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Teva Thrush Duo

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Teva Thrush Duo

(Clotrimazole, Fluconazole)

PACKAGE LEAFLET: INFORMATION FOR THE USER

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you.

• Keep this leaflet. You may need to read it again.

• Ask your pharmacist if you need more information or advice.

• If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

• You must talk to a doctor if you do not feel better of if you feel worse after 7 days.

What is in this leaflet:

1. What Teva Thrush Duo is and what it is used for

2. What you need to know before you use Teva Thrush Duo

3. How to use Teva Thrush Duo

4. Possible side effects

5. How to store Teva Thrush Duo

6. Contents of the pack and other information

1. WHAT TEVA THRUSH DUO IS AND WHAT IT IS USED FOR

Thrush Duo is one of a group of medicines called “antifungals” This pack contains a cream and a single capsule. The cream contains the active substance Clotrimazole and the capsule contains the active substance Fluconazole.

The medicine can be used to treat thrush (vaginal candidiasis) and external symptoms of thrush (vulval candidiasis). It may also be used by the woman’s sexual partner to treat associated penile thrush (candidal balanitis). The capsule can be taken by both men and women, the cream can be used by both partners too. If a woman and her partner both intend to take the capsule you will need one pack each.

Thrush is a common infection caused by a yeast (or fungus), which may live harmlessly in the vagina without you even noticing it. However, in certain circumstances, it may develop into an infection in the vagina and symptoms may spread to the surrounding area. The symptoms may include one or more of the following:

• itching of the vagina and surrounding area (the vulva)

• redness and swelling of the tissues of the vagina and vulva.

• soreness of the vagina and vulva

• a white non-smelling discharge from the vagina.

Thrush may aggravated by sexual intercourse, but it is not a sexually transmitted disease. Sometimes, however, thrush can be passed to your partner through sexual intercourse.

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

• soreness and redness of the penis

• tightness of the foreskin

• a white non-smelling penile discharge.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE TEVA THRUSH DUO

This medicine can be used by adults between the ages of 16 and 60 years. However, some people should not use this medicine or should seek the advice of their pharmacist or doctor first.

DO NOT USE Teva Thrush Duo if you:

• are allergic (hypersensitive) to clotrimazole or fluconazole, to other medicines you have taken to treat fungal infections or to any of the other ingredients of Thrush Duo (listed in section 6). The symptoms may include itching, reddening of the skin or difficulty in breathing

• are taking astemizole, terfenadine (antihistamine medicines for allergies)

• are taking cisapride (used for stomach upsets)

• are taking pimozide or midazolam (used for treating mental illness)

• are taking quinidine (used for treating heart arrhythmia)

• are taking erythromycin (an antibiotic for treating infections)

• are taking halofantrine (for treatment of malaria)

• are pregnant or breast feeding.

Warnings and precautions

Talk to your pharmacist or doctor if you:

• have never had these symptoms before

• have other symptoms not normally associated with thrush, such as an infection affecting the whole body

• have had thrush more than twice in the last 6 months

• are under 16 years, or 61 years or older

• or your partner have been exposed to a sexually transmitted disease.

• have liver or kidney problems, or have had unexplained jaundice (yellowing of the skin and eyes)

• suffer from heart disease, including heart rhythm problems, or have abnormal levels of potassium, calcium or magnesium in your blood

• have AIDS (you may be more likely to experience skin reactions)

• have any other long-term illness, or receive regular treatment from your doctor

• are taking any other medicines, except for the contraceptive ‘pill’ (see “Taking other medicines”)

• have lower stomach pain, or pain or a burning sensation on passing urine.

• develop severe skin reactions (itching, reddening of the skin or difficulty breathing)

• are unsure about the cause of your symptoms

• are a man and:

- your sexual partner does not have thrush

- you have an abnormal discharge or leakage from your penis

- you have sores, ulcers or blisters on your penis

- your penis has started to smell.

