- morphine sulfate
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original can be viewed in PDF format using the link above.
The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet is: PL 06934/0182.
ZOMORPH 10mg, 30mg, 60mg, 100mg, 200mg capsules
PACKAGE LEAFLET: INFORMATION FOR THE USER
Zomorph 10mg, 30mg, 60mg, 100mg, 200mg capsules
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
In this leaflet:
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
1. WHAT ZOMORPH CAPSULES ARE AND WHAT THEY ARE USED FOR
Zomorph capsules belong to a group of medicines called opioid analgesics or ‘painkillers’. They contain the active ingredient morphine sulfate in a special slow-release form which gives relief from severe pain over a period of 12 hours, particularly pain associated with cancer.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZOMORPH CAPSULES
DO NOT take Zomorph capsules if:
Warning and precautions
Talk to your doctor or pharmacist before taking Zomorph capsules.
The dose should be reduced or stopped if you:
The capsules should be used with caution if you have:
Talk to your doctor or pharmacist if you experience any of the following symptoms while taking Zomorph capsules:
If you are going to have surgery, tell your doctor or dentist that you are taking Zomorph capsules.
All brands of slow-release forms of morphine like Zomorph capsules are not equivalent.
Other medicines and Zomorph capsules:
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription.
This is especially important if you are taking any of the medicines mentioned below:
Taking with food and drink
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’re taking Zomorph capsules.
Pregnancy, breast-feeding and fertility
Zomorph capsules should not be taken if you are pregnant, planning to become pregnant or breast-feeding.
Ask your doctor or pharmacist before taking any medicine.
If Zomorph capsules is used for a long time during pregnancy, there is a risk of the new-born child having drug withdrawal (abstinence) symptoms which should be treated by a doctor.
Driving and using machines
The medicine can affect your ability to drive as it may make you sleepy or dizzy.
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.
Zomorph capsules contain sucrose and [60 mg strength only] sunset yellow (E110)
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’.
3. HOW TO TAKE ZOMORPH CAPSULES
Always take Zomorph capsules exactly as your doctor has told you; check with him/her if you are not sure.
The usual dose is:
Adults - one capsule, swallowed whole with a glass of water, every 12 hours.
Elderly - a reduced dose may be prescribed.
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.
If you take more Zomorph capsules than you should
Contact your doctor or nearest casualty immediately if you, or someone you know, have taken too many capsules. Remember to take any remaining medicine and this leaflet with you if possible.
People who have taken an overdose may 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.
If you forget to take Zomorph capsules
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.
If you stop taking Zomorph capsules
Do not stop treatment with Zomorph capsules unless agreed with your doctor. If you want to stop the treatment with Zomorph capsules, ask your doctor how to slowly decrease the doses so you avoid abstinence symptoms. Abstinence symptoms may include body aches, tremors, diarrhoea, stomach pain, nausea, flu-like symptoms, fast heartbeat and large pupils. Psychological symptoms include an intense feeling of unsatisfaction, anxiety and irritability
Should this occur, please consult your doctor or pharmacist.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Zomorph capsules can cause side effects, although not everybody gets them.
Important side effects or symptoms to look out for and what to do if you are affected:
If you are affected by these important side effects or get any sudden wheeziness, swelling of the eyelids, face or lips, rash or itching especially those covering your whole body contact a doctor immediately.
The following side effects have also been reported:
Very common side effects (May affect more than 1 in 10 people):
Common (may affect up to 1 in 10 patients):
Uncommon (may affect up to 1 in 100 patients):
Not known (frequency cannot be estimated from available data):
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 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.
5. HOW TO STORE ZOMORPH CAPSULES
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 shown on the pack.
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.
6. FURTHER INFORMATION
What Zomorph capsules contain
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.
What Zomorph capsules look like & contents of the pack
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.
Marketing Authorisation Holder
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: United Kingdom: Ethypharm UK - email: [email protected]m.com
This leaflet was last revised: February 2019