Package Insert: Information for the User

InistonCough and CongestionSyrup

Triprolidina/Pseudoephedrine/Dextromethorphan

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 your doctor if your symptoms worsen or do not improve after5 days.

Iniston Tos y Congestión is an association of pseudoephedrine, dextromethorphan, and triprolidine.

Pseudoephedrine acts as a nasal decongestant, dextromethorphan is an antitussive for the relief of unproductive cough (irritative cough, nervous cough) and triprolidine alleviates nasal secretion.

It is indicated for symptomatic relief of unproductive cough (irritative cough, nervous cough) accompanied by congestion and nasal secretion associated with common cold and flu in adults and children aged 6 years and above.

You should consult your doctor if it worsens or does not improve after5 days.

Do not take InistonCough and Congestion

- If you are allergic to the active ingredients, other sympathomimetics such as antihistamines or any of the other components of this medication (listed in section 6).

- If you have asthma.

- If you have a cough accompanied by abundant secretions.

- If you have a serious 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 by your medication

- If you have a severe, acute (sudden) or chronic (long-term) kidney disease, or kidney failure - If you are in the first trimester of pregnancy.

- If you are or have been treated with other medications in the last 2 weeks, such as monoamine oxidase inhibitors (MAOIs) (used to treat depression or Parkinson's disease or other diseases (See Iniston Cough and Congestion with other medications) as it may cause a significant increase in blood pressure and/or hypertensive crisis.

- If you have inflammatory bowel disease that manifests with frequent diarrhea (ulcerative colitis).

- If you have glaucoma (elevated eye pressure).

- If you have hyperthyroidism.

- Children under 6 years old.

Warnings and precautions

• If after 5 days of treatment you do not improve or have a cough accompanied byfever, rashorpersistent headacheyou should stop treatment and consult your doctor.
• If you are to undergo surgery, discontinue treatment at least 24 hours before.
• Cases of reversible posterior encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported after the use of medications containing pseudoephedrine. PRES and RCVS are rare diseases that may involve a reduction in blood flow to the brain. Stop using Iniston Cough and Congestion immediately and seek immediate medical attention if you experience symptoms that may be signs of PRES or RCVS (see section 4 "Possible side effects").

Consult your doctor or pharmacist before starting to take Iniston Cough and Congestion:

• If small pustules form, mainly non-follicular, which may or may not be accompanied by fever and a disseminated edematous erythema, mainly located in the skin folds, trunk, and upper limbs, especially in the first 2 days of treatment. You may have generalized acute pustular exanthema that should be medically monitored.
• If sudden abdominal pain, rectal bleeding, or other symptoms of ischemic colitis develop. Discontinue treatment and consult a doctor.
• If you have been told that you are a slow metabolizer of CYP2D6 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
  • predisposition to glaucoma (elevated intraocular pressure)
  • prostatic enlargement in men and/or difficulty urinating
  • moderate or severe kidney disease with reduced function.
  • liver disease with reduced function
  • peptic ulcer disease or duodenal ulcer (between the stomach and intestine)
  • sedated, weakened, or bedridden patients

If you have chronic or persistent cough, such as that due to smoking or asthmaas it may worsen the expectoration and increase the resistance of the respiratory tract, or when the cough is accompanied by excessive mucus production.

Patients with a persistent respiratory condition such as emphysema, chronic bronchitis, asthma, or a cough accompanied by excessive mucus production should consult a doctor before using this product.

Cases of abuse with dextromethorphan have been described, therefore, this possibility should be taken into account, and the medication should be administered under strict medical control and for short periods of time in individuals with a tendency to abuse or dependence, especially adolescents, as it may cause severe adverse effects (see subheading "If you take more Iniston Cough and Congestion than you should").

This medication may cause dependence. Therefore, treatment should be of short duration.

It is recommended not to use it at the same time as other medications for cough or nasal congestion. See "Iniston Cough and Congestion with other medications".

Abdominal pain or rectal bleeding may occur with the use of Iniston Cough and Congestion due to ischemic colitis. If these gastrointestinal symptoms appear, discontinue treatment and contact your doctor or seek immediate medical attention. See section 4.

Children and adolescents

This medication is contraindicated in children under 6 years old.

