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• leaflet MAH GENERIC_PL 25821-0023

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PACKAGE LEAFLET: INFORMATION FOR THE USER

CEFADROXIL 500 mg CAPSULES

IN THIS LEAFLET:

1.    What Cefadroxil Capsules are and what they are used for

2.    Before you take Cefadroxil Capsules

3.    How to take Cefadroxil Capsules

4.    Possible side effects

5.    How to store Cefadroxil Capsules

6.    Further information.

1.    WHAT CEFADROXIL CAPSULES ARE AND WHAT THEY ARE USED FOR

Cefadroxil is an antibiotic and belongs to a group of medicines called cephalosporins.

Cefadroxil is used to treat bacterial infections of:

•    the respiratory tract (nose, throat and lungs) such as pneumonia, acute and chronic bronchitis, sinusitis and laryngitis; and an infection of the tubes of the ear called otitis media.

•    the skin and soft tissue such as boils and bed sores

•    the urinary system (bladder and kidneys)

•    the female reproductive system

•    the bones and joints.

2.    BEFORE YOU TAKE CEFADROXIL CAPSULES Do not take Cefadroxil Capsules if you:

•    are allergic (hypersensitive) to Cefadroxil, any other cephalosporins, or any of the other ingredients of Cefadroxil Capsules (these are listed in section 6, Further Information)

•    are allergic (hypersensitive) to penicillins or any other related antibiotics known as beta-lactam drugs.

Take special care with Cefadroxil Capsules

Tell your doctor or pharmacist before taking this medicine if you:

•    have or ever had colitis (a kind of severe diarrhoea with blood in stool) with the use of antibiotics

•    have kidney problems

•    have or ever had any kind of allergies or asthma

•    are allergic to aspirin, as you may have more chances of developing an allergic reaction to one of the ingredients (colouring agent) in this medicine, namely Carmoisine (E122)

•    need a Coombs test. Cefadroxil Capsules may cause a positive result. This also applies on newborn whose mother received treatment with cephalosporins before delivery.

If you have any serious life-threatening infection or require large doses or require repetitive administrations per day, as your doctor will administer injectable cephalosporins in such cases.

Tell your doctor or pharmacist while taking this medicine:

•    if you develop new symptoms during the course of an existing infection, as these may be due to a second infection

•    if you develop colitis (a kind of severe diarrhoea with blood in stool).

Regular monitoring of blood counts, liver or kidney function should be done, especially if you are using cefadroxil for longer period.

Certain chemical tests are used to check for sugar in your urine. You should be aware that, Cefadroxil Capsules may cause a false positive reaction. This does not occur with dipstick type tests.

Cefadroxil is not indicated for the treatment of infection around the brain or spinal cord (meningitis).

Cefadroxil is not indicated for prevention of rheumatic fever.

Taking other medicines

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

including medicines obtained without a prescription.

Care is needed if you are taking:

•    antibiotics such as tetracycline, erythromycin, sulphonamide, chloramphenicol (used to treat infections)

•    other antibiotics such as aminoglycoside, polymyxin, colistin or loop diuretics such as furosemide should be avoided, as these medicines if taken with cefadroxil, can affect your kidneys

•    anticoagulants such as warfarin or thrombocyte aggregation inhibitors (medicines used to thin the blood)

•    probenecid (used to treat gout, a form of arthritis)

•    birth control pills

•    diuretics (water tablets) and fluid, may leads to increase in urine formation

•    cholestyramine (used for reducing cholesterol levels in the blood).

Presence of loose stool (diarrhoea) may impair effectiveness of Cefadroxil Capsules.

Taking Cefadroxil with food and drink

Cefadroxil Capsule can be taken with or without food.

Pregnancy and breast-feeding

Tell your doctor if you are pregnant, think you may be pregnant, likely to become pregnant or are breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Cefadroxil Capsule is not expected to have any effect on your ability to drive or use machines.

Important information about some of the ingredients of Cefadroxil Capsules

This medicine contains Carmoisine E 122, it may cause allergic reactions.

3. HOW TO TAKE CEFADROXIL CAPSULES

Always take Cefadroxil Capsules exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Your medicine is provided as capsules. Swallow the capsules(s) whole with a drink of water. If you have been told to take your medicine twice a day, space the doses as evenly as possible through the day (for example, you may take your doses at about 8.00 a.m. and 8.00 p.m. on each day).

The dose of this medicine will be different for different patients, depending on the condition and severity of illness. Your doctor will be able to decide on the dose that’s right for you.

Adults and children weighing more than 40 kilogram: The usual dose is one to two Cefadroxil 500 mg capsules to be taken twice a day. In certain conditions (skin infections and uncomplicated urinary infections), two capsules of Cefadroxil 500 mg to be taken once a day, may be recommended.

If you have kidney problems your doctor may give you a slightly lower dose.

Adults and children (7 years and above) weighing less than 40 kilogram: If you are giving Cefadroxil to your child your doctor will work out the right dose depending on your child's weight.

