Solvetusan

Leaflet attached to the packaging: patient information

Solvetusan

60 mg, tablets

Levodropropizine

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

Take this medicine always exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or you feel worse, contact your 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 associated with upper and lower respiratory tract infections, whooping cough, or cough in lung cancer.
Solvetusan is indicated for use in adults and children with a body weight over 30 kg.
If after 7 days there is no improvement or you feel worse, consult your doctor.

2. Important information before taking Solvetusan

When not to take Solvetusan

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

Warnings and precautions

Before starting to take Solvetusan, discuss it with your 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

Particular 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 with a body weight below 30 kg.

Solvetusan and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
In human studies, no changes in the EEG record were found during the administration of levodropropizine in combination with benzodiazepines (sedatives).
In sensitive individuals, caution should be exercised when taking sedatives at the same time.

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 you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
The medicine is contraindicated in pregnant or breastfeeding women, as well as in women planning pregnancy.

Driving and using machines

No studies have been conducted to assess the ability to drive and/or operate machinery.
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 mechanical devices and inform them of this possibility.

Solvetusan contains lactose monohydrate and sodium

Lactose monohydrate
If you have previously been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.
Sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Solvetusan

Take this medicine always exactly as described in this patient leaflet or as directed by your doctor or pharmacist.
In case of doubt, consult your doctor or pharmacist.
Do not take Solvetusan for more than 7 days without consulting your doctor.

Recommended dose

Adults and children with a body weight over 30 kg:
1 tablet 1 to 3 times a day at intervals of at least 6 hours.
Solvetusan should be taken orally.
The dividing line on the tablet only facilitates breaking it for easier swallowing and not dividing into equal doses.
Treatment should be continued until the cough disappears or as recommended by your doctor.
In any case, if the cough does not disappear after 7 days of treatment, stop taking the medicine and consult your 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

If you take more of the medicine than recommended, tell your doctor or pharmacist immediately.
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 you forget to take Solvetusan, take the next dose at the usual time.
In case of further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Solvetusan can cause side effects, although not everybody gets them.
During the use of 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 contact your doctor or go to the Emergency Department of the nearest hospital immediately if you experience 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) - very rare (less than 1 in 10,000 patients);
• 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 or breathing - very rare (less than 1 in 10,000 patients);
• severe skin reactions (hives, itching) or skin diseases, e.g., those involving blistering (epidermolysis) - frequency not known;
• heart rhythm disorders (irregular heartbeat, risk of bigeminia) - frequency not known;
• hypoglycemic coma (loss of consciousness due to significantly decreased blood sugar levels) - frequency not known;
• fainting - frequency not known;
• seizures - frequency not known.

Contact your doctor immediately if you experience any of the above side effects, as they may be life-threatening.
Additionally, 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 to oneself);
• shortness of breath, cough, swelling of the respiratory mucosa;
• asthenia (general weakness) and lower limb weakness.

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 infant 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 this patient leaflet reduces the risk of side effects.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your 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
Jerozolimskie Avenue 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 allow for the collection of more information on the safety of the medicine.

5. How to store Solvetusan

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton.
The expiry date refers to the last day of the month.
Store in a temperature below 25°C.
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. Each tablet contains 60 mg of levodropropizine.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, sodium carboxymethylcellulose (type A), magnesium stearate.

What Solvetusan looks like and contents of the pack

Solvetusan is a white, round, biconvex tablet with a dividing line on one side, 9.0 mm in diameter.
The dividing line on the tablet only facilitates breaking it for easier swallowing and not dividing into equal doses.
The pack contains: 20 tablets.

Marketing authorization holder

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

Manufacturer

Aflofarm Farmacja Polska Sp. z o.o.
Szkolna 31
95-054 Ksawerów

Date of last revision of the leaflet: