FLUIMUCIL ANTIBIOTICO

Patient Information Leaflet

FLUIMUCIL ANTIBIOTIC 250 mg film-coated tablets, ANTIBIOTIC 125 mg/4 g granules for oral solution

Thiamphenicol glycinate acetylcysteinate
Please read this leaflet carefully before using 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 their symptoms are the same as yours, as 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

1. What Fluimucil Antibiotic is and what it is used for
2. What you need to know before taking Fluimucil Antibiotic
3. How to take Fluimucil Antibiotic
4. Possible side effects
5. How to store Fluimucil Antibiotic
6. Contents of the pack and other information

1. What Fluimucil Antibiotic is and what it is used for

Fluimucil Antibiotic belongs to the group of antibacterial medicines.
Fluimucil Antibiotic is used for the treatment of respiratory tract infections caused by bacteria sensitive to thiamphenicol (an antibiotic), where mucus stagnation complicates or delays recovery, as the medicine helps to fluidify secretions.
Fluimucil Antibiotic is indicated in adults for the treatment of:

• acute bronchitis (recent onset inflammation of the bronchi accompanied by cough with sputum);
• chronic bronchitis (persistent inflammation of the bronchi accompanied by cough with sputum);
• slowly resolving bronchopneumonia and pneumonia (inflammation of the bronchi and lungs);
• pulmonary abscess (pus collection in the lungs);
• obstructive emphysema (a lung disease causing breathing difficulties);
• bronchiectasis (dilation of certain airways);
• bronchopulmonary complications following surgical procedures, such as bronchopneumonia and atelectasis (total or partial collapse of a lung due to failure of pulmonary alveoli to expand);
• facilitation of bronchoaspiration procedures under anaesthesia and prevention of infectious complications;
• nonspecific infectious conditions with bronchial sputum associated with pulmonary tuberculosis (a lung infection);
• retention of secretions with insufficient drainage from cavitary lesions (abscesses).

Fluimucil Antibiotic is indicated in children over 6 months of age for the treatment of:

• bronchitis and bronchopneumonia (inflammation of the bronchi and lungs), particularly those with slow resolution;
• bronchiolitis (respiratory infections in children under 2 years of age);
• pertussis (an infectious and contagious disease characterized by severe bouts of dry cough);
• cystic fibrosis (a hereditary disease characterized by bronchial obstruction due to secretion of very thick and viscous mucus).

2. What you should know before taking Fluimucil Antibiotic

Do not use Fluimucil Antibiotic if:

• you are allergic to thiamphenicol glycinate acetylcysteinate or to any of the other ingredients of this medicine (listed in section 6);
• you have or have had bone marrow failure (reduced production of blood cells by the bone marrow);
• you have anuria (lack of urine production and excretion);
• you have a deficiency of an enzyme called glucose-6-phosphate dehydrogenase (an inherited genetic disorder that may cause destruction of red blood cells following a recent illness or use of certain medicines);
• you are breastfeeding (see "Pregnancy, breastfeeding and fertility"). Fluimucil Antibiotic must not be used in children under 6 months of age.

Warnings and precautions
Talk to your doctor or pharmacist before using Fluimucil Antibiotic.
Use this medicine only for the length of time considered necessary by your doctor for resolving the infection.
Do not exceed 10 days of treatment unless otherwise prescribed by your doctor; in such case, periodic blood tests will be required, and treatment should be discontinued if the number of white blood cells decreases significantly.
With prolonged use, optic neuritis (inflammation of the optic nerve that may cause pain and visual disturbances) and peripheral neuritis (a neurological disorder causing pain, numbness, tingling, weakness, loss of muscle tone, balance problems, and difficulty in coordinating movements) may occur.
The possible presence of a sulfurous odour does not indicate product deterioration but is characteristic of the active substance contained in it.

Other medicines and Fluimucil Antibiotic
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No studies have been conducted. Fluimucil Antibiotic may affect the metabolism of certain drugs.
It is recommended not to use Fluimucil Antibiotic with other bactericidal antibiotics (medicines used to treat bacterial infections).

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

Pregnancy
Data on the use of Fluimucil Antibiotic in pregnant women are limited.
Thiamphenicol crosses the placenta.
Animal studies have shown thiamphenicol to be embryotoxic (i.e. causing malformations).
The administration of Fluimucil Antibiotic during pregnancy should only be considered if the expected benefit to the mother outweighs the risk to the fetus or infant.

Breastfeeding
Fluimucil Antibiotic is excreted in breast milk and may cause adverse effects in the infant.
Fluimucil Antibiotic is contraindicated during breastfeeding; interrupt breastfeeding during treatment with Fluimucil Antibiotic (see "Do not use Fluimucil Antibiotic if").

Fertility
There are no clinical data available on male or female fertility.
Animal studies with doses higher than the therapeutic dose have shown negative effects on fertility. These effects are reversible, meaning they resolve upon discontinuation of treatment.

Driving and using machines
No studies have been performed.
It is not known whether Fluimucil Antibiotic affects the ability to drive or use machinery.

Fluimucil Antibiotic 250 mg film-coated tablets contain sunset yellow (E110)
May cause allergic reactions.

Fluimucil Antibiotic 250 mg film-coated tablets contain sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. essentially "sodium-free".

