Package leaflet: Information for the patient

DISSOLVIN 200 mg granules for oral solution

N-Acetylcysteine
Please read all of this leaflet carefully before you take 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 told you to do.

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 effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice any improvement or if your symptoms worsen after 10 days.

Contents of this leaflet:

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

1. What DISSOLVIN is and what it is used for

This medicinal product contains the active substance acetylcysteine, which belongs to a group of medicines called expectorants - mucolytics, used to help eliminate mucus from the respiratory tract.
DISSOLVIN is indicated for the treatment of respiratory tract diseases characterised by increased production of thick and viscous mucus (dense and viscous hypersecretion).
Consult your doctor if you do not feel better or feel worse after 10 days.

2. What you need to know before taking DISSOLVIN

Do not take DISSOLVIN

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 DISSOLVIN.
Take this medicine with caution and always under medical supervision in the following cases:

if you suffer from a chronic inflammatory bronchial disease called bronchial asthma. Stop taking the medicine if you experience dyspnea (difficulty breathing) due to bronchial muscle contraction (bronchospasm) after taking it. Consult your doctor also if such symptoms have occurred in the past;
if you are histamine intolerant, allergic reactions (hypersensitivity) may occur during treatment with DISSOLVIN;
if you have or have had a stomach or intestinal condition called peptic ulcer, especially if you are taking other medicines together with DISSOLVIN that may cause stomach problems (gastrotoxic drugs).

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 bronchial secretions by coughing (expectorating), consult your doctor, who will recommend 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 preparation but is due to acetylcysteine.
Laboratory tests: Acetylcysteine may interfere with certain blood and urine tests (colorimetric assay for salicylates and tests for ketones). Inform your doctor that you are taking this medicine before undergoing any laboratory tests.

Other medicines and DISSOLVIN
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 taking:

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 (meteorism), as it may reduce the effectiveness of DISSOLVIN;
oral antibiotics (medicines used to treat infections), except loracarbef. Take these medicines at least two hours apart from DISSOLVIN;
nitroglycerin, used for certain heart conditions. Concurrent use of this medicine with DISSOLVIN may cause low blood pressure (hypotension) and headache (cephalalgia).

Do not mix the DISSOLVIN solution with other medicines.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are 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
DISSOLVIN does not affect the ability to drive vehicles or operate machinery.

DISSOLVIN contains sucrose, sunset yellow (E 110), and lactose
This medicine contains sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine. This medicine contains 2.24 g of sucrose per sachet, which should be considered in patients with diabetes mellitus, especially if multiple sachets are taken daily.
This medicine contains sunset yellow (E 110), a dye that may cause allergic reactions.
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

3. How to take DISSOLVIN

Take this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Instructions for use

Dissolve the contents of the sachet in a glass containing a small amount of water, stirring if necessary with a teaspoon.
Take the medicine immediately after preparing the solution.
The recommended dose of DISSOLVIN for adults is 1 sachet of 200 mg, 2–3 times daily.
The duration of treatment is 5 to 10 days for acute conditions. For chronic conditions, the physician may extend the treatment duration up to 1 month or longer.
This medicine is intended for use in adults only.

If you take more DISSOLVIN 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 DISSOLVIN
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 can cause side effects, although not everyone 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;
fever (pyrexia);
decrease in blood pressure.

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

bronchial muscle contractions (bronchospasm);
difficulty in breathing (dyspnoea);
digestive difficulties (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 experience changes in mucous membranes or skin, stop taking the medicine;
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 DISSOLVIN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp". 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 you no longer use. This will help protect the environment.

6. Package contents and other information

What DISSOLVIN contains

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

Description of the appearance of DISSOLVIN and package contents
Carton containing 30 sachets of 3 g.
Marketing Authorization Holder
Epifarma S.r.l. – Via San Rocco, 6 – 85033 Episcopia (PZ)
Manufacturer
Mipharm S.p.A. – Via Bernardo Quaranta, 12 – 20139 Milan