LEVODROPROPIZINA FG 60 mg/ NL Oral drops, solution

Содержание инструкции

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

LEVODROPROPIZINA FG 60 mg/ml oral drops, solution

Levodropropizina

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

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

LEVODROPROPIZINA FG contains the active ingredient levodropropizine which belongs to a group
of medicines called cough suppressants.
This medicine is indicated 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 you take LEVODROPROPIZINA FG

Do not take LEVODROPROPIZINA FG

• 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 high 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 “Pregnancy and breastfeeding” section).

Do not administer this medicine to children under the age of two years (see “Children” section).

Warnings and precautions
Consult your doctor or pharmacist before taking LEVODROPROPIZINA FG.
Take this medicine with caution and inform your doctor:

• if you suffer from severe kidney problems (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 “Other medicines and LEVODROPROPIZINA FG” section).

Cough medicines only treat the symptoms and should be used only while awaiting diagnosis of the
triggering cause 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 be taken even if you suffer
from diabetes.
LEVODROPROPIZINA FG does not contain gluten, therefore it is not contraindicated if you suffer from
coeliac disease.

Children
Do not give this medicine to children under 2 years of age (see “Do not take
LEVODROPROPIZINA FG” section).

Other medicines and LEVODROPROPIZINA FG
Tell 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, are planning a pregnancy or are breastfeeding with milk
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, or are breastfeeding with milk
mother's milk, ask your doctor or pharmacist for advice before taking this medicine.
Do not take LEVODROPROPIZINA FG if you are or suspect you are pregnant or are
breastfeeding (see “Do not take LEVODROPROPIZINA FG” section).

Driving and operating machinery
This medicine can cause drowsiness (see section 4 “Possible side effects”). If
you experience this symptom, avoid driving vehicles or operating machinery

LEVODROPROPIZINA FG contains para-hydroxybenzoates
This medicine contains para-hydroxybenzoates which may cause allergic reactions (even
delayed), such as contact dermatitis and rarely immediate reactions with manifestation of
urticaria and bronchospasm (narrowing of the bronchi, which can cause difficulty breathing).

3. How to take LEVODROPROPIZINA FG

Take this medicine following exactly the instructions of 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 recommended doses are:
Adults
20 drops (corresponding to 60 mg), up to 3 times a day, at intervals of at least 6 hours between one
administration and the next, unless otherwise prescribed by your doctor.

Use in children over 2 years of age:
The dose will be established by the doctor, based on 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 can be taken up to 3 times a day, at intervals of at least 6 hours between one
administration and the next.
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.
It is recommended to take and administer the medicine away from meals, on an empty stomach.

Caution: do not exceed the indicated doses.

If you take more LEVODROPROPIZINA FG than you should
In case of accidental ingestion/taking of an excessive dose of LEVODROPROPIZINA FG
immediately inform your doctor or go to the nearest hospital.
In most cases, patients have experienced mild abdominal pain and vomiting.
The doctor will establish the most suitable therapy for you based on the severity of the symptoms.

If you forget to take LEVODROPROPIZINA FG
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 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 (pupil dilation), bilateral blindness (affecting both eyes);
• allergic and anaphylactoid reactions, palpebral edema (eyelid swelling), 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 decrease 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 (itching), 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
levodropropizina
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 a few feeds.

Reporting of side effects
If you get any side effects, even if not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at: www.agenziafarmaco.gov.it/it/responsabili. By reporting
side effects you can help provide more information on the safety of this
medicine.

5. How to store LEVODROPROPIZINA FG

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 21 weeks.
Store at a temperature below 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 LEVODROPROPIZINA FG 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 LEVODROPROPIZINA FG and contents of the pack
LEVODROPROPIZINA FG is a solution
LEVODROPROPIZINA FG is available in30 ml bottle with dropper.

Marketing Authorisation Holder
FG S.r.l. – Via San Rocco, 6 – 85033 Episcopia (PZ) - Italy

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

LEVODROPROPIZINA FG 30 mg/5 ml syrup

Levodropropizina

Generic 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.

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

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

LEVODROPROPIZINA FG contains the active ingredient levodropropizine which belongs to a group
of medicines called cough suppressants.
This medicine is indicated 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 you take LEVODROPROPIZINA FG

Do not take LEVODROPROPIZINA FG

• 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 high 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 the section “Pregnancy and breastfeeding”).

Do not administer this medicine to children under two years of age (see section
“Children”).

Warnings and precautions
Consult your doctor or pharmacist before taking LEVODROPROPIZINA FG.
Take this medicine with caution and inform your doctor:

• if you suffer from severe kidney problems (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 LEVODROPROPIZINA FG”).

Cough medicines only treat the symptoms and should only be used while awaiting diagnosis of the
triggering cause 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.
LEVODROPROPIZINA FG 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 section “Do not take
LEVODROPROPIZINA FG”).

Other medicines and LEVODROPROPIZINA FG
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, are planning a pregnancy, or are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.
Do not take LEVODROPROPIZINA FG if you are pregnant or breastfeeding (see section “Do not take
LEVODROPROPIZINA FG”).

Driving and using machines
This medicine can cause drowsiness (see section 4 “Possible side effects”). If
you experience this symptom, avoid driving vehicles or using machinery.

LEVODROPROPIZINA FG 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 before taking this medicine. To be considered in people affected by diabetes mellitus.
This medicine contains para-hydroxybenzoates (methyl-parahydroxybenzoate, propyl-para-
hydroxybenzoate) which may cause allergic reactions (including delayed ones), such as contact dermatitis and rarely immediate reactions with manifestation of urticaria and bronchospasm
(narrowing of the bronchi, which can cause difficulty breathing).

3. How to take LEVODROPROPIZINA FG

Take this medicine following exactly the instructions in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, ask 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 recommended doses are:
Adults
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 of age:
The recommended dose, based on the child's 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 can be administered up to 3 times a day, at intervals of at least 6 hours between administrations.

Method of administration
The package includes a measuring cup with markings corresponding to 3 - 5 and 10 ml.
To open the package, press firmly on the cap and rotate it counterclockwise at the same time.
The syrup must be drunk.
It is recommended to take and administer the medicine away from meals, on an empty stomach.

Warning:do not exceed the indicated doses.

If you take more LEVODROPROPIZINA FG than you should
In case of accidental ingestion/administration of an excessive dose of LEVODROPROPIZINA FG
immediately inform your doctor or go to the nearest hospital.
In most cases, patients have experienced mild abdominal pain and vomiting.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

If you forget to take LEVODROPROPIZINA FG
Do not take a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, ask 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 (pupil dilation), bilateral blindness (affects both eyes);
• allergic and anaphylactoid reactions, palpebral edema (eyelid swelling), angioedema (swelling of the deep dermis and subcutaneous tissue that 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 decrease 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 (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
levodropropizina
One case of drowsiness, hypotonia (decreased muscle tone) and vomiting has been reported in a
newborn after levodropropizine intake by the breastfeeding 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, please tell your
doctor or pharmacist. You can also report side effects directly through the
national reporting system at: www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store LEVODROPROPIZINA FG

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 below 25°C.

6. Contents of the pack and other information

What LEVODROPROPIZINA FG 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 LEVODROPROPIZINA FG and contents of the pack
LEVODROPROPIZINA FGis available in 200ml bottle with graduated measuring cup.

Marketing Authorisation Holder
FG S.r.l. – Via San Rocco, 6 –85033 Episcopia (PZ) - Italy

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