Respifortin

Package Leaflet: Information for the Patient

Respifortin, 600 mg, Effervescent Tablets

Acetylcysteine

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

This Medication Should Always be Taken Exactly as Described in this Package Leaflet or as Advised by a Doctor, Pharmacist, or Nurse.

• Keep this Package Leaflet, You May Need to Read it Again.
• If You Need Advice or Further Information, Consult a Pharmacist.
• If You Experience any Side Effects, Including those not Listed in this Package Leaflet, Tell Your Doctor or Pharmacist. See Section 4.
• If There is no Improvement or if You Feel Worse after 5 Days, Consult a Doctor.

Package Leaflet Contents:

• 1. What is Respifortin and What is it Used for
• 2. Important Information Before Taking Respifortin
• 3. How to Take Respifortin
• 4. Possible Side Effects
• 5. How to Store Respifortin
• 6. Package Contents and Other Information

1. What is Respifortin and What is it Used for

Respifortin Effervescent Tablets Contain the Active Substance Acetylcysteine, which Reduces the Viscosity of Bronchial Secretions and Facilitates Expectoration.
Respifortin is Indicated for the Short-Term Treatment of Acute Respiratory Disorders (Common Cold) Associated with the Production of Thick, Viscous Mucus in Adults.
If Symptoms do not Improve or Worsen after 5 Days of Treatment, Consult a Doctor.

2. Important Information Before Taking Respifortin

When Not to Take Respifortin

• If You are Allergic to Acetylcysteine or any of the Other Ingredients of this Medication (Listed in Section 6),
• In Asthmatic Status,
• If You Have Phenylketonuria (See also "Respifortin Contains Aspartame"),
• If You Have Active Gastric or Duodenal Ulcer,
• In Children Under 2 Years of Age, as the Active Substance: Acetylcysteine may Cause Respiratory Obstruction in Children Under 2 Years of Age (See also Section 3).

Warnings and Precautions

Before Taking Respifortin, Discuss with Your Doctor or Pharmacist if:

• You Have Had or Currently Have Chronic Asthma (as the Medication may Cause Bronchospasm and Shortness of Breath);
• You are Over 65 Years Old;
• You Currently Have or Have Had Respiratory Failure;
• You Have Had Gastric or Duodenal Ulcer in the Past;
• You are Allergic to Histamine, as Respifortin may Cause Intolerance Symptoms: Headache, Nasal Congestion, Itching.

Rare but Serious Skin Reactions, such as Stevens-Johnson Syndrome and Lyell's Syndrome, Have Been Observed with Acetylcysteine Treatment.
If You Experience any Skin or Mucous Membrane Changes During Respifortin Treatment, Stop Taking the Medication and Consult a Doctor Immediately.
Respifortin may Affect the Results of Some Laboratory Tests (Salicylate Determination by Colorimetry and Ketone Determination in Urine).

Children and Adolescents

Due to the Amount of Active Substance, Respifortin Should not be Used in Children and Adolescents Under 18 Years of Age.

Respifortin and Other Medications

Tell Your Doctor or Pharmacist About all Medications You are Currently Taking or Plan to Take.

• Do not Take Respifortin with Cough Suppressants, as they May Weaken the Cough Reflex and Make it Difficult to Expectorate the Secretion Thinned by Respifortin.
• Reports of Inactivation of Antibiotics by Acetylcysteine and Other Mucolytic Agents Come from In VitroExperiments in which these Substances were Mixed Directly.
  However, for Safety Reasons, Acetylcysteine and Antibiotics Should be Taken Separately, with an Interval of at Least 2 Hours.
• Respifortin may Enhance the Effect of Nitroglycerin and Other Nitrates (Medications Used for Cardiovascular Diseases and Angina Pectoris).
  If You are Taking Nitroglycerin or a Similar Acting Medication from the Nitrate Group, Consult a Doctor Before Taking Respifortin.
• Concomitant Use with Carbamazepine may Lead to a Decrease in Carbamazepine Plasma Concentration Below the Therapeutic Level.
• Activated Carbon may Weaken the Effect of Respifortin.
• It is not Recommended to Dissolve Other Medications with Respifortin.

If You are Uncertain Whether You are Taking any of the Above Medications, Consult a Doctor or Pharmacist.

Pregnancy and Breastfeeding

If You are Pregnant or Breastfeeding, Think You may be Pregnant or are Planning to Have a Child, Consult a Doctor or Pharmacist Before Taking this Medication.
As a Precaution, it is Recommended to Avoid Taking Respifortin During Pregnancy.
The Doctor will Decide Whether to Stop Breastfeeding or Stop Taking Respifortin, Considering 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 not Known.

Respifortin Contains Sodium

This Medication Contains 183.4 mg of Sodium in Each Effervescent Tablet, which Corresponds to 9.17% of the Maximum Recommended Daily Intake of Sodium (2 g) by the WHO for Adults.

Respifortin Contains Isomalt

This Medication Contains Isomalt (a Sweetener). If You Have Previously Been Diagnosed with Intolerance to Some Sugars, Consult a Doctor Before Taking the Medication.

Respifortin Contains Aspartame

This Medication Contains 39.9 mg of Aspartame in Each Effervescent Tablet. Aspartame is a Source of Phenylalanine.
It may be Harmful to Patients with Phenylketonuria. This is a Rare Genetic Disorder in which Phenylalanine Accumulates in the Body due to its Impaired Excretion.

