PATIENT INFORMATION LEAFLET

Transcription

1 PATIENT INFORMATION LEAFLET Page 1 of 8

2 PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER Stavudine Capsules 30 mg * Stavudine Read all of this leaflet carefully before you start taking this medicine. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, health care provider 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. In this leaflet: 1. What Stavudine Capsules 30 mg is and what it is used for 2. Before you take Stavudine Capsules 30 mg 3. How to take Stavudine Capsules 30 mg 4. Possible side effects 5. How to store Stavudine Capsules 30 mg 6. Further information 1. WHAT STAVUDINE CAPSULES 30 MG IS AND WHAT IT IS USED FOR Stavudine Capsules 30 mg belongs to a group of antiviral medicines, also known as antiretrovirals, called nucleoside analogue reverse transcriptase inhibitors (NRTIs). These are used to treat Human Immunodeficiency Virus (HIV) infection. Stavudine Capsules 30 mg is used in antiretroviral combination therapy for the treatment of HIV infection. Stavudine Capsules 30 mg reduces the amount of HIV virus in your body and keeps it at a low level. It also increases CD4 cell counts. CD4 cells are a type of white blood cell that plays an important role in maintaining a healthy immune system to help fight infection. Response to treatment with Stavudine Capsules 30 mg varies between patients. Your doctor or health care provider will be monitoring the effectiveness of your treatment. 2. BEFORE YOU TAKE STAVUDINE CAPSULES 30 MG Do not take Stavudine Capsules 30 mg if: You are allergic (hypersensitive) to stavudine or any of the other ingredients of Stavudine Capsules 30 mg (see: What Stavudine Capsules 30 mg contains). Take special care with Stavudine Capsules 30 mg It is important that your doctor or health care provider knows about all your symptoms even when you think they are not related to HIV infection. Before using this medicine, you should have told your doctor or health care provider: if you suffer from kidney disease or liver disease (such as hepatitis), if you have had peripheral neuropathy (persistent tingling or numbness or pain in the feet and/or hands) if you have suffered from pancreatitis (inflammation of the pancreas) if you have diabetes. * Trade names are not prequalified by WHO. This is under local DRA responsibility. Throughout this WHOPAR the proprietary name is given as an example only. Page 2 of 8

3 Lactic acidosis Females, particularly if very overweight, and patients with liver disease may be more at risk of getting a rare, but serious side effect called lactic acidosis, a build up of lactic acid in the body. If lactic acidosis occurs, it usually develops after a few months of treatment. Deep rapid breathing, drowsiness, and non specific symptoms such as nausea, vomiting and stomach pain, might indicate the development of this condition (see section 4). Your doctor or health care provider will monitor you for any signs that you may be developing lactic acidosis, while you are being treated with Stavudine Capsules 30 mg. Fat distribution Redistribution, accumulation or loss of body fat may occur in patients receiving combination antiretroviral therapy. Some NRTIs, such as stavudine, have been associated with a loss of body fat (lipoatrophy). Contact your doctor or health care provider if you notice loss of fat from legs, arms and face, increased fat in the belly (abdomen), breast enlargement and fatty lumps on the back of the neck ('buffalo hump'). Peripheral neuropathy Stavudine Capsules 30 mg may cause peripheral neuropathy and paraesthesia, a persistent numbness, tingling or pain in the feet and / or hands and or muscle weakness. Please inform your doctor or health care provider as soon as possible when you notice any of these signs. Pancreatitis Inflammation of the pancreas (pancreatitis) has been reported in some patients taking stavudine (see Undesirable effects ). Your doctor or health care provider will monitor you for signs and symptoms of pancreatitis. Liver disease/hepatitis Please talk to your doctor or health care provider if you have a history of liver disease. Patients with chronic hepatitis B or C and treated with antiretroviral agents are at increased risk for severe and potentially fatal liver adverse events and may require blood tests for control of liver function. Immune Reactivation Syndrom In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-hiv treatment is started. It is believed that these symptoms are due to an improvement in the body's immune response, enabling the body to fight infections that may have been present with no obvious symptoms. If you notice any symptoms of infection, please inform your doctor or health care provider immediately. Bone problems Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue) Your risk of developing this disease may be higher - if your immune system is severely compromised - if you have been taken combination antiretroviral therapy for a long time - if you drink alcohol regularly - if you use corticosteroids (certain medicines suppressing your immune system) - if you are overweight If you notice joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement, inform your doctor or health care provider. Page 3 of 8

