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AFF Tablet 10'S

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    Introduction About AFF TABLET

    AFF TABLET is a combination of Atorvastatin, Fenofibrate and Folic acid which belongs to a group of medicines called Lipid-lowering agents and Vitamins. It is used to lower the increased levels cholesterol and triglycerides in blood when a low-fat diet and lifestyle modifications have failed. It is used to lower the levels of total cholesterol, LDL cholesterol and triglycerides in the blood and helps raise the good cholesterol (HDL cholesterol).

    High cholesterol is a condition in which you have too many lipids (fats) in your blood. It is also called hyperlipidemia or hypercholesterolemia.

    Along with the management your doctor may advise you to follow low fat diet and non- medical managements such as exercise and weight loss to lower the cholesterol.

    Do not take AFF TABLET if you have severe respiratory failure, liver, kidney problems. Consult your doctor before taking it.

    AFF TABLET is not recommended for use in pregnant woman or if you are planning to have baby and in breast-feeding woman. Consult your doctor before taking it.

    AFF TABLET is not recommended for use in children and adolescents below 18 years and it should be used with caution in elderly patients of 65 years and above.

    The common side effects of taking AFF TABLET are headache, nausea, constipation, flatulence, indigestion, diarrhoea, abdominal pain. Consult your doctor if the side effects does not improve.

    Uses Of AFF TABLET

    • Used to lower the increased levels cholesterol and triglycerides in blood when a low-fat diet and lifestyle modifications have failed

    How AFF TABLET Works

    AFF TABLET is a combination of Atorvastatin, Fenofibrate and Folic acid. Atorvastatin works by blocking 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA) reductase, an enzyme that's needed for the liver to produce cholesterol. Fenofibrate lowers bad cholesterol and fats (LDL, triglycerides) and raise good cholesterol in the blood. Folic acid acts by reducing homocysteine levels, which may contribute to decreased cholesterol synthesis.

    How to use AFF TABLET

    Take AFF TABLET as advised by your physician. Swallow this medicine with a glass of water and do not crush or chew the medicine. Your doctor will decide the right dose and duration depending upon your age, body weight and disease condition.

    Side Effects Of AFF TABLET

    Common

    • inflammation of the nasal passages
    • pain in the throat
    • bleeding from nose
    • allergic reactions
    • high blood sugar levels
    • headache
    • nausea
    • constipation
    • indigestion
    • diarrhea
    • abdominal pain
    • flatulence
    • joint pain, muscle pain and back pain
    • signs of decreased liver function such as yellowing of skin and eyes
    • signs of high creatinine kinase include swelling, fatigue (feeling tired), loss of appetite

    Uncommon

    • anorexia (loss of appetite)
    • weight gain
    • low blood sugar levels
    • nightmares, insomnia (lack of sleep)
    • dizziness, numbness or tingling in the fingers and toes, reduced pain or touch
    • altered taste sensation
    • loss of memory
    • blurred vision
    • ringing in ears and/or head
    • vomiting, belching, abdominal pain
    • dark urine, light-colored stools, joint pain, and jaundice
    • rash, skin rash and itching, hives
    • hair loss, neck pain, muscle fatigue
    • feeling unwell, weakness, chest pain, swelling especially in the ankles, raised temperature
    • sensitivity to light
    • gallstones
    • blood clot in legs leading to redness and swelling

    Rare

    • visual disturbance
    • unexpected bleeding or bruising
    • tendon injury
    • pain and muscle inflammation, muscle weakness
    • reduced sex drive

    Stop taking AFF TABLET and contact your doctor immediately if you experience any of the following side effects:

    • muscle pain, tenderness or weakness, muscle breakdown leading to the signs of decreased urination, dark red or brown urine (kidney damage)
    • signs of allergic reactions, including swelling of the face, lips, tongue, and/or throat
    • serious illness with severe peeling and swelling of the skin, blistering of the skin, mouth, eyes, genitals and fever, skin rash with pink-red blotches especially on palms of hands or soles of feet which may blister

    How To Manage Side Effects

    Diarrhoea:

    To avoid dehydration in your body, drink plenty of fluids such as water, fruit juices or electrolytes. If the condition worsens, consult your physician immediately.

