PATIENT INFORMATION LEAFLET

frispec 6.5 mg/ml Syrup

Guaifenesin

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

Follow exactly the administration instructions for the medicine contained in this leaflet or those 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 any side effects, consult your doctor or pharmacist even if they do not appear in this leaflet.
• You should consult a doctor if you get worse or do not improve after 7 days of treatment.

Guaifenesin, the active ingredient of this medication, belongs to the group of medications known as expectorants.

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

For adults and children over 2 years old.

Consult a doctor if it worsens or does not improve after 7 days of treatment.

Do not take Frispec:

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

Warnings and precautions:

Consult your doctor, pharmacist, or nurse before starting to take 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 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 to undergo a urine test, it is essential to inform your doctor or nurse that you are taking or have recently taken this medication, as it may alter some results.

Children

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

Taking Frispec with other medications:

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

This medication should not be taken with other cough medications (antitussives or cough suppressants)

Taking Frispec with food, drinks, and alcohol:

You can take this medication with or without food.

Do not consume alcohol while taking this medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

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

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

Driving and operating machinery:

If during treatment with this medication you experience dizziness, do not drive or operate machinery.

Frispec contains saccharose, parahydroxybenzoic acid, glycerol, sodium benzoate, and sodium

This medication contains saccharose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

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

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

This medication may cause headaches, stomach discomfort, and diarrhea because it contains glycerol.

This medication contains 0.1 g of sodium benzoate in each unit of volume equivalent to 0.1 g / weight volume.

This medication contains less than 1 mmol of sodium (23 mg) per unit of volume; it is essentially “sodium-free”.

Follow exactly the medication administration instructions contained in this leaflet or those 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.

Individuals over 65 years old: the same as for adults.

Patients with renal/hepatic disease: must consult the doctor.

Use in children

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

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

Children under 2 years old: contraindicated

Administration form

This medication is taken orally.

Shake the bottle before use. Measure the amount to take with the spoon provided in the package.

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

You must consult a doctor if it worsens or does not improve after 7 days of treatment

If you take more frispec than you should:

If you take more medication than you should, you may experience stomach discomfort, nausea, diarrhea, and drowsiness.

Prolonged and high-dose use of this medication may cause kidney stones.

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

Like all medications, frispec may produce adverse effects, although not everyone will experience them.

These may include: nausea, vomiting, diarrhea, stomach discomfort, headache, and dizziness.

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

• Allergic reactions, including skin eruptions (which may be severe, with the appearance of blisters, abrasions, and skin peeling) and itching.

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of frispec:

• The active principle is guaifenesin. Each ml of syrup contains 6.5 mg of guaifenesin
• The other components (excipients) are methylparahydroxybenzoate (E-218), anise essence, pine essence, sodium benzoate (E-211), saccharose, glycerol (E-422), sodium saccharin, and purified water.

Appearance of the product and contents of the packaging

Clear oral solution with an anise odor. frispec is presented in a bottle containing 150 ml.

Holder of the marketing authorization

Farline Comercializadora de Productos Farmacéuticos, S.A.

C/ Santa Engracia, 31

28010 – Madrid (Spain)

Responsible for manufacturing

ALCALÁ FARMA, S.L.

Avenida de Madrid 82,

Alcala de Henares.28802. Spain

Date of the last review of this leaflet:September 2022

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/