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The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 06934/0183.
ZOMORPH capsules
Zomorph 10mg, 30mg, 60mg, 100mg, 200mg capsules
(morphine sulfate)
This medicine contains morphine which is an opioid, which can cause addiction. You can get withdrawal symptoms if you stop taking it suddenly.
1. What Zomorph capsules are and what they are used for
2. What you need to know before you take Zomorph capsules
3. How to take Zomorph capsules
4. Possible side effects
5. How to store Zomorph capsules
6. Contents of the pack and other information
This medicine has been prescribed for you for relief from severe pain, particularly pain associated with cancer, over a period of 12 hours thanks to its special slow release form.
It contains morphine which belongs to a class of medicines called opioids, which are ‘pain relievers’. This medicine has been prescribed/provided to 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 doctor should have explained how long you will be taking it for and when it is appropriate to stop, how to do this safely.
If you are going to have an operation, please tell the doctor at the hospital that you are taking these capsules.
Tolerance, dependence, and addiction
This medicine contains morphine which is an opioid medicine. Repeated use of opioids can result in the drug being less effective (you become accustomed to it, known as tolerance). Repeated use of Zomorph capsules can also lead to dependence, abuse, and addiction, which may result in life-threatening overdose. The risk of these side effects can increase with a higher dose and longer duration of use.
Dependence or addiction can make you feel that you are no longer in control of how much medicine you need to take or how often you need to take it.
The risk of becoming dependent or addicted varies from person to person. You may have a greater risk of becoming dependent on or addicted to Zomorph capsules if:
If you notice any of the following signs whilst taking Zomorph capsules, it could be a sign that you have become dependent or addicted:
If you notice any of these signs, speak to your doctor to discuss the best treatment pathway for you, including when it is appropriate to stop and how to stop safely (See section 3, If you stop taking Zomorph capsules).
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 doctor 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.
Talk to your doctor or pharmacist before taking this medicine if you:
Acute generalized exanthematous pustulosis (AGEP) has been reported in association with Zomorph capsules treatment. Symptoms usually occur within the first 10 days of treatment. Tell your doctor if you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking Zomorph capsules or other opioids. Stop using Zomorph capsules and seek medical attention immediately, if you notice any of the following symptoms: blistering, widespread scaly skin or pus-filled spots together with fever.
Sleep-related breathing disorders
Zomorph capsules can cause sleep-related breathing disorders such as sleep apnoea (breathing pauses during sleep) and sleep related hypoxemia (low oxygen level in the blood). The symptoms can include breathing pauses during sleep, night awakening due to shortness of breath, difficulties to maintain sleep or excessive drowsiness during the day. If you or another person observe these symptoms, contact your doctor. A dose reduction may be considered by your doctor.
Contact your doctor if you experience severe upper abdominal pain possibly radiating to the back, nausea, vomiting or fever as this could be symptoms associated with inflammation of the pancreas (pancreatitis) and the biliary tract system.
You may experience hormonal changes while taking these capsules. Your doctor may want to monitor these changes.
All brands of slow-release forms of morphine like Zomorph capsules are not equivalent.
Concomitant use of Zomorph capsules and sedative medicines, such as benzodiazepines or related drugs, increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible.
However, if your doctor does prescribe Zomorph capsules together with sedative medicines, the dosage and duration of concomitant treatment should be limited by your doctor.
Please tell your doctor about all sedative medicines you are taking and follow your doctor’s dosage recommendation closely.
It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.
If you are taking or have recently taken any other medicines, or might take any other medicines, please tell your doctor or pharmacist. If you take these capsules with some other medicines, the effect of the capsules or the other medicine may be changed.
Tell your doctor or pharmacist if you are taking any of the medicines mentioned below:
Also tell your doctor if you have recently been given an anaesthetic.
Drinking alcohol whilst taking Zomorph 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 are taking Zomorph capsules.
Do not take Zomorph capsules if you are pregnant or think you might be pregnant unless you have discussed this with your doctor and the benefits of treatment are considered to outweigh the potential harm to the baby.
If you use Zomorph capsules during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated, such as high-pitched crying, irritability and restlessness, shaking (tremor), feeding difficulties and sweating.
Do not take Zomorph capsules while you are breastfeeding as morphine passes into breast milk and will affect your baby.
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.
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.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
[60 mg strength only] The capsules contain sunset yellow (E110), which may cause allergic reactions.
