BISOLVON CALMATOS 2.13 mg/ml ORAL SOLUTION

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:

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.

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/).