Lisomucil dry cough

Package leaflet: Information for the user

LEVODROPROPIZINE EG 30 mg/5 ml syrup
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 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 effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if you experience worsening of symptoms after 2 weeks of treatment.

Contents of this leaflet:

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

1. What LEVODROPROPIZINE EG is and what it is used for

LEVODROPROPIZINE EG contains the active substance levodropropizine, a substance belonging to a group of medicines known as cough suppressants.
This medicine is used for the treatment of cough symptoms.
Consult your doctor if you do not feel better or if you feel worse after 2 weeks of treatment.

2. What you need to know before taking LEVODROPROPIZINA EG

Do not take LEVODROPROPIZINA EG

• if you are allergic to levodropropizina 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 section “Children”).

Warnings and precautions
Talk to your doctor or pharmacist before taking LEVODROPROPIZINA EG:

• 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 the treatment of anxiety and you are particularly sensitive (See section “Other medicines and LEVODROPROPIZINA EG”). Cough suppressants only treat symptoms and should only be used while awaiting diagnosis of the underlying cause and/or treatment of the underlying disease. Therefore, do not use for prolonged periods. If after a short period of treatment (2 weeks) there is no noticeable improvement, consult your doctor.

LEVODROPROPIZINA EG 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 section “Do not take
LEVODROPROPIZINA EG”).
Other medicines and LEVODROPROPIZINA EG
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 may be pregnant, plan to become pregnant, or are breastfeeding,
consult your doctor or pharmacist before taking this medicine.
Do not take LEVODROPROPIZINA EG if you are pregnant or suspect you are pregnant, or if you are breastfeeding
(See section “Do not take LEVODROPROPIZINA EG”).
Avoid using this medicine if you are planning a pregnancy.
Driving and operating machinery
This medicine may cause drowsiness (see section “Possible side effects”). If you experience
this symptom, avoid driving or operating machinery.
LEVODROPROPIZINA EG contains sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this
medicine.
LEVODROPROPIZINA EG contains parahydroxybenzoates
Parahydroxybenzoates may cause allergic reactions (including delayed reactions).
LEVODROPROPIZINA EG contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose (10 ml), i.e. essentially ‘sodium-free’.

3. How to take LEVODROPROPIZINA EG

Take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Continue taking 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 recommended doses are:
Adults: 10 ml of syrup up to 3 times daily, with at least 6 hours between each dose.

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

• 3 ml of syrup if the child weighs between 10 and 20 kg;
• 5 ml of syrup if the child weighs between 20 and 30 kg. The syrup may be administered up to 3 times daily, with at least 6 hours between each dose.
  Warning: Do not exceed the indicated doses.

Method of administration
The package includes a dosing cup with markings corresponding to 3, 5, 7, and 10 ml.
To open the bottle, press down firmly on the cap while simultaneously turning it counterclockwise.
The syrup should be taken orally.
It is recommended to take the medicine away from meals, on an empty stomach.

If you take more LEVODROPROPIZINA EG than you should
In case of accidental ingestion or overdose of LEVODROPROPIZINA EG, inform your doctor immediately or go to the nearest hospital. In most cases, patients have experienced abdominal pain and vomiting.

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 are non-severe, and symptoms resolved upon discontinuation of treatment and, in some cases, with specific pharmacological treatment.
The adverse reactions reported have an unknown frequency (the frequency cannot be estimated from the available data):

• mydriasis (dilation of the eye 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 skin sensation, tingling), tonic-clonic seizure (grand mal), petit mal seizure, hypoglycemic coma (loss of consciousness caused by a severe drop 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 bile excretion);
• urticaria, erythema (redness of the skin), exanthema (skin rash), pruritus, angioedema (facial and mucosal swelling), 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 after 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 consult your doctor or pharmacist. You may also report side effects directly via the national reporting system at: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store LEVODROPROPIZINA EG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Exp.".
The expiry date refers to the last day of that month.
The shelf life of the medicine after first opening the bottle is 6 weeks.
Do not store above 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 LEVODROPROPIZINA EG 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 LEVODROPROPIZINA EG and contents of the pack
LEVODROPROPIZINA EG is available in a 200 ml bottle with a graduated dosing cup.
Marketing Authorization Holder
EG S.p.A., Via Pavia, 6 – 20136 Milan
Manufacturer
Doppel Farmaceutici S.r.l., Via Martiri delle Foibe 1 - 29016 Cortemaggiore - Piacenza

Package leaflet: Information for the user

LEVODROPROPIZINE EG 60 mg/ml oral drops, solution
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, 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 harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What LEVODROPROPIZINA EG is and what it is used for

LEVODROPROPIZINA EG contains the active substance levodropropizina, a substance belonging to a group of medicines called antitussives.
This medicine is used to treat cough symptoms.
Consult your doctor if you do not feel better or if you feel worse after 2 weeks of treatment.

