PATIENT INFORMATION LEAFLET Page 1 of 7
PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER Aciclovir 200 mg Tablets 1 Aciclovir 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 200 mg Tablets are and what they are used for 2. What you need to know before you take Aciclovir 200 mg Tablets 3. How to take Aciclovir 200 mg Tablets 4. Possible side effects 5. How to store Aciclovir 200 mg Tablets 6. Further information 1. WHAT ACICLOVIR 200 MG TABLETS ARE AND WHAT THEY ARE USED FOR Aciclovir 200 mg Tablets is 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 200 mg Tablets 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 200 MG TABLETS Do not take Aciclovir 200 mg Tablets if you are allergic (hypersensitive) to aciclovir, valaciclovir, or any of the other ingredients of Aciclovir 200 mg Tablets (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, 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
avoid intercourse, when symptoms of infection are present, even if you are taking medicines to treat them. Take special care with Aciclovir 200 mg Tablets 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 200 mg Tablets can affect the way some medicines work. Also some other medicines can affect the way Aciclovir 200 mg Tablets work. In particular tell your health care provider if you are taking any of the following medicines: - emtricitabine,, 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 - ciclosporin, 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 200 MG TABLETS 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 200 mg Tablets, 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: 200 mg (1 tablet) five times daily, approximately every 4 hours and leaving out the night time dose (for example: 7am, 11am, 3pm, 7pm and 11pm), for 5-10 days; or 400 mg (2 tablets) three times daily, approximately every 8 hours, for 5-10 days Page 3 of 7
To treat chickenpox (varicella infection) and shingles (herpes zoster infection): 800 mg (4 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: The usual dose is 200 mg (1 tablet) four times daily, approximately every 6 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 200 mg (1 tablet) four times daily, approximately every 6 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 (4 tablets) four times daily 2-5 years: 400 mg (2 tablets) four times daily Under 2 years: 200 mg (1 tablet) four times daily 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. 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. Children under 2 years should take half of the adult doses. Your health care provider will tell you how long your child should take this medicine. 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 200 mg Tablets. 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 200 mg Tablets 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 200 mg Tablets 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 200 mg Tablets. 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 200 mg Tablets can cause side effects, although not everybody gets them. Page 4 of 7
Stop taking Aciclovir 200 mg Tablets and inform your health care provider immediately if you have a severe allergic reaction (may affect up to 1 in 1,000 people). 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 10 00 people) - blood tests indicating changes to the working of the liver and kidneys Very Rare side effects (may affect up to 1 in 10 000 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
- 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 200 MG TABLETS Keep out of the reach and sight of children. Do not use Aciclovir 200 mg Tablets after the expiry date stated on the label or carton. The expiry date refers to the last day of the month. Do not store above 30 C. Store tablets in the original blister in the provided carton. Medicines should not be disposed of via wastewater or household waste. Ask your health care provider how to dispose of medicines no longer required. These measures will help to protect the environment. 6. FURTHER INFORMATION What Aciclovir 200 mg Tablets contains The active ingredient is aciclovir. The other ingredients are: Croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyvinyl pyrrolindone (povidone) and sodium lauryl sulfate. What Aciclovir 200 mg Tablets looks like and content of the pack Aciclovir 200 mg Tablets are white to off-white, oval tablets. They are marked with I on left side of the break line and M on right side of the break line on one side of the tablet and have a break line on the other side to help you half them. The primary packs are blister cards of 10 tablets (comprised of PVC-Aluminium and PVC/PVDC- Aluminium foil). Each blister card is packed in a carton. Pack size: 10 tablets. Supplier Mylan Laboratories Limited Plot No.564/A/22, Road No. 92, Jubilee Hills Hyderabad 500096 Telangana India Manufacturer Mylan Laboratories Limited Plot No. H-12 & H-13 MIDC, Waluj Industrial Area Aurangabad. 431136 Maharashtra State India For any information about this medicinal product, please contact the supplier. This leaflet was last revised in January 2018. Detailed information on this medicine is available on the World Health Organization (WHO) web site: https://extranet.who.int/prequal/ Page 6 of 7
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