Solvetusan

Package Leaflet: Information for the Patient

Solvetusan

60 mg/10 ml, syrup

Levodropropizinum

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this package leaflet for the patient, or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after 7 days, they should consult a doctor.

Table of Contents of the Leaflet

• 1. What is Solvetusan and what is it used for
• 2. Important information before taking Solvetusan
• 3. How to take Solvetusan
• 4. Possible side effects
• 5. How to store Solvetusan
• 6. Contents of the pack and other information

1. What is Solvetusan and what is it used for

Solvetusan contains the active substance levodropropizine, which has antitussive and bronchodilatory effects.
Solvetusan is indicated for the symptomatic treatment of non-productive (dry) cough.
Many data indicate that this medicine effectively inhibits cough of various origins, such as cough in lung cancer, cough associated with upper and lower respiratory tract infections, or whooping cough.
If there is no improvement or the patient feels worse after 7 days, they should consult a doctor.

2. Important information before taking Solvetusan

When not to take Solvetusan:

• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6);
• in patients with excessive bronchial secretion and impaired ciliary function of the bronchial epithelium (Kartagener syndrome, ciliary dyskinesia);
• in pregnant or breastfeeding women.

Warnings and precautions

Before starting treatment with Solvetusan, the patient should discuss it with their doctor or pharmacist.
Solvetusan is a medicine used for the symptomatic treatment of non-productive (dry) cough and can only be used while waiting for the diagnosis of the cause of the cough and/or the effect of the treatment of the underlying disease.

Elderly patients

Special caution should be exercised when using levodropropizine in elderly patients (over 65 years), as there is evidence of changed sensitivity to many medicines in this group of patients.

Patients with renal impairment

Caution is recommended when using the medicine in patients with severe renal impairment (creatinine clearance <35 ml min).< p>

Children

Do not use in children under 2 years of age.

Solvetusan and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
In human studies, no changes in EEG recording were found during the administration of levodropropizine in combination with benzodiazepines (sedatives).
In sensitive individuals, caution should be exercised when taking sedatives concomitantly.

Using Solvetusan with food and drink

Due to the lack of information on the effect of meals on the absorption of the medicine, it is recommended to take it between meals.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
The medicine is contraindicated in pregnant or breastfeeding women, as well as in women planning to become pregnant.

Driving and using machines

No studies have been conducted to assess the ability to drive and use machines.
However, since the medicine may rarely cause drowsiness (see also section 4, Possible side effects), caution should be exercised in patients who intend to drive or operate machinery and inform them of this possibility.

Solvetusan contains sucrose, propyl parahydroxybenzoate, and methyl parahydroxybenzoate, benzyl alcohol, propylene glycol, and ethanol

Sucrose

10 ml of Solvetusan syrup contains 4 g of sucrose. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

Propyl parahydroxybenzoate and methyl parahydroxybenzoate

The medicine contains propyl parahydroxybenzoate and methyl parahydroxybenzoate, which may cause allergic reactions (including late reactions), such as contact dermatitis, and rarely: immediate reactions, such as urticaria or bronchospasm.

Benzyl alcohol

The medicine contains 0.2 mg of benzyl alcohol in 10 ml of syrup.
Benzyl alcohol may cause allergic reactions.
Do not give to young children (under 3 years) for more than a week without consulting a doctor or pharmacist.
Pregnant or breastfeeding women should consult their doctor before using the medicine, as large amounts of benzyl alcohol may accumulate in their body and cause side effects (metabolic acidosis).
Patients with liver or kidney disease should consult their doctor before using the medicine, as large amounts of benzyl alcohol may accumulate in their body and cause side effects (metabolic acidosis).

Propylene glycol

The medicine contains 13 mg of propylene glycol in 10 ml of syrup.

Ethanol

The medicine contains small amounts of ethanol (alcohol) (4 mg/10 ml syrup).

3. How to take Solvetusan

This medicine should always be taken exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.
Do not take Solvetusan for more than 7 days without consulting a doctor.

Recommended dose

Children over 2 years old:
10-20 kg: 3 ml syrup 3 times a day;
21-30 kg: 5 ml syrup 3 times a day;
31-40 kg: 8 ml syrup 3 times a day.
Adults and adolescents over 12 years old with a body weight over 40 kg:
10 ml syrup up to 3 times a day.

Method of administration:

Solvetusan should be taken orally, 3 times a day, at intervals of at least 6 hours.
A measuring cup is provided with the syrup bottle, allowing the dose to be measured, including 2.5 ml, 3 ml, 5 ml, 10 ml, and 15 ml.
The bottle is equipped with an additional safety feature, a child-resistant cap. To open the bottle, press the cap and turn it in the direction indicated by the arrow.
Treatment should be continued until the cough disappears or as directed by the doctor.
In any case, if the cough does not disappear after 7 days of treatment, it is recommended to stop taking the medicine and consult a doctor.
Remember that cough is a symptom of a disease and the underlying disease should be diagnosed and treated.

