Momex SR Modified (Sustained) Release Tablets [Morphine sulphate] CONSUMER MEDICINE INFORMATION What is in this leaflet This leaflet answers some common questions about Momex SR Tablets. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Momex SR tablets against the benefits s/he expects they will have for you. If you have any concerns about taking this medicine ask your doctor or pharmacist. Keep this leaflet with the medicine. You may need to read it again. What Momex SR is used for Momex SR contains morphine sulphate which belongs to a group of medicines called opioid analgesics. Momex SR tablets are used for treating chronic severe pain. Your doctor may have prescribed Momex SR for another purpose. Ask your doctor if you have any questions about why Momex SR has been prescribed for you. Before you use Momex SR tablets When you must not use Momex SR tablets (discuss with your doctor) If you have allergies to: Momex SR or other medications that contain morphine sulphate any medications known as opioid analgesics e.g. codeine any ingredient listed at the end of this leaflet if you are suffering from any severe breathing problems, such as severe asthma if you suffer from irregular or rapid heart beats if you suffer from heart disease if you regularly drink large amounts of alcohol if you suffer from fits or convulsions if you have had a head injury or brain tumour C:Products/Morphine/Momex/CMI_19122012_2 Page 1 of 6
if you are about to have an operation or within 24 hours after an operation if you have any liver disease if you have paralytic ileus if you are taking medicine for depression called a 'monoamine oxidase inhibitor' or have taken any in the last two weeks if you are pregnant or breast feeding, unless your doctor advises that you can use Momex SR. Ask your doctor about the risks and benefits involved in an infant under 1 year of age do not use Momex SR after the expiry date (Exp) printed on the pack. Do not take Momex SR tablets if the package shows any signs of tampering. Before you start to use Momex SR You must tell your doctor if: you are using any other medicines, including: cimetidine gabapentin propranolol rifampicin buprenorphine, nalbuphine, pentazocine or other opioids any medicines that you have bought from a pharmacy or supermarket Tell your doctor if you have any of the following conditions, stomach pains or constipation problems with breathing kidney or liver disease increased prostate size low blood pressure narrowing of the urinary tract bile duct disease or inflammation of the pancreas disorientation, hallucinations or severe headaches low activity of the adrenal gland (Addison's disease) inflammatory bowel disease Tell your doctor or pharmacist if you take any other medicines, including: medication for depression medication to help you sleep medication for allergy medication for stomach discomfort such as antacids pain relievers alcohol medication for Parkinsons Disease medication to stop you vomitting medication for the treatment of HIV infection C:Products/Morphine/Momex/CMI_19122012_2 Page 2 of 6
These medicines or alcohol may increase the side effects of Momex SR. Your doctor or pharmacist can tell you what to do if you are taking any of these medicines. Do not start to take any other medicine unless prescribed or approved by your doctor. This includes medicines you can buy without a prescription from a pharmacy, supermarket or health food shop. Using Momex SR tablets How to take Momex SR tablets Momex SR tablet must be swallowed whole. Momex SR tablets must not be chewed, crushed or dissolved. take this medicine exactly as directed by your doctor. Momex SR tablets should be taken every 12 hours. Momex SR must be taken regularly to control the pain. Taking Momex SR at regular time intervals means that the onset of pain is prevented. Momex SR should not be taken when you feel you need it as this will cause some pain to be experienced. do not take any alcohol while you are being treated with Momex SR. the amount of Momex SR needed to give good pain relief varies. The doctor will take into account your age, weight, level of pain and medical history when choosing your dose. it is important to take the tablets at the times you have been told to. If, however, you begin to experience pain and you are taking your Momex SR as prescribed ('breakthrough pain') contact your doctor as your dosage may have to be reviewed. If you forget to take Momex SR If you forget to take a dose, contact your doctor or pharmacist for advice. If you have trouble remembering when to take your medicine, ask your pharmacist for some hints. An example is taking your medicine at the same time each day such as 8 am and 8 pm. What to do in case of an overdose In the event of an overdose you should straight away contact a doctor or the Poisons Information Centre for advice, or go to the Casualty Department of your nearest hospital. Even if there are no signs of discomfort or poisoning it is important that you take immediate action. If someone takes an overdose they will probably become drowsy, tired, confused, have a very low blood pressure, experience difficulties in breathing and possibly become unconscious. While you are using Momex SR tablets C:Products/Morphine/Momex/CMI_19122012_2 Page 3 of 6
