PAIDOTERIN DESCONGESTIVO JARABE (Syrup)

Introduction

Leaflet: information for the user

PAIDOTERIN DECONGESTANT

Syrup

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

• Keep this leaflet, as you may need to read it again. If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What PAIDOTERIN DECONGESTANT syrup is and what it is used for
2. What you need to know before taking PAIDOTERIN DECONGESTANT syrup
3. How to take PAIDOTERIN DECONGESTANT syrup
4. Possible side effects
5. Storage of PAIDOTERIN DECONGESTANT syrup
6. Package contents and additional information

1. What is PAIDOTERIN DECONGESTANT syrup and what is it used for

PAIDOTERIN DECONGESTANTsyrup is an association of phenylephrine, diphenhydramine, and chlorpheniramine. Phenylephrine is a sympathomimetic amine that acts on the alpha-adrenergic receptors of the respiratory tract mucosa to produce vasoconstriction that temporarily reduces the swelling associated with inflammation of the mucous membranes lining the nasal passages, acting as a decongestant.

Diphenhydramine and chlorpheniramine are two antihistamines that prevent, but do not reverse, histamine-mediated responses. The antimuscarinic actions of antihistamines provide a sedating effect on the nasal mucosa.

It relieves the symptoms of congestion of the upper respiratory tract mucosa that accompanies allergic rhinitis, perennial or seasonal.

2. BEFORE TAKING PAIDOTERIN DECONGESTANT syrup

Do not take PAIDOTERIN DECONGESTANT syrup:

• If you are hypersensitive to any of the components of the medication.
• Children under 2 years of age.

Be careful with PAIDOTERIN DECONGESTANT syrup:

Administer with caution in patients with hypertension, severe cardiovascular disease, glaucoma, prostatic hypertrophy, bladder neck obstruction, and urinary retention.

Patients sensitive to an antihistamine may be sensitive to others.

Use of other medications:

Antihistamines may potentiate the depressant effects on the CNS when administered concomitantly with CNS depressant medications, tricyclic antidepressants, maprotiline, MAO inhibitors, and alcohol. They may also potentiate the anticholinergic effects of medications with anticholinergic action.

The pressor effects may be potentiated when phenylephrine is administered concomitantly with doxapram, methyldopa, or trimethaphan. Phenylephrine, used concomitantly with digitalis glycosides, may increase the risk of cardiac arrhythmias and exacerbate the vasoconstriction induced by ergot alkaloids or methysergide. It may also prolong and intensify the stimulant cardiac and vasopressor effects of sympathomimetic amines. The pressor response to phenylephrine may be blocked by prior administration of alpha-adrenergic blockers, and phenylephrine may inhibit the therapeutic effects of beta-adrenergic blockers. The risk of severe ventricular arrhythmias may increase when phenylephrine is administered simultaneously with halogenated hydrocarbon anesthetics by inhalation.

PAIDOTERIN DECONGESTANTsyrup is compatible with any sulfonamide or antibiotic therapy.

Tell your doctor or pharmacist if you are taking or have recently taken any other medication, including those purchased without a prescription.

Use in children:

Do not administer to children under 2 years of age.

Use in the elderly:

In the elderly, anticholinergic and CNS stimulant effects are likely to occur, and there is a risk of precipitating undiagnosed glaucoma.

Pregnancy and lactation:

The safety of PAIDOTERIN DECONGESTANTsyrup has not been established during pregnancy. Its use is not recommended in breastfeeding women due to the risk of adverse effects in the child, such as unusual excitement or irritability, as small amounts of antihistamines are excreted in breast milk.

Driving and using machines:

Since the medication can cause drowsiness, the ability to drive and operate machinery may be impaired, potentially being hazardous.

Use in athletes:

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

Important information about some of the components of PAIDOTERIN DECONGESTANT syrup:

• 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.
  • It may cause tooth decay.
  • It may cause allergic reactions (possibly delayed) because it contains methylparaben sodium (E-219).
  • This medication may cause allergic reactions because it contains amaranth (E-123). It may trigger asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take PAIDOTERIN DECONGESTANT syrup

Instructions for proper use

Follow the administration instructions for PAIDOTERIN DECONGESTANT syrup indicated by your doctor.

Consult your doctor or pharmacist if you have doubts.

The recommended doses are:

Children from 2 to 6 years:5 ml every 6 or 8 hours.

Children from 6 to 12 years:10-15 ml every 6 or 8 hours.

Adults:15-20 ml every 6 or 8 hours.

It should be administered preferably after meals.

The dosage can be done using the 5 ml graduated dosing syringe included in the presentation or using a small spoon (equivalent to 5 ml).

Do not exceed, at most, twice the indicated doses for each intake.

If you take more PAIDOTERIN DECONGESTANT syrup than you should:

If acute overdose occurs, treatment consists of administering an emetic or gastric lavage with 5% sodium bicarbonate solution, activated charcoal, and catharsis. If ventricular tachycardia appears, lidocaine and, if there is no response, propranolol will be administered. In case of convulsions, diazepam. In case of severe hypertension, nitroprusside or phentolamine. If anticholinergic effects are uncontrollable, physostigmine will be administered. Electrocardiographic and vital sign monitoring will be performed, and in symptomatic patients, urine and blood electrolyte control.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91562 04 20, indicating the medication and the amount ingested.

If you forget to take PAIDOTERIN DECONGESTANT syrup:

Do not take a double dose to make up for forgotten doses.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, PAIDOTERIN DECONGESTANT syrupmay have side effects, although not everyone will experience them.

Exceptionally, drowsiness. Rarely, blood dyscrasias, increased skin sensitivity to the sun, increased sweating, and loss of appetite may appear. Also, with rare incidence, a paradoxical reaction (nightmares, excitement, nervousness, etc.) may appear, more likely in children and elderly patients; in these patients, it is more likely that confusion, difficulty or pain during urination, and drowsiness will occur.

If you consider that any of the side effects you are experiencing is serious or if any side effect not mentioned in this leaflet appears, inform your doctor or pharmacist.

5. Storage of PAIDOTERIN DECONGESTANT syrup

Keep out of the reach and sight of children.

The bottle should be kept in the original packaging, protected from light and excessively low temperatures.

Do not use PAIDOTERIN DECONGESTANTsyrup after the expiration date shown on the packaging after Cad:. The expiration date is the last day of the month indicated.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need in the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of PAIDOTERIN DECONGESTANT syrup

• The active ingredients are phenylephrine hydrochloride, diphenhydramine hydrochloride, and chlorpheniramine maleate. The other components are sodium saccharin, sucrose, amaranth (E-123), methylparaben sodium (E-219), glycerol, sodium citrate, citric acid, strawberry flavor, and purified water.

Appearance of the product and package contents

PAIDOTERIN DECONGESTANT syrupis a red liquid with a strawberry flavor, presented in a 100 ml package, provided with a 5 ml dosing syringe.

Marketing authorization holder and manufacturer

Laboratorio ALDO-UNIÓN, S.L.

Calle Baronesa de Maldà, 73

08950 Esplugues de Llobregat (Barcelona)

SPAIN

This leaflet was approved: March 2012

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