Package Insert: Information for the User

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

Pseudoephedrine Hydrochloride / Guaifenesin

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

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

• Keep this package insert, as you may need to refer to 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 not listed in this package insert. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 5 days.

Respidina Expectorante Junioris an association of pseudoephedrine and guaifenesin. Pseudoephedrine acts as a nasal decongestant and guaifenesin is an expectorant that helps in the expulsion of phlegm (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 aged 7 to 12 years.

Consult a doctor if it worsens or does not improve after 5 days.

Do not take Respidina expectorante junior:

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

• If you have severe high blood pressure (hypertension) or uncontrolled hypertension.
• If you have severe coronary artery disease.
• If you have severe, acute (sudden), or chronic 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 section “Taking Respidina expectorante 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 accompanied by fever, rash, or persistent headache, you should stop treatment and consult your doctor.
• If you are to undergo surgery, discontinue treatment at least 24 hours before.

Consult your doctor or pharmacist before starting to take Respidina expectorante junior:

• If you have:

• Hyperthyroidism
• Diabetes
• Cardiovascular disease, such as arrhythmias and angina
• Mild or moderate hypertension
• High intraocular pressure (glaucoma)
• Prostatic hypertrophy 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 excessive mucus production.

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

There have been reported cases of reversible posterior leukoencephalopathy syndrome (RPLS) and reversible cerebral vasoconstriction syndrome (RCVS) after 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 expectorante junior immediately and seek medical attention if you experience symptoms that may be signs of RPLS or RCVS (see section 4 “Possible side effects”).

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

It is recommended not to use at the same time with medications for cough or nasal congestion. See the section “Taking Respidina expectorante 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.

Patients over 60 years old

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

Interference with diagnostic 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 Respidina expectorante junior with other medications

Inform your doctor or pharmacist if you are taking, 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 discontinue 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 medications to lower blood pressure or to promote urine excretion (such as beta-blockers, ACE inhibitors, rauwolfia alkaloids such as reserpine, methyldopa, guanetidine) as it may reduce the effectiveness of these medications.
• Monamine oxidase inhibitors (MAOIs) that include antidepressants such as tranilcipromina, moclobemida, medications for Parkinson's disease such as selegilina: as they may increase the effects of pseudoephedrine, causing severe high blood pressure, high fever, and headache. It is recommended to avoid concurrent administration of these medications and even in the 15 days following the end of treatment with MAOIs.
• Cancer medications such as procarbazina or anti-infectious medications such as linezolida as they may increase the effects of pseudoephedrine.
• Central nervous system stimulants (amphetamine, xanthines) as they may cause nervousness, irritability, insomnia, or possibly seizures or alteration of heart rhythm (arrhythmias).
• Digitalis glycosides (used for the heart) as they may cause 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 heart rate (arrhythmias).
• Nitrates (used for angina) as their effects may be reduced.
• Other medications belonging to the pseudoephedrine group (sympathomimetics), 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 suppressants, as it may increase secondary effects.

Taking Respidina expectorante junior with food and drinks

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

Pregnancy and lactation

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

This medication should not be taken during the first trimester of pregnancy, it is contraindicated.

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

Driving and operating machinery

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

Respidina expectorante junior contains saccharose

This medication contains saccharose. If your doctor has indicated that you have an 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 5 ml.

It may cause tooth decay.

Respidina expectorante junior contains yellow orange (E-110)

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

Respidina expectorante junior contains parahydroxybenzoate of methyl (E-218) and parahydroxybenzoate of propyl (E-216)

It may cause allergic reactions (possibly delayed) and, exceptionally, bronchospasm (sudden sensation of choking) because it contains parahydroxybenzoate of methyl (E-218) and parahydroxybenzoate of propyl (E-216).

Respidina expectorante junior contains sodium

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

Use in athletes

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

Follow exactly the administration instructions of the medication contained in this leaflet or those 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 treatment duration should be as short as possible. The treatment should not continue once the 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 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.

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, arrhythmias, and difficulty urinating. In more severe cases, they may include: decreased potassium levels in the blood (hypokalemia), mental disorder with altered perception of reality (psychosis, delirium), convulsions, coma, and hypertensive crisis.

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

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

Like all medications, this medicationmay cause adverse effects, although not everyone experiences them.

Severe adverse effects (unknown frequency): serious diseases affecting the blood vessels in the brain known as reversible posterior leukoencephalopathy syndrome (RPLS) and reversible cerebral vasoconstriction syndrome (RCVS)

Stop using Respidina Expectorant Junior 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

• discomfort

• vomiting

• confusion

• seizures

• changes in vision

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

• More frequently: nervousness, restlessness, difficulty sleeping, anxiety, tremors. Alteration of taste.
• Less frequently: hyperactivity, hyperexcitability, dizziness and vertigo, headache, uncoordinated movements, tremors, drowsiness, dilated pupils, rapid heart rate, elevated blood pressure. Nausea, vomiting, diarrhea with blood, constipation, gastrointestinal discomfort. Dermatitis, urticaria, skin rash. Difficulty or pain urinating. Increased sweating, pallor and weakness.
• Rarely: hallucinations, nightmares, screaming and confusion in children, insomnia. Alterations in heart rhythm and slow heart rate. In very rare cases, myocardial infarction and, at very high doses, seizures, confusion and headache. Respiratory difficulty, diarrhea.
• Unknown frequency: Inflammation of the colon due to insufficient blood supply (ischemic colitis). Decreased blood flow to the optic nerve (ischemic optic neuropathy).

Reporting Adverse Effects

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

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

Do not store at a temperature above 86°F (30°C).

Discard 12 months after opening.

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.

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition ofRespidina expectorant junior

• The active principles are pseudoephedrine hydrochloride and guaifenesin: Each milliliter 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 B (E-110), quinoline yellow (E-104), banana flavor, sodium saccharin (E-954), and purified water.

Appearance of the product and contents of the packaging

Respidina expectorant junioris a transparent yellow solution with a banana flavor.

The medicine is presented in:

• Amber glass bottle with a metal cap containing 120 ml of oral solution.

• Amber polyethylene terephthalate bottles with a polypropylene cap containing 120 ml of oral solution.

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

Holder of the marketing authorization and responsible for manufacturing

Cinfa Laboratories, S.A.

Olaz-Chipi Road, 10. Areta Industrial Estate

31620 Huarte (Navarra) - Spain

Last review date of this leaflet: April 2024

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