BISOLSEC 2.13 MG/ML Roztwór doustny
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Treść ulotki
- What is Pentοssiverina Opella Healthcare and what is it used for
- What you need to know before taking Pentοssiverina Opella Healthcare
- How to take Pentοssiverina Opella Healthcare
- Possible side effects
- How to store Pentοssiverina Opella Healthcare
- Package Contents and Other Information
Pentοssiverina Opella Healthcare 2.13 mg/ml oral solution
Pentoxifylline citrate
Read 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 told you to.
- Keep this leaflet. You may need to read it again.
- If you want more information or advice, ask your pharmacist.
- If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.
- Talk to your doctor if you do not feel better or if your symptoms get worse after 7 days.
Contents of this leaflet:
- 1. What Pentοssiverina Opella Healthcare is and what it is used for
- 2. What you need to know before you take Pentοssiverina Opella Healthcare
- 3. How to take Pentοssiverina Opella Healthcare
- 4. Possible side effects
- 5. How to store Pentοssiverina Opella Healthcare
- 6. Contents of the pack and other information
1. What is Pentοssiverina Opella Healthcare and what is it used for
Pentοssiverina Opella Healthcare is indicated for the symptomatic treatment of dry cough (non-
productive cough) in adults and children starting from 6 years of age. The medicine is an antitussive, which acts
by reducing the overstimulation of the cough center, thus normalizing the cough reflex.
Consult your doctor if cough symptoms worsen, if you experience chest pain or if the cough persists
for more than one week. Pentοssiverina Opella Healthcare is indicated for occasional use and should not be
used continuously for more than 2 weeks.
2. What you need to know before taking Pentοssiverina Opella Healthcare
Do not take Pentοssiverina Opella Healthcare:
- if you are allergic to pentoxiverine 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, depression of your awareness of the environment and reduced reactivity to external stimulation, etc.
- if you are a pregnant or breastfeeding woman
- the product should not be taken by children under 2 years of age.
Warnings and precautions
The use of Pentοssiverina Opella Healthcare is not recommended in case of reduced liver function.
Do not take this product unless your doctor has decided it is safe for you.
Talk to your doctor or pharmacist before taking Pentossiverina Opella Healthcare 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 very abundant production of mucus,
- increased intraocular pressure (glaucoma), enlargement of the prostate gland (benign prostatic hyperplasia), blockage of the urinary flow, intestinal obstruction or ulcer in the stomach or duodenum,
- high blood pressure or irregular heartbeat,
- a disease called myasthenia gravis.
Children and adolescents
Pentossiverina Opella Healthcare should not be used in children under 6 years of age. Pentoxiverina
Opella Healthcare is not recommended for children when the cough causes a very
abundant production of mucus.
In particular, children prone to convulsions should be monitored during treatment.
Other medicines and Pentοssiverina Opella Healthcare
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
Pentοssiverina Opella Healthcare may enhance the effects of substances that cause central nervous system depression (e.g. sleeping pills, medicines that induce drowsiness and sedation and antihistamines).
Pentοssiverina Opella Healthcare with food, beverages and alcohol
Pentossiverina Opella Healthcare can be taken during meals or on an empty stomach. Pentoxiverina
Opella Healthcare may enhance the effects of alcohol.
Pregnancy, breastfeeding and fertility
Pentossiverina Opella Healthcare should not be taken during pregnancy or breastfeeding due to
possible harmful effects on the baby (e.g. breathing difficulties, convulsions, symptoms of central nervous system depression) (see section “Do not take Pentοssiverina Opella Healthcare”).
Driving and operating machinery
This medicine can occasionally cause fatigue even when taken as prescribed.
Since fatigue can affect reactions, the ability to drive vehicles and use machinery may
be impaired.
Pentοssiverina Opella Healthcare contains benzoic acid, sorbitol, propylene glycol, benzyl alcohol and
sodium
Pentossiverina Opella Healthcare contains 11.25 mg of benzoic acid in each 15 ml dosage unit.
Pentossiverina Opella Healthcare contains 4.5 g of sorbitol in each 15 ml dosage unit.
Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to
certain sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic
disease in which a person cannot break down fructose, consult your doctor before you (or your child)
take or receive this medicine.
Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.
Pentossiverina Opella Healthcare contains 1.5 g of propylene glycol in each 15 ml dosage unit.
If you suffer from a liver or kidney disease, do not take this medicine unless recommended by
your doctor. The doctor may perform further checks during the intake of this medicine.
Pentossiverina Opella Healthcare oral solution contains:
0.708 mg of benzyl alcohol in each 15 ml dosage unit.
Benzyl alcohol can cause allergic reactions.
Ask your doctor or pharmacist if you have a liver or kidney disease. This is because large
amounts of benzyl alcohol can accumulate in your body and can cause side effects (called
"metabolic acidosis").
Pentossiverina Opella Healthcare contains less than 1 mmol of sodium (23 mg) per 15 ml dosage unit,
meaning it is essentially "sodium-free".
