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BISOLVON CALMATOS 2.13 mg/ml ORAL SOLUTION

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About the medicine

How to use BISOLVON CALMATOS 2.13 mg/ml ORAL SOLUTION

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introduction

Package Leaflet: Information for the User

Bisolvon Calmatos 2.13 mg/ml Oral Solution

Pentoxiverine Citrate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist.

  • Keep this leaflet, as you may need to read it again.
  • If you need advice or more information, consult your pharmacist.
  • If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
  • You should consult a doctor if your symptoms worsen or do not improve after 7 days.

Contents of the Package Leaflet

  1. What is Bisolvon Calmatos and what is it used for
  2. What you need to know before taking Bisolvon Calmatos
  3. How to take Bisolvon Calmatos
  4. Possible side effects
  5. Storage of Bisolvon Calmatos
  6. Package Contents and Additional Information

1. What is Bisolvon Calmatos and what is it used for

Bisolvon Calmatos is indicated for the treatment of symptoms of dry cough (non-productive cough) in adults and children from 6 years of age. The medicine is an antitussive, reducing the overstimulation of the cough center and thus normalizing the cough reflex.

Contact your doctor if your cough symptoms worsen, you experience chest pain, or your cough persists for more than a week. Pentoxiverine is indicated only for temporary use and should not be used continuously for more than 2 weeks.

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

2. What you need to know before taking Bisolvon Calmatos

Do not takeBisolvon Calmatos

  • if you are allergic to the active substance or to any of the other components of this medicine (listed in section 6).
  • if you have breathing difficulties
  • if you have symptoms of central nervous system depression, such as drowsiness, low muscle tone, reduced awareness of your surroundings, and response to external stimulation, etc.
  • if you are pregnant or breastfeeding
  • the product should not be used in children under 6 years of age.

Warnings and Precautions

Pentoxiverine is not recommended if you have reduced liver function. Do not take this product unless your doctor has decided that it is safe for you to do so.

Consult your doctor or pharmacist before starting to take pentoxiverine if you have:

  • reduced kidney function,
  • a long-lasting cough (due, for example, to asthma, reduced lung capacity, or smoking) or if the cough produces a large amount of mucus,
  • increased intraocular pressure (glaucoma), enlarged prostate (benign prostatic hyperplasia), urinary flow obstruction, intestinal obstruction, or stomach or duodenal ulcers,
  • high blood pressure or irregular heartbeats,
  • a disease called myasthenia gravis.

Children and Adolescents

Pentoxiverine should not be used in children under 6 years of age. Pentoxiverine is not recommended for children if the cough produces a large amount of mucus.

In particular, children who are prone to seizures should be monitored during treatment.

Other Medicines and Bisolvon Calmatos

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pentoxiverine may increase the effects of substances that cause central nervous system depression (e.g., sleeping pills, sedating medications, and antihistamines).

Taking Bisolvon Calmatos with Food, Drinks, and Alcohol

Pentoxiverine can be taken with food or on an empty stomach.

This medicine may increase the effects of alcohol.

Pregnancy, Breastfeeding, and Fertility

Pentoxiverine should not be used during pregnancy or breastfeeding due to possible harmful effects on the baby (i.e., breathing difficulties, seizures, symptoms of central nervous system depression) (see section "Do not take Bisolvon Calmatos").

Driving and Using Machines

This medicine may occasionally cause fatigue, even if taken according to the prescription instructions. As fatigue can affect reaction ability, the ability to drive and use machines may be impaired.

Bisolvon Calmatos contains Benzoic Acid, Sorbitol, Propylene Glycol, Benzyl Alcohol, and Sodium.

This medicine contains 11.25 mg of benzoic acid in each 15 ml dose.

This medicine contains 4.5 g of sorbitol in each 15 ml dose.

Sorbitol is a source of fructose. If your doctor has told you (or your child) that you have an intolerance to certain sugars, or you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot break down fructose, consult your doctor before taking this medicine.

Sorbitol may cause gastrointestinal upset and a mild laxative effect.

This medicine contains 1.5 g of propylene glycol in each 15 ml dose.

If you are pregnant or breastfeeding, do not take this medicine unless it is recommended by your doctor. Your doctor may perform additional checks while you are taking this medicine.

If you have liver or kidney failure, do not take this medicine unless it is recommended by your doctor. Your doctor may perform additional checks while you are taking this medicine.

This medicine contains 0.708 mg of benzyl alcohol in each 15 ml dose.

Benzyl alcohol may cause allergic reactions.

Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol can accumulate in your body and cause side effects (metabolic acidosis).

Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol can accumulate in your body and cause side effects (metabolic acidosis).

This medicine contains less than 23 mg of sodium (1 mmol) per 15 ml dose; it is essentially "sodium-free".

3. How to take Bisolvon Calmatos

Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose, based on the user's age and weight, is presented in the following table:

Age

Weight (kg)

Dose (ml)

Children from 6 to 15 years

20 - 26

5 ml 3-4 times a day

27 - 45

7.5 ml 3-4 times a day

46 - 60

15 ml 3-4 times a day

Adolescents from 15 years and Adults

> 60

15 ml 3-4 times a day

If the cough also causes sore throat, it is recommended to gargle with the solution before swallowing the dose.

If the irritating cough causes sleep problems, the last dose should be taken shortly before bedtime.

Use in Children and Adolescents

Read the recommended dose table.

Do not use for children under 6 years of age.

If you take more Bisolvon Calmatos than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Bisolvon Calmatos

Do not take a double dose to make up for forgotten doses.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

4. Possible Side Effects

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

Allergic reactionsthat 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, localized skin swelling, urticaria, blistering rash, itching, skin rash.

  • If you have any of these symptoms, stop using the medicine and seek medical help immediately.

Other possible side effects:

Common (may affect up to 1 in 10 people): upper abdominal pain, diarrhea, 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 small children), apnea, shortness of breath, respiratory depression (especially in small children), breathing difficulties, low white blood cell count.

Frequency not known: restlessness, hallucinations, confusion, blurred vision, temporary rash.

Reporting of Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Bisolvon Calmatos

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the label and carton after EXP. The expiry date is the last day of the month stated.

Do not use after 6 months of first opening.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Bisolvon Calmatos

  • The active substance is pentoxiverine citrate. Each ml of oral solution contains 2.13 mg of pentoxiverine citrate equivalent to 1.35 mg of pentoxiverine.
  • The other components are: benzoic acid, liquid sorbitol (non-crystallizing) (E420), glycerol, propylene glycol, citric acid monohydrate, sodium citrate, sodium saccharin, pear flavor (contains flavoring substances), juniper flavor (contains flavoring substances, benzyl alcohol [E1519] and alpha-tocopherol [E307]), purified water.

Appearance of the Product and Package Contents

Bisolvon Calmatos is a clear to almost clear, colorless to almost colorless liquid.

It is available in 95 ml and 190 ml amber glass bottles with a child-resistant screw cap.

The bottle is opened by pressing the cap down and turning it counterclockwise. The dosing cup is made of polypropylene and has graduation marks for 5, 7.5, and 15 ml.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Opella Healthcare Spain S.L.

C/ Rosselló i Porcel 21

08016 Barcelona (Spain)

Sanofi Group

Manufacturer

NextPharma SAS

17, route de Meulan

78520 Limay (France)

This medicine is authorized in the EEA member states under the following names:

Austria: Mucomat Reizhusten 2,13 mg/ml Lösung zum Einnehmen

Belgium: Pentoxyverine Sanofi 2.13 mg/ml drank

Bulgaria: ????????????? ?????? 2,13 mg/ml ????????? ???????

