What is a Patient Information Leaflet and why is it useful?

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 leaflet can be viewed using the link above.

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 are: PL 06934/0184, PL 06934/0183, PL 06934/0186, PL 06934/0185, PL 06934/0182.


ZOMORPH capsules

PACKAGE LEAFLET: INFORMATION FOR THE USER

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.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  • 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is 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

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 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. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZOMORPH CAPSULES

DO NOT take Zomorph capsules if:

  • you are allergic to morphine or any of the other ingredients of this medicine (listed in section 6)
  • you have breathing difficulties such as obstructive airways disease or respiratory depression. Your doctor will have told you if you have these conditions. Symptoms may include breathlessness, coughing or breathing more slowly or weakly than expected
  • you have unexplained abdominal pains
  • you have a condition where your stomach empties more slowly than it should (delayed gastric emptying)
  • you have severe liver problems
  • you have severe headache (raised intracranial pressure), for example from a head injury, or if you feel sick. This is because the capsules may make these symptoms worse or hide the extent of the head injury
  • you have fits (convulsions)
  • you have recently consumed a large amount of alcohol, or have been intoxicated
  • you have a risk of bowel obstruction (paralytic ileus)
  • you are taking a type of medicine for depression known as monoamine oxidase inhibitors (MAOIs), or have taken this type of medicine in the last 14 days
  • the patient is a child.

Warning and precautions

Talk to your prescriber before taking this medicine if you:

  • 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.
  • feel you need to take more of Zomorph capsules 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.

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.

The dose should be reduced or stopped if you:

  • are elderly
  • have liver or kidney problems
  • have an underactive thyroid.

The capsules should be used with caution if you have:

  • breathing problems, such as impaired lung function or severe bronchial asthma. Your doctor will have told you if you have these conditions. Symptoms may include breathlessness and coughing
  • convulsions (fits)
  • dependence (severe withdrawal symptoms if the medicine is withdrawn suddenly)
  • low blood pressure
  • a severe heart problem after long-term lung disease (severe cor pulmonale)
  • inflammation of the pancreas (which causes severe pain in the abdomen and back) or problems with your gall bladder
  • an inflammatory bowel disorder
  • an enlarged prostate gland, in which case you may have problems passing urine
  • have poor adrenal gland function (your adrenal gland is not working properly which may cause symptoms including weakness, weight loss, dizziness, feeling or being sick)
  • and in patients in a state of shock.

Talk to your doctor or pharmacist if you experience any of the following symptoms while taking Zomorph capsules:

  • Weakness, fatigue, lack of appetite, nausea, vomiting or low blood pressure. This may be a symptom of the adrenals producing too little of the hormone cortisol, and you may need to take hormone supplement.
  • Loss of libido, impotence, cessation of menstruation. This may be because of decreased sex hormone production.

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:

  • Rifampicin to treat e.g. tuberculosis
  • 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 dose 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 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 when experiencing such symptoms.
  • Other opioid analgesics, such as buprenorphine, butorphanol, nalbuphine or pentazocine
  • Medicines for depression, i.e. MAOIs and antidepressants
  • Anaesthetics
  • Antipsychotics (for psychiatric diseases), anxiolytics (for anxiety), phenothiazines (for schizophrenia)
  • Hypnotics/sedatives (for sleeping problems)
  • Cyclizine, mexiletine, metoclopramide, domperidone (for nausea and vomiting)
  • Muscle relaxants
  • Medicines to treat high blood pressure
  • Gabapentin to treat epilepsy or neuropathic pain (pain due to nerve problems)
  • Medicines used to prevent or relieve the symptoms of an allergy (antihistamines)
  • Medicines to treat Parkinson’s disease
  • Certain types of medicines to stop you feeling or being sick
  • Cimetidine to treat stomach ulcers, indigestion or heartburn
  • Ritonavir (for AIDS treatment).

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

Do not take Zomorph capsules 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 Zomorph capsules during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.

Do not take Zomorph capsules while you are breastfeeding as morphine passes into breast milk and will affect your baby.

Driving and using machines

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.

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 prescriber has told you; check with him/her if you are not sure.

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

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.

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.

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 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.

Pregnancy

Do not take Zomorph capsules 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 Zomorph capsules during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.

Do not take Zomorph capsules while you are breastfeeding as morphine passes into breast milk and will affect your baby.

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:

  • Serious allergic reaction which causes difficulty in breathing or dizziness
  • A condition where you breathe more slowly or weakly than expected (respiratory depression).

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):

  • Constipation (your doctor can prescribe a laxative to overcome this problem)
  • Feeling sick (nausea)

Common (may affect up to 1 in 10 patients):

  • Confusion, difficulty in sleeping
  • Drowsiness, headache, dizziness, involuntary muscle contractions
  • Vomiting (being sick), dry mouth, abdominal pain or discomfort
  • Loss of appetite (anorexia)
  • Itching, skin rash
  • Feeling of unusual weakness, generally feeling unwell

Uncommon (may affect up to 1 in 100 patients):

  • Allergic reactions
  • Mood changes, agitation, a feeling of extreme happiness, hallucinations
  • Fits (convulsions), increase in muscle tension, involuntary contractions of muscles (myoclonus), abnormal skin sensations like tingling or numbness (paraesthesia), fainting, changes in taste
  • Blurred vision
  • Dizziness
  • Palpitations
  • Flushing, low blood pressure
  • Breathing difficulties (possibly due to fluid on the lungs) or wheezing
  • Indigestion, blockage of the intestine (ileus)
  • Hives
  • Abdominal pain
  • Swelling of the hands, ankles or feet
  • Abnormal blood test results (increased levels of liver enzymes)

Not known (frequency cannot be estimated from available data):

  • Decreased sex drive
  • Excitation (particularly in the elderly), drug dependence, abnormal thoughts
  • Sedation, increased pressure in the brain, pain due to a something which does not normally provoke pain), an increased sensitivity to pain, sweating
  • Miosis (contraction of the pupil in the eye)
  • Faster or slower than usual heartbeat
  • Light-headedness when standing, high blood pressure
  • Decreased cough reflex
  • Colicky abdominal pain or discomfort, an increase in the severity of symptoms associated with inflammation of the pancreas (severe pain in the abdomen and back)
  • Burning sensation or difficulty when passing urine
  • Absence of menstrual periods, impotence
  • Low body temperature
  • Dependence and addiction (see section “How do I know if I am addicted?”)
  • Abstinence symptoms in babies born to mothers who have used Zomorph (See section 2 ‘Pregnancy, breastfeeding and fertility’)

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.

How do I know if I am addicted?

If you notice any of the following signs whilst taking Zomorph capsules, 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.

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 25ºC 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:

  • titanium dioxide (E171) - 10mg, 30mg, 60mg and 100mg capsules
  • quinoline yellow (E104) - 10mg capsules
  • erythrosine (E127) - 30mg capsules
  • sunset yellow (E110) - 60mg capsules.

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

Ethypharm
194, Bureaux de la Colline - Bâtiment D
92213 Saint-Cloud cedex
France

Manufacturer

Ethypharm
Chemin de la poudrière
76 120 Grand-Quevilly
France

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

United Kingdom:
Ethypharm UK

This leaflet was last revised: March 2020

C12666 8834483