MORPHGESIC SR 100MG TABLETS

Active substance: MORPHINE SULPHATE

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Package Leaflet : Information for the user 075-0026-APIL

Treatment with morphine should not be withdrawn suddenly, particulary if the medicine has been used by the patient for a long time. The use of the drug should be gradually withdrawn to avoid unnecessary side effects. If you take more Morphgesic SR Tablets than you should Please be aware of the symptoms you may experience from taking too much of your morphgesic SR medicine. These include extreme drowsiness, pinpoint pupils, confusion, cold and clammy skin, a weak pulse, shallow breathing or fainting. If you have taken too many Morphgesic SR tablets, contact your doctor or nearest hospital emergency department immediately. Take the container and any remaining tablets with you. If you forget to take Morphgesic SR Tablets: If you forget to take a dose, just take the next dose at the usual time, DO NOT take a double dose. 4. POSSIBLE SIDE EFFECTS Like all medicines Morphgesic SR Tablets can cause side effects, although not everybody gets them. If you notice: swelling of your stomach pain and discomfort being sick (vomiting) constipation. Stop taking this medicine and seek medical advice immediately. These may be signs of a condition called Paralytic Ileus (paralysis of the bowel). The most common side effects of Morphgesic SR Tablets are: feeling sick (nausea) being sick constipation drowsiness confusion Other side effects of Morphgesic SR Tablets may include: dry mouth; sweating; headache; facial flushing (red face); dizziness, light-headedness, vertigo, fainting or experiencing pins and needles; high blood pressure; raised intracranial pressure (severe headache, feeling sick); swelling (oedema); generally feeling unwell; decreased heart rate; slow or irregular heart beat; palpitations; restlessness, confusion, disorientation or mood changes; seeing or hearing things that are not really there (hallucinations); an elevated sense of well-being (euphoria); breathing difficulties such as wheezing or cough decreased; itching or nettle rash; a feeling of unusual weakness; stomach pain; exacerbation of pancreatitis (this can cause severe pain in the abdomen and back, nausea, vomiting, constipation and dry mouth); changes in taste; anorexia; constriction of the pupils (small pupils); vision abnormalities; unusual body movements, particularly of the hands, arms or legs;



muscle twitches, spasms, tremors or injury; fits; loss of periods or decreased sex drive; a reduction in body temperature.

Morphgesic SR 10 mg, 30 mg, 60 mg and 100 mg Tablets
Morphine sulphate
Read all of this leaflet carefully before you start taking this medicine. - 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects becomes severe, or if you notice any effects not listed in the leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Morphgesic SR Tablets are and what they are used for 2. Before you take Morphgesic SR Tablets 3. How to take Morphgesic SR Tablets 4. Possible side effects 5. How to store Morphgesic SR Tablets 6. Further information 1. WHAT MORPHGESIC SR TABLETS ARE AND WHAT THEY ARE USED FOR The name of your medicine is Morphgesic SR Tablets. Morphgesic SR Tablets contain the active ingredient morphine sulphate which belongs to a group of medicines called opioid analgesics and is used for pain relief. Morphgesic SR Tablets act on the nervous system and muscles to give prolonged relief from severe pain for up to 12 hours. 2. BEFORE YOU TAKE MORPHGESIC SR TABLETS Do not take Morphgesic SR Tablets if you: are allergic to morphine sulphate or any of the other ingredients in Morphgesic SR Tablets (allergic reactions include mild symptoms such as itching and/or rash. More severe symptoms include swelling of the face, lips, tongue and/or throat with difficulty in swallowing or breathing); have any long standing lung disease (such as obstructive airways disease or bronchitis); are having an asthma attack; have recently suffered any head injury or have been told that you have raised pressure around your brain; have liver disease; have any problems with your stomach or bowel (where your bowel or stomach function has slowed down or stopped working); often drink large amounts of alcohol; are taking, or have recently taken (within the last 14 days) a medicine from a group of anti-depressants called monoamine oxidase inhibitors (MAOIs); have heart failure caused by long term lung disease; are about to have an operation, or have had an operation in the last 24 hours; are pregnant or think you may be pregnant or if you are breast-feeding; have a rare form of tumour affecting part of the body known as the adrenal glands. Morphgesic SR Tablets are not recommended for children. Take special care with Morphgesic SR Tablets if you: have any problems with your thyroid or adrenal glands; have poor liver or kidney function; are a man with an enlarged prostate gland; have an inflammatory bowel disease such as ulcerative colitis; have epilepsy or suffer from fits (seizures); are suffering with shock; are suffering from myasthenia gravis (a disease which affects the muscles); have bowel problems e.g. inflammatory bowel disorder; have low blood pressure and a decreased volume of blood circulating (hypovolaemia); are addicted to any medicine like morphine; suffer with a disease of your bile duct; have pancreatitis (swelling of the pancreas); are elderly.

