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AZOCAN-P - patient leaflet, side effects, dosage

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Patient leaflet - AZOCAN-P

1. what azocan-p is and what it is used for

Fluconazole, the active ingredient, belongs to a group of medicines called anti-fungal agents and it is used to treat infections caused by fungi and may also be used to stop you from getting a candidal infection. The most common cause of fungal infections is yeast called Candida.

Azocan-P is used to treat a fungal infection called vaginal thrush (in women) and associated candidal balanitis (in men).

What is vaginal thrush?

Vaginal thrush is caused by tiny yeast called Candida. Many women have the yeast living quite happily and problem-free within their bodies. However, the natural balance that keeps Candida under control can be upset by other factors, e.g. antibiotics, diabetes, poor general health, the Pill, or damage to vaginal tissues. Then the levels of yeast become too high and thrush develops. The most common symptoms are:

l Itching around the outside of the vagina.

l Soreness which becomes worse with rubbing and scratching. Also the salt in urine can sting the sore tissue.

l A white, non-smelling discharge from the vagina.

Not every woman who has thrush will have all of these symptoms. Some general advice to help stop thrush coming back:

l Wash regularly, but do not wash and dry yourself too harshly.

l Avoid tight clothing.

l Wear cotton underwear and stockings rather than tights.

l Avoid perfumed soaps, bath additives and vaginal deodorants.

l Change your tampon frequently as a blood-soaked tampon can provide ideal conditions for yeast growth.

Sexual intercourse can damage delicate tissue and aggravate thrush. Vaginal thrush is not “VD”, but may be passed on to your partner through intercourse. If your attack of thrush was successfully treated, but keeps coming back, your partner may need to take Azocan- P himself. If you are unsure why your thrush keeps coming back, or are unsure if your partner has thrush, you or your partner should see a doctor.

What is candidal balanitis?

Candidal balanitis (penile thrush) is caused by yeast called Candida. Balanitis is the medical term used to describe inflammation of the end of the penis. The foreskin may also be inflamed. Thrush can be passed on from your partner through sexual intercourse.

(Thrush is not “VD” – see “What is vaginal thrush?”). The most common symptoms are:

l Soreness, redness and irritation of the penis.

l Tightness of the foreskin.

l A white, non-smelling discharge from the penis.

l Not every man who has candidal balanitis will have all of these symptoms.

2. what you need to know before you take azocan-p

Do not take AZOCAN-P if:

l You have ever had an allergic reaction to fluconazole, to other medicines you have taken to treat fungal infections or to any of the other ingredients of this medicine (listed in section 6). The symptoms may include itching, reddening of the skin or difficulty in breathing.

l You are taking terfenadine or astemizole (antihistamine medicines for allergies), cisapride (used for stomach upsets), pimozide (used for treating mental illness), quinidine (used for treating heart arrhythmia), erythromycin (an antibiotic for treating infections).

Warnings and precautions

Talk to your doctor or pharmacist before taking Azocan-P

l if you have any disease or illness affecting your liver or kidneys

l if you suffer from heart disease, including heart rhythm problems

l if you have abnormal levels of potassium, calcium or magnesium in your blood

l if you develop severe skin reactions (itching, reddening of the skin or difficulty in breathing)

l if you develop signs of ‘adrenal insufficiency' where the adrenal glands do not produce adequate amounts of certain steroid hormones such as cortisol (chronic, or long lasting fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain)

l if you or your partner have had exposure to a sexually transmitted disease

l if you are unsure about the cause of your symptoms

Women only: If

l You have any abnormal or irregular vaginal bleeding or a blood stained discharge.

l You have vulval or vaginal sores, ulcers or blisters.

l You are experiencing lower abdominal pain or burning on passing urine.

Men only: If

l Your sexual partner does not have vaginal thrush.

l You have penile sores, ulcers or blisters.

l You have an abnormal penile discharge (leakage).

l Your penis has started to smell.

l You have pain on passing urine.

Other medicines and AZOCAN-P

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines including medicines obtained without a prescription.