    Nausea or Vomiting:

    Take this medicine with, or just after meals. Stick to simple meals. Avoid eating oil rich or spicy foods. Consult your doctor if there is no improvement in symptoms.

    Headache:

    Apply hot or cold-water bag on your head. Try to take rest in a quiet and dark room. Drink tea or coffee. Massage the scalp or head with mild pressure. Consult your doctor for advice.

    Skin rash:

    Try to avoid hot showers because it may cause skin irritation. Avoid frequent contact and rubbing over the affected area. Use sunscreen and protective clothing when outdoors. If this symptom does not get better, speak to a doctor.

    Warning & Precautions

    Pregnancy

    AFF TABLET is not recommended for use in pregnant woman or if you are planning to become pregnant. Consult your doctor before taking it.

    Breastfeeding

    AFF TABLET should not be used in breast feeding women. Consult your doctor before taking it.

    Driving and Using Machines

    AFF TABLET does not affect your ability to drive or while operating any machineries. Take special care while driving or operating machines since it may cause dizziness.

    Alcohol

    Avoid consumption of alcohol as it may increase the risk of side effects. Consult your doctor before taking it.

    Kidney

    Do not take AFF TABLET if you have severe kidney problems. Consult your doctor before taking AFF TABLET.

    Liver

    Do not take AFF TABLET if you have liver problems. Consult your doctor before taking AFF TABLET.

    Allergy

    Do not take AFF TABLET if you are allergic to Atorvastatin, Fenofibrate and Folic acid or any other ingredients of this medicine.

    Lungs

    AFF TABLET should be used with caution in patients having severe respiratory failure. Consult your doctor before taking AFF TABLET.

    Others

    AFF TABLET is not recommended for use if you:

    • have gall bladder disease
    • have inflammation of pancreas
    • have unmanageed vitamin B12 deficiency
    • have pernicious anemia or another condition caused by vitamin B12 deficiency
    • have a malignant (cancerous) disease

    Before taking AFF TABLET, inform your doctor if you:

    • have thyroid problems or under-active thyroid gland (hypothyroidism)
    • have repeated or unexplained muscle aches or pains, or family history of muscle problem
    • have ever had stroke with bleeding into the brain, or have small pockets of fluid in the brain from previous strokes
    • have a folate dependent tumor

    Use in pediatrics:

    AFF TABLET is not recommended for use in children and adolescents below 18 years of age. Consult your doctor for advice before taking [GBNKRYWORD].

    Use in geriatrics:

    AFF TABLET should be used with caution in elderly patients above 65 years of age. Consult your doctor for advice.

    Interactions

    A. Drug-Drug interactions:

    Before taking AFF TABLET inform your doctor if you are taking any of the following medicine:

    • ciclosporin (medicine used in organ transplant patients)
    • warfarin, phenprocoumon, acenocoumarol or fluindione (used to manage blood clots)
    • gemfibrozil, colestipol, clofibrate (medicines used to lower cholesterol)
    • medicines used to manage bacterial and fungal infections (Ex. erythromycin, fusidic acid clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampin, fusidic acid)
    • amlodipine, diltiazem, digoxin, verapamil, amiodarone (medicines used to manage heart problems)
    • letermovir (medicine used to manage viral infections)
    • medicines used in the management of HIV (Ex. ritonavir, lopinavir, atazanavir, indinavir, tipranavir/ritonavir)
    • telaprevir, boceprevir and the combination ofelbasvir/grazoprevir, ledipasvir/sofosbuvir (medicines used in the management of hepatitis C)
    • warfarin (medicine that reduces blood clotting)
    • oral contraceptives (Ex. drospirenone and ethinylestradiol)
    • phenytoin, phenobarbital, primidone, sodium valproate and carbamazepine, stiripentol (medicine used to manage epilepsy)
    • aluminum or magnesium, cimetidine (medicine used for heartburn and peptic ulcers)
    • phenazone, aspirin (painkiller)
    • St John’s Wort (herbal medicine used to manage depression)
    • trimethoprim, chloramphenicol and cotrimoxazole
    • sulfasalazine (medicine used to manage ulcerative colitis, Crohn’s disease, or rheumatoid arthritis)
    • methotrexate (medicine to manage Crohn’s disease, psoriasis, or rheumatoid arthritis)
    • lithium (medicine used to manage mental health problems)
    • triamterene (medicine used to manage swelling or oedema)
    • general anesthesia like propofol, ketamine

    B.Drug-Food interaction:

    Avoid eating or drinking grapefruit juice while taking AFF TABLET as it may increase the risk of side effects.

