Label: information for the user

SENIORAL syrup for children

Clocinizine dihydrochloride/Phenylpropanolamine hydrochloride

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

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the adverse effects you are experiencing is severe or if you notice any adverse effect not mentioned in this label, inform your doctor or pharmacist

SENIORALsyrup for childrencontains two active ingredients: clocinizine and phenylpropanolamine.

Clocinizine belongs to the group of antihistamines, medications used for the relief of allergic reactions.

Phenylpropanolamine belongs to the group of adrenergic agonists, used for the relief of nasal congestion.

SENIORALsyrup for childrenis used only for the temporary relief of nasal congestion in colds, rhinitis, and nasal congestion associated with sinusitis.

Do not take SENIORALchildren's syrup

• If you are allergic (hypersensitive) to phenylpropanolamine or clocinizine or any of the other components of SENIORAL children's syrup
• If you have high blood pressure (hypertension), if you have any thyroid disease (hyperthyroidism) or have heart disease (severe coronary disease or angina pectoris)
• If you are taking any medication for depression or Parkinson's disease that inhibits monoamine oxidase (MAO) (see below: Use of other medications)
• In children under 2 years old.

Be especially careful with SENIORALchildren's syrup

• Do not exceed the maximum recommended dose (see3. How to take SENIORAL children's syrup), as severe adverse effects may occur (seeIf you take more SENIORALchildren's syrupthan you should).
• If you have diabetes mellitus, have elevated eye pressure (glaucoma) or have prostate enlargement (prostatic hypertrophy) or urinary retention, as these conditions may worsen.

Use of other medications

Inform your doctor or pharmacist if you are using, or have recently used, other medications, including those purchased without a prescription.

• If administered with medications that inhibit the monoamine oxidase enzyme (MAO), used for depression (tranylcypromine, moclobemide) or for Parkinson's disease (selegiline), severe adverse effects may occur, manifesting as strong headache, sudden elevation of temperature. If you have taken one of these medications, waitat least 15 days before taking SENIORALchildren's syrup. If you are unsure if your medication contains an MAO inhibitor, consult your doctor or pharmacist before taking SENIORALchildren's syrup.
• If you are taking other medications, consult your doctor or pharmacist before taking SENIORALchildren's syrup.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Women who are breastfeeding should not take this medication, as it passes through breast milk and may affect the infant.

Driving and operating machinery

Do not drive or operate tools or machinery, as SENIORAL may impair your concentration and reflexes.

Use in athletes

It is reported to athletes that this medication contains a component that may result in a positive analytical test for doping control.

SENIORAL children's syrup contains alcohol (ethanol), methyl parahydroxybenzoate (E-218) and saccharose.

This medication contains 103 mg of alcohol (ethanol) per 15 ml, which is equivalent to 0.87% v/v. The amount of alcohol in this medication is equivalent to less than 3 ml of beer or 1 ml of wine.

The small amount of alcohol in this medication has no perceptible effects.

This medication contains methyl parahydroxybenzoate (E-218). It may cause allergic reactions (possibly delayed).

This medication contains 12.3 g of saccharose per 15 ml.This should be taken into account by patients with diabetes mellitus. If your doctor has told you that you have intolerance to certain sugars, consult with him before taking this medication.

Follow exactly the administration instructions for SENIORAL children's syrup as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

The normal dose is:

For children aged 2 to 5 years: The maximum dose is 7.5 ml three times a day (22.5 ml/day), which should be taken before meals and a minimum of 6 hours should be left between each dose.

For children aged 5 to 12 years: The maximum dose is 15 ml three times a day (45 ml/day), which should be taken before meals and a minimum of 6 hours should be left between each dose.

If symptoms do not improve within 5 days or are accompanied by high fever, consult your doctor before continuing treatment.

SENIORAL children's syrup is administered orally, using the dosing cup.

The syrup should be taken before meals. A minimum of 6 hours should be left between each dose.

Remember to take your medication.

Use in children

Do not use in children under 2 years.

If you take more SENIORAL children's syrup than you should

If you have taken more doses than recommended, you may experience cardiac and neurological alterations. In this case, a gastric lavage should be performed and symptoms treated. Consult your doctor or pharmacist.

If you take higher doses than recommended, you may experience nervousness, dizziness, palpitations, tremors, agitation, and, very rarely, hallucinations, convulsions, and cerebral hemorrhage. If you experience any of these symptoms, discontinue use of this medication immediately and consult your doctor.

In case of excessive or accidental intake of SENIORAL children's syrup, go immediately to your doctor or the nearest hospital emergency service or consult the Toxicological Information Service (phone: 91 562 04 20), indicating the medication and the amount ingested. Bring this leaflet with you if possible.

If you forgot to take SENIORAL children's syrup

Do not take a double dose to compensate for the missed doses. Take your dose as soon as possible. If less than 6 hours remain before taking the next dose, wait until then to take your syrup.

If you interrupt treatment with SENIORAL children's syrup

Your doctor will indicate the duration of treatment with SENIORAL children's syrup. If treatment is interrupted before the indicated period is completed, symptoms of your disease may recur.

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

Like all medications, SENIORALoral solution for childrenmay cause adverse effects, although not everyone will experience them.

Cardiovascular Effects: Alterations in heart rhythm (palpitations, tachycardia), elevation of blood pressure (hypertension), which can sometimes be severe (hypertensive crisis).

Effects on the Nervous System: Restlessness, dizziness, insomnia, headache, unusual behavior. Occasionally, it may cause sedation and drowsiness.

Other adverse effects include gastrointestinal discomfort (nausea and vomiting), constipation, confusion, euphoria, visual disturbances, dry mouth, and difficulty urinating.

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed 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 on the safety of this medication.

Keep out of the reach and sight of children.

Do not use SENIORAL Children's Syrup after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Store in its original packaging.

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

Composition of SENIORAL children's syrup

• Theactive principles are: Dyclonine dihydrochloride and phenylpropanolamine hydrochloride. Each 100 ml of syrup contains 15 mg of dyclonine dihydrochloride and 130 mg of phenylpropanolamine hydrochloride. Each 15 ml (a dose) of syrup contains: dyclonine dihydrochloride, 2.25 mg and phenylpropanolamine hydrochloride, 19.50 mg.
• Theother components are: Sucrose, ethanol, methyl parahydroxybenzoate (E-218), 30 GS 750 cassia extract, concentrated hydrochloric acid and purified water.

Appearance of the product and content of the packaging

SENIORALchildren's syrup is a reddish-colored syrup, which ispresented in containers containing a bottle containing 150 ml and a spoon with several dosing measures.

Holder of the marketing authorization

Laboratorios ERN, S.A.

C/Perú, 228

08020 Barcelona, Spain

Manufacturers responsible

Laboratorios ERN, S.A.

C/Gorchs Lladó, 188

Pol. Ind. Can Salvatella

08210 Barberá del Vallés (Barcelona), Spain.

This leaflet was approved in July 2011.

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/.