Frionex 600 mg effervescent tablets
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Frionex 600 mg effervescent tablets
Acetylcysteine
Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.
Always follow exactly the instructions for use provided in this leaflet or as instructed 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 adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
- You should consult a doctor if you worsen or do not improve after 5 days.
Contents of this leaflet
- What Frionex is and what it is used for
- What you need to know before taking Frionex
- How to take Frionex
- Possible side effects
- How to store Frionex
- Contents of the pack and other information
1. What Frionex is and what it is used for
Acetylcysteine, the active substance in this medicine, belongs to a group of medicines called mucolytics, which work by reducing the viscosity of mucus, making it thinner and easier to eliminate.
This medicine is indicated to help remove excess mucus and phlegm in colds and flu, for adults.
You should consult a doctor if you worsen or do not improve after 5 days.
2. What you need to know before taking Frionex
Do not take Frionex:
- If you are allergic to acetylcysteine or to any of the other ingredients of this medicine (listed in section 6).
- Do not administer to children under 2 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before starting this medicine.
If you have asthma or suffer from a serious respiratory disease, you should consult your doctor before taking this medicine.
The possible sulphurous odour (like rotten eggs) of the medicine is characteristic of the active substance and does not indicate that the medicine is spoiled.
If you experience stomach discomfort when taking the medicine, stop treatment and consult your doctor or pharmacist. Caution is recommended in patients with peptic ulcer or history of peptic ulcer.
During the first days of treatment, you may notice an increase in mucus and phlegm, which will gradually decrease during the course of treatment.
Children and adolescents
Children and adolescents should not take this medicine. There are other more suitable formulations available for this population.
Taking Frionex with other medicines
Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.
Concomitant therapy with nitroglycerin may cause headache, and the development of hypotension—which may be severe—should be monitored.
Concomitant administration with the antiepileptic carbamazepine may lead to reduced efficacy of carbamazepine.
Do not take together with antitussive medicines (for cough) or with those that reduce bronchial secretions (such as antihistamines and anticholinergics), as this may cause accumulation of liquefied mucus.
When taking medicines containing minerals such as iron or calcium, or medicines with antibiotics such as (amphotericin B, sodium ampicillin, cephalosporins, lactobionate, erythromycin, and some tetracyclines), separate the administration of these medicines from this one by at least 2 hours.
Dissolving this medicine together with other medicines is not recommended.
Taking Frionex with food and drinks
Taking food and drinks does not affect the effectiveness of this medicine.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Its use should be avoided during breastfeeding.
Driving and using machines
There is no evidence of effects on the ability to drive or operate machinery.
Frionex contains lactose, sorbitol (E-420), and sodium
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.
This medicine contains 0.52 mg of sorbitol in each tablet.
This medicine contains 138.83 mg of sodium (main component of table/cooking salt) per tablet. This corresponds to 6.9% of the maximum recommended daily sodium intake for an adult.
3. How to take Frionex
Follow exactly the instructions for use provided in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.
Recommended dose:
Adults: 1 tablet, once daily. Do not exceed the dose of 1 tablet per day.
How to take:
This medicine is taken orally.
Dissolve in a glass of water; do not drink until effervescence has completely stopped. It is recommended to drink plenty of fluids throughout the day.
You should consult a doctor if your condition worsens or does not improve after 5 days of treatment.
Use in children and adolescents
This medicine must not be used in children and adolescents. There are other formulations more suitable for this population.
If you take more Frionex than you should
If you take more acetylcysteine than you should, you may experience: nausea, vomiting, stomach burning and pain, diarrhoea, or any other adverse effect described in section 4. Possible side effects.
In case of overdose or accidental ingestion, consult your doctor or pharmacist, or call the Toxicology Information Service at telephone number: 91.562.04.20, indicating the medicine and the amount taken.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The following adverse effects may occur:
Uncommon (may affect up to 1 in 100 patients): hypersensitivity, headache, tinnitus, tachycardia, vomiting, diarrhoea, stomatitis, abdominal pain, nausea, urticaria, skin rash, angioedema, pruritus, increased body temperature, hypotension.
Rare (may affect up to 1 in 1,000 patients): somnolence, bronchospasm, breathing difficulty, gastrointestinal discomfort.
Very rare (may affect up to 1 in 10,000 patients): allergic reactions, anaphylactic shock, haemorrhage, severe skin reactions such as Stevens-Johnson syndrome and Lyell syndrome, sometimes identified with the concomitant use of at least one other medicinal product.
Frequency not known (cannot be estimated from available data): facial swelling.
If any changes occur in the skin or mucous membranes, administration of acetylcysteine must be stopped immediately and medical advice sought.
Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Frionex
Keep this medicine out of sight and reach of children.
No special storage conditions are required.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Package contents and additional information
Composition of Frionex
- The active substance 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 flavour (contains sorbitol (E-420)), sodium cyclamate, sodium saccharin (E-954), sodium citrate (E-331).
Appearance of the product and contents of the pack
Frionex is presented in blister packs containing effervescent tablets that are round, white, with a smooth surface free of defects, and with a score line on one side.
Each pack contains 20 effervescent tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Kern Pharma, S.L.
Venus, 72 - Pol. Ind. Colón II
08228 Terrassa - Barcelona
Spain
Manufacturer
Hermes Pharma Gmbh
Hans-Urmiller-Ring 52
82515, Wolfratshausen
Germany
Date of latest revision of this package leaflet: November 2021
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.