KOFITUSS 60 mg /Ml Oral Drops, Solution

Зміст інструкції

1. KOFITUSS SEDATIVO TOSSE 30 mg/5 ml syrup
   1. What is KOFITUSS SEDATIVO TOSSE and what is it used for
   2. What you need to know before taking KOFITUSS SEDATIVO TOSSE
   3. How to take KOFITUSS SEDATIVO TOSSE
   4. Possible side effects
   5. How to store KOFITUSS SEDATIVO TOSSE
   6. Contents of the pack and other information
2. KOFITUSS SEDATIVO TOSSE 60 mg/ml oral drops, solution
   1. What is KOFITUSS SEDATIVO TOSSE and what is it used for
   2. What you need to know before taking KOFITUSS SEDATIVO TOSSE
   3. How to take KOFITUSS SEDATIVO TOSSE
   4. Possible side effects
   5. How to store KOFITUSS SEDATIVO TOSSE
   6. Contents of the pack and other information

KOFITUSS SEDATIVO TOSSE 30 mg/5 ml syrup

Levodropropizine
Equivalent medicine

Read this leaflet carefully before taking this medicine as 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 want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after 2 weeks of treatment.

Contents of this leaflet:

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

1. What is KOFITUSS SEDATIVO TOSSE and what is it used for

Consult your doctor if you do not feel better or if you feel worse after 2 weeks of treatment.
KOFITUSS SEDATIVO TOSSE contains the active ingredient levodropropizine, which belongs to a group of
medicines called cough sedatives that calm the cough (antitussive activity), preventing bronchial contraction (antibronchospastic activity) and relieving allergies (anti-allergic activity).
This medicine is indicated for the treatment of cough.

2. What you need to know before taking KOFITUSS SEDATIVO TOSSE

Do not take KOFITUSS SEDATIVO TOSSE

• if you are allergic to levodropropizine or any of the other ingredients of this medicine (listed in section 6);
• if you suffer from a disease of the bronchi, characterized by high mucus production (bronchial hypersecretion);
• if you have been born with certain disorders of the respiratory mucosa characterized by a reduced ability to expel mucus (Kartagener syndrome, ciliary dyskinesia);
• if you are pregnant or breastfeeding (See section “Pregnancy and breastfeeding”).

Do not administer this medicine to children under two years of age (see subsection
"Children").

Warnings and precautions
Consult your doctor or pharmacist before taking KOFITUSS SEDATIVO TOSSE.
Take this medicine with caution and inform your doctor:

• if you suffer from severe impairment of kidney function (severe renal insufficiency with creatinine clearance below 35 ml/min);
• if you are an elderly person, as sensitivity to various medicines is altered in the elderly;
• if you are taking sedative medicines (for the treatment of anxiety) and you are a particularly sensitive individual (See section “Other medicines and KOFITUSS SEDATIVO TOSSE”).

Cough medicines only treat the symptoms and should only be used while awaiting diagnosis of the cause
triggering it and/or the effect of therapy for the underlying disease.
Do not therefore use for prolonged treatments. After a short period of treatment (2 weeks) without appreciable
results, consult your doctor.
KOFITUSS SEDATIVO TOSSE does not contain gluten, therefore it is not contraindicated if you suffer from celiac
disease.

Children
Do not give this medicine to children under 2 years of age (see subsection "Do not take KOFITUSS
SEDATIVO TOSSE").

Other medicines and KOFITUSS SEDATIVO TOSSE
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Take this medicine with caution and inform your doctor if you are taking sedative medicines, used for the
treatment of anxiety.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.
If you are pregnant or breastfeeding, do not take this medicine (See section “Do not take KOFITUSS
SEDATIVO TOSSE”).

Driving and operating machinery
This medicine can cause drowsiness. Therefore, avoid driving vehicles or operating machinery if
you experience these symptoms.

KOFITUSS SEDATIVO TOSSE contains sucrose and para-hydroxybenzoates
This medicine contains 4 g of sucrose per dose (10 ml). If your doctor has diagnosed you with an
intolerance to certain sugars, contact him/her before taking this medicine. To be taken into consideration in
people affected by diabetes mellitus.
This medicine contains para-hydroxybenzoates (methyl-parahydroxybenzoate, propyl-parahydroxybenzoate) which
can cause allergic reactions (including delayed reactions).

