Solvetusan

Package leaflet: Information for the patient

Solvetusan
60 mg/10 ml, syrup
Levodropropizinum
Read the following leaflet carefully before taking this medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 7 days, or if your condition worsens, consult your doctor.

Leaflet contents

1. What Solvetusan is and what it is 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 Solvetusan is and what it is used for

Solvetusan contains the active substance levodropropizine, which has antitussive
and bronchospasmolytic properties.
Solvetusan is indicated for the symptomatic treatment of non-productive (dry) cough.
A number of data indicate that this medicine effectively suppresses cough of various origins, such as cough associated with lung cancer, cough related to infections of the upper and lower respiratory tract, or whooping cough.
If there is no improvement after 7 days, or if your condition worsens, consult your doctor.

2. Important information before taking Solvetusan

When not to take Solvetusan:

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

Warnings and precautions
Before starting treatment with Solvetusan, consult your doctor or pharmacist.
Solvetusan is a medicine used for symptomatic treatment of non-productive (dry) cough
and should only be used while awaiting diagnosis of the underlying cause of cough and/or response to treatment
of the disease causing the cough.
Elderly patients
Particular caution should be exercised when administering levodropropizine to elderly patients
(over 65 years of age), as there is evidence of altered sensitivity to many drugs in this patient group.
Patients with renal impairment
Caution is recommended when administering this medicine to patients with severe renal impairment (creatinine clearance < 35 ml/min).
Children
Do not use in children under 2 years of age.
Solvetusan and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines planned for future use.
Human studies have not shown any changes in EEG curve recordings during administration of
levodropropizine in combination with benzodiazepines (sedative medicines).
However, caution should be exercised in particularly sensitive individuals when taking
sedative medicines concomitantly.
Taking Solvetusan with food and drink
Due to lack of information on the effect of food on drug absorption, it is recommended to take the medicine between meals.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
The medicine is contraindicated in women who are pregnant or planning pregnancy, as well as during breastfeeding.
Driving and operating machinery
Studies assessing the ability to drive and/or operate machinery have not been conducted.
However, since the medicine may rarely cause drowsiness (see also section 4 Possible side effects), caution should be exercised in patients intending to drive or operate mechanical equipment, and they should be informed of this possibility.
Solvetusan contains sucrose, propyl parahydroxybenzoate and methyl parahydroxybenzoate,
benzyl alcohol, propylene glycol, ethanol and sodium
Sucrose
10 ml of Solvetusan syrup contains 4 g of sucrose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Propyl parahydroxybenzoate and methyl parahydroxybenzoate
The medicine contains propyl parahydroxybenzoate and methyl parahydroxybenzoate, which may
cause allergic reactions (including delayed-type reactions), such as contact dermatitis; 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 administer to young children (under 3 years of age) for longer than one week without medical advice from a doctor or pharmacist.
Pregnant or breastfeeding women should consult a doctor before using this medicine, as large amounts of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called metabolic acidosis).
Patients with liver or kidney disease should consult a doctor before using this medicine, as large amounts of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called metabolic acidosis).
Propylene glycol
The medicine contains 13 mg of propylene glycol in 10 ml of syrup.
Ethanol
This medicine contains 4 mg of alcohol (ethanol) in 10 ml of syrup. The amount of alcohol in 10 ml of this medicine is equivalent to less than approximately 1 ml of beer or approximately 1 ml of wine.
The small amount of alcohol in this medicine will not cause noticeable effects.
Sodium
The medicine contains 7.82 mg of sodium in 10 ml of syrup.
The medicine contains 23.46 mg of sodium (main component of table salt) in 30 ml of syrup. This corresponds to 1.17% of the maximum recommended daily dietary sodium intake for adults.

