RESPIDINA 120 mg PROLONGED-RELEASE TABLETS

Introduction

Leaflet: information for the user

Respidina 120 mg prolonged-release tablets

Pseudoephedrine hydrochloride

Contents of the leaflet

1. What Respidina is and what it is used for
2. What you need to know before taking Respidina
3. How to take Respidina
4. Possible side effects
5. Storage of Respidina

Contents of the pack and additional information

1. What Respidina is and what it is used for

Pseudoephedrine acts as a nasal decongestant.

It is indicated for the local and temporary relief of nasal congestion associated with rhinitis, common cold, and flu in adults and adolescents from 12 years of age.

You should consult a doctor if your symptoms worsen or if they persist for more than 5 days.

2. What you need to know before taking Respidina

Do not take Respidina:

• If you are allergic to pseudoephedrine, other nasal decongestants, or any of the other components of this medicine (listed in section 6).
• If you have very high blood pressure (severe hypertension) or uncontrolled hypertension.
• If you have heart or blood vessel disease, or have had a cerebral hemorrhage.
• If you are taking or have taken in the last two weeks monoamine oxidase inhibitor (MAOI) antidepressants, as this can cause a rise in blood pressure (see section "Taking Respidina with other medicines").
• If you have difficulty urinating or urinary obstruction.
• If you have severe kidney disease, acute (sudden) or chronic (long-term), or kidney failure.
• If you have narrow-angle glaucoma (high eye pressure).
• If you have hyperthyroidism.
• If you are pregnant or breastfeeding.
• If you are under 12 years old.

Warnings and precautions

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

Consult your doctor or pharmacist before starting to take Respidina.

• If you are taking other medicines that contain nasal decongestants, you should not take this medicine.
• You should stop treatment at least 24 hours before surgery.
• You should interrupt treatment and consult your doctor if, during treatment with this medicine, you notice or are diagnosed with high blood pressure, rapid or strong heartbeats, palpitations, or heart rhythm disorders, nausea, or headache.

You should consult your doctor before taking this medicine if you have:

• diabetes
• high blood pressure
• heart disease or have had a heart attack
• high eye pressure
• epilepsy or risk of seizures
• severe liver disease with reduced function
• difficulty urinating, urinary obstruction
• enlarged prostate (prostatic hypertrophy)
• moderate or severe kidney disease with reduced function
• stomach ulcer or intestinal obstruction or bladder
• over 60 years old
• have had acute asthma attacks (bronchospasm)
• adrenal gland tumor producing hormones that affect heart rate and blood pressure (pheochromocytoma)

• The simultaneous use of cocaine with pseudoephedrine can increase cardiovascular effects and the risk of side effects.

• Small balls may appear in the stool that are remnants of the medicine, but this is not harmful and does not affect the efficacy of the medicine.
• Patients with gastrointestinal obstruction should not use oral prolonged-release forms without consulting a doctor.
• Patients should be warned to interrupt treatment and consult a doctor in case of persistent abdominal pain or vomiting.
• Pseudoephedrine, the active ingredient of this medicine, can be habit-forming if taken in large quantities.
• You should avoid consuming alcohol during treatment with this medicine.

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

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 may involve reduced blood flow to the brain. Stop using Respidina immediately and seek immediate medical attention if you experience symptoms that may be signs of PRES or RCVS (for symptoms, see section 4 "Possible side effects").

Children

Children under 12 years old should not take this medicine, it is contraindicated.

Taking Respidina with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

In particular, inform them if you are using any of the following medicines, as it may be necessary to modify the dose of one 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.
• Antidepressants (tricyclic and monoamine oxidase inhibitors) as they may cause a hypertensive crisis: headache, very high fever, and increased blood pressure (see section "Do not take Respidina").
• Nervous system stimulants (amphetamines, xanthines) as they may cause nervousness, irritability, insomnia, or possibly convulsions or heart rhythm disorders (arrhythmias).
• Certain medicines to lower blood pressure or to promote urine elimination (such as beta-blockers, ACE inhibitors, rauwolfia alkaloids like reserpine, methyldopa, guanethidine, and reserpine) as they may cause a decrease in blood pressure and possible hypertensive emergency.
• Oral anticoagulants such as acenocoumarol as they may decrease the action of acenocoumarol.
• Dihydroergotamine (ergotamine derivative for headache treatment) as it may cause a severe increase in blood pressure.
• Digitalis glycosides (used for heart conditions) as they may cause heart rhythm disorders.
• Thyroid hormones (used for thyroid diseases) as the effects of both hormones and pseudoephedrine may be increased.
• Levodopa and selegiline (used for Parkinson's treatment) as they may cause a severe increase in blood pressure, very high fever, and headache.
• Linezolid (used as an antibacterial) as it may cause an increase in blood pressure.
• Nitrates (used for angina pectoris treatment) as the effects of nitrates may be reduced.
• Procarbazine (used to treat cancer) as it may cause a severe increase in blood pressure, very high fever, and headache.

