Dompe Fluifort 2.7g Granules For Oral Solution 10 Sachets

1. NAME OF THE MEDICINAL PRODUCT FLUIFORT 2.7 g granules for oral solution

2. WHAT IT IS Preparations for coughs and colds; expectorants excluded associations with cough suppressants, mucolytics.

3. WHY IT IS USED FLUIFORT 2.7 g granules for oral solution is used as a mucolytic, fluidifying agent in acute and chronic respiratory diseases.

4. WHEN IT SHOULD NOT BE USED

Hypersensitivity to the active substance or to any of the excipients. The product should not be administered to patients with gastroduodenal ulcer. Do not administer in known or suspected pregnancy and while breastfeeding (see What to do during pregnancy and lactation).

Pediatrics, geriatrics and specific clinical pictures: the drug should not be administered in pediatric patients (under 11 years).

5. PRECAUTIONS FOR USE There are no known phenomena of addiction or dependence.

6. WHICH MEDICINES OR FOODS MAY CHANGE THE EFFECT OF THE MEDICINAL PRODUCT Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription. In controlled clinical trials no interactions with the most common drugs used in the treatment of diseases of the upper and lower airways, nor with food and with laboratory tests, have been highlighted.

7. IT IS IMPORTANT TO KNOW THAT Fluifort 2.7 g granules for oral solution does not affect low-calorie or controlled diets and can also be administered to diabetic patients.

Fluifort 2.7 g granules for oral solution does not contain gluten; therefore the medicine is not contraindicated for people suffering from celiac disease.
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7.1 When it can only be used after consulting your doctor Patients who have had a gastroduodenal ulcer in the past should consult their doctor before taking Fluifort 2.7 g granules for oral solution.

7.2 What to do during pregnancy and breastfeeding Ask your doctor or pharmacist for advice before taking any medicine. Although the active substance is neither teratogenic nor mutagenic and has not shown negative effects on reproductive function in animals, Fluifort should not be administered during pregnancy. Since no data are available regarding the passage of carbocysteine lysine salt monohydrate into breast milk, use during lactation is contraindicated. Its use should also be avoided if you suspect a pregnancy or wish to plan a maternity leave.

7.3 Effects on ability to drive and use machines Fluifort 2.7 g granules for oral solution does not affect the ability to drive or use machines.

7.4 Important information about some of the ingredients Aspartame Fluifort 2.7 g granules for oral solution contains aspartame as a sweetener, which is a source of phenylalanine. It can be dangerous in patients with phenylketonuria.

8. HOW TO USE THIS MEDICINAL PRODUCT 8.1 HOW MUCH One sachet per day.

In consideration of the pharmacokinetic characteristics, this posology is maintained even in patients with renal and hepatic insufficiency.

Warning: do not exceed the indicated doses.

8.2 WHEN AND FOR HOW LONG Once a day. Consult your doctor if the disorder occurs repeatedly or if you notice any recent change in its characteristics. Warning: use only for short periods of treatment. Carbocisteine lysine salt monohydrate can also be used for prolonged periods; in this case it is advisable to follow the doctor's advice.

8.3 HOW To dissolve the contents of the sachet in about half a glass of water, stirring well.

9. WHAT TO DO IF YOU TAKE AN EXCESSIVE DOSE OF THE MEDICINAL PRODUCT The symptoms reported in case of overdose are: headache, nausea, vomiting, diarrhea, stomach pain, skin reactions, alteration of the sensory systems. There is no specific antidote; it is advisable to induce vomiting and possibly perform gastric lavage followed by specific supportive therapy. In case of accidental ingestion / intake of an excessive dose of Fluifort, notify your doctor immediately or go to the nearest hospital.
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If you have any questions about the use of Fluifort 2.7 g granules for oral solution, ask your doctor or pharmacist.

10. UNDESIRABLE EFFECTS Like all medicines, Fluifort 2.7 g granules for oral solution can cause side effects, although not everybody gets them. Side effects that may occur with Fluifort 2.7 g granules for oral solution, classified by system organ (SOC), are as follows:

Skin, subcutaneous tissue disorders: skin rash, urticaria, erythema, exanthema, bullous rash / erythema, pruritus, angioedema, dermatitis. Gastrointestinal disorders: abdominal pain, nausea, vomiting, diarrhea. Nervous system disorders: dizziness. Respiratory, thoracic and mediastinal disorders: dyspnoea. Vascular disorders: redness.

Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.

11. EXPIRY AND STORAGE Expiry: see the expiry date printed on the package. The expiry date refers to the product in intact packaging, correctly stored. Warning: do not use the medicine after the expiry date shown on the package. This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.

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

It is important to always have the information on the medicine available, therefore keep both the box and the package leaflet.

12. COMPOSITION 1 sachet of 5 grams contains: Active ingredient: carbocysteine lysine salt monohydrate equal to 2.7 g of carbocysteine lysine salt Excipients: citric acid, mannitol, povidone, natural cedar flavor, natural orange flavor, juice orange, aspartame, maltodextrin

13. HOW IT LOOKS Granules for oral solution: box of 10 sachets

14. Holder of the marketing authorization Dompé pharmaceutici SpA - Via San Martino, 12 - 20122 Milan
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15. Manufacturer Dompé pharmaceutici SpA - Via Campo di Pile - L'Aquila