LEUCOVORIN-TEVA 10 mg/ml CONCENTRATE FOR SOLUTION FOR INFUSION folinic acid as the calcium salt PACKAGE LEAFLET: INFORMATION FOR THE USER

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1 LEUCOVORIN-TEVA 10 mg/ml CONCENTRATE FOR SOLUTION FOR INFUSION folinic acid as the calcium salt PACKAGE LEAFLET: INFORMATION FOR THE USER Read all of this leaflet carefully before you start using 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 you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. In this leaflet: 1. What Leucovorin-Teva is and what it is used for 2. Before you receive Leucovorin-Teva 3. How to receive Leucovorin-Teva 4. Possible side effects 5. How to store Leucovorin-Teva 6. Further information 1. WHAT LEUCOVORIN-TEVA IS AND WHAT IT IS USED FOR Leucovorin-Teva belongs to a group of drugs called antidotes. Antidotes prevent the damage caused by other substances. Leucovorin-Teva is used: to help prevent the side effects of treatment or overdose with the medicine methotrexate and similar medicines to treat certain kinds of anaemia in combination with the medicine fluorouracil, for the treatment of certain forms of colon cancer (metastatic colorectal carcinoma). 2. BEFORE YOU RECEIVE LEUCOVORIN-TEVA Do NOT receive Leucovorin-Teva if you: are allergic (hypersensitive) to calcium folinate or any of the other ingredients of this medicine suffer from anaemia caused by a lack of vitamin B 12 (for example pernicious anaemia). Take special care with Leucovorin-Teva Tell your doctor or nurse before you start to receive this medicine if you: are suffering from diarrhoea or stomach problems are or may be dehydrated are suffering from diarrhoea or inflammation/ulceration of the mouth e.g. mouth ulcers and cold sores after being treated with 5-fluorouracil suffer from excess fluid around the lungs or abdominal cavity (pleural or peritoneal effusions) have kidney problems are pregnant, trying to become pregnant or breast-feeding. Elderly and/or debilitated patients have been found to be at greater risk of severe stomach problems or diarrhoea while receiving Leucovorin-Teva. Please speak to your doctor immediately if you are affected.

2 Taking other medicines Talk to your doctor if you are taking or receiving any of the following: anti-epileptics e.g. phenobarbital, primidone, phenytoin 5-fluorouracil (see above, Tell your doctor before you start to receive this medicine). Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including any medicines obtained without a prescription. Pregnancy and breast-feeding If you are pregnant, planning to become pregnant or breast-feeding, ask your doctor or nurse for advice before receiving this medicine. Driving and using machines Leucovorin-Teva is not expected to affect your ability to drive or operate machinery. Important information about some of the ingredients of Leucovorin-Teva This medicinal product contains 0.1 mmol (or 3 mg) sodium per ml. This should be taken into consideration by patients on a controlled sodium diet. 3. HOW TO RECEIVE LEUCOVORIN-TEVA Leucovorin-Teva is given either into a vein (intravenously) as an injection or infusion, or into a muscle as an injection (intramuscular injection). Your medicine will be administered by a doctor or nurse. Leucovorin-Teva 10 mg/ml Concentrate for Solution for Infusion is intended for single dose use only. Any unused solution should be discarded immediately after use. If you are given an intravenous infusion, Leucovorin-Teva may be diluted with the recommended infusion fluids, sodium chloride or glucose solution, before administration. The sterile solution for injection should be visually inspected for clarity, particulate matter, discolouration and damage to the container before it is given to you. The solution should only be used if it is clear and the container is undamaged. The dosage can vary from patient to patient. Your doctor will decide what dosage is best for you. Your dose and the way Leucovorin-Teva is administered will depend on the severity and type of condition you have, as well as your weight. In general, the usual dosage is: Adults (including the elderly): When used to reduce the harmful effects of methotrexate The usual dose is 10 mg/m 2 given 24 hours after starting the methotrexate infusion. For the next 60 hours the same dose is repeated every 6 hours. After you have been given a few injections or infusions, it may be possible to switch to tablets. Your doctor may want to monitor you with tests during your treatment with methotrexate and Leucovorin-Teva. As a pretreatment of advanced colorectal cancer to enhance the effect of 5-fluorouracil Higher doses of Leucovorin-Teva are given. Your doctor will calculate what dose you receive. Antidote to the folic acid antagonists trimetrexate, trimethoprim and pyrimethamine: To prevent the harmful effects of trimetrexate (used for the treatment of certain forms of pneumonia, especially in patients with AIDS) Leucovorin-Teva is usually given every day during trimetrexate treatment until 72 hours after the last dose. Your doctor will administer 20 mg/m 2 of Leucovorin-Teva by infusion for 5-10 minutes. This will be repeated every 6 hours. The total dose will be 80 mg/m 2 a day. Tablets are a possible alternative to infusion.