The usual dose is one Cefadroxil 500 mg Capsule to be taken twice a day.

Your doctor will advice you to take this capsule for at least 10 days in certain kind of infections.

If you take more Cefadroxil Capsules than you should - If you take more Cefadroxil Capsules than your usual daily dose, you may have nausea (feeling sick); unusually increased reflexes; unusual movements, including trembling and shaking of the hands and fingers, twisting movements of the body, shuffling walk and stiffness of the arms and legs; seeing, feeling or hearing things that are not there; kidney problems; altered consciousness or coma. Consult your doctor or go to the nearest hospital casualty department immediately. Take this leaflet or some capsules with you so that your doctor will know what you have taken.

If you forget to take Cefadroxil Capsules, do not worry and take them as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take a double dose to make up for forgotten individual doses.

If you stop taking Cefadroxil Capsules

Do not stop taking Cefadroxil without talking to your doctor, even if you feel better. It is important that you take the full course of Cefadroxil prescribed by your doctor.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Cefadroxil Capsules can cause side effects, although not everybody gets them. Very serious side effects

If any of the following happen, stop taking Cefadroxil Capsules and tell your doctor immediately or go to your nearest hospital emergency department:

•    severe skin reaction, rashes or skin eruptions (such as red patches or spots, ulcers, crusts or raised areas), itching, swelling, breathing difficulties or any other unusual problems

•    rare skin condition with severe blisters and bleeding in the lips, eyes, mouth, nose and genitals.

These side effects are but serious. You may need urgent medical attention.

Serious side effects

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

Commonly reported: (affects 1 to 10 users in 100)

•    skin rash, itching, hives.

Rarely reported: (affects 1 to 10 users in 10,000)

•    fever, swelling, skin rash, enlargement of the lymph nodes, these symptoms may be due to hypersensitivity reaction (serum-sickness like reaction)

•    yellowing of the skin and/or eyes (liver disease), sudden liver failure

•    dark discoloration of urine, bloody or cloudy urine or any change in your urine output (this may be due to a condition called interstitial nephritis).

Very rarely reported: (affects less than 1 user in 10,000)

•    tiredness, headaches, being short of breath when exercising, dizziness, looking pale and yellowing of the skin and/or eyes, these symtoms may be due to destruction of red blood cells (haemolytic anaemia)

•    diarrhoea, usually with blood and mucus, stomach pain, fever. You may have these symptoms due to inflammation of the colon (large bowel).

Other side effects

Tell your doctor if you notice any of the following:

Commonly reported: (affects 1 to 10 users in 100)

•    gastrointestinal disturbances including nausea, indigestion, diarrhoea, vomiting or abdominal discomfort, swollen, red, sore tongue.

Uncommonly reported: (affects 1 to 10 users in 1,000)

•    fungus growth and problems such as skin changes (reddish patches) and/or cream coloured patches on mucous membranes (e.g. oral thrush) in males and females, along with vaginal itching or discharge (in females) may occur.

Rarely reported: (affects 1 to 10 users in 10,000)

•    changes in blood count, like increase level of certain type of white cells in your blood; bleeding or bruising more easily than normal and frequent infections caused by changes to blood cells (generally these changes occur while long-term use and reversible upon discontinuation of treatment)

•    fever and chills caused by a medicine (drug fever)

•    joint pain

•    elevation of liver enzymes

Very rarely reported: (affects less than 1 user in 10,000)

•    dizziness, headache, nervousness, sleeplessness, fatigue

•    fits (seizure), particulary in presence of kidney problems

It has been reported that the result of the Coombs' test can be transiently positive during or after treatment with cefadroxil.

Not known: frequency not known

•    fever.

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

5.    HOW TO STORE CEFADROXIL CAPSULES

Keep out of the reach and sight of children. Keep container in the outer carton.

Do not use Cefadroxil Capsules after the expiry date that is stated on the outer packaging. 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. FURTHER INFORMATION What Cefadroxil Capsules contains:

•    The active ingredient is cefadroxil as monohydrate equivalent to 500 mg anhydrous cefadroxil

•    The other ingredients are microcrystalline cellulose, magnesium stearate, crospovidone and talc. The gelatin shell contains carmoisine E122, patent V blue E131 and titanium dioxide E171. The printing ink contains shellac, black iron oxide E172 and_potassium hydroxide.

What Cefadroxil Capsules looks like and contents of the pack:

Cefadroxil 500 mg Capsules are deep blue/light blue.

Cefadroxil Capsules are available in packs of 14, 20 or 100 capsules. All pack sizes may not be marketed.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation Holder:

Focus Farma B.V.

Lagedijk 1-3

1541 KA Koog aan de Zaan The Netherlands

Company responsible for manufacture:

Ranbaxy Ireland Limited Spafield, Cork Road Co-Tipperary,

Republic of Ireland

This leaflet was last revised in May 2016