Label: information for the user

Effective antiallergic nasal spray solution

oxymetazoline hydrochloride, chlorphenamine maleate

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

Follow exactly the administration instructions for the medication contained in this label or those indicated by your doctor or pharmacist.

• Keep this label, as you may need to refer to it again.

• For advice or more information, consult your pharmacist.
• Consult your doctor or pharmacist if you experience any adverse effects, even if they are not listed in this label. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 3 days.

respibien antialérgico is an association of 2 active principles, oximetazoline and chlorphenamine. Oximetazoline belongs to the group of medicines known as direct-acting sympathomimetics and has a decongestant effect. Chlorphenamine belongs to the group of medicines known as antihistamines that help reduce excess nasal secretion.

This medicine is used for the local and temporary relief of nasal congestion caused by allergic rhinitis.

No use respibien antialérgico

Warnings and Precautions

Consult your doctor or pharmacist before starting to use respibien antialérgico.

Consult your doctor if you are taking medications used to treat depression (tricyclic antidepressants) ormedications with similar action and you experience stomach or intestinal problems (gastrointestinal).

In rare cases, due to its content of oxymetazoline, this medication may increase nasal congestion symptomsinstead of reducing them; this is due to its temporary effects and prolonged use may cause this result, knownas rebound effect.

Therefore, do not exceed the recommended dose in section 3 How to use respibien antialérgico.

To avoid contagion, the medication should not be used by more than 1 person and the applicator should becleaned always after each use, with a clean and damp cloth.

Other Medications and respibien antialérgico

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

This medication should not be used by people taking or having taken during the last 2 weeks: medications usedto treat depression (tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs)) or a medication tolower blood pressure (methyldopa) because it may potentiate the appearance of adverse effects.

It should not be used in case of being treated with a tranquilizer (phenothiazine) or medications to treat asthma.

The simultaneous use of this medication with alcohol or other medications such as tranquilizers and those usedfor insomnia or anxiety (central nervous system depressants) may potentiate the occurrence of adverse effects.

Interference with Analytical Tests

If you are going to undergo any analytical test (blood, urine, skin tests using allergens, etc.) inform yourdoctor that you are using this medication, as it may alter the results of these tests.

Children

Not to be used in children under 6 years.

Children may be especially prone to the appearance of adverse effects of this medication.

Use in People Over 65 Years

Consult your doctor or pharmacist as older people are more sensitive to the adverse effects of this medication.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult yourdoctor or pharmacist before using this medication.

This medication should not be used during pregnancy or breastfeeding, as it may cause severe adverse effectsin the newborn.

Driving and Operating Machinery

Although it is not expected that this medication will affect the ability to drive or operate machinery, if younotice drowsiness or dizziness, do not drive or operate hazardous machinery.

respibien antialérgico contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per ml; this is essentially "sodium-free".

Follow exactly the administration instructions of the medication contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and children over 6 years old:

It is recommended to perform 1 application in both nostrils, once a day, in case of need, another application can be performed at 12 hours. Do not use more than 2 times in 24 hours.

Children under 6 years old:

This medication cannot be used in children under 6 years old.

Method of use:

This medication is used via the nose.

If it is the first time you use this product or have not used it for a long time, it is necessary to load the sprayer. To do this, keeping the container away from the body, press the sprayer several times until a finely powdered liquid comes out.

Blow your nose well before using this medication.

Perform 1 rapid and firm pulse in each nostril, inhaling deeply while pressing the sprayer and keeping your head up.

To avoid contagion, the container can only be used by 1 person.

After each application, clean the tip of the applicator with a clean and damp cloth and close the container immediately.

The maximum duration of treatment is 3 days. If symptoms worsen or persist after 3 days of continuous treatment, interrupt it and consult your doctor.

If it is necessary to repeat the treatment, it must be done several days after having finished the previous treatment.

If you use more antiallergic respibien than you should

By excessive or very continuous dose application, you may notice: headache, tremors, insomnia, excessive sweating, palpitations, tachycardia, increased blood pressure or sleep disturbances.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use respibien antiallergic

Do not use a double dose to compensate for the missed doses.

If necessary, use it again as indicated in section 3. How to use respibien antiallergic.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The excessive or continued use of this medicine may lead to an increase in nasal congestion. During the period of use of oxymetazoline by nasal route and chlorphenamine by oral route at doses higher than those of this medicine, the following adverse reactions have occurred whose frequency has not been established with precision.

The most frequent side effects are: stinging at the application site, dryness, nasal mucosa itching or sneezing. Mild drowsiness, dizziness, muscle weakness; these side effects in some patients may disappear spontaneously after 2-3 days of using the medicine. Difficulty in facial movements, clumsiness, tremors, alterations in sensations and paresthesias, dry mouth, loss of appetite, alterations in taste or smell, gastrointestinal discomfort such as nausea, vomiting, diarrhea, constipation, stomach pain, as well as urinary retention, nasal and throat dryness, mucous thickening, sweating, blurred vision or other visual disturbances.

The side effects that can occur in rare cases are: tremors, palpitations, headache, nausea, skin redness (exanthema), anxiety, increased blood pressure, tachycardia, and hallucinations. Generally with high doses and more frequently in elderly patients and children, nervous excitement with symptoms such as restlessness, insomnia, nervousness, and even convulsions.

Other side effects: chest tightness, lung noises, rapid or irregular heartbeats (tachycardia) generally with overdose, liver disorders (which may present with stomach or abdominal pain, dark urine, or other symptoms), allergic reactions, some of which can be severe (cough, difficulty swallowing, rapid heartbeats, itching, swelling of eyelids or around the eyes, face, tongue, difficulty breathing, etc.), photosensitivity, cross-reactivity allergy to other related chlorphenamine medications, rarely blood disorders such as changes in blood cell levels such as agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia, and pancitopenia; blood pressure changes, swelling (edema), ear alterations, impotence, menstrual disorders.

If you consider that any of the side effects you experience is severe or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not appearing in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

This medication does not require special conservation conditions.

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.

Do not dispose of medications through drains or trash. Deposit the 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 the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of the antiallergic response

• The active principles are oxymetazoline hydrochloride and chlorphenamine maleate.

Each ml contains 0.5 mg (65 micrograms per pulse of 0.13 ml) of oxymetazoline hydrochloride and 0.5 mg (65 micrograms per pulse of 0.13 ml) of chlorphenamine maleate.

• The other components (excipients) are: sodium chloride, sodium dihydrogen phosphate dihydrate, sodium hydrogen carbonate, thimerosal, niaouli essence, phosphoric acid and/or sodium hydroxide (to adjust the pH) and purified water.

Appearance of the product and contents of the packaging

This medication is a transparent and slightly viscous aqueous nasal spray solution.

It is packaged in a high-density polyethylene bottle, white, provided with a dosing pump and a screw cap that ensures its correct conservation.

Each package contains 15 ml of nasal spray solution.

Holder of the marketing authorization and responsible for manufacturing

Cinfa Laboratories, S.A.

Olaz-Chipi Highway, 10. Areta Industrial Estate

31620 Huarte (Navarra) – Spain

Last review date of this leaflet:December 2021

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