4 General You will need to take Stavudine Capsules 30 mg every day. This medicine helps to control your condition, but it is not a cure for HIV infection. You may continue to develop other infections and other illnesses associated with HIV disease. You should keep in regular contact with your doctor or health care provider. Do not stop taking your medicine without first talking to your doctor or health care provider. Treatment with Stavudine Capsules 30 mg has not been shown to eliminate the risk of passing HIV infection on to others by sexual contact or by blood transfer. You should continue to use appropriate precautions to prevent this. Taking other medicines Please tell your doctor, health care provider or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. These may affect the action of Stavudine Capsules 30 mg or Stavudine Capsules 30 mg may affect their action. Stavudine Capsules 30 mg should not be taken with zidovudine, didanosine or ribavirin (other antivirals). Stavudine Capsules 30 mg may also interact with doxorubicin, an anticancer medicine and hydroxyurea. Taking Stavudine Capsules 30 mg with food and drink Stavudine Capsules 30 mg may be taken with or without food. Pregnancy If you become pregnant, or are planning to become pregnant, you must contact your doctor or health care provider to discuss the potential adverse effects and the benefits and risks of your antiretroviral therapy to you and your child. Be sure to tell your doctor immediately if you are or may be pregnant. Breastfeeding Stavudine is probably excreted into breast milk. If you want to breastfeed your baby you should ask a doctor or healthcare provider for advice on the risks and benefits. Driving and using machines No studies on the effects of stavudine on the ability to drive and use machines have been performed. However, you should take into account the state of your health and the possible side effects of stavudine before considering driving or using machines. Important information about some of the ingredients of Stavudine Capsules 30 mg If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. Page 4 of 8

5 3. HOW TO TAKE STAVUDINE CAPSULES 30 MG Always take Stavudine Capsules 30 mg exactly as your doctor or health care provider told you. You should check with your doctor, health care provider or pharmacist if you are not sure. The daily dose for adults and children whose body weight is 25 kg or more: Take one capsule (30 mg) twice daily with approximately 12 hours between each dose. Stavudine Capsules 30 mg is not recommended for use in children weighing less than 25 kg, as appropriate dose reductions for the weight of the child cannot be made. Stavudine Capsules 30 mg may be taken with or without food. If you have problems swallowing capsules you could carefully open the capsule and mix its contents with some food. If you have a kidney problem, your dose may have to be adjusted. Please follow the instructions of your doctor or health care provider. If you take more Stavudine Capsules 30 mg than you should If you have taken too many capsules or if someone accidentally swallows some, there is no immediate danger. However, you should contact your doctor or health care provider, or the nearest hospital emergency department for further advice. If you forget to take Stavudine Capsules 30 mg If you accidentally miss a dose, take it as soon as you remember, and then continue as before. If your next dose is due in less than 6 hours, do not take the forgotten dose, but take the next regular dose when it is due. Then simply take your normal dose when the next one is due. Do not take a double dose to make up for forgotten individual doses. If you have any further questions on the use of this product, ask your doctor or health care provider or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Stavudine Capsules 30 mg can cause side effects, although not everybody gets them. When treating HIV infection, it is not always possible to differentiate between unwanted effects caused by Stavudine Capsules 30 mg, or those caused by any other medicines you may be taking at the same time, or by the HIV disease. For this reason, it is important that you inform your doctor or health care provider of any change in your health. Short-term adverse reactions to combination antiretroviral therapy are common. After you start taking Stavudine Capsules 30 mg short lasting reactions like pain in upper abdomen, nausea, diarrhoea and headache may occur; these reactions are usually mild and disappear within a few weeks. Common long-term side effects include neuropathy, changes in fat distribution and metabolic abnormalities. Page 5 of 8

