SENIORAL Syrup for Children

Introduction

Leaflet: information for the user

SENIORAL syrup for children

Clocinizine dihydrochloride/Phenylpropanolamine hydrochloride

Read the entire leaflet carefully before starting to take the medicine, 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 medicine has been prescribed to 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 serious or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

Contents of the leaflet

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

1. What SENIORAL syrup for children is and what it is used for

SENIORAL syrup for children has two active ingredients: clocinizine and phenylpropanolamine.

Clocinizine belongs to the group of antihistamines, drugs used to relieve allergic reactions.

Phenylpropanolamine belongs to the group of adrenergic agonists, which are used to relieve nasal congestion.

SENIORAL syrup for children is used only for the temporary relief of nasal congestion in colds, rhinitis, and nasal congestion associated with sinusitis.

2. What you need to know before taking SENIORAL syrup for children

Do not take SENIORALsyrup for children

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

Be careful with SENIORALsyrup for children

• Do not exceed the maximum recommended dose (see 3. How to take SENIORAL syrup for children), as serious side effects may occur (see If you take more SENIORALsyrup for childrenthan you should).
• If you have diabetes mellitus, have high eye pressure (glaucoma), or have prostate problems (prostatic hypertrophy) or urinary retention, as these conditions may worsen.

Use of other medications

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

• If administered with drugs that inhibit the enzyme monoamine oxidase (MAOI), which are used for depression (tranycypromine, moclobemide) or for Parkinson's disease (selegiline), serious side effects may occur, which manifest as severe headache, sudden temperature elevation. If you have taken one of these medications, wait at least 15 days before taking SENIORALsyrup for children. If you are not sure if your medication contains an MAOI, consult your doctor or pharmacist before taking SENIORAL syrup for children.
• If you are being treated with other medications, consult your doctor or pharmacist before taking SENIORAL syrup for children.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

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

Driving and using machines

Do not drive or operate tools or machines because SENIORAL may decrease your ability to concentrate and react.

Use in athletes

Athletes are informed that this medication contains a component that may result in a positive doping test.

SENIORAL syrup for children contains alcohol (ethanol), methyl parahydroxybenzoate (E-218), and sucrose.

This medication contains 103 mg of alcohol (ethanol) per 15 ml, which is equivalent to 0.87% v/v. The amount of alcohol per 15 ml of 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 noticeable effects.

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

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

3. How to take SENIORAL syrup for children

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

The normal dose is:

In children from 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.

In children from 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 after 5 days or are accompanied by high fever, consult your doctor before continuing treatment.

SENIORAL syrup for children 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 of age.

If you take more SENIORALsyrup for childrenthan you should

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

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

In case of excessive or accidental ingestion of SENIORAL syrup for children, go immediately to the doctor or the Emergency Department of the nearest hospital or consult the Toxicology Information Service (telephone: 91 562 04 20), indicating the medication and the amount ingested. Bring this leaflet with you if possible.

If you forget to take SENIORALsyrup for children

Do not take a double dose to make up for forgotten doses. Take your dose as soon as possible. If there are less than 6 hours left until the next dose, wait until that time to take your syrup.

If you stop treatment with SENIORAL syrup for children

Your doctor will indicate the duration of treatment with SENIORAL syrup for children. If treatment is stopped before the end of the period indicated by your doctor, the symptoms of your disease may recur.

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

4. Possible side effects

Like all medications, SENIORAL syrup for children may cause side effects, although not everyone experiences them.

Cardiovascular effects: Changes in pulse (with unknown frequency: strong, rapid, or irregular heartbeat (palpitations), tachycardia), increased blood pressure (hypertension), which can sometimes be severe (hypertensive crises).

Effects on the nervous system: Restlessness, dizziness, insomnia, headache, abnormal behavior. Occasionally, it may cause sedation and somnolence.

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

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's pharmacovigilance system: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of SENIORAL syrup for children

Keep out of the reach and sight of children.

Do not use SENIORAL syrup for children after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.

Store in the original package.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. 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. Package contents and additional information

Composition of SENIORAL syrup for children

• The active ingredients are: Clocinizine dihydrochloride and phenylpropanolamine hydrochloride. Each 100 ml of syrup contains 15 mg of clocinizine dihydrochloride and 130 mg of phenylpropanolamine hydrochloride. Each 15 ml (one dose) of syrup contains: clocinizine dihydrochloride, 2.25 mg, and phenylpropanolamine hydrochloride, 19.50 mg.
• The other components are: Sucrose, ethanol, methyl parahydroxybenzoate (E-218), blackcurrant extract 30 GS 750, concentrated hydrochloric acid, and purified water.

Appearance of the product and package contents

SENIORAL syrup for children is a reddish syrup, which comes in boxes containing a bottle with 150 ml and a dosing cup with several measuring marks.

Marketing authorization holder

Laboratorios ERN, S.A.

C/Perú, 228

08020 Barcelona, Spain

Manufacturers

Laboratorios ERN, S.A.

C/Gorchs Lladó, 188

Pol. Ind. Can Salvatella

08210 Barberá del Vallés (Barcelona), Spain.

This leaflet was approved in May 2025.

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