TESCO HEALTH THRUSH RELIEF 150 MG CAPSULE, FLUCONAZOLE 150 MG CAPSULES, BELLS HEALTHCARE THRUSH RELIEF ORAL 150 MG CAPSULE - patient leaflet, side effects, dosage

Patient leaflet - TESCO HEALTH THRUSH RELIEF 150 MG CAPSULE, FLUCONAZOLE 150 MG CAPSULES, BELLS HEALTHCARE THRUSH RELIEF ORAL 150 MG CAPSULE

I. What Bell's Healthcare Thrush Relief Oral ISOmg Capsule is and what it is used for

2. What you need to know before you take Bell's Healthcare Thrush Relief Oral ISOmg Capsule

3. Howto take Bell's Healthcare Thrush Relief Oral

ISOmg Capsule

4. Possible side effects

5. How to store Bell's Healthcare Thrush Relief Oral ISOmg Capsule

6. Contents of the pack and other information

I. WHAT BELL'S HEALTHCARE THRUSH RELIEF ORAL I50MG CAPSULE IS AND WHAT IT IS USED FOR

Fluconazole is an antifungal agent. Your medicine is used for treating a fungal infection called vaginal thrush. Vaginal thrush is caused by a yeast called

Candida. Many women have this yeast living in their bodies harmlessly. If something such as antibiotics, ill health or the pill upsets the natural balance that keeps Candida under control, then candidal infections occur.

The most common symptoms of vaginal thrush are:

Redness and swelling of the tissues of the vagina and vulva
Itching around the outside of the vagina
Soreness
A white, non-smelling discharge from the vagina.

You may have one or more of these symptoms.

If your partner has penile thrush he may have one or more of the following symptoms:

Soreness and redness of the penis
Tightness ofthe foreskin
Awhile non-smelling penile discharge.

To stop thrush coming back:

Wash regularly
Avoid tight clothing
Wearcottonunderwearand stockings ratherthan tights
Avoid perfumed soaps and bath additives
Changeyourtamponfrequently.

Sexual intercourse can damage these delicate tissues and make thrush worse. Occasionally you can pass thrush to your partner through intercourse.

2. what you need to know before you take

BELL'S HEALTHCARE THRUSH RELIEF ORAL ISOMG CAPSULE

This medicine can be used by adults between the ages of 16 and 60 years.

You should take Bell's Healthcare Thrush Relief Oral ISOmg Capsule only ifyou are sure that you have vaginal thrush. Remember that other infections can cause similar symptoms to thrush and that you could have more than one type of infection at the same time. Ifyou are in any doubt that you have thrush orthinkyou could have another infection at the same time, you should see your doctor before you take fluconazole.

Do not take Bell's Healthcare Thrush Relief Oral ISOmg Capsule

if you are allergic 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
if you are taking astemizole, terfenadine (antihistamine medicines for allergies)
ifyou aretakingcisapride (used for stomach upsets)
ifyou aretakingpimozide (used fortreating mental illness)
ifyouaretakingquinidine(usedfortreatingheartarrhythmia)
if you are taking erythromycin (an antibiotic for treating infections)
if you are taking amiodarone (used for treating uneven heartbeats ‘arrhythmias’).

Warnings and precautions

Talk to your doctor or pharmacist before taking Fluconazole

if you have liveror kidney problems
ifyou suffer from heart disease, including heart rhythm problems
ifyou have abnormal levels of potassium, calcium or magnesium inyourblood
if you develop severe skin reactions (itching, reddening of the skin or difficulty in breathing)
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).

Other medicines and Bell's Healthcare Thrush Relief Oral ISOmg Capsule:

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

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

There are some medicines that may interact with Fluconazole. Make sure your doctor knows ifyou are taking any of the following medicines:

rifampicin or rifabutin (antibiotics for infections)
alfentanil, fentanyl (used as anaesthetic)
amitriptyline, nortriptyline (used as anti-depressant)
amphotericin B, voriconazole (anti-fungal)
medicines that thin the blood to prevent blood clots (warfarin or similar medicines)
benzodiazepines (midazolam, triazolam or similar medicines) used to helpyou sleep or for anxiety
carbamazepine, phenytoin (used fortreating fits)
olaparib (used for treating ovarian cancer)
nifedipine, isradipine, amlodipine, felodipine and losartan (for hypertension – high blood pressure)
cidosporin, everolimus, sirolimus or tacrolimus (to prevent transplant rejection)
cydosphosphamide, vinca alkaloids (vincristine, vinblastine or similar medicines) used fortreating cancer
halofantrine (used fortreating malaria)
statins (atorvastatin, simvastatin and fluvastatin or similar medicines) used for reducing high cholesterol levels
methadone (used for pain)
celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam,

meloxicam, diclofenac (Non-Steroidal Anti-Inflammatory Drugs (NSAID))

oral contraceptives
prednisone (steroid)
zidovudine, also known as AZT; saquinavir (used in HIV-infected patients)
medicines for diabetes such as chlorpropamide, glibendamide, glipizide or tolbutamide
theophylline (used to control asthma)
vitamin A (nutritional supplement)
ivacaftor (used fortreating cystic fibrosis)
amiodarone (used fortreating uneven heartbeats ‚arrhythmias‘)
hydrochlorothiazide (a diuretic).
tofacitinib (used for treating rheumatoid arthritis)

Bell's Healthcare Thrush Relief Oral l50mg Capsule with food and drink

You can take your medicine with or without a meal at any time of day. Take the capsule with a glass of water.

Pregnancy, breast-feeding and fertility

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

You should not take Fluconazole while you are pregnant unless your doctor has told you to. You can continue breast-feeding after taking a single dose of ISOmg Fluconazole. You should not breast-feed if you are taking a repeated dose of Fluconazole.

Driving and using machines

Bell's Healthcare Thrush Relief Oral ISOmg Capsule may occasionally cause dizziness or fits. If affected do not drive or use machinery.

Bell's Healthcare Thrush Relief Oral l50mg Capsule contain lactose.

If you have been told by your doctor that you have an intolerance to some sugars,contactyourdoctor beforetakingthis medicinal product.

3. how to take bell's healthcare thrush relief oral isomg capsule

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist ifyou are not sure.

You should read the instructions on the pack. Bell's Healthcare Thrush ReliefOral ISOmg Capsule should only betaken by mouth.

The whole course of treatment for vaginal thrush is one capsule which you take by mouth. Take the capsule with aglass of water.

Some women notice an improvement after one day and the thrush should clear up after 2 days. If symptoms persist for more than 7 days, consult yourdoctor.

If after treatment with Bell's Healthcare Thrush Relief Oral ISOmg Capsule you have a re-occurrence of thrush, you should only take this product again if it has been more than 7 days since your last treatment.

If you experience a thrush infection more than twice over a six month period,consult yourdoctor.

Remember that Fluconazole can only treat thrush. It cannot treat other infections of the genitals. If you still have any sort of symptoms one or two days after you have taken Fluconazole, you should visit your doctor in case you have another type of infection.

If you take more Bell's Healthcare Thrush Relief Oral l50mg Capsule than you should.

Ifyou (or someone else) swallow a lot of capsules at the same time, or you think a child has swallowed any of the capsules, contact your nearest hospital casualty department or your doctor immediately.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. These can be seen even with a single dose of ISOmg.

A few people develop allergic reactions

although serious allergic reactions are rare. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. Ifyou get any of the following symptoms,

tell your doctor immediately.

sudden wheezing, difficulty in breathing or tightness in the chest
swellingof eyelids, faceor lips
itchingall overthe body, reddeningoftheskin or itchy red spots
skin rash
severe skin reactions such as a rash that causes blistering (this can affect the mouth and tongue).

Bell's Healthcare Thrush Relief Oral ISOmg Capsule may affect your liver. The signs of liver problems include:

tiredness
loss of appetite
vomiting
yellowing of your skin or the whites of your eyes (jaundice).

Bells Healthcare Thrush Relief Oral ISOmg Capsule may affect your adrenal glands and the levels of steroid hormones produced. The signs of adrenal problems include:

tiredness
muscleweakness
loss of appetite
weight loss
abdominal pain.

If any of these happen, stop taking Fluconazole and tell your doctor immediately.

Other side effects:

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

Common side effects (may affect up to I in 10 people) are:

headache
stomach discomfort, diarrhoea, feeling sick, vomiting
increases in blood tests of liver function
rash.

Uncommon side effects which (may affect up to I in 100 people) are:

reduction in red blood cells which can make skin pale and cause weakness or breathlessness
decreased appetite
inability to sleep, feeling drowsy
fits, dizziness, sensation of spinning, tingling, prickling or numbness, changes in sense of taste
constipation, difficult digestion, wind, dry mouth
muscle pain
liver damage and yellowing of the skin and eyes (jaundice)
wheals, blistering (hives), itching, increased sweating
tiredness, general feeling of being unwell, fever.

Rare side effects (may affect up to I in 1,000 people) are:

lower than normal white blood cells that help defend against infections and blood cells that help to stop bleeding
red or purple discoloration of the skin which may be caused by low platelet count, other blood cell changes
blood chemistry changes (high blood levels of cholesterol, fats)
low blood potassium
shaking
abnormal electrocardiogram (ECG), change in heart rate or rhythm
liverfailure
allergic reactions (sometimes severe), including widespread blistering rash and skin peeling, severe skin reactions, swelling of the lips or face
hairloss.

Frequency not known, but may occur (cannot be estimated from the available data):

hypersensitivity reaction with skin rash, fever, swollen glands, increase in a type of white blood cell (eosinophilia) and inflammation of internal organs (liver, lungs, heart, kidneys and large intestine) (Drug Reaction or rash with Eosinophilia and Systemic Symptoms (DRESS)).

Reporting of side effects

Ifyou get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:

or search for MHRA yellow Card in the Google Play or Apple App store.

By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store bell's healthcare thrush relief oral i50mg capsule

Keep out of the sight and reach of children.

Do not use Bell's Healthcare Thrush Relief Oral I SOmg Capsule after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

The product does not require any special storage conditions within Europe.

Medicines should not be disposed of via the wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. contents of the pack and other information

What Bell's Healthcare Thrush Relief Oral l50mg Capsule contain

- The active substance is fluconazole. Each capsule contains I SOmg of fluconazole.
- The other ingredients are lactose, starch, sodium lauryl sulphate, colloidal silicon dioxide and magnesium stearate. The capsule shell is gelatine and the colouring agents are titanium dioxide (E171) and Patent BlueV(EI3l).

What Bell's Healthcare Thrush Relief Oral ISOmg Capsule look like and the contents of the pack

Each capsule has a blue body and cap. Bell's Healthcare Thrush Relief Oral I SOmg Capsule come in a pack containing one capsule.

Marketing Authorisation Holder and Manufacturer

Relonchem Limited

Cheshire House,Gorsey Lane, Widnes,Cheshire, WA8 ORP, UK.

Distributor:

PL20395/0042 E

Date leaflet approved: July 2019.