Tell your doctor immediately if you are taking astemizole, terfenadine (an antihistamine for treating allergies) or cisapride (used for stomach upsets) or pimozide (used for treating mental illness) or quinidine (used for treating heart arrhythmia) or erythromycin (an antibiotic for treating infections) as these should not be taken with Azocan-P (see section: “Do not take Azocan-P if you”).

There are some medicines that may interact with Azocan-P. Make sure your doctor knows if you are taking any of the following medicines:

l nifedipine, isradipine, amlodipine, felodipine and losartan (for hypertension-high blood pressure)

l rifampicin, rifabutine (antibiotics for infections)

l medicines that thin the blood to prevent blood clots (Warfarin or similar medicines)

l benzodiazepines (midazolam, triazolam or similar medicines) used to help you sleep or for anxiety

l olaparib (used for treating ovarian cancer)

l chlorpropamide, glibenclamide, glipizide or tolbutamide (used to control diabetes)

l phenytoin, carbamazepine (used for treating fits)

l ciclosporin, everolimus, sirolimus or tacrolimus (to prevent transplant rejection)

l theophylline (used to control asthma)

l tofacitinib (used for treating rheumatoid arthritis)

l zidovudine, also known as AZT, or saquinavir (used in HIV-infected patients)

l prednisone (steroid)

l oral contraceptives

l alfentanil, fentanyl (used as anaesthesia)

i celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (Non

Steroidal Anti-Inflammatory Drugs (NSAID))

i amitriptyline and nortriptyline (used as anti-depressant)

i amphotericin B, voriconazole (anti-fungal)

i cyclophosphamide and vinca alkaloids (vincristine, vinblastine or similar medicines) used for treating cancer

i halofantrine (used for treating malaria)

i statins (atorvastatin, simvastatin and fluvastatin or similar medicines) used for reducing high cholesterol levels

i vitamin A (nutritional supplement)

i methadone (used for pain)

i ivacaftor (used for treating cystic fibrosis)

i amiodarone (used for treating uneven heartbeats ‚arrhythmias‘)

i hydrochlorot­hiazide (a diuretic)

Azocan-P with food and drink

You may take the capsule with or without a meal.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant, are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

You should not take Azocan-P while you are pregnant unless your doctor has told you to.

You can continue breast-feeding after taking a single dose of Azocan-P up to 150 mg.

You should not breast-feed if you are taking a repeated dose of Azocan-P.

Driving and using machines

When driving vehicles or using machines, it should be taken into account that occasionally dizziness or fits may occur.

Azocan-P contains lactose (milk sugar) and sodium (salt)

This medicine contains a small amount of lactose (milk sugar). If your doctor has told you that you have an intolerance to some sugars, such as lactose, please contact your doctor before taking this medicine.

Azocan-P capsules contain less than 1 mmol sodium (23 mg) per capsule, that is to say essentially 'sodium-free’

3. how to take azocan-p

Adults aged 16–60 years: The dose is one capsule. Swallow the capsule whole with a drink of water.

Not recommended for use in children under 16 years or adults over 60 years.

Consult your doctor if symptoms have not been relieved within 1 week of taking this medicine.

If symptoms worsen at any time talk to your doctor.

If you take more capsules than you should: Contact your doctor or the nearest hospital as soon as possible.

  • 4. POSSIBLE SIDE-EFFECTS

5. how to store azocan-p

i Keep out of the sight and reach of children.

i Do not store above 25oC.

i Do not use your medicine after the expiry date shown on the carton after EXP. The expiry date refers to the last day of the month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. contents of the pack and other information

What AZOCAN-P contains

The capsule contains 150mg fluconazole as the active ingredient. The capsule also contains lactose, pregelatinised maize starch, sodium laurilsulfate, colloidal anhydrous silica, magnesium stearate, purified talc and the capsule shell also contains gelatin, sodium laurilsulfate, water and the colours brilliant blue (E133) and titanium dioxide (E171).

What AZOCAN-P looks like and contents of pack

This medicine is supplied as a pack of single blue capsule.

Marketing Authorisation Holder and Manufacturer

FDC International Ltd, Unit 6, Fulcrum 1, Solent Way, Whiteley, Fareham,

Hampshire, PO15 7FE

Hard to see or read the leaflet? Call+ 44(0) 1489 565222 f­or help.

This leaflet was last revised in February 2020.

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