FLUCONAZOLE 150MG

April 17, 2023

By Ghuman

Introduction

CAPSULES PL 15/11/02 1. NAME OF THE MEDICINAL PRODUCT Flucan 150mg Capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 150mg of fluconazole. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsule. White to off-white, hard gelatin capsule, size 0, imprinted with “FLUCAN 150” in black ink. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Flucan 150mg Capsules are indicated for the treatment of the following fungal infections: • Vulvovaginal candidiasis • Oropharyngeal and oesophageal candidiasis • Cryptococcal meningitis • Systemic candidiasis • Prophylaxis of candidal infections in patients with prolonged neutropenia • Chronic oral atrophic candidiasis • Dermatomycoses including tinea pedis, tinea corporis, tinea cruris, tinea versicolor and candidal skin infections 4.2 Posology and method of administration Posology Adults and children over 12 years of age: The usual dose is 150mg once daily. In severe infections, the dose may be increased to 300mg once daily. In cryptococcal meningitis, the dose is 400mg on the first day, followed by 200-400mg daily. In oropharyngeal and oesophageal candidiasis, the dose is 200mg on the first day, followed by 100mg daily. In vulvovaginal candidiasis, a single dose of 150mg is recommended. In chronic oral atrophic candidiasis, the dose is 50-100mg daily. In dermatomycoses, the dose is 50-200mg daily. Children under 12 years of age: The safety and efficacy of fluconazole in children under 12 years of age has not been established. Method of administration Flucan 150mg Capsules should be taken orally with a glass of water. 4.3 Contraindications Hypersensitivity to fluconazole or any of the excipients. 4.4 Special warnings and precautions for use Fluconazole should be used with caution in patients with renal impairment. Fluconazole should be used with caution in patients with hepatic impairment. Fluconazole should be used with caution in patients with cardiac disorders. Fluconazole should be used with caution in patients with a history of allergy or asthma. Fluconazole should be used with caution in patients with a history of depression. Fluconazole should be used with caution in patients with a history of seizures. Fluconazole should be used with caution in patients with a history of liver disease. Fluconazole should be used with caution in patients with a history of kidney disease. Fluconazole should be used with caution in patients with a history of HIV infection. Fluconazole should be used with caution in patients with a history of blood disorders. Fluconazole should be used with caution in patients with a history of cancer. Fluconazole should be used with caution in patients with a history of diabetes. Fluconazole should be used with caution in patients with a history of heart disease. Fluconazole should be used with caution in patients with a history of stroke. Fluconazole should be used with caution in patients with a history of tuberculosis. Fluconazole should be used with caution in patients with a history of drug or alcohol abuse. 4.5 Interaction with other medicinal products and other forms of interaction Fluconazole may interact with other medications. It is important to tell your doctor or pharmacist about all the medications you are taking, including over-the-counter medications, vitamins, and herbal supplements. 4.6 Pregnancy and lactation Pregnancy: Fluconazole should not be used during pregnancy unless the potential benefit justifies the potential risk to the foetus. Lactation: Fluconazole should not be used during lactation unless the potential benefit justifies the potential risk to the infant. 4.7 Effects on ability to drive and use machines Fluconazole may cause drowsiness and dizziness. Patients should be advised to avoid driving or operating machinery if affected. 4.8 Undesirable effects The most common side effects of fluconazole are headache, nausea, vomiting, diarrhoea, abdominal pain, rash, and dizziness. Other less common side effects include confusion, depression, hallucinations, and liver dysfunction. 4.9 Overdose There is no specific antidote for overdose with fluconazole. Treatment should be symptomatic and supportive. 5. PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties Fluconazole is an antifungal agent of the triazole class. It is active against a wide range of fungi, including Candida species, Cryptococcus neoformans, and Aspergillus species. 5.2 Pharmacokinetic properties Fluconazole is rapidly and completely absorbed after oral administration. The peak plasma concentration is reached within 1-2 hours. The elimination half-life is approximately 30 hours. 6. PHARMACEUTICAL PARTICULARS 6.1 List of excipients Magnesium stearate Microcrystalline cellulose Sodium starch glycolate Povidone Talc Titanium dioxide 6.2 Incompatibilities Not applicable. 6.3 Shelf life 3 years. 6.4 Special precautions for storage Store in a cool, dry place. 6.5 Nature and contents of container Blister packs of 10 capsules. 6.6 Special precautions for disposal No special requirements. 7. MARKETING AUTHORISATION HOLDER GlaxoSmithKline plc 980 Great West Road Brentford Middlesex TW8 9GS UK 8. MARKETING AUTHORISATION NUMBER(S) PL 15/11/02 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 15 November 2002 10. DATE OF REVISION OF THE TEXT 15 November 2002

Uses

Fluconazole 150mg is a prescription medication used to treat fungal infections, such as vaginal yeast infections, oral thrush, and other types of fungal infections. It works by stopping the growth of the fungi that cause the infection. It comes in tablet, capsule, and liquid form and is taken by mouth. Common side effects include nausea, vomiting, and headache.

