Frobemucil

Package leaflet: Information for the patient

Frobemucil 600 mg effervescent tablets

Equivalent Medicine
acetylcysteine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Frobemucil is and what it is used for

This medicinal product contains the active substance acetylcysteine, which belongs to a group of medicines called mucolytic expectorants, used to help eliminate mucus from the respiratory tract.
Frobemucil is indicated for the treatment of respiratory tract diseases characterized by increased production of thick and viscous mucus (dense and viscous hypersecretion).

2. What you need to know before taking Frobemucil

Do not take Frobemucil

• if you are allergic to acetylcysteine or to any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant or breastfeeding (see section “Pregnancy, breastfeeding and fertility”);

Frobemucil must not be used in children under 2 years of age (see section “Children”).
Warnings and precautions
Talk to your doctor or pharmacist before taking Frobemucil.
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. Immediately stop taking the medicine if you experience bronchial muscle contraction (bronchospasm).
• if you are histamine intolerant, allergic reactions (hypersensitivity) may occur during treatment with Frobemucil;
• if you currently have or have previously had a stomach and/or intestinal ulcer (peptic ulcer), especially if you are concurrently taking medicines with toxic effects on the stomach and/or intestine (gastrolesive drugs).

This medicine may liquefy bronchial secretions and thus increase the volume of mucus within the bronchi, particularly at the beginning of treatment. Therefore, if this occurs and you are unable to clear bronchial secretions by coughing (expectoration), consult your doctor, who will advise you on an appropriate method to remove the mucus (postural drainage or bronchoaspiration).
If you notice a sulfur-like odour, do not be alarmed, as this does not indicate any deterioration of the medicine but is due to acetylcysteine.
Laboratory tests: acetylcysteine may interfere with certain blood and urine analyses (colorimetric assay for salicylate determination and tests for ketone detection). Inform your doctor that you are taking this medicine before undergoing any laboratory tests.
Children
Frobemucil must not be administered to children under 2 years of age, as their limited ability to eliminate bronchial secretions may lead to bronchial obstruction and impair normal breathing.
Other medicines and Frobemucil
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking any of the following medicines:

• cough suppressants (antitussives). These medicines and Frobemucil must not be taken simultaneously, as this may lead to mucus accumulation in the bronchi.
• activated charcoal, used to treat digestive disorders or to eliminate intestinal gas, as it may reduce the effectiveness of Frobemucil;
• oral antibiotics (except loracarbef), used to treat bacterial infections, as they may have their effect reduced. Take oral antibiotics at least two hours apart from Frobemucil.
• nitroglycerin, used for certain heart conditions, as concomitant use with Frobemucil may cause low blood pressure (hypotension) and headache (cephalaea). If you need to take both medicines together, your doctor must monitor you closely.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Take this medicine during pregnancy or while breastfeeding only if strictly necessary and under direct medical supervision.
Driving and using machines
Frobemucil does not impair the ability to drive or operate machinery.
Frobemucil contains lactose, sodium and sorbitol
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.
This medicine contains 138.85 mg of sodium (a main component of table salt) per tablet. This corresponds to 6.9% of the maximum daily dietary intake recommended for an adult.
This medicine contains 40 mg of sorbitol per tablet.

3. How to take Frobemucil

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Method of administration
Dissolve the tablet in a glass of water and mix with a teaspoon.
Do not mix other medicines with the Frobemucil solution.
The recommended dose is 1 effervescent tablet (600 mg) daily, preferably in the evening, or as prescribed
by your doctor.
The duration of treatment ranges from 5 to 10 days.
If you take more Frobemucil than you should
Cases of overdose have not been reported. Symptoms of an excessive dose may include nausea, vomiting,
and diarrhea.
If you have taken/ingested more than the prescribed amount of this medicine, contact your doctor immediately
or go to the Emergency Department of the nearest hospital.
If you forget to take Frobemucil
Do not take a double dose to make up for the missed 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 experiences them.
The following side effects may occur:
Common (may affect up to 1 in 10 people):

• skin irritation characterized by red spots (rash).

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
• fever (pyrexia)
• decrease in blood pressure
• urticaria, skin rash, swelling of the face, lips, mouth, tongue or throat which may cause difficulty in breathing and swallowing (angioedema), itching.

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

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

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

• severe drop in blood pressure which, if untreated, may lead to collapse, coma and death (anaphylactic shock), severe allergic reactions (anaphylactic/anaphylactoid reaction)
• bleeding (haemorrhage).

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

• bronchial obstruction
• swelling (oedema) of the face.

