Iniston Tos y Congestion jarabe

Patient Information Leaflet

Introduction

Patient Information Leaflet

Iniston Cough and Congestion Syrup

Triprolidine/Pseudoephedrine/Dextromethorphan

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

Always follow exactly the instructions for use provided in this leaflet or as directed 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 effects not listed in this leaflet. See section 4.
• You should consult your doctor if you worsen or do not improve after 5 days.

Leaflet contents:

1. What Iniston Cough and Congestion is and what it is used for
2. What you need to know before taking Iniston Cough and Congestion
3. How to take Iniston Cough and Congestion
4. Possible adverse effects
5. How to store Iniston Cough and Congestion
6. Package contents and additional information

1. What Iniston Cough and Congestion is and what it is used for

Iniston Cough and Congestion is a combination of pseudoephedrine, dextromethorphan, and triprolidine.

Pseudoephedrine acts as a nasal decongestant, dextromethorphan is a cough suppressant for relief of dry cough (irritating cough, nervous cough), and triprolidine helps relieve nasal discharge.

It is indicated for the symptomatic relief of dry cough (irritating cough, nervous cough) accompanied by nasal congestion and nasal discharge associated with the common cold and influenza in adults and children aged 6 years and older.

You should consult your doctor if symptoms worsen or do not improve after 5 days.

2. What you need to know before taking Iniston Cough and Congestion

Do not take Iniston Cough and Congestion

• If you are allergic to the active substances, to other sympathomimetics, to antihistamine medicines, or to any of the other components of this medicine (listed in section 6).
• If you have asthmatic cough.
• If you have a cough accompanied by abundant secretions.
• If you have a severe lung disease.
• If you have severe hypertension (high blood pressure) or severe coronary artery disease.
• If you have very high blood pressure (severe hypertension) or uncontrolled hypertension despite medication.
• 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 or have been treated in the last 2 weeks with other medicines such as monoamine oxidase inhibitors (MAOIs) (used to treat depression, Parkinson's disease, or other conditions) (see section "Taking Iniston Cough and Congestion with other medicines"), as this may cause an increase in blood pressure and/or hypertensive crisis.
• If you have an inflammatory bowel disease causing frequent diarrhea (ulcerative colitis).
• If you have glaucoma (increased eye pressure).
• If you have hyperthyroidism.
• Children under 6 years of age.

Warnings and precautions

• If your symptoms do not improve after 5 days of treatment, or if you develop cough accompanied by fever, rash, or persistent headache, stop treatment and consult your doctor.
• If you are scheduled for surgery, discontinue treatment at least 24 hours beforehand.
• Cases of reversible posterior encephalopathy syndrome (RPES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported following the use of medicines containing pseudoephedrine. RPES and RCVS are rare conditions that may involve reduced blood flow to the brain. Stop using Iniston Cough and Congestion immediately and seek urgent medical attention if you experience symptoms that could indicate RPES or RCVS (see section 4 "Possible side effects" for symptoms).

Consult your doctor or pharmacist before taking Iniston Cough and Congestion:

• If small pustules appear, mainly non-follicular, which may or may not be accompanied by fever and disseminated edematous erythema, primarily located in skin folds, trunk, and upper limbs, especially within the first 2 days of treatment. You may be experiencing acute generalized exanthematous pustulosis, which requires medical monitoring.

• If you suddenly develop abdominal pain, rectal bleeding, or other symptoms suggestive of ischemic colitis. Treatment must be stopped and a doctor consulted.

• If you have been identified as a poor CYP2D6 metabolizer or are taking other medications.

• If you have:

  • Atopic dermatitis (inflammatory skin disease)
  • Diabetes
  • Cardiovascular disease, particularly those with coronary heart disease or mild to moderate hypertension
  • A predisposition to glaucoma (elevated eye pressure)
  • Enlarged prostate in men and/or difficulty urinating
  • Moderate or severe kidney disease with reduced function
  • Liver disease or disorder with reduced function
  • Stenosing peptic ulcer (digestive ulcer) or pyloroduodenal ulcer (between stomach and intestine)
  • Patients who are sedated, debilitated, or bedridden

If you have chronic or persistent cough, such as that caused by smoking or asthma, as it may impair expectoration and increase airway resistance, or when cough is accompanied by excessive mucus production.

