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

What Flukloxacillin Meda is and what it is used for

The active substance in Flukloxacillin Meda, flukloxacillin, is penicillin (antibacterial drug) that prevents the bacterium from building a normal cell wall. Without a functioning cell wall, the bacterium dies quickly. Flucloxacillin Meda differs from regular penicillin in that it is stable against an enzyme ( beta-lactamase ), which has the ability to break down regular penicillin.

Flucloxacillin Meda is used for infections of the skin and soft tissues as well as infections of the joints, bones, and lungs.

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

What you need to know before you use Flukloxacillin Meda

Do not use Flukloxacillin Meda

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

Warnings and cautions

Talk to your doctor or pharmacist before using Flukloxacillin Meda.

  • If you are hypersensitive to cephalosporins (another group of antibacterial drugs), consult your doctor before using Flukloxacillin Meda.
  • There is a risk of diarrhea and colon infection. If you have problems with diarrhea, you should therefore consult a doctor.
  • There is a risk of liver damage, it is rare but probably increases with older age and with longer treatment.
  • If you are taking or will be taking 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 Meda

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. The effects of certain medicines can affect or be affected by the treatment with Flukloxacillin Meda, for example, some medicines for tumors and disorders of the immune system (methotrexate), for gout (probenecid), and some blood thinners ( warfarin ).

Flucloxacillin Meda with food and drink

Flucloxacillin Meda has the best effect if the medicine is taken between meals.

Pregnancy and breastfeeding

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

No known risks when used during pregnancy.

Flucloxacillin passes into breast milk but is unlikely to affect breastfed infants. However, consult a physician if more than temporary use of Flukloxacillin Meda during breast-feeding.

Driving and using machines

Flucloxacillin Meda has no or negligible effect on the ability to drive and use machines. If you get dizzy, do not 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 Meda contains sodium

The 500 mg tablet contains 29 mg of sodium, (the main ingredient in table salt/table salt). This corresponds to 1.5% of the highest recommended daily intake of sodium for adults.

The 750 mg tablet contains 44 mg of sodium. This corresponds to 2% of the highest recommended daily intake of sodium for adults.

1 g tablet contains 58 mg sodium. This corresponds to 3% of the maximum recommended daily sodium intake for adults.

This should be considered by patients on a low-salt diet.

How to take Flukloxacillin Meda

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. Even if you feel better after just a few days, the entire treatment must be completed according to the prescription. Otherwise, some bacteria may survive for a while, grow and cause a new outbreak of infection.

If you take more Flukloxacillin Meda then you should

If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you forget to take Flukloxacillin Meda

If you forget to take a dose, take it as soon as possible. Then continue as before. Do not take a double dose to make up for a forgotten tablet.

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.

Contact a doctor immediately if any of the following serious side effects occur:

Flucloxacillin Meda may in rare cases affect the white blood cells so that the defense of infection deteriorates. If you get an infection with symptoms such as fever with severe general deterioration or fever with local infection symptoms such as sore throat/throat/mouth or difficulty urinating, you should see a doctor as soon as possible so that a blood test can rule out a lack of white blood cells ( agranulocytosis ). It is important that you then information about your medication.

Flucloxacillin Meda may in rare cases cause a severe acute allergic reaction ( anaphylactic reaction ). Such a reaction can be life-threatening. If one or more of the following symptoms occur, contact a doctor or emergency department immediately. The symptoms of such a reaction may be reddening of the skin, itchy hives ( urticaria ), shortness of breath, and dizziness.

Tell your doctor immediately if you have prolonged or severe diarrhea. This may be a sign of colitis caused by the Clostridium difficile bacterium and may require treatment. This side effect is rare.

Serious skin side effects have been reported (occurring in an unknown number of users). Red scaly rash with bumps under the skin and blisters (exanthematous pustulosis ). Contact a doctor immediately if you get any of these symptoms.

Other side effects:

Common ( may affect up to  1 in 10 people):

  • Stomach upset, mainly nausea, or diarrhea
  • Rash.

Uncommon (may affect up to  1 in 100 people):

  • Hives
  • Blood picture change ( eosinophilia ).

Rare (may affect up to  1 in 1,000 people):

  • Liver effects.

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

  • Itching.
  • Blood and fluid disturbances (metabolic acidosis due to high anion gap), which occurs 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):

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

There is a risk of liver damage, it is rare but probably increases with older age and longer treatment.

5. How to store Flukloxacillin Meda

1 g tablet: Do not store above 30 ° C.

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 or label after “EXP” or “EXP”. The expiration date is the last day of the specified month.

Tablet packs (unit dose) have a shelf life limited to 6 months after the aluminum outer bag has been opened. After “OPENING DATE”, the date of opening is written, both on the aluminum bag and the cartons enclosing the printing packaging.

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. One tablet contains flucloxacillin sodium monohydrate equivalent to flucloxacillin 500 mg, 750 mg, and 1 g respectively.
  • The other ingredients are magnesium stearate, povidone, croscarmellose sodium, microcrystalline cellulose. Film coating: dye (titanium dioxide E171), macrogol, paraffin, hypromellose.

What the medicine looks like and the contents of the pack

500 mg: White, oblong tablet with a scoreline on one side, 8 x 17 mm.

Marking

750 mg: White, oblong, tablet marked with “FL | UC ”on one side and with break notch on the other side, 8 x 20 mm.
1 g: White, elliptical, tablet with a scoreline and marked on one side, 9.6 x 21 mm.

The tablets 500 mg, 750 mg, and 1 g can be divided into two equal parts.

Pack sizes:

500 mg: 30, 50 and 100 tablets in a plastic jar and 98 (2 x 49) x 1 tablets in a pressure pack (single dose).

750 mg: 20, 30, 50 and 100 tablets in plastic jar and 98 (2 x 49) x 1 tablets in pressure pack (single dose).
1 g: 21, 30, 50 and 75 tablets in a plastic jar.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Meda AB

Box 906

170 09 Solna

Phone 08-630 19 00

Muhammad Nadeem

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