SENIORAL Syrup for Adults

Introduction

Leaflet: information for the user

SENIORAL adult syrup

Clocinizine dihydrochloride/Phenylpropanolamine hydrochloride

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

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

SENIORAL adult syrup has two active ingredients: clocinizine and phenylpropanolamine.

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

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

SENIORAL adult syrup 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 adult syrup

Do not take SENIORAL adult syrup

• If you are allergic (hypersensitive) to phenylpropanolamine or clocinizine or any of the other components of this medication (listed in section 6).
• If you have high blood pressure (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 12 years of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to take SENIORAL adult syrup.

• Do not exceed the maximum recommended dose (see 3. How to take SENIORAL adult syrup), as serious side effects may occur (see If you take more SENIORAL adult syrup than 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.

Other medications and SENIORAL adult syrup

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

• 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 increase in temperature. If you have taken one of these medications, wait at least 15 days before taking SENIORAL adult syrup. If you are not sure if your medication contains an MAOI, consult your doctor or pharmacist before taking SENIORAL adult syrup.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this 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 adult syrup contains alcohol (ethanol), methyl parahydroxybenzoate (E-218), and sucrose.

This medication contains 163 mg of alcohol (ethanol) per 15 ml, which is equivalent to 1.38% v/v. The amount of alcohol per 15 ml of this medication is equivalent to less than 4 ml of beer or 2 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 9.5 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 adult syrup

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

The recommended dose is:

In adults and children over 12 years: The maximum dose is 15 ml (one tablespoon) 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 adult syrup is administered orally.

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 12 years of age.

If you take more SENIORAL adult syrup than 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 intake of SENIORAL adult syrup, 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 SENIORAL adult syrup

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 dose.

If you stop treatment with SENIORAL adult syrup

Your doctor will indicate the duration of treatment with SENIORAL adult syrup. If you stop before completing the period indicated by your doctor, your disease symptoms may recur.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

Cardiovascular effects: changes in pulse (with unknown frequency: strong, fast, 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 think any of the side effects you are experiencing are serious or if you notice any side effect not mentioned in this leaflet, tell 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 help provide more information on the safety of this medication.

5. Storage of SENIORAL adult syrup

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

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging.

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 adult syrup

• The active ingredients are: clocinizine dihydrochloride and phenylpropanolamine hydrochloride. Each 100 ml of syrup contains 22.5 mg of clocinizine dihydrochloride and 200 mg of phenylpropanolamine hydrochloride. Each 15 ml (one dose) of syrup contains: clocinizine dihydrochloride, 3.375 mg, and phenylpropanolamine hydrochloride, 30 mg.
• The other components are: sucrose, ethanol, methyl parahydroxybenzoate (E-218), blackcurrant extract 30 GS 705, concentrated hydrochloric acid, and purified water.

Appearance of the product and package contents

SENIORAL adult syrup is a colorless syrup, which comes in boxes containing a bottle with 150 ml.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios ERN, S.A.

C/Perú, 228

08020 Barcelona, Spain

Manufacturer

Laboratorios ERN, S.A.

C/Gorchs Lladó, 188

Pol. Ind. Can Salvatella

08210 Barberá del Vallés (Barcelona), Spain.

Date of the last revision of this leaflet: 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/.