500 mg / 750 mg / 1g film-coated tablets
flucloxacillin

What Flucloxacillin Orion is and what it is used for

The active substance in Flucloxacillin Orion is flucloxacillin. Flucloxacillin is penicillin ( antibiotic ) that prevents bacteria from building a normal cell wall. Without a functioning cell wall, the bacteria die quickly. Flucloxacillin Orion is stable against an enzyme ( beta-lactamase ), which can break down regular penicillin.

Flucloxacillin Orion is used for:

  • the infection you in the skin and soft tissues
  • infection of the joints, bones, and lungs (eg pneumonia, chronic bronchitis )

Flucloxacillin contained in Flucloxacillin Orion may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you take Flucloxacillin Orion

Do not take Flucloxacillin Orion

  • if you are allergic to flucloxacillin, penicillin, or any of the other ingredients of this medicine (listed in section 6).

Warning and caution

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

  • is allergic to cephalosporins ( antibiotics )
  • is older
  • have a liver disease
  • receive flucloxacillin for a long time
  • take or will take paracetamol.

With concomitant use of flucloxacillin and paracetamol, there is a risk of blood and fluid disturbances (metabolic acidosis due to high anion gap, so-called HAGMA), which occurs when the acidity of blood plasma increases, especially in certain patient groups who are at increased risk, e.g. patients with severe renal impairment, sepsis or malnutrition and especially when using maximum daily doses of paracetamol. HAGMA is a serious condition that requires urgent treatment.

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 because some medicines may affect or be affected by treatment with Flucloxacillin Orion. These include, for example:

  • certain medicines for tumors and disorders of the immune system (methotrexate)
  • certain medicines for gout (probenecid)
  • certain blood thinners ( warfarin )

Flucloxacillin Orion with food, drink, and alcohol

Flucloxacillin Orion contains sodium.

The 500 mg tablets contain 1.2 mmol (28 mg) sodium per tablet, the 750 mg tablets contain 1.8 mmol (42 mg) sodium per tablet and 1 g tablets contain 2.4 mmol (56 mg) sodium per tablet. This should be considered by patients on a low-salt diet.

Pregnancy, breastfeeding, and fertility

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 using this medicine.

There are no known risks associated with use during pregnancy. Flucloxacillin passes into breast milk but is unlikely to affect breastfed infants. Your doctor will assess whether you can take Flucloxacillin Orion during pregnancy or while breast-feeding.

Driving and using machines

The drug has no or negligible effect on the ability to drive or use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects.

Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Flucloxacillin Orion contains excipients

The 500 mg tablets contain 1.2 mmol (28 mg) sodium per tablet, the 750 mg tablets contain 1.8 mmol (42 mg) sodium per tablet and 1 g tablets contain 2.4 mmol (56 mg) sodium per tablet. This should be considered by patients on a low-salt diet.

How to take Flucloxacillin Orion

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. Your doctor will decide on a dose to suit you.

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

If you take more Flucloxacillin Orion then you should

If you have ingested too much medicine or if e.g. if a child has accidentally ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment 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, you must complete the entire course of Flucloxacillin Orion as prescribed. Otherwise, some bacteria may survive, grow in numbers and cause a new outbreak of infection one.

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

4. Possible side effects

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

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

  • Symptoms of a severe allergic reaction, such as swelling of the face, tongue, or throat, difficulty swallowing, hives, and difficulty breathing
  • Severe diarrhea, usually with blood or mucus, stomach pain, and fever (pseudomembranous colitis )
  • Decreased number of white blood cells ( agranulocytosis or neutropenia ) that cause fever and severe deterioration of your general condition or fever with local symptoms of infection, such as sore throat or mouth or difficulty urinating
  • Signs of liver damage or diseases, such as darker urine or paler stools, yellowing of the skin, or whites of the eyes (jaundice)
  • Sudden onset and severe rash, which may include blistering or peeling of the skin and mucous membranes (erythema multiforme, Stevens-Johnson syndrome, or toxic epidermal necrolysis ). In severe reactions, fever, sores on the surface of the eye, and joint pain can also occur.


Common  (may affect up to 1 in 10 people)

  • Nausea or diarrhea
  • Rash.

Uncommon  (may affect up to 1 in 100 people)

  • A large number of a certain type of white blood cell ( eosinophilia )
  • Hives

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

  • Itching

Very rare cases of blood and fluid disturbances (metabolic acidosis due to high anion gap), which occur when the acidity of blood plasma increases, with concomitant use of flucloxacillin and paracetamol, usually in patients with risk factors (see section 2).

Has been reported ( occurs in an unknown number of users)

  • Dizziness
  • Stomach ache, vomiting
  • Serious skin side effects
    • Red, scaly rash with bumps under the skin and blisters (exanthematous pustulosis ). Contact a doctor immediately if you get any of these symptoms.

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

Reporting of side effects ar

If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects, you can help increase drug safety information.

The Medical Products Agency,

Box 26,

SE-751 03 Uppsala.

5. How to store Flucloxacillin Orion

No special storage instructions.

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 can after EXP. The expiration date is the last day of the specified 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 packaging and other information

Content declaration

  • The active substance is flucloxacillin 1 tablet contains flucloxacillin sodium monohydrate equivalent to 500 mg, 750 mg, or 1 g flucloxacillin.
  • Other ingredients are tablet core: Magnesium stearate, povidone, croscarmellose sodium, microcrystalline cellulose. Film coating: Titanium dioxide, macrogols, easily flowing paraffin, hypromellose.

What the medicine looks like and the contents of the pack

Film-coated tablet (tablet).

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

750 mg: White to off-white, capsule-shaped, film-coated biconvex tablet, marked “Y” on one side and ’06’ with a notch between “0” and “6” on the other side, 20.4 x 8.4 mm. The tablet can be divided into two equal doses.

1 g:  White to off-white, oval, film-coated biconvex tablet, marked with ‘T’ on one side and ’63’ with a notch between ‘6’ and ‘3’ on the other side, 9.8 x 21.3 mm. The tablet can be divided into two equal doses.

Pack sizes:

500 mg: 30, 50, and 100 tablets in a plastic jar

750 mg: 20, 30, 50, and 100 tablets in a plastic jar

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

The jar contains a desiccant.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Orion Corporation

Orionvägen 1

FI-02200 Espoo

Finland

Manufacturer

Orion Corporation Orion Pharma

Orionvägen 1

FI-02200 Espoo

Finland

For further information about this medicine, contact your local Marketing Authorization Holder.

Orion Pharma AB

medinfo@orionpharma.com

Muhammad Nadeem

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