Seniors (65 years and older)

Seniors may be especially sensitive to the adverse effects of this medication because it contains pseudoephedrine, which can cause hallucinations, depression of the central nervous system, seizures, and death in overdose.

Interference with laboratory 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/using this medication, as it may alter the results.

Iniston Cough and Congestion with other medications

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

In particular, if you are using some of the following medications, as it may be necessary to modify the dose of some of them or discontinue treatment:

• Amiodarone or quinidine (to treat heart arrhythmias)
• Anti-inflammatory drugs (celecoxib, parecoxib, or valdecoxib)
• Bupropion (medication used to quit smoking)
• Expectorants or mucolytics (medications used to reduce the density or facilitate the elimination of mucus and phlegm)
• Haloperidol (medication used to treat psychotic disorders)
• Inhibitors of serotonin reuptake (medications to treat depression such as paroxetine, fluoxetine)
• Alkalizing agents (sodium bicarbonate, citrates) as they may make pseudoephedrine eliminate more slowly and increase its effect and its toxicity.
• Inhalation anesthetics as they may increase the risk of heart problems.
• Some medications to lower blood pressure or to facilitate urine elimination (such as beta-blockers, ACE inhibitors, rauwolfia alkaloids such as reserpine, methyldopa, guanetidine) as it may reduce the effectiveness of these medications.
• Medications that inhibit monoamine oxidase (MAOIs) that include antidepressants such as tranylcypromine, moclobemide,medications for Parkinson's disease such as selegiline,antineoplastics such as procarbazine,or anti-infectives such as linezolid: as they may increase the effects of pseudoephedrine, causing severe hypertension, high fever, and headache. Discontinue the administration of these medications and even in the 15 days following the end of treatment with MAOIs.
• Stimulants of the nervous system (amphetamine, xanthines) as it 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 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 nervous system, its use with pseudoephedrine may increase adverse effects on the heart.
• Other medications belonging to the pseudoephedrine group (sympathomimetics), as they may potentiate the effects of this medication.
• Alcohol or medications that produce depression on the central nervous system (e.g. tricyclic antidepressants, barbiturates, anesthetics, procarbazine, etc.) may potentiate the depressive effects of these medications or antihistamines, such as triprolidine, causing symptoms of overdose.
• Tricyclic antidepressants or maprotiline (tetracyclic antidepressant) or other medications with anticholinergic action (such as Belladonna or Belladonna alkaloids): may potentiate the anticholinergic effects of these medications or antihistamines such as triprolidine. If gastrointestinal problems occur, inform patients to report them as soon as possible to their doctor, as it may cause paralytic ileus.
• Phenobarbital and phenytoin: increased risk of phenytoin toxicity (ataxia, hyperreflexia, nystagmus, tremor).
• Ototoxic medications: may mask symptoms of ototoxicity such as tinnitus, dizziness, and vertigo.
• Phototoxic medications: may increase phototoxic effects
• Metoprolol used to treat cardiovascular diseases.
• Isoconazole used to treat invasive aspergillosis and mucormycosis.

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

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

Iniston Cough and Congestion with food and beverages

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

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

Pregnancy and lactation

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication. The use of medications during pregnancy may be hazardous to the embryo or fetus, and should be monitored by your doctor.

This medication is contraindicated in the first trimester of pregnancy.

This medication is excreted in breast milk, therefore, it should not be used during lactation.

Driving and operating machinery

Be cautious if you drive a vehicle or operate machinery

Iniston Cough and Congestion contains saccharose

This medication contains saccharose. If your doctor has told you 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 5.7 g of saccharose per dose of 10 ml. It may cause tooth decay.

Iniston Cough and Congestion contains ethanol

This medication contains approximately 0.431 g of alcohol (ethanol) per 10 ml, which is equivalent to 43.1 mg/ml. The amount of alcohol contained in each dose (10 ml) of this medication is equivalent to 11 ml of beer or 4 ml of wine. The amount of alcohol contained in this medication will not cause any effect in adults and adolescents, and its effects in children will not be noticeable. This medication may have some effects in younger children, such as drowsiness. The alcohol contained in this medication may alter the effect of other medications you are taking concomitantly. If you are taking other medications, consult your doctor or pharmacist. If you are pregnant or breastfeeding, consult your doctor or pharmacist before taking this medication. If you are an alcoholic, consult your doctor or pharmacist before taking this medication.

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Iniston Cough and Congestion contains Red 40 (E-124)

This medication may cause allergic reactions because it contains Red 40 (E-124). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

Iniston Cough and Congestion contains Methylparaben (E-218)

This medication may cause allergic reactions (possibly delayed) because it contains methylparaben.

Iniston Cough and Congestion contains Sorbitol (E-420)

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

Iniston Cough and Congestion contains Sodium Benzoate (E-211)

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

Iniston Cough and Congestion contains Sodium

This medication contains less than 1 mmol of sodium (23 mg) per spray, that is, it is practically sodium-free.

Warning to athletes: It is reported to athletes that this medication contains pseudoephedrine, which may establish a positive analytical result in doping control.

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

The recommended dose is:

Adults and children over 12 yearsold: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 product is contraindicated in children under 6 years.

Over 60 years: Do not take without consulting a doctor.

How to take:

This medication is taken orally.

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

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

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

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

The taking of this medication with other foods or beverages 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.

You should consult your doctor if you worsen, if symptoms persist 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 indicated, you may experience the following symptoms: nausea and vomiting, involuntary muscle contractions, agitation, confusion, drowsiness, altered consciousness, involuntary and rapid eye movements, cardiac disorders (tachycardia), coordination disorders, psychosis with visual hallucinations, hyperexcitability, hypertension, and ischemic colitis.

Other symptoms in case of massive overdose may be: coma, severe respiratory problems, and seizures.

Immediately contact your doctor or hospital if you experience any of the mentioned symptoms.

In children, very high doses may cause a state of somnolence or lethargy, hallucinations, hysteria, facial edema, excitability, nausea, vomiting, and alterations 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.

Exceptionally, cases of abuse with medications containing dextromethorphan have been reported, particularly by adolescents, with severe adverse effects, such as rapid heartbeats, lethargy, increased or decreased blood pressure, dilated pupil, agitation, vertigo, gastrointestinal discomfort, hallucinations, mumbling 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, consult your doctor, or call the Toxicological Information Service (phone 91.562.04.20), indicating the medication and the amount ingested.

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

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

• Severe diseases affecting the blood vessels of the brain known as reversible posterior leukoencephalopathy syndrome (RPLS) and reversible cerebral vasoconstriction syndrome (RCVS).
• Stop using Iniston Tos and Congestion 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

• Malaise

• Vomiting

• Confusion

• Seizures

• Changes in vision

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

The same frequency of cardiac disorders such as arrhythmia, myocardial infarction, palpitations, and tachycardia were reported. Among respiratory disorders, epistaxis was reported very rarely. As gastrointestinal disorders, abdominal pain and discomfort, ischemic colitis, diarrhea, and vomiting were reported. Regarding skin and subcutaneous tissue disorders, generalized acute erythematous pustular psoriasis, angioedema, pruritus, urticaria, eczema, and erythematous eczema were reported. Others: Dysuria and urinary retention, hypersensitivity, fatigue, increased blood pressure, and decreased appetite.

In the event of seizures or hallucinations, stop taking this medication 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 that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use. Website:www.notificaRAM.es

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

No special storage conditions are required.

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.

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

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the Pharmacy Take-Back Point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of InistonTos and Congestion

The active principles are triprolidina, pseudoefedrina hydrochloride, and dextrometorfano. Each ml of syrup contains 0.25 mg of triprolidina hydrochloride, 6 mg of pseudoefedrina hydrochloride, and 2 mg of dextrometorfano hydrobromide.

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

Appearance of the product and contents of the packaging

InistonTos and Congestionis a clear, red-colored liquid with a characteristic odor.

It is available in amber glass packaging of 120 ml or 200 ml, closed with an aluminum cap with a silver-plated interior coating. It includes a spoon or a graduated measuring cup.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

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

Responsible for manufacturing:

DELPHARM ORLEANS

5 Avenue de Concyr

45071 Orleans Cedex 2

France

Date of the last review of this prospectus:May 2024

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