In very rare cases, a rare skin condition characterized by severe blisters and bleeding of the lips, eyes, mouth, nose and genitals (Stevens-Johnson syndrome) and a serious skin reaction (toxic epidermal necrolysis or Lyell's syndrome) have been reported. If any of these side effects occur, stop treatment immediately.
Also consult your doctor if you experience prolonged bleeding time (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 Frobemucil

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.
The shelf life after first opening the tube is 24 months.
Tablets in polypropylene tube: do not store above 30°C.
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 Frobemucil contains

• The active substance is acetylcysteine. Each effervescent tablet contains 600 mg of acetylcysteine.
• The other components are: anhydrous citric acid, ascorbic acid, disodium hydrogen citrate dihydrate, sodium cyclamate, sodium saccharin, mannitol, sodium hydrogen carbonate, anhydrous sodium carbonate, anhydrous lactose, lemon flavour “AU” (code 132; containing sorbitol).

Description of the appearance of Frobemucil and pack contents
Polypropylene tube with polyethylene cap supplied with a desiccant, containing 10 effervescent tablets.
Laminated aluminium foil sheet containing 10 effervescent tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Cooper Consumer Health B.V.
Verrijn Stuartweg 60 – 1112 AX Diemen
(The Netherlands)
Manufacturer
HERMES PHARMA GmbH, Hans-Urmiller-Ring 52, 82515 Wolfratshausen, Germany

Patient Information Leaflet

Frobemucil 600 mg effervescent tablets

Generic Medicine
acetylcysteine
Please read this leaflet carefully before taking 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 may be dangerous.
• 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 Frobemucil is and what it is used for
2. What you need to know before taking Frobemucil
3. How to take Frobemucil
4. Possible side effects
5. How to store Frobemucil
6. Contents of the pack and other information

1. What Frobemucil 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 facilitate the elimination of mucus from the respiratory tract, and to a group of medicines called antidotes, used to counteract the toxic effects of certain substances.

Frobemucil is indicated for the treatment of respiratory tract diseases characterised by increased production of thick and viscous mucus (dense and viscous hypersecretion), such as:

• acute bronchitis, chronic bronchitis and its exacerbations;
• pulmonary emphysema;
• cystic fibrosis (mucoviscidosis);
• bronchiectasis (bronchial dilation).

This medicine is also used to counteract the toxic effects of certain substances (antidotal treatment), particularly in:

• accidental or intentional poisoning with paracetamol (an anti-inflammatory medicine);
• uropathy (urinary tract diseases) caused by medicines such as iso- and cyclophosphamide (chemotherapeutic agents).

2. What you need to know before taking Frobemucil

Do not take Frobemucil

• if you are allergic to acetylcysteine or to any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant or breastfeeding (see section “Pregnancy, breastfeeding and fertility”).

Frobemucil must not be used in children under 2 years of age for the treatment of respiratory diseases, but only as an antidote (see section “Children”).

Warnings and precautions

Talk to your doctor or pharmacist before taking Frobemucil.

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. Immediately stop taking the medicine if you experience bronchial muscle contraction (bronchospasm).
• if you are histamine-intolerant, allergic reactions (hypersensitivity) may occur during treatment with Frobemucil;
• if you currently have or have previously had a stomach and/or intestinal ulcer (peptic ulcer), especially if you are concurrently taking medicines that are toxic to the stomach and/or intestine (gastrolesive drugs).

This medicine may liquefy bronchial secretions and thus increase the volume of mucus within the bronchi, particularly at the beginning of treatment. Therefore, if this occurs and you are unable to expel the bronchial 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 sulphur-like odour, do not be concerned, as this does not indicate any deterioration of the medicine, but is due to acetylcysteine.

Laboratory tests: Acetylcysteine may interfere with certain blood and urine analyses (colorimetric assay for salicylates and tests for ketones). Inform your doctor that you are taking this medicine before undergoing any laboratory tests.

Children

Frobemucil must not be administered to children under 2 years of age for the treatment of respiratory problems, because their limited ability to clear bronchial secretions may lead to bronchial obstruction and impair normal breathing.

Other medicines and Frobemucil

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

In particular, inform your doctor if you are taking any of the following medicines:

• cough suppressants (antitussives). These medicines and Frobemucil must not be taken simultaneously, as this may result in mucus accumulation in the bronchi.
• activated charcoal, used to treat digestive disorders or to eliminate intestinal gases, as it may reduce the effect of Frobemucil;
• oral antibiotics (except loracarbef), used to treat bacterial infections, as they may reduce the effectiveness of the antibiotic. Take oral antibiotics at least two hours apart from Frobemucil.
• nitroglycerin, used for certain heart conditions, as concomitant use with Frobemucil may cause a drop in blood pressure (hypotension) and headache (cephalalgia). If you need to take both medicines, your doctor must monitor you closely.

