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FLOXAPEN ORAL SUSPENSION 125 MG / 5 ML, FLUCLOXACILLIN ORAL SUSPENSION 125 MG / 5ML - Patient leaflet, side effects, dosage

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Patient leaflet - FLOXAPEN ORAL SUSPENSION 125 MG / 5 ML, FLUCLOXACILLIN ORAL SUSPENSION 125 MG / 5ML

1. What Flucloxacillin Oral Suspension is and what it is used for


2. What you need to know before you take Flucloxacillin Oral Suspension


3. How to take Flucloxacillin Oral Suspension


4. Possible side effects


5. How to store Flucloxacillin Oral Suspension


6. Contents of the pack and other information

1. What Flucloxacillin Oral Suspension is and what it is used for

Flucloxacillin is an antibiotic used to treat infections by killing the bacteria that can cause them. It belongs to a group of antibiotics called “penicillins”.

Flucloxacillin Oral Suspension is used to treat:

  • chest infections
  • throat or nose infections
  • ear infections
  • skin and soft tissue infections
  • heart infections
  • bones and joints infection
  • meningitis
  • digestive system infections
  • blood infections
  • kidney, bladder or the urethra (the tube which carries urine from the bladder) infections.

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

2. what you need to know before you take flucloxacillin oral suspension

Do not take Flucloxacillin Oral Suspension and tell your doctor if you or your child:

  • are allergic to flucloxacillin, penicillin, any other antibiotic or any of the other ingredients of this medicine (listed in section 6)
  • have ever had liver problems after taking flucloxacillin.

Warnings and precautions

Talk to your doctor or pharmacist before taking Flucloxacillin Oral Suspension if you or your child:

  • has liver or kidney problems
  • have any serious illness, other than this infection
  • are 50 years old or over
  • are giving this medicine to a newborn child.
  • are taking or will be taking paracetamol.

There is a risk of blood and fluid abnormality (high anion gap metabolic acidosis) which occurs when there is an increase in plasma acidity, when flucloxacillin is used concomitantly with paracetamol, particularly in certain groups of patients at risk, e.g. patients with severe renal impairment, sepsis or malnutrition, especially if the maximum daily doses of paracetamol are used. High anion gap metabolic acidosis is a serious disease that must have urgent treatment.

Other medicines and Flucloxacillin Oral Suspension

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

  • probenecid (to treat gout)
  • other antibiotics (used to treat infections)

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 or pharmacist for advice before taking this medicine.

Tests

Regular monitoring of liver and kidney function should be performed whilst taking Flucloxacillin Oral Suspension.

Tell your doctor that you are taking Flucloxacillin Oral Suspension if you are having liver function tests as Flucloxacillin may affect the results.

Flucloxacillin Oral Suspension contains sodium, sucrose and sodium benzoate

  • Each 5ml spoonful of Oral Suspension contains 10mg of sodium, this is particularly important if you are on a reduced salt diet.
  • If you, or your child have been told by your doctor that you have an intolerance to some sugars, contact them before taking this medicine, as it contains sucrose.
  • This medicine also contains sodium benzoate which is a mild irritant to the skin, eyes and mucous membrane. It may increase the risk of jaundice in newborn babies.

3. how to take flucloxacillin oral suspension

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

Swallow the Oral Suspension half to one hour before meals. Never take more than the recommended dose each day.

The recommended dose is

  • Adults and children over 10 years: 10ml four times a day.
  • Joint infections (osteomyelitis) or heart infections (endocarditis) – up to 8g daily in divided doses, six to eight hourly.
  • 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.
  • Children 2 to 10 years: one 5ml spoonful four times a day.
  • Children under 2 years: 2.5 ml four times a day, your pharmacist will explain how to give this to your child.
  • Premature or babies less than 4 weeks old – Not recommended.
  • Severe kidney disease: your doctor may reduce the dose, maximum dose in adults is 1g every 8–12 hours.

If you still feel unwell after finishing the treatment, speak to your doctor.

If you take more than you should

If you (or someone else) swallow a lot of Oral Suspension at the same time, or you think another child may have swallowed any contact your nearest hospital casualty department or tell your doctor immediately. Symptoms of an overdose include feeling or being sick and diarrhoea.

If you forget to take the Oral Suspension

Do not take a double dose to make up for a forgotten dose. If you forget to take a dose take it as soon as you remember it and carry on as before, try to wait about four hours before taking the next dose.

If you stop taking the Oral Suspension

Do not stop treatment early because some bacteria may survive and cause the infection to come back.

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

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Please tell your doctor or pharmacist if you notice any of the following effects or any effects not listed.

Stop taking Flucloxacillin Oral Suspension and contact your doctor at once if you experience any of the following:

  • hypersensitivity or severe allergic reaction including itchy rash, itching, sore mouth or eyes, swelling of the face, lips, throat or tongue or breathing problems.
  • severe bloody diarrhoea (pseudomembranous colitis).
  • blisters or ulcers (Stevens-Johnson syndrome) or a severe rash with reddening, peeling and swelling of the skin that resembles burns (toxic epidermal necrolysis).