Things you must do Visit your doctor regularly for a check up and always discuss with your doctor any problems or difficulties during or after taking Momex SR tablets. Tell your doctor if your pain is getting worse or you are having more frequent breakthrough pain. Take Momex SR tablets as your doctor has prescribed. Keep enough Momex SR tablets with you to last over weekends and holidays. Before having any type of surgery, tell your doctor or anaesthetist you are taking Momex SR tablets. Things to be careful of You may feel drowsy when you begin to take Momex SR tablets. If you drink alcohol, the drowsiness may be worse. Ask your doctor's advice about whether or not it will be safe for you to drive or operate any machinery whilst taking Momex SR. You may suffer from nausea or vomiting when taking Momex SR tablets. If you vomit 2-3 hours after your dose your pain may come back as you will not have absorbed your morphine. If this happens speak to your doctor. Your doctor may prescribe some medicine to help stop you vomiting. Constipation can be caused by morphine. You should speak to your doctor about your diet and the proper use of laxatives. Things you must not do Remember, Momex SR tablets should be taken strictly according to your doctor's instructions. Do not change your dose of Momex SR unless your doctor has told you to. Do not give this medicine to anyone else. Side Effects Tell your doctor or pharmacist as soon as possible if you have any concerns while taking Momex SR tablets. Momex SR tablets help most people with the severe pain of cancer, but they may have unwanted side effects in some people. All medicine can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some side effects. Ask your doctor or pharmacist to answer any questions you may have. The more common side effects are: C:Products/Morphine/Momex/CMI_19122012_2 Page 4 of 6
constipation drowsiness sweating confusion dizziness nausea or vomiting Other effects include difficulties in breathing skin troubles such as rash (red spots), itching lumps or hives swelling of the eyelids, face or lips wheezing, chest pain or tightness, reduced sexual functioning, flushing of the face, faintness or heart palpitations, hallucinations Tell your doctor if you notice any other effects, even if it is not on this list. Some people may get other side effects while taking Momex SR. Will I become addicted to my Momex SR Opioid analgesics such as morphine sulphate have been used to treat chronic cancer pain for many years. In most cases addiction does not occur. However over time your body becomes used to taking morphine, so if you suddenly stop taking your Momex SR tablets you may experience some symptoms of withdrawal. It is important that you discuss this issue with your doctor. Storage Keep your tablets in the blister pack until it is time to take them. If you take the tablets out of the blister pack they will not keep as well. Keep Momex SR tablets in a cool dry place where the temperature stays below 25 degrees C. Do not store Momex SR tablets or any other medicine in the bathroom or near a sink. Heat and dampness can destroy some medicines. Keep Momex SR tablets where young children cannot reach them. A locked cupboard at least one and a half metres above the ground is a good place to store medicines. Do not leave Momex SR in the car on hot days. Disposal Return any unused medicine to your pharmacist. C:Products/Morphine/Momex/CMI_19122012_2 Page 5 of 6
Product Description What Momex SR looks like Momex SR Tablets (modified [sustained] release) come in four strengths: 10 mg buff coloured, biconvex, smooth, round, film coated tablets with 10 on one face, each containing morphine sulphate 10 mg 30 mg violet coloured, biconvex, smooth, round, film coated tablets with 30 on one face, each containing morphine sulphate 30 mg 60 mg orange coloured, biconvex, smooth, round, film coated tablets with 60 on one face, each containing morphine sulphate 60 mg 100 mg grey coloured, biconvex, smooth, round, film coated tablets with 100 on one face, each containing morphine sulphate 100 mg Momex SR Tablets (modified [sustained] release) come in cartons of 28 tablets. Ingredients Active ingredient Morphine sulphate Inactive ingredients Lactose (except the 100 mg), hydroxyethylcellulose, hypromellose, povidone, talc purified, and magnesium stearate. The tablet coatings contain a different colourant for each strength, as follows: 10 mg Opadry buff OY-3607 30 mg Opadry violet OY-6708 60 mg Opadry orange OY-3533 100 mg - Opadry grey OY-8238 Australian registration numbers: Momex SR 10 mg AUST R 132253 Momex SR 30 mg AUST R 132255 Momex SR 60 mg AUST R 132257 Momex SR 100 mg AUST R 132259 Sponsor Distributor Southern Cross Pharma Pty Ltd Aspen Pharma Pty Ltd 56 Illabunda Drive 34-36 Chandos St Malua Bay St Leonards NSW 2536 NSW 2065 Date of Information: 19 December 2012 C:Products/Morphine/Momex/CMI_19122012_2 Page 6 of 6