Iniston Mucosidad y Congestion 20 mg/ml + 6 mg/ml syrup

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Iniston mucus and congestion 20 mg/ml + 6 mg/ml syrup

Guaifenesin/Pseudoephedrine

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

Always follow exactly the instructions for use of this medicine as described in this leaflet or as directed 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 adverse effects not listed in this leaflet. See section 4.
• You should consult your doctor if you worsen or do not improve after 5 days.

Contents of the leaflet:

1. What Iniston mucus and congestion is and what it is used for
2. What you need to know before taking Iniston mucus and congestion
3. How to take Iniston mucus and congestion
4. Possible side effects
5. Storage of Iniston mucus and congestion
6. Contents of the pack and other information

1. What it is and what it is used for

Iniston Mucus and Congestion is a combination of pseudoephedrine and guaifenesin.

Pseudoephedrine acts as a nasal decongestant, and guaifenesin is an expectorant that relieves productive cough by reducing phlegm (mucus) and facilitating its expulsion.

It is indicated in adults and children aged 7 years and older to relieve productive cough, reduce mucus and phlegm, and treat colds and flu accompanied by nasal congestion.

• You should consult your doctor if symptoms worsen or do not improve after 5 days.

2. What you need to know before starting Iniston Mucus and Congestion

Do not take Iniston Mucus and Congestion

• If you are allergic to the active substances, to other sympathomimetics, to antihistamine medicines, or to any of the other ingredients of this medicine (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 not managed by your medication.
• If you have severe acute (sudden) or chronic (long-term) kidney disease, or kidney failure.
• If you are in the first trimester of pregnancy.
• If you are currently receiving or have received treatment with monoamine oxidase inhibitors (MAOIs) within the last 2 weeks. (See section "Taking Iniston Mucus and Congestion with other medicines.")

Children under 7 years of age.

Warnings and precautions

• If after 5 days of treatment your symptoms do not improve, or if you develop cough, fever, rash, or persistent headache, you should stop treatment and consult your doctor.
• If you are scheduled for surgery, you must discontinue treatment at least 24 hours beforehand.

• If you suffer from:
• • hyperthyroidism
  • diabetes
  • cardiovascular disease, mild or moderate hypertension
  • high intraocular pressure (glaucoma)
  • prostate enlargement in men, difficulty urinating, urinary obstruction
  • moderate or severe kidney disease with reduced function
  • chronic or persistent cough, such as that due to asthma, or when cough is accompanied by excessive phlegm production

It is recommended not to use this medicine simultaneously with other cough or nasal decongestant medicines. See “Taking Iniston Mucus and Congestion with other medicines”.

Sudden abdominal pain or rectal bleeding may occur when taking Iniston Mucus and Congestion due to inflammation of the colon (ischemic colitis). If these gastrointestinal symptoms occur, stop taking Iniston Mucus and Congestion and contact your doctor or seek immediate medical attention. See section 4.

Cases of reversible posterior encephalopathy syndrome (RPES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported following the use of medicines containing pseudoephedrine. RPES and RCVS are rare conditions that may involve reduced blood flow to the brain. Stop using Iniston Mucus and Congestion immediately and seek immediate medical assistance if you experience symptoms that could be signs of RPES or RCVS (for symptoms, see section 4 "Possible side effects").

With Iniston Mucus and Congestion, blood flow to the optic nerve may be reduced. If you experience sudden vision loss, stop taking Iniston Mucus and Congestion and contact your doctor or seek immediate medical attention. See section 4.

Children and adolescents

This medicine is contraindicated in children under 7 years of age.

Patients over 60 years of age may be especially sensitive to the adverse effects of sympathomimetic amines. Overdose of such sympathomimetic amines in patients over 60 years of age may cause hallucinations, central nervous system (CNS) depression, seizures, and death.

Interference with diagnostic tests:

If you are due to have any diagnostic tests (including blood and urine tests, skin tests using allergens, etc.), inform your doctor that you are taking/using this medicine, as it may alter test results.

Taking Iniston Mucus and Congestion with other medicines

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

In particular, if you are using any of the following medicines, dosage adjustment or discontinuation of treatment may be necessary:

• Urinary alkalinizing agents (sodium bicarbonate, citrates), as they may cause pseudoephedrine to be eliminated more slowly, increasing its effect and toxicity.
• Inhalational anesthetics, as they may increase the risk of heart problems.
• Certain antihypertensive medicines or diuretics (such as beta-blockers, ACE inhibitors, rauwolfia alkaloids such as reserpine, methyldopa, guanethidine), as they may reduce the effectiveness of these medicines.
• Monoamine oxidase inhibitors (MAOIs), including antidepressants such as tranylcypromine, moclobemide; medicines for Parkinson's disease such as selegiline; anticancer medicines such as procarbazine; or anti-infectives such as linezolid: as they may enhance the effects of pseudoephedrine, causing severe increase in blood pressure, very high fever, and headache. Concomitant administration of these medicines should be avoided, as well as within 15 days after stopping MAOI treatment.
• Central nervous system stimulants (amphetamines, xanthines), as they may cause nervousness, irritability, insomnia, or possibly seizures or disturbances in heart rhythm (arrhythmias).
• Digitalis glycosides (used for heart conditions), as they may cause disturbances in cardiac rhythm.
• Thyroid hormones (used for thyroid disorders), as the effects of both the hormones and pseudoephedrine may be increased.
• Levodopa (used for the treatment of Parkinson's disease), as it may increase heart rate (arrhythmias).
• Nitrates (used for the treatment of angina pectoris), as the effects of nitrates may be reduced.
• Cocaine, which, in addition to stimulating the central nervous system, when used together with pseudoephedrine may increase effects on the heart.
• Other medicines belonging to the pseudoephedrine group (sympathomimetic medicines), as they may enhance its effects.

