Maxipulmon

Leaflet attached to the packaging: patient information

Maxipulmon, 3 mg/ml, syrup

Butamirate citrate

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

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 7 days or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Maxipulmon and what is it used for
• 2. Important information before taking Maxipulmon
• 3. How to take Maxipulmon
• 4. Possible side effects
• 5. How to store Maxipulmon
• 6. Package contents and other information

1. What is Maxipulmon and what is it used for

Maxipulmon contains the active substance – butamirate citrate. Butamirate citrate is a non-opioid cough suppressant.

Indications for use

Symptomatic treatment of non-productive (dry) cough of various origins.
If there is no improvement after 7 days or the patient feels worse, they should contact their doctor.

2. Important information before taking Maxipulmon

When not to take Maxipulmon:

• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6);
• in the first trimester of pregnancy (see section "Pregnancy and breastfeeding").

Warnings and precautions

Due to the suppression of the cough reflex by butamirate citrate, expectorant medicines should be avoided (see section "Maxipulmon and other medicines").

Children

Maxipulmon should not be used in children under 3 years of age.

Maxipulmon and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Expectorant medicines should be avoided, as they may lead to the accumulation of secretions in the airways, increasing the risk of bronchospasm and respiratory tract infections.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
Do nottake Maxipulmon during the first trimester of pregnancy.
The medicine should not be taken during the second and third trimesters of pregnancy.
Breastfeeding
The medicine should not be taken during breastfeeding.

Driving and using machines

Maxipulmon may cause drowsiness. Therefore, caution should be exercised when driving or operating machines. Children taking the medicine should avoid riding bicycles and scooters.

Maxipulmon contains propylene glycol, sorbitol, sodium, and benzoic acid

Propylene glycol

The medicine contains 2.18 mg of propylene glycol in each ml of syrup.

Sorbitol

The medicine contains 406 mg of sorbitol in each ml of syrup. The energy value is 2.6 kcal/g of sorbitol.
Sorbitol is a source of fructose. If the patient (or their child) has previously been diagnosed with intolerance to some sugars or has been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which the patient's body does not break down fructose, they should consult their doctor before taking the medicine or giving it to their child.
Sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect.

Sodium

The medicine contains 6.21 mg of sodium (the main component of common salt) in each ml of syrup. This corresponds to 0.31% of the maximum recommended daily intake of sodium in the diet for adults.

Benzoic acid

The medicine contains 0.58 mg of benzoic acid in each ml of syrup.
Benzoic acid may cause local irritation.

3. How to take Maxipulmon

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
The medicine should be taken orally.

Recommended dose

• children aged 3 to 6 years: 2.5 ml of syrup 3 times a day;
• children aged 6 to 12 years: 5 ml of syrup 3 times a day;
• adolescents over 12 years: 7.5 ml of syrup 3 times a day;
• adults: 7.5 ml of syrup 4 times a day.

Do not take Maxipulmon for more than 7 days without consulting a doctor.

A measuring cup or oral syringe with an adapter is attached to the packaging, making it easier to measure the exact dose.

Instructions for using the dosing device in the form of an oral syringe with an adapter

• 1. Unscrew the bottle cap.
• 2. Place the attached adapter in the bottle neck opening.
• 3. The oral syringe should be firmly inserted into the adapter recess.
• 4. To fill the syringe, the bottle should be turned upside down and then carefully move the syringe plunger down, drawing the syrup to the desired mark on the scale.
• 5. The bottle should be turned back to its original position and the syringe carefully removed from the bottle.
• 6. The syringe tip should be placed in the mouth, and then, slowly pressing the plunger, the syrup should be administered carefully to avoid choking.
• 7. After taking the medicine, the bottle should be closed, and the syringe washed and dried.

Taking a higher dose of Maxipulmon than recommended

In case of taking a higher dose of the medicine than recommended, the patient should immediately consult their doctor or pharmacist.
In case of taking a higher dose of the medicine than recommended, the following symptoms may occur: drowsiness, nausea, vomiting, diarrhea, dizziness, and decreased blood pressure.

Missing a dose of Maxipulmon

A double dose should not be taken to make up for a missed dose.
If there are any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Maxipulmon can cause side effects, although not everybody gets them.
The following side effects may occur when taking Maxipulmon:

Rare (occurring in 1 to 10 people out of 10,000):

• drowsiness;
• nausea;
• diarrhea;
• hives (light-red, itchy blisters on the skin).

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181 C, 02-222 Warsaw
tel.: + 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 help gather more information on the safety of the medicine.

5. How to store Maxipulmon

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25 ° C. Do not store in the refrigerator or freeze.
Do not use this medicine after the expiry date stated on the label and carton.
The expiry date refers to the last day of the month.
Shelf life after first opening: 3 months.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Maxipulmon contains

• -The active substance of the medicine is butamirate citrate. 1 ml of syrup contains 3 mg of butamirate citrate .
• -Other ingredients are: liquid sorbitol, non-crystallizing (E 420), sucralose (E 955), sodium chloride, benzoic acid (E 210), glycerol (E 422), sodium hydroxide, raspberry flavor AR 0320 (Himbeere fl. (mixture of flavoring substances and solvent), 3-cis-hexenol, propylene glycol 1,2, vanillin), vanilla flavor AR 0345 (diacetyl, ethyl acetate, vanillin, propylene glycol 1,2, water), purified water.

What Maxipulmon looks like and what the package contains

Maxipulmon is a syrup. The syrup is colorless to yellow with a raspberry-vanilla flavor.
The bottle is made of brown glass type III with an aluminum cap with a foam LDPE seal and an oral syringe with a capacity of 5 ml, graduated every 0.1 ml (cylinder and plunger tip made of LDPE, plunger made of polystyrene) with an LDPE connector or a measuring cup made of PP with a capacity of 15 ml, graduated every 2.5 ml, in a cardboard box.
The package contains 120 ml of syrup.

Marketing authorization holder

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

Manufacturer

Aflofarm Farmacja Polska Sp. z o.o.
ul. Krzywa 2
95-030 Rzgów
Date of last update of the leaflet:30.05.2022