Flucloxacillin 125 mg / 5 ml powder for oral solution – patient leaflet, side effects, dosage

1. WHAT FLUCLOXACILLIN POWDER FOR ORAL SOLUTION IS AND WHAT IT IS USED FOR

• Piperacillin (an antibiotic taken by injection),
• Sugammadex (used with general anaesthetics),
• Other antibiotics (used to treat infections)
• Voriconazole (used against fungal infections)
• kidney, bladder or the urethra (the tube which carries urine from the bladder) infections. 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 Powder for Oral Solution is used to treat:

• chest infections
• throat or nose infections
• ear infections
• skin and soft tissue infections
• meningitis
• heart infections
• bones and joints infection
• digestive system infections
• blood infections

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FLUCLOXACILLIN POWDER FOR ORAL SOLUTION

• Warfarin (medicine to prevent blood clotting), Do not take Flucloxacillin Powder for Oral Solution 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 Powder for Oral Solution 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.
• The use of flucloxacillin, especially in high doses, may reduce the potassium levels in the blood (hypokalaemia). Your doctor may measure your potassium levels regularly during the therapy with higher doses of flucloxacillin.

Other medicines and Flucloxacillin Powder for Oral Solution

Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

Especially:

• Probenecid or sulfinpyrazone (to treat gout),
• Methotrexate (a chemotherapy drug),

• Oral typhoid vaccine (antibiotics can make this less effective),

  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.

  Driving and using machines

  Flucloxacillin Oral Solution may have insignificant or no influence on the ability to drive and use machines.

  Tests

  Regular monitoring of liver and kidney function should be performed whilst taking Flucloxacillin Powder for Oral Solution. Tell your doctor that you are taking Flucloxacillin Powder for Oral Solution if you are having liver function tests as this medicine may affect the results.

  Flucloxacillin Powder for Oral Solution contains Sucrose

  This medicinal product contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

  The 125mg/5ml solution contains 6.331 mg sodium per 5ml dose and the 250mg/5ml solution contains 12.661 mg sodium per 5ml dose. These medicines contain less than 1 mmol sodium (23mg) per 5ml dose, that is to say essentially “sodium free”.

3. HOW TO TAKE FLUCLOXACILLIN POWDER FOR ORAL SOLUTION

Always take Flucloxacillin Powder for Oral Solution exactly as your doctor has told you.

If you are not sure, check with your doctor or pharmacist.

Doses:

• Adults and children over 10 years: 125mg/5ml solution - 10ml four times a day and 250mg/5ml solution - 5ml four times a day.

• Children 2 to 10 years: 125mg/5ml solution - 5ml four times a day and 250mg/5ml solution - 2.5ml four times a day, your pharmacist will explain how to give this to your child.

• Children under 2 years: 125mg/5ml solution - 2.5 ml four times a day and 250mg/5ml solution

  • 1.25 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.

When to take your medicine

Take powder for oral solution at least 1 hour before or 2 hours after meals. Never take more than the recommended dose each day.

To reduce the risk of pain in your oesophagus (the tube that connects your mouth with your stomach) take a full glass of water (250ml) after oral solution intake and do not lie down immediately after oral solution intake. It is important that you take your medicine at the right times.

If you take more Flucloxacillin Powder for Oral Solution than you should

If you (or someone else) swallow a lot of Oral Solution 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 Flucloxacillin Powder for Oral Solution

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 Flucloxacillin Powder for Oral Solution

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, Flucloxacillin Powder for Oral Solution 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 Powder for Oral Solution 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). If bloody diarrhoea develops, flucloxacillin treatment should be discontinued and appropriate therapy should be initiated

• jaundice (yellow colour in the skin and whites of the eyes), hepatitis (liver inflammation)

  • sometimes these effects on the liver can be delayed for up to 2 months after finishing treatment.
• 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 (may affect up to 1 in 10 people): minor stomach disturbances e.g. stomach upset, diarrhoea or feeling sick - Should be mild and wear off after a few days. If severe or lasting longer, tell your doctor. Heartburn and indigestion.

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

Very rare (may affect up to 1 in 10,000 people): 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. Blood and lymphatic system disorders like neutropenia (reduction in white blood cells) including agranulocytosis (serious low level of white blood cells). People with this condition are at very high risk of serious infections due to their suppressed immune system. Patients are advised to report any signs and symptoms of infection to their doctor. Eosinophilia (an increased number of eosinophils in the blood). Joint or muscle pain or fever, may develop after 2 days or more from the start of treatment with Flucloxacillin Powder for Oral Solution. Changes in liver function test results (reversible when treatment is discontinued). 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).

Low potassium levels in the blood

(hypokalaemia), which can cause muscle weakness, twitching or abnormal heart rhythm. Pain in oesophagus (the tube that connects mouth with stomach) and other related symptoms, such as difficulties in swallowing, heartburn, throat irritation or chest pain.

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.

If any of the side effects get serious, or if you notice any side effect not listed in this leaflet, you should contact your doctor or pharmacist.

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: www.mhra.gov.uk/yellowcard 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 POWDER FOR ORAL SOLUTION

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 label. The expiry date refers to the last day of that month.

Dry powder: Store in dry place below 30°C, Store in original package. Protect from light.

Reconstituted solution: Store up to 7 days at 2°C - 8°C in a refrigerator.

Do not throw away any medicines via wastewater. 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 Powder for Oral Solution contains

Each 5ml of powder for oral solution contains 125mg or 250mg of flucloxacillin as flucloxacillin sodium. The other ingredients are sucrose, sucralose, orange flavour and menthol flavour.

What Flucloxacillin Powder for Oral Solution looks like and contents of the pack

Powder: White granular powder, free from agglomerates and caking.

Reconstituted solution: Colourless solution with orange odour.

Flucloxacillin 125mg/5ml and 250mg/5ml Powder for Oral Solution are available in the size of 100ml on reconstitution in the Translucent HDPE round bottle with White Round polypropylene CR Cap.

Marketing Authorization Holder

Flamingo Pharma (UK) Ltd.

^st1 Floor, Kirkland House, 11-15 Peterborough Road, Harrow, Middlesex, HA1 2AX, United Kingdom.

Manufacturer

Flamingo Pharma (UK) Limited

The Bloc, 38 Springfield Way, Anlaby, Hull, HU10 6RJ, United Kingdom.

This leaflet was last revised in 08/2023.

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