Shilova 500 mg/1000 mg Tablets

    Shilova 500 mg/1000 mg Tablets

    S4


    1. What SHILOVA TABLETS is and what it is used for

    SHILOVA TABLETS is used:

    • For the treatment of herpes zoster (shingles).
    • To reduce the duration of pain associated with shingles.
    • For the episodic treatment of recurrent genital herpes in patients with normal immune systems.
    • For the prevention of recurrent herpes simplex infection of the skin and mucous membrane of the ano - genital area.

    2. What you need to know before you take SHILOVA TABLETS

    Do not take SHILOVA TABLETS:

    • If you are allergic to valaciclovir, aciclovir, or any of the other ingredients of SHILOVA TABLETS (listed in section 6).
    • If you are pregnant or breastfeeding.

    Warnings and precautions

    Special care should be taken with SHILOVA TABLETS:

    • If you have impaired kidney function.
    • If you have advanced HIV disease.
    • If you had a bone marrow or kidney transplant.
    • Caution should be exercised when administering SHILOVA TABLETS to elderly patients. Dose reduction is recommended for elderly patients with kidney problems.
    • If you are taking other medication that has an effect on the kidneys.

    Use in genital herpes: It is recommended that patients using SHILOVA TABLETS continuously to prevent or reduce recurrent outbreaks, or to reduce the risk of transmitting the virus that causes genital herpes, also avoid contact when symptoms are present and always use condoms.

    SHILOVA TABLETS do not cure genital herpes or completely eliminate the risk of transmission. Because genital herpes is a sexually transmitted disease, you should minimise having intercourse when you have an outbreak of herpes or show any symptoms. This will avoid the risk of spreading herpes to your partner.

    Children and adolescents

    There is no data for use of SHILOVA TABLETS in children.

    SHILOVA TABLETS with food, drink and alcohol

    SHILOVA TABLETS can be taken with or without food.

    Pregnancy, breastfeeding and fertility

    Safety of SHILOVA TABLETS in pregnant and lactating women has not been established. 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 taking SHILOVA TABLETS.

    Driving and using machinery:

    SHILOVA TABLETS may cause dizziness and problems with your vision. If affected, do not drive or operate machinery. It is not always possible to predict to what extent SHILOVA TABLETS 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 SHILOVA TABLETS affects them.

    Other medicines and SHILOVA TABLETS:

    Always tell your healthcare provider if you are taking any other medicine. (This includes all complementary or traditional medicines.)

    • Cimetidine and probenecid may prolong the effects of SHILOVA TABLETS by reducing its elimination through urine.
    • Care is required (with monitoring for changes in kidney function) if administering high doses of SHILOVA TABLETS with medicines which affect other aspects of kidney function, for example the medicine ciclosporin and tacrolimus.

    3. How to take SHILOVA TABLETS

    Do not share medicines prescribed for you with any other person. Always take SHILOVA TABLETS exactly as your doctor has instructed you. Your doctor will tell you how long your treatment with SHILOVA TABLETS will last. You should check with your doctor or pharmacist if you are unsure. If you have the impression that the effect of SHILOVA TABLETS is too strong or too weak, talk to your doctor or pharmacist.

    SHILOVA TABLETS may be given with or without food. Dosage in adults varies depending on the treatment you require as instructed by your doctor. Dosage must be altered depending on the kidney function. Dose modification is not required in patients with mild to moderate liver abnormalities. No data is available for dosage in children.

    If you take more SHILOVA TABLETS than you should

    In the event of overdose, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

    If you forget to take SHILOVA TABLETS: Do not take a double dose to make up for forgotten individual doses.

    4. Possible side effects

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

    If any of the following happens, stop taking SHILOVA TABLETS and tell your doctor immediately or go to the casualty department at your nearest hospital:

    • swelling of the hands, feet, ankles, face, lips and 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 SHILOVA TABLETS. You may need urgent medical attention or hospitalisation.

    Kidney failure and nervous system problems are infrequent but can be serious in some patients taking SHILOVA TABLETS. Nervous system problems include aggressive behaviour, unsteady movement, shaky movements, confusion, speech problems, hallucinations (seeing or hearing things that are really not there), seizures, and coma.

    Always tell your healthcare provider if you have kidney problems before taking SHILOVA TABLETS. Call your doctor right away if you get a nervous system problem while you are taking SHILOVA TABLETS.

    Frequent side effects of SHILOVA TABLETS in adults include headache, nausea, stomach pain, vomiting, and dizziness.

    Other less frequent side effects in adults include painful periods in women, joint pain, depression, low blood cell counts, and changes in tests that measure how well the liver and kidneys work. The most common side effect seen in children < 18 years of age was headache.

    Frequency Unknown A serious skin reaction may occur known as (DRESS) Drug reaction with eosinophilia and systemic symptoms which may cause a serious skin reaction that may affect one or more organs) .You may experience the following 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.

    Talk to your healthcare provider if you develop any side effects that concern you.

    Reporting of side effects

    If you get side effects, talk to your doctor or, pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (whoumc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of SHILOVA TABLETS.

    5. How to store SHILOVA TABLETS

    Store at or below 25 °C. Keep HDPE containers tightly closed. Keep the blisters in the carton until required for use. STORE ALL MEDICINES OUT OF REACH OF CHILDREN. Return all unused medicine to your pharmacist. Do not dispose of unused medicine.

    Important Disclaimer

    The Shilova 500 mg/1000 mg Tablets professional information leaflet below is the property of Aurogen 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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