This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.
Always take Zomorph capsules exactly as your doctor has told you; check with him/her if you are not sure.
Before starting treatment and regularly during treatment, your doctor will discuss with you what you may expect from using Zomorph capsules, when and how long you need to take it, when to contact your doctor, and when you need to stop it (see also, If you stop taking Zomorph capsules, in this section).
Swallow your capsules whole with a glass of water. Do not break, crush or chew them.
Zomorph capsules are designed to work properly over 12 hours when swallowed whole. If a capsule is broken, or the content of the capsule is crushed or chewed, the entire 12-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 must only take the capsules by mouth. The content of the capsule should never be crushed or injected as this may lead to serious side effects, which may be fatal.
You should take your capsules every 12 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 in the evening.
If you have difficulty swallowing capsules, the entire capsule contents can be sprinkled onto a spoonful of semi-solid food (such as plain yoghurt) and swallowed.
To open the capsule, hold upright to contain the granules at the bottom then gently squeeze the top and twist to remove, taking care not to spill the contents. Do not chew or crush the granules. This can be dangerous, causing serious problems such as an overdose, which may be fatal.
The usual dose is one capsule, every 12 hours.
However, the dose will depend on your age, weight and the severity of your pain. If you are elderly or weigh less than 70 kg your doctor may suggest a lower dose. Your doctor will decide how many capsules you should take.
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.
There is a risk that you may become addicted to or dependent on these capsules (a need to keep taking the medicines). If you take these for a long time you can become used to the effects and you may need to take higher doses to control your pain.
Call your doctor or nearest hospital immediately if you, or someone you know, have taken too many capsules, as you may need emergency treatment.
People who have taken an overdose may feel very sleepy, sick, dizzy or get pneumonia from inhaling vomit or foreign matter (symptoms may include breathlessness, cough and fever).
People who have taken an overdose may also have breathing difficulties leading to unconsciousness or even death.
People who have taken an overdose may also have extreme miosis (constriction of pupils in the eyes), low blood pressure, a fall in body temperature and coma.
When seeking medical attention make sure that you take this leaflet and any remaining capsules with you to show to the doctor.
If you remember within 4 hours of missing your dose, take a capsule straight away. Take your next dose at the normal time. If you are more than 4 hours late taking your dose, please call your doctor for advice. Do not take a double dose to make up for the one forgotten.
Do not suddenly stop taking this medicine. If you want to stop taking this medicine, discuss this with your doctor 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.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, Zomorph capsules can cause side effects, although not everybody gets them.
Stop using Zomorph capsules and seek medical attention immediately if you notice any of the following symptoms:
Severe skin reaction with blistering, widespread scaly skin, pus-filled spots together with fever. This could be a condition called Acute Generalized Exanthematous Pustulosis (AGEP).
The most serious side effect, although uncommon, is a condition where you breathe more slowly or weakly than expected (respiratory depression). Tell your doctor immediately if this happens to you.
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.
Drug Withdrawal
When you stop taking Zomorph capsules, 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.
If you notice any of the following signs whilst taking Zomorph capsules, it could be a sign that you have become addicted.
If you notice any of these signs, it is important you talk to your doctor.
The following side effects may also occur:
Very common side effects (May affect more than 1 in 10 people):
Common side effects (may affect up to 1 in 10 people):
Uncommon side effects (may affect up to 1 in 100 people):
Frequency not known (frequency cannot be estimated from the available data):
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. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Store below 25°C in a dry place, protected from heat. Do not use Zomorph capsules after the expiry date stated on the blister and the carton after “EXP”. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
The active ingredient is morphine sulfate BP; each capsule contains either 10mg, 30mg, 60mg, 100mg or 200mg of this substance.
The other ingredients are sucrose, maize starch, polyethylene glycol 4000, ethyl-cellulose, cetyl alcohol, sodium lauryl sulfate, dibutyl sebacate, talc, gelatin, iron oxide ink (E172), and the following colourings:
See end of Section 2 for further, important information on sunset yellow and sucrose.
The capsules are made in different colours to identify each strength:
10mg - yellow/clear
30mg - pink/clear
60mg - orange/clear
100mg - white/clear
200mg - clear.
They are packed in aluminium/PVC blisters; each pack contains 6 blisters x 10 capsules.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in December 2023.
C13658 8834488