SENIORAL TABLETS

Introduction

Package Leaflet: Information for the User

SENIORAL 5 mg/30 mg tablets

Clocinizine dihydrochloride/Phenylpropanolamine hydrochloride

Read the entire package leaflet carefully before starting to take the medicine, as it contains important information for you.

• Keep this package 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 side effects you are experiencing is serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

Contents of the Package Leaflet

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. Storage of SENIORAL tablets
6. Contents of the pack and further information

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

SENIORAL tablets have 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 tablets are 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 tablets

Do not take SENIORALtablets

• if you are allergic (hypersensitive) to phenylpropanolamine or clocinizine or any of the other components of SENIORAL tablets.
• 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 medicine for depression or Parkinson's disease that inhibits monoamine oxidase (MAOI) (see below: Use of other medicines).
• in children under 12 years of age.

Be careful with SENIORALtablets

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

Use of other medicines

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

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Women who are breastfeeding should not take this medicine, 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 can decrease your concentration and reflexes.

Use in athletes

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

3. How to take SENIORAL tablets

Follow the administration instructions of SENIORAL tablets exactly as indicated by your doctor. Consult your doctor or pharmacist if you have doubts.

The normal dose is:

In adults and children over 12 years old:The maximum dose is 1 tablet three times a day (3 tab/day) to be taken before meals, and a minimum time of 6 hours should be left between each intake. If symptoms do not improve after 5 days or are accompanied by high fever, consult your doctor before continuing treatment.

SENIORAL tablets are administered orally.

Tablets should be taken before meals. A minimum time of 6 hours should be left between each intake.

Remember to take your medicine.

Use in children

Do not use in children under 12 years of age.

If you take more SENIORALtabletsthan you should

If you have taken more than the recommended dose, you may experience cardiac and neurological alterations. In this case, 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, stop using this medicine immediately and consult your doctor.

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

If you forget to take SENIORALtablets

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 before taking the next dose, wait until that time to take your tablet.

If you stop taking SENIORAL tablets

Your doctor will indicate the duration of treatment with SENIORAL tablets. If you stop before completing 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 medicines, SENIORAL tablets can cause side effects, although not everyone will experience them.

Cardiovascular effects: Pulse alterations (with unknown frequency: strong and 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 consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this package 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 package 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 medicine.

5. Storage of SENIORAL tablets

Keep out of the reach and sight of children.

Do not use SENIORAL tablets after the expiration date stated on the packaging. The expiration date is the last day of the month indicated.

Store in the original packaging.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Contents of the pack and further information

Composition of SENIORAL tablets

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

Appearance and packaging of the product

SENIORAL tablets are presented in packs containing 20 white, round 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 Barberá del Vallés, Barcelona, Spain.

This package leaflet was approved in May 2025.

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