BISOLSEC 2.13 MG/ML ORAL SOLUTION 1 GLASS BOTTLE OF 190 ML

Name
Bisolsec 2.13 mg/ml oral solution
Pentoxiverin citrate


What it is and what it is used for
Bisolsec is indicated for the symptomatic treatment of dry cough (non-productive cough) in adults and children aged 6 years and older. The medicine is an antitussive, which works by reducing overstimulation of the cough center, thus normalizing the cough reflex.

Contact your doctor if your cough symptoms get worse, if you experience chest pain or if your cough persists for more than a week. Bisolsec is for occasional use and should not be used continuously for more than 2 weeks.


What you need to know before taking the medicine
Do not take Bisolsec:
- if you are allergic to pentoxiverin or any of the other ingredients of this medicine (listed in section 6)
- if you suffer from breathing difficulties
- if you have symptoms of central nervous system depression such as drowsiness, low muscle tone, depressed awareness of your environment and reduced responsiveness to external stimulation, etc.
- if you are a pregnant or breastfeeding woman
- the product should not be taken by children under 6 years of age.


Warnings and precautions
The use of Bisolsec is not recommended if you have impaired liver function. Do not take this product unless your doctor has decided that it is safe for you.

Talk to your doctor or pharmacist before taking Bisolsec if you have:
- reduced kidney function,
- long-lasting cough (due for example to asthma, reduced lung capacity or smoking) or if the cough causes a lot of mucus to be produced,
- increased pressure inside the eye (glaucoma), enlargement of the prostate gland (benign prostatic hyperplasia), blockage of urine flow, intestinal obstruction or ulcer in the stomach or duodenum,
- high blood pressure or irregular heartbeat,
- a disease called myasthenia gravis.

Children and adolescents
Bisolsec should not be used in children under 6 years of age. Bisolsec is not recommended for children when the cough causes a very abundant mucus production.

In particular, children subject to seizures should be monitored during treatment.


Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Allergic reactions that can be serious:
• Very rare ( may affect up to 1 in 10,000 people )
These include the following symptoms: difficulty breathing or dizziness (anaphylactic shock), hypersensitivity, localised swelling of the skin, hives, rash with blistering, itching, skin rash.
• If you experience any of these symptoms, stop using the medicine and consult a doctor immediately.

Other possible side effects:
Common ( may affect up to 1 in 10 people ): upper abdominal pain, diarrhoea, dry mouth, nausea, vomiting.

Uncommon ( may affect up to 1 in 100 people ): drowsiness, tiredness.

Very rare ( may affect up to 1 in 10,000 people ): decreased blood pressure, fits (especially in young children), apnoea, shortness of breath, respiratory depression (especially in young children), difficulty breathing, reduction in the number of white blood cells.

Frequency not known : restlessness, hallucinations, confusional state, blurred vision, transient skin rash.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.