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3. How to take Pentοssiverina Opella Healthcare
Take this medicine following exactly the instructions in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
The recommended dose, based on the age and weight of the user, is shown in the following table:
| Age | Body weight (kg) | Dosage (ml) |
| Children aged between 6 and 15 years | d
| 5 ml 3-4 times a day |
| 7.5 ml 3-4 times a day | |
a
| 15 ml 3-4 times a day | |
| Adolescents aged > 15 years and adults | n > 60 | 15 ml 3-4 times a day |
If the cough is also accompanied by a sore throat, it is recommended to gargle with the dose of oral solution
before swallowing it.
If the dry cough disturbs sleep, the last dose should be taken shortly before bedtime.
Use in children and adolescents
See the dosage table.
Contraindicated in children under 6 years of age.
If you take more Pentοssiverina Opella Healthcare than you should
If you have taken an excessive amount of this medicine, seek immediate medical attention or go to hospital.
If you forget to take Pentοssiverina Opella Healthcare
Do not take a double dose to make up for a missed dose.
If you have any doubts about using this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Allergic reactions that may be serious:
- Very rare ( may affect up to 1 in 10,000 people)
- Include the following symptoms: difficulty breathing or dizziness (anaphylactic shock), hypersensitivity, localised skin swelling, urticaria, blistering skin rash, itching, 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, fatigue.
Very rare ( may affect up to 1 in 10,000 people): decreased blood pressure, seizures
(especially in young children), apnea, shortness of breath, respiratory depression (especially
in young children), difficulty breathing, reduced number of white blood cells.
Frequency not known: restlessness, hallucinations, confusion, blurred vision, transient rash.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.
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5. How to store Pentοssiverina Opella Healthcare
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and on the label of the bottle
after “ EXP.” The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Period of validity after first opening: 6 months.
Do not dispose of any medicine in 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 Pentοssiverina Opella Healthcare contains
- The active ingredient is pentoxiverine citrate. 1 ml of oral solution contains 2.13 mg of pentoxiverine citrate, equivalent to 1.35 mg of pentoxiverine.
- The other excipients are: benzoic acid, liquid sorbitol (non-crystallizing) (E420), glycerol, propylene glycol, citric acid monohydrate, sodium citrate dihydrate, sodium saccharin, pear aroma, gin aroma (contains flavouring substances, benzyl alcohol [E1519] and alpha-tocopherol [E307]), purified water.
Description of the appearance of Pentοssiverina Opella Healthcare and package contents
Pentοssiverina Opella Healthcare is a clear or almost clear liquid, colourless or almost colourless.
Dark glass bottle containing 95 ml and 190 ml with a child-resistant tamper-evident screw cap. The cap
is opened by pressing down and rotating it simultaneously in an anti-clockwise direction. The measuring cup in
polypropylene is equipped with graduations corresponding to 5 ml, 7.5 ml and 15 ml
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Opella Healthcare Italy S.r.l.
Viale L. Bodio, 37/B
20158 Milan
Manufacturer
NextPharma SAS
17, route de Meulan
78520 Limay
France
This medicinal product is authorised in the Member States of the EEA with the following denominations:
Austria: Macomat Reizhusten 2,13 mg/ml Lösung zum Einnehmen
Belgium: Pentoxyverine Sanofi 2,13 mg/ml drank
Denmark: Bisoltec
Finland: Biseltoc 2,13 mg/ml oraaliliuous
Greece: Bisoldry 2,13 mg/ml πόσιμο διάλυμα
Spain: Bisolvon Calmatos 2,13 mg/ml Solución Oral
Italy: Pentοssiverina Opella Healthcare
Luxembourg: Pentoxyverine Sanofi 2.13 mg/ml Solution buvable
Netherlands: Bisolsek pento 2,13 mg/ml drank
Portugal: Pentoxiverina Bisoltussin
Norway: Biseltoc
Sweden: Biseltoc
- Kraj rejestracji
- Postać farmaceutycznaOral solution, 2.13 MG/ML
- Kod ATCR05DB05
- Substancja czynna
- Wymaga receptyNie
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki BISOLSEKPostać farmaceutyczna: Oral suspension, 708/100 MLSubstancja czynna: cloperastineProducent: AESCULAPIUS FARMACEUTICI SRLBez receptyPostać farmaceutyczna: Oral suspension, 7.08 MG/MLSubstancja czynna: cloperastineProducent: FIDIA FARMACEUTICI S.P.A.Bez receptyPostać farmaceutyczna: Syrup, 15 MG/5 MLSubstancja czynna: dropropizineBez recepty
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BISOLSEK nie wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w BISOLSEK jest pentoxyverine. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
BISOLSEK jest produkowany przez OPELLA HEALTHCARE ITALY S.R.L.. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie BISOLSEK jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
Polska posiada dobrze rozwiniętą infrastrukturę ochrony zdrowia w dużych miastach, takich jak Warszawa, Kraków, Wrocław i Gdańsk. Apteki są łatwo dostępne i działają zgodnie z obowiązującymi przepisami, zapewniając dostęp do leków na receptę.
Możesz kupić BISOLSEK w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
Aby uzyskać receptę, możesz skorzystać z Oladoctor:
Inne leki zawierające tę samą substancję czynną (pentoxyverine) to m.in. KLOEL, KLOFEND, KORYFIN TOSSE SEDATIVO. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
