Kofimucil mucolytic

Package leaflet: Information for the patient

KOFIMUCIL MUCOLYTIC 200 mg granules for oral solution

Acetylcysteine
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement or if your symptoms worsen after a short period of treatment.

Contents of this leaflet:

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

1. What KOFIMUCIL MUCOLITICO is and what it is used for

This medicinal product contains the active substance N-acetylcysteine, which belongs to a group of
medicines called mucolytic expectorants, used to facilitate the removal of mucus from the
respiratory tract.
KOFIMUCIL MUCOLITICO is indicated for the treatment of respiratory tract diseases
characterized by increased production of thick and viscous mucus (dense and viscous hypersecretion).
Consult your doctor if you do not improve or feel worse after short periods of treatment.

2. What you need to know before taking KOFIMUCIL MUCOLYTIC

Do not take KOFIMUCIL MUCOLYTIC

• if you are allergic to acetylcysteine, to similar substances, or to any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant or breastfeeding (see section “Pregnancy and breastfeeding”);
• if the person taking this medicine is a child under 12 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking KOFIMUCIL MUCOLYTIC.
Take this medicine with caution and always under medical supervision in the following cases:

• if you suffer from a bronchial inflammatory disease called bronchial asthma. Discontinue taking the medicine if you experience difficulty breathing or bronchial muscle spasms (bronchospasm); consult your doctor also if you have previously experienced such symptoms;
• if you are histamine intolerant, allergic reactions (hypersensitivity) may occur during treatment with KOFIMUCIL MUCOLYTIC;
• if you have or have had a stomach or intestinal condition called peptic ulcer, especially if you are concurrently taking other medicines that cause stomach problems (gastrotoxic drugs) together with KOFIMUCIL MUCOLYTIC.

This medicine may increase the volume of bronchial mucus (bronchial secretions), especially at the beginning of treatment. Therefore, if this occurs and you are unable to clear the secretions by coughing (expectorate), consult your doctor, who will advise you on a method to remove the mucus (postural drainage or bronchoaspiration).
If you notice a sulfur-like odor, do not be concerned, as this does not indicate deterioration of the product but is due to the presence of acetylcysteine.
Laboratory tests: Acetylcysteine may interfere with certain blood and urine analyses (colorimetric assay for salicylate determination and tests for ketones). Inform your doctor that you are taking this medicine before undergoing any laboratory tests.

Other medicines and KOFIMUCIL MUCOLYTIC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take this medicine if you are using:

• cough suppressants (antitussives), as they may lead to mucus accumulation in the bronchi.

Take this medicine with caution and consult your doctor if you are taking any of the following medicines:

• activated charcoal, used to treat digestive disorders or intestinal gas (flatulence), as it may reduce the effectiveness of KOFIMUCIL MUCOLYTIC;
• antibiotics taken orally for treating infections. Take these medicines at least two hours apart from KOFIMUCIL MUCOLYTIC;
• nitroglycerin, used for certain heart conditions. Concurrent use of this medicine with KOFIMUCIL MUCOLYTIC may cause a drop in blood pressure (hypotension), which may be severe, and headache (cephalalgia).

Do not mix the KOFIMUCIL MUCOLYTIC solution with other medicines.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you are pregnant or breastfeeding, take this medicine only if strictly necessary and under direct medical supervision.

Driving and using machines
KOFIMUCIL MUCOLYTIC does not affect the ability to drive or operate machinery.

KOFIMUCIL MUCOLYTIC contains sucrose and sunset yellow (E 110)
This medicine contains sucrose (each single dose of KOFIMUCIL MUCOLYTIC contains 2.24 g of sucrose), a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
This medicine contains sunset yellow (E 110), a dye. It may cause allergic reactions.

3. How to take KOFIMUCIL MUCOLYTIC

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
This medicine is intended for adults only.

Instructions for use of KOFIMUCIL MUCOLITICO:

Dissolve the contents of the sachet in a glass containing a small amount of water, stirring with a
teaspoon.
Take the medicine immediately after preparing the solution.
The recommended dose of KOFIMUCIL MUCOLITICO for adults is 1 sachet of 200 mg, 2–3
times a day.
The duration of treatment is 5 to 10 days. In chronic forms, the physician may decide to prolong the
duration of treatment.
Consult your doctor if the condition occurs frequently or if you notice any changes in its
symptoms.
If you take more KOFIMUCIL MUCOLITICO than you should
Symptoms of overdose may include nausea, vomiting, and diarrhoea.
In case of ingestion/absorption of an excessive dose of this medicine, contact your doctor immediately or go to the nearest hospital.
If you forget to take KOFIMUCIL MUCOLITICO
Do not take a double dose to make up for the forgotten dose.
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 may cause side effects, although not everybody gets them.
The following side effects may occur:
Uncommon (may affect up to 1 in 100 people)

• allergic reactions (hypersensitivity);
• headache (cephalalgia);
• ringing in the ears (tinnitus);
• increased heart rate (tachycardia);
• vomiting;
• diarrhoea;
• inflammation of the mouth (stomatitis);
• abdominal pain;
• nausea;
• skin irritations (urticaria, rash);
• swelling due to fluid accumulation around the mouth and eyes (angioedema);
• itching (pruritus);
• fever (pyrexia);
• low blood pressure.

Rare (may affect up to 1 in 1,000 people)

• bronchial muscle contractions (bronchospasm);
• difficulty breathing (dyspnoea);
• digestive problems (dyspepsia).

Very rare (may affect up to 1 in 10,000 people)

• severe allergic reactions (anaphylactic shock, anaphylactic/anaphylactoid reaction);
• bleeding (haemorrhage).

Not known (frequency cannot be estimated from the available data)

• blockage of the bronchi (bronchial obstruction);
• swelling (oedema) of the face.

Contact your doctor if you experience any of the following side effects:

• skin lesions (Stevens-Johnson syndrome or Lyell’s syndrome). If you notice changes in the mucous membranes or skin, stop taking the medicine immediately;
• blood disorders (reduced platelet aggregation).

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 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 KOFIMUCIL MUCOLYTIC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from moisture.
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 KOFIMUCIL MUCOLITIC 200 mg granules for oral solution contains

• The active substance is N-acetylcysteine: each sachet contains 200 mg of N-acetylcysteine.
• The other components are: granular orange juice, orange flavour, saccharin, sunset yellow (E 110), sucrose.

Description of the appearance of KOFIMUCIL MUCOLITIC and contents of the pack
Carton containing 30 sachets.
Marketing Authorization Holder
Pool Pharma S.r.l. – Via Basilicata, 9 – 20098 San Giuliano Milanese (MI)
Manufacturer
Mipharm S.p.A. – Via Bernardo Quaranta, 12 – 20139 MILAN