Patient Information Leaflet

FLUCACID 1 g tablets

Flucloxacillin
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What FLUCACID is and what it is used for
What you need to know before taking FLUCACID
How to take FLUCACID
Possible side effects
How to store FLUCACID
Contents of the pack and other information

1. What FLUCACID is and what it is used for

FLUCACID contains the active substance flucloxacillin, which belongs to the group of antibiotics resistant to beta-lactamases (enzymes produced by bacteria that can inactivate penicillins).
FLUCACID is indicated for the treatment of all infections caused by bacteria sensitive to flucloxacillin.
It works by inhibiting beta-lactamases and enhancing the activity of other broad-spectrum semi-synthetic penicillins, such as Amoxicillin, Ampicillin, etc.
Therefore, the infections treated with this medicine are severe infections affecting various organs and systems.
Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking FLUCACID

Do not take FLUCACID

if you are allergic to flucloxacillin, to other substances chemically similar, especially penicillins and cephalosporins, or to any of the other ingredients of this medicine (listed in section 6).
if you are pregnant (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking FLUCACID.
In particular:

if you experience severe hypersensitivity or anaphylactic reactions. These reactions have mostly been reported following parenteral administration of penicillin, and much more rarely after oral administration. However, such reactions are more likely to occur if you have a history of hypersensitivity to multiple allergens, such as asthma, hay fever, or urticaria. Therefore, before starting treatment, you must inform your doctor of any previous history of hypersensitivity reactions to penicillins, cephalosporins, or other substances capable of causing allergies, especially drugs. In case of an allergic reaction, treatment must be discontinued and appropriate therapy initiated (vasopressor amines, antihistamines, corticosteroids), or, in the case of anaphylaxis, immediate treatment with adrenaline or other appropriate emergency measures.
if you have kidney problems. In this case, the maximum recommended dose is 2 g within 24 hours, administered as a single dose.

Inform your doctor if:

you are taking antibacterial medicines at high doses and for prolonged periods, as they may mask symptoms of syphilis still in the incubation phase. In such cases, your doctor will perform tests to diagnose syphilis.
you are taking penicillins or other antibiotics for a prolonged period. This may promote the growth of microorganisms not sensitive to these medicines (including fungi). In such cases, your doctor will prescribe an appropriate treatment.
you are taking or will take paracetamol: There is a risk of blood composition changes and electrolyte imbalance (metabolic acidosis with high anion gap) occurring when plasma acidity increases, particularly when flucloxacillin is co-administered with paracetamol, especially in certain high-risk patient groups, such as patients with severe renal impairment, blood infection, or malnutrition, particularly if maximum daily doses of paracetamol are used. Metabolic acidosis with high anion gap is a serious condition requiring urgent treatment.
if you develop diarrhoea
if you are on a low-salt diet

Other medicines and FLUCACID
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
In particular:

probenecid (a medicine used to treat gout)
oral contraceptives, as administration of FLUCACID, like other antibiotics, may reduce the effectiveness of the contraceptive pill.
aminoglycoside antibiotics (used to treat infections). Concurrent administration with these medicines may increase the effect of FLUCACID.

FLUCACID with food
The presence of food in the stomach reduces drug absorption (see section “How to take FLUCACID”). Take FLUCACID half an hour before meals, as food in the stomach reduces absorption of the medicine.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
The use of FLUCACID during pregnancy should only be considered by a doctor if clearly needed.

Breastfeeding
Since FLUCACID passes into breast milk, your doctor will need to decide whether you should stop breastfeeding and start treatment, or alternatively continue breastfeeding while avoiding administration of the medicine.

Driving and using machines
FLUCACID does not affect the ability to drive vehicles or operate machinery.

3. How to take FLUCACID

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Adults
The recommended dose is one tablet every 6–8 hours, according to medical judgment.
Children (8–14 years)
The recommended dose is half a tablet every 8 hours, according to medical judgment.
To achieve maximum blood concentration, FLUCACID should be taken
half an hour before meals, as the presence of food in the stomach reduces the absorption of
the medicine.
In cases of severe gastrointestinal disorders with vomiting and/or diarrhoea, sufficient
absorption of the tablets cannot be guaranteed.
If you take more FLUCACID than you should
There are no known reports of toxic effects from FLUCACID overdose.
Possible symptoms of overdose include gastrointestinal disturbances, electrolyte imbalances
(increased or decreased levels of Sodium, Potassium and Chloride in the blood), neuromuscular disturbances and seizures.
In case of ingestion of excessive doses of the medicine, emergency measures should be directed towards counteracting the symptoms that may occur.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Inform your doctor or pharmacist if you experience any side effect, even if not listed below.
Stop taking the medicine and contact your doctor immediately if you experience any of the
following symptoms:

Hypersensitivity or a severe allergic reaction which may manifest as itchy rash (urticaria), itching, mouth or eye pain, swelling of the face, lips, throat and tongue, breathing difficulties
Severe bloody diarrhoea (pseudomembranous colitis).

Inform your doctor if you experience any of the following symptoms:

Glossitis (inflammation of the tongue), stomatitis (inflammation of the oral mucosa), nausea, vomiting, diarrhoea, epigastric pain (upper stomach pain), flatulence, anorexia.
Abnormal liver function (increase in liver enzymes which may lead to changes in certain clinical tests), liver inflammation (hepatitis), yellowing of the skin (jaundice), low levels of white blood cells and platelets in the blood which may result in unusual bruising or tendency to bleed (damage to red blood cells);
Rarely, severe reduction, even severe, in kidney function, increased blood urea nitrogen and serum creatinine; isolated cases of interstitial nephritis (a form of acute kidney damage) have been reported.
Eosinophilia (increase in eosinophils, a type of white blood cell), neutropenia (decrease in neutrophils, a type of white blood cell), agranulocytosis (severe decrease in all types of white blood cells), thrombocytopenia (reduced platelet count), and anaemia, sometimes haemolytic (caused by the breakdown of red blood cells). These are usually reversible upon discontinuation of treatment.
Very rarely, during treatment with high-dose beta-lactam antibiotics in patients with renal impairment, metabolic encephalopathy (a form of brain damage) has been observed.

Other side effects (frequency not known): Severe skin reactions.
A red skin rash with crusts, swellings under the skin, and blisters (exanthematous pustulosis).
Very rare side effects (up to 1 in 10,000 people): Very rare cases of changes in blood composition and electrolyte imbalance (metabolic acidosis with high anion gap) occurring when plasma acidity increases, particularly when flucloxacillin is co-administered with paracetamol, generally in the presence of risk factors (see section 2).
If you experience any of these symptoms, contact your doctor immediately.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse.
You can also report side effects directly via the national reporting system at the following website:
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store FLUCACID

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after Exp..
The expiry date refers to the last day of that month.
Store the medicine in a cool and dry place.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What FLUCACID contains

The active substance is flucloxacillin. Each tablet contains 1.088 g of crystalline monohydrate sodium flucloxacillin (equivalent to 1 g of flucloxacillin acid).
The other components are: microcrystalline cellulose, polyvinylpyrrolidone, magnesium stearate, sodium carboxymethylamido.

Description of the appearance of FLUCACID and pack contents
Tablets for oral use. Pack containing 12 tablets.
Marketing Authorization Holder
EURO-PHARMA S.r.l. – Via Garzigliana, 8 - 10127 Turin
Manufacturer
FRANCIA FARMACEUTICI INDUSTRIA FARMACO BIOLOGICA S.R.L. - Via dei Pestagalli
n. 7 - 20138 Milan