RESPIDINA EXPECTORANT JUNIOR 6 mg/mL + 20 mg/mL ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Respidina Expectorant Junior 6 mg/ml + 20 mg/ml Oral Solution

Pseudoephedrine Hydrochloride / Guaifenesin

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 side effects not listed in this package leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 5 days.

Contents of the Package Leaflet

1. What Respidina Expectorant Junior is and what it is used for
2. What you need to know before taking Respidina Expectorant Junior
3. How to take Respidina Expectorant Junior
4. Possible side effects
5. Storage of Respidina Expectorant Junior
6. Package Contents and Additional Information

1. What Respidina Expectorant Junior is and what it is used for

Respidina Expectorant Junior is an association of pseudoephedrine and guaifenesin. Pseudoephedrine acts as a nasal decongestant and guaifenesin is an expectorant that helps expel mucus.

This medication is used to relieve nasal congestion and to facilitate the expulsion of excess mucus and phlegm in colds and flu in children from 7 to 12 years old.

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

2. What you need to know before taking Respidina Expectorant Junior

Do not take Respidina Expectorant Junior:

• If you are allergic to pseudoephedrine, guaifenesin, or any other component of this medication (listed in section 6).

• If you have very high blood pressure (severe hypertension) or uncontrolled hypertension.
• If you have a severe coronary artery disease.
• 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 monoamine oxidase inhibitors (MAOIs) in the last 2 weeks (see "Taking Respidina Expectorant Junior 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, rash, or 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.

Consult your doctor or pharmacist before starting to take Respidina Expectorant Junior:

• If you have:

• Hyperthyroidism
• Diabetes
• Cardiovascular disease, such as arrhythmias and cardiac ischemia
• Mild or moderate hypertension
• High eye pressure (glaucoma)
• Prostate enlargement in men, difficulty urinating, urinary obstruction
• Moderate or severe kidney disease.

• 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.

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

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

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

It is recommended not to use it at the same time as medications for cough or nasal congestion. See the section "Taking Respidina Expectorant Junior with other medications".

Children and Adolescents

Due to the amount of pseudoephedrine contained in this medication, children under 7 years old should not take it.

Patient Over 60 Years Old

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

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 Respidina Expectorant Junior with Other Medications

Inform your doctor or pharmacist if you are taking, 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 alkalinizers (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 medications (MAOIs) that include antidepressants such as tranylcypromine, moclobemide, medications for Parkinson's disease such as selegiline: as they may increase the effects of pseudoephedrine, causing severe increases 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 treatment with MAOIs.
• Cancer medications such as procarbazine or anti-infective medications such as linezolid as they may increase the effects of pseudoephedrine.
• Central nervous system stimulants (amphetamines, xanthines) as they may cause nervousness, irritability, insomnia, or possibly convulsions or heart rhythm alterations (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.
• Other medications belonging to the pseudoephedrine group (sympathomimetic medications), as they may potentiate the effects of pseudoephedrine.

The simultaneous use of cocaine with this medication, in addition to stimulating the nervous system, may increase the effects on the heart and the risk of adverse effects.

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

Taking Respidina Expectorant Junior 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 plan to become pregnant, consult your doctor or pharmacist before using this medication.

You should not take this medication during the first trimester of pregnancy; it is contraindicated.

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

Driving and Using Machines

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

Respidina Expectorant Junior 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.

It may cause cavities.

Respidina Expectorant Junior Contains Yellow Orange S (E-110)

This medication may cause allergic reactions because it contains Yellow Orange S (E-110). It may provoke asthma, especially in patients allergic to acetylsalicylic acid.

Respidina Expectorant Junior Contains Methyl Parahydroxybenzoate (E-218) and Propyl Parahydroxybenzoate (E-216)

It may cause allergic reactions (possibly delayed) and, exceptionally, bronchospasm (sudden feeling of suffocation) because it contains Methyl Parahydroxybenzoate (E-218) and Propyl Parahydroxybenzoate (E-216).

