Respidina Expectorante Junior 6 mg/ml + 20 mg/ml oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Respidina expectorant junior 6 mg/ml + 20 mg/ml oral solution

Pseudoephedrine hydrochloride / Guaifenesin

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

Follow exactly the instructions for administration of the medicine contained in this leaflet or those indicated 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 a doctor if your condition worsens or if you do not improve after 5 days.

Leaflet contents

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 adverse effects
5. Storage of Respidina expectorant junior
6. Contents of the pack and other information

1. What Respidina expectorant junior is and what it is used for

Respidina expectorant junior is a combination of pseudoephedrine and guaifenesin. Pseudoephedrine acts as a nasal decongestant, and guaifenesin is an expectorant that helps expel mucus (phlegm).

This medicine 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.

You should consult a doctor if symptoms worsen or do 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, other sympathomimetics, or any of the other ingredients of this medicine (listed in section 6).

• If you have very high blood pressure (severe hypertension) or uncontrolled hypertension due to medication.

• If you have severe coronary artery disease.

• 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 within the last 2 weeks, treatment with monoamine oxidase inhibitors (MAOIs) (see section "Taking Respidina expectorant junior with other medicines").

• Children under 7 years of age.

Warnings and precautions

• If after 5 days of treatment your symptoms have not improved, or if your cough persists or is accompanied by 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.

Consult your doctor or pharmacist before taking Respidina expectorant junior if:

• You suffer from:

• Hyperthyroidism

• Diabetes

• Cardiovascular disease, such as arrhythmias or cardiac ischemia

• Mild or moderate hypertension

• High eye pressure (glaucoma)

• Enlarged prostate in men, difficulty urinating, or urinary obstruction

• Moderate or severe kidney disease or disorder.

• If you have chronic or persistent cough, such as that due to asthma, or when cough is accompanied by abundant mucus production.

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

Sudden abdominal pain or rectal bleeding may occur while taking 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 this medicine simultaneously with cough or nasal congestion medicines. See section "Taking Respidina expectorant junior with other medicines".

Children and adolescents

Due to the amount of pseudoephedrine contained in this medicine, children under 7 years of age must not take it.

Patients over 60 years of age

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

Interference with diagnostic tests

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

Taking Respidina expectorant junior with other medicines

Inform your doctor or pharmacist if you are taking, 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 slow the elimination of pseudoephedrine, 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 like reserpine, methyldopa, guanethidine), as they may reduce the effectiveness of these medicines.
• Monoamine oxidase inhibitor (MAOI) medicines, including antidepressants such as tranylcypromine, moclobemide, or Parkinson's disease medicines such as selegiline: these may enhance the effects of pseudoephedrine, causing severe high 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.
• Anticancer medicines such as procarbazine or anti-infectives 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 seizures or heart rhythm disturbances (arrhythmias).
• Digitalis glycosides (used for heart conditions), as they may cause disturbances in heart rhythm.
• Thyroid hormones (used for thyroid disorders), as the effects of both the hormones and pseudoephedrine may be increased.
• Levodopa (used to treat Parkinson's disease), as it may increase heart rate (arrhythmias).
• Nitrates (used to treat angina pectoris), as their effects may be reduced.
• Other medicines belonging to the same group as pseudoephedrine (sympathomimetic medicines), as they may enhance its effects.

The simultaneous use of cocaine with this medicine may further stimulate the central nervous system and increase effects on the heart and the risk of adverse reactions.

Guaifenesin should not be combined with cough suppressants, as this 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 medicine.

You must not take this medicine during the first trimester of pregnancy, as it is contraindicated.

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

Driving and using machines

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

Respidina expectorant junior contains sucrose

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

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

It may cause dental caries.

Respidina expectorant junior contains sunset yellow (E-110)

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

Respidina expectorant junior contains methylparahydroxybenzoate (E-218) and propylparahydroxybenzoate (E-216)

It may cause allergic reactions (possibly delayed) and, exceptionally, bronchospasm (sudden sensation of suffocation) because it contains methylparahydroxybenzoate (E-218) and propylparahydroxybenzoate (E-216).

Respidina expectorant junior contains sodium

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

Use in athletes

Athletes are advised that this medicine contains a component that may result in a positive analytical doping test.

3. How to take Respidina expectorant junior

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Use in children and adolescents

The recommended dose for children aged between 7 and 12 years (approximate weight between 21.5 kg and 43 kg) is 5 ml every 8 hours (3 times daily).

Children under 7 years of age must not take this medicine; it is contraindicated.

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

This medicine is administered orally using the dosing cup provided. Use the graduated cup to measure the exact dose. Rinse the cup 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 the treatment period.

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 bedtime to reduce the possibility of insomnia in patients who have difficulty sleeping.

If you take more Respidina expectorant junior than you should

Symptoms of pseudoephedrine overdose may include: rapid breathing, excitation, nervousness, irritability, restlessness, tremors, seizures, palpitations, increased blood pressure, changes in heart rhythm (arrhythmias), and difficulty urinating. In more severe cases the following may occur: decreased potassium levels in the blood (hypokalaemia), mental disturbances with altered perception of reality (psychosis, delirium), seizures, coma, and hypertensive crises.

Symptoms of guaifenesin overdose may include nausea and vomiting; kidney stones may appear in cases of abuse of medicines containing guaifenesin.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Serious adverse effects (frequency not known): serious diseases affecting the blood vessels in the brain known as reversible posterior encephalopathy syndrome (RPES) and reversible cerebral vasoconstriction syndrome (RCVS).

Stop using Respidina expectorant junior 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

During the use of this medicine, the following adverse effects have been observed, although their frequency could not be precisely determined:

• More frequently: nervousness, restlessness, difficulty sleeping, anxiety, tremor. Taste disturbances.
• Less frequently: hyperactivity, hyperexcitability, dizziness and vertigo, headache, uncoordinated movements, tremor, somnolence, pupil dilation, rapid heartbeat, elevated blood pressure. Nausea, vomiting, bloody diarrhoea, constipation, gastrointestinal discomfort. Dermatitis, urticaria, skin rash. Difficulty or pain during urination. Increased sweating, pallor, and weakness.
• Rarely: hallucinations, nightmares, screaming, and confusion in children, insomnia. Heart rhythm disturbances and slow heartbeat. In very rare cases, myocardial infarction, and at very high doses, seizures, confusion, and headache. Breathing difficulties, diarrhoea.
• Frequency “Not known”: inflammation of the colon due to insufficient blood supply (ischaemic colitis). Reduced blood flow to the optic nerve (ischaemic optic neuropathy).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, 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: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Respidina expectorant junior

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

Do not store above 30°C.

Discard 12 months after opening.

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

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Respidina expectorant junior

• The active substances 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, methylparahydroxybenzoate (E-218), propylparahydroxybenzoate (E-216), orange yellow S (E-110), quinoline yellow (E-104), banana flavour, sodium saccharin (E-954) and purified water.

Nature of the product and pack contents

Respidina expectorant junior is a yellow, transparent oral solution with a banana flavour.

The medicine is available in:

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

• Amber polyethylene terephthalate (PET) bottles containing 120 ml of oral solution, fitted with a polypropylene cap.

Each pack includes a dosing cup with graduations 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 most recent revision of this leaflet: April 2024

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