FRISPEC 6.5 mg/ml SYRUP

Introduction

PACKAGE LEAFLET: Information for the user

frispec 6.5 mg/ml Syrup

Guaifenesin

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

Follow the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist even if they are not listed in this leaflet.
• You should consult a doctor if your condition worsens or does not improve after 7 days of treatment.

Contents of the package leaflet:

1. What is frispec and what is it used for
2. What you need to know before taking frispec
3. How to take frispec
4. Possible side effects
5. Storage of frispec
6. Package contents and additional information

1. What is frispec and what is it used for

Guaifenesin, the active ingredient of this medicine, belongs to the group of medicines called expectorants.

It is indicated to relieve productive cough by reducing phlegm (mucus) and facilitating its expulsion.

For adults and children over 2 years old.

You should consult a doctor if your condition worsens or does not improve after 7 days of treatment.

2. What you need to know before taking frispec

Do not take frispec:

• If you are allergic to guaifenesin or any of the other components of this medicine (listed in section 6)
• • Children under 2 years old cannot take this medicine.

Warnings and precautions:

Consult your doctor, pharmacist, or nurse before taking Frispec if:

• You have had a cough for more than 7 days or if your cough is recurrent or accompanied by fever, rash, or persistent headache
• You have a persistent cough that may be caused by asthma
• You have a cough with a large amount of mucus (phlegm)
• You have severe liver or kidney problems

Interference with laboratory tests

If you are going to have a urine test, it is essential that you inform your doctor or nurse that you are taking or have recently taken this medicine, as it may alter some results.

Children

Children under 2 years old cannot take this medicine because it is contraindicated.

Taking frispec with other medicines:

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medicine.

It is not recommended to take this medicine with other cough medicines (antitussives or cough suppressants)

Taking frispec with food, drinks, and alcohol:

You can take this medicine with or without food.

Do not drink alcohol while being treated with this medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

This medicine should not be used during pregnancy unless your doctor prescribes it.

Do not take this medicine if you are breastfeeding unless your doctor prescribes it.

Driving and using machines:

If you experience dizziness during treatment with this medicine, do not drive or use machines.

frispec contains sucrose, methyl parahydroxybenzoate, glycerol, sodium benzoate, and sodium

This medicine contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Patients with diabetes mellitus should note that this medicine contains 9.75 g of sucrose per 15 ml.

It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E-218).

This medicine may cause headache, stomach upset, and diarrhea because it contains glycerol.

This medicine contains 0.1 g of benzoic acid salt per unit volume, equivalent to 0.1 g / weight volume.

This medicine contains less than 1 mmol of sodium (23 mg) per unit volume; that is, it is essentially "sodium-free".

3. How to take frispec

Follow the administration instructions of the medicine contained in this leaflet or as indicated by your doctor, pharmacist, or nurse. In case of doubt, consult your doctor, pharmacist, or nurse.

The recommended dose is:

Adults and adolescents over 12 years old: administer 30 ml (195 mg) every 4 hours if necessary.

Over 65 years old: the same as for adults.

Patient with kidney/liver disease: should consult a doctor.

Use in children

Children from 6 to 12 years old: administer 15 ml (97.5 mg) every 4 hours if necessary.

Children from 2 to 5 years old: administer under medical control 7.5 ml (48.75 mg) every 4 hours if necessary.

Children under 2 years old: it is contraindicated

Method of administration

This medicine is taken orally.

Shake the bottle before use. Measure the amount to be taken with the measuring spoon provided with the package.

The syrup can be taken alone or mixed with water. You should take a glass of water after taking each dose.

You should consult a doctor if your condition worsens or does not improve after 7 days of treatment

If you take more frispec than you should:

If you take more medicine than you should, you may experience stomach upset, nausea, diarrhea, and drowsiness.

Prolonged and high-dose use of this medicine may produce kidney stones.

In case of overdose or accidental ingestion, consult your doctor, go to a medical center, or call the Toxicology Information Service (phone: 91 562 04 20), indicating the medicine and the amount ingested.

4. Possible side effects

Like all medicines, frispec can cause side effects, although not everyone gets them.

The following may occur: nausea, vomiting, diarrhea, stomach upset, headache, and dizziness.

If you experience any of the following side effects, stop taking this medicine and consult your doctor immediately:

• Allergic reactions including skin rash (which can be severe, with blisters, abrasion, and peeling of the skin) and itching.

Reporting side effects:

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: http://www.aemps.gob.es/

5. Storage of frispec

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date stated on the package after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Deposit the packages and medicines you no longer need at the SIGRE point in your pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of frispec:

• The active ingredient is guaifenesin. Each ml of syrup contains 6.5 mg of guaifenesin
• The other ingredients (excipients) are methyl parahydroxybenzoate (E-218), anise essence, pine essence, sodium benzoate (E-211), sucrose, glycerol (E-422), sodium saccharin, and purified water.

Appearance of the product and package contents

Transparent oral solution with anise flavor. frispec is presented in a bottle containing 150 ml.

Marketing authorization holder

Farline Comercializadora de Productos Farmacéuticos, S.A.

C/ Santa Engracia, 31

28010 – Madrid (Spain)

Manufacturer

ALCALÁ FARMA, S.L.

Avenida de Madrid 82,

Alcala de Henares. 28802. Spain

Date of the last revision of this leaflet:September 2022

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/