Some of these effects are more common if you are mobile than if you are confined to bed. Sometimes Morphgesic SR Tablets can aggravate spasm (or contraction) of the bile duct (which is attached to the gall bladder) or ureter (which drains urine from the kidneys to the bladder). These effects can lead to abdominal pain or difficulty in passing water. Some people may become addicted to this medicine when treatment continues for a long time. If any of the side effects becomes severe, or if you notice any side effects not listed in the leaflet, please tell your doctor or pharmacist immediately. 5. HOW TO STORE YOUR MEDICINE Do not store above 25C. Store in the original package. Do not use Morphgesic SR Tablets after the expiry date, which is stated on the packaging. The date refers to the last day of that month. KEEP OUT OF THE REACH AND SIGHT OF CHILDREN. 6. FURTHER INFORMATION What Morphgesic SR Tablets contain There are 4 different strengths (10 mg, 30 mg, 60 mg and 100 mg) of Morphgesic SR Tablets. The active substance is Morphine Sulphate. The other ingredients are lactose (except 100 mg tablets), povidone, hydroxyethylcellulose, talc, magnesium stearate, hypromellose (E464), macrogol and industrial methylated spirit 99%. The different strength tablets also contain the following colourants: 10 mg Tablets: Titanium Dioxide (E171), Iron Oxide Yellow (E172) and Iron Oxide Red (E172). 30 mg Tablets: Titanium Dioxide (E171), Erythrosine (E127), Indigo Carmine (E132) and Sunset Yellow (E110). 60 mg Tablets: Titanium Dioxide (E171) and Sunset Yellow (E110). 100 mg Tablets: Titanium Dioxide (E171) and Iron Oxide Black (E172). What Morphgesic SR looks like and the contents of the pack 10 mg tablets are buff, embossed with 10 on one face and contain 10 mg of the active ingredient morphine sulphate. 30 mg tablets are violet, embossed with 30 on one face and contain 30 mg of the active ingredient morphine sulphate. 60 mg tablets are orange, embossed with 60 on one face and contain 60 mg of the active ingredient morphine sulphate. 100 mg tablets are grey, embossed with 100 on one face and contain 100 mg of the active ingredient morphine sulphate. Each strength of Morphgesic SR Tablets is available in packs containing 10 or 60 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer: Marketing Authorisation Holder: Waymade Plc t/a Amdipharm, Regency House, Miles Gray Road, Basildon, Essex SS14 3AF. Manufacturer: Custom Pharmaceuticals Limited, Conway Street, Hove, East Sussex BN3 3LW. Date of preparation: April 2008

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If any of these apply to you, or if you are not sure, tell your doctor before taking Morphgesic SR Tablets. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is especially important if you are taking medicines for: depression (e.g. amitriptyline, imipramine or dosulepin) psychoses (e.g. chlorpromazine, promazine) sedative or hypnotic purposes (e.g. zopiclone, zolpidem) anaesthesia (e.g. thiopental, isoflurane) palpitations (e.g. mexiletine, propranolol or esmolol) nausea and vomiting (e.g. metoclopramide, domperidone) ulcer healing (e.g. cimetidine, ranitidine) Morphine may increase the effects of medicines used to control high blood pressure, relax muscles or act as tranquilisers. Taking Morphgesic SR Tablets with food and drink Do not drink alcohol while taking Morphgesic SR tablets, as the tablets can increase the effects of alcohol. Pregnancy and Breast-feeding Do not take Morphgesic SR Tablets if you are, or think that you may be pregnant or if you are breast-feeding. Driving and using machinery Do not drive or operate machinery while you are taking Morphgesic SR Tablets. Important information about some of the ingredients of Morphgesic SR Tablets The colourant E110 is present in the 30 mg and 60 mg tablets. This can cause an allergic-type reaction including asthma. This reaction is more common in those people who are allergic to aspirin. Tell your doctor before taking this medicine if you have been told that you have an intolerance to some sugars. This is because Morphgesic SR Tablets (except 100 mg tablets) contains a small amount of lactose, a type of sugar. 3. HOW TO TAKE YOUR MEDICINE Always take Morphgesic SR Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual starting dose is one or two 10 mg tablets twice daily. The total daily dose should be taken in two divided doses at 12 hourly intervals. For instance, if you take a tablet at 8 oclock in the morning, you should take your next tablet at 8 oclock in the evening. Swallow your tablets whole with water. Do not crush or chew them. Your doctor may change your dose depending on your response and how severe your pain is. Do not exceed the recommended dose.

JOB NO: Originator:

1012 McCombe

FINISHED SIZE 160 x 240

PRODUCT NAME: Morphgesic PIL

Date: 05.05.09 Colours Used: BLK

ARTWORK SCALE 100%

COMPONENT: PIL PIP CODE:

FONT SIZE 8pt VERSION: 5

075-0026-APIL

MEDIA TECH
one stop solution

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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