Patient Information Leaflet

Respifortin, 600 mg, effervescent tablets
Acetylcysteinum
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by the
physician, pharmacist, or nurse.

Keep this leaflet for future reference.
If you need advice or further information, consult your pharmacist.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 5 days of treatment, or if you feel worse, contact your doctor.

Table of contents:

What Respifortin is and what it is used for
Important information before taking Respifortin
How to take Respifortin
Possible side effects
How to store Respifortin
Contents of the pack and other information

1. What Respifortin is and what it is used for

Respifortin effervescent tablets contain acetylcysteine as the active substance, which reduces
the viscosity of bronchial secretions and facilitates expectoration.
Respifortin is indicated in adults for short-term treatment as a mucolytic agent that liquefies
respiratory tract secretions and facilitates their expectoration in acute respiratory disorders (common cold) associated with excessive production of thick and sticky mucus.
If symptoms have not improved or worsened after 5 days of treatment, consult your doctor.

2. Important information before taking Respifortin

When not to take Respifortin

if the patient is allergic to acetylcysteine or to any of the other ingredients of this medicine (listed in section 6),
during asthmatic conditions,
if the patient has phenylketonuria (see also section "Respifortin contains aspartame"),
if the patient has active gastric or duodenal ulcer,
in children under 2 years of age, because the active substance acetylcysteine may cause airway obstruction in children under 2 years of age (see also section 3).

Warnings and precautions
Before starting treatment with Respifortin, consult a doctor or pharmacist if:

the patient has had or suffers from chronic bronchial asthma (as the medicine may cause bronchospasm and shortness of breath);
the patient is elderly (over 65 years of age);
the patient currently has or has previously had respiratory insufficiency;
the patient has previously been diagnosed with gastric or duodenal ulcer;
the patient is allergic to histamine, as Respifortin may cause intolerance symptoms such as headache, rhinitis, or itching.

Very rarely, severe skin adverse reactions have been observed during treatment with acetylcysteine,
e.g. Stevens-Johnson syndrome and Lyell's syndrome. If any skin or mucosal changes occur during treatment with Respifortin,
the medicine should be discontinued immediately and the patient should contact a doctor without delay.
Respifortin may interfere with the results of certain laboratory tests (colorimetric determination of salicylates
and urine ketone testing).
Children and adolescents
Due to the amount of active substance, Respifortin should not be used in children and adolescents under 18 years of age.
Interaction of Respifortin with other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines planned for use.

Do not take Respifortin with antitussive medicines, as they suppress the cough reflex and may hinder expectoration of sputum liquefied by Respifortin.
Reports on inactivation of antibiotics by acetylcysteine and other mucolytic agents originate only from in vitro studies, in which these substances were mixed directly. However, for safety reasons, acetylcysteine and antibiotics should be administered separately, with an interval of at least 2 hours.
Respifortin may enhance the effect of nitroglycerin and other nitrates (medicines used in cardiovascular diseases and ischemic heart disease). If the patient is taking nitroglycerin or another similarly acting nitrate, medical advice should be sought before taking Respifortin.
Concomitant use with carbamazepine may lead to a reduction in carbamazepine plasma concentration below the therapeutic level.
Activated charcoal may reduce the effect of Respifortin.
It is not recommended to dissolve other medicines together with Respifortin.

If the patient is unsure whether they are taking any of the medicines listed above, they should
consult a doctor or pharmacist.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child,
she should consult a doctor or pharmacist before using this medicine.
As a precautionary measure, use of Respifortin during pregnancy is not recommended.
The doctor will decide whether breastfeeding should be discontinued or treatment with Respifortin stopped,
taking into account the benefits of breastfeeding for the child and the benefits of treatment for the mother.
Driving and operating machinery
The effect of Respifortin on the ability to drive and operate machinery is unknown.
Respifortin contains sodium
This medicine contains 183.4 mg of sodium per tablet, equivalent to 9.17% of the maximum recommended daily intake of 2 g sodium for adults according to WHO guidelines.
Respifortin contains isomalt
This medicine contains isomalt (a sweetening agent). If the patient has previously been diagnosed with intolerance to certain sugars, they should consult a doctor before taking this medicine.
Respifortin contains aspartame
This medicine contains 39.9 mg of aspartame per tablet. Aspartame is a source of phenylalanine.
It may be harmful for patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to impaired excretion.

3. How to take Respifortin

This medicine should always be taken exactly as described in this patient information leaflet or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Recommended dose
Adults
1 effervescent tablet once daily (corresponding to 600 mg of acetylcysteine once daily).

