Aciclovir Solution

    Aciclovir Solution

    S4


    1. What ACICLOVIR VIATRIS is and what it is used for

    What ACICLOVIR VIATRIS is:
    ACICLOVIR VIATRIS belongs to a group of medicines called antivirals and works by preventing the multiplication of the virus in the body that causes an infection.

    What ACICLOVIR VIATRIS is used for:
    ACICLOVIR VIATRIS is used to treat various viral infections, e.g. shingles and chickenpox.

    2. What you need to know before you are given ACICLOVIR VIATRIS

    ACICLOVIR VIATRIS should not be administered to you:
    If you are hypersensitive (allergic) to aciclovir or any of the other ingredients of ACICLOVIR VIATRIS (listed in section 6).

    Warnings and precautions

    Tell your doctor or health care professional before being given the injection if you:
    • Are pregnant or want to become pregnant.
    • Are breastfeeding your baby.
    • Have or had kidney or liver problems.
    • Are dehydrated (water/fluid loss in the body).
    • Have conditions affecting your brain or nervous system.

    Take special care with ACICLOVIR VIATRIS:
    • ACICLOVIR VIATRIS should be used with caution in patients with renal (kidney) impairment.
    • If you are elderly.
    • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported with the use of aciclovir. DRESS appears initially as flu-like symptoms and a rash on the face then an extended rash with a high body temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes.

    Other medicines and ACICLOVIR VIATRIS

    If you are taking other medicines on a regular basis, including complementary or traditional medicines, the use of ACICLOVIR VIATRIS with these medicines may cause undesirable interactions. Always tell your health care professional if you are taking any other medicines (this includes complementary or traditional medicines). Please consult your doctor, pharmacist, or other health care professional, for advice.

    Tell your doctor if you are taking any of the following medicines:
    • Do not use ACICLOVIR VIATRIS together with probenecid (treatment for gout), as it decreases renal (kidney) excretion.
    • Medicines used to treat ulcers such as cimetidine.
    • Mycophenolate mofetil, ciclosporin, and tacrolimus, medicines used to lower your body’s natural immunity in patients who receive organ transplants.

    Pregnancy and breastfeeding and fertility

    If you are pregnant or breast feeding your baby, think you may be pregnant or are planning to have a baby while taking this medicine, please consult your doctor, pharmacist, or other healthcare professional for advice before you are given ACICLOVIR VIATRIS. The safe use of ACICLOVIR VIATRIS has not been established in pregnant and breastfeeding patients.

    Driving and using machinery

    It is not always possible to predict to what extent ACICLOVIR VIATRIS may interfere with the daily activities of a patient. As ACICLOVIR VIATRIS may cause dizziness, confusion and hallucinations, patients should ensure that they do not engage in the above activities until they are aware of the measure to which ACICLOVIR VIATRIS affects them.

    3. How to receive ACICLOVIR VIATRIS

    Do not share medicines prescribed to you with any other person. You will not be expected to give yourself ACICLOVIR VIATRIS. It will be given to you by a person who is qualified to do so. Your health care professional will decide on the correct dose for you. This medicine will be administered by slow intravenous infusion (into a vein) over 1 hour. The treatment will usually be for 5 days. Your doctor will tell you how long your treatment with ACICLOVIR VIATRIS will last.

    If you have the impression that the effect of ACICLOVIR VIATRIS is too strong or too weak, tell your doctor or pharmacist.

    If you are given more ACICLOVIR VIATRIS than you should
    Since a health care professional will administer ACICLOVIR VIATRIS, he/she will control the dose. However, in the event of overdose your doctor will manage the overdose. If you have been given too much ACICLOVIR VIATRIS, you may:
    • Feel confused and agitated.
    • See or hear things that are not there (hallucinations).
    • Have fits (seizures).
    • Become unconscious (coma).

    If you missed a dose of ACICLOVIR VIATRIS
    Since a healthcare professional will administer ACICLOVIR VIATRIS, it is unlikely that the dose will be missed.

    4. Possible side effects

    ACICLOVIR VIATRIS can have side effects. Not all side effects reported for ACICLOVIR VIATRIS are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking ACICLOVIR VIATRIS, please consult your doctor, pharmacist, or other healthcare professional for advice.

    If any of the following happens, stop taking ACICLOVIR VIATRIS and tell your doctor immediately or go to the casualty department at your nearest hospital:
    • Swelling of the hands, feet, ankles, face, lips, mouth, or throat, which may cause difficulty in swallowing or breathing.
    • Rash or itching.
    • Fainting.

    These are all very serious side effects. If you have them, you may have had a serious allergic reaction to ACICLOVIR VIATRIS. You may need urgent medical attention or hospitalisation.

    Tell your doctor if you notice any of the following:
    The following side effects have been reported frequently:
    • Inflammation of the veins causing pain, discomfort and swelling in the body.

    The following side effects have been reported less frequently:
    • Blood disease such as aneamia (reduced number of red blood cells), leukopenia (decrease in white blood cells) or low number of platelets.
    • Lowering in your blood pressure.
    • Headaches, tiredness, fever, dizziness, irritation, confusion, and coma.
    • Seeing experiences that appear real but are not (hallucination).
    • Shortness of breath.
    • Nausea, vomiting, diarrhoea, stomach pains.
    • Liver disease (yellowing of the eyes and/or skin).

    • Hair loss.
    • Kidney problems or disease.
    • Discoloured or blood in your urine.
    • Rashes, itching, swelling of the skin (angioedema), photosensitivity (extreme sensitivity to the sun).

    The following side effects have been reported but the frequency is unknown:
    • Drug Reaction with Eosinophilia and Systemic Symptoms also known as DRESS or drug hypersensitivity syndrome, which is characterised by widespread rashes, high body temperature, liver enzyme elevations, blood abnormalities (eosinophilia), enlarged lymph nodes and possibly other body organs involvement (see section 2).

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

    Reporting of side effects
    Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare providers are asked to report any suspected adverse reactions to SAHPRA via the “6.04 Adverse Drug Reactions 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 ACICLOVIR VIATRIS.

    5. How to store ACICLOVIR VIATRIS

    • Before reconstitution: Store at or below 25 ° C. Keep containers dry and tightly closed.
    • After reconstitution: After reconstitution with water for injections, the solution can be stored for 12 hours when stored at or below 25 ° C. Preferably use the reconstituted solution immediately.
    • After reconstitution/dilution in a suitable intravenous fluid, the solution can be stored for 12 hours when stored at or below 25 ° C.
    • Do not store reconstituted solution in refrigerator.

    • ACICLOVIR VIATRIS is a single dose vial, discard any unused portion.
    • KEEP OUT OF THE REACH OF CHILDREN.
    • Store in the original package / container.
    • Protect from light / moisture.
    • Do not store in a bathroom.
    • 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).

    Important Disclaimer

    The Aciclovir Solution professional information leaflet below is the property of Viatris South Africa and is provided on Somayeza exactly as issued, with no.. alterations or editorial changes. We make every effort to keep content current by updating documents as soon as new versions become available. Somayeza serves as a trusted access point for healthcare professionals, but does not replace official sources or clinical judgement. For more details, please read our full disclaimer. read more>>

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