Patient Information Leaflet

Guajazyl, 125 mg/5 ml, syrup
Guaifenesinum
Please read the following information carefully 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 a
physician or pharmacist.

Keep this leaflet for future reference.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 7 days of treatment, or if symptoms worsen, consult your doctor.

Table of Contents

What Guajazyl is and what it is used for
What you need to know before taking Guajazyl
How to take Guajazyl
Possible side effects
How to store Guajazyl
Contents of the pack and other information

1. What Guajazyl is and what it is used for

Guajazyl is an expectorant medicine. After oral administration, it increases the volume of mucus secretions in the bronchi and trachea and reduces their viscosity. It relieves cough and facilitates expectoration.
Indications for Guajazyl
An expectorant used in the treatment of cough.

2. Important information before using Guajazyl

When not to use Guajazyl:

if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
in children under 6 years of age;
in patients with liver insufficiency, alcohol-related disease, epilepsy, brain damage, or psychiatric disorders – due to the ethanol content.

Warnings and precautions
Before starting treatment with Guajazyl, consult a doctor or pharmacist.
If cough is persistent, lasts longer than one week, recurs, or is accompanied by fever, rash, or persistent headache, consult a doctor, as cough may be a symptom of a serious disease.
Do not use this medicine without medical advice in smokers, patients with bronchial asthma, chronic bronchitis, or pulmonary emphysema.
Metabolites of guaifenesin may affect laboratory test results for 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA); however, they do not cause false-positive results in healthy individuals.

Guajazyl with other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Guajazyl should be used with caution in patients with hypertension, heart disease, diabetes, peripheral vascular disease, benign prostatic hyperplasia, or glaucoma who are taking phenylpropanolamine.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Guajazyl should not be used during pregnancy and breastfeeding due to its ethanol content.

Driving and operating machinery
15 mL of syrup (1 tablespoon), a single adult dose, contains 562 mg of ethanol (alcohol).
Ethanol affects the ability to drive and operate machinery and 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 certain sugars, the patient should consult a doctor before taking this medicine.

Guajazyl contains the azo dye carmine red (E 124)
This medicine may cause allergic reactions.

Guajazyl contains ethylparaben (ethyl p-hydroxybenzoate)
This medicine may cause allergic reactions (delayed-type reactions possible).

Guajazyl contains ethanol
15 mL of syrup (1 tablespoon), a single adult dose, 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 in patients with alcohol-related disease.

3. How to use Guajazyl

This medicine should always be taken exactly as described in the patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a 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
Unless otherwise advised by a doctor, the usual dose of Guajazyl is:

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

Take the syrup after meals, with a small amount of liquid.
Do not take two doses at the same time.

Taking more Guajazyl than recommended
Severe disturbances after ingestion of even large doses of guaifenesin have not been observed. Symptoms in such cases may include nausea and vomiting, stomach pain, diarrhoea, or drowsiness.
In case of overdose, the doctor will provide symptomatic treatment.
If you take more than the recommended dose of this medicine, seek immediate advice from a doctor or pharmacist.

Missing a dose of Guajazyl
Do not take a double dose to make up for a missed dose.

Stopping Guajazyl
Discontinuation of the medicine does not lead to adverse symptoms.

If you have any further questions about 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 everybody gets them.
Gastrointestinal disorders: gastric discomfort, nausea, vomiting, diarrhoea.
Nervous system disorders: dizziness, headache.
Immune system disorders: skin rash, urticaria.
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 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.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Guajazyl

Keep the medicine out of the 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 stated month.
Store below 25°C.
Keep in the original packaging to protect from light.
Period of use after opening the package: 28 days.
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 packaging and other information

What Guajazyl contains

The active substance is guaifenesin. 5 ml of syrup contains 125 mg of guaifenesin.
The other ingredients (excipients) are: sucrose, carmine red (E 124), ethyl parahydroxybenzoate, ethanol, food-grade rum flavoring, povidone, purified water.

What Guajazyl looks like and contents of the pack
An amber glass bottle with an aluminium cap contains 150 g or 200 g of syrup.
Marketing Authorisation Holder and Manufacturer
Chemiczno-Farmaceutyczna Spółdzielnia Pracy ESPEFA
ul. J. Lea 208, 30-133 Kraków, Poland, tel. 12 639 27 27
Information for blind and partially sighted people: 800-007-777