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265 x180mm - sidel

PACKAGE LEAFLET: INFORMATION FOR THE USER

AMOXICILLIN 250mg & 500mg CAPSULES

Amoxicillin Trihydrate

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 effect not listed in this leaflet, please tell your doctor or pharmacist.

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

The name of your medicine is Amoxicillin 250mg Capsules or Amoxicillin 500mg Capsules. They contain the active ingredient called Amoxicillin.

Amoxicillin capsules are antibiotics for treating infections. They belong to a group of antibiotics called “Penicillins” and work by killing the bacteria that can cause infections.

Amoxicillin capsules can treat a wide range of infections including those of the chest (bronchitis or pneumonia), tonsils (tonsillitis), ears (otitis media), the bladder or the urethra (the tube which carries urine from the bladder), kidneys, the female reproductive system including infections caused by difficulties during childbirth (puerperal sepsis and septic abortion), abdomen (intra-abdominal sepsis and peritonitis), heart (endocarditis), blood (septicaemia), skin, teeth and gum (abscesses).

They are also used to treat gonorrhoea (a sexually transmitted infection), infections associated with pregnancy & typhoid and Paratyphoid fevers (caused by a group of bacteria called Salmonella), inflammation of the bone and bone marrow (osteomyelitis) and inflammation of the membranes that cover the brain and spinal cord (meningitis).

2. BEFORE YOU TAKE AMOXICILLIN CAPSULES

Do not take Amoxicillin Capsules

if you are allergic (hypersensitive) to Amoxicillin Trihydrate, Penicillin (or any other antibiotics) or any of the other ingredients in the product. See section 6.

Take special care with Amoxicillin Capsules

Seek advice from your doctor before treatment if you

•    have, or think you have glandular fever

•    have been taking Amoxicillin for a long time

•    suffer from kidney problems

In premature children and during the neonatal period: renal, hepatic and haematological functions should be monitored.

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.

Certain medicines may be affected by treatment with Amoxicillin capsules, for example:

•    Warfarin, used to prevent blood clots

•    Contraceptive Pills

•    Methotrexate, used to treat arthritis, psoriasis and certain types of cancer

•    Allopurinol, Sulfinpyrazone & Probenecid, used in treating gout or excess uric acid in the blood.

Pregnancy and breast-feeding

Before you start to take these capsules, please tell your doctor or pharmacist if you are pregnant, or may become pregnant or if you are breast-feeding.

3. HOW TO TAKE AMOXICILLIN CAPSULES

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

METHOD AND ROUTE OF ADMINISTRATION

Amoxicillin capsules should be swallowed with water. You may take the medicine with or after food unless the label advises a specific time.

You should drink several glasses of water each day of your treatment, unless told otherwise by your doctor.

Keep taking your medicine until your prescribed course is finished. Do not stop just because you feel better. If you stop too soon, the infection may return.

DOSAGE

Adults (including elderly patients):

The usual adult dosage for most infections is 250mg (one capsule every eight hours). This may be doubled in more severe infections.

Other dosages which may be given are:

For severe or recurrent respiratory tract infections - 3g twice daily.

For urinary tract infections - Two 3g doses with 10-12 hours between doses.

Gonorrhoea (a sexually transmitted infection) - A single 3g dose (combined with 1g of Probenecid)

Prevention of endocarditis- inflammation of the heart lining, heart muscles and heart valves (during dental procedures) - 3g orally given one hour before treatment followed by second dose six hours later, if necessary.

Dosage may be lower than those listed above in the patients with kidney problems

Children:

Children weighing less than 40 kg

The daily dosage for children is 40 - 90 mg/kg/day in two to three divided doses (not exceeding 3 g/day) depending on the indication, severity of the disease and the susceptibility of the pathogen

Dosing three times daily is associated with enhanced efficacy, thus twice daily dosing is only recommended when the dose is in the upper range.

Children weighing more than 40 kg should be given the usual adult dosage.

Other dosages which may be given are:

Tonsillitis: 50 mg/kg/day in two divided doses.

Acute otitis media: In areas with high prevalence of pneumococci with reduced susceptibility to penicillins, dosage regimens should be guided by national/local recommendations.

Early Lvme disease (isolated erythema migrans): 50 mg/kg/day in three divided doses, over 14-21days.

Prophylaxis for endocarditis: 50 mg amoxicillin/kg body weight given as a single dose one hour preceding the surgical procedure.

Impaired renal function: The dose should be reduced. In patients with a creatinine clearance of less than 30 ml/min an increase in the dosage interval and a reduction in the total daily dose is recommended

Children (up to 10 years of age):

Prevention of endocarditis - inflammation of the heart lining, heart muscles and heart valves (during dental procedures) - Same precautions apply as for adult dose.

•    Children (5-10 years) - Half the adult dose

•    Children (under 5 years) - Quarter the adult dose

Children (under 10 years of age):

For children under 10, it is recommended that the alternative liquid preparation is used.

If you take more Amoxicillin Capsules than you should

If you accidentally take too many Amoxicillin capsules, contact your doctor or local hospital at once. Show the doctor your pack of capsules.

If you forget to take your Amoxicillin Capsule

If you forget to take a capsule at the right time, take it as soon as you remember. Then carry on as before. Do not take a double dose to make up for a forgotten dose.

If you stop taking Amoxicillin Capsules

Do not stop taking Amoxicillin capsule without talking to your doctor, even if you feel better. If you stop your medicine before the end of the course, some bacteria may survive and cause the infection to come back.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, Amoxicillin Capsules can cause some side effects, although not everybody gets them.

Very serious side effects - If any of the following happens, stop taking Amoxicillin capsules and tell your doctor immediately or go to the nearest hospital emergency department:

•    Rare allergic (hypersensitive) reactions such as difficulty of breathing, swelling of your face, throat or tongue, skin rash, itching and hives

Common (occur in less than 1 in 10 patients, but by more than 1 patient in 100 patients)

•    Nausea (feeling of sickness) or diarrhoea

•    Skin rash

Uncommon (occur in less than 1 in 100 patients, but by more

than 1 patient in 1,000 patients)

•    Vomiting

Very rare (experienced by fewer than 1 patient in 10,000 patients)

•    Reduction (reversible) in blood cell counts including anaemia (a reduction in the body’s red blood cells or haemoglobin which may be characterised by feeling weak or light-headed) or a longer time taken for blood to clot. Tell your doctor if you are taking Amoxicillin capsules if you are having blood tests.

•    Excessive body movement (hyperkinesias), dizzyness or convulsions. People who are on high doses of Amoxicillin capsules or whose kidneys do not work properly experience convulsions

•    Thrush (a yeast infection of the vagina, mouth or skin folds). You can get treatment for thrush from your doctor or pharmacist.

•    Tooth discolouration. The colour usually returns to normal with brushing

•    Inflammation of the liver and Jaundice (yellowing of the skin and whites of your eyes)

•    Inflammation of the kidney. Tell your doctor that you are taking Amoxicillin capsules if you are having Amoxicillin capsules, as it may effect the results

•    Forming of crystals in the urine

•    Colitis (inflammation in the bowel, causing abdominal pain, diarrhoea, fever, sometimes with bleeding).

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.

5. HOW TO STORE AMOXICILLIN CAPSULES

Do not store above 25°C.

Keep out of the reach and sight of children.

Do not use Amoxicillin capsules after the expiry date which is stated on the pack.

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 environment.

6. FURTHER INFORMATION

What Amoxicillin capsules contain:

The capsules are available in two strengths containing either 250mg or 500mg of Amoxicillin.

The only other ingredient in the capsule core is Magnesium Stearate.

The capsule shell contains gelatin, erythrosine (E127), E172 (iron oxides) and titanium dioxide (E171).

What Amoxicillin capsules look like and contents of the pack: 250mg capsules: Red/white, size 2 capsules, marked AMOX 250 in black.

500mg capsules: Red/white, size 0 capsules, marked AMOX 500 in black.

Blister: Packs of 12, 15 & 21 Securitainers: Packs of 4, 100, 500 & 1000 Not all pack sizes may be marketed.

MA Holder: Special Concept Development (UK) Limited,

Unit 1-7 Colonial Way, Watford, Hertfordshire, WD24 4YR

Manufacturer:

Ascenders, Suite No 129,

Devonshire House,

582 Honeypot Lane,

Stanmore HA7 1JS, UK.

PL 36722/ 0019 PL 36722/ 0020