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Roche Products (India) Pvt Ltd

Cellcept Oral Suspension 175ml

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    INTRODUCTION ABOUT CELLCEPT ORAL SUSPENSION

    CELLCEPT ORAL SUSPENSION contains Mycophenolate mofetil which belongs to the group of medicines called Immunosuppressants. It is used to manage your body from rejecting a transplanted organ (such as kidney transplantation in adults and children, heart and liver transplantation in adults). It is also given with other medications such as corticosteroids and ciclosporin.

    Your doctor will perform some regular blood tests to monitor any changes in blood cells or signs of infection.

    CELLCEPT ORAL SUSPENSION can cause birth defects and miscarriage, hence it is strictly not recommended for use in pregnant women and breastfeeding women.

    CELLCEPT ORAL SUSPENSION is not recommended for use in children under 2 years of age. Contact your doctor before taking it.

    CELLCEPT ORAL SUSPENSION should be used with caution in elderly patients aged 65 years or above. Contact your doctor before taking CELLCEPT ORAL SUSPENSION.

    The most common side effects of taking CELLCEPT ORAL SUSPENSION are nausea, vomiting, diarrhoea, stomach pain, headache, high blood pressure and a low number of white blood cells. Contact your doctor if the above side effects worsen.

    USES OF CELLCEPT ORAL SUSPENSION

    • Used to manage your body from rejecting a transplanted organ (such as a kidney, heart, and liver)

    HOW CELLCEPT ORAL SUSPENSION WORKS

    CELLCEPT ORAL SUSPENSION belongs to immunosuppressants which reduce the action of the body's own defence system (the immune system) and manages rejection of the transplanted organ.

    DIRECTIONS FOR USE

    Take CELLCEPT ORAL SUSPENSION as advised by your physician. Shake well before each use. Your dosage will vary depending on the type of transplant you received. Do not stop the medicine suddenly without the concern of your doctor.

    SIDE EFFECTS OF CELLCEPT ORAL SUSPENSION

    COMMON

    • nausea
    • constipation
    • swelling in the legs
    • high blood pressure
    • fast heartbeat
    • changes in blood sugar  
    • rashes
    • headache
    • dizziness
    • tremors
    • diarrhoea, vomiting, stomach pain, low white, red blood cells and infections (in adults and children)
    • fever, sore throat (in children)

    RARE

    Stop taking CELLCEPT ORAL SUSPENSION and contact your physician immediately if you experience any of the following side effects:

    • rashes, swelling of the face, lips, tongue or throat causing difficulty in breathing (anaphylaxis or angioedema)
    • symptoms of brain infection called progressive multifocal leukoencephalopathy includes weakness on one side of the body, lack of interest (apathy), confusion, or thinking problems unable to control muscles
    • high fever, runny nose or sore throat or flu-like symptoms, such as an upset stomach, stomach pain, vomiting or diarrhoea, ear pain or headache, pain while urination, white patches in the mouth or throat
    • unexpected bruising or bleeding
    • cuts, abrasions and incisions that are red, warm with pus

    HOW TO MANAGE SIDE EFFECTS

    Diarrhoea:

    Drink lots of fluids, such as water or fruit juice to keep yourself hydrated. Contact your doctor if the diarrhea did not improve.

    Headache:

    Rest and relax. Drink plenty of fluids such as water and electrolytes. Apply a pain-relieving balm on the head if necessary. Do not consume alcohol. Contact your doctor if the headache did not improve.

    Nausea and Vomiting:

    Take the medicine, with or just after a meal. Stick to simple meals. Avoid eating oily or spicy food. Contact your doctor if nausea and vomiting worsen.

    Dizziness:

    Try to rest and relax. Get enough sleep. Avoid driving or operating any machines while you are feeling dizzy. Do not drink alcohol, as it can aggravate your dizziness. Contact your doctor if the dizziness did not improve.