Pregnancy, breastfeeding and fertility

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

Take this medicine during pregnancy or while breastfeeding only if strictly necessary and under direct medical supervision.

Driving and using machines

Frobemucil does not impair the ability to drive vehicles or operate machinery.

Frobemucil contains lactose, sodium and sorbitol

This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

This medicine contains 138.85 mg of sodium (the main component of table salt) per tablet. This corresponds to 6.9% of the maximum daily recommended dietary intake for an adult.

This medicine contains 40 mg of sorbitol per tablet.

Additionally, only for antidotal treatment: Sorbitol is a source of fructose. If your doctor has told you that you (or the child) have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot metabolize fructose, speak with your doctor before you (or the child) take this medicine.

It may cause gastrointestinal disturbances and has a mild laxative effect.

3. How to take Frobemucil

Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Method of administration
Dissolve the tablet in a glass containing some water and mix with a teaspoon.
Do not mix other medicines with the Frobemucil solution.
Treatment of respiratory tract diseases
The recommended dose is 1 effervescent tablet (600 mg) daily, preferably in the evening, or as prescribed by
the physician.
The duration of treatment varies from 5 to 10 days in acute forms; in chronic forms, treatment should continue,
at the physician's discretion, for periods of several months.
Treatment of accidental or intentional paracetamol poisoning
The recommended initial dose is 140 mg per kg of body weight, administered as soon as possible, within 10
hours of paracetamol ingestion. Subsequently, the dose is 70 mg per kg of body weight every 4 hours for 1–3 days.
Treatment of uropathy caused by ifosfamide and cyclophosphamide
In a typical chemotherapy cycle with ifosfamide and cyclophosphamide of 1,200 mg/m² body surface area per day
for 5 days every 28 days, the recommended dose is 4 g per day, divided into 4 doses of 1 g each on the days of
chemotherapy treatment.
If you take more Frobemucil than you should
No cases of overdose have been reported. Symptoms of an excessive dose may include nausea, vomiting,
and diarrhoea.
In case of ingestion/overdose of this medicine, contact your doctor immediately or go to the Emergency Room of the nearest hospital.
If you forget to take Frobemucil
Do not take a double dose to make up for the missed 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 everybody will experience them.
The following side effects may occur:
Common (may affect up to 1 in 10 people):

• skin irritation characterized by red spots (rash).

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
• urticaria, skin rash, swelling of the face, lips, mouth, tongue or throat which may cause difficulty in breathing and swallowing (angioedema), itching.
• fever (pyrexia)
• decrease in blood pressure

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

• difficulty breathing (dyspnoea)
• digestive problems (dyspepsia)
• contraction of bronchial muscles (bronchospasm).

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

• severe drop in blood pressure which, if untreated, may lead to collapse, coma and death (anaphylactic shock), severe allergic reactions (anaphylactic/anaphylactoid reaction)
• bleeding (haemorrhage).

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

• obstruction of the bronchi
• swelling (oedema) of the face.

In very rare cases, a rare skin condition characterized by severe blisters and bleeding of the lips, eyes, mouth, nose and genitals (Stevens-Johnson syndrome) and a severe skin reaction (toxic epidermal necrolysis or Lyell's syndrome) have been reported. If you experience any of these side effects, stop treatment immediately.
Also consult your doctor if you experience prolonged bleeding time (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 Frobemucil

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.
The shelf life after first opening the tube is 24 months.
Tablets in polypropylene tube: do not store above 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Frobemucil contains

• The active substance is acetylcysteine. One effervescent tablet contains 600 mg of acetylcysteine.
• The other components are: citric acid anhydrous, ascorbic acid, disodium hydrogen citrate dihydrate, sodium cyclamate, sodium saccharin, mannitol, sodium hydrogen carbonate, anhydrous sodium carbonate, anhydrous lactose, lemon flavour “AU” (code 132; containing sorbitol).

Description of the appearance of Frobemucil and contents of the pack
Polypropylene bottle with polyethylene cap, supplied with a desiccant, containing 30 effervescent tablets.
Laminated aluminium foil sheet containing 30 effervescent tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Cooper Consumer Health B.V.
Verrijn Stuartweg 60 – 1112 AX Diemen
(The Netherlands)
Manufacturer
HERMES PHARMA GmbH, Hans-Urmiller-Ring 52, 82515 Wolfratshausen, Germany