2. What you need to know before taking LEVODROPROPIZINA EG

Do not take LEVODROPROPIZINA EG

• if you are allergic to levodropropizina 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 section “Children”).

Warnings and precautions
Talk to your doctor or pharmacist before taking LEVODROPROPIZINA EG:

• 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 individuals;
• if you are taking sedative medicines for the treatment of anxiety and you are particularly sensitive (See section “Other medicines and LEVODROPROPIZINA EG”). 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.

This medicine does not affect low-calorie or controlled diets and may be taken even if you have diabetes.
LEVODROPROPIZINA EG does not contain gluten and is therefore not contraindicated if you have celiac disease.
Children
Do not give this medicine to children under 2 years of age (see section “Do not take LEVODROPROPIZINA EG”).
Other medicines and LEVODROPROPIZINA EG
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 for the treatment of anxiety.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Do not take LEVODROPROPIZINA EG if you are pregnant (suspected or confirmed) or breastfeeding (see section “Do not take LEVODROPROPIZINA EG”).
Avoid using this medicine if you are planning a pregnancy.
Driving and using machines
This medicine may cause drowsiness (see section “Possible side effects”). If you experience this symptom, avoid driving or operating machinery.
LEVODROPROPIZINA EG contains methyl 4-hydroxybenzoate
Parahydroxybenzoates may cause allergic reactions (including delayed reactions).
LEVODROPROPIZINA EG contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose (20 drops), i.e. essentially ‘sodium-free’.
LEVODROPROPIZINA EG contains propylene glycol
This medicine contains 50 mg of propylene glycol per dose (20 drops).
If you are pregnant or breastfeeding, do not take this medicine unless otherwise recommended by your doctor. Your doctor may carry out additional monitoring during treatment.
If you suffer from liver or kidney disease, do not take this medicine unless otherwise recommended by your doctor. Your doctor may carry out additional monitoring during treatment.

3. How to take LEVODROPROPIZINA EG

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, stop treatment and consult your doctor.

The recommended doses are:
Adults: 20 drops (equivalent to 60 mg), up to 3 times daily, with at least 6 hours between each administration, 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:

• 3 drops if the child weighs between 7 and 10 kg;
• 4 drops if the child weighs between 11 and 13 kg;
• 5 drops if the child weighs between 14 and 16 kg;
• 6 drops if the child weighs between 17 and 19 kg;
• 7 drops if the child weighs between 20 and 22 kg;
• 8 drops if the child weighs between 23 and 25 kg;
• 9 drops if the child weighs between 26 and 28 kg;
• 10 drops if the child weighs between 29 and 31 kg;
• 11 drops if the child weighs between 32 and 34 kg;
• 12 drops if the child weighs between 35 and 37 kg;
• 13 drops if the child weighs between 38 and 40 kg;
• 14 drops if the child weighs between 41 and 43 kg;
• 15 drops if the child weighs between 44 and 46 kg;
• 20 drops if the child weighs more than 46 kg.
  The drops may be administered up to 3 times daily, with at least 6 hours between each administration.

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.
It is recommended to take and administer LEVODROPROPIZINA EG away from meals.

If you take more LEVODROPROPIZINA EG than you should
In case of accidental ingestion/overdose of LEVODROPROPIZINA EG, contact your doctor immediately or go to the nearest hospital.
If you take an excessive dose of this medicine, you may experience: abdominal pain and vomiting, which are not severe.
Your doctor will determine the most appropriate treatment for you based on the severity of symptoms.

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 have been mild, and symptoms resolved upon discontinuation of therapy and, in some cases, with specific pharmacological treatment.

The adverse reactions reported have an unknown frequency (the 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 the 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 seizure (grand mal), petit mal seizure, hypoglycemic coma (loss of consciousness caused by a severe drop in blood glucose levels);
• palpitations, tachycardia (accelerated heart rate), 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 by temporarily suspending 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, talk to your doctor or pharmacist. You may also report adverse effects directly via the national reporting system at: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. How to store LEVODROPROPIZINA EG

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 of the medicine after first opening the bottle is 21 weeks.
Do not store above 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 LEVODROPROPIZINA EG contains

• The active substance is levodropropizine. Each 100 ml of solution contains 6 g of levodropropizine.
• The other components are: propylene glycol, xylitol, sodium saccharin, methyl p-hydroxybenzoate, mixed berry flavor, anise flavor, anhydrous citric acid, purified water.

Description of the appearance of LEVODROPROPIZINA EG and the contents of the pack
LEVODROPROPIZINA EG is a solution.
LEVODROPROPIZINA EG is available in a 30 ml bottle with dropper.
Marketing Authorization Holder
EG S.p.A., Via Pavia, 6 – 20136 Milan
Manufacturer
Doppel Farmaceutici s.r.l., Via Martiri delle Foibe 1 - 29016 Cortemaggiore - Piacenza