3. How to Take Respifortin

This Medication Should Always be Taken Exactly as Described in this Package Leaflet or as Advised by a Doctor or Pharmacist.
In Case of Doubt, Consult a Doctor or Pharmacist.
The Recommended Dose is:

Adults

1 Effervescent Tablet Once a Day (Corresponding to 600 mg of Acetylcysteine Once a Day).

Use in Children and Adolescents

Due to the Amount of Active Substance, Respifortin 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 Colorless.
Note:Do not Take the Medication Before Bedtime Due to Difficulty in Expectorating Thinned Secretion During Sleep.
The Last Dose of Respifortin Should be Taken at Least 4 Hours Before Bedtime.
During Treatment, it is Recommended to Increase Fluid Intake.
Duration of Treatment

Do not Take Respifortin for More than 5 Days Without a Doctor's Recommendation.

Overdose of Respifortin

In Case of Overdose, Consult a Doctor or Pharmacist Immediately.
Possible Symptoms of Overdose may Include Gastrointestinal Symptoms such as Nausea, Vomiting, Diarrhea.

Missed Dose of Respifortin

In Case of a Missed Dose, Take it as Soon as Possible.
Do not Take a Double Dose to Make up for the Missed Dose.
In Case of Further Doubts About the Use of this Medication, Consult a Doctor or Pharmacist.

4. Possible Side Effects

Like all Medications, Respifortin can Cause Side Effects, although not Everybody Gets them.

Serious Side Effects

Serious Allergic Reactionswith Difficulty Breathing, Low Blood Pressure, Hives, Rash, Angioedema (Swelling of the Skin and/or Subcutaneous Tissues, e.g., Face, Limbs, Joints), Itching are Uncommon Side Effects.
There are Very Rare Reports of Serious Skin Reactions, such as Stevens-Johnson Syndrome and Lyell's Syndrome, as well as Serious Allergic Reactions (Anaphylactic Shock, Anaphylactic Reaction, or Anaphylactoid Reaction) After Taking Respifortin.
If You Experience any of the Above Side Effects, Stop Taking Respifortin and Consult a Doctor Immediately.
If You Experience any Skin or Mucous Membrane Changes, Stop Taking Respifortin and Consult a Doctor Immediately.
Uncommon(May Occur in Less than 1 in 100 but More than 1 in 1,000 People):
Allergic Reactions, Headache, Tinnitus, Increased Heart Rate (Tachycardia), Stomatitis, Vomiting, Diarrhea, Abdominal Pain, Nausea, Skin Changes: Urticaria, Rash, Itching, Angioedema, Fever, Low Blood Pressure.
Rare(May Occur in Less than 1 in 1,000 but More than 1 in 10,000 People):
Bronchospasm, Shortness of Breath, Dyspepsia.
Very Rare(May Occur in Less than 1 in 10,000 People):
Serious Allergic Reactions (Anaphylactic Shock, Anaphylactic Reaction, Anaphylactoid Reaction), Bleeding.
Frequency Not Known(Frequency Cannot be Estimated from the Available Data):
Facial Edema.

Reporting Side Effects

If You Experience any Side Effects, Including those not Listed in this Package Leaflet, Tell Your Doctor or Pharmacist.
Side Effects can be Reported Directly to the Department of Medicinal Product Monitoring, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 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.
By Reporting Side Effects, You can Help Provide More Information on the Safety of this Medication.

5. How to Store Respifortin

Store the Medication in a Place Out of Sight and Reach of Children.
Do not Store Above 25°C.
Keep the Container Tightly Closed to Protect from Light and Moisture.
Do not Use this Medication After the Expiration Date Stated on the Packaging After the "Expiration Date:" or EXP.
Do not Use the Medication After 28 Days from the First Opening of the Container.
Medications Should not be Disposed of via Wastewater or Household Waste.
Ask a Pharmacist How to Dispose of Medications that are no Longer Needed.
This will Help Protect the Environment.

6. Package Contents and Other Information

What Respifortin Contains

• The Active Substance of the Medication 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 Flavor (Tetrarome Lemon P 0551 987323): Corn Maltodextrin, Flavoring Substances, Alpha-Tocopherol (E307).

What Respifortin Looks Like and What the Package Contains

Respifortin is a White, Round, Flat Effervescent Tablet with a Beveled Edge and a Smooth Surface on Both Sides of the Tablet.
Respifortin is Available in a Propylene Container with a LDPE Closure, Containing a Desiccant (Silica Gel), in a Cardboard Box Also Containing the Patient Information Leaflet.
Package Size: 10 Effervescent Tablets

Marketing Authorization 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 Authorized for Marketing in the Member States of the European Economic Area Under the Following Names:

Countries:

Bulgaria
Респифортин, 600 mg ефервесцентни таблетки
Lithuania
Respifortin 600 mg šnypščiosios tabletės
Romania
Mucofortin 600 mg, comprimate efervescente
Slovakia
Mucofortin 600 mg
For More Detailed Information, Please Contact the Marketing Authorization Holder's Representative.

Date of Last Revision of the Package Leaflet:

Detailed Information on this Medication is Available on the Website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: www.urpl.gov.pl