Quatrefolic® Primary biologically active form of folate | Levomefolic acid Consumer Medicine Information 1. What is in the leaflet? 1. You have any allergies to any other 5. While you are taking Quatrefolic® medicines, foods, preservatives, dyes This leaflet answers some of the more or additives. Things you MUST do: common questions about Quatrefolic® If you experience any allergic reaction 1. If you become pregnant while taking capsules. or other side effects after consuming Quatrefolic®, tell your healthcare It does not contain all the available Quatrefolic® you should discontinue use professional immediately. information. It does not take the place of and consult with your healthcare 2. If you are about to start taking a new talking to your healthcare professional. professional. medicine, tell your healthcare All medicines have risks and benefits. Your 2. You are pregnant or planning to professional that you are taking doctor has weighed the risks of you taking become pregnant. Quatrefolic®. Quatrefolic® capsules against the benefits 3. You are breastfeeding or planning to 3. If you are planning to have surgery, they expect it will have for you. breastfeed. including dental surgery, tell your If you have any concerns about taking this 4. You have or have had any other healthcare professional that you are medicine, ask your healthcare professional. health problems or issues including: taking Quatrefolic®. Keep this leaflet with the medicine. Iron deficiency (anemia) or think that 4. Always follow your healthcare You may need to read it again. you might be anemic. professional’s instructions carefully. 5. You drink large amounts of alcohol. Things you MUST NOT do: 2. What Quatrefolic® is used for 6. You are taking other medicines. 1. Do not heat Quatrefolic® or add into hot Quatrefolic® contains levomefolate Tell your healthcare professional if you foods. glucosamine which is a form of biologically are taking any other medicines, including 2. Do not expose Quatrefolic® to extreme active folate, 5-methyltetrahydrofolate (5- any that you get without a prescription. heat conditions for extended periods of MTHF). Some medicines may be affected by time. Dietary folate and synthetic folic acid are not Quatrefolic®, or may affect how well it 3. Do not exceed the stated daily dose. biologically active and need to be converted works. You may need to take different into 5-MTHF in a multistep process, amounts of your medicine, or you may need 6. Side Effects requiring the enzyme to take different medicines. Your doctor will methylenetetrahydrofolate reductase advise you. Quatrefolic® has low risk of side effects (MTHFR). Individuals with polymorphic Your healthcare professional has more when taken as directed. forms of this enzyme cannot convert information on medicines to be careful with Ask your healthcare professional to adequate amounts of biologically active or avoid while taking Quatrefolic®. answer any questions you may have. folate. 5-MTHF can bypass the MTHFR If you have not told your healthcare However, get medical help right away if enzyme to meet nutritional demands. Folate professional about any of the above, tell you notice any symptoms of a serious is essential for DNA synthesis, cell division, them before you start taking allergic reaction, including: red blood cell production and homocysteine metabolism. Demands for folate increase • rash during pregnancy due to increased 4. How to take Quatrefolic® • itching/swelling (face/tongue/throat) requirements for foetal growth and 1. Follow all directions given to you by • dizziness development. your healthcare professional carefully. • trouble breathing. Your healthcare professional may have 2. Take Quatrefolic® exactly as your These side effects are usually mild and dose prescribed Quatrefolic® for another healthcare professional has related. Most of them disappear completely reason. prescribed. in a few days to a few weeks after the dose of Ask your healthcare professional if you This may differ from the information Quatrefolic® is lowered or stopped. have any questions concerning why contained in this leaflet. Tell your doctor if you notice anything else Quatrefolic® as been prescribed for you. 3. How much Quatrefolic® should be that is making you feel unwell. Quatrefolic® is not addictive. taken? One (1) capsule a day. Do not exceed the 7. After taking Quatrefolic® 3. Before you take Quatrefolic® stated dose. 4. How to take Quatrefolic® Storage Vitamin supplements should not replace a Capsules should be swallowed whole. Keep Quatrefolic® in its bottle until it is balanced diet. Do not take any capsules that are time to take it. If you take the capsules out of If symptoms persist consult your damaged. the bottle they may not keep well. healthcare professional. 5. How long to take Quatrefolic® Store Quatrefolic® below 30°C. Do not take while on warfarin therapy. Take Quatrefolic® as long as your Do not store Quatrefolic®, or any other Do not exceed the stated dose except on healthcare professional prescribes. medicine, in a bathroom or near a sink. Do medical advice. If you have had a baby 6. If you forget to take Quatrefolic® not leave it in the car or on a window sill. with a neural tube defect/spina bifida, seek Do not try to make up for missed doses Heat and dampness can destroy the medicine. specific medical advice. by taking an extra dose. This may Protect Quatrefolic® from light. Do not take Quatrefolic® if: increase the chance of experiencing an Keep out of the reach of children 1. You have had an allergic reaction to unwanted side effect. Quatrefolic®, or any ingredient in Do not exceed the stated dose. 8. Product description Quatrefolic® (listed in section 8). If it is almost time for your next dose, 2. The safety seal is broken, missing or skip the dose you missed and take the What Quatrefolic® looks like: shows signs of tampering. next dose when you are supposed to. Quatrefolic® is a hard clear capsule. If you are unsure of what to do, check 3. The expiry date (EXP) printed on the Quatrefolic® is packed in a recyclable bottle with your healthcare professional. pack has passed. with a safety seal over the cap. Quatrefolic® If you take this medicine after the expiry 6. If you have taken too much is available in bottles containing 60 capsules. date has passed, it may not work as well. Quatrefolic®(overdose) Ingredients: Please visit your healthcare professional If you are not sure you should start taking if there are signs of discomfort. Tell Active Ingredients PER capsule: Quatrefolic® contact your health them how much Quatrefolic® you took Levomefolate glucosamine 0.926 mg professional. and they will determine what action is Equiv. Levomefolic acid 500 µg Before you take Quatrefolic®, tell your best for your health. Excipient Ingredients: doctor if: • Cellulose Quatrefolic® Published by MIMS December 2017 1 • Hypromellose • Silica • Magnesium stearate Quatrefolic® is suitable for vegetarians Quatrefolic® is dairy and gluten free 9. Translation Not available 10. Manufacturer Quatrefolic® is supplied in Australia by: Medlab Clinical Limited™ 66 McCauley Street Alexandria NSW 2015 Toll free: 1300 369 570 Quatrefolic® is covered by US patent No 7,947,662 and it is a registered trademark of Gnosis S.p.a. Australian Listing Number AUST L 287400 This Leaflet was prepared in Aug 2017 Medlab Clinical Limited™ Quatrefolic® Published by MIMS December 2017 2.