Package Leaflet: Information for the User

Frionex 600 mg Effervescent Tablets

Acetylecysteine

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

Follow exactly the administration instructions contained in this leaflet or those given by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• Consult your pharmacist if you need advice or more information.
• Consult your doctor or pharmacist if you experience any side effects, even if they do not appear in this leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 5 days.

Acetilcisteine, the active ingredient of this medication, belongs to a group of medications called mucolytics, which act by reducing the viscosity of mucus, liquefying it, and facilitating its elimination.

This medication is indicated to facilitate the elimination of excess mucus and phlegm in colds and flu, for adults.

You should consult a doctor if it worsens or does not improve after 5 days.

Do not take Frionex:

• If you are allergic to acetylcysteine, or to any of the other components of this medication (listed in section 6).
• Do not administer to children under 2 years old.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication.

If you are asthmatic or have a severe respiratory disease, you must consult with your doctor before taking this medication.

The possible sulfurous smell (like rotten eggs) of the medication is due to the active ingredient, but it does not indicate that the medication is in poor condition.

If you experience stomach discomfort while taking the medication, discontinue treatment and consult your doctor or pharmacist. Caution is recommended for patients with peptic ulcers or a history of peptic ulcers.

During the first few days of treatment, you may observe an increase in mucus and phlegm, which will decrease over time.

Children and adolescents

Children and adolescents should not take this medication. There are other presentations more suitable for this population.

Frionex with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Concomitant therapy with nitroglycerin may cause headaches and hypotension, which can be severe.

Concomitant administration with the antiepileptic carbamazepine may reduce the efficacy of carbamazepine.

Do not take concurrently with cough medications or those that reduce bronchial secretions (such as antihistamines and anticholinergics), as it may cause a buildup of fluidified mucus.

When taking medications containing minerals such as iron or calcium, or antibiotics like amphotericin B, ampicillin sodium, cephalosporins, lactobionate, erythromycin, and some tetracyclines, you should separate your intake from this medication by at least 2 hours.

Do not dissolve this medication with other medications.

Frionex with food and beverages

The intake of food and beverages does not affect the efficacy of this medication.

Pregnancy, breastfeeding, and fertility

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

It is recommended to avoid taking this medication during breastfeeding.

Driving and operating machines

There is no evidence of effects on the ability to drive and operate machines.

Frionex contains lactose, sorbitol (E-420), and sodium

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

This medication contains 0.52 mg of sorbitol in each tablet.

This medication contains 138.83 mg of sodium (main component of table salt/for cooking) in each tablet. This is equivalent to 6.9% of the maximum daily sodium intake recommended for an adult.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

The recommended dose is:

Adults: 1 tablet, once a day. Do not exceed 1 tablet per day.

How to take:

This medication is taken orally.

Dissolve in a glass of water, do not drink until the effervescence has completely stopped. It is recommended to drink an abundant amount of liquid throughout the day.

You should consult a doctor if you worsen or do not improve after 5 days of treatment.

Use in children and adolescents

Children and adolescents cannot take this medication. There are other presentations more suitable for this population.

If you take more Frionex than you should

If you take more acetilcisteina than you should, you may notice: nausea, vomiting, heartburn and stomach pain, diarrhea or any other adverse effect described in section 4. Possible adverse effects.

In case of overdose or accidental ingestion, consult your doctor or pharmacist, or call the Toxicological Information Service, phone: 91.562.04.20, indicating the medication and the amount taken.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

The following adverse effects may occur:

Rare (may affect up to 1 in 100 patients): hypersensitivity, headache, tinnitus, tachycardia, vomiting, diarrhea, stomatitis, abdominal pain, nausea, urticaria, skin rash, angioedema, pruritus, increased body temperature, hypotension.

Uncommon (may affect up to 1 in 1,000 patients): drowsiness, bronchospasm, respiratory difficulty, digestive discomfort. Very rare (may affect up to 1 in 10,000 patients): allergic reactions, anaphylactic shock, hemorrhage, severe skin reactions such as Stevens-Johnson syndrome and Lyell syndrome, sometimes identified with the simultaneous use of another medication.

Unknown frequency (cannot be estimated from available data): facial swelling.

In case of any alteration in the skin or mucous membranes, discontinue acetilcysteine administration immediately and seek medical assistance.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an 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 on the safety of this medication.

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

No special storage conditions are required.

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.

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 Frionex

• The active principle is acetylcysteine. Each tablet contains 600 mg of acetylcysteine.
• The other components (excipients) are: anhydrous citric acid (E-330), ascorbic acid (E-300), sodium hydrogen carbonate (E-500), anhydrous sodium carbonate (E-500), lactose, mannitol (E-421), lemon aroma (contains sorbitol (E-420)), sodium cyclamate, sodium saccharin (E-954), sodium citrate (E-331).

Appearance of the product and contents of the packaging

Frionex is presented in blisters with effervescent round white tablets, with a smooth surface and no defects, and with a groove on one face.

Each package contains 20 effervescent tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Responsible for manufacturing

Hermes Pharma Gmbh

Hans-Urmiller-Ring 52

82515, Wolfratshausen

Germany

Last review date of this leaflet: November 2021

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