500 mg, 750 mg film-coated tablets
flucloxacillin

What Flucloxacillin Sandoz is and what it is used for

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

Flucloxacillin Sandoz is used against infection in the skin and soft tissues as well as infectious you in the joints, bones, and lungs.

Flucloxacillin contained in Flucloxacillin Sandoz 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.

2. What you need to know before you use Flucloxacillin Sandoz

Do not use Flucloxacillin Sandoz

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

Warnings and cautions

Talk to your doctor or pharmacist before using Flucloxacillin Sandoz.

  • if you are hypersensitive to cephalosporins (another group of antibacterial drugs)
  • 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.

The use of flucloxacillin, especially in high doses, may lower blood potassium levels ( hypokalaemia ). Your doctor may want to measure your potassium levels regularly during treatment with higher doses of flucloxacillin.

Other medicines and Flucloxacillin Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because certain medicines can affect or be affected by the treatment with Flucloxacillin Sandoz, for example, certain medicines:

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

Flucloxacillin Sandoz with food and drink

Flucloxacillin Sandoz 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 when using Flucloxacillin Sandoz during breast-feeding.

Driving and using machines

No known 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 Sandoz contains sodium

Flucloxacillin Sandoz 500 mg contains 29.9 mg sodium (the main ingredient in table salt/table salt) per tablet and Flucloxacillin Sandoz 750 mg contains 44.8 mg sodium per tablet. This corresponds to 1.49% for 500 mg and 2.24% for 750 mg of the highest recommended daily sodium intake for adults.

3. How to use Flucloxacillin Sandoz

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Take flucloxacillin tablets at least 1 hour before or 2 hours after a meal.

To reduce the risk of esophageal pain, swallow the tablet with a full glass of water (250 ml). Do not lie down immediately after taking the tablet.

Your doctor will decide which dose is right for you. Even if you feel better after just a few days, you must take the entire Flucloxacillin Sandoz regimen as prescribed. Otherwise, some bacteria may survive for a while, grow and cause a new outbreak of infection.

The tablet can be divided into two equal parts.

If you take more Flucloxacillin Sandoz then you should

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

If you forget to take Flucloxacillin Sandoz

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.

Flucloxacillin Sandoz 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/pharynx/mouth or urination problems, you should see a doctor as soon as possible so that blood tests can rule out a lack of white blood cells ( agranulocytosis, may affect up to 1 in 1000 users). It is important that you then information about your medication.

Flucloxacillin Sandoz 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, healthcare should be contacted immediately. The symptoms of such a reaction may be reddening of the skin, itchy hives ( urticaria ), shortness of breath, and dizziness.

In case of prolonged or severe diarrhea, you should consult a doctor.

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):

  • Inflammation of the colon.
  • Liver effects.

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, abdominal pain, vomiting.
  • Serious skin side effects: red, scaly rash with lumps under the skin and blisters (exanthematous pustulosis ). Contact a doctor immediately if you get any of these symptoms.
  • Low potassium levels in the blood ( hypokalaemia ) can cause muscle weakness, twitching, or abnormal heart rhythm.
  • Pain in the esophagus and other related symptoms, such as difficulty swallowing, heartburn, throat irritation, and chest pain.

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 with longer treatment.

5. How to store Flucloxacillin Sandoz

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

Do not store above 25 ° C.

Do not use this medicine after the expiry date which is stated on the carton or blister 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 sodium monohydrate corresponding to flucloxacillin 500 mg and 750 mg respectively.
  • The other ingredients are microcrystalline cellulose, povidone, magnesium stearate, colloidal anhydrous silica, croscarmellose sodium, titanium dioxide (E171), hypromellose, macrogol, methylcellulose, and carnauba wax.

What the medicine looks like and the contents of the pack

Flucloxacillin Sandoz 500 mg: White, oblong, biconvex tablet marked with “F 500” on one side and with a scoreline on the other side.

Flucloxacillin Sandoz 750 mg: White, oblong, biconvex tablet marked with “F 750” on one side and with a scoreline on the other side.

Pack sizes

16, 20, 30, 50, 98, 100 tablets

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark.

Muhammad Nadeem

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