Respidina Expectorant Junior Contains Sodium

This medication contains less than 23mg of sodium (1mmol) per ml; that is, it is essentially "sodium-free".

Use in Athletes

Athletes are informed that this medication contains a component that may result in a positive analytical test result.

3. How to Take Respidina Expectorant Junior

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.

Use in Children and Adolescents

The recommended dose in children between 7 and 12 years old (approximate weight between 21.5 kg and 43 kg) is 5 ml every 8 hours (3 times a day).

Children under 7 years old should not take this medication; it is contraindicated.

The duration of treatment should be as short as possible. Treatment should not continue once symptoms have disappeared.

This medication is administered orally using the dosing cup included. Use the graduated cup to measure the exact dose. Wash the cup 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.

Taking this medication with food or drinks 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.

If You Take More Respidina Expectorant Junior Than You Should

The symptoms of pseudoephedrine overdose may include: rapid breathing, excitement, nervousness, irritability, restlessness, tremors, convulsions, palpitations, increased blood pressure, alteration of heart rhythm (arrhythmias), and difficulty urinating. In more severe cases, it may cause: decreased potassium in the blood (hypokalemia), mental disorder with altered perception of reality (psychosis, delirium), convulsions, coma, and hypertensive crises.

The symptoms of guaifenesin overdose may include nausea and vomiting, and in cases of abuse of medications with guaifenesin, kidney stones may appear.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

4. Possible Side Effects

Like all medications, this medication may cause side effects, although not everyone may experience them.

Severe side effects (frequency not known): serious diseases affecting the blood vessels of the brain known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS)

Stop using Respidina Expectorant Junior 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 severe headache
• malaise
• vomiting
• confusion
• convulsions
• changes in vision

During the use of this medication, the following side effects have been observed, whose frequency could not be established with precision:

• More frequently: nervousness, restlessness, difficulty sleeping, anxiety, tremor. Alteration of taste.
• Less frequently: hyperactivity, hyperexcitability, dizziness and vertigo, headache, uncoordinated movements, tremor, somnolence, dilation of the pupils, rapid heartbeats, high blood pressure. Nausea, vomiting, bloody diarrhea, gastrointestinal discomfort. Dermatitis, urticaria, skin rash. Difficulty or pain when urinating. Increased sweating, paleness, and weakness.
• Rarely: hallucinations, nightmares, screaming, and confusion in children, insomnia. Alterations in heart rhythm and slow heartbeats. In very rare cases, infarction and, at very high doses, convulsions, confusion, and headache. Respiratory difficulty, diarrhea.
• Frequency "Not known": Inflammation of the colon due to insufficient blood irrigation (ischemic colitis). Decreased blood flow to the optic nerve (ischemic optic neuropathy).

Reporting Side Effects

If you experience any type of side effect, consult your doctor or pharmacist, 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: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Respidina Expectorant Junior

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

Do not store at a temperature above 30°C.

Discard 12 months after opening.

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.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Respidina Expectorant Junior

• The active ingredients are pseudoephedrine hydrochloride and guaifenesin: Each ml of oral solution contains 6 mg of pseudoephedrine hydrochloride and 20 mg of guaifenesin.
• The other components (excipients) are: glycerol (E-422), sucrose, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), Yellow Orange S (E-110), Quinoline Yellow (E-104), banana flavor, sodium saccharin (E-954), and purified water.

Appearance of the Product and Package Contents

Respidina Expectorant Junior is a clear yellow solution with a banana flavor.

The medication is presented in:

• A topaz glass bottle with a contents of 120 ml oral solution, provided with a metal cap.

• Topaz polyethylene terephthalate bottles with a contents of 120 ml oral solution, provided with a polypropylene cap.

Each package is provided with a dosing cup with a graduation ranging from 2.5 ml to 15 ml.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the Last Revision of this Package Leaflet: April 2024

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