Package Insert: Information for the User

Respidina 120 mg Extended-Release Tablets

Pseudoephedrine Hydrochloride

Contents of the package and additional information

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 12 years of age and older.

Consult a doctor if symptoms worsen, or if symptoms persist for more than 5 days.

Do not take Respidina:

• If you are allergic to pseudoephedrine, other nasal decongestants, or any of the other components of this medication (listed in section 6).
• If you have severe high blood pressure (hypertension) or uncontrolled hypertension with your medication.
• If you have a heart disease or vascular disease, or have had a cerebral hemorrhage.
• If you are taking or have taken in the last two weeks monoamine oxidase inhibitors (MAOIs) antidepressants, as it may cause an increase in blood pressure (see section "Taking Respidina with other medications").
• If you have or have had difficulty urinating and/or urinary obstruction.
• If you have severe, acute (sudden), or chronic (long-term) kidney disease, or kidney failure.
• If you have narrow-angle glaucoma (elevated eye pressure).
• If you have hyperthyroidism.
• If you are pregnant or breastfeeding.
• If you are a child under 12 years old.

Warnings and precautions

Abdominal pain or rectal bleeding may occur due to ischemic colitis with the use of Respidina. 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 medications that contain nasal decongestants, do not take this medication.
• Stop treatment at least 24 hours before surgery.
• Stop treatment and consult your doctor if during treatment with this medication you notice or are diagnosed with high blood pressure (hypertension), rapid or strong heartbeats (tachycardia), palpitations, or arrhythmias, nausea, or headache.

Consult your doctor before taking this medication if you have:

• Diabetes
• High blood pressure (hypertension)
• Any heart disease or have had a heart attack
• High eye pressure (ocular hypertension)
• 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 or bladder obstruction
• Over 60 years old
• Had acute asthma attacks (bronchospasm)
• Adrenal gland tumor that affects heart rate and blood pressure (pheochromocytoma)

• The simultaneous use of cocaine with pseudoephedrine may increase cardiovascular effects and the risk of adverse effects.

• Small pellets may appear in the stool, which are remnants of the medication, but this is not harmful and does not affect the efficacy of the medication.
• Patients with gastrointestinal obstruction should not use oral prolonged-release forms without consulting a doctor.
• Warn patients to stop treatment and consult a doctor if they experience persistent abdominal pain or vomiting.
• Pseudoephedrine, the active ingredient in this medication, can cause dependence if taken in large quantities, which can be harmful.
• Avoid consuming alcohol during treatment with this medication.

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

There have been reported cases of reversible posterior encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) after use of pseudoephedrine-containing medications. PRES and RCVS are rare diseases that may involve reduced blood flow to the brain. Stop using Respidina immediately and seek medical attention if you experience symptoms that may be signs of PRES or RCVS (see section 4 "Possible adverse effects").

Children

Children under 12 years old cannot take this medication, it is contraindicated.

Taking Respidina with other medications

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

Particularly inform if you are using any of the following medications, as it may be necessary to modify the dose of one of them or stop treatment with one of them:

• Urinary acidifiers (ammonium chloride).
• 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.
• Antidepressants (tricyclics and MAOIs) as it may cause hypertensive crisis: severe headache, very high fever, and increased blood pressure (See section "Do not take Respidina").
• Central nervous system stimulants (amphetamine, xanthines) as it may cause nervousness, irritability, insomnia, or possibly seizures or arrhythmias.
• Some medications to lower blood pressure or promote urine elimination (such as beta-blockers, ACE inhibitors, rauwolfia alkaloids like reserpine, methyldopa, guanethidine, and reserpine) as it may cause decreased blood pressure and possible hypertensive urgency.
• Oral anticoagulants like acenocoumarol as they may decrease the action of acenocoumarol.
• Dihydroergotamine (ergotamine derivative for headache treatment) as it may cause severe increase in blood pressure.
• Digitalis glycosides (used for the heart) as they may cause arrhythmias.
• Thyroid hormones (used for thyroid diseases) as the effects of both hormones and pseudoephedrine may be increased.
• Levodopa and selegiline (used for Parkinson's disease) as they may cause severe increase in blood pressure, very high fever, and headache.
• Linezolid (used as an antibiotic) as it may cause an increase in blood pressure.
• Nitrates (used for angina pectoris) as their effects may be reduced.
• Procarbazine (used to treat cancer) as it may cause severe increase in blood pressure, very high fever, and headache.

This medication should not be used with other medications to relieve nasal congestion.

Interference with diagnostic tests:

If you are to undergo any diagnostic test (including blood, urine, skin tests that use allergens, etc.) inform your doctor that you are taking this medication, as it may alter the results.

Taking Respidina with food, drinks, and alcohol

This medication can be taken with or without food.

Avoid consuming alcoholic beverages during treatment with this medication.

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

Pregnancy and breastfeeding

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

This medication is contraindicated during pregnancy and lactation.

Athletes

Inform athletes that this medication contains a component that may produce a positive result in doping control tests.

Driving and operating machinery

It is not expected that treatment with this medication, at recommended doses, will cause decreased reaction time or drowsiness, vertigo, or dizziness, but if so, do not drive or operate hazardous machinery.

Respidina contains hydrogenated ricin oil

This medication may cause stomach discomfort and diarrhea due to the presence of hydrogenated ricin oil.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The usual dose is:

• Adults and adolescents 12 years and older: 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.
• People 60 years and older?The dosage should be established by the doctor, as it may be necessary to reduce the usual dose.
• Patients with kidney, liver, or heart disease: may need a lower dose, so it is necessary to consult the doctor.

Use in children

Children under 12 years old cannot take this medication, it is contraindicated.

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

It should be swallowed with some liquid, preferably water.

It can be taken with or without food.

If the medication is administered at night, it should be taken a few hours before going to bed to reduce the possibility of insomnia in patients with difficulty sleeping.

Consult your doctor if it worsens, if symptoms worsen or persistmorethan 5 days of treatment or if accompanied by high fever.

If you take more Respidina than you should

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

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

If you forgot to take Respidina

If you forgot to take Respidina and symptoms continue, do not take a double dose to compensate for the missed dose.

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

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

Severe adverse effects (known 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 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 pseudoephedrine use, the following adverse effects have been observed, whose frequency has not been established with precision:

• Most frequently: nervousness, restlessness, difficulty sleeping, anxiety, tremors. Alteration of taste.
• Less frequently: hyperactivity, hyperexcitability, dizziness, headache, uncoordinated movements, dilated pupils, rapid heart rate, elevated blood pressure. Nausea, vomiting, diarrhea with blood. Dermatitis, urticaria, skin rash. Painful urination. Increased sweating, pallor, and weakness.
• Rarely: nightmares, screaming, and confusion in children. Alterations in heart rhythm and slow heart rate. Difficulty breathing, diarrhea.
• Very rarely: myocardial infarction, and at very high doses, hallucinations, seizures, confusion, and headache.
• Unknown frequency: ischemic colitis due to inadequate 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 not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products 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).

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. Dispose of the packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition ofrespidina

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

Appearance of the product and contents of the packaging

Respidinais presented in the form of prolonged-release coated tablets, white in color, cylindrical and biconvex with the logo “r”.

Each package contains 6 or 14 prolonged-release tablets.

Title of the marketing authorization and responsible manufacturer

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Areta Industrial Estate.

31620 Huarte (Navarra) - Spain

Date of the last review 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