INISTOLIN PEDIATRIC COUGH & CONGESTION 2 mg/ml + 6 mg/ml SYRUP

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Inistolin Pediatric Cough and Congestion 2 mg/ml + 6 mg/ml syrup

Dextromethorphan/Pseudoephedrine

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

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

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

Contents of the package leaflet:

1. What is Inistolin Pediatric Cough and Congestion and what is it used for
2. What you need to know before taking Inistolin Pediatric Cough and Congestion
3. How to take Inistolin Pediatric Cough and Congestion
4. Possible side effects
5. Storage of Inistolin Pediatric Cough and Congestion
6. Contents of the pack and further information

1. What is Inistolin Pediatric Cough and Congestion and what is it used for

Inistolin Pediatric Cough and Congestion is an association of pseudoephedrine and dextromethorphan.

Pseudoephedrine acts as a nasal decongestant and dextromethorphan is a cough suppressant.

Inistolin Pediatric Cough and Congestion is indicated in children from 7 to 12 years old to relieve non-productive coughs (irritative cough, nervous cough) accompanied by nasal congestion associated with common cold and flu.

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

2. What you need to know before taking Inistolin Pediatric Cough and Congestion

Do not take Inistolin Pediatric Cough and Congestion

• If you are allergic to the active substances, to other sympathomimetics such as antihistamine medications or to any of the other components of this medicine (listed in section 6).
• If you are or have been in the last 2 weeks under treatment with:

• Medicines for treating depression such as serotonin reuptake inhibitors.
• Medicines that inhibit monoamine oxidase (MAOIs).
• Bupropion (see section "Taking Inistolin Pediatric Cough and Congestion with other medicines").

• If you have a severe lung disease, asthmatic cough, and cough accompanied by expectoration,
• If you have high blood pressure (hypertension) or severe heart or blood vessel 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.

Children under 7 years old.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Inistolin Pediatric Cough and Congestion:

• If you have chronic or persistent cough, such as that caused by smoking, or when the cough is accompanied by excessive secretion, unless your doctor has indicated it.
• Patients who are sedated, debilitated, or bedridden.
• If you have:
• • hyperthyroidism
  • diabetes
  • cardiovascular disease, hypertension
  • high eye pressure (glaucoma)
  • difficulty urinating, urinary obstruction
  • moderate or severe kidney disease with reduced function
  • liver disease
  • atopic dermatitis.

You must suspend treatment at least 24 hours before surgery.

There have been reports of abuse with medicines containing dextromethorphan in adolescents, which can cause serious side effects (see section "If you take more Inistolin Pediatric Cough and Congestion than you should").

This medicine can cause dependence. Therefore, treatment should be short-term.

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

It is recommended not to use it at the same time with other medicines for nasal congestion. See section "Taking Inistolin Pediatric Cough and Congestion with other medicines".

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

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

Children and adolescents

This medicine is contraindicated in children under 7 years old.

Over 60 years old

People over 60 years old may be especially sensitive to the side effects of sympathomimetic amines. Overdose of these 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 medicine, as it may alter the results.

Taking Inistolin Pediatric Cough and Congestion with other medicines

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

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

• Urinary acidifiers (ammonium chloride).
• 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 medicines for lowering blood pressure or for promoting urine elimination (such as beta-blockers, ACE inhibitors, rauwolfia alkaloids such as reserpine, methyldopa, guanethidine) as they may cause a decrease in blood pressure and possible hypertensive urgency.
• Medicines that inhibit monoamine oxidase (MAOIs) that include 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 increase the effects of pseudoephedrine, causing severe increase in blood pressure, very high fever, and headache. The concomitant administration of these medicines should be avoided, even in the 15 days following the end of treatment with MAOIs.
• Antidepressant serotonin reuptake inhibitors (paroxetine, fluoxetine).
• Tricyclic antidepressants.
• Bupropion (used to quit smoking).
• Central nervous system stimulants (amphetamines, xanthines) as they may cause nervousness, irritability, insomnia, or possibly convulsions or heart rhythm disturbances (arrhythmias).
• Digitalis glycosides (used for the heart) as they may cause heart rhythm disturbances.
• 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 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 the effects on the heart.
• Other medicines belonging to the pseudoephedrine group (sympathomimetic medicines), as they may potentiate its effects.

• Medicines that produce depression of the central nervous system (such as those used for insomnia or anxiety, for Parkinson's disease, for allergy).
• Medicines used for pain and inflammation relief (celecoxib, parecoxib, valdecoxib).
• Medicines used for treating high blood pressure (hypertension), such as propranolol, and heart rhythm disturbances (cardiac arrhythmias), such as amiodarone or quinidine.
• Medicines used to increase mucus secretion.

Do not use with other medicines for nasal congestion.

Consult your doctor or pharmacist before taking Inistolin Pediatric Cough and Congestion:

If you are taking other medicines such as antidepressants or antipsychotics, Inistolin Pediatric Cough and Congestion may interact with these medicines and you may experience changes in your mental state (e.g., agitation, hallucinations, coma) and other effects such as body temperature above 38°C, increased heart rate, high blood pressure, and exaggerated reflexes, muscle stiffness, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, and diarrhea).

Taking Inistolin Pediatric Cough and Congestion with food, drinks, and alcohol

While taking this medicine, you cannot drink alcoholic beverages, as it may increase the appearance of side effects of this medicine.

Do not take the medicine with grapefruit or bitter orange juiceas it may increase the effects of dextromethorphan. Bitter orange juice with pseudoephedrine may cause a hypertensive crisis.

The rest of the food and drinks do not affect the efficacy of the medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. The consumption of medicines during pregnancy can be hazardous to the embryo or fetus and should be monitored by your doctor.

This medicine is contraindicated in the first trimester of pregnancy.

There is not enough information about the use of this medicine during pregnancy, so you should not use this medicine if you are pregnant, unless your doctor indicates otherwise.

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

Driving and using machines

If you feel dizzy or vertigo during treatment with this medicine, do not drive or use hazardous machines.

Inistolin Pediatric Cough and Congestion contains sucrose

This medicine contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine. Patients with diabetes mellitus should be aware that this medicine contains 2.85 g of sucrose per 5 ml dose.

Inistolin Pediatric Cough and Congestion contains sorbitol (E-420)

This medicine contains sorbitol. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Inistolin Pediatric Cough and Congestion contains methyl parahydroxybenzoate (E-218)

This medicine contains methyl parahydroxybenzoate (E-218). It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E-218).

Inistolin Pediatric Cough and Congestion contains Ponceau 4R (E-124)

This medicine may cause allergic reactions because it contains Ponceau 4R (E-124). It can cause asthma, especially in patients allergic to acetylsalicylic acid.

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

3. How to take Inistolin Pediatric Cough and Congestion

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

The recommended dose is:

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 under 7 years old: cannot take this medicine, 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 intake.

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

It is recommended to take this medicine with meals and drink plenty of water during treatment. Do not take it with grapefruit or bitter orange juice or with alcoholic beverages (see section "Taking Inistolin Pediatric Cough and Congestion with food, drinks, and alcohol").

If the medicine 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 the symptoms persist for more than 5 days of treatment, or if they are accompanied by high fever.

If you take more Inistolin Pediatric Cough and Congestion than you should

If you take more Inistolin Pediatric Cough and Congestion than indicated, you may experience the following symptoms: nausea and vomiting, involuntary muscle contractions, agitation, confusion, somnolence, disorders of consciousness, rapid and involuntary eye movements, cardiac disorders (accelerated heart rate), coordination disorders, psychosis with visual hallucinations, and hyperexcitability.

Other symptoms in case of massive overdose may be: coma, severe respiratory problems, and convulsions.

Contact your doctor or hospital immediately if you experience any of the mentioned symptoms.

There have been reports of abuse with medicines containing dextromethorphan in adolescents, which can cause serious side effects, such as tachycardia (accelerated heart rate), lethargy, hypertension or hypotension (high or low blood pressure), mydriasis (pupil dilation), agitation, vertigo, gastrointestinal discomfort, hallucinations, slurred speech, nystagmus (involuntary and uncontrolled eye movement), fever, tachypnea (rapid and shallow breathing), brain damage, ataxia (uncoordinated movements), convulsions, respiratory depression, loss of consciousness, arrhythmias (irregular heartbeats), and death.

In case of overdose or accidental ingestion, consult your doctor or call the Toxicology Information Service (telephone 91.562.04.20), indicating the medicine and the amount ingested.

Severe side effects may occur in children in case of overdose, including neurological disorders. Caregivers should not exceed the recommended dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

-With unknown frequency: severe diseases affecting the blood vessels of the brain known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS).

Stop using Inistolin Pediatric Cough and Congestion immediately and seek urgent medical attention if you experience 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, tremor. Alteration of taste.
• Less frequently: hyperactivity, hyperexcitability, dizziness, and vertigo, headache, uncoordinated movements, pupil dilation, rapid heart rate, high blood pressure. Nausea, vomiting, constipation, diarrhea with blood. Dermatitis, urticaria, skin rash. Difficulty urinating. Increased sweating, paleness, and weakness.
• Rarely: hypersensitivity reactions, hallucinations, nightmares, screaming, and confusion in children. Heart rhythm disturbances and slow heart rate. In very rare cases, infarction, and at very high doses, convulsions, mental confusion, and headache. Skin rashes and angioedema (swelling of certain areas of the skin), pruritus, urticaria, rash have also been described.
• With unknown frequency: colon inflammation due to insufficient blood irrigation (ischemic colitis) and decreased blood flow to the optic nerve (ischemic optic neuropathy).

Reporting of side effects

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

5. Storage of Inistolin Pediatric Cough and Congestion

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 expiration date that appears on the packaging after CAD. The expiration date is 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 should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines at the Sigre Point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Inistolin Pediatric Cough and Congestion

The active ingredients are pseudoephedrine hydrochloride and dextromethorphan hydrobromide: Each ml of syrup contains 6 mg of pseudoephedrine hydrochloride and 2 mg of dextromethorphan hydrobromide.

The other components (excipients) are: sucrose, sorbitol (E-420), sodium saccharin, sodium benzoate (E-211), methyl parahydroxybenzoate (E-218), strawberry flavoring, red ponceau 4R (E-124), and purified water.

Appearance of the Product and Package Contents

Inistolin Pediatric Cough and Congestion is a transparent red liquid with a characteristic strawberry flavor.

It is available in a 120 ml and 200 ml amber glass bottle closed with an aluminum capsule with a silver interior coating. 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:

Laboratorios Alcalá Farma, S.L.

Avenida de Madrid, 82

Alcalá de Henares,

28802 (Madrid)

Spain

Date of the Last Revision of this Leaflet:May 2024

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