INISTON MUCOSITY AND CONGESTION 20 mg/ml + 6 mg/ml SYRUP

Introduction

Package Leaflet: Information for the User

Iniston Mucosidad y Congestión20 mg/ml + 6 mg/ml syrup

Guaifenesina/Pseudoefedrina

Read the package leaflet carefully before starting to take this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package 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 package leaflet. See section 4.
• You should consult your doctor if it worsens or does not improve after 5 days.

Contents of the Package Leaflet:

1. What Iniston Mucosidad y Congestión is and what it is used for
2. What you need to know before taking Iniston Mucosidad y Congestión
3. How to take Iniston Mucosidad y Congestión
4. Possible side effects

5 Conservation of Iniston Mucosidad y Congestión

1. Package contents and additional information

1. What it is and what it is used for

Iniston Mucosidad y Congestión is an association of pseudoephedrine and guaifenesin.

Pseudoephedrine acts as a nasal decongestant and guaifenesin is an expectorant that relieves productive cough by decreasing mucus and facilitating its expulsion.

It is indicated in adults and children from 7 years old to relieve productive cough by decreasing mucus and phlegm in colds and flu accompanied by nasal congestion.

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

2. What you need to know before taking Iniston Mucosidad y Congestión

Do not takeIniston Mucosidad y Congestión

• If you are allergic to the active ingredients, to other sympathomimetics such as antihistamine medications, or to any of the other components of this medication (listed in section 6).
• If you have severe hypertension (high blood pressure) or severe coronary artery disease.
• If you have very high blood pressure (severe hypertension) or uncontrolled hypertension
• If you have severe kidney disease, acute (sudden) or chronic (long-term), or kidney failure
• If you are in the first trimester of pregnancy
• If you are or have been treated with other monoamine oxidase inhibitor (MAOI) medications in the last 2 weeks. (See section on taking Iniston Mucosidad y Congestión with other medications)

Children under 7 years old.

Warnings and precautions

• If after 5 days of treatment you do not improve or have a cough, or it is accompanied by fever, rashor persistent headache, you should stop treatment and consult your doctor.
• If you are going to have surgery, you should stop treatment at least 24 hours in advance.

• If you have:
• • hyperthyroidism
  • diabetes
  • cardiovascular disease, mild or moderate hypertension
  • high eye pressure (glaucoma)
  • enlarged prostate in men, difficulty urinating, urinary obstruction
  • moderate or severe kidney disease with reduced function.
  • If you have chronic or persistent cough, such as that due to asthma, or when the cough is accompanied by a large amount of mucus.

It is recommended not to use it at the same time as other medications for cough or nasal congestion. Consult "Taking Iniston Mucosidad y Congestión with other medications".

Abdominal pain or rectal bleeding may occur with the use of Iniston Mucosidad y Congestión due to colon inflammation (ischemic colitis). If these gastrointestinal symptoms appear, stop taking Iniston Mucosidad y Congestión and contact your doctor or seek immediate medical attention. See section 4.

There have been reports of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) after the use of medications containing pseudoephedrine. PRES and RCVS are rare diseases that can involve a reduction in blood flow to the brain. Stop using Iniston Mucosidad y Congestión immediately and seek immediate medical attention if you present symptoms that may be signs of PRES or RCVS (to know the symptoms, consult section 4 "Possible side effects").

With Iniston Mucosidad y Congestión, blood flow to the optic nerve may be reduced. If you suffer a sudden loss of vision, stop taking Iniston Mucosidad y Congestión and contact your doctor or seek immediate medical attention. See section 4.

Children and adolescents

This medication is contraindicated in children under 7 years old.

People over 60 years old may be especially sensitive to the adverse effects of sympathomimetic amines. Overdose of these sympathomimetic amines in patients over 60 years old can cause hallucinations, central nervous system depression, convulsions, and death.

Interference with analytical tests:

If you are going to undergo any diagnostic test (including blood tests, urine tests, skin tests using allergens, etc.), inform your doctor that you are taking/using this medication, as it may alter the results.

