PATIENT INFORMATION LEAFLET

Transcription

1 PATIENT INFORMATION LEAFLET Page 1 of 7

2 PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER Aciclovir Tablets USP 400 mg * Aciclovir 400 mg Tablets 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 health care provider. - This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your health care provider. In this leaflet: 1. What Aciclovir Tablets USP 400 mg are and what they are used for 2. What you need to know before you take Aciclovir Tablets USP 400 mg 3. How to take Aciclovir Tablets USP 400 mg 4. Possible side effects 5. How to store Aciclovir Tablets USP 400 mg 6. Further information 1. WHAT ACICLOVIR TABLETS USP 400 MG ARE AND WHAT THEY ARE USED FOR Aciclovir Tablets USP 400 mg is an antiviral medicine. Antivirals stop the growth of viruses which cause infections. The active substance is aciclovir. If you have Human Immunodeficiency Virus (HIV) infection/aids, Aciclovir Tablets USP 400 mg can be used to: Treat herpes simplex virus infections of the skin and mucous membranes e.g. cold sores and genital herpes (except in newborns or in children whose immune system is weak and not working properly) Treat chickenpox (varicella infection) and shingles (herpes zoster infection) Stop herpes simplex infections returning after you have had them Stop you from getting herpes simplex infections of the skin and mucous membranes e.g. cold sores and genital herpes if your immune system is weak and not working properly 2. BEFORE YOU TAKE ACICLOVIR TABLETS USP 400 MG Do not take Aciclovir Tablets USP 400 mg if you are allergic (hypersensitive) to aciclovir, valaciclovir, or any of the other ingredients of Aciclovir Tablets USP 400 mg (see section 6: Contents of the pack and other information). If you are not sure if any of the above apply to you, talk to your health care provider before taking this medicine. Viruses causing herpes and varicella infections can be transmitted through body contact. To avoid transmitting the infections to other parts of your body or to other people: wash your hands often, avoid contact with lesions or rash, avoid intercourse, when symptoms of infection are present, even if you are taking medicines to treat them. 1 Trade names are not prequalified by WHO. This is the national medicines regulatory authority's responsibility. Throughout this WHOPAR the proprietary name is given as an example only. Page 2 of 7

3 Take special care with Aciclovir Tablets USP 400 mg and talk to your health care provider before taking these tablets if: - your kidneys are not functioning properly - you are elderly (over 65 years of age). Your health care provider may check if your kidneys function properly and keep functioning properly - you have nervous system abnormalities To avoid dehydration, it is important to drink plenty of water whilst taking aciclovir tablets, especially if you are elderly or take high doses of aciclovir. Taking other medicines Tell your health care provider if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is because Aciclovir Tablets USP 400 mg can affect the way some medicines work. Also some other medicines can affect the way Aciclovir Tablets USP 400 mg work. In particular tell your health care provider if you are taking any of the following medicines: - emtricitabine, entecavir, used to treat HIV (Human Immunodeficiency Virus) - tenofovir disoproxil, used to treat HIV or Hepatitis B - entecavir, used to treat Hepatitis B - probenecid, used to treat gout - cimetidine, used to treat stomach ulcers - cyclosporine, used after organ transplantation - theophylline, used in patients with breathing difficulties such as asthma 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 health care provider for advice before taking this medicine. Driving and using machines Aciclovir tablets may make you feel drowsy or sleepy. If they affect you in this way do not drive, operate machinery or do anything that requires you to be alert. 3. HOW TO TAKE ACICLOVIR TABLETS USP 400 MG Always take your medicine exactly as your health care provider has told you. Your health care provider will inform you accordingly. You should check with your health care provider if you are not sure. You can take your medicine with food or between meals. Swallow the tablets with water. For children younger than 6 years who have difficulties swallowing tablets, you can crush the tablets and add them to a small amount of semi-solid food or liquid. Have the child eat or drink the mixture immediately. It is important to drink plenty of water while you are being treated with Aciclovir Tablets USP 400 mg, in particular if your kidneys are not working properly or if you are over 65 years of age. The dose that you should take will depend on what you have been given aciclovir for. Your health care provider will discuss this with you. Adults To treat herpes simplex infections of the skin and mucous membranes e.g. cold sores and genital herpes: 400 mg (1 tablet) three times daily, approximately every 8 hours, for 5-10 days To treat chickenpox (varicella infection) and shingles (herpes zoster infection): 800 mg (2 tablets) five times daily, approximately every 4 hours and leaving out the night time dose (for example: 7am, 11am, 3pm, 7pm and 11pm), for 7 days It is important to take the first dose as soon as possible after the first signs of infection. To stop herpes simplex infections returning after you have had them: Page 3 of 7