Patients with persistent respiratory conditions such as emphysema, chronic bronchitis, bronchial asthma, or cough with excessive secretions should consult a doctor before using this product.

Cases of dextromethorphan abuse have been reported; therefore, this possibility should be considered, and the medicine should be administered under strict medical supervision and for short durations in individuals with a tendency to abuse or dependence, especially adolescents, due to the risk of serious adverse effects (see subsection "If you take more Iniston Cough and Congestion than you should").

This medicine may cause dependence. Therefore, treatment should be short-term.

It is recommended not to use other cough or nasal decongestant medicines simultaneously. See "Taking Iniston Cough and Congestion with other medicines".

Sudden abdominal pain or rectal bleeding may occur with the use of Iniston Cough and Congestion due to inflammation of the colon (ischemic colitis). If these gastrointestinal symptoms occur, stop taking Iniston Cough and Congestion and contact your doctor or seek immediate medical attention. See section 4.

Children and adolescents

This medicine is contraindicated in children under 6 years of age.

Patients over 60 years of age

Patients over 60 years may be especially sensitive to the adverse effects of this medicine because it contains pseudoephedrine. Overdose of pseudoephedrine may cause hallucinations, central nervous system (CNS) depression, seizures, and death.

Interference with diagnostic tests:

If you are scheduled for 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 Iniston Cough and Congestion 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 adjustments or discontinuation of treatment may be necessary:

• Amiodarone or quinidine (for treating heart arrhythmias)
• Anti-inflammatory drugs (celecoxib, parecoxib, or valdecoxib)
• Bupropion (used to stop smoking)
• Expectorants or mucolytics (medicines used to reduce mucus thickness or facilitate mucus clearance)
• Haloperidol (used to treat psychotic disorders)
• Serotonin reuptake inhibitors (medicines used to treat depression such as paroxetine, fluoxetine)
• Urinary alkalinizing agents (sodium bicarbonate, citrates), which may slow the elimination of pseudoephedrine, increasing its effect and toxicity.
• Inhaled anesthetics, as they may increase the risk of heart problems.
• Certain blood pressure-lowering or diuretic medicines (such as beta-blockers, ACE inhibitors, Rauwolfia alkaloids like reserpine, methyldopa, guanethidine), as they may reduce the effectiveness of these medicines.
• Monoamine oxidase inhibitors (MAOIs), including antidepressants such as tranylcypromine, moclobemide, Parkinson’s disease medicines like selegiline, anticancer drugs like procarbazine, or antimicrobials like linezolid: these may enhance the effects of pseudoephedrine, causing severe increases in 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.
• 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), which may cause disturbances in heart rhythm.
• Thyroid hormones (used for thyroid disorders), as the effects of both the hormones and pseudoephedrine may be enhanced.
• Levodopa (used to treat Parkinson’s disease), as it may increase heart rate (arrhythmias).
• Nitrates (used to treat angina), as their effects may be reduced.
• Cocaine, which, in addition to stimulating the central nervous system, may increase adverse cardiac effects when used with pseudoephedrine.
• Other medicines belonging to the pseudoephedrine group (sympathomimetic medicines), as they may enhance its effects.
• Alcohol or medicines that cause central nervous system depression (e.g., tricyclic antidepressants, barbiturates, anesthetics, procarbazine, etc.), as their depressant effects or those of antihistamines such as triprolidine may be enhanced, potentially causing overdose symptoms.
• Tricyclic antidepressants or maprotiline (tetracyclic antidepressant), or other medicines with anticholinergic action (such as belladonna or belladonna alkaloids): anticholinergic effects of these medicines or antihistamines like triprolidine may be enhanced. If gastrointestinal problems occur, patients should be advised to inform their doctor immediately, as paralytic ileus may develop.
• Phenytoin and fosphenytoin: increased risk of phenytoin toxicity (ataxia, hyperreflexia, nystagmus, tremor).
• Ototoxic medicines: symptoms of ototoxicity such as tinnitus, dizziness, and vertigo may be masked.
• Photosensitizing medicines: photosensitizing effects may be increased.
• Metoprolol, used to treat cardiovascular conditions.
• Isavuconazole, used to treat invasive aspergillosis and mucormycosis.

