FROBEMUCIL 600 mg Effervescent Tablet

Зміст інструкції

1. Frobemucil 600 mg effervescent tablets
   1. What is Frobemucil and what is it 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
2. Frobemucil 600 mg effervescent tablets
   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

Frobemucil 600 mg effervescent tablets

Equivalent Medicinal Product
acetylcysteine

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Frobemucil and what is it used for?

This medicine contains the active ingredient acetylcysteine, which belongs to a group of medicines
called mucolytic expectorants, used to facilitate the elimination of mucus from the respiratory tract.
Frobemucil is indicated for the treatment of respiratory diseases characterized by an increase
in the 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 should 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 the control of your doctor in the following cases:

• if you suffer from an inflammatory disease of the bronchi called bronchial asthma. Stop taking the medicine immediately if you experience bronchospasm (contraction of the bronchial muscles).
• if you are intolerant to histamine, allergic reactions (hypersensitivity) may occur when taking Frobemucil;
• if you suffer from or have suffered in the past from stomach and/or intestinal ulcers (peptic ulcer), especially if taking medicines with toxic effects on the stomach and/or intestines (gastrolesive drugs).

This medicine can liquefy bronchial secretions and therefore increase the volume of mucus
within the bronchi, especially at the beginning of treatment. Therefore, if this occurs and you are unable to eliminate
the bronchial secretions (expectorate) through coughing, consult your doctor who will indicate a method for
eliminating the mucus (postural drainage or bronchoaspiration).
If you notice a sulfurous odor, do not worry as this does not indicate any alteration of the medicine,
but is due to the acetylcysteine.
Laboratory tests: acetylcysteine can interfere with some blood and urine tests (colorimetric dosage for the determination of salicylates and tests to determine ketones). Tell your doctor that you are
taking this medicine before undergoing tests.

Children
Frobemucil should not be given to children under 2 years of age because their limited
ability to eliminate bronchial secretions can obstruct the bronchi and prevent normal breathing.

Other medicines and Frobemucil
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Tell your doctor in particular if you are taking any of the following medicines:

• cough medicines (antitussives). These medicines and Frobemucil should not be taken at the same time, as this can cause mucus to accumulate in the bronchi.
• activated charcoal, used to treat digestive disorders or to eliminate intestinal gas, as it may decrease the effect of Frobemucil;
• oral antibiotics (except loracarbef), used to treat infections caused by bacteria, as it may decrease the effect of the antibiotic. Take oral antibiotics at least two hours apart from taking Frobemucil.
• nitroglycerin, used for some heart conditions, as when taken together with Frobemucil it can cause a drop in blood pressure (hypotension) and headache. If you need to take both medicines at the same time, your doctor will need to monitor you.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Take this medicine if you are pregnant or breastfeeding only if strictly
necessary and under the direct supervision of your doctor.

Driving and operating machinery
Frobemucil does not impair the ability to drive vehicles and operate machinery.

Frobemucil contains lactose, sodium and sorbitol
This medicine contains lactose. If your doctor has diagnosed you with intolerance to certain sugars, contact
them before taking this medicine.
This medicine contains 138.85 mg of sodium (the main component of table salt) per tablet.
This is equivalent to 6.9% of the recommended daily intake of sodium for an adult.
This medicine contains 40 mg of sorbitol per tablet.

3. How to take Frobemucil

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Method of administration
Dissolve the tablet in a glass containing a little water and mix with a teaspoon.
Do not mix other medicines with the Frobemucil solution.
The recommended dose is 1 effervescent tablet (600 mg) per day, preferably in the evening, or as
prescribed by your doctor.
The duration of therapy varies 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 be nausea, vomiting
and diarrhea.
In case of ingestion/taking of an excessive dose of this medicine, immediately inform your
doctor 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 a 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 gets 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
• ringing in the ears (tinnitus)
• increased heart rate (tachycardia)
• vomiting, diarrhea, 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 that can cause difficulty in breathing and swallowing (angioedema), itching.