3. How to take KOFITUSS SEDATIVO TOSSE

Take this medicine following exactly as indicated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Take this medicine until the symptoms disappear. If after 2 weeks of treatment you do not notice any improvement, stop the treatment and consult your doctor.
The package contains a measuring cup with markings corresponding to 3, 5 and 10 ml with which you can dose the syrup. To open the package, you need to press firmly on the cap and rotate it counterclockwise at the same time.

Adults
The recommended dose is 10 ml of syrup up to 3 times a day, at intervals of at least 6 hours between administrations.

Use in children over 2 years
The recommended dose, based on the child's weight, is:

• between 10 and 20 Kg: 3 ml;
• between 20 and 30 Kg: 5 ml.

The syrup can be taken up to 3 times a day, at intervals of at least 6 hours between administrations.

Warning: do not exceed the indicated doses

If you take more KOFITUSS SEDATIVO TOSSE than you should
Following the intake of an excessive dose of this medicine, the following may occur: abdominal pain and vomiting, which are not serious.
The doctor will establish the most appropriate therapy for you based on the severity of the symptoms.
In case of ingestion/intake of an excessive amount of this medicine, seek immediate medical attention or go to the nearest hospital.

If you forget to take KOFITUSS SEDATIVO TOSSE
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.
Most of the adverse reactions that have occurred following the intake of levodropropizine
are not serious and the symptoms resolved with discontinuation of therapy and, in some cases, with specific
pharmacological treatment.
The adverse reactions observed have an unknown frequency (the frequency cannot be defined based on
available data):

• mydriasis (pupil dilation), bilateral blindness (affecting both eyes);
• allergic and anaphylactoid reactions, palpebral edema (swelling of the eyelid), angioedema (deep dermal and subcutaneous tissue swelling that can also affect mucous membranes), urticaria;
• nervousness, drowsiness, personality alteration, personality disorder; syncope (transient loss of consciousness), dizziness, vertigo, tremors;
• paresthesia (abnormal skin sensation, tingling), tonic-clonic seizure (grand mal) and petit mal seizure, hypoglycemic coma (loss of consciousness caused by a severe reduction in blood glucose levels);
• palpitations, tachycardia (accelerated heartbeat), atrial bigeminy (irregular heartbeat);
• hypotension (low blood pressure);
• dyspnea (difficulty breathing), cough, edema (swelling) of the respiratory tract;
• stomach pain, abdominal pain, nausea, vomiting, diarrhea;
• cholestatic hepatitis (liver inflammation due to blockage of bile excretion);
• urticaria, erythema (skin redness), exanthema (skin rash), pruritus, angioedema (swelling of the face and mucous membranes), skin reactions, glossitis (inflammation of the tongue) and aphthous stomatitis (painful ulcers in the mouth);
• epidermolysis (rare and potentially serious skin diseases);
• weakness of the lower limbs;
• general malaise, generalized edema (swelling), asthenia (physical weakness).

Additional side effects in newborns breastfed by mothers who have taken levodropropizine
One case of drowsiness, hypotonia (reduced muscle tone) and vomiting has been reported in a newborn after
levodropropizine intake by the breastfeeding mother. The symptoms appeared after feeding and
resolved spontaneously by suspending breastfeeding for some feeds.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please 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 KOFITUSS SEDATIVO TOSSE

Keep this medicine out of the sight and reach of children.
Do not take this medicine after the expiry date which is stated on the pack after “Exp.”.
The expiry date refers to the last day of that month.
The shelf life of the product after first opening the bottle is 6 weeks.
Store at a temperature not exceeding 25°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 KOFITUSS SEDATIVO TOSSE contains

• The active ingredient is levodropropizine. Each 100 ml of solution contains 600mg of levodropropizine.
• The other ingredients are: sucrose, methyl-parahydroxybenzoate, propyl-parahydroxybenzoate, citric acid monohydrate, sodium hydroxide, cherry flavour, purified water.

Description of the appearance of KOFITUSS SEDATIVO TOSSE and contents of the pack
200ml bottle with graduated measuring cup.

