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• Flucloxacillin Orion film-coated tablet ENG PL

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Package leaflet: Information for the user

Flucloxacillin Orion 500 mg film-coated tablets

Flucloxacillin Orion 750 mg film-coated tablets

Flucloxacillin Orion 1 g film-coated tablets

flucloxacillin

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

• 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

The active substance in Flucloxacillin Orion is flucloxacillin. Flucloxacillin is a penicillin (antibiotic), which prevents bacteria from building up a normal cell wall. Without functioning cell walls, bacteria die quickly. Flucloxacillin Orion is stable against an enzyme (lactamase), which is capable of breaking down ordinary penicillin.

Flucloxacillin Orion is used for:

• infections of the skin and soft tissues

• infections of the joints, bone and lungs (e.g. pneumonia, chronic bronchitis).

Do not take Flucloxacillin Orion

Warnings and precautions

Talk to your doctor or pharmacist before taking Flucloxacillin Orion if you:

• are allergic to cephalosporin (antibiotics)

• are elderly

• have a liver disease

• receive flucloxacillin for a long period.

Other medicines and Flucloxacillin Orion

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is important as certain medicines may influence or be influenced by the treatment with Flucloxacillin Orion. These include for example:

• certain medicines against tumours and disorders of the immune system (methotrexate)

• certain medicines against gout (probenecid)

• certain blood-thinning medicines (warfarin).

Pregnancy and breast-feeding

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

There are no known risks in connection with use during pregnancy. Flucoxacillin passes into the mother’s milk but is not likely to affect infants who are breast-fed. Your doctor will assess whether you can take Flucloxacillin Orion during pregnancy or breast-feeding.

Driving and using machines

This medicine has no or negligible influence on the ability to drive and use machines.

Flucloxacillin Orion contains sodium

The 500 mg tablets contain sodium 1.2 mmol (28 mg) per tablet, the 750 mg tablets contain sodium 1.8 mmol (42 mg) per tablet and the 1 g tablets contain sodium 2.4 mmol (56 mg) per tablet. To be taken into consideration by patients on a controlled sodium diet.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The doctor determines the dose so that it is suitable for you.

Take the tablets between meals to get the best effect of Flucloxacillin Orion.

If you take more Flucloxacillin Orion than you should

If you have taken too much of the medicine or if, for example, a child has taken the medicine by mistake, contact your doctor, hospital <to be completed nationally> for an assessment of the risk and advice.

If you forget to take Flucloxacillin Orion

If you forget to take a dose, take it as soon as you remember. Do not take a double dose to make up for a forgotten dose.

If you stop taking Flucloxacillin Orion

Even if you feel better after a few days, it is important that you complete the whole course of treatment with Flucloxacillin Orion according to the prescription. Otherwise, some bacteria may survive, grow in numbers and cause a new outbreak of the infection.

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

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

Stop taking Flucloxacillin Orion and contact a doctor immediately if you get any of the following symptoms of rare side effects (may affect up to 1 in 1,000 people)

• Symptoms of severe allergic reaction such as swelling of the face, tongue or throat, difficulties in swallowing, nettle rash and breathing difficulties

• Severe diarrhoea, usually with blood or mucous, stomach pain, fever (pseudomembranous colitis)

• Reduction in the number of white blood cells (agranulocytosis or neutropenia) causing fever and serious weakening of your general condition or fever with local infection symptoms such as sore throat or mouth or urinary problems

• Signs of liver injury or disease such as darker urine or paler stools, yellowing of the skin or the white of the eyes (jaundice)

• Sudden onset of severe rash which may include blistering or peeling of the skin and mucous membranes (erythema multiforme, Stevens-Johnson syndrome or toxic epidermal necrolysis). Severe reactions may also be associated with fever, ulcers on the surface of the eyes, and joint pains.

Common (may affect up to 1 in 10 people)

• Nausea or diarrhoea

• Skin rashes.

Uncommon (may affect up to 1 in 100 people)

• Large number of a certain type of white blood cells (eosinophilia)

• Nettle rash.

Very rare (may affect up to 1 in 10,000 people)

Frequency not known (cannot be estimated from the available data)

• Dizziness

• Abdominal pain, vomiting.

Itching in the genitals may be caused by fungal overgrowth. White coating in the mouth, especially on the tongue may also be caused by a fungal infection.

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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Flucloxacillin Orion

This medicinal product does not require any special storage conditions.

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

Do not use this medicine after the expiry date which is stated on the carton and bottle label after EXP. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Flucloxacillin Orion contains

• The active substance is flucloxacillin. Each tablet contains flucloxacillin sodium monohydrate equivalent to 500 mg, 750 mg or 1 g flucloxacillin.

• The other ingredients are:

Tablet core: magnesium stearate, povidone, croscarmellose sodium, microcrystalline cellulose

Film-coating: titanium dioxide, macrogols, light liquid paraffin, hypromellose.

What Flucloxacillin Orion looks like and contents of the pack

Film-coated tablet (tablet).

500 mg: White to off-white, capsule shaped, film-coated biconvex tablets debossed with ‘Y’ on one side and ‘05’ with score line between ‘0’ and ‘5’ on the other side, 17.4 x 8.1 mm. The tablet can be divided into equal doses.

750 mg: White to off - white, capsule shaped, film - coated biconvex tablets debossed with ‘Y’ on one side and ‘06’ with score line between ‘0’ and ‘6’ on the other side, 20.4 x 8.4 mm. The tablet can be divided into equal doses.

1 g: White to off-white, elliptical shaped, film-coated biconvex tablets debossed with ‘T’ on one side and ‘63’ with score line between ‘6’ and ‘3’ on the other side, 9.8 x 21.3 mm. The tablet can be divided into equal doses.

Pack sizes:

500 mg: 30, 50 and 100 tablets in plastic container.

750 mg: 20, 30, 50 and 100 tablets in plastic container.

1 g: 21, 30, 50 and 75 tablets in plastic container.

Each container contains desiccant.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

Manufacturer

Orion Corporation Orion Pharma

Orionintie 1

FI-02200 Espoo

Finland

This leaflet was last revised in September 2016.