Pamidronate, NL/H/4442/001, 09.03.20 Package leaflet: Information for the user Pamidronate Disodium Teva 3 mg/ml concentrate for solution for infusion Pamidronate disodium Read all of this leaflet carefully before you are given this medicine because it contains important information for you. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or nurse. If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet: 1. What Pamidronate Disodium Teva is and what it is used for 2. What you need to know before you are given Pamidronate Disodium Teva 3. How Pamidronate Disodium Teva is given 4. Possible side effects 5. How to store Pamidronate Disodium Teva 6. Contents of the pack and other information 1. What Pamidronate Disodium Teva is and what it is used for The active ingredient in Pamidronate Disodium Teva is called pamidronate disodium. Pamidronate Disodium Teva belongs to a group of medicines called the bisphosphonates which can help to regulate the amount of calcium in the blood. Pamidronate Disodium Teva is used to: reduce high levels of calcium in the blood caused by cancers reduce bone loss in patients with breast cancer that has spread to the bones reduce bone loss and fractures in patients with multiple myeloma (a tumour of bone marrow cells). 2. What you need to know before you are given Pamidronate Disodium Teva You must not be given Pamidronate Disodium Teva: if you are allergic to pamidronate disodium, any other bisphosphonates e.g. alendronic acid, or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Talk to your doctor or nurse before you are given Pamidronate Disodium Teva: if you are on a low sodium diet if you are taking any other medicines to lower calcium in your blood if you have fits if you have had thyroid surgery if you have a reduced number of red blood cells (anaemia), white blood cells (leukopenia) or platelets (thrombocytopenia) if you have kidney problems, or kidney impairment if you have heart problems if you have any liver problems if you have calcium or vitamin D deficiency if you have a feverish illness e.g. flu or something similar. if you had or have pain, swelling or numbness of the jaw, a feeling of heaviness in the jaw or loosening of a tooth. Your doctor may recommend a dental examination before you start treatment with Pamidronate Disodium Teva. 1 Pamidronate, NL/H/4442/001, 09.03.20 If you are having dental treatment or are due to undergo dental surgery, tell your dentist that you are being treated with Pamidronate Disodium Teva and inform your doctor about your dental treatment. While being treated with Pamidronate Disodium Teva, you should maintain good oral hygiene (including regular teeth brushing) and receive routine dental check-ups. Contact your doctor and dentist immediately if you experience any problems with your mouth or teeth such as loose teeth, pain or swelling, non-healing of sores or discharge, as these could be signs of a condition called osteonecrosis of the jaw. Patients who are undergoing chemotherapy and/or radiotherapy, who are taking steroids, who are undergoing dental surgery, who do not receive routine dental care, who have gum disease, who are smokers, or who were previously treated with a bisphosphonate (used to treat or prevent bone disorders) may have a higher risk of developing osteonecrosis of the jaw. There is a risk of fracture of the thigh bone (femur), particularly in patients receiving long-term treatment for osteoporosis (see section 4 Possible side effects). You must make sure that you do not become dehydrated while you are being treated with Pamidronate Disodium Teva. Talk to your doctor to make sure you are aware how much you must drink. Your doctor will want to check your progress by carrying out a number of tests e.g. blood tests and kidney function tests. Remind your doctor that you are taking Pamidronate Disodium Teva before they do any tests. The results may be affected by Pamidronate Disodium Teva. Children and adolescents Pamidronate Disodium Teva is not suitable for treating children. Other medicines and Pamidronate Disodium Teva Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. In particular, tell your doctor or nurse if you are taking any of the following: any other bisphosphonate medicines e.g. alendronic acid or risendronate sodium any medicines that reduce levels of calcium such as calcitonin any other medicines that can affect the kidneys thalidomide (used to treat some cancers) as the risk of kidney problems may be increased. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before being given this medicine. If you are pregnant or are planning to become pregnant, you should not be given Pamidronate Disodium Teva except in cases of life-threatening hypercalcaemia. Breast-feeding during treatment with Pamidronate Disodium Teva is not recommended. Driving and using machines Pamidronate Disodium Teva may cause sleepiness or dizziness. If you are affected, DO NOT drive or operate machinery. Pamidronate Disodium Teva contains sodium This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium- free’. 3. How Pamidronate Disodium Teva is given 2 Pamidronate, NL/H/4442/001, 09.03.20 The medicine will be given to you very slowly into a vein via a drip (intravenous infusion). Your medicine will be administered by a doctor or nurse, who will prepare the infusion. The infusion will take from one to several hours depending on the dose. Your doctor will decide how many infusions you will need and how often they will be given. During treatment you will have blood tests and may be asked to provide urine samples. Recommended dose: The dose given to you will depend upon your medical condition, the levels of calcium in your blood and how well your kidneys are working. For hypercalcaemia: 15-90 mg given as a single or several infusions over 2-4 days. For bone diseases and bone pain: 90 mg every 4 weeks. In some patients the dose may be given every 3 weeks at the same time as chemotherapy. Your doctor may also have prescribed treatment with Calcium and Vitamin D at the same time as Pamidronate Disodium Teva. If you are given more Pamidronate Disodium Teva than you should As this medicine will be given to you by a doctor or nurse whilst you are in hospital it is unlikely that you will be given too little or too much. If nevertheless you have received doses higher than those recommended you will be carefully monitored by your doctor or nurse. If you think you have been given too much Pamidronate Disodium Teva, tell your doctor or nurse straight away. If you are not given Pamidronate Disodium Teva As this medicine will be given to you whilst you are in hospital it is unlikely that you will miss a dose. If nevertheless you are not given your dose or think you may have missed a dose, you should ask your doctor or nurse immediately. If you have any further questions on the use of this medicine, ask your doctor or nurse. 4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects are usually mild and disappear as treatment continues. Serious side effects: Tell your doctor immediately if the following happens: Very common: may affect more than 1 in 10 people flu-like symptoms and a mild fever (increase in body temperature) which occurs within the first 48 hours of treatment and usually lasts no more than 24 hours. If these symptoms last for longer, tell your doctor. Uncommon: may affect up to 1 in 100 people an allergic reaction causing a sudden itchy rash (hives), wheezing and coughing, swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing). Rare: may affect up to 1 in 1,000 people unusual fracture of the thigh bone particularly in patients on long-term treatment for osteoporosis may occur rarely. Contact your doctor if you experience pain, weakness or discomfort in your thigh, hip or groin as this may be an early indication of a possible fracture of the thigh bone. 3 Pamidronate, NL/H/4442/001, 09.03.20 Some patients notice an increase in bone pain soon after starting treatment. This usually improves after a few days, but if it does not, tell your doctor. These are serious side effects. You may need urgent medical attention. Other side effects: Very common: may affect more than 1 in 10 people fever, shivering, tiredness and flushing changes in blood test results (including low calcium and low phosphate levels). Common: may affect up to 1 in 10 people pain, redness or swelling at the infusion site, including inflammation of a vein which can sometimes lead to a blood clot skin rash, unusual bleeding or unexplained bruising joint, muscle, bone or generalised pain feeling sick or being sick, loss of appetite, stomach pain, inflammation of the stomach lining (gastritis) which may cause pain and sickness, constipation or diarrhoea headache, tiredness, difficulty sleeping conjunctivitis low calcium levels in the blood, leading to muscle cramps/spasms and pins and needles (tingling/numbness in the hands and feet) high blood pressure reduction in the number of white blood cells (leucopenia, lymphocytopenia), which makes infections more likely reduction in red blood cells (anaemia) which can cause weakness or breathlessness changes in blood test results (including low magnesium, low potassium and increased blood creatinine levels).