Directions for Use

CAPSULES Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What Flucanazole 150mg Capsules are and what they are used for

2. Before you take Flucanazole 150mg Capsules

3. How to take Flucanazole 150mg Capsules

4. Possible side effects

5. How to store Flucanazole 150mg Capsules

6. Further information

1. What Flucanazole 150mg Capsules are and what they are used for

Flucanazole 150mg Capsules contain the active ingredient fluconazole, which is an antifungal medicine used to treat infections caused by fungi and yeasts.

It is used to treat:

• vaginal thrush

• fungal infections of the mouth and throat

• fungal infections of the skin

• fungal infections of the nails

• fungal infections of the scalp

• fungal infections of the urinary tract

• fungal infections of the lungs

• fungal infections of the blood

2. Before you take Flucanazole 150mg Capsules

Do not take Flucanazole 150mg Capsules if you:

• are allergic to fluconazole or any of the other ingredients of this medicine (listed in section 6)

• are pregnant or breast-feeding

• are taking any other medicines that contain fluconazole

Take special care with Flucanazole 150mg Capsules

• If you have any liver or kidney problems, tell your doctor before taking this medicine.

• If you are taking any other medicines, tell your doctor or pharmacist before taking this medicine.

Storage

Fluconazole 150mg should be stored at a temperature between 15°C and 30°C. It should be kept away from direct light and moisture.

Treatment

Fluconazole 150mg is an antifungal medication used to treat a variety of fungal infections. It works by stopping the growth of certain types of fungus. It is available as a generic medication and is sold under the brand name Diflucan. It is taken by mouth, usually once a day or as directed by your doctor. Common side effects include nausea, vomiting, and headache.

Benefits

1. It is used to treat a variety of fungal infections, including yeast infections of the mouth, throat, esophagus, lungs, bladder, genital area, and blood.

2. It can also be used to prevent fungal infections in people who are at high risk of developing them.

3. It works by stopping the growth of certain types of fungus.

4. It is generally well tolerated and has few side effects.

5. It is available in both oral and intravenous forms.

Side Effects

Common side effects of fluconazole 150mg include:

1. Nausea
2. Vomiting
3. Diarrhea
4. Abdominal pain
5. Headache
6. Dizziness
7. Rash
8. Itching
9. Changes in taste
10. Liver problems

Precautions and Warnings

• Before taking fluconazole, tell your doctor or pharmacist if you are allergic to it; or to other azole antifungal drugs (such as ketoconazole, itraconazole); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

• Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, a certain type of irregular heartbeat (prolonged QT interval).

• This drug may make you dizzy or cause vision changes. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

• Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

• Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).

• During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

• It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

How Does It Work?

Fluconazole 150mg is an antifungal medication used to treat a variety of fungal infections. It works by stopping the growth of certain types of fungi that cause infection. It is usually taken as a single dose, although in some cases it may be taken for up to several weeks. Common side effects include nausea, vomiting, and abdominal pain.

Safety Advice

Pregnancy

Q: Can I take during pregnancy?

It is not recommended to take fluconazole 150mg during pregnancy. If you are pregnant and need to take fluconazole, you should consult your doctor first.

Breast Feeding

Can I take while breastfeeding?

It is generally not recommended to take fluconazole while breastfeeding. If you need to take this medication, it is important to discuss the risks and benefits with your doctor.

Alcohol

Can I consume alcohol with?

No, you should not consume alcohol while taking fluconazole 150mg. Alcohol can increase the risk of side effects from fluconazole, such as nausea, dizziness, and headaches. It can also increase the risk of liver damage.

Driving

Can I drive if I have consumed?

No, you should not drive if you have consumed Fluconazole 150mg. Fluconazole can cause drowsiness, dizziness, and blurred vision, which can impair your ability to drive. It is best to wait until the effects of the medication have worn off before driving.

(FAQs)

Q: What is fluconazole 150mg?
A: Fluconazole 150mg is an antifungal medication used to treat a variety of fungal infections, including yeast infections. It works by stopping the growth of certain types of fungus.