Natussic

Package Leaflet: Information for the Patient

Natussic, 7.5 mg/5 ml, Syrup

Butamirate Citrate

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 Package Leaflet or as Advised by a Doctor or Pharmacist.

• This 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 Side Effects, Including those 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 5 to 7 Days, the Doctor Should be Consulted.

Table of Contents of the Leaflet

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

1. What is Natussic and What is it Used For

The Active Substance of Natussic is Butamirate Citrate.
Natussic is a Cough Medication Intended for Symptomatic Treatment of Cough of Various Origins.
If There is no Improvement or the Patient Feels Worse After 5 to 7 Days, the Doctor Should be Consulted.

2. Important Information Before Taking Natussic

When Not to Take Natussic:

• If the Patient is Allergic to the Active Substance or any of the Other Ingredients of this Medication (Listed in Section 6).

Warnings and Precautions

If the Cough Persists for More than 7 Days, the Doctor Should be Consulted.
Due to the Suppression of the Cough Reflex by Butamirate Citrate, Medications that Induce Coughing Should be Avoided (See "Natussic and Other Medications").

Children

Natussic Syrup Should not be Used in Children Under 3 Years of Age.

Natussic and Other Medications

The Doctor or Pharmacist Should be Informed About all Medications Currently or Recently Taken by the Patient, as well as any Planned Medications.
Concomitant Use of Expectorant Medications Should be Avoided, as it may Lead to Accumulation of Secretions in the Airways, Increasing the Risk of Bronchospasm and Respiratory Tract Infections.

Pregnancy, Breastfeeding, and Fertility

If the Patient is Pregnant, 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.

Driving and Operating Machinery

Natussic may Cause Drowsiness. Therefore, Caution Should be Exercised When Driving or Operating Machinery.

Natussic Contains 2500 mg of Sorbitol in 5 ml of Syrup

Sorbitol is a Source of Fruuctose. If the Patient has Previously been Diagnosed with Intolerance to some Sugars or has been Diagnosed with Hereditary Fructose Intolerance, a Rare Genetic Disorder in which the Patient's Body does not Break Down Fruuctose, the Patient Should Consult a Doctor Before Taking the Medication or Giving it to a Child. The Energy Value is 2.6 kcal/g of Sorbitol.
Sorbitol may Cause Gastrointestinal Discomfort and may have a Mild Laxative Effect.

Natussic Contains 5 mg of Benzoic Acid in 5 ml of Syrup

Natussic Contains 96% Ethanol

The Medication Contains Small Amounts of Ethanol (Alcohol), Less than 100 mg per Dose.

3. How to Take Natussic

This Medication Should Always be Taken Exactly as Described in the Package Leaflet or as Advised by a Doctor or Pharmacist. In Case of Doubt, the Doctor or Pharmacist Should be Consulted.
Without Consulting a Doctor, Natussic Should not be Used for More than 5 to 7 Days.
Natussic Syrup is Taken Orally.
A Measuring Spoon is Included with the Medication to Measure the Correct Dose of Syrup.
The Measuring Spoon Should be Washed and Dried After Each Use.
The Usual Dose is:
Children from 3 to 6 Years: 5 ml of Syrup Three Times a Day,
Children from 6 to 12 Years: 10 ml of Syrup Three Times a Day,
Adolescents Over 12 Years: 15 ml of Syrup Three Times a Day,
Adults: 15 ml of Syrup Four Times a Day.
Natussic Syrup Should not be Used in Children Under 3 Years of Age.

Taking a Higher Dose of Natussic than Recommended

In Case of Taking a Higher Dose of the Medication than Recommended, the Following Symptoms may Occur:
Drowsiness, Nausea, Vomiting, Diarrhea, Dizziness, and Decreased Blood Pressure.
In Case of Taking a Higher Dose of the Medication than Recommended, the Doctor Should be Consulted Immediately.

Missing a Dose of Natussic

A Double Dose Should not be Taken to Make up for a Missed Dose.
In Case of any Further Doubts About Taking the Medication, the Doctor or Pharmacist Should be Consulted.

4. Possible Side Effects

Like all Medications, Natussic can Cause Side Effects, although not Everybody gets them.
Rare Side Effects (in 1 to 10 per 10,000 People):
Drowsiness,
Nausea,
Diarrhea,
Hives.
If these Symptoms Occur, the Medication Should be Stopped and the Doctor Consulted.

Reporting Side Effects

If any Side Effects Occur, including those not Listed in the Leaflet, the Doctor or Pharmacist Should be Informed. 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. +48 22 49 21 301, fax: +48 22 49 21 309,
e-mail: [email protected].
Side Effects can also be Reported to the Marketing Authorization Holder.
Reporting Side Effects will Help to Gather more Information on the Safety of the Medication.

5. How to Store Natussic

Store in a Tight, Original Package, at a Temperature Below 25°C.
The Medication Should be Stored Out of Sight and Reach of Children.
The Medication Should not be Used After the Expiration Date on the Package.
The Expiration Date Refers to the Last Day of the Specified Month.
Shelf Life After First Opening the Bottle: 3 Months.
Medications Should not be Disposed of in Sewers 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 Natussic Contains

• The Active Substance of the Medication is Butamirate Citrate. 5 ml of Syrup Contains 7.5 mg of Butamirate Citrate (1 ml of Syrup Contains 1.5 mg of Butamirate Citrate).
• Other Ingredients (Excipients) are: Liquid Sorbitol, Non-Crystallizing, Glycerol, Sodium Saccharin (E 954), Vanillin, Benzoic Acid (E 210), Sodium Hydroxide, 96% Ethanol (v/v), Purified Water.

What Natussic Looks Like and What the Package Contains

Natussic Syrup is a Colorless, Transparent Syrup with a Characteristic Taste and Vanilla Smell.
The Bottle is Made of Brown Glass Type III with an HDPE Cap and a Foamed PE Seal, with a Measuring Spoon Made of PP, in a Cardboard Box.
Package Sizes:
1 Bottle of 100 ml
1 Bottle of 200 ml

Marketing Authorization Holder and Manufacturer

"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E

Information About the Medication

tel. 22 742 00 22
e-mail: [email protected]

Date of the Last Update of the Leaflet: