Zomorph 10mg, 30mg, 60mg, 100mg, 200mg capsules – patient leaflet, side effects, dosage

1. What Zomorph capsules are and what they are used for

• A condition where the bowel does not work properly (ileus)

Other medicines and Zomorph capsules:

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.

2. What you need to know before you take Zomorph capsules

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.

• Changes in taste, indigestion

3. How to take Zomorph capsules

• A feeling of dizziness or ‘spinning’, fainting, seizures, fits or convulsions

4. Possible side effects

• Agitation, mood changes, hallucinations, a feeling of extreme happiness

5. How to store Zomorph capsules

• Unusual muscle stiffness

6. Contents of the pack and other information

• Tingling or numbness
• Difficulty in passing urine

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.

• Low blood pressure, facial flushing (redness of the face)
• WHAT ZOMORPH CAPSULES ARE AND WHAT THEY ARE USED FOR
• Palpitations
• Swelling of the hands, ankles or feet

Please tell your doctor about all sedative medicines you are taking and follow your doctor’s dosage recommendation closely.

• Hives

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.

• A worsening in liver function tests (seen in blood test)

Adults

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.

• Blurred vision

The usual dose is one capsule, every 12 hours.

• Muscle spasms.

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.

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.

Frequency not known (frequency cannot be estimated from the available data):

• Problems with breathing during sleep (sleep apnoea syndrome)

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.

• Dependence and addiction (see section “How do I know if I am addicted?”)

If you find that you are still in pain whilst taking these capsules discuss this with your doctor.

• Unpleasant or uncomfortable mood, abnormal thoughts
• An increased sensitivity to pain

Tell your doctor or pharmacist if you are taking any of the medicines mentioned below:

Do not exceed the dose recommended by your doctor. You should check with your doctor or pharmacist if you are not sure.

• Reduction in size of the pupils in the eye
• A fast or slow heartbeat
• Medicines to help you sleep (for example benzodiazepines, tranquillisers, hypnotics or sedatives)
• WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZOMORPH CAPSULES
• High blood pressure

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 or if someone accidentally swallows your capsules

• Decreased cough reflex
• Medicines to treat psychiatric or mental disorders (such as phenotiazines), anxiolytics (for anxiety)
• 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)

DO NOT take Zomorph capsules if:

• you are allergic to morphine or any of the other ingredients of this medicine (listed in section 6);

  • Muscle relaxants

  • Medicines to treat high blood pressure

    • Impotence, decreased sexual drive, absence of menstrual periods

• you have breathing problems such as obstructive airways disease, respiratory depression, or severe asthma. Your doctor will have told you if you have these conditions. Symptoms may include breathlessness, coughing or breathing more slowly or weakly than expected;

  • Cimetidine to treat stomach ulcers, indigestion or heartburn

    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).

    • Withdrawal symptoms in babies born to mothers who have used Zomorph capsules in pregnancy (See section 2 ‘Pregnancy, breastfeeding and fertility’). Reporting of side effects
  • Certain types of medicines to stop you feeling or being sick
  • Medicines used to prevent or relieve the symptoms of an allergy (antihistamines)

• 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 ;

  • Rifampicin to treat tuberculosis

    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.

  • Ritonavir to treat HIV

    People who have taken an overdose may also have breathing difficulties leading to unconsciousness or even death.

  • Medicines to treat Parkinson’s disease

• you have a condition where the small bowel (part of your gut) does not work properly (paralytic ileus), your stomach empties more slowly than it should (delayed gastric emptying) or you have severe pain in your abdomen;

  • Gabapentin to treat epilepsy or neuropathic pain (pain due to nerve problems)

    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.

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

• you have recent onset liver disease;

  1. 5. HOW TO STORE ZOMORPH CAPSULES

• you are taking a type of medicine for depression known as monoamine oxidase inhibitors (examples include tranylcypromine, phenelzine, isocarboxazid, moclobemide and linezolid), or you have taken this type of medicine in the last two weeks;

  • Other opioid analgesics, such as buprenorphine, butorphanol, nalbuphine or pentazocine.

    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.

    Keep this medicine out of the sight and reach of children.

Also tell your doctor if you have recently been given an anaesthetic. Taking Zomorph capsules with alcohol

Store below 25ºC 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.

• the patient is a child.

  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.

If you are going to have an operation, please tell the doctor at the hospital that you are taking these capsules.

If you stop taking Zomorph capsules

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.

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.

Warning and precautions

Talk to your doctor or pharmacist before taking this medicine if you:

Pregnancy, breast-feeding and fertility

• are or have ever been addicted to opioids, alcohol, prescription medicines, or illegal drugs;

  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.

  1. 6. CONTENTS OF THE PACK AND OTHER INFORMATION
• 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 doctor who will discuss your treatment and may change your dose or switch you to an alternative pain reliever;

  If you have any further questions on the use of this product, ask your doctor or pharmacist.

  What Zomorph capsules contain

  The active ingredient is morphine sulfate BP; each capsule contains either 10mg, 30mg, 60mg, 100mg or 200mg of this substance.

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

  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:

  1. 4. POSSIBLE SIDE EFFECTS

• 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;

  Like all medicines, Zomorph capsules can cause side effects, although not everybody gets them.

  Driving and using machines

  • titanium dioxide (E171) - 10mg, 30mg, 60mg and 100mg capsules

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.

• have an under-active thyroid gland (hypothyroidism), severe kidney or liver problems as you may need a lower dose;

  • quinoline yellow (E104) - 10mg capsules

All medicines can cause allergic reactions, although serious allergic reactions are uncommon.

• erythrosine (E127) - 30mg capsules
• have a severe headache or feel sick as this may indicate that the pressure in your skull is increased;
• sunset yellow (E110) - 60mg capsules.

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.

• suffer from, or have ever suffered from epilepsy, seizures, fits or convulsions;

  See end of Section 2 for further, important information on sunset yellow and sucrose.

• have low blood pressure;

  This medicine can affect your ability to drive as it may make you sleepy or dizzy.

  What Zomorph capsules look like & contents of the pack

• have a severe heart problem after long-term lung disease (severe cor pulmonale);

  • Do not drive while taking this medicine until you know how it affects you.

    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.

    The capsules are made in different colours to identify each strength: 10mg - yellow/clear

• have inflammation of the pancreas (which causes severe pain in the abdomen and back) or problems with your gall bladder;

  • It is an offence to drive while you have this medicine in your body over a specified limit unless you have a defence (called the ‘statutory defence’).

    30mg - pink/clear

• have an inflammatory bowel disorder;

  • This defence applies when:

    60mg - orange/clear

    Drug Withdrawal

• you suffer from constipation;

  o The medicine has been prescribed to treat a medical or dental problem, and

  100mg - white/clear

  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.

• have prostate problems;

  200mg - clear.

• experience weakness, fatigue, lack of appetite, nausea, vomiting or low blood pressure. This may be a symptom of the adrenal glands producing too little of the hormone ‘cortisol’, and you may need to take a hormone supplement;

  o You have taken it according to the instructions given by the doctor and in the information provided with the medicine.

  They are packed in aluminium/PVC blisters; each pack contains 6 blisters x 10 capsules.

  • Please note that it is still an offence to drive if you are unfit because of the medicine (i.e. your ability to drive is being affected).

• have loss of libido, impotence, cessation of menstruation. This may be because of decreased sex hormone production.

  How do I know if I am addicted?

  Marketing Authorisation Holder

  Manufacturer

  If you notice any of the following signs whilst taking Zomorph capsules, it could be a sign that you have become addicted.

  Ethypharm

  Ethypharm

  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.

  194, Bureaux de la Colline – Bâtiment D

  Chemin de la poudrière, 76 120 Grand-Quevilly, France.

Taking this medicine regularly, particularly for a long time, can lead to addiction. 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.

• You need to take the medicine for longer than advised by your doctor

  92213 Saint-Cloud cedex

• You feel you need to use more than the recommended dose

  France

• You are using the medicine for reasons other than prescribed

  For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: United Kingdom: Ethypharm UK - email: medinfo@ ethypharm.com

Rarely, increasing the dose of this medicine can make you more sensitive to pain. If this happens, you need to speak to your doctor about your treatment. Addiction can cause withdrawal symptoms when you stop taking this medicine. Withdrawal symptoms can include restlessness, difficulty sleeping, irritability,

• When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again.

Zomorph capsules contain sucrose and [60 mg strength only] sunset yellow (E110)

If you notice any of these signs, it is important you talk to your doctor.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

This leaflet was last revised in May 2021.