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

• - difficulty breathing (dyspnea)
• digestive problems (dyspepsia)
• constriction of the bronchial muscles (bronchospasm).

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

• severe drop in blood pressure which, if not treated, can lead to collapse, coma and death (anaphylactic shock), severe allergic reactions (anaphylactic/anaphylactoid reaction)
• bleeding (hemorrhage).

Not known(frequency cannot be estimated based on available data):

• obstruction of the bronchi
• swelling (edema) 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 occurred. If these side effects occur,
stop treatment immediately.
Also consult your doctor if you experience a prolonged bleeding time (reduced
platelet aggregation).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through 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 which is stated on the pack after “Scad.”. The expiry date refers to the last day of that month.
The period of validity after first opening the tube is 24 months.
Tablets in polypropylene tube: do not store at a temperature above 30°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Frobemucil contains

• The active ingredient is acetylcysteine. 1 effervescent tablet contains 600 mg of acetylcysteine.
• The other ingredients are: anhydrous citric acid, ascorbic acid, disodium citrate dihydrate, sodium cyclamate, sodium saccharin, mannitol, sodium hydrogen carbonate, anhydrous sodium carbonate, anhydrous lactose, lemon aroma “AU” (code 132; containing sorbitol).

Description of the appearance of Frobemucil and contents of the pack
Polypropylene tube with a polyethylene cap equipped with a desiccant containing 10 effervescent tablets.
Laminated aluminum foil containing 10 effervescent tablets.

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

Frobemucil 600 mg effervescent tablets

Equivalent Medicinal Product
acetylcysteine

Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell 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 you take 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 medicine contains the active ingredient 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 effect of certain substances.
Frobemucil is indicated for the treatment of diseases of the respiratory system characterized by an increase
in the production of dense and viscous mucus (dense and viscous hypersecretion) such as:

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

This medicine is also used to counteract the toxic effect of certain substances (antidotal
treatment), in particular for:

• accidental or intentional poisoning with paracetamol (an anti-inflammatory medicine);
• uropathy (diseases of the urinary tract), 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 any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant or breastfeeding (see “Pregnancy, breastfeeding and fertility” section).

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Frobemucil.
Take this medicine with caution and always under the control of your doctor in the following cases:

• if you suffer from an inflammatory disease of the bronchi called bronchial asthma. Stop taking the medicine immediately if you have bronchospasm (contraction of the bronchial muscles).
• if you are intolerant to histamine, allergic reactions (hypersensitivity) may occur when taking Frobemucil;
• if you suffer from or have suffered in the past from stomach and/or intestinal ulcers (peptic ulcer), especially if taking medicines with toxic effects on the stomach and/or intestines (gastrolesive drugs).

This medicine may thin bronchial secretions and therefore increase the volume of mucus within the bronchi, especially at the beginning of treatment. Therefore, if this occurs and you are unable to eliminate bronchial secretions (expectorate) through coughing, consult your doctor who will indicate a method for eliminating mucus (postural drainage or bronchoaspiration).
If you notice a sulfurous odor, do not worry as this does not indicate any alteration of the medicine, but is due to the acetylcysteine.
Laboratory tests: acetylcysteine may interfere with some blood and urine tests (colorimetric dosage for the determination of salicylates and tests to determine ketones). Inform your doctor that you are taking this medicine before undergoing tests.

Children
Frobemucil should not be administered to children under 2 years of age for the treatment of respiratory problems because their limited ability to eliminate bronchial secretions may obstruct the bronchi and prevent normal breathing.