4 The usual dose is 400 mg twice times daily, approximately every 12 hours. Your health care provider may prescribe you a different dose or fewer doses per day. To stop you from getting herpes simplex infections if your immune system is weak and not working properly: The usual dose is 400 mg twice times daily, approximately every 12 hours. Your health care provider may prescribe you a different dose. Your health care provider will tell you how long you should take this medicine. Children To treat herpes simplex infections of the skin and mucous membranes: Children 2 years and older should take the same doses as adults. Children under 2 years should take half of the adult doses. To treat chickenpox (varicella infection): 6 years and over: 800 mg (2 tablets) four times daily 2-5 years: 400 mg (1 tablet) four times daily Other formulations containing less aciclovir are available for dosing for children aged <2 years. Children should take aciclovir for 5 days. It is important to take the first dose as soon as possible after the first signs of infection. Your health care provider will tell you how long you should take this medicine. To stop children from getting herpes simplex infections if their immune system is weak and not working properly: Children 2 years and older should take the same doses as adults. Your health care provider will tell you how long your child should take this medicine. Other formulations containing less aciclovir are available for dosing for children aged <2 years. Patients with kidney problems or patients over 65 years of age If you have kidney problems, your health care provider may prescribe you a lower dose of Aciclovir Tablets USP 400 mg. If you are over 65 years of age, your kidneys may work less well. In this case, your health care provider may also prescribe you a lower dose. If you take more Aciclovir Tablets USP 400 mg than you should If you accidentally take too many tablets, immediately contact your health care provider. If you have taken too much aciclovir, you may feel or be sick, or feel confused. If you forget to take Aciclovir Tablets USP 400 mg It is important not to miss a dose. If you miss a dose of this medicine, contact your health care provider for advice. Do not take a double dose to make up for a forgotten tablet. If you vomit less than 1 hour after taking this medicine, take another dose. You do not need to take another dose if you were sick more than 1 hour after taking Aciclovir Tablets USP 400 mg. If you have any further questions on the use of this medicine, ask your health care provider. 4. POSSIBLE SIDE EFFECTS Like all medicines, Aciclovir Tablets USP 400 mg can cause side effects, although not everybody gets them. Stop taking Aciclovir Tablets USP 400 mg and inform your health care provider immediately if you have a severe allergic reaction (may affect up to 1 in 1,000 people). Page 4 of 7

5 Signs may include: - rash, itching or hives on your skin - swelling of the face, lips, tongue, throat, or other parts of your body - difficulty breathing, shortness of breath, wheezing - collapse In addition, if any of the following side effects gets serious, or if you notice any other unexpected or unusual symptoms not listed in this leaflet, please tell your health care provider. Common side effects (may affect up to 1 in 10 people): - dizziness - headache - feeling or being sick - diarrhoea - stomach pain - skin rashes (including skin rashes after exposure to light (photosensitivity) - itching - tiredness - fever Uncommon side effects (may affect up to 1 in 100 people) - pale or red irregular raised patches with severe itching (hives) - hair loss Rare side effects (may affect up to 1 in people) - blood tests indicating changes to the working of the liver and kidneys Very Rare side effects (may affect up to 1 in people) - reduced numbers of red blood cells (anaemia), which can make the skin pale and cause weakness and breathlessness - reduced numbers of blood platelets (which help to stop any bleeding) - reduced numbers of white blood cells (cells that help defend against infections) - feeling agitated or confused - inability to think or judge clearly - hallucinations (seeing or hearing things that aren t there) - fits - shaking or tremors - feeling unusually sleepy or drowsy - unsteadiness when walking and lack of coordination - difficulty speaking - unconsciousness (coma) - paralysis of part or all of your body - inflammation of the liver (hepatitis) and yellowing of your skin and whites of your eyes (jaundice) - kidney problems - pain in your lower back, the kidney area of your back or just above your hip (renal pain) Side effects of which it is not known how often they may occur - blood in urine - red rash on the skin of the hands and arms which may also involve the mouth (erythema multiforme) Page 5 of 7

6 - potentially life-threatening reactions with fever, flu-like effects and blistering or peeling of the skin which may involve the mouth, eyes and genitalia (Stevens-Johnson syndrome, toxic epidermal necrolysis) - swollen and painful lymph nodes - rash with purple spots because of damage to small blood vessels - aggressive behaviour - confusion, concentration problems, disorganized behaviour (delirium) - tingling ( pins and needles ) or numbness in your hands and feet - swelling, pain and cramps in the digestive system - muscle pain Reporting of side effects If you get any side effects, talk to your health care provider. This includes any possible side effects not listed in this leaflet. By reporting side effects, you can help provide more information on the safety of this medicine. 5. HOW TO STORE ACICLOVIR TABLETS USP 400 MG Keep out of the reach and sight of children. Do not use Aciclovir Tablets USP 400 mg after the expiry date stated on the label. The expiry date refers to the last day of the month. Do not store above 30 C. Store in the original package. Protect from moisture. 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 Aciclovir Tablets USP 400 mg contains The active ingredient is aciclovir. The other ingredients are: Microcrystalline cellulose, Sodium starch glycolate, Colloidal silicon dioxide, Ferric oxide, Povidone, Magnesium stearate What Aciclovir Tablets USP 400 mg looks like and content of the pack Pink, shield-shaped, flat tablets, debossed with J on one side and 49 in a triangle on the other side. No score-line. 100 tablets are packed in 120cc HDPE container closed with 38mm child resistant plastic caps with pulp liners along with purified cotton 12 gram/yard. 500 tablets are packed in 500cc HDPE container closed with 53mm continuous thread plastic caps with pulp liners along with absorbent cotton 12 gram/yard. Supplier Hetero Labs Limited Hetero Corporate, 7-2-A2 Industrial Estates Sanath Nagar Hyderabad Telangana India Tel: / 24/25 /26 /27/ / 7272 / 7744 Manufacturer Hetero Labs Limited, Unit V Sy No. 439, 440, 441 & 458 APIIC Formulation SEZ Polepally village, Jadcherla Mandal Mahaboob Nagar District Telangana India Tel: contact@heterodrugs.com Page 6 of 7

7 Fax: / contact@heterodrugs.com For any information about this medicinal product, please contact the supplier. This leaflet was last revised in April Detailed information on this medicine is available on the World Health Organization (WHO) web site: Page 7 of 7