Rifletus: detailed information

Package leaflet: Information for the patient

RIFLETUS 60 mg/ml oral drops, solution

Levodropropizine
Equivalent medicine
Please read all of 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 they have the same symptoms as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What RIFLETUS is and what it is used for
What you need to know before taking RIFLETUS
How to take RIFLETUS
Possible side effects
How to store RIFLETUS
Contents of the pack and other information

1. What RIFLETUS is and what it is used for

RIFLETUS contains the active substance levodropropizine, which belongs to a group of medicines called
antitussives (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 taking RIFLETUS

Do not take RIFLETUS

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 respiratory mucosa disorders 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 RIFLETUS.
Take this medicine with caution and inform your doctor:

if you have severe kidney problems (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 RIFLETUS”).

Cough suppressant medicines only treat 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.
RIFLETUS 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 RIFLETUS”).
Other medicines and RIFLETUS
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, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Do not take RIFLETUS if you are pregnant or suspect you may be pregnant, or if you are breastfeeding (see section “Do not take RIFLETUS”).
Driving and using machines
This medicine may cause drowsiness (see section 4 “Possible side effects”). If you experience this symptom, avoid driving or operating machinery.
RIFLETUS contains parahydroxybenzoates
This medicine contains parahydroxybenzoates which may cause allergic reactions (including delayed reactions) such as contact dermatitis, and rarely immediate reactions with symptoms such as urticaria and bronchospasm (narrowing of the airways, which may cause breathing difficulties).

3. How to take RIFLETUS

Take this medicine exactly as directed 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.
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 body 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.
It is recommended to take the medicine away from mealtimes.
Warning: Do not exceed the recommended doses.
If you take more RIFLETUS than you should
In case of accidental ingestion/overdose of RIFLETUS, contact your doctor immediately or go to the nearest hospital.
If you take an excessive dose of this medicine, you may experience mild abdominal pain and vomiting.
Your doctor will decide the most appropriate treatment depending on the severity of symptoms.
If you forget to take RIFLETUS
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 side effects

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

mydriasis (dilation of the pupil of the eye), 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, drowsiness, personality alteration, personality disorder;
syncope (transient loss of consciousness), dizziness, vertigo, tremors, paresthesia (abnormal skin sensation, tingling), tonic-clonic seizure (grand mal), petit mal attack, hypoglycemic coma (loss of consciousness caused by a severe reduction in blood glucose levels);
palpitations, tachycardia (increased 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 side effects in breastfed newborns whose mothers have taken levodropropizine
One case of drowsiness, hypotonia (reduced muscle tone), and vomiting has been reported in a newborn after the breastfeeding mother took levodropropizine. Symptoms appeared after breastfeeding and resolved spontaneously by temporarily withholding 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 effects, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report side effects directly via 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 RIFLETUS

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 product's shelf life after first opening the bottle is 21 weeks.
Store below 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 RIFLETUS 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 parahydroxybenzoate, forest fruit flavor, anise flavor, anhydrous citric acid, purified water.

Description of the appearance of RIFLETUS and contents of the pack
RIFLETUS is a solution
RIFLETUS is available in 30 ml bottles with dropper.
Marketing Authorization Holder
Epifarma S.r.l. – Via San Rocco, 6 – 85033 Episcopia (PZ) - Italy
Manufacturer
Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe, 1 - 29016 Cortemaggiore (PC) - Italy

Patient information leaflet

RIFLETUS 30 mg/5 ml syrup

Levodropropizine
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 of the 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 improvement or if your symptoms worsen after 2 weeks of treatment.

Contents of this leaflet:

What RIFLETUS is and what it is used for
What you need to know before taking RIFLETUS
How to take RIFLETUS
Possible side effects
How to store RIFLETUS
Contents of the pack and other information

1. What RIFLETUS is and what it is used for

RIFLETUS contains the active substance levodropropizine, which belongs to a group of medicines called
antitussive agents (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 taking RIFLETUS

Do not take RIFLETUS

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 respiratory mucosa disorders characterized by reduced ability to expel mucus (Kartagener syndrome, ciliary dyskinesia);
if you are pregnant or breastfeeding (see section “Pregnancy and breastfeeding”).

if you have severe kidney problems (severe renal impairment 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 RIFLETUS”).

Cough suppressant medicines only treat symptoms and should only be used 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.
RIFLETUS does not contain gluten and is therefore not contraindicated if you have coeliac disease.
Children
Do not give this medicine to children under 2 years of age (see section “Do not take RIFLETUS”).
Other medicines and RIFLETUS
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, think you may be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Do not take RIFLETUS if you are pregnant or think you might be pregnant, or if you are breastfeeding (see section “Do not take RIFLETUS”).
Driving and using machines
This medicine may cause drowsiness (see section 4 “Possible side effects”). If you experience this symptom, avoid driving or operating machinery.
RIFLETUS 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 consideration in patients with diabetes mellitus.
This medicine contains parahydroxybenzoates (methyl-parahydroxybenzoate, propyl-parahydroxybenzoate) which may cause allergic reactions (including delayed reactions) such as contact dermatitis, and rarely immediate reactions with urticaria and bronchospasm (narrowing of the airways, which may cause breathing difficulties).

3. How to take RIFLETUS

Take this medicine exactly as stated in this leaflet or as directed 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.
Recommended doses:
Adults
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 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 a day, with at least 6 hours between each administration.
Method of administration
The package includes a dosing cup with markings corresponding to 3, 5 and 10 ml.
To open the container, press down firmly on the cap and simultaneously turn it counterclockwise.
The syrup should be taken orally.
It is recommended to take and administer the medicine away from meals.
Warning: Do not exceed the recommended doses.
If you take more RIFLETUS than you should
In case of accidental ingestion or overdose of RIFLETUS, inform your doctor immediately or go to the nearest hospital.
If you take an excessive dose of this medicine, you may experience: abdominal pain and non-severe vomiting.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.
If you forget to take RIFLETUS
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 everyone gets 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 a frequency not known (frequency cannot be estimated from the available data):

mydriasis (dilation of the pupil of the eye), 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) and petit mal attack, 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 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 side 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 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: 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 RIFLETUS

Keep this medicine out of 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 is stable for 6 weeks after first opening of the bottle.
Store below 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 RIFLETUS 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 RIFLETUS and contents of the pack
RIFLETUS is available in a 200 ml bottle with a graduated dosing cup.
Marketing Authorization Holder
Epifarma S.r.l. – Via San Rocco, 6 – 85033 Episcopia (PZ) - Italy
Manufacturer
Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe, 1 - 29016 Cortemaggiore (PC) - Italy