Taking Iniston Mucosidad y Congestión with other medications

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

In particular, if you are using any of the following medications, it may be necessary to modify the dose of some of them or interrupt treatment:

• Urinary alkalizers (sodium bicarbonate, citrates) as they may cause pseudoephedrine to be eliminated more slowly and increase its effect and toxicity.
• Inhaled anesthetics as they may increase the risk of heart problems.
• Certain medications to lower blood pressure or to promote urine elimination (such as beta-blockers, ACE inhibitors, rauwolfia alkaloids such as reserpine, methyldopa, guanethidine) as they may decrease the effectiveness of these medications.
• Monoamine oxidase inhibitor (MAOI) medications, including antidepressants such as tranilcipromine, moclobemide, medications for Parkinson's disease such as selegiline, anticancer medications such as procarbazine, or anti-infective medications such as linezolid: as they may increase the effects of pseudoephedrine, causing severe increase in blood pressure, very high fever, and headache. The concomitant administration of these medications should be avoided, even in the 15 days following the end of MAOI treatment.
• Central nervous system stimulants (amphetamines, xanthines) as they may cause nervousness, irritability, insomnia, or possibly convulsions or alteration of heart rhythm (arrhythmias)
• Digitalis glycosides (used for the heart) as they may produce alterations in heart rhythm.
• Thyroid hormones (used for thyroid diseases) as the effects of both hormones and pseudoephedrine may be increased.
• Levodopa (used for Parkinson's disease treatment) as it may increase heart rate (arrhythmias).
• Nitrates (used for angina pectoris treatment) as the effects of nitrates may be reduced.
• Cocaine, which, in addition to stimulating the central nervous system, its use with pseudoephedrine may increase the effects on the heart.
• Other medications belonging to the pseudoephedrine group (sympathomimetic medications), as they may potentiate the effects of pseudoephedrine.

Guaifenesin should not be combined with cough suppressant medications, as it may increase side effects.

Taking Iniston Mucosidad y Congestión with food and beverages

Do not take with bitter orange juice as it may cause a hypertensive crisis.

Pregnancy and lactation

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. The use of medications during pregnancy can be hazardous to the embryo or fetus and should be monitored by your doctor.

This medication is contraindicated in the first trimester of pregnancy.

Pseudoephedrine is excreted in breast milk, so this medication should not be used during the lactation period.

Driving and using machines

If you feel dizzy or vertigo during treatment with this medication, do not drive.

Iniston Mucosidad y Congestión contains sucrose

This medication contains sucrose. If your doctor has told you 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 3g of sucrose per 5ml dose.

Iniston Mucosidad y Congestión contains tartrazine (E-102) and orange yellow S (E-110)

This medication may cause allergic reactions because it contains tartrazine (E-102) and orange yellow S (E-110). It can cause asthma, especially in patients allergic to acetylsalicylic acid.

Iniston Mucosidad y Congestión contains methyl parahydroxybenzoate (E-218) and propyl parahydroxybenzoate (E-216)

It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E-218) and propyl parahydroxybenzoate (E-216).

Athletes are informed that this medication contains a component that can establish a positive analytical result in a doping test.

3. How to take Inistón Mucosidad y Congestión

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and children over 12 years old: 10 ml every 8 hours (2 spoonfuls), 3 times a day.

Children between 7 and 12 years old (approximate weight between 21.5 kg and 43 kg): take 5 ml every 8 hours, 3 times a day.

Children between 2 and 6 years old (approximate weight between 10 kg and 21.5 kg): cannot take this medication, it is contraindicated.

How to take:

This medication is taken orally.

Use the graduated spoon to measure the exact dose. Wash the spoon after each intake.

It is recommended to drink a glass of water after each intake, take the medication with meals, and drink plenty of water during treatment.

Do not take with bitter orange juice as it may cause a hypertensive crisis.

Taking this medication with food or beverages does not affect its efficacy.

