INTRODUCTION
FLEX 150 TABLET contains Fluconazole which belongs to the group of medicines called Anti-fungal agents. It is used to treat various fungal infections such as systemic candidiasis (fungal infection affecting the blood, brain, heart, eyes or other parts of the body), mucosal candidiasis (fungal infection affecting the mouth, throat or denture sore mouth), cryptococcosis (fungal infection mainly affecting the lungs and brain), vaginal candidiasis (fungal infection of the vagina and tissues at the opening of vagina (vulva)).
Also, it prevents fungal infections in immunocompromised patients considered at risk as a consequence of HIV infection or low white blood cell count after cytotoxic chemotherapy, radiotherapy or bone marrow transplant. ?
Before taking FLEX 150 TABLET, inform your doctor if you have liver, kidney or heart problems, abnormal levels of potassium, calcium, or magnesium in your blood, are prone to develop severe skin reactions and have a history of adrenal insufficiency. ?
FLEX 150 TABLET is not recommended for use in pregnant and breast-feeding women unless clearly advised by the doctor. FLEX 150 TABLET should be used with caution in children and adolescents (from birth to 17 years of age). It should be used with caution in elderly patients particularly with renal impairment.
The most common side effects of taking FLEX 150 TABLET are headache, nausea, vomiting diarrhea, abdominal pain, and indigestion. Consult your doctor if any of the side effect gets worse.
USES OF FLEX 150 TABLET

Treats various fungal infections (such as systemic candidiasis, mucosal candidiasis, cryptococcosis and vaginal candidiasis) ?

Prevents fungal infection in immunocompromised patients

HOW FLEX 150 TABLET WORKS
FLEX 150 TABLET works by stopping the action of an enzyme called ergosterol, which is an integral part of the fungal cell membrane to increase its cellular permeability. Thereby, making the cell membrane more permeable and stops the fungal growth. This type of action is useful in treating and preventing various fungal infections.
DIRECTIONS FOR USE
Take FLEX 150 TABLET as advised by your physician. Swallow FLEX 150 TABLET with a glass of water and do not chew or crush the medicine. The correct dose and duration for you will be decide by the doctor depending upon your age, body weight and type of infection.
SIDE EFFECTS OF FLEX 150 TABLET

COMMON

Headache

Nausea, vomiting

Diarrhea

Abdominal pain

Indigestion

Acne

UNCOMMON

Seizures, dizziness, altered nerve sensation and taste

Skin rash with itching, abnormal odor from skin and dry skin

Abnormal changes in vision

Constipation, flatulence and dry mouth

Thirst, tiredness, body pain and fever

Weakness, general feeling of discomfort, rigor

Pharyngitis, herpes simplex viral infection

Loss of appetite

Back, muscle pain, muscle spasm

Renal pain

Head spinning sensation (vertigo)

Insomnia, and nervousness

Muscle overactivity (hypertonia)

Increased urine output

Abnormal or heavy vaginal bleeding, painful menses, vaginal discharge and disorder, uterine spasm, female sexual dysfunction ?

Hot flushes, excess sleepiness

Deafness, increased blood pressure, low oxygen levels, intolerance to oral intake, inflamed and sore mouth (in children)

RARE

Allergic reactions

Low white blood cells and platelet count ?

Hair loss

Damage to liver causing liver failure, hepatitis, and necrosis

Skin reactions (like steven johnson syndrome and toxic epidermal necrolysis)

Shaking

Change in heart rate or rhythm
Stop taking FLEX 150 TABLET and contact your doctor immediately if you experience any of the following side effects:
Sudden wheezing, difficulty in breathing or tightness in the chest, swelling of eyelids, face or lips, itching all over the body, reddening of the skin or itchy red spots

Skin rash that causes blistering in mouth and tongue

Signs of liver problems (tiredness, loss of appetite, vomiting and yellowing of the skin or whites of the eyes)

Signs of DRESS syndrome or drug hypersensitivity syndrome (widespread rash, high body temperature and enlarged lymph nodes)

