Label: information for the user

SENIORAL syrup for adults

Clocinizine dihydrochloride/Phenylpropanolamine hydrochloride

Read this label carefully before starting to take this medicine, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to others, 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 not listed in this label. See section 4.

SENIORALsyrup for adultscontains two active ingredients: clocinizine and phenylpropanolamine.

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

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

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

Do not take SENIORALadult syrup

• If you are allergic (hypersensitive) to phenylpropanolamine or clocinizine or any other component of this medication (listed in section 6).
• If you have high blood pressure (hypertension), if you have any thyroid disease (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 mono-amino-oxidase (MAO) (see below: Use of other medications).
• In children under 12 years old.

Warnings and precautions

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

• Do not exceed the maximum recommended dose (see3. How to take SENIORAL adult syrup), as severe adverse effects may occur (seeIf you take more SENIORALadult syrupthan you should).
• If you have diabetes mellitus, have elevated eye pressure (glaucoma) or have prostate enlargement (prostatic hypertrophy) or urinary retention, as these conditions may worsen.

Other medications and SENIORAL adult syrup

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

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

Pregnancy and lactation

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

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

Driving and operating machines

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

Use in athletes

Inform athletes that this medication contains a component that may result in a positive analytical test for doping control.

SENIORAL adult syrup contains alcohol (ethanol), methyl parahydroxybenzoate (E-218) and saccharose.

This medication contains 163 mg of alcohol (ethanol) per 15 ml, equivalent to a 1.38% v/v. The amount of alcohol in 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 perceptible effects.

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

This medication contains 9.5 g of saccharose per 15 ml. This should be taken into account by patients with diabetes mellitus. If your doctor has told you that you have intolerance to certain sugars, consult with him before taking this medication.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

For adults and children over 12 years old:The maximum dose is 15 ml (one tablespoon) three times a day (45 ml/day), which will be 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.

SENIORALadult syrupis administered orally.

The syrup should be taken before meals. It should 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 SENIORALadult syrupthan 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 the 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 SENIORALadult syrup, 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 SENIORALadult syrup

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 tablespoon of syrup.

If you interrupt treatment with SENIORAL adult syrup

Your doctor will indicate the duration of treatment with SENIORALadult syrup. If you interrupt before completing the indicated period of time, your symptoms may reappear.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Cardiovascular Effects: alterations in heart rhythm (palpitations, tachycardia), elevation of blood pressure (hypertension), which can sometimes be severe (hypertensive crises).

Effects on the Nervous System: restlessness, dizziness, insomnia, headache, unusual behavior. Occasionally, it may produce 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 on the safety of this medication.

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

Do not use this medication after the expiration date that appears 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 drains or trash. Dispose of packaging and medications you no longer need 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 adult syrup

• The active principles 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), 30 GS 705 cassia extract, concentrated hydrochloric acid, and purified water.

Appearance of the product and contents of the packaging

SENIORAL adult syrup is an colorless syrup, which is presented in containers containing a bottle that contains 150 ml.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios ERN, S.A.

C/Perú, 228

08020 Barcelona, España

Responsible for manufacturing

Laboratorios ERN, S.A.

C/Gorchs Lladó, 188

Pol. Ind. Can Salvatella

08210 Barberá del Vallés (Barcelona). España.

Last review date of this leaflet: October 2020

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