Marketing Authorisation Holder
POOL PHARMA Srl – Via Basilicata, 9 –20098 San Giuliano Milanese (MI)- Italy

Manufacturer
Doppel Farmaceutici Srl - Via Martiri delle Foibe, 1- 29016 Cortemaggiore (PC) – Italy
Vamfarma s.r.l. - Via Kennedy, 5 - 26833 Comazzo (LO) - Italy

KOFITUSS SEDATIVO TOSSE 60 mg/ml oral drops, solution

levodropropizine
Generic medicine

Read this leaflet carefully before you start to take 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 their symptoms are the same as yours, as it could 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 KOFITUSS SEDATIVO TOSSE is and what it is used for
• 2. What you need to know before you take KOFITUSS SEDATIVO TOSSE
• 3. How to take KOFITUSS SEDATIVO TOSSE
• 4. Possible side effects
• 5. How to store KOFITUSS SEDATIVO TOSSE
• 6. Contents of the pack and other information

1. What is KOFITUSS SEDATIVO TOSSE and what is it used for

Consult a doctor if you do not feel better or if you feel worse after 2 weeks of treatment
KOFITUSS SEDATIVO TOSSE contains the active ingredient levodropropizine which belongs to a group of
medicines called cough sedatives that calm the cough (antitussive activity), preventing the contraction of the
bronchi (antibronchospastic activity) and relieving allergy symptoms (anti-allergic activity).
This medicine is indicated for the treatment of cough.

2. What you need to know before taking KOFITUSS SEDATIVO TOSSE

Do not take KOFITUSS SEDATIVO TOSSE

• if you are allergic to levodropropizine or any of the other ingredients of this medicine (listed in section 6);
• if you suffer from a bronchial disease, characterized by high mucus production (bronchial hypersecretion);
• if you have been born with certain disorders of the respiratory mucosa characterized by a reduced ability to expel mucus (Kartagener syndrome, ciliary dyskinesia);
• if you are pregnant or breastfeeding (See section “Pregnancy and breastfeeding”).

Do not administer this medicine to children under two years of age (see subsection "Children").

Warnings and precautions
Consult your doctor or pharmacist before taking KOFITUSS SEDATIVO TOSSE.
Take this medicine with caution and inform your doctor:

• if you suffer from severe kidney function impairment (severe renal insufficiency with creatinine clearance below 35 ml/min);
• if you are an elderly person, as sensitivity to various medicines is altered in the elderly;
• if you are taking sedative medicines (for the treatment of anxiety) and are a particularly sensitive individual (See section “Other medicines and KOFITUSS SEDATIVO TOSSE”).

Cough medicines only treat the symptoms and should only be used while awaiting diagnosis of the cause
triggering it and/or the effect of therapy for the underlying disease.
Therefore, do not use for prolonged treatments. After a short period of treatment (2 weeks) without appreciable
results, consult your doctor.
This medicine does not affect low-calorie or controlled diets and can also be taken if you suffer from diabetes.
KOFITUSS SEDATIVO TOSSE does not contain gluten, therefore it is not contraindicated if you suffer from
celiac disease.

Children
Do not give this medicine to children under 2 years of age (see subsection "Do not take KOFITUSS
SEDATIVO TOSSE").

Other medicines and KOFITUSS SEDATIVO TOSSE
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Take this medicine with caution and inform your doctor if you are taking sedatives, used for the
treatment of anxiety.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
If you are pregnant or breastfeeding, do not take this medicine (See section “Do not
take KOFITUSS SEDATIVO TOSSE”).

Driving and operating machinery
This medicine can cause drowsiness. Therefore, avoid driving vehicles or operating machinery if
you experience these symptoms.

KOFITUSS SEDATIVO TOSSE contains para-hydroxybenzoates
This medicine contains para-hydroxybenzoates which can cause allergic reactions (including delayed reactions).

3. How to take KOFITUSS SEDATIVO TOSSE

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have doubts
consult your doctor or pharmacist.
Take this medicine until the symptoms disappear. If after 2 weeks of treatment you do not notice
improvements, stop the treatment and consult your doctor.
Dilute the drops in half a glass of water.

Adults
The recommended dose is 20 drops (60 mg), up to 3 times a day, at intervals of at least 6 hours between one
administration and the other, unless otherwise prescribed by the doctor.