Taking a higher dose of Solvetusan than recommended

In case of taking a higher dose of the medicine than recommended, the patient should immediately inform their doctor or pharmacist. In case of overdose with clinical symptoms, the doctor will immediately start symptomatic treatment and, if necessary, apply standard emergency procedures (gastric lavage, activated charcoal, parenteral fluid administration, etc.).

Missing a dose of Solvetusan

Do not take a double dose to make up for a missed dose.
If the patient forgets to take Solvetusan, they should take the next dose at the usual time.
In case of any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Solvetusan can cause side effects, although not everybody gets them.
During treatment with Solvetusan, side effects occur very rarely. In most cases, they are not serious and the symptoms disappear after stopping the treatment, sometimes only requiring specific pharmacological treatment.

Stop taking Solvetusan and immediately consult a doctor or go to the Emergency Department of the nearest hospital if the patient experiences any of the following side effects:

• allergic reaction occurring within 20 minutes of taking the medicine (rash, severe swelling of the face, lips or throat, difficulty breathing, speaking or swallowing, sudden drop in blood pressure, slow or fast heart rate, paleness, anxiety, sweating, dizziness, loss of consciousness, respiratory or cardiac arrest);
• angioedema (severe allergic reaction - sudden swelling of the lips, tongue, throat, face, limbs or joints without itching or pain). Swelling in the head and neck area may cause difficulty swallowing and breathing;
• severe skin reactions (hives, itching) or skin diseases, e.g., those involving blistering (epidermolysis);
• heart rhythm disorders (irregular heartbeat, risk of bigeminy);
• hypoglycemic coma;
• fainting;
• seizures.

Immediately consult a doctor if the patient experiences any of the above side effects, as they may be life-threatening.
In addition, the following may occur:
Very rare(less than 1 in 10,000 patients):

• hives, rash, erythema, itching, skin reactions;
• stomach pain, abdominal pain, nausea, vomiting, diarrhea;
• general malaise;
• dizziness, balance disorders, tremors, tingling, numbness;
• heart rhythm disorders (palpitations, tachycardia), decreased blood pressure;
• irritability, drowsiness, depersonalization (feeling of strangeness);
• shortness of breath, cough, swelling of the mucous membrane of the respiratory tract;
• asthenia (general weakness) and weakness of the lower limbs.

Frequency not known(frequency cannot be estimated from the available data):

• glossitis and aphthous stomatitis with fever;
• cholestatic hepatitis (inflammation caused by bile flow obstruction from the liver);
• cases of generalized edema, fainting, and weakness;
• seizures: grand mal seizure (tonic-clonic seizures) and petit mal seizure (non-convulsive, so-called petit mal seizure);
• pupil dilation and loss of vision. In both cases, the symptoms disappeared after discontinuation of the medicine;
• drowsiness, decreased muscle tone, and vomiting in newborns, which were attributed to the transfer of levodropropizine to the baby through breast milk. The symptoms appeared after breastfeeding and disappeared spontaneously after skipping a few breastfeeds;
• eyelid edema.

Taking Solvetusan according to the recommendations in the package leaflet for the patient reduces the risk of side effects.

Reporting side effects

If side effects occur, including those not listed in the leaflet, the patient should inform their doctor or pharmacist.
Side effects can be reported directly to the Department of Post-Marketing Surveillance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181 C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Solvetusan

Keep the medicine out of sight and reach of children.
Store in a temperature below 25°C. Do not store in the refrigerator or freeze.
Do not use this medicine after the expiry date stated on the label and carton.
The expiry date refers to the last day of the month.
Shelf life after first opening the bottle: 12 months.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Solvetusan contains

• The active substance of the medicine is levodropropizine. 10 ml of syrup contains 60 mg of levodropropizine.
• The other ingredients are: sucrose, citric acid monohydrate, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), cherry flavor (ethyl acetate, isoamyl acetate, benzaldehyde, benzyl alcohol, eugenol, vanillin, ethanol, propylene glycol), sodium hydroxide, 32% solution, purified water.

What Solvetusan looks like and what the pack contains

Solvetusan is a colorless to light yellow syrup with a cherry flavor and aroma.
The pack consists of a brown glass bottle, type III, closed with an LDPE/PP cap, child-resistant, and a measuring cup made of PP with a capacity of 15 ml, graduated at 2.5 ml, 3 ml, 5 ml, 10 ml, and 15 ml, in a cardboard box.
The pack contains 150 ml or 200 ml of syrup.

Marketing authorization holder

Aflofarm Farmacja Polska Sp. z o. o.
ul. Partyzancka 133/151
95-200 Pabianice
phone: (42) 22-53-100

Manufacturer

ABC FARMACEUTICI S.P.A.
Via Cantone Moretti, 29
10015 Ivrea
Italy

Date of last revision of the leaflet: