Pulmopect

PATIENT INFORMATION LEAFLET

Leaflet attached to the packaging: patient information

Pulmopect 30 mg/ 5 ml, syrup

Levodropropizinum

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.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or you feel worse, consult a doctor.

Table of contents of the leaflet

• 1. What is Pulmopect and what is it used for
• 2. Important information before taking Pulmopect
• 3. How to take Pulmopect
• 4. Possible side effects
• 5. How to store Pulmopect
• 6. Contents of the pack and other information

1. What is Pulmopect and what is it used for

Pulmopect contains the active substance levodropropizine, which belongs to a group of cough suppressant medicines.
Pulmopect is indicated for the treatment of symptoms of dry, non-productive cough.
If after 7 days there is no improvement or you feel worse, consult a doctor.

2. Important information before taking Pulmopect

When not to take Pulmopect:

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
• if you have bronchial secretions (excessive mucus production from the bronchi), a condition characterized by the production of large amounts of mucus (phlegm).
• if you have respiratory disorders characterized by reduced ability to expel mucus (Kartagener syndrome, ciliary dyskinesia).
• in pregnant or breastfeeding women.

Do not take this product in children under 2 years of age (see "Children").

Warnings and precautions

Before taking Pulmopect, discuss it with your doctor or pharmacist:

• if you have severe kidney function disorders (severe renal impairment with creatinine clearance below 35 ml/min),
• elderly patients, as their sensitivity to medicines changes,
• if you are taking sedative medicines used to treat anxiety and are particularly sensitive (see "Pulmopect and other medicines").

Pulmopect is a cough medicine. It can only be used while waiting for a diagnosis of the cause of the cough and/or during treatment of the underlying disease.
Do not take Pulmopect for a long time. If after 7 days there is no improvement, consult a doctor.

Children

Do not take in children under 2 years of age.

Pulmopect and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take.
In particular, inform your doctor about taking sedative medicines (used to treat anxiety).

Taking Pulmopect with food and drink

It is recommended to take the medicinal product between meals.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
The medicine is contraindicated in pregnant or breastfeeding women.

Driving and using machines

Pulmopect may cause drowsiness (see section 4 "Possible side effects").
If this symptom occurs, avoid driving or operating machinery.

Pulmopect contains sucrose

5 ml of Pulmopect contains 3 g of sucrose. If you have previously been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.

Pulmopect contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per 5 ml of product, which means the medicine is considered "sodium-free”.

3. How to take Pulmopect

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Do not take Pulmopect for more than 7 days without consulting a doctor.

Adult administration

The recommended dose is 10 ml three times a day, at intervals of not less than 6 hours between doses.

Administration in children over 2 years of age

10-20 kg: the recommended dose is 3 ml of syrup three times a day.
20-30 kg: the recommended dose is 5 ml of syrup three times a day.

Method of administration:

Pulmopect should be taken orally, three times a day, at intervals of at least 6 hours. The bottle with the syrup comes with a measuring cup that allows you to measure 3, 5, 10 ml.
The bottle is equipped with an additional safety feature, a child-resistant closure. To open the bottle, press the cap and turn it in the direction indicated by the arrow.
Treatment should be continued until the cough disappears or as directed by the doctor.
In any case, if the cough does not disappear after 7 days of treatment, it is recommended to discontinue the use of the medicine and consult a doctor. Remember that cough is a symptom of a disease and the disease that causes it should be diagnosed and treated.

Overdose of Pulmopect

In case of overdose, immediately inform a doctor or pharmacist. In case of overdose with clinical symptoms, the doctor will immediately initiate symptomatic treatment and, if necessary, apply standard emergency procedures (gastric lavage, activated charcoal, parenteral fluid administration, etc.).

Missed dose of Pulmopect

Do not take a double dose to make up for a missed dose.
If you forget to take Pulmopect, take the next dose at the usual time.
If you have any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Pulmopect can cause side effects, although not everybody gets them.
During treatment with Pulmopect, side effects occur very rarely. In most cases, they are not serious and the symptoms disappear after discontinuation of treatment, sometimes only requiring specific pharmacological treatment.
Stop taking the medicine and seek medical help immediately if you experience any of the following symptoms:

• severe skin reactions (hives, itching) or skin diseases, such as those with blistering (epidermolysis);
• irregular heartbeat (risk of cardiac arrhythmia);
• allergic reaction/anaphylaxis, in the form of swelling, shortness of breath, vomiting, and diarrhea;
• dangerously low blood sugar levels, which can lead to loss of consciousness (hypoglycemic coma).

Inform your doctor if you experience any of the following side effects or if they worsen:
Very rare (less than 1 in 10,000 patients):

• hives, skin redness, rash, itching, skin reactions, severe allergic reactions, such as facial swelling, lip or throat swelling (angioedema);
• stomach pain, abdominal pain, nausea, vomiting, diarrhea;
• allergic reactions, including immediate, general malaise;
• dizziness, balance disorders, tremors, tingling, numbness;
• palpitations, tachycardia, decreased blood pressure;
• irritability, drowsiness, depersonalization (disorders of perception of oneself and the environment);
• shortness of breath, cough, swelling of the respiratory mucosa;
• asthenia and weakness of the lower limbs.

The following side effects have also been reported:

• inflammation of the tongue and aphthous stomatitis with fever;
• inflammatory condition caused by obstruction of bile flow from the liver (cholestatic hepatitis);
• pupil dilation and loss of vision. In both cases, the symptoms disappeared after discontinuation of the medicine;
• swelling of the eyelids, which can be considered as angioedema (rapid allergic reaction with rash);
• seizures - grand mal seizure (clonic-tonic seizures) and petit mal seizure (non-convulsive, so-called petit mal seizure).

Additional side effects in children

• drowsiness, decreased muscle tone, and vomiting in a newborn, breastfed by a mother who took levodropropizine. These symptoms appeared after breastfeeding and disappeared on their own after skipping a few feedings (breastfeeding).

Taking Pulmopect as directed in the patient leaflet reduces the risk of side effects.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, inform your 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 181C
02-222 Warsaw
tel.: 22 49-21-301
fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Reporting side effects can help gather more information on the safety of the medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Pulmopect

Keep the medicine out of sight and reach of children.
Store in the original packaging to protect from light. Do not store in the refrigerator or freeze.
Do not use this medicine after the expiry date stated on the label of the bottle and carton after: Expiry date (EXP). The expiry date refers to the last day of the specified month.
Do not use this medicine after 6 months from the date of first opening of the bottle.
Medicines should not be disposed of via wastewater or household waste containers. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Pulmopect contains

• The active substance of the medicine is levodropropizine. 5 ml of syrup contains 30 mg of levodropropizine.
• The other ingredients are: citric acid monohydrate, sodium hydroxide, sucrose, raspberry flavor A [flavoring substances and preparations, natural flavoring substances, propylene glycol (E1520), ethanol], purified water.

What Pulmopect looks like and what the pack contains

Pulmopect is a clear, light yellow syrup with a raspberry flavor.
The packaging consists of an orange glass type III bottle with a PP or PP/PE (HDPE) cap with a child-resistant closure, LDPE seal, and a 15 ml PP measuring cup, graduated for 2/2.5/3/4/5/6/7/7.5/8/9/10/11/12/12.5/15 ml, in a cardboard box.
Pack sizes: 100 ml, 125 ml, or 200 ml of syrup.
Not all pack sizes may be marketed.

Marketing authorization holder

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Importer

Adamed Pharma S.A.
ul. Marszałka J. Piłsudskiego 5
95-200 Pabianice
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola PLA3000
Malta

Date of last revision of the leaflet: