Leaflet: information for the user

SENIORAL 5 mg/30 mg tablets

Clocinizine dihydrochloride/Phenylpropanolamine hydrochloride

Read the entire leaflet carefully before starting to take the medicine, because 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 for 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 severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

SENIORALtabletshas two active principles: 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.

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

Do not take SENIORALtablets

• if you are allergic (hypersensitive) to phenylpropanolamine or clocinizine or any other component of SENIORAL tablets.
• if you have high blood pressure (hypertension), if you have a thyroid disease (hyperthyroidism) or heart disease (severe coronary disease or angina pectoris).
• if you are taking any medication for depression or Parkinson's disease that inhibits mono-amino-oxidase (MAO) (see below: Use of other medications).
• in children under 12 years old.

Be especially careful with SENIORALtablets

• Do not exceed the maximum recommended dose (see3. How to take SENIORAL tablets), as it may cause severe adverse effects (seeIf you take more SENIORAL tablets than you should).
• If you have diabetes mellitus, high eye pressure (glaucoma) or prostate enlargement (prostatic hypertrophy) or urinary retention, as it may worsen these conditions.

Use of other medications

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

• If administered with medications that inhibit mono-amino-oxidase (MAO), used for depression (tranylcypromine, moclobemide) or Parkinson's disease (selegiline), severe adverse effects may occur, manifesting as strong headache and sudden elevation of temperature. If you have taken one of these medications, waitat least 15 days before taking SENIORALtablets. If you are unsure if your medication contains an MAO inhibitor, consult your doctor or pharmacist before taking SENIORALtablets.
• If you are taking other medications, consult your doctor or pharmacist before taking SENIORALtablets.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

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

Driving and operating machinery

Do not drive or operate tools or machines, as SENIORAL may impair your concentration and reflexes.

Use in athletes

It is reported to athletes that this medication contains a component that may result in a positive analytical control for doping as positive.

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

The usual dose is:

For adults and children over 12 years old:The maximum dose is 1 tablet three times a day (3 tablets/day) taken before meals and should leave a minimum time of 6 hours between each dose. 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.

Tablets should be taken before meals. Leave a minimum time of 6 hours between each dose.

Remember to take your medication.

Use in children

Do not use in children under 12 years old.

If you take more SENIORAL tablets than you should

If you have taken more doses than recommended, you may experience cardiac and neurological alterations. In this case, perform gastric lavage and treat symptoms. 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 medication immediately and consult your doctor.

In case of excessive or accidental intake of SENIORAL tablets, go immediately to your doctor or the nearest hospital emergency service or consult the Toxicological Information Service (phone: 91 562 04 20), indicating the medication and the amount ingested. Bring this leaflet with you if possible.

If you forgot to take SENIORAL tablets

Do not take a double dose to compensate for the missed doses. Take your dose as soon as possible. If less than 6 hours remain before taking the next dose, wait until then to take your tablet.

If you interrupt treatment with SENIORAL tablets

Your doctor will indicate the duration of treatment with SENIORAL tablets. If treatment is interrupted before completing the indicated period, symptoms of your disease may reappear.

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

Like all medications, SENIORALtabletscan cause adverse effects, although not everyone will experience them.

Cardiovascular Effects: Changes in heart rhythm (palpitations, tachycardia), elevated blood pressure (hypertension), which can sometimes be severe (hypertensive crisis).

Effects on the Nervous System: Restlessness, dizziness, insomnia, headache, unusual behavior. Occasionally, it can cause sedation and drowsiness.

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 are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep out of the reach and sight of children.

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

Store in the original packaging.

Do not dispose of medications through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of SENIORAL tablets

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

Appearance of the product and contents of the packaging

SENIORALtabletsare presented in boxes containing 20 round white tablets.

Holder of the marketing authorization

Laboratorios ERN, S.A.

C/Perú, 228

08020 Barcelona, Spain

Responsible for manufacturing

Laboratorios ERN, S.A.

C/Gorchs Lladó, 188

Pol. Ind. Can Salvatella

08210 Barberá del Vallés, Barcelona. Spain.

This leaflet was approved in June 2011.

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.