Guaiazil

Package Leaflet: Information for the Patient

Guajazyl, 125 mg/5 ml, Syrup

Guaifenesin

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the package leaflet for the patient or as advised by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet

• 1. What is Guajazyl and what is it used for
• 2. Important information before taking Guajazyl
• 3. How to take Guajazyl
• 4. Possible side effects
• 5. How to store Guajazyl
• 6. Package contents and other information

1. What is Guajazyl and what is it used for

Guajazyl is an expectorant medicine. After oral administration, it increases the volume of mucous secretion in the bronchi and trachea, and also reduces its viscosity. It relieves cough and facilitates expectoration.

Indications for use of Guajazyl

Expectorant medicine used in the treatment of cough.

2. Important information before taking Guajazyl

When not to take Guajazyl:

• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6);
• in children under 6 years of age;
• in patients with liver failure, alcoholism, epilepsy, brain damage, or mental illness - due to the content of ethanol.

Warnings and precautions

Before starting to take Guajazyl, the patient should discuss it with their doctor or pharmacist.
If the cough is persistent, lasts for more than a week, recurs, is accompanied by fever, rash, or persistent headaches, the patient should consult their doctor, as the cough may be a symptom of a serious illness.
The medicine should not be taken without a doctor's recommendation in people who smoke, patients with asthma, chronic bronchitis, or emphysema.
Metabolism products of guaifenesin may affect the results of laboratory tests for 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA); however, they do not cause false-positive results in healthy individuals.

Guajazyl and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.
In patients with hypertension, heart disease, diabetes, peripheral vascular disease, prostatic hyperplasia, and glaucoma, taking phenylpropanolamine, Guajazyl should be used with caution.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Guajazyl should not be taken during pregnancy and breastfeeding, due to the content of ethanol.

Driving and operating machinery

15 ml of syrup (1 tablespoon), a single dose for adults, contains 562 mg of ethanol (alcohol).
Ethanol affects the ability to drive and operate machinery, and also reduces psychomotor performance (e.g., swimming, working at heights).

Guajazyl contains sucrose

The medicine contains 9.86 g of sucrose (sugar) in 15 ml of syrup (1 tablespoon). If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

Guajazyl contains the azo dye Ponceau 4R (E 124)

The medicine may cause allergic reactions.

Guajazyl contains ethyl parahydroxybenzoate

The medicine may cause allergic reactions (possible late-type reactions).

Guajazyl contains ethanol

15 ml of syrup (1 tablespoon), a single dose for adults, contains 562 mg of ethanol.
This should be taken into account when administering to pregnant or breastfeeding women, children, and high-risk groups, such as patients with liver disease or epilepsy. Harmful to individuals with alcoholism.

3. How to take Guajazyl

This medicine should always be taken exactly as described in the package leaflet for the patient or as advised by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
The medicine is taken orally.
1 teaspoon contains 5 ml, which is 6.2 g of syrup.
1 tablespoon contains 15 ml, which is 18.7 g of syrup.
Recommended dose

If the doctor does not recommend otherwise, the usual dose of Guajazyl is:

• for children from 6 to 12 years of age: 5 ml of syrup (1 teaspoon) 3 or 4 times a day.
• for adults and children over 12 years of age: 15 ml of syrup (1 tablespoon) 3 or 4 times a day.

The syrup should be taken after a meal, with a small amount of liquid.
Do not take two doses at the same time.

Taking a higher dose of Guajazyl than recommended

No serious disorders have been reported after taking even large doses of guaifenesin. Symptoms in such cases are nausea and vomiting, stomach pain, diarrhea, or drowsiness may occur.
In case of overdose, the doctor will provide symptomatic treatment.
If a higher dose of the medicine than recommended is taken, the patient should immediately consult their doctor or pharmacist.

Missing a dose of Guajazyl

A double dose should not be taken to make up for a missed dose.

Stopping treatment with Guajazyl

Discontinuation of the medicine does not cause any side effects.
In case of any further doubts regarding the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Guajazyl can cause side effects, although not everybody gets them.
Gastrointestinal disorders: stomach discomfort, nausea, vomiting, diarrhea.
Nervous system disorders: dizziness, headaches.
Immune system disorders: skin rash, urticaria.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor or pharmacist. 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,
Website: https://smz.ezdrowie.gov.pl
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 medicine.

5. How to store Guajazyl

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
Store at a temperature below 25°C.
Store in the original packaging to protect from light.
Shelf life after opening the packaging: 28 days.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Guajazyl contains

• The active substance of the medicine is guaifenesin. 5 ml of syrup contains 125 mg of guaifenesin.
• The other ingredients (excipients) are: sucrose, Ponceau 4R (E 124), ethyl parahydroxybenzoate, ethanol, rum flavor, povidone, purified water.

What Guajazyl looks like and what the packaging contains

A brown glass bottle with an aluminum cap contains 150 g or 200 g of syrup.

Marketing authorization holder and manufacturer

Chemiczno-Farmaceutyczna Spółdzielnia Pracy ESPEFA
ul J. Lea 208, 30-133 Kraków, Poland, tel. 12 639 27 27

Information for the blind and visually impaired: 800-007-777

Date of last revision of the leaflet:19.04.2023