• are a woman and:

- you have any abnormal or irregular vaginal bleeding, or a blood stained discharge

- you have sores, ulcers or blisters on your vulva or vagina.

Taking 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 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 Thrush Duo (see section: “Do not take this medicine”).

There are some medicines that may interact with Thrush Duo.

Make sure your doctor knows if you are taking any of the following medicines:

• medicines that thin your blood to prevent blood clots (e.g. warfarin or similar medicines)

• statins (e,.g. atorvastatin, simvastatin or fluvastatin or similar medicines) used for reducing high cholesterol levels

• medicines for mental health conditions (tricyclic antidepressants e.g. amitriptyline, nortriptyline) or for epilepsy (e.g. carbamazepine or phenytoin)

• methadone (used for pain)

• fentanyl, alfentanil, or non-steroidal anti-inflammatory medicines (NSAIDs) e.g. celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (for pain relief or inflammation)

• medicines for diabetes such as chlorpropamide, glibenclamide, glipizide or tolbutamide

• rifampicin or rifabutin (antibiotics for infections)

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

• amphotericin B, voriconazole (anti-fungals)

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

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

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

• halofantrine (used for treating malaria)

• oral contraceptives

• prednisone (steroid)

• zidovudine, also known as AZT; saquinavir (used in HIV-infected patients)

• theophylline (used to control asthma)

• vitamin A (nutritional supplement).

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

Taking Thrush Duo with food and drink

You can take the capsule with or without a meal.

Pregnancy and breast-feeding

Do not use if you are pregnant, think you may be pregnant or are breast feeding.

Women of childbearing age must use a reliable form of contraception when using this medicine. The ingredients in the cream, however, may affect the latex used in contraceptives such as condoms and diaphragms. This may reduce the effectiveness of the contraceptives. You should therefore use other methods of contraception for at least 5 days after using the cream.

Driving and using machines

This medicine is not expected to affect your ability to drive or use machines. However, the medicine may cause dizziness and occasionally fits or other side effects that may affect you. You should not drive or use machines until you are sure you are not affected.

Important information about some of the ingredients of this medicine

The capsule contains a small amount of lactose (milk sugar). If you have been told by your doctor that you have an intolerance to some sugars, please contact your doctor before taking this medicine.

Cetyl alcohol and stearyl alcohol in the cream may cause local skin reactions (e.g contact dermatitis).

Treating thrush:

You can help the treatment to work if you follow these simple self-help tips:

• although the infected area will itch, do not scratch as this will damage the surface of the skin and cause the infection to spread further.

• keep the affected areas of the skin clean

• pay particular attention to drying the skin but avoid excessive rubbing.

To help prevent thrush from coming back once you have treated it, follow these simple steps:

• wash daily

• try to avoid washing with perfumed soaps or using vaginal deodorants

• do not rub hard with sponges or flannels and avoid hot baths with strong perfumed with strong perfumed oils

• wear cotton underwear and loose fitting clothing

• try to avoid wearing tights, nylon underwear and tight fitting clothing

• after going to the toilet, wipe yourself from the front to the back, as a thrush infection may be transferred from the bowel

• change your sanitary protection regularly.

3. HOW TO USE TEVA THRUSH DUO

Check that the capsule foil is not broken before first use. If it is don’t take that capsule.

Check that the tube seal is not broken before first use. If it is, don’t use the cream.

Pierce tube seal with end of cap.

Age	How much	How often
Adults aged 16 to 60 years	Capsule: One capsule	Once daily
Adults aged 16 to 60 years	Cream: Apply a thin layer to the affected area	Two or three times a day for 2 weeks

Swallow the capsule with water.

The cream is for use on the skin only. For women, apply the cream to the vulva and surrounding areas. For men, apply the cream to the penis.

Do not use for children under 16 years, or if you are an adult of 61 years or older, unless your doctor tells you to.

Do not use more than the amount recommended above.

