Flucloxacillin 500mg Capsules

Document: leaflet MAH GENERIC_PL 16363-0042 change

PACKAGE LEAFLET: INFORMATION FOR THE USER

Flucloxacillin 250mg Capsules BP Flucloxacillin 500mg Capsules BP

(flucloxacillin sodium)

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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

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

What is in this leaflet

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

2. What you need to know before you take Flucolxacillin Capsules

3. Flow to take Flucloxacillin Capsules

4. Possible side effects

5. Flow to store Flucloxacillin Capsules

6. Contents of the pack and other information

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

Flucloxacillin sodium belongs to a class of antibiotics called “penicillinase-resistant penicillins” and is used to treat bacterial infections including:

Skin and soft tissue infections

• Boils, abscesses, carbuncles (A painful localized bacterial infection of the skin and subcutaneous tissue that usually has several openings through which pus is discharged.)

• Furunculosis (A skin condition characterized by the development of recurring boils.)

• Cellulitis (inflammation of tissue below the skin)

• Infected skin conditions e.g. ulcer, eczema, and acne

• Infected wounds, infected burns

• Protection for skin grafts

• Impetigo (a contagious skin disease, esp. of children, usually caused by streptococcal bacteria, marked by a superficial pustular eruption, particularly on the face.)

Respiratory tract infections

• Pneumonia (inflammation of the lungs with congestion.), lung abscess, empyema (a collection of pus in a body cavity, especially in the lung cavity)

• Sinusitis (inflammation of a sinus or the sinuses.)

• Pharyngitis (inflammation of the mucous membrane of the pharynx; sore throat)

• Tonsillitis (inflammation of the tonsils).

• Quinsy (tonsillar abscess.)

• Otitis media (inflammation of middle ear)

• Otitis Externa (Inflammation of the external auditory canal)

Other infections

• Osteomyelitis (affecting the bone and bone marrow)

• Enteritis (affecting the intestinal tract, especially the small intestine)

Black

• Endocarditis (inflammation of the lining of the heart and its valves),

• Urinary tract infections

• Meningitis (a serious disease characterised by inflammation of the membranes around the brain or spinal cord)

• Septicaemia (blood poisoning).

Flucloxacillin capsules can also be used to prevent infections during major surgery, particularly heart or orthopaedic surgery.

I. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FLUCOLXACILLIN CAPSULES

Do not take Flucloxacillin Capsules if you:

• Are allergic (hypersensitive) to penicillins/flucloxacillin sodium or any of the other ingredients in the product (see Section 6 and end of Section 2)

• Have previous history of liver problems from taking flucloxacillin.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine if you:

• age over 50 years old

• any serious illness other than infection

• Impaired kidney function

• Liver problems.

Other medicines and Flucloxacillin Capsules

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

• Probenecid (used in the treatment of gout)

• Other antibiotics (used to treat infections)

Flucloxacillin Capsules with food and drink

The capsules should be administered half to one hour before meals.

Pregnancy and breast-feeding

Flucloxacillin Capsules should only be used by pregnant women if considered essential by the doctor. Flucloxacillin passes into breast milk, so ask your doctor for advice before taking any medicine.

Tests

Regular monitoring of liver and kidney function should be performed whilst taking flucloxacillin capsules for a long period of time. Tell your doctor that you are taking flucloxacillin capsules if you are having urine tests or blood tests because it may affect the results

Driving and using machines

Flucloxacillin Capsules are not expected to affect your ability to drive or operate machinery. Flucloxacillin Capsule contains Sodium

Flucloxacillin Capsules contain approximately 51 mg of sodium per g. This is particularly important if you are on a reduced salt diet.

3. HOW TO TAKE FLUCLOXACILLIN CAPSULES

Always take the capsules exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

For oral use only.

Swallow the capusle whole with water, do not chew them, half to one hour before meal.

Adults: one 250mg capsule four times a day, your doctor may prescribe a different dose for severe infections.

Osteomyelitis, endocarditis: up to 8g a day in divided doses (every 6-8 hours)

To prevent infection due to surgery-1 to 2g by injection into a vein, at the same time as the anaesthetic, followed by 500mg six hourly either by mouth or injection into a vein or muscle for up to 72 hours.