Consult your doctor or pharmacist before taking Iniston Cough and Congestion.

If you are taking other medicines such as antidepressants or antipsychotics, Iniston Cough and Congestion may interact with them, and you may experience changes in your mental state (e.g., agitation, hallucinations, coma) and other effects such as body temperature above 38°C, increased heart rate, high blood pressure, exaggerated reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).

Taking Iniston Cough and Congestion with food and drinks

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

Do not consume alcoholic beverages during treatment with this medicine, as it may cause drowsiness and increase adverse effects.

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. Taking medicines during pregnancy may be harmful to the embryo or fetus and should be supervised by your doctor.

This medicine is contraindicated during the first trimester of pregnancy.

This medicine is excreted in breast milk and therefore should not be used during breastfeeding.

Driving and using machines

Exercise caution if driving or operating machinery.

Iniston Cough and Congestion contains sucrose

This medicine contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Patients with diabetes mellitus should be aware that this medicine contains 5.7 g of sucrose per 10 ml dose. It may cause dental caries.

Iniston Cough and Congestion contains ethanol

This medicine contains approximately 0.431 g of alcohol (ethanol) per 10 ml, equivalent to 43.1 mg/ml. The amount of alcohol in each 10 ml dose is equivalent to 11 ml of beer or 4 ml of wine. The alcohol content in this medicine will not cause any effect in adults and adolescents, and its effects in children will not be significant. However, this medicine may have some effects in younger children, such as drowsiness. The alcohol in this medicine may alter the effect of other concomitantly taken medicines. If you are taking other medicines, consult your doctor or pharmacist. If you are pregnant or breastfeeding, speak with your doctor or pharmacist before taking this medicine. If you are alcohol-dependent, speak with your doctor or pharmacist before taking this medicine.

Iniston Cough and Congestion contains carmine red A (E-124)

This medicine may cause allergic reactions because it contains carmine red A (E-124). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

Iniston Cough and Congestion contains methylparahydroxybenzoate (E-218)

This medicine may cause allergic reactions (possibly delayed) because it contains methylparahydroxybenzoate.

Iniston Cough and Congestion contains sorbitol (E-420)

This medicine contains 2 g of sorbitol per 10 ml dose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking/using this medicine.

Iniston Cough and Congestion contains sodium benzoate (E-211)

This medicine contains 10 mg of sodium benzoate per 10 ml dose. This medicine may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).

Iniston Cough and Congestion contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e., it is practically sodium-free.

Warning for athletes:
Athletes are advised that this medicine contains pseudoephedrine, which may result in a positive doping test.

3. How to take Iniston Cough and Congestion

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

Recommended dose:

Adults and children over 12 years: take 10 ml every 6–8 hours. Do not take more than 4 times a day. The maximum daily dose is 40 ml.

Children between 6 and 12 years: take 5 ml every 8 hours. Do not take more than 3 times a day.

Children under 6 years: This medicine is contraindicated in children under 6 years of age.

Patients over 60 years: Do not take without consulting your doctor.

How to take:

This medicine is taken orally.

Use the dosing cup or spoon provided in the package to measure the exact dose. Rinse the cup or spoon after each use.

It is recommended to drink a glass of water after each dose, to take the medicine with meals, and to drink plenty of fluids during treatment.

Do not take with alcoholic beverages, as this may cause adverse effects.

Do not take with grapefruit juice, as it may cause a hypertensive crisis.

Taking this medicine with other foods or drinks does not affect its efficacy.

If taking this medicine at night, it should be taken several hours before bedtime to reduce the possibility of insomnia in patients who have difficulty sleeping.

Consult your doctor if your condition worsens, if symptoms persist for more than 5 days of treatment, or if they are accompanied by high fever.

