Senioral tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

SENIORAL 5 mg/30 mg tablets

Clocinizine dihydrochloride/Phenylpropanolamine hydrochloride

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you and must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you think any of the side effects you experience is serious or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents

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

1. What SENIORAL tablets are and what they are used for

SENIORAL tablets contain two active substances: clemastine and phenylpropanolamine.

Clemastine 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 tablets are used solely for the temporary relief of nasal congestion in colds, rhinitis, and nasal congestion associated with sinusitis.

2. What you need to know before starting to take SENIORAL tablets

Do not take SENIORAL tablets

• if you are allergic (hypersensitive) to phenylpropanolamine or clocinizine or to any of the other components of SENIORAL tablets.
• if you have high blood pressure (arterial hypertension), if you have a thyroid disorder (hyperthyroidism), or suffer from 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.

Take special care with SENIORAL tablets

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

Use of other medicines

Inform your doctor or pharmacist if you are using or have recently used any other medicines, even those obtained without a prescription.

• If administered together with drugs that inhibit the enzyme monoamine oxidase (MAOI), used for depression (tranilcipromine, moclobemide) or for Parkinson's disease (selegiline), serious adverse effects may occur, manifested 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 tablets. If you are unsure whether your medication contains an MAOI drug, consult your doctor or pharmacist before taking SENIORAL tablets.
• If you are undergoing treatment with other medicines, consult your doctor or pharmacist before taking SENIORAL tablets.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

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

Driving and operating machinery

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

Use in athletes

Athletes are advised that this medicine contains a component that may lead to a positive analytical result in doping controls.

3. How to take SENIORAL tablets

Follow exactly the instructions for use of SENIORAL tablets provided by your doctor. If you have any doubts, consult your doctor or pharmacist.

The usual dose is:

In adults and children over 12 years of age: The maximum dose is 1 tablet three times a day (3 tablets/day), taken before meals, with a minimum interval of 6 hours between doses. If symptoms do not improve within 5 days or are accompanied by high fever, consult your doctor before continuing treatment.

SENIORAL tablets are administered orally.

The tablets 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 tablets than you should

If you have taken more than the recommended dose, 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 tablets, go immediately to your doctor or the nearest hospital emergency department, or contact the Toxicology Information Service (telephone: 91 562 04 20), stating the name of the medicine and the amount ingested. Bring this leaflet with you if possible.

If you forget to take SENIORAL tablets

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 tablet.

If you stop treatment with SENIORAL tablets

Your doctor will advise you on the duration of treatment with SENIORAL tablets. If treatment is stopped before the end of the period indicated by your doctor, symptoms of your condition may recur.

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

4. Possible adverse effects

Like all medicines, SENIORAL tablets may cause adverse effects, although not everyone 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 crises).

Nervous system effects: Restlessness, dizziness, insomnia, headache, abnormal 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 Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of SENIORAL tablets

Keep out of the reach and sight of children.

Do not use SENIORAL tablets after the expiry date shown on the packaging. 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 drains or in household waste. Unused medicines and their containers should be taken to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of SENIORAL tablets

• The active substances are: Clocinizine dihydrochloride and phenylpropanolamine hydrochloride. Each tablet contains 5 mg of clocinizine dihydrochloride and 30 mg of phenylpropanolamine hydrochloride.
• The other components are: Microcrystalline cellulose, calcium hydrogen phosphate dihydrate (Emcompress), sodium carboxymethylstarch (Explotab), magnesium stearate and talc.

Appearance of the product and contents of the pack

SENIORAL tablets are presented in cartons containing 20 round white tablets.

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 Barberà del Vallès, Barcelona, Spain.

This leaflet was approved in May 2025.

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