Elderly: Same doses as for adults.

Patients with severe kidney impairment: Lower doses may be used.

Children (2-10 years): One half of the adult dose taken in syrup form.

Under 2 years: Quarter adult dose taken in syrup form.

Make sure you complete your prescribed course; do not stop taking Flucloxacillin Capsules if you feel better.

If you take more Flucloxacillin Capsules than you should

Contact your doctor or nearest hospital casualty department if you or a child have swallowed too much medicine. Take this leaflet and any remaining capsules with you, if possible. Symptoms of overdose include nausea, vomiting, diarrhoea.

If you forget to take Flucloxacillin Capsules

If you miss a dose, take the capsules as soon as you remember and carry on as before. If it is almost time for your next dose, skip the forgotten dose and continue as usual.

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

. POSSIBLE SIDE EFFECTS

Like all medicines, Flucloxacillin Capsules can cause side effects, although not everybody gets them. STOP taking Flucloxacillin Capsules and contact your doctor if you experience any of the following:

• Allergic reaction, symptoms of which includes rash, itching, difficulty in breathing or swelling of the face, lips, throat or tongue

• Severe bloody diarrhoea (pseudomembranous colitis)

Tell your doctor if you notice any of the following side effects or notice any other effects not listed:

COMMON SIDE EFFECTS: (occurs in less than 1 in 10 users)

• Minor gastrointestinal disturbances (e.g. diarrhoea, nausea & vomiting)

UNCOMMON SIDE EFFECTS: (occurs less than 1 in 1000 users)

• Rash

• Urticaria (itchy skin eruption)

• Purpura (brownish-red spots on the skin)

VERY RARE SIDE EFFECTS: (occurs in lesst than 1 in 10,000 users)

• Blood abnormalities i.e. neutropenia and thrombocytopenia Flaemolytic anaemia

• Anaphylactic Shock (severe allergic reaction)

• Angioneurotic Oedema (rapid swelling)

• Pseudomembranous colitis (type of inflammation of the colon)

• Hepatitis (inflammation of the liver) and cholestatic jaundice (yellowing of the skin and whites of the eyes)

• Changes in liver function tests

• Erythema multiforme (a red rash caused by hypersensitivity to a drug or disease or other allergen),

• Stevens-Johnson syndrome (severe inflammatory eruption of the skin) and toxic epidermal necroylsis (skin that resembles burns)

• Arthralgia (pain in a joint) and myalgia (pain in the muscles).

• Interstitial nephritis (Nephritis in which the interstitial connective tissue is chiefly affected)

• Fever

Reporting of side effects:

If you 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: www.mhra.gov.uk/yellowcard.

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

i. HOW TO STORE FLUCLOXACILLIN CAPSULES

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

Do not store above 25°C. Store in the original pack and keep tightly closed.

Do not use the capsules after the expiry date is stated on the label.

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.

i. CONTENTS OF THE PACK AND OTHER INFORMATION

What Flucloxacillin Capsules contains

The active substance is flucloxacillin sodium, 250mg or 500mg per capsule.

The other ingredients are:

• Magnesium stearate (E572), Colloidal anhydrous silica.

• Body- red iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171), gelatin.

• Cap - black iron oxide (E172), titanium dioxide (E171), gelatin.

• Ink components - titanium dioxide (E171), shellac (E904), industrial methylated spirits, soya lecithin, dimethyl siloxane, mono- and di-glycerides of fatty acids (E471), methyl cellulose, polyethylene glycol stearate, xanthan gum, benzoic acid, polyethylene glycol, sorbic acid.

See Section 2 'Important information about some of the ingredients of Flucloxacillin Capsules'.

What Flucloxacillin Capsules look like and contents of the pack

The capsules are hard gelatin, elongated with caramel body and black cap printed with 'FLU250MIL' for the 250mg strength, or 'FLU500MIL' for the 500mg strength. They are available in white plastic containers containing 14, 28, 100, 250, 500 and 1000 capsules, or blister strips of 14, 28 and 100 capsules (not all pack sizes may be marketed).

Marketing Authorisation Holder

Milpharm Limited

Ares, Odyssey Business Park,

West End Road,

South Ruislip, HA4 6QD,

United Kingdom

Manufacturer