HOW TO MANAGE SIDE EFFECTS
Diarrhea:
Drink lot of fluids, such as water or fruit juice to keep yourself hydrated. Do not take any medicine on your own to treat diarrhea without consulting your doctor.
Nausea or vomiting:
Stick to simple meals while receiving this medicine. Avoid eating oily rich, fried or spicy foods. Do not lie down or sleep immediately after eating. Consult your doctor if the symptom does not improve.
Stomach pain:
Try to take rest and relax. Eat and drink slowly or try to have smaller and frequent meals. Keep a heat pad on your stomach. If the symptom does not improve, contact your doctor.
Headache:
Drink ample amount of water and avoid skipping meals. Get adequate rest. Try to be relaxed and stress free. Apply pain relieving balm on your forehead if necessary. Consult your doctor if the symptom does not improve.? ?
Dizziness:
Lie down until dizziness is gone, then get up slowly. Move slowly and carefully, do not hurry. Get adequate rest. Drink plenty of water and other fluids. Avoid coffee, cigarettes, alcohol, and drugs. Consult your doctor if the symptom gets worse.
WARNING & PRECAUTIONS

PREGNANCY
FLEX 150 TABLET is not recommended for use during pregnancy unless considered clearly necessary. Consult your doctor before taking FLEX 150 TABLET.
BREASTFEEDING
FLEX 150 TABLET is not recommended for use in breastfeeding women after repeated use or after high dose of this medicine. You may continue breast-feeding after single dose of FLEX 150 TABLET. Consult your doctor before taking FLEX 150 TABLET.
DRIVING AND USING MACHINES
Do not drive or operate any machines if you experience dizziness or fits after taking FLEX 150 TABLET.
KIDNEY
FLEX 150 TABLET should be used with caution in patients with kidney dysfunction. Consult your doctor before taking FLEX 150 TABLET.
LIVER
FLEX 150 TABLET should be used with caution in patients with liver dysfunction. Consult your doctor before taking FLEX 150 TABLET.
ALLERGY
FLEX 150 TABLET is not recommended for use if you are allergic to fluconazole or other azole anti-fungals (such as itraconazole or posaconazole).
HEART DISEASE
FLEX 150 TABLET should be used with caution in patients with heart rhythm problems. Consult your doctor for advice before taking FLEX 150 TABLET.
OTHERS
FLEX 150 TABLET is not recommended for use if you:
Rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
Before taking FLEX 150 TABLET, inform your doctor if you:
Have abnormal levels of potassium, calcium, or magnesium in your blood

Are prone to develop severe skin reactions (itching, reddening of the skin or difficulty in breathing)

Have history of adrenal insufficiency

Have no improvement in fungal infection
Use in Pediatrics:
FLEX 150 TABLET should be used with caution in children and adolescents (from birth to 17 years of age). Consult child?s doctor for advice before administration of FLEX 150 TABLET to your child.
Use in Geriatrics: ?
FLEX 150 TABLET should be used with caution in elderly patients particularly with renal impairment. Your doctor may adjust the dose depending upon kidney function. Consult your doctor for advice before taking FLEX 150 TABLET.
INTERACTIONS
A. Drug-Drug Interactions:
Before taking FLEX 150 TABLET, inform your doctor, if you are taking any of the following medicines:
Medicines used to treat diabetes medicines (Ex. glyburide, tolbutamide, glipizide, chlorpropamide)

Medicines used to treat high blood pressure (Ex. hydrochlorothiazide, nifedipine, isradipine, amlodipine, felodipine and losartan)

Medicines used as blood thinners (Ex. warfarin)

Medicines used to use to prevent rejection of organ transplants (Ex. cyclosporine, tacrolimus, sirolimus)

Rifampicin or rifabutin (used to treat tuberculosis)

Astemizole, terfenadine (used to treat certain type of allergies)

Medicines used to control seizures /fits (Ex. phenytoin or carbamazepine)

Theophylline (used to control asthma)

Cisapride (used to treat heartburn)

Medicines used to treat heart diseases (Ex. quinidine, amiodarone)

Medicines used to treat depression (Ex. amitriptyline, nortriptyline)

Pimozide (used to control motor or verbal tics)

Amphotericin B, voriconazole (medicine for treating various fungal infections)

Erythromycin (used for treating bacterial infections)

Cyclosphosphamide, medicines used for treatment of cancer (Ex. vincristine or vinblastine)

Alfentanil, fentanyl (used as general anesthetic)

Halofantrine (for treating malaria)

Medicines used to treat high cholesterol levels (Ex. atorvastatin, simvastatin, and fluvastatin)

