Prospecto: Information for the User

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

Guaifenesin/Pseudoephedrine

Read this entire prospect carefully before starting to take this medication, as it contains important information for you.

Follow exactly the medication administration instructions contained in this prospect or those indicated by your doctor or pharmacist.

• Keep this prospect, as you may need to refer to it again.
• If you need advice or more information, consult your pharmacist.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.
• You should consult your doctor if you worsen or do not improve after5 days.

1.What isIniston Mucosidad y Congestiónand for what it is used

2.What you need to know before starting to takeIniston Mucosidad y Congestión

3.How to takeIniston Mucosidad y Congestión

4.Possible adverse effects

5Storage ofIniston Mucosidad y Congestión

6.Contents of the package and additional information

Iniston thins mucus and congestionis an association 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 above to relieve productive cough by reducing mucus and phlegm in colds and flu accompanied by nasal congestion.

• He should consult his doctor if it worsens or does not improve after5 days.

Do not takeIniston mucosidad y congestión

- If you are allergic to the active ingredients, to other sympathomimetics such as antihistamines 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 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 or have been treated with other monoamine oxidase inhibitors (MAOIs) in the last 2 weeks. (See "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 accompanied by fever, rash or persistent headache, you should stop treatment and consult your doctor.
• If you are to undergo surgery, you should stop taking the treatment at least 24 hours before.

• If you have:
• • hyperthyroidism
  • diabetes
  • cardiovascular disease, mild or moderate hypertension
  • high eye pressure (glaucoma)
  • prostate enlargement 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 at the same time with other medications for cough or nasal congestion. See "Taking Iniston mucosidad y congestión with other medications".

Abdominal pain or rectal bleeding may occur due to 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.

Cases of reversible posterior leukoencephalopathy syndrome (RPLS) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported after use of pseudoephedrine-containing medications. PRES and RCVS are rare diseases that may involve a reduction in blood flow to the brain. Stop using Iniston Mucosidad y Congestión immediately and seek immediate medical attention if you experience symptoms that may be signs of RPLS or RCVS (see section 4 "Possible side effects").

Iniston Mucosidad y Congestión may reduce blood flow to the optic nerve. If you experience sudden vision loss, 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 amines in patients over 60 years old may cause hallucinations, depression of the central nervous system, seizures, and death

Interference with laboratory tests:

If you are to undergo any diagnostic test (including blood, urine, 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 taken recently or may need to take any other medication.

Particularly, if you are using any of the following medications, as it may be necessary to modify the dose of some of them or the interruption of treatment:

• Urinary alkalinizers (sodium bicarbonate, citrates) as they may make pseudoephedrine eliminate more slowly and increase its effect and toxicity.
• Inhalation anesthetics as they may increase the risk of heart problems.
• Some blood pressure-lowering medications or diuretics (such as beta-blockers, ACE inhibitors, rauwolfia alkaloids such as reserpine, metildopa, guanetidina) as they may reduce the effectiveness of these medications.
• Monamine oxidase inhibitors (MAOIs) that include antidepressants such as tranilcipromina, moclobemida, Parkinson's disease medications such as selegilina, anticancer medications such as procarbazina, or anti-infectious medications such as linezolida: as they may increase the effects of pseudoephedrine, causing severe high blood pressure, high fever, and headache. It is recommended to avoid the simultaneous administration of these medications, even in the 15 days following the end of treatment with MAOIs.
• Central nervous system stimulants (amphetamine, xanthines) as they may cause nervousness, irritability, insomnia, or possibly seizures or alteration of the 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) as it may increase the heart rate (arrhythmias).
• Nitrates (used for angina pectoris) as their effects may be reduced.
• Cocaine, which in addition to stimulating the central nervous system, its use with pseudoephedrine may increase its effects on the heart.
• Other medications belonging to the group of pseudoephedrine (sympathomimetic medications), as they may potentiate the effects of this medication.

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

Taking Iniston mucosidad y congestión 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, consult your doctor or pharmacist before using this medication. The consumption of medications during pregnancy may be dangerous for 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 breastfeeding.

