Package leaflet: Information for the patient

Pulmopect 30 mg/5 ml, syrup
Levodropropizinum
Please read carefully all the information in this leaflet before using 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
physician or pharmacist.

Keep this leaflet, so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 7 days, or if you feel worse, consult your doctor.

Table of contents of the leaflet

What Pulmopect is and what it is used for
Important information before taking Pulmopect
How to take Pulmopect
Possible adverse reactions
How to store Pulmopect
Contents of the pack and other information

1. What Pulmopect is and what it is used for

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

2. Important information before using Pulmopect

When not to use Pulmopect:

if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6),
if the patient has bronchial mucus plug (excessive mucus production in the bronchi), a condition characterized by excessive mucus (phlegm) production,
if the patient has respiratory disorders characterized by reduced ability to clear mucus (Kartagener syndrome, ciliary dyskinesia),
in pregnant and breastfeeding women.

This product should not be used in children under 2 years of age (see "Children").
Warnings and precautions
Before starting treatment with Pulmopect, consult a doctor or pharmacist:

if the patient has severe kidney function disorders (severe renal impairment with creatinine clearance below 35 ml/min),
in elderly patients, as sensitivity to drugs may be altered,
if the patient is taking sedatives used in the treatment of anxiety and is particularly sensitive (see "Pulmopect and other medicines").

Pulmopect is a medicine used in the treatment of cough. It may be used only while awaiting diagnosis of the cause of cough and/or during treatment of the disease causing the cough.
Pulmopect should not be used for long-term treatment. If there is no improvement after 7 days, consult a doctor.
Children
Do not use in children under 2 years of age.
Pulmopect and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. In particular, inform the doctor about the use of sedative medicines (used in the treatment of anxiety).
Taking Pulmopect with food and drink
It is recommended to take this medicinal product between meals.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
The medicine is contraindicated in women who are pregnant or planning to become pregnant, as well as during breastfeeding.
Driving and operating machinery
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 the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this 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 use Pulmopect

This medicine should always be taken exactly as described in the patient information leaflet or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Do not use Pulmopect for longer than 7 days without consulting a doctor.
Use in adults
The recommended dose is 10 ml three times daily, with intervals of at least 6 hours between doses.
Use in children over 2 years of age
10–20 kg: the recommended dose is 3 ml of syrup three times daily.
20–30 kg: the recommended dose is 5 ml of syrup three times daily.
Method of administration:
Pulmopect should be taken orally, three times daily at intervals of at least 6 hours. The bottle of syrup is supplied with a measuring device allowing measurement of 3, 5, and 10 ml.
The bottle is equipped with an additional safety feature: a child-resistant cap. To open the bottle, press down on the cap and turn it in the direction indicated by the arrow.
Treatment should be continued until cough subsides or as directed by a physician.
If cough persists after 7 days of treatment, discontinue use and consult a doctor. Remember that cough is a symptom of disease and the underlying condition causing it should be diagnosed and treated appropriately.
Overdose of Pulmopect
If more medicine has been taken than recommended, inform your doctor or pharmacist immediately. In case of overdose with clinical symptoms, the doctor will immediately initiate symptomatic treatment and, if necessary, apply standard emergency procedures (e.g. 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 a patient forgets to take Pulmopect, the next dose should be taken at the usual time.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Adverse reactions during treatment with Pulmopect occur very rarely. In most cases, these are not serious complications and symptoms resolve after discontinuation of treatment, sometimes requiring only specific pharmacological treatment.

Treatment should be discontinued and immediate medical help sought if any of the following symptoms occur in the patient:

severe skin reactions (e.g. urticaria, itching) or skin disorders, such as those involving blister formation (epidermolysis);
irregular heartbeat (risk of cardiac arrhythmias);
allergic/anaphylactic reaction, manifested by swelling, shortness of breath, vomiting and diarrhoea;
dangerously low blood sugar levels, which may lead to loss of consciousness (hypoglycaemic coma).

Inform a doctor if any of the following adverse reactions occur or worsen:
Very rare (less than 1 in 10,000 patients):

urticaria, skin redness, rash, itching, skin reactions, severe allergic reactions such as swelling of the face, lips, mouth or throat (angioedema);
stomach pain, abdominal pain, nausea, vomiting, diarrhoea;
allergic reactions, including immediate general malaise;
dizziness, balance disturbances, tremor, tingling, numbness;
palpitations, tachycardia, hypotension;
irritability, drowsiness, depersonalization (disturbances in perception of self and surroundings);
shortness of breath, cough, oedema of the respiratory mucosa;
lack of energy (asthenia) and weakness of the lower limbs.

Additionally, the following adverse reactions have been reported:

glossitis and aphthous stomatitis with fever;
inflammation due to impaired bile outflow from the liver (cholestatic hepatitis);
pupillary dilation and loss of vision. In both cases, symptoms resolved after discontinuation of the drug;
eyelid oedema, which is usually considered angioedema (rapid allergic reaction with rash);
epileptic seizures – grand mal seizure (clonic-tonic convulsions) and petit mal seizure (non-convulsive, so-called petit mal seizure).

Additional adverse reactions in children

drowsiness, decreased muscle tone and vomiting in a newborn breastfed by a mother who took levodropropizine. These symptoms occurred after breastfeeding and resolved spontaneously after skipping several feeds.

Using Pulmopect according to the recommendations provided in the patient information leaflet reduces the risk of adverse reactions.
Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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 adverse reactions helps to collect more information on the safety of the medicine.
Adverse reactions can also be reported to the responsible entity.

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 bottle label and carton: Expiry date (EXP). The expiry date refers to the last day of the month indicated.
Do not use this medicine after 6 months from the date of first opening of the bottle.
Medicines must not be disposed of via wastewater or household waste. 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 is levodropropizine. 5 ml of syrup contains 30 mg of levodropropizine.
Other ingredients include: citric acid monohydrate, sodium hydroxide, sucrose, raspberry flavour A [flavouring substances and preparations, natural flavouring substances, propylene glycol (E1520), ethanol], purified water.

What Pulmopect looks like and contents of the pack
Pulmopect is a clear, light yellow raspberry-flavoured syrup.
The packaging consists of a type III amber glass bottle with a PP or PP/PE (HDPE) screw cap with child-resistant closure, LDPE sealing, and a PP measuring cup with a capacity of 15 ml, graduated at 2/2.5/3/4/5/6/7/7.5/8/9/10/11/12/12.5/15 ml, contained in a cardboard box.
Pack sizes: 100 ml, 125 ml or 200 ml of syrup.
Not all pack sizes may be marketed.
Marketing Authorisation 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