3 If you have received a higher than normal dose of trimetrexate, your doctor will administer Leucovorin-Teva after stopping trimetrexate. Leucovorin-Teva, 40 mg/m 2 is given into a vein over 3 days, every 6 hours. After stopping treatment with high doses of trimethoprim (an antibiotic) you may receive Leucovorin-Teva, 3-10 mg a day. Your doctor will decide on the duration of this treatment. If you receive a high dose of pyrimethamine (used for the treatment of malaria and for an infection caused by the parasite toxoplasmosis) or when it is used for a long period, Leucovorin-Teva, 5-50 mg a day will be given at the same time. To treat certain kinds of anaemia: You may receive up to 1 mg daily. If you receive more Leucovorin-Teva than you should As a doctor or nurse will be giving you your medicine, it is unlikely that you will receive an incorrect dose. Tell your doctor or nurse if you have any concerns about the amount of medicine that you receive. If you stop receiving Leucovorin-Teva When Leucovorin-Teva is used in combination with methotrexate and treatment is stopped abruptly, the side effects of methotrexate may re-occur. Therefore Leucovorin-Teva should not be stopped abruptly. If you have any further questions on the use of this product, ask your doctor or nurse. 4. POSSIBLE SIDE EFFECTS Like all medicines, Leucovorin-Teva can cause side effects, although not everybody gets them. A few people may develop a severe allergic reaction. This is a rare but very serious side effect. If you experience any of the following symptoms tell your doctor or nurse immediately: swelling of the face, hands, feet, lips, tongue or throat difficulty swallowing or breathing. When used with methotrexate or 5-fluorouracil The following side effects have been reported at the approximate frequencies shown: Uncommon (affecting fewer than one person in 100 but more than one person in 1000) fever. Rare (affecting fewer than one person in 1000 but more than one in 10,000) stomach problems difficulty sleeping, agitation, depression increased number of fits in patients with epilepsy. Very Rare (affecting fewer than one person in 10,000) allergic reactions, rashes, itching, shortness of breath. When used with 5-fluorouracil alone The following side effects may occur at the approximate frequencies shown: Very Common (affecting more than one person in 10) feeling sick or being sick diarrhoea swelling of the lining of the nose, mouth, vagina or anus. Reporting of side effects

4 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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: ; Fax: Website: medsafety@hpra.ie. By reporting side effects you can help provide more information on the safety of this medicine. 5. HOW TO STORE LEUCOVORIN-TEVA Keep out of the reach and sight of children. Leucovorin-Teva is a clear yellow concentrate for solution for infusion. If the solution is cloudy or particles are visible the solution should be discarded. Store in a refrigerator at 2-8 C. Once aseptically diluted, the solution must be used within 24 hours of preparation when stored in a refrigerator at 2-8 C. The solution must be used within 8 hours of preparation when stored at room temperature (below 25 C). Keep the vial in the outer carton in order to protect from light. Do not use Leucovorin-Teva after the expiry date that is stated on the outer packaging. The expiry date refers to the last day of that month. 6. FURTHER INFORMATION What Leucovorin-Teva contains The active ingredient is calcium folinate. The other ingredients are sodium chloride, sodium hydroxide, hydrochloric acid, water for injections. What Leucovorin-Teva looks like and contents of the pack Leucovorin-Teva is a sterile concentrate for solution for infusion, containing folinic acid 10 mg/ml (as calcium folinate) and is available as an injection in vials of 5 ml (50 mg/vial), 10 ml (100 mg/vial), 20 ml (200 mg/vial), 30 ml (300 mg/vial) and 50 ml (500 mg/vial) capacities. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, P.O. Box 43028, 3540 AA Utrecht, The Netherlands. Manufacturer: Teva Pharmaceuticals Works Private Limited Company H-2100 Gödöllő, Táncsics Mihály út 82, Hungary Pharmachemie B.V. P.O. Box 552 Swensweg 5

5 2003 RN Haarlem The Netherlands Marketing Authorisation Number: PA 749/1/1 This leaflet was last revised in July 2015