml (5–10 mg) every four hours

Children 1 to 5 years

The most that should be taken is 0.25 ml (5 mg) 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 Concentrated 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

People who have taken an overdose may also get pneumonia from inhaling vomit or foreign matter, symptoms of this may include breathlessness, cough or fever.

In more severe cases, very high doses could cause your blood circulation and breathing 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 Concentrated

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 Concentrated

Do not suddenly stop taking this medicine. If you want to stop taking this medicine, discuss this with your prescriber first. They will tell you how to do this, usually by reducing the dose gradually so that any unpleasant withdrawal effects are kept to a minimum. Withdrawal symptoms such as restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating may occur if you suddenly stop taking this medicine.

4. possible side effects

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

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)
Dry mouth or sweating
Seeing or hearing things that are not there (hallucinations) or feeling confused
Increased sensitivity to pain
Dependence and addiction (see section “How do I know if I am addicted”)

Drug Withdrawal

When you stop taking ORAMORPH Concentrated, you may experience drug withdrawal symptoms, which include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating.

How do I know if I am addicted?

If you notice any of the following signs whilst taking ORAMORPH Concentrated, 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 prescriber

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
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
Muscles feeling tense
The black circle in the centre of your eyes (pupil) getting smaller (miosis)

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: or search for MHRA Yellow Card in the Google Play or Apple App Store Ireland

HPRA Pharmacovigilance

Website:

5. how to store oramorph concentrated 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 Concentrated above 25°C. Store in the original container in order to protect from light.

Please return any remaining medicine to your pharmacist 4 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 Concentrated contains

Each ml contains 20 mg of morphine sulfate as the active ingredient
The other ingredients are disodium edetate, sodium benzoate (E211), citric acid, amaranth (E123) and purified water