Flegatussin Caps

Package Leaflet: Information for the Patient

FlegatussinCaps, 8 mg, Soft Capsules
Bromhexine Hydrochloride

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 the Patient Information Leaflet or as Advised by a Doctor or Pharmacist.

• The 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 Undesirable Effects, Including any Possible Undesirable Effects not Listed in the Leaflet, the Doctor or Pharmacist Should be Informed. See Section 4.
• If There is no Improvement or the Patient Feels Worse After 4-5 Days, the Doctor Should be Contacted.

Table of Contents of the Leaflet

• 1. What is Flegatussin Capsand What is it Used For
• 2. Important Information Before Taking Flegatussin Caps
• 3. How to Take Flegatussin Caps
• 4. Possible Undesirable Effects
• 5. How to Store Flegatussin Caps
• 6. Package Contents and Other Information

1.

What is FlegatussinCapsand What is it Used For
Flegatussin CapsContains the Active Substance Bromhexine Hydrochloride, which Thins the Secretions of the Respiratory Tract and has an Expectorant Effect.
Flegatussin CapsFacilitates Coughing Up and Cleansing of the Bronchi.
The Indication for the Use of Flegatussin Capsis Acute and Chronic Respiratory Tract Diseases with Difficult Expectoration of Thick Secretions.

2.

Important Information Before Taking FlegatussinCaps
When Not to Take FlegatussinCaps:

• If the Patient is Allergic to Bromhexine Hydrochloride or any of the Other Ingredients of this Medication (Listed in Section 6);
• In Children Under 12 Years of Age.

Warnings and Precautions

Before Starting to Take Flegatussin Caps, the Doctor or Pharmacist Should be Consulted if:

• The Patient has a Disease Called Ciliary Dyskinesia with Impaired Motor Function of the Bronchi,
• The Patient has Liver or Kidney Function Disorders,
• The Patient has Difficulty Expectoring or has Asthma,
• The Patient has Gastric or Duodenal Ulcer Disease,
• The Patient Experiences Shortness of Breath, Fever, and Purulent Sputum.

Severe Skin Reactions Associated with the Use of Bromhexine have been Reported. If a Rash Appears (Including Changes in Mucous Membranes, e.g. Mouth, Throat, Nose, Eyes, Genital Organs), the Use of Flegatussin CapsShould be Discontinued and a Doctor Should be Consulted Immediately.
If the Patient has Inflammatory Diseases of the Respiratory Tract with Accompanying Bacterial Infection, Flegatussin CapsShould be Used Simultaneously with Antibiotics and Bronchodilators Prescribed by the Doctor. Proper Hydration of the Patient is Important, Especially when Fever is Present. Proper Hydration of the Body Increases the Thinning of Bronchial Secretions and Facilitates Expectoration.
Bronchial Secretions Should be Expectored Carefully.

Children and Adolescents

Not to be Used in Children Under 12 Years of Age.
FlegatussinCapsand Other Medications
The Doctor or Pharmacist Should be Informed About all Medications Currently or Recently Taken by the Patient, as well as any Medications Planned to be Taken.
The Medication Should be Used with Caution with Atropine and Other Anticholinergic Medications, as they Cause Dryness of the Mucous Membranes.
Flegatussin CapsShould not be Administered Simultaneously with Cough Suppressants (e.g. Containing Codeine), as this may Lead to a Dangerous Accumulation of Bronchial Secretions due to a Weakened Cough Reflex.
The Medication may Enhance the Irritating Effect of Salicylates and Other Non-Steroidal Anti-Inflammatory Drugs on the Gastrointestinal Tract Mucosa.
Concomitant Use of Bromhexine and Antibiotics (Medications Used to Treat Infections: Ampicillin, Amoxicillin, Cefuroxime, Erythromycin, Doxycycline, Oxytetracycline) may Lead to an Increased Concentration of the Antibiotic in the Lungs.

Pregnancy and Breastfeeding

If the Patient is Pregnant or Breastfeeding, or Thinks She may be Pregnant or is Planning to have a Child, She Should Consult a Doctor or Pharmacist Before Taking this Medication.
Pregnancy
The Use of the Medication is not Recommended, Especially in the First Trimester of Pregnancy. In the Remaining Period of Pregnancy, the Medication may be Used only if, in the Doctor's Opinion, the Benefit to the Mother Outweighs the Potential Risk to the Fetus.
Breastfeeding
The Use of the Medication is not Recommended During Breastfeeding.

Driving and Operating Machinery

Caution Should be Exercised, as Dizziness or Drowsiness may Occur.
FlegatussinCapsContains Sorbitol (E 420)
The Medication Contains 69.03 mg of Sorbitol in Each Capsule. Sorbitol is a Source of Fructose. If the Patient has Previously been Diagnosed with Intolerance to some Sugars or has a Rare Genetic Disorder, Hereditary Fructose Intolerance, in which the Patient's Body does not Break Down Fructose, the Patient Should Consult a Doctor Before Taking the Medication or Administering it to a Child.
FlegatussinCapsContains Patent Blue V (E 131)
The Medication may Cause Allergic Reactions.
FlegatussinCapsContains Sodium
The Medication Contains Less than 1 mmol (23 mg) of Sodium per Capsule, i.e. the Medication is Considered "Sodium-Free".