Do not use with other medicines to relieve nasal congestion.

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 this medicine, as it may alter the results.

Taking Respidina with food, drinks, and alcohol

This medicine can be taken with or without food.

Alcohol consumption should be avoided during treatment with this medicine.

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.

This medicine is contraindicated during pregnancy and breastfeeding.

Athletes

Athletes are informed that this medicine contains a component that may produce a positive result in doping tests.

Driving and using machines

It is not expected that treatment with this medicine at the recommended doses will cause a decrease in reaction capacity or drowsiness, dizziness, or vertigo, but if so, do not drive or operate hazardous machinery.

Respidina contains hydrogenated castor oil

This medicine may cause stomach upset and diarrhea because it contains hydrogenated castor oil.

3. How to take Respidina

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

The usual dose is:

• Adults and adolescents from 12 years of age: 1 tablet (120 mg of pseudoephedrine) every 12 hours. The maximum daily dose is 2 tablets (240 mg of pseudoephedrine). Do not take more than 2 tablets of pseudoephedrine (240 mg) within 24 hours.
• Over 60 years old: the dosage should be established by the doctor, as it may be necessary to reduce the usual dose.
• Patient with kidney, liver, or heart disease: may need a lower dose, so it is necessary to consult a doctor.

Use in children

Children under 12 years old should not take this medicine, it is contraindicated.

Respidinais administered orally. The tablet should be taken whole, not divided, chewed, or dissolved.

It should be swallowed with some liquid, preferably water.

It can be taken with or without food.

If the medicine is administered at night, it should be taken a few hours before bedtime to reduce the possibility of insomnia in patients with sleep difficulties.

You should consult your doctor if your symptoms worsen or if they persist for more than 5 days of treatment or if they are accompanied by high fever.

If you take more Respidina than you should

If you take more Respidinathan you should, you may notice: rapid breathing, excitement, nervousness, irritability, restlessness, tremors, convulsions, palpitations, increased blood pressure, heart rhythm disorders (arrhythmias), difficulty urinating. In more severe cases, it can cause: decreased potassium in the blood (hypokalemia), mental disorder with altered perception of reality (psychosis), convulsions, coma, and hypertensive crises.

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

If you forget to take Respidina

If you forget to take Respidina and your symptoms continue, do not take a double dose to make up for the forgotten dose.

If necessary, take it again as indicated in section 3. How to take Respidina.

4. Possible side effects

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

Severe side effects (known frequency): serious diseases that affect the blood vessels of the brain, known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS).

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

During the use of pseudoephedrine, the following side effects have been observed, whose frequency cannot be established with certainty:

• Very common: nervousness, restlessness, difficulty sleeping, anxiety, tremor. Taste alteration.
• Common: hyperactivity, hyperexcitability, dizziness, headache, uncoordinated movements, dilated pupils, rapid heartbeats, high blood pressure. Nausea, vomiting, bloody diarrhea. Dermatitis, urticaria, skin rash. Difficulty urinating. Increased sweating, paleness, and weakness.
• Uncommon: nightmares, screaming, and confusion in children. Heart rhythm disorders and slow heartbeats. Breathing difficulties, diarrhea.
• Rare: heart attack, and at very high doses, hallucinations, convulsions, confusion, and headache.
• Frequency not known: colon inflammation due to insufficient blood supply (ischemic colitis). Decreased blood flow to the optic nerve (ischemic optic neuropathy).

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Respidina

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

Do not store above 30°C.

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

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Contents of the pack and additional information

Composition ofRespidina

• The active ingredient is pseudoephedrine. Each prolonged-release tablet contains 120 milligrams of pseudoephedrine (as hydrochloride).
• The other ingredients are: microcrystalline cellulose, hypromellose, anhydrous colloidal silica, hydrogenated castor oil, magnesium carbonate, pregelatinized corn starch, magnesium stearate, carbomers, opadry Y-1-7000 (hypromellose, titanium dioxide (E-171), and macrogol 400).

Appearance of the product and packaging contents

Respidinais presented in the form of white, cylindrical, and biconvex prolonged-release tablets with the logo "r".

Each pack contains 6 or 14 prolonged-release tablets.

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 leaflet:April 2024

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