Senioral syrup for adults

Patient Information Leaflet

Introduction

Patient Information Leaflet

SENIORAL syrup for adults

Clocinizine dihydrochloride/Phenylpropanolamine hydrochloride

Read the entire leaflet carefully before you start taking this medicine, 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 medicine has been prescribed for you only and must not be given 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 adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What SENIORAL syrup for adults is and what it is used for
2. What you need to know before taking SENIORAL syrup for adults
3. How to take SENIORAL syrup for adults
4. Possible side effects
5. How to store SENIORAL syrup for adults
6. Contents of the pack and other information

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

SENIORAL syrup for adults contains two active substances: clocinizine and phenylpropanolamine.

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

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

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

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

Do not take SENIORAL syrup for adults

• If you are allergic (hypersensitive) to phenylpropanolamine or clocinizine, or to any of the other components of this medicine (listed in section 6).
• If you have high blood pressure (arterial hypertension), suffer from a thyroid disorder (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 (MAOI) (see below: Use of other medicines).
• In children under 12 years of age.

Warnings and precautions

Talk to your doctor or pharmacist before taking SENIORAL syrup for adults.

• Do not exceed the maximum recommended dose (see 3. How to take SENIORAL syrup for adults), as serious adverse effects may occur (see If you take more SENIORAL syrup for adults than you should).
• If you have diabetes mellitus, increased intraocular pressure (glaucoma), or prostate disorders (prostatic hypertrophy) or urinary retention, as these conditions may worsen.

Other medicines and SENIORAL syrup for adults

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

• If taken together with drugs that inhibit the enzyme monoamine oxidase (MAOI), used for depression (tranilcypramine, moclobemide) or for Parkinson's disease (selegiline), serious adverse effects may occur, such as severe headache and sudden rise in body temperature. If you have taken any of these medicines, wait at least 15 days before taking SENIORAL syrup for adults. If you are unsure whether your medication contains an MAOI drug, consult your doctor or pharmacist before taking SENIORAL syrup for adults.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Breastfeeding women should not take this medicine, as it passes into breast milk and may affect the infant.

Driving and use of machines

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

Use in athletes

Athletes should be informed that this medicine contains a component that may lead to a positive result in doping controls.

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

This medicine contains 163 mg of alcohol (ethanol) per 15 ml, equivalent to 1.38% v/v. The amount of alcohol in 15 ml of this medicine is equivalent to less than 4 ml of beer or 2 ml of wine.

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

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

This medicine contains 9.5 g of sucrose per 15 ml. This should be considered by patients with diabetes mellitus. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take SENIORAL syrup for adults

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Recommended dose:

For adults and children over 12 years of age: The maximum dose is 15 ml (one tablespoon) three times a day (45 ml/day), to be taken before meals, with a minimum interval of 6 hours between doses. If symptoms do not improve after 5 days or are accompanied by high fever, consult your doctor before continuing treatment.

SENIORAL syrup for adults is administered orally.

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

Remember to take your medicine.

Use in children

Do not use in children under 12 years of age.

If you take more SENIORAL syrup for adults than you should

If you have taken a higher dose than recommended, you may experience cardiac and neurological disturbances. In such cases, gastric lavage should be performed and symptoms treated. Consult your doctor or pharmacist.

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

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

If you forget to take SENIORAL syrup for adults

Do not take a double dose to make up for missed doses. Take the missed dose as soon as possible. However, if less than 6 hours remain before the next scheduled dose, wait until that time to take your dose of syrup.

If you stop treatment with SENIORAL syrup for adults

Your doctor will advise you on the duration of treatment with SENIORAL syrup for adults. If treatment is stopped before completing the period indicated by your doctor, symptoms of your condition may reappear.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everybody experiences them.

Cardiovascular effects: pulse disturbances (frequency not known: strong heartbeat that may be fast or irregular (palpitations), tachycardia), increased blood pressure (hypertension), which may sometimes be severe (hypertensive crisis).

Nervous system effects: restlessness, dizziness, insomnia, headache, unusual behaviour. Sedation and somnolence may occasionally occur.

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 experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of SENIORAL syrup for adults

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Store in the original packaging.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of SENIORAL cough syrup for adults

• The active substances 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 dose (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), cassis extract 30 GS 705, concentrated hydrochloric acid and purified water.

Appearance of the medicinal product and contents of the container

SENIORAL cough syrup for adults is a colourless syrup supplied in cartons containing one 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 most recent revision of this leaflet: May 2025.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.