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Introduction About SCLERIFUMA 120 CAPSULE
SCLERIFUMA 120 CAPSULE contains Dimethyl Fumarate which belongs to the group of medicines called Immunosuppressive Agent. It is used to manage relapsing-remitting forms of multiple sclerosis in patients aged 13 years and older. Multiple sclerosis is a long-term condition that affects the brain and the spinal cord. Relapsing-remitting Multiple sclerosis is characterised by repeated attacks (relapses) of nervous system symptoms such as walking difficulties, feeling off balance, visual difficulties (e.g., blurred, or double vision).
Before and during the management your doctor will perform blood tests to determine your health condition. Avoid consumption of alcohol while taking SCLERIFUMA 120 CAPSULE as it may cause gastritis (inflammation of the stomach). SCLERIFUMA 120 CAPSULE is not recommended in patients with (PML) progressive multifocal leukoencephalopathy (a rare brain infection). SCLERIFUMA 120 CAPSULE should be used with caution in patients with lung problems (such as pneumonia), severe kidney and liver problems, stomach or bowel disease.
SCLERIFUMA 120 CAPSULE is generally not recommended for use in pregnant or breastfeeding women. Safety data of SCLERIFUMA 120 CAPSULE for children below 13 years of age has not been established yet. The most common side effects of taking SCLERIFUMA 120 CAPSULE are flushing (reddening of face), diarrhea, nausea or stomach pain. Contact your doctor if your symptoms get worse.
Uses Of SCLERIFUMA 120 CAPSULE
- manages relapsing-remitting forms of multiple sclerosis
How SCLERIFUMA 120 CAPSULE Works
SCLERIFUMA 120 CAPSULE functions by managing the body's defence mechanism from destroying the brain and spinal cord. Additionally, it might manage multiple sclerosis from getting worse in the future.
How to use SCLERIFUMA 120 CAPSULE
Take SCLERIFUMA 120 CAPSULE as advised by your physician. Take the medicine with a glass of water. Do not crush, dissolve or chew the medicine. Take it with food. Depending on your age, body weight, and medical state, your doctor will determine the appropriate dose and duration for you.
Side Effects Of SCLERIFUMA 120 CAPSULE
Common
- reddening of the face or body feeling warm, hot, burning or itchy (flushing)
- loose stools (diarrhoea)
- nausea and vomiting
- stomach pain or stomach cramps
- gastroenteritis (inflammation of the lining of intestines), gastritis (stomach lining inflammation)
- dyspepsia (unable to digest)
- itchy skin, rashes
- erythema (red or pink blotches on the skin)
- hair loss
- throat pain, cough, and painful menstrual periods (mostly in children)
Rare
- allergic reactions
Stop taking SCLERIFUMA 120 CAPSULE and contact your physician immediately if you experience any of the following side effects:
- severe (anaphylaxis) allergic reactions such as reddening of the face or body, feeling warm, hot, burning, or itchy (flushing), red rash or hives (rashes), angioedema (swelling of the face, lips, mouth, or tongue), wheezing, shortness of breath or difficulty breathing, hypotension (loss of consciousness or dizziness)
- serious kidney disorder (Fanconi Syndrome) (symptoms include passing more urine, drinking more water than normal, weaker muscles, you break a bone, or just have aches and pains)
- symptoms of herpes zoster (shingles)
- a rare brain infection called progressive multifocal leukoencephalopathy (PML) (symptoms include new or worsening weakness on one side of the body, clumsiness, changes in vision, thinking, memory, personality changes, or communication difficulties)
How To Manage Side Effects
Diarrhoea:
Drink plenty of water and fruit juice to keep yourself hydrated. Contact your doctor if the diarrhoea did not improve.
Nausea and vomiting:
Stick to simple meals. Avoid eating oily or spicy food. If nausea and vomiting does not improve, consult your doctor.
Skin rash:
Hot water can irritate the skin, so avoid taking hot showers. Do not scratch the affected area. Contact your doctor if the rashes did not improve.
Stomach pain:
Avoid oily and spicy food. Keep a heat pad on your stomach. consult your doctor if symptoms do not improve.
Warning & Precautions
Pregnancy
SCLERIFUMA 120 CAPSULE is generally not recommended for use in pregnant women or women planning to have a baby, unless considered necessary. Contact your doctor before taking SCLERIFUMA 120 CAPSULE.
Breastfeeding
SCLERIFUMA 120 CAPSULE is generally not recommended for use in breastfeeding women, unless considered necessary. Contact your doctor before taking SCLERIFUMA 120 CAPSULE.
Driving and Using Machines
SCLERIFUMA 120 CAPSULE does not affect your ability to drive or operate machines.
Alcohol
Avoid consumption of alcohol while taking SCLERIFUMA 120 CAPSULE as it may cause gastritis (inflammation of the stomach), especially in those who are already at risk for gastritis. Contact your doctor before taking SCLERIFUMA 120 CAPSULE.
Kidney
SCLERIFUMA 120 CAPSULE should be used with caution in patients with severe kidney disease. Contact your doctor before taking SCLERIFUMA 120 CAPSULE.
Liver
SCLERIFUMA 120 CAPSULE should be used with caution in patients with severe liver diseases. Contact your doctor before taking SCLERIFUMA 120 CAPSULE.
Allergy
Do not take SCLERIFUMA 120 CAPSULE if you are allergic (hypersensitive) to dimethyl fumarate or any other ingredients of this medicine.
Lungs
SCLERIFUMA 120 CAPSULE should be used with caution in patients with lung diseases (such as pneumonia). Contact your doctor before taking SCLERIFUMA 120 CAPSULE.
Others
SCLERIFUMA 120 CAPSULE is not recommended for use if you:
- have (PML) progressive multifocal leukoencephalopathy (a rare brain infection)
Before taking SCLERIFUMA 120 CAPSULE, inform your doctor if you have:
- stomach or bowel disease
Use in paediatrics:
Safety data of SCLERIFUMA 120 CAPSULE for children below 13 years of age has not been established yet. Contact your doctor before taking SCLERIFUMA 120 CAPSULE.
Interactions
A. Drug-Drug interactions:
Before taking SCLERIFUMA 120 CAPSULE, inform your doctor if you are taking any of the following medicine:
- fumarates (fumaric acid esters) (used to manage psoriasis)
- other medications that affect the immune system (Ex. natalizumab, fingolimod, alemtuzumab, teriflunomide, ocrelizumab or cladribine)
- medicines to manage cancer (Ex. rituximab or mitoxantrone)
- medications that can have harmful effects on the kidneys, which include some antibiotics (Ex. gentamicin, neomycin)
- diuretics (used to manage blood pressure)
- specific types of painkillers (such as ibuprofen)
- lithium (used for mental illness)
- live vaccines (medicines used to manage infections)
Overdosage:
If you or anyone else accidentally takes too much of SCLERIFUMA 120 CAPSULE, consult your doctor immediately or visit the nearby hospital.
Synopsis
| Drug | : | Dimethyl Fumarate |
| Pharmacological Category | : | Immunosuppressive Agent |
| Therapeutic Indication | : | Relapsing forms of multiple sclerosis |
| Dosage Forms | : | Capsule |
More Information
- Keep SCLERIFUMA 120 CAPSULE out of the sight and reach of children
- Store SCLERIFUMA 120 CAPSULE below 25°C
FAQs About SCLERIFUMA 120 CAPSULE
What is SCLERIFUMA 120 CAPSULE used for?
SCLERIFUMA 120 CAPSULE is used to manage relapsing-remitting forms of multiple sclerosis in patients aged 13 years and older. Relapsing-remitting Multiple sclerosis is characterised by repeated attacks (relapses) of nervous system symptoms such as walking difficulties, feeling off balance, visual difficulties (e.g., blurred, or double vision).
What are the parameters to be monitored while taking SCLERIFUMA 120 CAPSULE?
Prior to the management your doctor will perform blood tests to determine the number of white blood cells and frequent monitoring of the liver and kidney is recommended during therapy. Consult your doctor for more information.
How does SCLERIFUMA 120 CAPSULE work?
SCLERIFUMA 120 CAPSULE functions by managing the body's defence mechanism from destroying the brain and spinal cord. Additionally, it might manage Multiple Sclerosis from getting worse in the future.
Can SCLERIFUMA 120 CAPSULE be used in pregnant and breastfeeding women?
No, SCLERIFUMA 120 CAPSULE is generally not recommended for use in pregnant and breastfeeding women, unless considered necessary. Contact your doctor before taking SCLERIFUMA 120 CAPSULE.
Can SCLERIFUMA 120 CAPSULE affect thyroid function?
No, SCLERIFUMA 120 CAPSULE does not affect the functioning of the thyroid gland (an organ that secretes hormones to regulate metabolism). Consult your doctor for more information.
References
1. Robert J. Kizior, Keith J. Hodgson. Dimethyl fumarate. Saunders Nursing Drug handbook 2021. 29th edition. 2021. Page – 343.
2. Cada DJ, Levien TL, Baker DE. Dimethyl fumarate.NIH: National Library of Medicine, National Center for Biotechnology Information. Pubmed Central. September 2013. [Accessed on 5th August 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3847980/
3. Ghasemi N, Razavi S, Nikzad E. Multiple Sclerosis: Pathogenesis, Symptoms, Diagnoses and Cell-Based Therapy. NIH: National Library of Medicine, National Center for Biotechnology Information. Pubmed Central. April-June 2017. [Accessed on 5th August 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5241505/
4. FUJIFILM Diosynth Biotechnologies Denmark ApS. Electronic Medicines Compendium (EMC). [Revised in May 2022] [Accessed on 5th August 2022] https://www.medicines.org.uk/emc/files/pil.5256.pdf
5. FUJIFILM Diosynth Biotechnologies Denmark ApS. European Medical Agency. [Revised in September 2018] [Accessed on 5th August 2022] https://www.ema.europa.eu/en/documents/product-information/tecfidera-epar-product-information_en.pdf
6. Biogen Inc. U.S. Food & Drug Administration. [Revised in January 2017] [Accessed on 5th August 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204063s017lbl.pdf
Useful Diagnostic Tests
- complete blood count
- kidney function test
- liver function test
- magnetic resonance imaging scan
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