Kofituss cough sedative

Patient Information Leaflet

KOFITUSS COUGH SUPPRESSANT 30 mg/5 ml syrup

Levodropropizine
Equivalent medicine
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 2 weeks of treatment.

Contents of this leaflet:

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

1. What KOFITUSS COUGH SUPPRESSANT is and what it is used for

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

2. What you need to know before taking KOFITUSS SEDATIVE COUGH

Do not take KOFITUSS SEDATIVE COUGH

• if you are allergic to levodropropizine or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from a bronchial disease characterized by excessive mucus production (bronchial hypersecretion);
• if you have been born with certain disorders of the respiratory mucosa characterized by 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
Talk to your doctor or pharmacist before taking KOFITUSS SEDATIVE COUGH.
Take this medicine with caution and inform your doctor:

• if you have severe reduction in kidney function (severe renal insufficiency with creatinine clearance below 35 ml/min);
• if you are elderly, as sensitivity to various medicines may be altered in older people;
• if you are taking sedative medicines (used to treat anxiety) and you are particularly sensitive (See section “Other medicines and KOFITUSS SEDATIVE COUGH”).

Cough suppressants treat only the symptoms and should be used only while awaiting diagnosis of the underlying cause and/or the effect of treatment for the underlying disease.
Therefore, do not use for prolonged treatments. If after a short period of treatment (2 weeks) there is no noticeable improvement, consult your doctor.
KOFITUSS SEDATIVE COUGH does not contain gluten and therefore is not contraindicated if you have celiac disease.
Children
Do not give this medicine to children under 2 years of age (see subsection "Do not take KOFITUSS SEDATIVE COUGH").
Other medicines and KOFITUSS SEDATIVE COUGH
Inform 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 to treat anxiety.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or 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 SEDATIVE COUGH”).
Driving and using machines
This medicine may cause drowsiness. Therefore, avoid driving vehicles or operating machinery if you experience these symptoms.
KOFITUSS SEDATIVE COUGH contains sucrose and parahydroxybenzoates
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. This should be taken into account in patients with diabetes mellitus.
This medicine contains parahydroxybenzoates (methyl-parahydroxybenzoate, propyl-parahydroxybenzoate) which may cause allergic reactions (including delayed reactions).

3. How to take KOFITUSS SEDATIVE COUGH

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.
Take this medicine until symptoms disappear. If you do not notice any improvement after 2 weeks of treatment, stop taking it and consult your doctor.
The package contains a dosing cup with markings corresponding to 3, 5 and 10 ml, which you can use to measure the syrup. To open the bottle, press down firmly on the cap and simultaneously turn it counterclockwise.

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

Use in children over 2 years of age
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 may be taken up to 3 times a day, with at least 6 hours between each dose.

Warning: Do not exceed the recommended doses.

If you take more KOFITUSS SEDATIVE COUGH than you should
After taking an excessive dose of this medicine, symptoms such as abdominal pain and vomiting, usually not severe, may occur.
Your doctor will determine the most appropriate treatment depending on the severity of symptoms.
In case of accidental ingestion or overdose, contact your doctor immediately or go to the nearest hospital.

If you forget to take KOFITUSS SEDATIVE COUGH
Do not take a double dose to make up for the forgotten dose.
If you have any doubts about how to use 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.
Most of the adverse reactions observed following administration of levodropropizine were non-severe, and symptoms resolved upon discontinuation of therapy and, in some cases, with specific pharmacological treatment.

The adverse reactions reported have a frequency not known (the frequency cannot be estimated from the available data):

• mydriasis (dilation of the eye pupil), bilateral blindness (affecting both eyes);
• allergic and anaphylactoid reactions, palpebral edema (swelling of the eyelid), angioneurotic edema (swelling of deep dermis and subcutaneous tissue, which may also affect mucous membranes), urticaria;
• nervousness, somnolence, personality alteration, personality disorder; syncope (transient loss of consciousness), dizziness, vertigo, tremors;
• paresthesia (abnormal skin sensation, tingling), tonic-clonic convulsions (grand mal seizures) and petit mal seizures, 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 impaired biliary excretion);
• urticaria, erythema (redness of the skin), exanthema (skin rash), pruritus, angioedema (swelling of the face and mucous membranes), skin reactions, glossitis (inflammation of the tongue), and aphthous stomatitis (painful mouth ulcers);
• epidermolysis (rare and potentially serious skin disorders);
• weakness of the lower limbs;
• general malaise, generalized edema (swelling), asthenia (physical weakness).

Additional side effects in breastfed newborns whose mothers have taken levodropropizine
One case of somnolence, hypotonia (reduced muscle tone), and vomiting has been reported in a newborn following maternal intake of levodropropizine. Symptoms appeared after breastfeeding and resolved spontaneously after temporarily suspending breastfeeding for a few feeds.

Following the instructions provided in this leaflet reduces the risk of side effects.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist.
You may also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store KOFITUSS COUGH SEDATIVE

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging 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 below 25°C.
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 KOFITUSS SEDATIVE COUGH contains

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

Description of the appearance of KOFITUSS SEDATIVE COUGH and contents of the pack
200 ml bottle with graduated dosing cup.
Marketing Authorization 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

Patient Information Leaflet

KOFITUSS COUGH SUPPRESSANT 60 mg/ml oral drops, solution

levodropropizine
Generic medicine
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, as it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What KOFITUSS COUGH SUPPRESSANT is and what it is used for
2. What you need to know before taking KOFITUSS COUGH SUPPRESSANT
3. How to take KOFITUSS COUGH SUPPRESSANT
4. Possible side effects
5. How to store KOFITUSS COUGH SUPPRESSANT
6. Package contents and other information

1. What KOFITUSS SEDATIVO TOSSE is and what it is 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 substance levodropropizine, which belongs to a group of
medicines called cough suppressants that calm cough (antitussive activity), prevent bronchial contractions (antibronchospastic activity), and relieve allergy symptoms (anti-allergic activity).
This medicine is indicated for the treatment of cough.