Other medicines and Frobemucil
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Tell your doctor in particular if you are taking any of the following medicines:

• cough medicines (antitussives). These medicines and Frobemucil should not be taken at the same time, as this may cause an accumulation of mucus in the bronchi.
• activated charcoal, used to treat digestive disorders or to eliminate intestinal gas, as it may decrease the effect of Frobemucil;
• oral antibiotics (except loracarbef), used to treat infections caused by bacteria, as it may decrease the effect of the antibiotic. Take oral antibiotics at least two hours apart from taking Frobemucil.
• nitroglycerin, used for some heart conditions, as when taken together with Frobemucil it may cause a drop in blood pressure (hypotension) and headache. If you need to take both medicines at the same time, your doctor will need to monitor you.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Take this medicine if you are pregnant or breastfeeding only if strictly necessary and under the direct supervision of your doctor.

Driving and operating machinery
Frobemucil does not impair the ability to drive vehicles and operate machinery.

Frobemucil contains lactose, sodium and sorbitol
This medicine contains lactose. If your doctor has diagnosed you with intolerance to certain sugars, contact them before taking this medicine.
This medicine contains 138.85 mg of sodium (the main component of table salt) per tablet.
This is equivalent to 6.9% of the recommended daily intake with the diet of an adult.
This medicine contains 40 mg of sorbitol per tablet.

In addition, only for antidotal treatment: sorbitol is a source of fructose. If your doctor has told you that you (or your child) are intolerant to certain sugars, or if you have a diagnosis of hereditary fructose intolerance, a rare genetic disease in which patients cannot metabolize fructose, talk to your doctor before you (or your child) take this medicine.
It may cause gastrointestinal problems and have a mild laxative effect.

3. How to take Frobemucil

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
Method of administration
Dissolve the tablet in a glass containing a little water and mix with a teaspoon.
Do not mix other medicines with the Frobemucil solution.

Treatment of respiratory system diseases
The recommended dose is 1 effervescent tablet (600 mg) per day, preferably in the evening, or according to
medical prescription.
The duration of therapy varies from 5 to 10 days in acute forms and in chronic forms it should be continued, at
the doctor'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, to be administered as soon as possible, within 10
hours of taking paracetamol. Subsequently, the dose is 70 mg per kg of body weight at
intervals of 4 hours for 1-3 days.

Treatment of iso- and cyclophosphamide uropathy
In a typical chemotherapy cycle with iso- and cyclophosphamide of 1,200 mg/m² of body surface area per day
for 5 days every 28 days, the recommended dose is 4 g per day to be divided into 4 doses of 1 g on the days
of chemotherapeutic treatment.

If you take more Frobemucil than you should
No cases of overdose have been reported. Symptoms of an excessive dose may be nausea, vomiting
and diarrhea.
In case of ingestion/taking an excessive dose of this medicine, immediately inform your
doctor 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 a 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 gets 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
• ringing in the ears (tinnitus)
• increased heart rate (tachycardia)
• vomiting, diarrhea, inflammation of the mouth (stomatitis), abdominal pain, nausea
• urticaria, skin rash, swelling of the face, lips, mouth, tongue or throat which can 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 (dyspnea)
• digestive problems (dyspepsia)
• constriction of the bronchial muscles (bronchospasm).

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

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

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

• obstruction of the bronchi
• swelling (edema) 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 manifested. If such side effects occur,
stop treatment immediately.
Also consult your doctor if you experience a prolonged bleeding time (reduced
platelet aggregation).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist.
You can also report side effects directly through 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 which is stated on the pack after “Scad.”. The expiry date refers to the last day of that month.
The period of validity after first opening the tube is 24 months.
Tablets in polypropylene tube: do not store at a temperature above 30°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Frobemucil contains

• The active ingredient is acetylcysteine. 1 effervescent tablet contains 600 mg of acetylcysteine.
• The other ingredients are: anhydrous citric acid, ascorbic acid, disodium citrate dihydrate, sodium cyclamate, sodium saccharin, mannitol, sodium hydrogen carbonate, anhydrous sodium carbonate, anhydrous lactose, lemon aroma “AU” (code 132; containing sorbitol).

Description of the appearance of Frobemucil and contents of the pack
Polypropylene tube with a polyethylene cap equipped with a desiccant containing 30 effervescent tablets.
Laminated aluminum foil containing 30 effervescent tablets.

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