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

  • Common (occurs in less than 1 in 10 users): minor stomach disturbances e.g. stomach upset or diarrhoea.
  • Very rare (occurs in less than 1 in 10,000 users): inflammation of the kidney or liver, jaundice (skin or the white of your eyes turning yellow), changes in numbers of blood cells (causing unexplained bleeding, bruising or skin discolouration), anaemia, skin rash with circular, red patches (Erythema multiforme), severe skin rash with flushing, fever. Joint or muscle pain or fever, may develop after 2 days or more from the start of treatment with Flucloxacillin Oral Suspension. Very rare cases of blood and fluid abnormality (high anion gap metabolic acidosis) which occurs when there is an increase in plasma acidity, when flucloxacillin is used concomitantly with paracetamol, generally in the presence of risk factors (see section 2).
  • Not known (frequency cannot be estimated from the available data):

Serious skin reactions – A red, scaly rash with bumps under the skin and blisters (exanthematous pustulosis). Contact a doctor immediately if you get any of these symptoms.

Some of these reactions can be delayed for up to two months after finishing the treatment.

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:or search for MHRA Yellow Card in the Google Play or Apple App Store.

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

5. how to store flucloxacillin oral suspension

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

If any medicine is left after two weeks (14 days), return it to your pharmacist.

Keep the medicine in its original bottle and store it in the fridge (5°C). Do not freeze the medicine.

Do not use this medicine after the expiry date stated on the label/carton/bot­tle. 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 Oral Suspension contains

  • The active substance (the ingredient that makes the oral suspension work) is flucloxacillin. 5ml contains 125mg of the active ingredient.
  • The other ingredients are saccharin sodium, sucrose, xanthan gum (E415), citric acid, sodium citrate, sodium benzoate (E211), orange, tutti frutti and menthol flavours.

What Flucloxacillin Oral Suspension looks like and contents of the pack

Flucloxacillin Oral Suspension comes in a bottle containing 100ml of a white to off-white liquid mixture, called a suspension.

Marketing Authorisation Holder

Accord Healthcare Limited

Sage House 319 Pinner Road North Harrow Middlesex HA1 4HF United Kingdom

Manufacturer

Actavis Group PTC ehf, Reykjav'kurvegur 76–78, 220 Hafnarfjordur, Iceland Balkanpharma – Dupnitsa AD

3 Samokovsko Shosse Str.

Dupnitsa 2600,

Bulgaria

This leaflet was last revised in December 2017

Accord Healthcare Ltd, North Harrow, HA1 4HF, UK

Frequently Asked Questions

What is Floxapen Oral Suspension used for?

Floxapen Oral Suspension is an antibiotic used to treat various bacterial infections, such as skin infections, respiratory infections, and bone infections.

How does Flucoloxacillin work in the body?

Flucoloxacillin works by killing bacteria or preventing their growth, helping your body fight off infections.

What should I do if I miss a dose of Floxapen?

If you miss a dose of Floxapen, take it as soon as you remember. If it's almost time for your next dose, skip the missed dose and continue with your regular schedule.

Can I take Floxapen with food?

Yes, you can take Floxapen with food to help reduce stomach upset.

Are there any common side effects of Floxapen Oral Suspension?

Common side effects may include nausea, vomiting, diarrhea, or an upset stomach. Contact your doctor if these persist.

Is it safe to use Floxapen during pregnancy?

Consult your doctor before using Floxapen during pregnancy or if you're breastfeeding to discuss potential risks.

Can I consume alcohol while taking Flucoloxacillin?

It's best to avoid alcohol while taking Flucoloxacillin as it may increase the risk of side effects.

How long does it take for Floxapen to start working?

You may start to feel better within a few days of starting treatment; however, it's important to complete the full course prescribed by your doctor.

What should I do if I experience an allergic reaction to Flucoloxacillin?

If you experience symptoms like rash, itching, or swelling, seek medical attention immediately. You may have an allergy to this medicine.

Can children take Floxapen Oral Suspension?

Yes, Floxapen can be prescribed for children; however, always follow your doctor's dosage recommendations based on their weight and age.

What happens if I take too much Floxapen?

Taking too much Floxapen can lead to serious side effects. Seek medical help immediately if you suspect an overdose.

Should I stop taking Floxapen when I feel better?

No, complete the full course of antibiotics as prescribed by your doctor even if you feel better to ensure the infection is fully treated.

Can Flucoloxacillin interact with other medications?

Yes, Flucoloxacillin may interact with other medications. Always inform your doctor about all medications and supplements you're taking.

Is there a specific storage requirement for Floxapen Oral Suspension?

Store Floxapen at room temperature away from moisture and heat. Shake well before use and check expiration dates regularly.

What are some signs that my condition is not improving while taking Floxapen?

If symptoms worsen or do not improve after completing the medication course, contact your healthcare provider for further evaluation.

Can I take pain relievers while on Floxapen therapy?

Yes, most over-the-counter pain relievers are safe; however, consult your doctor for specific recommendations based on your health history.

Are there dietary restrictions while taking Flucoloxacillin?

There are no specific dietary restrictions with Flucoloxacillin; however, a balanced diet can support recovery.

What should I tell my doctor before starting Floxapen treatment?

Inform your doctor about any allergies you have, current medications you're taking, and any existing health conditions.

Can I drive after taking Flucoloxacillin?

Flucoloxacillin generally does not impair driving ability; however, if you feel dizzy or unwell after taking it, avoid driving until you feel better.