    Stomach pain:

    Try to rest and relax. Eat small meals but take them frequently. Keep a heating pad on your stomach. Contact your doctor if the stomach pain did not improve.

    Constipation:

    Eat fibre rich foods such as fresh fruits, vegetables, and cereals. Drink lots of water and exercise more regularly. Contact your doctor if constipation did not improve.

    WARNING & PRECAUTIONS

    PREGNANCY

    CELLCEPT ORAL SUSPENSION is generally not recommended for use in pregnant women as it may cause birth defects and miscarriage and inform your doctor if you are planning to have a child. Contact your doctor before taking CELLCEPT ORAL SUSPENSION.

    BREASTFEEDING

    CELLCEPT ORAL SUSPENSION is generally not recommended for use in breastfeeding women as small amounts of the medicine can pass into the mother’s milk. Contact your doctor before taking CELLCEPT ORAL SUSPENSION.

    DRIVING AND USING MACHINES

    Do not drive or operate any machines if you feel drowsy, numb or confused after taking CELLCEPT ORAL SUSPENSION.

    KIDNEY

    CELLCEPT ORAL SUSPENSION should be used with caution in patients with kidney diseases. Contact your doctor before taking CELLCEPT ORAL SUSPENSION.

    LIVER

    CELLCEPT ORAL SUSPENSION should be used with caution in patients with liver diseases. Contact your doctor before taking CELLCEPT ORAL SUSPENSION.

    ALLERGY

    Do not take CELLCEPT ORAL SUSPENSION if you are allergic (hypersensitive) to Mycophenolate mofetil or to other ingredients of this medicine.

    OTHERS

    CELLCEPT ORAL SUSPENSION is not recommended for use if you:

    • have hereditary enzyme deficiencies such as Lesch-Nyhan (neurogenetic disorder) and Kelley-Seegmiller syndrome (partial deficiency of the enzyme hypoxanthine guanine phosphoribosyl transferase)

    Before taking CELLCEPT ORAL SUSPENSION, inform your doctor if you:

    • have infections (Ex. fever or sore throat)
    • have any unexpected bruising (skin discolouration from a skin or tissue injury) or bleeding
    • have digestive problems (stomach ulcers)
    • have a rare problem with your metabolism called phenylketonuria (a hereditary condition that results in an accumulation of phenylalanine in the blood)
    • are planning to get live vaccinations
    • have lymphoma or skin cancer
    • fungal infections

    Use in pediatrics:

    CELLCEPT ORAL SUSPENSION is not recommended for children below 2 years of age as there is limited safety and efficacy data for this age group. Contact your doctor before taking CELLCEPT ORAL SUSPENSION.

    Use in geriatrics:

    CELLCEPT ORAL SUSPENSION should be used with caution in elderly patients aged 65 years or above. Contact your doctor before taking CELLCEPT ORAL SUSPENSION.

    INTERACTIONS

    A. Drug-Drug interactions:

    Before taking CELLCEPT ORAL SUSPENSION, inform your doctor if you are taking any of the following medicine:

    • azathioprine, tacrolimus, belatacept, cyclosporine A (suppress your immune system given after a transplant operation)
    • cholestyramine (medicine used to manage high cholesterol)
    • rifampicin (medicines used to manage infections such as TB)
    • medicines used to manage ulcer problems (antacids such as aluminium hydroxide, magnesium hydroxide, sodium bicarbonate, calcium carbonate or proton pump inhibitors such as omeprazole, rabeprazole, pantoprazole)
    • phosphate binders (used to reduce phosphate absorption into the blood is used by patients with chronic renal failure) such as ferric citrate, calcium acetate, sevelamer
    • antibiotics (medicines used to manage bacterial infections) amoxicillin and clavulanic acid, doxycycline, ciprofloxacin, clindamycin, metronidazole, azithromycin, trimethoprim/sulfamethoxazole, amikacin, cefadroxil, norfloxacin
    • isavuconazole (medicine used to manage fungal infections)
    • telmisartan (medicine used to manage high blood pressure)
    • activated charcoal (used to manage digestive problems)
    • acyclovir or ganciclovir (medicines used to manage viral infections)
    • oral contraceptives such as Ex. ethinylestradiol and levonorgestrel (medicines used to manage pregnancy)
    • probenecid (medicines used to manage gout)