Denmark: Biseltoc

Spain: Bisolvon Calmatos 2,13 mg/ml Solución Oral

Finland: Biseltoc 2.13 mg/ml oraaliliuos

Greece: BISOLDRY 2,13 mg/ml π?σιμο δι?λυμα

Italy: Pentοssiverina Sanofi

Luxembourg: Pentoxyverine Sanofi 2.13 mg/ml Solution buvable

Norway: Biseltoc

Portugal: Pentoxiverina Bisoltussin

Romania: Citrat de pentoxiverina Sanofi 2,13 mg/ml solu?ie orala

Netherlands: Bisolsek pento 2,13 mg/ml drank

Sweden: Biseltoc

Date of the last revision of this leaflet:07/2021

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).

Online doctors for BISOLVON CALMATOS 2.13 mg/ml ORAL SOLUTION

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Dr Tomasz Grzelewski is an MD, PhD specialist in allergy, paediatrics, general practice and sports medicine, with a clinical focus on dermatology, endocrinology, allergology and sports-related health. He has more than 20 years of clinical experience and completed his medical training at the Medical University of Łódź, where he defended his PhD thesis with distinction. His doctoral research was recognised by the Polish Society of Allergology for its innovative contribution to the field. Throughout his career, he has gained extensive expertise in diagnosing and managing a wide range of allergic and paediatric conditions, including modern allergen desensitisation techniques. For five years, Dr Grzelewski served as the Head of two paediatric departments in Poland, managing complex clinical cases and leading multidisciplinary teams. He also worked in medical centres in the United Kingdom, gaining experience across both primary care and specialist environments. With over a decade of telemedicine experience, he has provided online consultations across Europe and is valued for his clear, structured and evidence-based medical guidance. Dr Grzelewski is actively involved in clinical programmes focused on modern anti-allergic therapies. As a Principal Investigator, he leads research projects on sublingual and oral allergen desensitisation, supporting evidence-based progress in allergy treatment for both children and adults. In addition to his background in allergology and paediatrics, he completed dermatology studies through the Cambridge Education Group (Royal College of Physicians of Ireland) and a Clinical Endocrinology course at Harvard Medical School. This advanced training enhances his ability to manage skin manifestations of allergies, atopic conditions, urticaria, endocrine-related symptoms and complex immunological reactions. Patients commonly seek his care for: 

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Between 2013 and 2019, he completed the Integrated Master's Degree in Medicine at the Abel Salazar Institute of Biomedical Sciences in Porto, where he acquired a solid academic and clinical education.

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Alina Tsurkan

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Dr. Tsurkan’s approach is evidence-based and holistic. She works closely with each patient to develop an individualised care plan that addresses both symptoms and root causes. Her goal is to empower patients to take control of their health and maintain well-being through lifestyle adjustments, routine check-ups, and early intervention.

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  • Endocrinology: diabetes type 1 and type 2, prediabetes, thyroid disorders, metabolic syndrome, hormonal imbalance.
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Dr. Horobets combines evidence-based medicine with a patient-centred approach. He carefully evaluates each patient’s medical history and symptoms, offering clear explanations and structured treatment plans adapted to individual needs.

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Frequently Asked Questions

Is a prescription required for BISOLVON CALMATOS 2.13 mg/ml ORAL SOLUTION?
BISOLVON CALMATOS 2.13 mg/ml ORAL SOLUTION does not require a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in BISOLVON CALMATOS 2.13 mg/ml ORAL SOLUTION?
The active ingredient in BISOLVON CALMATOS 2.13 mg/ml ORAL SOLUTION is pentoxyverine. This information helps identify medicines with the same composition but different brand names.
Who manufactures BISOLVON CALMATOS 2.13 mg/ml ORAL SOLUTION?
BISOLVON CALMATOS 2.13 mg/ml ORAL SOLUTION is manufactured by Opella Healthcare Spain S.L.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of BISOLVON CALMATOS 2.13 mg/ml ORAL SOLUTION online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether BISOLVON CALMATOS 2.13 mg/ml ORAL SOLUTION is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to BISOLVON CALMATOS 2.13 mg/ml ORAL SOLUTION?
Other medicines with the same active substance (pentoxyverine) include ANGITUSS 6mg/mL SYRUP, BRONCHOSTOP NITE ORAL SOLUTION, CINFATUSINA 3.54 mg/ml ORAL SUSPENSION. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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