Use in children and adolescents
Due to the amount of active substance, this medicine should not be used in children and adolescents under 18 years of age.

Method of administration
The effervescent tablet should be dissolved in ½ glass of water and taken immediately after dissolution.
The solution is clear and colourless.

Note: Do not take this medicine before going to sleep due to difficulty in expectorating the liquefied secretions during sleep.
The last dose of Respifortin should be taken at least 4 hours before bedtime.

During treatment, it is recommended to drink increased amounts of fluids.

Duration of treatment
Do not use Respifortin for longer than 5 days without medical advice.

If you take more Respifortin than you should
If you take more than the recommended dose, contact your doctor or pharmacist immediately. Gastrointestinal symptoms such as nausea, vomiting, and diarrhoea may occur.

If you forget to take Respifortin
If you miss a dose, take it as soon as possible. Do not take a double dose to make up for the missed dose.

If you have any further doubts concerning 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 will experience them.
Serious adverse reactions
Severe allergic reactions presenting with difficulty in breathing, hypotension,
urticaria, rash, angioedema (swelling of the skin and/or subcutaneous tissues,
e.g. face, limbs, joints), itching, or hypersensitivity reactions are uncommon adverse reactions.
There have been very rare reports of severe skin reactions, such as Stevens-Johnson syndrome
and Lyell's syndrome, as well as severe allergic reactions (anaphylactic shock, anaphylactic
or anaphylactoid reactions) following the use of Respifortin.
If any of the above-mentioned adverse reactions occur, treatment with Respifortin must be stopped immediately
and medical advice should be sought.
In case of skin or mucosal lesions, administration of Respifortin should be discontinued immediately
and medical advice should be sought.
Uncommon (may affect fewer than 1 in 100 but more than 1 in 1,000 people):
hypersensitivity reactions, headache, tinnitus, increased heart rate (tachycardia),
oral mucositis, vomiting, diarrhoea, abdominal pain, nausea, skin reactions:
urticaria, rash, itching, angioedema, fever, hypotension.
Rare (may affect fewer than 1 in 1,000 but more than 1 in 10,000 people):
bronchospasm, dyspnoea, dyspepsia.
Very rare (may affect fewer than 1 in 10,000 people):
severe allergic reactions (anaphylactic shock, anaphylactic reaction, anaphylactoid reaction), haemorrhage.
Frequency not known (frequency cannot be estimated from the available data):
facial swelling.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions 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
of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: + 48 22 49 21 301,
fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Respifortin

Keep the medicine out of the sight and reach of children.
Do not store above 25°C.
Store the container tightly closed to protect from light and moisture.
Do not use this medicine after the expiry date stated on the packaging following the wording
"Expiry date:" or EXP. The expiry date refers to the last day of the stated month.
Do not use the medicine more than 28 days after first opening the container.
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 package and other information

What Respifortin contains

The active substance is acetylcysteine. One effervescent tablet contains 600 mg of acetylcysteine.
Other ingredients are: anhydrous citric acid, isomalt, sodium bicarbonate, ascorbic acid (E 300), aspartame (E 951), lemon flavour (Tetrarome Lemon P 0551 987323): corn maltodextrin, flavouring substances, alpha tocopherol (E307).

What Respifortin looks like and contents of the pack
Respifortin is a white, round, flat effervescent tablet with bevelled edges and a smooth surface on both sides of the tablet.
Respifortin is available in a polypropylene container with an LDPE closure, containing a desiccant (silica gel), placed in a cardboard box which also contains the patient leaflet.
Pack size: 10 effervescent tablets

Marketing Authorisation Holder
Natur Produkt Zdrovit Sp. z o.o.
ul. Nocznickiego 31
01-918 Warsaw
Tel. +48 22 569 8 200
Fax. +48 22 635 15 51
(NPZdrovit logo)

Manufacturer
Natur Produkt Pharma Sp. z o.o.
ul. Podstoczysko 30
07-300 Ostrów Mazowiecka
Tel. +48 29 644 29 00
Fax. +48 29 745 39 95

This medicinal product is authorised for sale in the European Economic Area countries under the following names:
Bulgaria Респифортин, 600 mg ефервесцентни таблетки
Lithuania Respifortin 600 mg šnypščiosios tabletės
Romania Mucofortin 600 mg, comprimate efervescente
Slovakia Mucofortin 600 mg

For further information, please contact the representative of the Marketing Authorisation Holder.
Detailed information on this medicinal product is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: www.urpl.gov.pl