6 Common side effects ( in between 1 in 1,000 and 1 in 100 patients treated): - changes in distribution of body fat (e.g. loss of fat from legs, arms and face, increased fat in the abdomen ("belly") and around internal organs, breast enlargement and fatty lumps on the back of the neck ("buffalo hump"). Loss of body fat has been shown to be not fully reversible after discontinuation of stavudine. Your doctor should monitor for clinical signs and symptoms of changes in your body shape.tell your doctor when you notice any changes in your body shape or loss from fat of your legs, arms, and face. The cause and long-term health effects of these conditions are not known at this time. - Peripheral neuropathy and paraesthesia (persistent numbness or tingling or pain in the feet and/or hands), usually reversible upon discontinuation - rash, (red, raised or itchy) - nausea, stomach pain, diarrhoea, dyspepsia - headache, fatigue, dizziness, sleepiness, difficulty sleeping, abnormal dreams, abnormal thinking, somnolence, depression - disturbance of fat metabolism (increased fats in the blood) and resistance to insulin and decreased liver function (increased liver enzymes), increased blood concentrations of lactic acid, of certain liver and pancreatic enzymes Uncommon side effects (in between 1 in 1,000 and 1 in 100 patients treated): - inflammation of the pancreas (pancreatitis), - a build up of lactic acid in the body, known as lactic acidosis, possibly involving loss of appetite, fatty liver, liver failure and/or motor weakness (see Take special care with Stavudine Capsules 30 mg ) - loss of appetite, vomiting, - inflammation of the liver (hepatitis), yellowing of the skin - breast enlargement - cough - feeling anxious, emotional lability - urticaria, joint pain, muscle pain, general weakness (asthenia) Rare side effects (in between 1 in 10,000 and 1 in 1,000 patients treated) - low red blood cell count (anaemia). If the number of red blood cells is reduced you may have symptoms of tiredness or breathlessness. - hyperglycaemia (high sugar levels in the blood) - hepatic steatosis (fat in the liver) Very rare (affects less than 1 in 10,000 patients treated) - neutropenia (low white blood cell count) and decrease of platelets (blood cells important for blood clotting). If you have a low platelet count you may notice that you bruise more easily and a reduction in your white blood cell count can make you more prone to infections. - development of diabetes mellitus - motor weakness (most often reported in the setting of symptomatic hyperlactataemia or lactic acidosis syndrome) - liver failure, Frequency not known: The following side effects have been reported in patients treated with medicines of the group of NRTIs, to which also stavudine belongs. However, frequency estimates for these effects are not available: - osteonecrosis (death of bone tissue) - immune reactivation syndrome (see Take special care with Stavudine Capsules 30 mg ). If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or health care provider or pharmacist as soon as possible. Page 6 of 8

7 5. HOW TO STORE STAVUDINE CAPSULES 30 MG Keep out of the reach and sight of children. Store below 25º C in the original container, protected from moisture. Do not use Stavudine Capsules 30 mg after the expiry date (exp) which is stated on the label. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6. FURTHER INFORMATION What Stavudine Capsules 30 mg contains The active ingredient is 30 mg stavudine. The other ingredients are microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, magnesium stearate and hard gelatine capsule shell. The capsule shell contains gelatine, titanium dioxide and sodium lauryl sulphate. Blue, red and black edible inks are also used. What Stavudine Capsules 30 mg looks like and contents of the pack Off-white to cream coloured, opaque, hard gelatine, self locked capsules of size 2 imprinted with 30 (blue) on cap and 30 (black) on body containing white to off-white powder available in blister packs or bottles of 60 capsules. Supplier and Manufacturer Ranbaxy Laboratories Limited Paonta Sahib District Sirmour Himachal Pardesh India. Phone No. ( ) , , , Fax No. - ( ) , address- ramesh.parekh@ranbaxy.com For any information about this medicinal product, please contact the local representative of the supplier: Mathys Kruger Medical Director Europe, CIS & Africa 6 th Floor CP House Uxbridge Road Ealing London W5 5TL United Kingdom +44(0) address: thys.kruger@ranbaxy.com Page 7 of 8

8 Dr. Saikiran Leekha M.D. Medical Advisor, Asia Paciffic and Middle-East Ranbaxy Laboratories Limited Plot No. 90, Sector 32 Gurgaon (Haryana), India Tel: Fax: address: Dr. Paurus Mehelli Irani Head- Medical Services, Ranbaxy Laboratories Ltd., Plot No.90, Sector-32, Gurgaon (Haryana) India Telephone No. : address: paurus.irani@ranbaxy.com This leaflet was last approved in March 2011 Detailed information on this medicine is available on the World Health Organization (WHO) web site: Page 8 of 8