    Overdosage:

    If you or anyone else accidentally takes too much of CELLCEPT ORAL SUSPENSION, consult your doctor immediately or visit the nearby hospital. Symptoms of overdosage are nausea, vomiting, diarrhoea, abdominal pain, indigestion, and haematological abnormalities such as leukopenia (decreased white blood cells) and neutropenia (decrease in neutrophils).

    SYNOPSIS

    Drug :   Mycophenolate mofetil
    Pharmacological Category :   Immunosuppressants
    Therapeutic Indication :   Prevents your body from rejecting a transplanted organ                       
    Dosage Forms :   Tablet, Capsule, Suspension, Oral suspension

    MORE INFORMATION

    • Keep CELLCEPT ORAL SUSPENSION out of the sight and reach of children
    • Store CELLCEPT ORAL SUSPENSION below 30°C

    FAQs ABOUT CELLCEPT ORAL SUSPENSION

    What is CELLCEPT ORAL SUSPENSION used for?

    It is used to manage your body from rejecting a transplanted organ (such as kidney transplantation in adults and children, heart and liver transplantation in adults). It is also given with other medications such as corticosteroids and ciclosporin.

    is CELLCEPT ORAL SUSPENSION safe in pregnancy?

    No. CELLCEPT ORAL SUSPENSION is strictly not recommended for use in pregnant women. Contact your doctor before taking it.

    Can I use CELLCEPT ORAL SUSPENSION in children?

    CELLCEPT ORAL SUSPENSION is not recommended for children below 2 years of age as there is limited safety and efficacy data for this age group. Contact your doctor before taking CELLCEPT ORAL SUSPENSION.

    How CELLCEPT ORAL SUSPENSION work?

    CELLCEPT ORAL SUSPENSION belongs to immunosuppressants which reduce the action of the body's own defence system (the immune system) and manages rejection of the transplanted organ.

    Can I use CELLCEPT ORAL SUSPENSION while breastfeeding?

    No, CELLCEPT ORAL SUSPENSION is generally not recommended for use in breastfeeding women as small amounts of the medicine can pass into the mother’s milk. Contact your doctor before taking it.

    REFERENCES

    1. KD Tripathi. Immunosuppressant Drugs. Essentials of Medical Pharmacology. Seventh Edition,2013. Page - 883.

    2. B Fulton, A Markham. Mycophenolate mofetil. A review of its pharmacodynamics and pharmacokinetic properties and clinical efficacy in renal transplantation. National Institute of Health. NLM. National Centre for Biotechnology Information. Pubmed.gov. 1996. [Accessed on 16th July 2022] https://pubmed.ncbi.nlm.nih.gov/8808168/

    3. Roche Products Limited. Electronic Medicines Compendium (EMC); [Revised on Jan 2022] [Accessed 16th July 2022] https://www.medicines.org.uk/emc/files/pil.1569.pdf

    4. Roche Pharma AG. European Medical Agency. [Accessed on 16th July 2022] https://www.ema.europa.eu/en/documents/product-information/cellcept-epar-product-information_en.pdf

    5. Roche Laboratories Inc. U.S. Food & Drug Administration. [Accessed on 16th July 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050722s021,050723s019,050758s019,050759s024lbl.pdf

    USEFUL DIAGNOSTIC TESTS

    • Complete blood count
    • Liver function test
    • Kidney function test

    AUTHOR DETAILS

    Written By Dr. Janet.C - Pharm.D
    Last updated on 14 Nov 2022 | 10:14 AM(IST)
    Lab updated