Patient Information Leaflet

Flumil 100 mg/ml Injectable Solution

Acetilcisteína

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What is Flumil 100 mg/ml and what is it used for

2.What you need to know before using Flumil 100 mg/ml

3.How to use Flumil 100 mg/ml

4.Possible side effects

5Storage of Flumil 100 mg/ml

6.Contents of the pack and additional information

Flumil 100 mg/ml contains the active ingredient acetilcisteína, which belongs to a group of medicines called mucolíticos that reduce the viscosity of mucus, liquefying it and facilitating its elimination from the respiratory tract.

Flumil 100 mg/ml is indicated to facilitate the elimination of excess mucus and phlegm in adults and children aged 2 years and above, in respiratory processes in the presence of bronchial hypersecretion such as:Acute and chronic bronchitis, chronic obstructive pulmonary disease (COPD), emphysema, pulmonary complications of cystic fibrosis, facilitation of maneuvers in anesthesia in bronchoscopies, bronchographies and bronchoaspiration, bronchiectasias, obstructive and infectious complications by tracheotomy and bronchopulmonary by surgical intervention.

No use Flumil 100 mg/ml:

• If you are allergic to the active ingredient or any of the other components of this medication (listed in section 6).
• Do not administer in children under 2 years old.

Advertencias and precautions

Consult your doctor or pharmacist before starting to use Flumil 100 mg/ml.

If you are asthmatic or have a severe respiratory disease, you must consult your doctor before taking this medication as it may cause respiratory difficulties (bronchospasm).

The possible sulfurous smell (like rotten eggs) of the medication is due to the active ingredient, but it does not indicate that its characteristics have been altered.

During the first days of treatment, you may observe an increase in mucus and phlegm, which will decrease over the course of treatment. If you are unable to effectively cough up mucus, a postural drainage and bronchoaspiration should be performed.

Administration by intravenous route will be carried out under strict medical supervision. It is more likely that adverse reactions will occur after intravenous perfusion if the medication is administered too quickly or in excessive amounts. Therefore, it is recommended to strictly follow the instructions in section 3. How to use Flumil 100 mg/ml.

Acetylcysteine is not compatible with rubber and certain metals, especially iron, nickel, and copper. It should be avoided to come into contact with materials that contain them.

It should be administered with caution in long-term treatment in patients with histamine intolerance.

Children and adolescents

The same precautions and warnings apply to children and adolescents.

It is contraindicated in children under 2 years old.

Use of Flumil 100 mg/ml with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

In the case of needing simultaneous treatment with nitroglycerin, hypotension (low blood pressure) should be monitored, which can be severe, and may cause headache.

The simultaneous use of carbamazepine, a medication used to combat epilepsy attacks, may increase the risk of attacks.

Do not administer concurrently with cough medications or with those that decrease bronchial secretions (such as antihistamines and anticholinergics), as it could lead to an accumulation of bronchial secretions.

It is recommended to administer antibiotics separately.

Do not dissolve Flumil 100 mg/ml with other medications.

Use of Flumil 100 mg/ml with food and drinks

The intake of food and drinks does not affect the efficacy of this medication.

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Acetylcysteine crosses the placenta. Therefore, the use of acetlycysteine during pregnancy is not recommended.

The excretion of acetlycysteine and its metabolites in breast milk is unknown. It should be avoided during lactation.

No data are available on the effect of acetlycysteine on human fertility. Animal studies do not indicate harmful effects on human fertility at recommended doses.

Driving and operating machines

No evidence of effects on the ability to drive and operate machines is available.

Flumil 100 mg/ml contains sodium

This medication contains 43 mg of sodium (main component of table salt) in each 3 ml ampoule. This corresponds to 2.15% of the maximum daily sodium intake recommended for an adult.

Interference with analytical tests

Acetylcysteine may interfere with the colorimetric method for determining salicylates.

Acetylcysteine may interfere with the ketone test in urine.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.This medication should be administered exactly as indicated by your doctor or pharmacist.In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Local administration:

Administration by nebulization

Adults and children 12 years and older: one 300 mg ampule one or two times a day for 5 to 10 days.

Children between 2 and 12 years: up to one 300 mg ampule one or two times a day for 5 to 10 days in cooperative children.