Driving and operating machinery

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

Iniston mucosidad y congestión contains saccharose

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

Patients with diabetes mellitus should note that this medication contains 3 g of saccharose per dose of 5ml.

Iniston mucosidad y congestión contains tartrazine (E-102) and yellow orange S (E-110)

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

Iniston mucosidad y congestión contains parahydroxybenzoate of methanol (E-218) and parahydroxybenzoate of propyl (E-216)

This medication may cause allergic reactions (possibly delayed) because it contains parahydroxybenzoate of methanol (E-218) and parahydroxybenzoate of propyl (E-216).

It is reported to athletes that this medication contains a component that may establish a positive analytical result as a control.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

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

Children between 7 and 12 years old (approximate weight between21.5 kgand43 kg): take 5 ml every 8 hours, 3 times a day

Children between 2 and 6 years old (approximate weight between10 kgand21.5 kg):This medication cannot be taken by children in this age group, 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 dose.

It is recommended to drink a glass of water after each dose, 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.

The taking of 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 you worsen, if symptoms persist for more than 5 days of treatment, or if they are accompanied by high fever

If you take more Inistón Mucosidad and Congestión than you should

If you take more Inistón Mucosidad and Congestión than you should, you may notice: drowsiness, irritability, restlessness, tremors, palpitations, convulsions, increased blood pressure, difficulty urinating, gastrointestinal discomfort, nausea, and vomiting,rapid breathing, excitement, nervousness, , alteration of heart rhythm (arrhythmias), insomnia, dilated pupils, anxiety, agitation, hallucinations, tachycardia, and bradycardia. In more severe cases, it may cause: decreased potassium in the blood (hypokalemia), mental disorder with altered perception of reality (psychosis), convulsions, coma, and hypertensive crisis, alterations in heart rate, intracerebral hemorrhage, muscle pain or muscle rupture (rhabdomyolysis), myocardial infarction, and ischemic intestinal 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, (phone 91.562.04.20), indicating the medication and the amount ingested.

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

During the period of use of this product, the following adverse effects have been observed, whose frequency has not been established with exactness:

- Serious diseases that affect the blood vessels of the brain known as reversible posterior leukoencephalopathy syndrome (RPLS) and reversible cerebral vasoconstriction syndrome (RCVS).

Stop using Inistón Mucosidad and Congestión immediately and seek urgent medical assistance if you experience symptoms that may be signs of reversible posterior leukoencephalopathy syndrome (RPLS) and reversible cerebral vasoconstriction syndrome (RCVS). These include:

• Sudden onset of severe headache

• Malaise

• Vomiting

• Confusion

• Seizures

• Changes in vision

- More frequently: Nervousness, restlessness, difficulty sleeping, anxiety, tremors, alteration of taste.

- Less frequently: Hyperactivity, hyperexcitability, dizziness and vertigo, headache, uncoordinated movements, dilated pupils, rapid heart rate, elevated blood pressure. Nausea, vomiting, diarrhea with blood. Dermatitis, urticaria, skin rash. Painful urination. Increased sweating, pallor, and weakness.

- In rare cases: 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 alterations, and slow heart rate,abdominal pain, urinary retention, nervous sensation, fatigue, increased blood pressure.In very rare cases, myocardial infarction, and at very high doses, seizures, confusion, and headache.

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 that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use. Website:www.notificaRAM.es

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

Do not store at a temperature above25°C. Store in the outer packaging to protect from light.

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.

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

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the Sigre Point of your 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 Inistón Mucosidad and Congestión

The active principles 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), yellow-orange S (E-110), and purified water.

Appearance of the product and contents of the packaging

Inistón Mucosidad and Congestión is a transparent yellow liquid with a banana flavor.

It is available in an amber glass container of 200 ml, closed with a white polipropylene cap. It includes a 5 ml graduated spoon.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

JNTL Consumer Health (Spain), S.L.

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

28033-Madrid

Spain

Responsible for manufacturing:

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 holder of the marketing authorization:

JNTL Consumer Health (Spain), S.L.

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

28033-Madrid

Spain

Last review date of this leaflet:May 2024

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