If the medication is taken at night, it should be taken a few hours before bedtime to reduce the possibility of insomnia in patients with difficulty sleeping.

You should consult your doctor if it worsens, if symptoms persist for more than 5 days of treatment, or if they are accompanied by high fever.

If you take more Inistón Mucosidad y Congestión than you should

If you take more Inistón Mucosidad y Congestión than you should, you may notice: drowsiness, irritability, restlessness, tremors, palpitations, convulsions, increased blood pressure, difficulty urinating, gastrointestinal upset, nausea, and vomiting, rapid breathing, excitement, nervousness, alteration of heart rhythm (arrhythmias), insomnia, mydriasis, anxiety, agitation, hallucinations, tachycardia, and bradycardia. In more severe cases, it can cause: decreased potassium in the blood (hypokalemia), mental disorder with altered perception of reality (psychosis), convulsions, coma, and hypertensive crises, alterations in heart rate, intracerebral hemorrhage, muscle pain or muscle rupture (rhabdomyolysis), myocardial infarction, and intestinal ischemic infarction.

Somnolence has been described in cases of overdose in children.

In case of overdose or accidental ingestion, go to a medical center or call the Toxicological Information Service (telephone 91.562.04.20), indicating the medication and the amount ingested.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

During the use of this product, the following side effects have been observed, whose frequency cannot be established with precision:

- Severe diseases affecting the blood vessels of the brain, known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS).

Stop using Inistón Mucosidad y Congestión immediately and seek urgent medical attention if you present symptoms that may be signs of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). These include:

• sudden and severe headache
• discomfort
• vomiting
• confusion
• convulsions
• changes in vision

• More frequently: nervousness, restlessness, difficulty sleeping, anxiety, tremors, alteration of taste.
• Less frequently: hyperactivity, hyperexcitability, dizziness and vertigo, headache, uncoordinated movements, dilation of the pupils, rapid heartbeats, high blood pressure. Nausea, vomiting, bloody diarrhea. Dermatitis, urticaria, skin rash. Difficulty urinating. Increased sweating, paleness, and weakness.
• Rarely: hypersensitivity reactions, angioedema (swelling of the face, lips, tongue, and/or throat with difficulty swallowing or breathing), agitation, anxiety, euphoria, hallucinations, nightmares, screaming, and confusion in children. Somnolence, alterations in heart rhythm, and slow heartbeats, abdominal pain, urinary retention, nervous sensation, fatigue, increased blood pressure. In very rare cases, infarction, and at very high doses, convulsions, confusion, and headache.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use. Website: www.notificaRAM.es

5. Conservation of

Keep this medication out of sight and reach of children.

Do not store above 25°C. Keep in the outer packaging to protect from light.

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

Do not use this medication if you observe that the packaging is broken or damaged at the time of purchase.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the Sigre Collection Point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Inistón Mucosidad y Congestión

The active ingredients are pseudoephedrine hydrochloride and guaifenesin: Each ml of syrup contains 6 mg of pseudoephedrine hydrochloride and 20 mg of guaifenesin.

The other components (excipients) are: sucrose, glycerol (E-422), sodium saccharin, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), banana flavoring, tartrazine (E-102), orange yellow S (E-110), and purified water.

Appearance of the product and package contents

Inistón Mucosidad y Congestión is a clear, yellow liquid with a banana flavor.

It is available in a 200 ml amber glass bottle, closed with a white polypropylene cap. It includes a 5 ml graduated spoon.

Marketing authorization holder and manufacturer

Marketing authorization holder:

JNTL Consumer Health (Spain), S.L.

Vía de los Poblados 1, Edificio E, 3rd floor

28033-Madrid

Spain

Manufacturer:

McNeil Iberica S.L.U.

Antigua Citra, N.11,

Km. 32,800,

Alcalá de Henares,

28805 Madrid

Spain

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

JNTL Consumer Health (Spain), S.L.

Vía de los Poblados 1, Edificio E, 3rd floor

28033-Madrid

Spain

Date of the last revision of this package leaflet:May 2024

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