Use in children over 2 years
The dose will be established by the doctor, based on the child's weight, as follows:

• between 7 and 10 Kg: 3 drops;
• between 11 and 13 Kg: 4 drops;
• between 14 and 16 Kg: 5 drops;
• between 17 and 19 Kg: 6 drops;
• between 20 and 22 Kg: 7 drops;
• between 23 and 25 Kg: 8 drops;
• between 26 and 28 Kg: 9 drops;
• between 29 and 31 Kg: 10 drops;
• between 32 and 34 Kg: 11 drops;
• between 35 and 37 Kg: 12 drops;
• between 38 and 40 Kg: 13 drops;
• between 41 and 43 Kg: 14 drops;
• between 44 and 46 Kg: 15 drops;
• weight greater than 46 Kg: 20 drops.

The drops can be taken up to 3 times a day, at intervals of at least 6 hours between one administration and
the other.
If the doctor treating your child deems it necessary, the dose may be increased up to a maximum
of 20 drops, 3 times a day.

Method of administration
Dilute the drops in half a glass of water.

Warning:do not exceed the indicated doses.

If you take more KOFITUSS SEDATIVO TOSSE than you should
Following the assumption of an excessive dose of this medicine, the following may occur: abdominal pain and
vomiting, not serious.
The doctor will establish the most suitable therapy for you based on the severity of the symptoms.
In case of ingestion/assumption of an excessive quantity of this medicine, immediately contact
your doctor or the nearest hospital.

If you forget to take KOFITUSS SEDATIVO TOSSE
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.
Most of the adverse reactions that have occurred following the intake of levodropropizine
are not serious and the symptoms have resolved with discontinuation of therapy and, in some cases, with specific
pharmacological treatment.
The adverse reactions observed have an unknown frequency (the frequency cannot be defined based on
available data):

• mydriasis (dilation of the pupil of the eye), bilateral blindness (affects both eyes);
• allergic and anaphylactoid reactions, palpebral edema (swelling of the eyelid), angioedema (swelling of the deep dermis and subcutaneous tissue which may also affect mucous membranes), urticaria;
• nervousness, drowsiness, personality alteration, personality disorder; syncope (transient loss of consciousness), dizziness, vertigo, tremors;
• paresthesia (abnormal skin sensation, tingling), tonic-clonic seizure (grand mal) and petit mal seizure, hypoglycemic coma (loss of consciousness caused by a severe reduction in blood glucose levels);
• palpitations, tachycardia (accelerated heartbeat), atrial bigeminy (irregular heartbeat);
• hypotension (low blood pressure);
• dyspnea (difficult breathing), cough, edema (swelling) of the respiratory tract;
• stomach pain, abdominal pain, nausea, vomiting, diarrhea;
• cholestatic hepatitis (liver inflammation due to blockage of bile excretion);
• urticaria, erythema (redness of the skin), exanthem (skin rash), pruritus, angioedema (swelling of the face and mucous membranes), skin reactions, glossitis (inflammation of the tongue) and aphthous stomatitis (painful ulcers in the mouth);
• epidermolysis (rare and potentially serious skin diseases);
• weakness of the lower limbs;
• general malaise, generalized edema (swelling), asthenia (physical weakness).

Additional side effects in newborns breastfed by mothers who have taken levodropropizine
One case of drowsiness, hypotonia (reduced muscle tone) and vomiting has been reported in a newborn after
levodropropizine intake by the nursing mother. The symptoms appeared after breastfeeding and
resolved spontaneously by suspending breastfeeding for a few feeds.

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 KOFITUSS SEDATIVO TOSSE

Keep this medicine out of the sight and reach of children.
Do not take 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 shelf life of the product after first opening of the bottle is 21 weeks.
Store at a temperature not exceeding 25°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 KOFITUSS SEDATIVO TOSSE contains

• The active ingredient is levodropropizine. Each 100 ml of solution contains 6 g of levodropropizine.
• The other ingredients are: propylene glycol, xylitol, sodium saccharinate, methyl parahydroxybenzoate, forest fruits flavour, anise flavour, anhydrous citric acid, purified water.

Description of the appearance of KOFITUSS SEDATIVO TOSSE and contents of the pack
30 ml bottle with dropper.

Marketing Authorisation Holder
Pool Pharma Srl – Via S. Basilicata, 9 – 20098 San Giuliano Milanese (MI)

Manufacturer
Doppel Farmaceutici Srl - Via Martiri delle Foibe, 1- 29016 Cortemaggiore (PC)