2. What you need to know before taking KOFITUSS SEDATIVE COUGH

Do not take KOFITUSS SEDATIVE COUGH

• if you are allergic to levodropropizine or to any of the other ingredients of this medicine (listed in section 6);
• if you have a bronchial disease characterized by excessive mucus production (bronchial hypersecretion);
• if you have been born with certain disorders of the respiratory mucosa characterized by 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
Talk to your doctor or pharmacist before taking KOFITUSS SEDATIVE COUGH.
Take this medicine with caution and inform your doctor:

• if you have severe reduction in kidney function (severe renal insufficiency with creatinine clearance below 35 ml/min);
• if you are elderly, as sensitivity to various medicines may be altered in older people;
• if you are taking sedative medicines (for treatment of anxiety) and are particularly sensitive (See section “Other medicines and KOFITUSS SEDATIVE COUGH”).

Cough suppressant medicines treat only the symptoms and should be used only while awaiting diagnosis of the underlying cause and/or the effect of treatment for the underlying disease.
Therefore, do not use for prolonged treatments. If after a short period of treatment (2 weeks) there is no noticeable improvement, consult your doctor.
This medicine does not affect low-calorie or controlled diets and may be taken even if you have diabetes.
KOFITUSS SEDATIVE COUGH does not contain gluten and therefore is not contraindicated if you have celiac disease.
Children
Do not give this medicine to children under 2 years of age (see subsection "Do not take KOFITUSS SEDATIVE COUGH").
Other medicines and KOFITUSS SEDATIVE COUGH
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
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 may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you are pregnant or breastfeeding, do not take this medicine (See section “Do not take KOFITUSS SEDATIVE COUGH”).
Driving and use of machines
This medicine may cause drowsiness. Therefore, avoid driving vehicles or operating machinery if you experience these symptoms.
KOFITUSS SEDATIVE COUGH contains parahydroxybenzoates
This medicine contains parahydroxybenzoates which may cause allergic reactions (including delayed reactions).

3. How to take KOFITUSS SEDATIVE COUGH

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
Continue taking this medicine until symptoms disappear. If you do not notice any improvement after 2 weeks of treatment,
discontinue use 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 daily, with at least 6 hours between each dose,
unless otherwise prescribed by your doctor.
Use in children over 2 years of age
The dose will be determined by the doctor according to 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;
• over 46 kg: 20 drops.

The drops may be taken up to 3 times daily, with at least 6 hours between each dose.
If the doctor treating your child considers it necessary, the dose may be increased up to a maximum of 20 drops, 3 times daily.
Method of administration
Dilute the drops in half a glass of water.
Warning: Do not exceed the recommended doses.
If you take more KOFITUSS SEDATIVE COUGH than you should
After taking an excessive dose of this medicine, symptoms such as abdominal pain and vomiting, usually not severe, may occur.
Your doctor will determine the most appropriate treatment based on the severity of symptoms.
In case of accidental ingestion or overdose of this medicine, seek immediate medical advice from your doctor or go to the nearest hospital.
If you forget to take KOFITUSS SEDATIVE COUGH
Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Most of the adverse reactions observed following administration of levodropropizine are non-severe, and symptoms resolved upon discontinuation of therapy and, in some cases, with specific pharmacological treatment.
The adverse reactions reported have an unknown frequency (frequency cannot be estimated from the available data):

• mydriasis (dilation of the pupil), bilateral blindness (affecting both eyes);
• allergic and anaphylactoid reactions, eyelid edema (swelling of the eyelid), angioneurotic edema (swelling of deep dermis and subcutaneous tissue, which may also affect mucous membranes), urticaria;
• nervousness, somnolence, personality alteration, personality disorder; syncope (transient loss of consciousness), dizziness, vertigo, tremors;
• paresthesia (abnormal sensation on the skin, tingling), tonic-clonic seizure (grand mal), petit mal seizure, hypoglycemic coma (loss of consciousness caused by a severe reduction in blood glucose levels);
• palpitations, tachycardia (rapid 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 impaired bile excretion);
• urticaria, erythema (redness of the skin), exanthema (skin rash), pruritus, angioedema (swelling of the face and mucous membranes), skin reactions, glossitis (inflammation of the tongue), and aphthous stomatitis (painful mouth ulcers);
• epidermolysis (rare and potentially serious skin disorders);
• weakness of the lower limbs;
• general malaise, generalized edema (swelling), asthenia (physical weakness).

Additional adverse effects in breastfed neonates whose mothers have taken levodropropizine
One case of somnolence, hypotonia (reduced muscle tone), and vomiting has been reported in a neonate following maternal intake of levodropropizine. Symptoms appeared after breastfeeding and resolved spontaneously upon temporary interruption of breastfeeding for a few feeds.
Following the instructions provided in this leaflet reduces the risk of adverse effects.
Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report adverse effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. How to store KOFITUSS COUGH SUPPRESSANT

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 product's shelf life after first opening the bottle is 21 weeks.
Store at a temperature not exceeding 25°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 KOFITUSS SEDATIVE COUGH contains

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

Description of the appearance of KOFITUSS SEDATIVE COUGH and contents of the pack
30 ml bottle with dropper.
Marketing Authorization 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)