Tuesday, March 6, 2012

Aciclovir Suspension 400mg / 5ml (Rosemont Pharmaceuticals Ltd)






Aciclovir 400mg/5ml Oral Suspension



  • 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 or your pharmacist.


  • This medicine has been prescribed only for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.


  • If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.




In this leaflet



  • 1. What is Aciclovir Oral Suspension and what is it used for


  • 2. Before you take Aciclovir Oral Suspension


  • 3. How to take Aciclovir Oral Suspension


  • 4. Possible side effects


  • 5. How to store Aciclovir Oral Suspension


  • 6. Further information





What is Aciclovir Oral Suspension and what is it used for



The name of your medicine is Aciclovir 400mg/5ml Oral Suspension (called aciclovir in this leaflet). This belongs to a group of medicines called antivirals.




Aciclovir can be used:



  • to treat herpes and other viral infections caused by the herpes virus (varicella zoster) such as chickenpox and shingles


  • to prevent recurrent attacks of herpes simplex


  • to help prevent those who have low immune systems from getting herpes infections.





Before you take Aciclovir Oral Suspension




Do not take Aciclovir and tell your doctor if:



  • you are allergic (hypersensitive) to aciclovir, valaciclovir or any other ingredients in this liquid (see section 6: Further Information). An allergic reaction can include a rash, itching or shortness of breath

Do not take this medicine if any of the above apply to you, talk to your doctor or pharmacist before taking aciclovir.





Take special care with Aciclovir



Before you take aciclovir tell your doctor if:



  • you have kidney problems


  • you are thirsty. You must make sure you drink plenty of 'liquids such as water' whilst taking this medicine

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using aciclovir.





Taking other medicines



Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines bought without a prescription, including herbal medicines.



In particular tell your doctor if you are taking any of the following medicines:



  • probenecid - used for gout


  • cimetidine - used for stomach acid


  • mycophenolate mofetil - used after transplant operations

Tests



Tell your doctor you are taking this medicine if you are going to have any blood or urine tests.





Pregnancy and Breast-feeding



Talk to your doctor before taking this medicine if you are pregnant, planning to become pregnant or are breast-feeding.





Driving and using machines



This medicine does not usually affect you being able to drive or use any tools or machines.





Important information about what is in Aciclovir Oral Suspension:



This medicine contains:



  • Methyl and propyl parahydroxybenzoates. These may cause an allergic reaction. This allergy may happen some time after starting the medicine


  • Liquid maltitol. If your doctor has told you that you cannot tolerate some sugars, talk to your doctor before taking this medicine





How to take Aciclovir Oral Suspension



Take this medicine as your doctor or pharmacist has told you. Look on the label and ask the doctor or pharmacist if you are not sure.




Taking this medicine



  • This medicine contains 400mg of aciclovir in each 5ml


  • Take this medicine by mouth


  • Always shake the bottle before use


  • If you feel that the effect of your medicine is too strong or too weak, do not change the dose yourself, but talk to your doctor or pharmacist

The usual doses are given below. These may be changed by your doctor:



Adults



Herpes Simplex



A lower strength suspension (200mg/5ml) is available for the treatment of herpes simplex



  • Take for at least 5 days


  • 2.5ml of suspension (200mg), five times each day


  • Take every four hours while awake (for example 6am, 10am, 2pm, 6pm, 10pm)

Shingles and Chickenpox



  • Take for 7 days


  • Two 5ml spoonfuls (800mg), five times each day


  • Take every four hours while awake (for example 6am, 10am, 2pm, 6pm, 10pm)

Children



Herpes Simplex



  • Take for at least 5 days


    Children over 2 years
    • 2.5ml suspension (200mg), five times each day


    • Take every four hours while awake (for example 6am, 10am, 2pm, 6pm, 10pm)


    Children under 2 years
    • 1.25ml of suspension (100mg), five times each day


    • Take every four hours while awake (for example 6am, 10am, 2pm, 6pm, 10pm)


Shingles



This medicine should not be used to treat shingles in children.



Chickenpox



  • Take for 5 days


    Age 6 and above
    • Two 5ml spoonfuls (800mg), four times each day


    Age 2 to 5 years
    • One 5ml spoonful (400mg), four times each day


    Under 2 years
    • 2.5ml of suspension (200mg), four times each day





Elderly and people with kidney problems



Your doctor may decide to lower your dose if you are elderly or have kidney problems.





If you take more aciclovir than you should



Talk to your doctor or go to your nearest hospital straight away.





If you forget to take Aciclovir Oral Suspension



Do not take a double dose (two doses at the same time) to make up for a forgotten dose. Take your next dose as soon as you remember, then go on as before. However, if it is nearly time for the next dose, skip the missed dose.



If you have any further questions on the use of this medicine, ask your doctor or pharmacist.






Possible side effects



Like all medicines, Aciclovir Oral Suspension can cause side effects although not everybody gets them.



If you have an allergic reaction to aciclovir see a doctor straight away



An allergic reaction may include:



  • any kind of skin rash, flaking skin, boils or sore lips and mouth


  • swelling of the face, lips, tongue or throat or difficulty breathing or swallowing


  • sudden wheezing, fluttering or tightness of the chest or collapse


If you get any of the following side effects, stop taking aciclovir and see your doctor as soon as possible:



  • feeling weak, dizzy or short of breath. This could be caused by something called ‘anaemia. This medicine may also cause changes in the results of blood tests such as a fall in the number of white blood cells


  • liver problems (hepatitis), yellowing of your skin or whites of the eyes (jaundice) or kidney failure (which usually returns to normal)


  • changes in blood tests that check the way your liver or kidneys are working


  • Feeling dizzy, confused or sleepy. Seeing or hearing things that are not there (hallucinations), fits or loss of consciousness. These effects are more likely to happen in people with kidney problems




Tell your doctor if you get any of these side effects:



  • skin rashes (causing itchiness or redness), itching or a skin rash that happens in people who are oversensitive to
    sunlight


  • dry eyes, changes in vision


  • feeling or being sick, diarrhoea or stomach pains


  • headaches


  • feeling very tired


  • hair loss

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.






How to store Aciclovir Oral Suspension



  • Keep out of the reach and sight of children


  • Do not store above 25°C


  • Take back to the pharmacy 1 month after you first open it


  • Do not use after the expiry date (month, year) stated on the label and carton


  • If it is out of date or you no longer want it, take it back to the pharmacy


  • Do not use Aciclovir Oral Suspension if you notice anything wrong with the medicine. Talk to your pharmacist


  • Medicines should not be disposed of via wastewater or household waste. Ask you pharmacist how to dispose of medicine no longer required.

These measures will help to protect the environment





Further information




What Aciclovir Oral Suspension contains



  • The active ingredient is aciclovir


  • The other ingredients are sodium methyl hydroxybenzoate (E219), sodium propyl hydroxybenzoate (E217), citric acid (E330), xanthan gum (E415), liquid maltitol (E965), nectar flavour (contains ethylvanillin, propylene glycol, lactic acid, nature identical and natural flavouring substances) and purified water.




What Aciclovir Oral Suspension looks like and contents of the pack



A white to light beige suspension with an odour of nectar.



It comes in a brown glass bottle holding 100ml of suspension.





Marketing Authorisation Holder and Manufacturer




Rosemont Pharmaceuticals Ltd

Yorkdale Industrial Park

Braithwaite Street

Leeds

LS11 9XE

UK





This leaflet was last approved in March 2008



P0389






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