Prospect: information for the user

PAIDOTERÍN DECONGESTANT

Syrup

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

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

1. What isPAIDOTERIN DECONGESTANT syrupand for what it is used

2. What you need to know before starting to takePAIDOTERIN DECONGESTANT syrup

3. How to takePAIDOTERIN DECONGESTANT syrup

4. Possible adverse effects

5. Storage ofPAIDOTERIN DECONGESTANT syrup

6. Contents of the package and additional information

PAIDOTERÍN DESCONGESTIVOsyrupis 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 the inflammation of the mucous membranes that line 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 the antihistamines provide a sedative effect on the nasal mucosa.

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

Do not take PAIDOTERÍN DESCONGESTIVO syrup:

• If you are allergic to any of the components of the medication.
• Children under 2 years old.

Be extra cautious with PAIDOTERÍN DESCONGESTIVO syrup:

Use with caution in patients with high blood pressure, severe cardiovascular disease, glaucoma, prostate hypertrophy, urinary tract obstruction, and urinary retention.

Patients sensitive to one antihistamine may be sensitive to others.

Use of other medications:

Antihistamines may potentiate the depressive effects on the CNS when administered 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 administering phenylephrine with doxapram, metildopa, or trimetaphan. Phenylephrine, used 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 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 be increased when administering phenylephrine with halogenated hydrocarbon anesthetics by inhalation.

PAIDOTERÍN DESCONGESTIVO syrup is compatible with any sulfamidic or antibiotic therapy.

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

Use in children:

Do not administer to children under 2 years old.

Use in the elderly:

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

Pregnancy and lactation:

The safety of PAIDOTERÍN DESCONGESTIVO syrup in pregnancy has not been established. It is not recommended for use in lactating women due to the risk of adverse effects in the infant, such as excitement or irritability, as small amounts of antihistamines are excreted in milk.

Driving and operating machinery:

Since the medication may cause drowsiness, the ability to drive and operate machinery may be impaired, posing a potential hazard.

Use in athletes:

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

Important information about some components of PAIDOTERÍN DESCONGESTIVO syrup:

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

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

Instructions for proper use

Follow exactly the administration instructions for PAIDOTERÍN DESCONGESTIVO syrup as indicated by your doctor.

Consult your doctor or pharmacist if you have any doubts.

The recommended doses are:

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

Children aged 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.

Dosage can be performed using the 5 ml graduated dropper included in the presentation or using a small spoon (equivalent to 5 ml).

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

If you take more PAIDOTERÍN DESCONGESTIVO syrup than you should:

If acute poisoning due to 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 will be administered and, if there is no response, propranolol. In case of seizures, diazepam. In case of severe hypertension, nitroprusside or fentolamine. If anticholinergic effects are unbearable, physostigmine will be administered. Electrocardiogram and vital sign monitoring will be performed and, in symptomatic patients, urine control and blood electrolyte control will be performed.

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

If you forgot to take PAIDOTERÍN DESCONGESTIVO syrup:

Do not take a double dose to compensate for the missed doses.

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

Like all medicationsPAIDOTERÍN DESCONGESTVO Syrupmay have adverse effects, although not all people will experience them.

Exceptionally, drowsiness. Rarely, blood disorders, 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 appearmore likely in children and elderly patients; in these patients, it is more likely to cause confusion, difficulty or pain during urination, and drowsiness.

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

Keep out of reach and sight of children.

The bottle must be stored in the original packaging protected from light and excessively low temperatures.

Do not use PAIDOTERÍN DECONGESTIVEsyrupafter the expiration date that appears on the packaging after Cad:. The expiration date is the last day of the month indicated

Medicines should not be disposed of through drains or in the trash. Deposit the containers and medicines you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition ofPAIDOTERÍN DECONGESTIVE syrup

- The active principles are Chlorhydrate of phenylephrine, Chlorhydrate of diphenhydramine and Maleate of chlorpheniramine. The other components are sodium saccharin, saccharose, amaranth (E-123), parahydroxybenzoate of methyl, sodium salt (E-219), glycerol, sodium citrate, citric acid, strawberry flavor and purified water.

Aspect of the product and content of the packaging

PAIDOTERÍN DECONGESTIVE syrupis a red liquid with strawberry flavor, presented in a 100 ml container, provided with a 5 ml dosing syringe.

Holder of the marketing authorization and responsible for the manufacture

Laboratorio ALDO-UNIÓN, S.L.

Calle Baronesa de Maldà, 73

08950 Esplugues de Llobregat (Barcelona)

SPAIN

This leaflet has been approved: March 2012

The detailed and updated information of this medicine is available on the webpageof the Spanish Agency of Medicaments and Sanitary Products (AEMPS) http://www.aemps.gob.es