    Overdosage:

    If you or anyone else accidentally took too much of AFF TABLET, consult your doctor immediately or visit any nearby hospital.

    Synopsis

    Drug :   Atorvastatin, Fenofibrate, Folic acid
    Pharmacological Category :   Hypolipidemic agents, Vitamins
    Therapeutic Indication :   High cholesterol          
    Dosage Forms :   Tablet

    More Information

    • Keep AFF TABLET out of reach of children
    • Store below 25°C

    FAQs About AFF TABLET

    Q: What is AFF TABLET used for?

    A: AFF TABLET is used to lower the increased levels cholesterol and triglycerides (other form of fat) in blood when a low-fat diet and lifestyle modifications have failed.

    Q: Can I drink alcohol while taking AFF TABLET?

    A: Avoid consumption of alcohol while taking AFF TABLET as it may increase the risk of side effects. Consult your doctor for advice.

    Q: Is AFF TABLET safe in pregnant and breast-feeding women?

    A: AFF TABLET is not recommended for use in pregnant woman or if you are planning to become pregnant and in breast-feeding woman. Consult your doctor before taking it.

    Q: Is AFF TABLET safe for use in children?

    A: AFF TABLET is not recommended for use in children and adolescents under 18 years of age. Your physician will prescribe you any other suitable medicine. Consult your doctor for advice before taking AFF TABLET.

    Q: Does AFF TABLET causes skin rash?

    A: Yes, it may cause skin rash in some individuals. Try to avoid hot showers because it may cause skin irritation. Avoid frequent contact and rubbing over the affected area. Use sunscreen and protective clothing when outdoors. If this symptom does not get better, speak to a doctor.

    References

    1. KD. Tripathi. Hypolipidemic drugs, Vitamins. Essentials of medical pharmacology. Eighth edition. 2019. Page – 682-693, 971.

    2. Jan Malik, Vojtech Melenovsky, Dan Wichterle, Tomas Haas, Jan Simek, Richard Ceska, Jaromir Hradec. Both fenofibrate and atorvastatin improve vascular reactivity in combined hyperlipidemia (fenofibrate versus atorvastatin trial - FAT). Cardiovascular Research, Volume 52, Issue 2, November 2001. [Accessed 21st July 2022] https://academic.oup.com/cardiovascres/article/52/2/290/260518

    3. James A Greenberg, Stacey J Bell, Yong Guan, and Yan-hong Yu, MD, PhD.  Folic Acid Supplementation and Pregnancy: More Than Just Neural Tube Defect Prevention. NIH National Library of Medicine, National center for biotechnology information. PubMed Central. 2011. [Accessed 21st July 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3218540/

    4. Sun Pharmaceutical Industries. Electronic Medicines Compendium (EMC). [Revised in April 2022] [Accessed 21st July 2022] https://www.medicines.org.uk/emc/files/pil.4339.pdf

    5. Merck/Schering-Plough Pharmaceuticals. U.S. Food & Drug Administration. [Revised in September 2007] [Accessed 21st July 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021445s019lbl.pdf

    6. Genus Pharmaceuticals. Electronic Medicines Compendium (EMC). [Revised in August 2020] [Accessed 21st July 2022] https://www.medicines.org.uk/emc/files/pil.5267.pdf

    7. Accord, Barnstaple. Electronic Medicines Compendium (EMC). [Revised in May 2019] [Accessed 21st July 2022] https://www.medicines.org.uk/emc/files/pil.5788.pdf                                                                                                                                                                                                                                        

     

    Useful Diagnostic Tests

    • Cholesterol-HDL
    • Cholesterol-LDL
    • Cholesterol–Total

    Author Details

    Written By Dr. Janet.C - Pharm.D
    Reviewed For Accuracy By Dr. Venkatesh Poludasu - MBBS
    Last updated on 05 Jan 2023 | 11:53 AM(IST)
    Lab updated