Fluimucil Antibiotic 125 mg/4 g oral granules for solution contain sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to use Fluimucil Antibiotico

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
Dosages may be adjusted at the doctor's discretion.
If necessary, the doctor may double the doses during the first 2–3 days of treatment.
Do not exceed the recommended maximum daily doses.

Fluimucil Antibiotico 250 mg film-coated tablets
Dosage
Adults and adolescents aged over 15 years
The recommended dose is 500 mg (equivalent to 2 tablets) 2–3 times daily, at regular intervals.

Children from 6 to 10 years of age
The recommended dose is 250 mg (equivalent to 1 tablet) 3 times daily.

Children over 10 years up to 15 years of age
The recommended dose is 500 mg (equivalent to 2 tablets) 2 times daily.

Method of administration
The tablets should be swallowed with a little water, without chewing.

Fluimucil Antibiotico 125 mg/4 g granules for oral solution
Dosage
Children from 6 months to 2 years of age
The recommended dose is 125 mg (equivalent to 1 dosing spoonful) 2 times daily.

Children over 2 years up to 6 years of age
The recommended dose is 250 mg (equivalent to 2 dosing spoonfuls) 2 times daily.

Method of administration
For oral use.
Prepare the oral solution immediately before administration.
Use the dosing cup provided in the package. Dissolve the granules in a quarter to half a glass of water. The dosing spoon provided contains 4 g of granules, equivalent to 125 mg of thiamphenicol.

Duration of treatment
Do not exceed 10 days of treatment (see "Warnings and precautions").

Elderly
Dose increase is not recommended in subjects over 65 years of age.

Moderate or severe renal impairment
If you have kidney problems, your doctor will evaluate whether a dose reduction is necessary.

If you take more Fluimucil Antibiotico than you should
Overdose may lead to bone marrow and haematological toxicity (i.e. a decrease in blood cells due to bone marrow dysfunction).
Gastrointestinal disturbances, alteration of intestinal bacterial flora, and development of new infections may also occur.
In case of accidental ingestion or intake of an excessive dose of Fluimucil Antibiotico, contact your doctor immediately or go to the nearest hospital.

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 everybody gets them.
The main reported side effects include bone marrow depression (reduced production of blood cells by the bone marrow), with anaemia (reduction in the number of red blood cells or in haemoglobin levels; haemoglobin is a protein found in red blood cells that carries oxygen in the blood), thrombocytopenia (reduction in the number of platelets), and leucopenia (reduction in white blood cells). These effects are dose- and duration-dependent and are reversible (i.e. resolve) upon discontinuation of treatment (see "Warnings and precautions").

The following side effects have been reported after administration of Fluimucil Antibiotic, although their frequency cannot be determined from the available data:

• anaemia,
• thrombocytopenia,
• leucopenia,
• hypersensitivity (allergic reactions),
• anaphylactic reactions (severe, rapidly occurring allergic reactions presenting as swelling of the face, eyes, lips, tongue and throat, breathing difficulties, increased heart rate with possible sudden drop in blood pressure),
• optic neuritis (inflammation of the optic nerve that may cause pain and visual disturbances),
• peripheral neuritis (a neurological disorder causing pain, numbness, tingling, weakness and loss of muscle tone, balance problems and difficulty in coordinating movements; see "Warnings and precautions"),
• nausea,
• vomiting,
• diarrhoea,
• skin rash (skin irritation which may appear red, blistered and itchy),
• alopecia (hair loss) in case of kidney problems,
• fever,
• Herxheimer-type reactions (causing fever, chills, headache, muscle pain and skin rash, occurring during treatment of typhoid fever, an infectious disease caused by Salmonella).

Additional side effects in neonates and preterm infants:
From clinical studies and adverse reaction reports, the frequency, type and severity of adverse reactions in children are the same as in adults.
In neonates and preterm infants, abdominal distension (swelling of the abdomen) and cyanosis (bluish discoloration of the skin) have been reported, leading to severe heart dysfunction and death.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fluimucil Antibiotic

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label after "Exp.".
The expiry date refers to the last day of that month.
The expiry date refers to the product in its original, unopened packaging, stored correctly.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Fluimucil Antibiotico 250 mg film-coated tablets contains

• The active substance is Tiamfenicol glycinate acetylcysteinate.
• The other components are: Sodium carboxymethylcellulose, Polyvinylpyrrolidone, Colloidal silica, Magnesium stearate, Hypromellose, Titanium dioxide (E 171), Talc, E 110, Polyethylene glycol 6000, Vanillin.

What Fluimucil Antibiotico 125 mg/4 g oral solution granules contains

• The active substance is Tiamfenicol glycinate acetylcysteinate.
• The other components are: Spray-dried orange juice granules, Orange flavour, Saccharin, E 110, Sucrose.

Description of the appearance of Fluimucil Antibiotico and pack contents

Fluimucil Antibiotico 250 mg film-coated tablets
Pack containing 16 tablets in PVC/PVDC/Al/PVDC blisters.

Fluimucil Antibiotico 125 mg/4 g granules for oral solution
Pack containing one 80 g glass bottle of granules with a polypropylene dosing cup.

Marketing Authorisation Holder
ZAMBON ITALIA s.r.l. - Via Lillo del Duca, 10 – 20091 Bresso (MI)

Manufacturer
Zambon S.p.A. - Via della Chimica 9 - Vicenza