Endotracheal-bronchial route

Adults and children 12 years and older: one 300 mg ampule (60 drops) one or two times a day for 5 to 10 days.

Children between 2 and 12 years: up to one 300 mg ampule (60 drops) one or two times a day for 5 to 10 days.

Parenteral administration:

Flumil 100 mg/ml can be administered in bronchial conditions when local treatment is impossible or difficult or when the doctor prefers the systemic route (lack of patient cooperation, bed rest, closed-circuit respiration, etc.).

Intramuscular route

Adults and children 12 years and older:one 300 mg ampule one or two times a day administered by deep injection.

Children between 2 and 12 years:150 mg (half ampule of 3 ml) one or two times a day administered by deep injection.

Intravenous route

The administration of acetilcisteína by intravenous route is performed under strict medical supervision.

The medication should be administered by slow infusion in saline solution or 5% glucose solution.

Adults and children 12 years and older: one 300 mg ampule one or two times a day.

Children between 2 and 12 years:150 mg (half ampule of 3 ml) one or two times a day.

Opening the ampule:

- Hold the ampule as indicated in Figure 1;

- Place the thumb on the colored point and exert pressure backwards as indicated in Figure 2.

Treatment duration

The treatment duration should be established according to the clinical evolution. The average duration is 5-10 days. The high general and local tolerability of Flumil 100 mg/ml allows prolonged treatments in certain cases.

If you use more Flumil 100 mg/ml than you should

If you have used more Flumil 100 mg/ml than you should, you may notice symptoms similar to those described in section 4, although more intense. In case of overdose or accidental massive administration, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91.562.04.20 indicating the medication and the amount used.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

The following adverse effects may occur, although their frequency cannot be established from the available information:

Local Use:

Allergic reactions (hypersensitivity), bronchial constriction and difficulty breathing (bronchospasm), increased nasal secretion (rhinorrhea), mouth ulcers (stomatitis), vomiting, nausea, urticaria, rash, or itching.

Parenteral Use:

Allergic reactions (hypersensitivity) of varying degrees, which may lead to anaphylactic shock, increased heart rate (tachycardia), bronchial constriction and difficulty breathing (bronchospasm, dyspnea), vomiting, nausea, facial swelling (angioedema), urticaria, flushing, rash, itching, facial edema, decreased blood pressure, decreased blood coagulation (increased prothrombin time, decreased platelet aggregation).

In very rare cases, severe skin reactions (Stevens-Johnson syndrome and Lyell syndrome) may occur, although in most cases, at least another suspected medication was identified as the trigger for the syndrome.

If any skin or mucous membrane alterations occur, discontinue acetilcysteine administration immediately. The specialist doctor will determine the subsequent treatment.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keepthis medicationout of the sight and reach of children.

No special storage conditions are required for this medication in its original packaging.

Do not use this medicationafter the expiration date that appears on the packaging after the abbreviation CAD. The expiration date is the last day of the month indicated.

Local Administration

It is recommended to open the ampule at the time of use. Used ampules can only be used for local use and should be stored in a refrigerator for a maximum of 24 hours.

Parenteral Administration

Once opened, use immediately. If not used immediately, storage times and conditions in use are the responsibility of the user.

The solution, once diluted for use (in 5% glucose solution or in 0.9% sodium chloride solution), remains stable for a period of 24 hours at 25°C.

Dispose of after use.

Medications should not be thrown away through drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Composition of Flumil 100 mg/ml

The active ingredient is acetylcysteine. Each 3 ml ampoule contains 300 mg of acetylcysteine.

The other components are:sodium edetate, sodium hydroxide (E524) (for pH adjustment) and water for injectable preparations.

Appearance of the product and content of the container

Appearance: amber glass ampoules with breaking point, containing 3 ml of transparent and colorless solution.

Each container contains 5 ampoules.

Holder of the marketing authorization and responsible for manufacturing

Zambon S.A.U.

Maresme, 5. Pol. Can Bernades-Subirà

08130 – Sta. Perpètua de Mogoda (Barcelona)

Responsible for manufacturing

Zambon S.p.A.

Via della Chimica, 9

36100 – Vicenza (Italy)

or

Biologici Italia Laboratories S.r.l.

Via Filippo Serpero, 2

20060 Masate (MI)

Italy

Last review date of this leaflet: May 2019

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.