3.

How to Take FlegatussinCaps
This Medication Should Always be Taken Exactly as Described in the Patient Information Leaflet or as Advised by a Doctor or Pharmacist. In Case of Doubt, a Doctor or Pharmacist Should be Consulted.
Recommended Dose
Adults and Adolescents Over 12 Years of Age: 1 Capsule 3 Times a Day.
Method of Administration
Oral Administration.
The Medication Should be Taken at Equal Time Intervals, After a Meal.
It is Recommended to Drink Plenty of Fluids During Treatment.
The Medication Should not be Taken Directly Before Bedtime.
If Symptoms do not Improve After 4-5 Days, a Doctor Should be Consulted.
The Medication is Usually Taken for 7 to 10 Days.
Taking a Higher Dose of FlegatussinCapsthan Recommended
No Symptoms of Bromhexine Overdose have been Described to Date. In Case of Overdose, Symptomatic Treatment may be Necessary.
In Case of Taking a Higher Dose of the Medication than Recommended, a Doctor or Pharmacist Should be Consulted Immediately.
Missing a Dose of FlegatussinCaps
A Double Dose Should not be Taken to Make Up for a Missed Dose.
In Case of any Further Doubts About the Use of this Medication, a Doctor or Pharmacist Should be Consulted.

4. Possible Undesirable Effects

Like all Medications, this Medication can Cause Undesirable Effects, although not Everybody gets them.
In Case of Severe Undesirable Effects such as: Hypersensitivity Reactions, Anaphylactic Reactions, including Anaphylactic Shock, Angioedema (Rapidly Progressing Edema of the Skin, Subcutaneous Tissue, Mucous Membranes or Submucosal Tissue) and Itching, Severe Skin Reactions (including Erythema Multiforme, Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, Generalized Pustular Rash), Bronchospasm, or in Case of Intensification of other Undesirable Effects, the Medication Should be Discontinued and a Doctor or the Emergency Department of the Nearest Hospital Should be Consulted.

Uncommon (Occurring in Less than 1 in 100 Patients):

Nausea, Abdominal Pain (Particularly Epigastric Pain), Vomiting, Diarrhea, Fever.

Rare (Occurring in Less than 1 in 1,000 Patients):

Hypersensitivity Reactions, Rash, Urticaria.

Frequency Not Known (Frequency Cannot be Estimated from the Available Data):

Anaphylactic Reactions, including Anaphylactic Shock, Angioedema (Rapidly Progressing Edema of the Skin, Subcutaneous Tissue, Mucous Membranes or Submucosal Tissue) and Itching, Severe Skin Reactions (including Erythema Multiforme, Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, Generalized Pustular Rash), Headache, Dizziness, Drowsiness, Decreased Blood Pressure, Bronchospasm, Nausea, Increased Activity of Liver Enzymes.

Reporting of Undesirable Effects

If any Undesirable Effects Occur, including any Undesirable Effects not Listed in this Leaflet, the Doctor or Pharmacist or Nurse Should be Informed. Undesirable Effects can be Reported Directly to the Department for 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Undesirable Effects can also be Reported to the Marketing Authorization Holder.
Reporting of Undesirable Effects Allows for the Collection of More Information on the Safety of the Medication.

5.

How to Store FlegatussinCaps
The Medication Should be Stored Out of Sight and Reach of Children.
Store in a Temperature Below 25°C.
Store in the Original Packaging to Protect from Light.
Do not Use this Medication After the Expiration Date Stated on the Packaging After EXP.
The Expiration Date Refers to the Last Day of the Specified Month.
Medications Should not be Disposed of in the Drain or Household Waste Containers. A Pharmacist Should be Asked how to Dispose of Unused Medications. This will Help Protect the Environment.

6. Package Contents and Other Information

What FlegatussinCapsContains

• The Active Substance of the Medication is Bromhexine Hydrochloride. Each Capsule Contains 8 mg of Bromhexine Hydrochloride.
• Other Ingredients are: Capsule Filling: Macrogol 600, Sodium Hydroxide, Ascorbic Acid (E 300), Purified Water; Capsule Shell: Gelatin, Sorbitol Liquid, Partly Dehydrated (E 420), Patent Blue V (E 131), Purified Water.

What FlegatussinCapsLooks Like and What the Package Contains
Flegatussin Capsis a Blue, Oval, Soft Capsule with a Seam in the Middle, Filled with an Oily Liquid.
PVC/PVDC/Aluminum Blister Packs in a Cardboard Box.
The Package Contains 20 or 40 Capsules.
Not all Pack Sizes may be Marketed.

Marketing Authorization Holder

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
Phone: +48 22 364 61 01

Manufacturer

Polpharma S.A.
Medana Division in Sieradz
Władysława Łokietka 10, 98-200 Sieradz

Date of the Last Update of the Leaflet: