INISTON COUGH & CONGESTION SYRUP

Introduction

Leaflet: information for the user

InistonCough and Congestionsyrup

Triprolidine/Pseudoephedrine/Dextromethorphan

Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.

Follow the administration instructions for the medicine contained in this leaflet or as 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult your doctor if it worsens or does not improve after 5 days.

Contents of the leaflet:

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 side effects
5. Storage of 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 an association of pseudoephedrine, dextromethorphan, and triprolidine.

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

It is indicated for the symptomatic relief of non-productive cough (irritative cough, nervous cough) accompanied by congestion and nasal secretion associated with the common cold and flu in adults and children from 6 years old.

You should consult your doctor if it worsens or does not improve after 5 days.

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

Do not take InistonCough and Congestion

• If you are allergic to the active ingredients, to other sympathomimetics such as antihistamine medications, or to any of the other components of this medicine (listed in section 6).
• If you have asthmatic cough.
• If you have 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
• If you have severe kidney disease, acute (sudden) or chronic (long-term), or kidney failure- If you are in the first trimester of pregnancy.
• If you are or have been treated in the last 2 weeks with other monoamine oxidase inhibitor (MAOI) type medications (used to treat depression or Parkinson's disease or other diseases (see section "Taking Iniston Cough and Congestion with other medications") as it can cause an increase in blood pressure and/or hypertensive crisis.
• If you have an 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, it does not improve or you have a cough that is accompanied by fever, rash, or persistent headache, you should stop treatment and consult your doctor.
• If you are going to have surgery, you should stop treatment at least 24 hours in advance.
• Cases of posterior reversible 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 can involve a reduction in blood flow to the brain. Stop using Iniston Cough and Congestion immediately and seek immediate medical attention if you present symptoms that may be signs of PRES or RCVS (to know the symptoms, consult 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 can be accompanied or not by fever and an edematous erythema disseminated mainly in skin folds, trunk, and upper limbs, especially in the first 2 days of treatment. You may suffer from acute generalized exanthematous pustulosis that should be medically monitored.
• If sudden abdominal pain, rectal bleeding, or other symptoms of ischemic colitis development appear. Treatment should be suspended, and a doctor should be consulted.
• 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 or moderate hypertension
  • predisposition to glaucoma (high eye pressure)
  • enlarged prostate in men and/or difficulty urinating
  • moderate or severe kidney disease with reduced function
  • liver disease with reduced function
  • peptic ulcer stenosis (digestive ulcer) or pyloroduodenal ulcer (between the stomach and intestine)
  • sedated, debilitated, or bedridden patients

If you have chronic or persistent cough, such as that due to smoking or asthma, as it can worsen expectoration and increase the resistance of the airways, or when the cough is accompanied by a large amount of phlegm secretion.

Patients with a persistent respiratory condition such as emphysema, chronic bronchitis, bronchial asthma, or where the cough is accompanied by excessive secretions 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 in people with a tendency to abuse or dependence, especially adolescents, as serious side effects can occur (see subsection "if you take more Iniston Cough and Congestion than you should").

This medication can cause dependence. Therefore, treatment should be short-term.

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

Sudden abdominal pain or rectal bleeding may occur with the use of Iniston Cough and Congestion due to colon inflammation (ischemic colitis). If these gastrointestinal symptoms appear, stop taking Iniston Cough and Congestion 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.

Over 60 years old

People over 60 years old may be especially sensitive to the side effects of this medication because it contains pseudoephedrine; pseudoephedrine overdose can cause hallucinations, central nervous system depression, convulsions, and death.

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

Taking Iniston Cough and Congestion with other medications

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

In particular, if you are using any of the following medications, it may be necessary to modify the dose of some of them or interrupt 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 decrease the density or facilitate the elimination of mucus and phlegm)
• Haloperidol (medication used to treat psychotic disorders)
• Serotonin reuptake inhibitors (medications to treat depression, such as paroxetine, fluoxetine)
• Urinary alkalizers (sodium bicarbonate, citrates), as they can cause pseudoephedrine to be eliminated more slowly and increase its effect and toxicity.
• Inhaled anesthetics, as they can increase the risk of heart problems.
• Certain medications to lower blood pressure or to promote urine elimination (such as beta-blockers, ACE inhibitors, rauwolfia alkaloids like reserpine, methyldopa, guanethidine), as it can decrease the effectiveness of these medications.
• Monoamine oxidase inhibitor (MAOI) medications, including antidepressants like tranilcipromine, moclobemide, medications for Parkinson's disease like selegiline, anticancer medications like procarbazine, or anti-infective medications like linezolid: as they can increase the effects of pseudoephedrine, causing severe hypertension, very high fever, and headache. The concomitant administration of these medications should be avoided, even in the 15 days following the end of MAOI treatment.
• Central nervous system stimulants (amphetamines, xanthines), as they can cause nervousness, irritability, insomnia, or possibly convulsions or heart rhythm alterations (arrhythmias)
• Digitalis glycosides (used for heart conditions), as they can produce alterations in heart rhythm.
• Thyroid hormones (used for thyroid diseases), as the effects of both hormones and pseudoephedrine can be increased.
• Levodopa (used to treat Parkinson's disease), as it can increase heart rate (arrhythmias).
• Nitrates (used to treat angina pectoris), as the effects of nitrates can be reduced.
• Cocaine, which, in addition to stimulating the central nervous system, can increase the adverse effects on the heart when used with pseudoephedrine.
• Other medications belonging to the pseudoephedrine group (sympathomimetic medications), as they can potentiate the effects of pseudoephedrine.
• Alcohol or medications that produce central nervous system depression (e.g., tricyclic antidepressants, barbiturates, anesthetics, procarbazine, etc.), as the depressant effects of these medications or antihistamines like triprolidine can be potentiated, possibly causing symptoms of overdose.
• Tricyclic antidepressants or maprotiline (tetracyclic antidepressant) or other medications with anticholinergic action (such as belladonna or belladonna alkaloids): the anticholinergic effects of these medications or antihistamines like triprolidine can be potentiated. If gastrointestinal problems appear, patients should be warned to inform their doctor as soon as possible, as paralytic ileus may occur.
• Phenytoin and fosphenytoin: increased risk of phenytoin toxicity (ataxia, hyperreflexia, nystagmus, tremor).
• Ototoxic medications: the symptoms of ototoxicity, such as tinnitus, dizziness, and vertigo, can be masked.
• Photosensitizing medications: the photosensitizing effects can be increased.
• Metoprolol used to treat cardiovascular system diseases.
• Isavuconazole used to treat invasive aspergillosis and invasive 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 can interact with these medications, 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, arterial hypertension, and exaggerated reflexes, muscle stiffness, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, and diarrhea).

Taking Iniston Cough and Congestion with food and drinks

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

Alcoholic beverages should not be consumed during treatment with this medication, as it can cause drowsiness and increase side 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 medication. The use of medications during pregnancy can 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 the breastfeeding period.

Driving and using machines

Be cautious when driving a vehicle or using machinery.

Iniston Cough and Congestion contains sucrose

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

Patient with diabetes mellitus should be aware that this medication contains 5.7 g of sucrose per 10 ml dose. It can cause cavities.

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 in each dose (10 ml) of this medication is equivalent to 11 ml of beer or 4 ml of wine. The amount of alcohol in this medication will not produce any effect in adults and adolescents, and its effects in children will not be noticeable. This medication may have some effects in smaller children, such as a feeling of sleepiness. The alcohol in this medication can 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, talk to your doctor or pharmacist before taking this medication. If you are addicted to alcohol, talk to your doctor or pharmacist before taking this medication.

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

This medication may cause allergic reactions because it contains cochineal red A (E-124). It can 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 10 ml dose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking/using this medication.

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

This medication contains 10 mg of sodium benzoate per 10 ml dose. This medication may increase the risk of jaundice (yellowing of the 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, i.e., it is virtually sodium-free.

Warning to athletes: Athletes are informed that this medication contains pseudoephedrine, which can result in a positive doping test.

3. How to take Iniston Cough and Congestion

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

The recommended dose is:

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: The use is contraindicated in children under 6 years.

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

How to take:

This medication is taken orally.

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

It is recommended to drink a glass of water after each intake, 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.

Taking 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 it 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 indicated, you may experience the following symptoms: nausea and vomiting, involuntary muscle contractions, agitation, confusion, somnolence, disorders of consciousness, involuntary and rapid eye movements, cardiac disorders (accelerated heart rate), 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 convulsions.

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

In children, very high doses can produce a state of drowsiness or lethargy, hallucinations, hysteria, facial edema, excitability, nausea, vomiting, and alterations in gait. In children and elderly patients, uncontrolled movements, excitement, tremors, mental disorder with altered perception of reality (psychosis), hallucinations, convulsions, difficulty sleeping, and fever can 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, dilation of the eye pupil, agitation, dizziness, gastrointestinal discomfort, hallucinations, slurred speech, involuntary eye movements, fever, rapid breathing, brain damage, uncontrolled movements, convulsions, respiratory depression, loss of consciousness, arrhythmias, and death.

In case of overdose or accidental ingestion, go to a medical center, your doctor, or call the Toxicology Information Service (telephone 91.562.04.20), indicating the medication and the amount ingested.

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not all people suffer from them.

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

• Serious diseases affecting the blood vessels of the brain, known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS).
• Stop using Iniston Cough and Congestion immediately and seek urgent medical attention if you present symptoms that may be signs of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). These include:

• severe headache of sudden onset
• discomfort
• vomiting
• confusion
• convulsions
• changes in vision
• According to the frequency data of adverse reactions collected from spontaneous reports of adverse reactions, the following adverse effects were presented in a very rare way (<1>
• Anxiety, euphoric mood, hallucinations, visual hallucinations, irritability, and agitation, stroke, headache, paresthesia, psychomotor hyperactivity, tremor, and somnolence

With the same frequency, cardiac disorders such as arrhythmia, myocardial infarction, palpitations, and tachycardia were presented. Among the respiratory disorders, epistaxis was rarely reported. As gastrointestinal disorders, abdominal pain and discomfort, ischemic colitis, diarrhea, and vomiting were reported. Regarding skin and subcutaneous tissue disorders, generalized acute erythematous pustulosis, angioedema, pruritus, urticaria, rash, and erythematous rash were presented. Others: dysuria and urinary retention, hypersensitivity, fatigue, increased blood pressure, and decreased appetite.

In case of convulsions 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 Pharmacovigilance System for Human Use Medicines. Website: www.notificaRAM.es

5. Conservation of Iniston Cough and Congestion

Keep this medication out of sight and reach of children.

It does not require special storage conditions.

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 thrown away through the sewers or in the trash. Deposit the packaging and medications that are no longer needed at the Sigre Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications that are no longer needed. This way, you will help protect the environment.

6. Packaging content and additional information

Composition of Iniston Cough and Congestion

The active ingredients 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 flavor, cochineal red A (E-124), menthol, vanillin, and purified water.

Appearance of the product and packaging content

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

It is available in a 120 ml or 200 ml amber glass bottle, closed with an aluminum cap with a silver-plated interior. It includes a graduated measuring spoon or 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 last revision of this prospectus:May 2024

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