Label: information for the user

TUSELIN DECONGESTANT 2 mg/ml+1 mg/ml syrup

Dextromethorphan hydrobromide / Phenylephrine hydrochloride

Read this label carefully before starting to take thismedicine,because it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this label or those indicated by your doctor or pharmacist.

• Keep this label, as you may need to read it again.

• If you need advice or more information, consult your pharmacist.
• Ifyou experience adverse effects, consult your doctor or pharmacist,even if they are not listed in this label. See section 4.
• You should consult a doctor if you worsen or do not improveafter 5 days.

Contents of the package and additional information

It is an antitussive and nasal decongestant medication.

It is indicated for the symptomatic treatment of cough that is not accompanied by expectoration (irritative cough, nervous cough) and nasal congestion in adults, adolescents, and children aged 6 years and older.

Consult a doctor if symptoms worsen or do not improve after 5 days of treatment.

Do not take Tuselin Descongestivo

• if you are allergic to dextromethorphan hydrobromide or phenylephrine hydrochloride or any of the other components of this medication (listed in section 6).
• if you are under 6 years old
• if you have a serious lung disease (respiratory insufficiency)
• if you have asthma
• if you have a cough accompanied by abundant secretions
• if you have severe hypertension

-if you are pre-diabetic or have juvenile diabetes, as it may cause an increase in blood glucose levels

Warnings and precautions

Consult your doctor or pharmacist before starting to take Tuselin Descongestivo if you are a patient:

• with liver disease
• cardiovascular disorders
• glaucoma (increased intraocular pressure)
• hyperthyroidism
• moderate hypertension
• diabetes (blood sugar)
• prostate disorders

This medication should not be used in cases of persistent or chronic cough, such as that caused by smoking, asthma, or emphysema, or when the cough is accompanied by abundant secretions.

Cases of abuse with dextromethorphan-containing medications have been described in adolescents, therefore, this possibility should be taken into account, as it may cause severe adverse effects (see section If you take more Tuselin Descongestivo than you should).

Children

Children under 6 years old should not take this medication, it is contraindicated.

Use in athletes

This medication contains phenylephrine, which may produce a positive result in doping control tests.

Use of Tuselin Descongestivo with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Do not take this medication during treatment with the following medications:

Interactions due to dextromethorphan:

• Monamine oxidase inhibitors (MAOIs):Medications used to treat depression. The administration of Tuselin Descongestive, furazolidine, pargyline, and procarbazine should be separated by at least 15 days after completing treatment.
• Antiarrhythmics(Quinidine).

Interactions due to phenylephrine:

• Antihypertensives or diuretics: Medications used to treat high blood pressure (hypertension).
• Tricyclic and tetracyclic antidepressants (maprotiline): Medications used to treat depression.
• Sympathomimetic amines.
• Alpha-adrenergic blockers.

• Beta-adrenergic blockers: Medications used to treat migraine; medications taken for childbirth; medications taken to treat high blood pressure, or other conditions.
• Hydrocarbon anesthetics by inhalation.
• Digitalis glycosides: Medications used for the heart.
• Ergot alkaloids (medications used for migraines such as dihydroergotamine, ergometrine, or methysergide; medications used for postpartum hemorrhage, such as methylergometrine, and medications for vascular disorders, such as ergoloid mesylates or ergotamines).
• Doxapram.
• Medications used to treat hypertension, such as methyldopa or trimethaphan.

Taking Tuselin Descongestive with food, drinks, and alcohol

Do not consume alcoholic beverages during treatment, as they may cause adverse reactions.

Do not take this medication with orange or bitter lemon juice, as it may increase the adverse effects of this medication

Pregnancy and lactation

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

Driving and operating machinery

In rare cases, during treatment, drowsiness and dizziness may occur, so if you notice these symptoms, you should not drive cars or operate hazardous machinery.

Tuselin Descongestive contains:

-Sucrose: 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 contains0.67 gof sucrose per ml.

• Red 40: This medication may cause allergic reactions because it contains Red 40 (E-124). It may cause asthma, especially in patients allergic to acetylsalicylic acid.
• Sodium: Patients on low-sodium diets should note that this medication contains 3.36 mg of sodium (0.15 mmol) of sodium per ml.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Adults and children over 12 years old:

Take 5-10 ml of syrup every 4-6 hours. Maximum daily dose: 60 ml divided into several doses (120 mg of dextromethorphan hydrobromide per day and 60 mg of phenylephrine hydrochloride per day)

Children between 6-12 years old:

Take 2.5-5 ml of syrup every 4-6 hours. Maximum daily dose: 30 ml divided into several doses (60 mg of dextromethorphan hydrobromide and 30 mg of phenylephrine hydrochloride per day).

Patients with liver insufficiency:

The dose should be reduced by half, not exceeding 4 daily doses.

If the cough worsens, persists for more than 5 days, or is accompanied by high fever, skin eruptions, or persistent headache, the clinical situation should be evaluated.

If you take more Tuselin Descongestivo than you should

If a overdose has been taken, the signs are: confusion, excitability, restlessness, nervousness, irritability, hypertension, palpitations, vomiting, headache, tingling in hands and feet.

Severe adverse effects have been reported in adolescents who abused medications containing dextromethorphan, including tachycardia, lethargy, hypertension or hypotension, mydriasis, agitation, vertigo, gastrointestinal disturbances, hallucinations, mumbling speech, nystagmus, fever, tachypnea, cerebral damage, ataxia, convulsions, respiratory depression, loss of consciousness, arrhythmias, and death.

High doses may cause in children a state of somnolence, hallucinations, nervousness, nausea, vomiting, or gait disturbances.

In cases of overdose or accidental ingestion, immediately go to a medical center or call the Toxicological Information Service, Telephone: 91.562.04.20, indicating the medication and the amount ingested.

If you forgot to take Tuselin Descongestivo

Do not take a double dose to compensate for the missed doses. If symptoms persist, restart treatment as indicated in section 3.

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

Rarely, drowsiness, gastrointestinal discomfort, dizziness, nervousness, mental confusion, or difficult breathing may appear. In this case, it is advisable to reduce the dosage.

The simultaneous consumption of alcohol during treatment may accentuate the appearance of secondary effects. Do not ingest alcoholic beverages during treatment.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is about possible adverse effects that do not appear 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 about the safety of this medication.

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

Store in the original packaging to protect it from light. Do not freeze.

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.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Tuselin Descongestivo

• Each ml of syrup contains as active principles: 2 mg of dextromethorphan hydrobromide and 1 mg of phenylephrine hydrochloride.
• The other components (excipients) are: Sucrose, sodium saccharin, sodium hydroxide, sorbic acid, disodium edetate, peppermint essence, Red C (E-124) and distilled water.

Appearance of the product and content of the packaging

Tuselin Descongestivo is a transparent, red-colored solution with a peppermint odor.

It is presented in topacio (PET) plastic bottles containing 100 or 200 ml of syrup.

Marketing authorization holder and manufacturer

Marketing authorization holder

KORHISPANA, S.L.

Ctra. Castellvell, 24

43206 REUS (Tarragona)

Manufacturer

Laboratorios SERRA PAMIES, S.A.

Ctra. Castellvell, 24

43206 REUS (Tarragona)

Last review date of this leaflet:May 2016.

Other sources of information

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