Guaifenesin should not be combined with cough suppressants, as this may increase side effects.

Taking Iniston Mucus and Congestion with food and drinks

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

Pregnancy and breastfeeding

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. Taking medicines during pregnancy may be dangerous for the embryo or fetus and should be monitored by your doctor.

This medicine is contraindicated during the first trimester of pregnancy.

Pseudoephedrine is excreted in breast milk; therefore, this medicine should not be used during breastfeeding.

Driving and use of machines

If you experience dizziness or vertigo during treatment with this medicine, you should not drive.

Iniston Mucus and Congestion contains sucrose

This medicine contains sucrose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

Patients with diabetes mellitus should be aware that this medicine contains 3 g of sucrose per 5 ml dose.

Iniston Mucus and Congestion contains tartrazine (E-102) and sunset yellow FCF (E-110)

This medicine may cause allergic reactions as it contains tartrazine (E-102) and sunset yellow FCF (E-110). It may provoke asthma, especially in patients allergic to acetylsalicylic acid.

Iniston Mucus and Congestion contains methyl parahydroxybenzoate (E-218) and propyl parahydroxybenzoate (E-216)

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

Athletes are advised that this medicine contains a component that may lead to a positive analytical finding in doping controls.

3. How to take Inistón Mucus and Congestion

Follow exactly the dosing instructions provided in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Recommended dose:

Adults and children over 12 years: 10 ml every 8 hours (2 teaspoonfuls), 3 times daily.

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

Children between 2 and 6 years (approximate weight between 10 kg and 21.5 kg): this medicine must not be used, it is contraindicated.

How to take:

This medicine is taken orally.

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

It is recommended to drink a glass of water after each dose, take the medicine with meals, and drink plenty of fluids throughout treatment.

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

Taking this medicine with food or drinks does not affect its efficacy.

If the medicine is taken at night, it should be taken a few hours before going to bed to reduce the possibility of insomnia in patients who have difficulty sleeping.

Consult your doctor if your condition worsens, if symptoms persist for more than 5 days of treatment, or if they are accompanied by high fever.

If you take more Inistón Mucus and Congestion than you should

If you take more Inistón Mucus and Congestion than recommended, you may experience: drowsiness, irritability, restlessness, tremor, palpitations, seizures, increased blood pressure, difficulty urinating, gastrointestinal discomfort, nausea and vomiting, rapid breathing, excitement, nervousness, heart rhythm disturbances (arrhythmias), insomnia, mydriasis, anxiety, agitation, hallucinations, tachycardia, and reflex bradycardia. In more severe cases, the following may occur: decreased potassium levels in the blood (hypokalemia), mental disorder with altered perception of reality (psychosis), seizures, coma, hypertensive crises, disturbances in heart rate, intracerebral hemorrhage, muscle pain or muscle breakdown (rhabdomyolysis), myocardial infarction, and ischemic intestinal infarction.

Drowsiness has been reported in cases of overdose in children.

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service (telephone 91.562.04.20), stating the name of the medicine and the amount ingested.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

The following adverse effects have been observed during the period of use of this product, although their frequency cannot be precisely determined:

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

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

• sudden, severe headache

• malaise

• vomiting

• confusion

• seizures

• changes in vision

• More frequently: nervousness, restlessness, difficulty sleeping, anxiety, tremor, taste disturbances.

• Less frequently: hyperactivity, hyperexcitability, dizziness and vertigo, headache, uncoordinated movements, pupil dilation, rapid heartbeat, elevated blood pressure. Nausea, vomiting, bloody diarrhea. Dermatitis, urticaria, skin rash. Painful urination. Increased sweating, pallor, 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. Drowsiness, heart rhythm disturbances and slow heartbeat, abdominal pain, urinary retention, nervous sensation, fatigue, increased blood pressure. In very rare cases, myocardial infarction; at very high doses, seizures, confusion, and headache.

Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines. Website: www.notificaRAM.es

5. Storage

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

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

Do not use this medicine after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the Sigre Collection Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Inistón Mucosidad y Congestión

The active substances 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 flavouring, tartrazine (E-102), orange yellow S (E-110) and purified water.

Appearance of the product and contents of the container

Inistón Mucosidad y Congestión is a yellow, transparent liquid with a banana flavour.

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

JNTL Consumer Health (Spain), S.L.

C/ Vía de los Poblados 1, Edificio E, planta 3

28033-Madrid

Spain

Manufacturer:

McNeil Iberica S.L.U.

Antigua Citra. N.11,

Km. 32,800,

Alcalá de Henares,

28805 Madrid

Spain

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

JNTL Consumer Health (Spain), S.L.

C/ Vía de los Poblados 1, Edificio E, planta 3

28033-Madrid

Spain

Date of the most recent review of this leaflet: May 2024

Detailed and up-to-date 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/.