If you take more Iniston Cough and Congestion than you should

If you take more Iniston Cough and Congestion than recommended, you may experience the following symptoms: nausea and vomiting, involuntary muscle contractions, agitation, confusion, drowsiness, disturbances of consciousness, involuntary and rapid eye movements, cardiac disorders (increased heart rate), coordination disorders, psychosis with visual hallucinations, hyperexcitability, hypertension, and ischemic colitis.

Other symptoms in cases of massive overdose may include: coma, severe breathing problems, and seizures.

Contact your doctor or hospital immediately if you experience any of the symptoms listed.

In children, very high doses may cause drowsiness or lethargy, hallucinations, hysteria, facial swelling, excitability, nausea, vomiting, and disturbances in gait. In children and elderly patients, uncontrolled movements, excitement, tremors, mental disorders with altered perception of reality (psychosis), hallucinations, seizures, difficulty sleeping, and fever may also occur.

Rare cases of abuse of medications containing dextromethorphan, particularly among adolescents, have been reported, leading to serious adverse effects such as rapid heartbeat, lethargy, increased or decreased blood pressure, pupil dilation, agitation, dizziness, gastrointestinal discomfort, hallucinations, slurred speech, involuntary eye movements, fever, rapid breathing, brain damage, uncontrolled movements, seizures, respiratory depression, loss of consciousness, arrhythmias, and death.

In case of overdose or accidental ingestion, go to a medical center, contact your doctor, or call the Toxicology Information Service (telephone 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.

During the period of use of this medicine, the following adverse effects have been observed, whose frequency could not be established accurately:

• Serious conditions affecting the blood vessels of the brain known as reversible posterior encephalopathy syndrome (RPES) and reversible cerebral vasoconstriction syndrome (RCVS).

• Stop using Iniston Cough and Congestion 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

  • According to frequency data of adverse reactions collected from spontaneous adverse reaction reports, the following adverse effects were reported very rarely (<1/10,000 patients):
  • Anxiety, euphoric mood, hallucinations, visual hallucinations, irritability, agitation, stroke, headache, paresthesia, psychomotor hyperactivity, tremor, and somnolence

With the same frequency, cardiac disorders such as arrhythmia, myocardial infarction, palpitations, and tachycardia have occurred. Among respiratory disorders, epistaxis was reported very rarely. Gastrointestinal disorders reported include abdominal pain and discomfort, ischemic colitis, diarrhea, and vomiting. Regarding skin and subcutaneous tissue disorders, acute generalized erythematous pustulosis, angioedema, pruritus, urticaria, rash, and erythematous rash have been observed. Other effects: dysuria and urinary retention, hypersensitivity, fatigue, increased blood pressure, and decreased appetite.

If seizures or hallucinations occur, stop taking this medicine immediately.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, 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 Medicinal Products. Website: www.notificaRAM.es

5. Storage of Iniston Cough and Congestion

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

No special storage conditions are required.

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.

Do not use this medicine if you notice that the packaging is broken or damaged at the time of purchase.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the Sigre Point located at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Iniston Cough and Congestion

The active substances are triprolidine, pseudoephedrine hydrochloride and dextromethorphan. Each ml of syrup contains 0.25 mg of triprolidine hydrochloride, 6 mg of pseudoephedrine hydrochloride and 2 mg of dextromethorphan hydrobromide.

The other components (excipients) are: sucrose, ethanol, sorbitol (E-420), sodium benzoate, methyl parahydroxybenzoate (E-218), blackberry flavour, cochineal red A (E-124), menthol, vanillin and purified water.

Appearance of the medicinal product and contents of the pack

Iniston Cough and Congestion is a clear red liquid with a characteristic odour.

It is available in amber glass bottles of 120 ml or 200 ml, closed with an aluminium cap with silver inner lacquer. It includes a dosing spoon or graduated dosing cup.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

JNTL Consumer Health (Spain), S.L.

JNTL Consumer Health (Spain), S.L.

C/ Vía de los Poblados 1, Edificio E, planta 3

28033-Madrid

Spain

Manufacturer:

DELPHARM ORLEANS

5 Avenue de Concyr

45071 Orleans Cedex 2

France

Date of the most recent revision of this leaflet: May 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/ .