Adco Acyclovir 200 mg Tablets

ADCO ACYCLOVIR 200 mg belongs to group of medicines called antivirals. ADCO ACYCLOVIR 200 mg is used for the treatment of the following:

• Herpes simplex infections of the skin and mucous membranes including initial and recurrent genital Herpes simplex virus infections.
• Suppression of recurrent Herpes simplex infections in immunocompetent patients.
• Prophylaxis of Herpes simplex infections in immunocompromised patients.
• Treatment of Herpes zoster if the lesions are not older than 72 hours.
• Treatment of Varicella zoster (chickenpox) within 24 hours after appearance of the typical chickenpox rash.

Do not take ADCO ACYCLOVIR 200 mg:

• If you are hypersensitive (allergic) to acyclovir, valaciclovir or any of the other ingredients of ADCO ACYCLOVIR 200 mg (listed in section 6).
• If you are pregnant or breastfeeding your baby.

Warnings and precautions

Take special care with ADCO ACYCLOVIR 200 mg:

• If you are elderly or have kidney problems, you may have a higher risk of side - effects and your doctor may watch you more closely.
• If you have kidney problems. Your doctor may prescribe a lower dose of ADCO ACYCLOVIR 200 mg.
• It is important that you drink plenty of water while taking high doses of ADCO ACYCLOVIR 200 mg.
• Serious skin reactions such as Drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in patients receiving ADCO ACYCLOVIR 200 mg. Combination of symptoms such as fever, severe rash, peeling skin, swelling of the face, swollen lymph glands, flu-like feeling, yellow skin or eyes, shortness of breath, dry cough, chest pain or discomfort, feel thirsty, urinating less often, less urine can be seen. If you experience any signs of serious skin reactions such as swelling, itching, red severe rash, stop using ADCO ACYCLOVIR 200 mg immediately and contact your doctor (see Section 4).

Other medicines and ADCO ACYCLOVIR 200 mg

Always tell your healthcare provider if you are taking any other medicine. (This includes all complementary or traditional medicines.) In particular tell your doctor or pharmacist if you are taking any of the following medicines:

• probenecid, used to treat gout
• cimetidine, used to treat stomach ulcers
• mycophenolate mofetil, used to stop your body rejecting transplanted organs.
• theophylline, used to treat asthma.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other healthcare provider for advice before using ADCO ACYCLOVIR 200 mg.

Driving and using machines

ADCO ACYCLOVIR 200 mg can cause dizziness. You should not drive or operate machinery if you experience this effect. It is not always possible to predict to what extent ADCO ACYCLOVIR 200 mg may interfere with the daily activities of a patient. Patients should ensure that they do not engage in the above activities until they are aware of the measure to which ADCO ACYCLOVIR 200 mg affects them.

ADCO ACYCLOVIR 200 mg contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking ADCO ACYCLOVIR 200 mg.

ADCO ACYCLOVIR 200 mg contains sodium. ADCO ACYCLOVIR 200 mg contains less than 1mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free’.

Do not share medicines prescribed for you with any other person. Always use ADCO ACYCLOVIR 200 mg exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will tell you how long your treatment with ADCO ACYCLOVIR 200 mg will last. If you have the impression that the effect of ADCO ACYCLOVIR 200 mg is too strong or too weak, tell your doctor or pharmacist.

Dosage in adults:

• Initial and recurrent herpes simplex infections of skin and mucous membranes: 200 mg (one ADCO Acyclovir 200 mg tablet) 5 times daily at 4 hourly intervals for 5 days, omitting the night dose. In severe initial infection, your doctor will extend your treatment. In immunocompromised patients, dosage could be increased to 400 mg (two ADCO ACYCLOVIR 200 mg tablets), or alternatively, intravenous dosing can be considered. The first dose should be administered as early as possible after start of infection.
• Suppression of recurrent genital herpes simplex infections in patients with a weakened immune system: 200 mg acyclovir (one ADCO ACYCLOVIR 200 mg tablet) 4 times daily at 6 hourly intervals, or 400 mg (two ADCO ACYCLOVIR 200 mg tablets) 12 hourly. The dose may be reduced to 200 mg acyclovir (one ADCO ACYCLOVIR 200 mg tablet) every 8 hours or even every 12 hours. Some patients may have breakthrough infections on 800 mg (four ADCO ACYCLOVIR 200 mg tablets) daily. Your doctor will interrupt therapy every 6 – 12 months to observe history of disease.
• Prevention of herpes simplex infections in patients with a weakened immune system: 200 mg 4 times daily at 6 hourly intervals. In severely immunocompromised patients, or impaired absorption from the gut, dosage could be doubled to 400 mg (two ADCO ACYCLOVIR 200 mg tablets) or alternatively, intravenous dosing can be considered.
• Treatment of varicella zoster in adolescents (12-18 years): A dose of 800 mg (four ADCO ACYCLOVIR 200 mg tablets) should be taken daily for 5 days.
• Treatment of varicella zoster and herpes zoster infections in adults: 800 mg (four ADCO ACYCLOVIR 200 mg tablets) 5 times daily at 4 hourly intervals for 7 days, omitting the night dose.
• Dosage in the elderly: Adequate hydration in patients taking high doses must be maintained. Patients with kidney problems should be given special attention.
• Treatment or prophylaxis of herpes simplex infections in patients with renal impairment: 200 mg every 12 hours if creatinine clearance 0-10 mL/minute.
• Treatment of varicella zoster in immunocompromised patients with renal impairment: 800 mg (four ADCO ACYCLOVIR 200 mg tablets) every 12 hours if creatinine clearance 0-10 mL/minute; 800 mg (four ADCO ACYCLOVIR 200 mg tablets) every 8 hourly intervals if creatinine clearance 10-25 mL/minute; 800 mg (four ADCO ACYCLOVIR 200 mg tablets) 5 times daily with 4 hourly intervals if creatinine clearance > 25 mL/minute. Patients on haemodialysis should receive their usual appropriate dose after each dialysis.
• Orally administered acyclovir in children less than 2 years of age has not yet been fully studied.

The tablets should be taken by mouth.

If you take more ADCO ACYCLOVIR 200 mg than you should: In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you forget to take ADCO ACYCLOVIR 200 mg: Take it as soon as you remember. However, if it is nearly time for your next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.

ADCO ACYCLOVIR 200 mg can have side effects. Not all side effects reported for ADCO ACYCLOVIR 200 mg are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking ADCO ACYCLOVIR 200 mg, please consult your health care provider for advice.

If any of the following happens, stop taking ADCO ACYCLOVIR 200 mg and tell your doctor immediately or go to the casualty department at your nearest hospital:

Frequent side effects include:

• headache
• feeling dizzy
• nausea
• diarrhoea
• vomiting
• stomach pains
• itchy skin (pruritis)
• skin rash
• skin reaction after exposure to light (photosensitivity)
• hives (urticaria)
• hair loss
• feeling tired
• fever

Less frequent side effects include:

• effects on some blood tests
• anaphylaxis (life-threatening allergic reaction)
• Angioedema (rapid swelling under the skin)
• agitation, confusion, shakiness, impaired coordination, slurred speech, hallucinations, psychotic symptoms, fits, drowsiness, brain diseases, coma
• shortness of breath
• Reversible rises in bilirubin and liver related enzymes
• inflammation of the liver (hepatitis)
• yellowing of your skin and whites of your eyes (jaundice)
• Increased blood urea and creatinine
• renal failure, renal pain

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of ADCO ACYCLOVIR 200 mg. You may also report to Adcock Ingram Limited using the following e-mail address: [email protected].

• Store all medicines out of reach of children.

• Store at or below 25°C in dry place. Protect from light.

• Store in the original package.

• Do not use after the expiry date stated on the label / carton / bottle.

• Return all unused medicine to your pharmacist.

• Do not dispose of unused medicine in drains or sewerage systems (e.g., toilets).