3. How to take Solvetusan

This medicine should always be taken exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Do not take Solvetusan for longer than 7 days without consulting a doctor.
Recommended dose
Children over 2 years of age
10-20 kg: 3 ml of syrup three times daily;
21-30 kg: 5 ml of syrup three times daily;
31-40 kg: 8 ml of syrup three times daily.
Adults and adolescents over 12 years of age weighing more than 40 kg:
10 ml of syrup up to three times daily.
Method of administration:
Solvetusan should be taken orally, three times daily, at intervals of at least 6 hours.
The syrup bottle is supplied with a measuring device allowing accurate measurement of doses, including 3, 5 and 10 ml.
The bottle is equipped with an additional safety feature: a child-resistant cap. To open the bottle, press down on the cap and turn it in the direction indicated by the arrow.
Treatment should be continued until cough subsides or as directed by a physician.
If cough persists after 7 days of treatment, discontinue use of the medicine and consult a doctor. Remember that cough is a symptom of disease and the underlying condition causing it should be diagnosed and treated appropriately.
Overdose of Solvetusan
In case of overdose, inform your doctor or pharmacist immediately. In cases of overdose with clinical symptoms, the doctor will initiate symptomatic treatment and, if necessary, apply standard emergency procedures (e.g. gastric lavage, activated charcoal, parenteral fluid administration, etc.).
Missed dose of Solvetusan
Do not take a double dose to make up for a missed dose.
If a patient forgets to take Solvetusan, they should take the next dose at the usual time.
If you have any further doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although they do not occur in everyone.
Adverse reactions during treatment with Solvetusan occur very rarely. In most cases, they are not severe complications and symptoms resolve after discontinuation of treatment, sometimes requiring only specific pharmacological treatment.
Solvetusan must be discontinued and the patient should immediately contact a doctor or
report to the nearest hospital Emergency Department if any of the following adverse
reactions occur:

• 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 rapid pulse, pallor, restlessness, sweating, dizziness, loss of consciousness, respiratory arrest or cardiac arrest);
• angioedema (severe allergic reaction - sudden swelling of lips, tongue, throat, face, limbs or joints without itching or pain). Swelling in the head and neck area may cause difficulty in swallowing and breathing;
• severe skin reactions (urticaria, itching) or skin disorders, e.g. with blister formation (epidermolysis);
• cardiac arrhythmias (irregular heartbeat, risk of atrial bigeminy);
• hypoglycemic coma;
• fainting;
• seizures.

Immediate medical advice should be sought if any of the above adverse reactions occur, as they may lead to life-threatening consequences.
In addition, the following may occur:
Very rare (less than 1 in 10,000 patients):

• urticaria, erythema, exanthema, pruritus, skin reactions;
• stomach pain, abdominal pain, nausea, vomiting, diarrhoea;
• general malaise;
• dizziness, balance disorders, tremors, tingling, numbness;
• cardiac disorders (palpitations, tachycardia), hypotension;
• irritability, drowsiness, depersonalization (feeling of self-estrangement);
• dyspnoea, cough, oedema of the respiratory mucosa;
• asthenia (general physical weakness) and weakness of lower limbs.

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

• glossitis and aphthous stomatitis with fever;
• cholestatic hepatitis (inflammatory condition caused by impaired bile outflow from the liver);
• cases of generalized oedema, fainting and weakness;
• epileptic seizures: grand mal seizure (clonic-tonic seizures) and petit mal seizure (non-convulsive, so-called petit mal seizure);
• pupillary dilation and loss of vision. In both cases, symptoms resolved after discontinuation of the drug;
• drowsiness, decreased muscle tone and vomiting in a newborn, attributed to transfer of levodropropizine taken by a breastfeeding mother into the infant's body. Symptoms occurred after breastfeeding and resolved spontaneously after skipping several feeds;
• eyelid oedema.

Using Solvetusan according to the recommendations provided in the patient leaflet reduces the risk of adverse reactions.
Reporting adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C, 02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to gather more information on the safety of the medicine.

5. How to store Solvetusan

Keep this medicine out of sight and reach of children.
Store 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 stated month.
Shelf life after first opening the bottle: 12 months.
Medicines must 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 packaging and other information

What Solvetusan contains

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

What Solvetusan looks like and contents of the pack
Solvetusan is a syrup, colourless to pale yellow, with a cherry taste and odour.
The packaging consists of an amber glass bottle of class III closed with a cap made of LDPE/PP,
child-resistant closure, and a measuring spoon made of PP with a capacity of 15 ml, graduated at 2.5 ml, 3 ml,
5 ml, 10 ml, 15 ml, included in a cardboard box.
The pack contains 150 ml or 200 ml of syrup.
Marketing Authorisation Holder
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
tel. (42) 22-53-100
Manufacturer
ICE S.p.A.
Cantone Moretti, 29
10015 Ivrea
Italy