Medicines used to treat painful conditions with inflammation (Ex. celecoxib, ibuprofen, and naproxen)

Prednisone (used to treat inflammatory disorders)

Antiviral medications used to treat HIV infection (Ex. ?saquinavir, zidovudine)

Tofacitinib (used to treat rheumatoid arthritis)

Ivacaftor (medicine used for treating cystic fibrosis)

Ibrutinib (used for treating blood cancer)

Midazolam, triazolam or similar medicines (used to induce sleep and treats anxiety)

Olaparib (used for treating ovarian cancer)

Methadone (used to treat chronic pain and also opioid dependance)
Overdosage:
If you or anyone else accidentally takes too much of FLEX 150 TABLET, consult your doctor immediately or visit the nearby hospital. Overdosage symptoms of FLEX 150 TABLET are hearing, seeing, feeling and thinking things that are not real (hallucination and paranoid behaviour).
SYNOPSIS

Drug :?? Fluconazole

Pharmacological Category :?? Triazoles

Therapeutic Indication :?? Prevent and treats various fungal infections

Dosage Forms :?? Tablet, Dispersible tablet, Capsule, Injection, Infusion, Dry syrup, Dusting powder, Gel, Cream, Ear drops, Eye drops, Soap

MORE INFORMATION

Keep FLEX 150 TABLET out of reach of children

Store at room temperature

FAQs ABOUT FLEX 150 TABLET
How does FLEX 150 TABLET work?
FLEX 150 TABLET works by stopping the action of an enzyme called ergosterol, which is an integral part of the fungal cell membrane to increase its cellular permeability. Thereby, making the cell membrane more permeable and stops the fungal growth. This type of action is useful in treating and preventing various fungal infections.
What if I forget to take a dose of FLEX 150 TABLET?
If you have missed a dose of FLEX 150 TABLET, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take the next scheduled dose. Do not double the dose of FLEX 150 TABLET to make up for the missed one as this may increase the chances of developing side effects.
What are the common side effects of FLEX 150 TABLET?
The common side effects of taking FLEX 150 TABLET are headache, nausea, vomiting, diarrhea, abdominal pain, indigestion and acne. Consult your doctor if any of the symptom gets worse or does not improve over the time
Can FLEX 150 TABLET be used in elderly patients?
FLEX 150 TABLET should be used with caution in elderly patients particularly with renal impairment. Your doctor may adjust the dose depending upon kidney function. Consult your doctor for advice before taking FLEX 150 TABLET.
Is FLEX 150 TABLET safe to use during pregnancy?
FLEX 150 TABLET is not recommended for use during pregnancy unless clearly advised by the doctor. Consult your doctor before taking FLEX 150 TABLET if you are pregnant or planning to get pregnant.
REFERENCES
1. KD. Tripathi. Section, Antifungal Drugs. Essentials of medical pharmacology. Seventh edition. 2013. Page ? 787.
2. Ameish Govindarajan;?Karlyle G. Bistas;?Curtis J. Ingold;?Ayham Aboeed. NIH National Library of Medicine, National center for biotechnology information. June 2022. [Accessed on 12th July 2022] https://www.ncbi.nlm.nih.gov/books/NBK537158
3. Josilene Chaves Ruela Corrra & Herida Regina Nunes Salgado. Review of Fluconazole Properties and Analytical Methods for Its Determination, Critical Reviews in Analytical Chemistry. May 2011. [Accessed on 12th July 2022] https://www.tandfonline.com/doi/abs/10.1080/10408347.2011.557980?journalCode=batc20
3. Viatris Ltd. Fluconazole. [Revised in March 2022] [Accessed on 12th July 2022] https://www.medsafe.govt.nz/profs/datasheet/f/fluconazolecapmylan.pdf
4. Accord Healthcare Limited. Electronic Medicines Compendium (EMC). [Revised in April 2021] [Accessed on 12th July 2022] https://www.medicines.org.uk/emc/files/pil.6086.pdf
5. FDC limited. Zocon (Fluconazole tablets) [Revised in July 2022] [Accessed on 12th July 2022] http://fdcindia.com/PackageInsert/ZoconTablets.pdf
USEFUL DIAGNOSTIC TESTS

Complete blood count

Liver function test

Net Qty

1 N

Item Weight

15 g

Ingredient

FLUCONAZOLE 150 mg

Hsn Code

30049029

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