If symptoms do not go away within 7 days talk to your doctor.

If symptoms clear up but return after 7 days, you can take another capsule, unless you had an allergic reaction the first time.

If you have thrush more than twice in six months you must see your doctor.

If you accidentally take a large number of capsules, or accidentally swallow some of the cream: Talk to a doctor or go to your nearest hospital casualty department straight away. Take your medicine and this leaflet with you.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

A few people develop allergic reactions although serious allergic reactions are rare. If you get any of the following symptoms, tell your doctor immediately.

• sudden wheezing, difficulty in breathing or tightness in the chest

• swelling of the eyelids, face, lips, neck, tongue or throat, low blood pressure, fainting (severe allergic reaction caused by the capsule or cream)

• itching all over the body, reddening of the skin or itchy red spots

• skin rash

• severe skin reactions such as a rash that causes blistering (this can affect the mouth and tongue) (caused by the capsule)..

You must not take this medicine again if you experience any of these serious side effects.

The 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).

If any of these happen tell your doctor immediately.

The capsule may cause:

Common side effects which may affect up to 1 in 10 people:

• headache, stomach discomfort, diarrhoea, feeling sick, vomiting

• increases in blood tests of liver function, rash

Uncommon side effects which may affect up to 1 in 100 people:

• reduction in red blood cells which can make skin pale and cause weakness or breathlessness

• decreased appetite, inability to sleep, feeling drowsy

• fit, dizziness, sensation of spinning, tingling, pricking 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 which may affect up to 1 in 1,000 people:

• 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

• low blood potassium, blood chemistry changes (high blood levels of cholesterol, fats)

• shaking

• abnormal electrocardiogram (ECG), change in heart rate or rhythm

• liver failure

• allergic reactions (sometimes severe), including widespread blistering rash and skin peeling, severe skin reactions, swelling of the lips or face

• hair loss.

These other effects are less serious. If they bother you talk to your pharmacist:

The cream may cause:

• irritation, discomfort, pain or a burning or stinging sensation

• other allergic skin reactions such as itchy rash, swelling, peeling or flaking of the skin, blisters. Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE TEVA THRUSH DUO

Keep this medicine out of the sight and reach of children.

Do not store above 30°C. Store in the original package. Use by the date on the end flap of the carton. The expiry date refers to the last day of that 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 Teva Thrush Duo contains

The capsule contains Fluconazole 150mg and the cream contains Clotrimazole 1% w/w, which are the active ingredients.

The capsule also contains lactose monohydrate, maize starch, sodium laurilsulfate, colloidal anhydrous silica, magnesium stearate. The capsule shell contains titanium dioxide (E171), gelatin, patent blue V (E131), printing ink (containing black iron oxide (E172), propylene glycol (E1520) and shellac glaze). The cream also contains sorbitan stearate, polysorbate 60, cetyl palmitate, stearyl alcohol, cetyl alcohol, 2-octyldodecanol, benzyl alcohol, purified water.

What Teva Thrush Duo looks like and contents of the pack

The pack contains one hard blue capsule printed with FLUCO 150, and a 20g tube of white cream.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation holder: TEVA UK Limited, Eastbourne, BN22 9AG.

Company responsible for manufacture: Teva Operations Poland Sp. z.o.o., ul. Mogilska 80, 31-546 Krakow, Poland.

This leaflet was last revised: December 2013 PL 00289/1476 PL 00289/1477

This is a representation of an electronic record that was signed electronically and this

PAGE IS THE MANIFESTATION OF THE ELECTRONIC SIGNATURE

Teva Pharmaceuticals Europe B.V

1.3.1 -150mg-capsule-teva-thrush-duo

Approvals

Signed by	Meaning of Signature	Server Date
Annette Huggett	Regulatory Affairs Approval	31-Jul-2014 04:33:40 PM

REG0066187 Version 2.0 Effective Page 7 of 7