MELOTIN MR Melatonin 2 mg modified release tablet

1 MELOTIN MR. Melatonin 2 mg modified release tablet Consumer Medicine Information For a copy of a large print leaflet, Ph: 1800 195 055. Tell your doctor if you have or have had any of When to take it What is in this leaflet the following medical conditions: Take your medicine at about the same time This leaflet answers some common questions liver problems each day, about 1-2 hours before you go to about Melatonin . It does not contain all the kidney problems bed. available information. It does not take the place an autoimmune disease Taking it at the same time each day will have the of talking to your doctor or pharmacist. best effect. It will also help you remember when a rare hereditary problem of galactose All medicines have risks and benefits. Your to take it. intolerance, LAPP lactase deficiency or doctor has weighed the risks of you taking glucose-galactose malabsorption Melatonin should be taken with food. Melatonin against the benefits they expect it will How long to take it if you smoke cigarettes have for you.

2 If you have not told your doctor about any of Continue taking Melatonin for as long as your If you have any concerns about taking this doctor tells you. the above, tell them before you take Melatonin . medicine, ask your doctor or pharmacist. Taking other medicines This medicine may be continued for up to thirteen Keep this leaflet with the medicine. weeks. You may need to read it again. Tell your doctor or pharmacist if you are taking any other medicines, including any that If you forget to take it What this medicine is used for you buy without a prescription from your If you forget to take your tablet , take another pharmacy, supermarket or health food shop. as soon as you remember before going to bed Melatonin is used to improve sleep quality and or wait until it is time for your next dose. Some medicines and Melatonin may interfere morning alertness in patients over 55 years of age with each other. These include: Do not take a double dose to make up for a with poor quality of sleep.

3 Hypnotics or tranquilisers ( forgotten dose. Melatonin belongs to a group of naturally This may increase the chance of you getting an benzodiazepines). occurring hormones produced in the body. unwanted side effect. certain medicine used to treat mood disorders It works by controlling the circadian rhythms and If you are not sure what to do, talk to your ( fluvoxamine, thioridazine and increasing the propensity to sleep. doctor or pharmacist. imipramine). Ask your doctor if you have any questions If you have trouble remembering to take your contraceptives or hormone replacement about why this medicine has been prescribed Melatonin , ask your pharmacist for some therapy containing oestrogen for you. hints. Your doctor may have prescribed it for another quinolones and rifampicin, used to treat reason. infections If you take too much (overdose). This medicine is only available with a doctor's carbamazepine, used to treat epilepsy Immediately telephone your doctor or the prescription. cimetidine Poisons Information Centre (telephone 13 11.)

4 26) for advice or go to Accident and This medicine is not addictive. psoralens used to treat skin problems ( Emergency at the nearest hospital, if you think There is not enough information to recommend psoriasis). that you or anyone else may have taken too the use of this medicine for children under the alcohol much Melatonin . Do this even if there are no age of 18 years. caffeine signs of discomfort or poisoning. The effect of adding Melatonin to other medicines You may need urgent medical attention. Before you take this medicine used to treat insomnia has not been examined. It When you must not take it is not known if Melatonin will increase or While you are using this medicine decrease the effects of other treatments for Do not take this medicine if you have an insomnia. Things you must do allergy to: If you are about to be started on any new These medicines may be affected by Melatonin or Melatonin may affect how well it works. You may need medicine, remind your doctor and pharmacist any of the ingredients listed at the end of this different amounts of your medicines, or you may that you are taking Melatonin .

5 Leaflet. need to take different medicines. Tell any other doctors, dentists and Some of the symptoms of an allergic reaction Your doctor and pharmacist have more pharmacists who treat you that you are taking may include: information on medicines to be careful with or this medicine. shortness of breath avoid while taking Melatonin . If you are going to have surgery, tell the wheezing or difficulty breathing surgeon or anaesthetist that you are taking How to take this medicine this medicine. swelling of the face, lips, tongue or other It may affect other medicines used during parts of the body Follow all directions given to you by your surgery. rash, itching or hives on the skin. doctor or pharmacist carefully. They may differ from the information contained If you become pregnant while taking Do not take Melatonin if you have been Melatonin , stop taking the tablets and tell your drinking alcohol, intend to drink alcohol or in this leaflet. doctor immediately. believe that you may have alcohol in your If you do not understand the instructions on the box, ask your doctor or pharmacist for Keep all your doctor's appointments so that blood stream.

6 Help. your progress can be checked. Do not take Melatonin if you are pregnant or Your doctor may do some tests from time to time breast-feeding. How much to take to make sure the medicine is working and to This medicine has not been studied in pregnant or The usual dose of Melatonin is one tablet once prevent unwanted side effects. breast-feeding women. a day. Things you must not do Do not take Melatonin after the expiry date There is no evidence that taking more than the printed on the pack or if the packaging is torn Do not take this medicine to treat any other recommended dose will increase the effect of complaints unless your doctor tells you to. or shows signs of tampering. Melatonin . If it has expired or is damaged, return it to your Do not give this medicine to anyone else, even pharmacist for disposal. How to take it if they have the same condition as you. If you are not sure whether you should start Swallow the tablet whole with a glass of water. Do not take more than the recommended dose taking Melatonin , talk to your doctor.

7 Do not crush, chew or divide your tablet . unless your doctor tells you to. Each Melatonin tablet has been specially designed Do not drink alcohol before or after taking this Before you start to take it to release the right dose of medicine while you medicine. Tell your doctor if you have any allergies to sleep. If you crush, chew or divide the tablet they any other medicines, foods, preservatives or will not work properly dyes. MELOTIN MR. Published by MIMS April 2021 1. Things to be careful of memory impairment Ingredients Be careful driving or operating machinery restless legs syndrome Each tablet contains 2 mg Melatonin as the active until you know how this medicine affects you. vertigo ingredient Melatonin rarely causes drowsiness. inflammation of the stomach lining It also contains the following: Nevertheless, it is not recommended to drive or ammonio methacrylate copolymer type B. arthritis operate machinery for 8 hours after you take it. Melatonin does not impair morning alertness, but increased duration of erection calcium hydrogen phosphate dihydrate if you suffer from drowsiness during the day you inflammation of the prostate gland lactose monohydrate should consult your doctor.

8 Thirst, passing large volumes of urine or colloidal anhydrous silica urination during the night purified talc Side effects The above list includes serious side effects that magnesium stearate Tell your doctor or pharmacist as soon as may require medical attention. Serious side Sponsor possible if you do not feel well while you are effects are rare. Generic Partners Pty Ltd taking Melatonin . If any of the following happen, tell your doctor 313 Burwood Road, Melatonin helps most people with insomnia, but immediately or go to Accident and Emergency Hawthorn VIC 3122. it may have unwanted side effects in a few at your nearest hospital: Distributed by Apotex Pty Ltd people. All medicines can have side effects. severe chest pain due to angina Sometimes they are serious, most of the time they This leaflet was prepared in March 2021. feeling your heartbeat (palpitations). are not. You may need medical attention if you hyperbilirubinaemia (changes in the get some of the side effects. composition of your blood which could cause Do not be alarmed by this list of possible side yellowing of the skin or eyes (jaundice).)

9 Effects. You may not experience any of them. loss of consciousness or fainting Ask your doctor or pharmacist to answer any The above list includes very serious side effects. questions you may have. You may need urgent medical attention or Tell your doctor or pharmacist if you notice hospitalisation. These side effects are very rare. any of the following and they worry you: Some side effects can only be found when your gastrointestinal upset reflux, vomiting, doctor does blood or urine tests from time to abnormal bowel sounds, flatulence (wind), time to check your progress. This includes: abdominal discomfort, upper abdominal pain reduced number of white blood cells or or indigestion platelets skin problems eczema, hand dermatitis, high level of fatty molecules psoriasis, rash, itchy rash, dry skin presence of red blood cells in the urine weight increase excretion of glucose in urine irritability, agitation or restlessness excess proteins in the urine anxiety or nervousness increased liver enzymes insomnia, abnormal dreams or early morning awakening low levels of calcium or sodium in the blood increased sex drive abnormal blood electrolytes migraine Tell your doctor or pharmacist if you notice anything that is making you feel unwell.

10 Visual impairment, blurred vision or watery eyes Other side effects not listed above may also occur in some patients. dizziness when standing or sitting lethargy or tiredness Storage and Disposal nail disorder Storage night sweats or night cramps Keep your tablets in the pack until it is time to dry mouth take them. halitosis (bad breath) If you take the tablets out of the pack, they may asthenia (feeling of weakness) not keep well. muscle spasms Keep your medicine in a cool dry place where salivary hypersecretion (excess saliva the temperature stays below 25 C. Keep it production) away from sunlight. The above list includes the more common side Do not store it or any other medicine in the effects of your medicine. They are usually mild bathroom or near a sink. Do not leave it on a and short-lived. window sill or in the car. Tell your doctor as soon as possible if you Heat and dampness can destroy some medicines. notice any of the following: Keep it where children cannot reach it. shingles A locked cupboard at least one-and-a-half metres above the ground is a good place to store pins and needles' feeling (paresthesia) medicines.