RESPIBIEN ANTIALLERGIC NASAL SPRAY SOLUTION

Introduction

Leaflet: information for the user

respibien antiallergic nasal spray solution

oxymetazoline hydrochloride, chlorphenamine maleate

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

Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.

• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 3 days.

Contents of the leaflet

1. What respibien antiallergic is and what it is used for
2. What you need to know before starting to use respibien antiallergic
3. How to use respibien antiallergic
4. Possible side effects
5. Storage of respibien antiallergic
6. Package contents and additional information

1. What respibien antiallergic is and what it is used for

respibien antiallergic is an association of 2 active ingredients, oxymetazoline and chlorphenamine. Oxymetazoline 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.

2. What you need to know before starting to use respibien antiallergic

Do not use respibien antiallergic

• If you are allergic to chlorphenamine, oxymetazoline, other nasal decongestants, or any of the other components of this medicine (listed in section 6).
• If you have recently undergone surgery on the head (cranial, transnasal, or transoral intervention).
• In case of dry inflammation of the nasal mucosa (dry rhinitis).
• If you have suffered asthma attacks when using any medicine with chlorphenamine or other medicines used for allergies (antihistamines).
• If you are asthmatic and when using allergy medicines (antihistamines) they have caused you bronchopulmonary problems.

Warnings and precautions

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

• If you are being treated with: medicines for depression, tranquilizers (phenothiazine), or to lower blood pressure (methyldopa).
• If you have had or have, even if only once, any of the following diseases or symptoms:
• high blood sugar levels (diabetes mellitus)
• high blood pressure (arterial hypertension)
• any heart or circulatory disease
• glaucoma or high intraocular pressure
• stomach problems such as obstructive ulcers or obstruction in the stomach outlet (pyloroduodenal obstruction)
• respiratory problems such as emphysema or bronchitis
• any thyroid disease
• prostate disease with difficulty urinating (prostatic hypertrophy or bladder neck obstruction).
• If you have ever suffered from insomnia or dizziness when treated with other sympathomimetic medicines, such as those used to treat heart diseases, low blood pressure (hypotension), or asthma.
• Patients allergic (sensitive) to any allergy medicine (antihistamine) should consult their doctor before using this medicine, as they may also be sensitive to other antihistamines like this one.

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

In rare cases, due to its oxymetazoline content, this medicine may increase nasal congestion symptoms instead of decreasing them; this is because its effects are temporary and prolonged use can cause this result, known as rebound effect.

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

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

Other medicines and respibien antiallergic

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

This medicine should not be used by people who are taking or have taken in the last 2 weeks: medicines used to treat depression (tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs)) or with a medicine to lower blood pressure (methyldopa), as it may increase the risk of side effects.

It should not be used in case of treatment with a tranquilizer (phenothiazine) or with medicines for asthma.

The simultaneous use of this medicine with alcohol or other medicines such as tranquilizers and those used to treat insomnia or anxiety (central nervous system depressants) may increase the risk of side effects.

Interference with analytical tests

If you are going to have any analytical tests (blood tests, urine tests, skin tests using allergens, etc.), inform your doctor that you are using this medicine, as it may alter the results of these tests.

Children

Do not use in children under 6 years of age.

Children may be especially prone to the appearance of side effects of this medicine.

Use in people over 65 years of age

Consult your doctor or pharmacist, as older people are more sensitive to the side effects of this medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

This medicine should not be used during pregnancy or breastfeeding, as it may cause serious side effects in the newborn.

Driving and using machines

Although it is not expected that this medicine will affect your ability to drive or use machines, if you feel drowsy or dizzy, do not drive or operate hazardous machinery.

respibien antiallergic contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per ml; that is, it is essentially "sodium-free".

3. How to use respibien antiallergic

Follow exactly the administration instructions of the medicine contained in this leaflet or as 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 of age:

It is recommended to perform 1 application in both nostrils, 1 time a day, and if necessary, another application can be performed after 12 hours. Do not use more than 2 times in 24 hours.

Children under 6 years of age:

This medicine cannot be used in children under 6 years of age.

Method of use:

This medicine is used nasally.

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 spray pump. To do this, keeping the container away from the body, press the spray pump several times until a finely atomized liquid comes out.

Blow your nose well before using this medicine.

Perform 1 quick and firm puff in each nostril, inhaling deeply while pressing the spray pump and keeping your head upright.

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

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

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

If it is necessary to repeat the treatment, it should be done several days after the previous treatment has ended.

If you use more respibien antiallergic than you should

Due to excessive or very continuous dosing, 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 Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use respibien antiallergic

Do not use a double dose to make up for forgotten 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 medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Excessive or continuous 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 could not be established with accuracy.

The most frequent side effects are: itching 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. It can also cause difficulty in facial movements, clumsiness, tremors, alterations in sensations and tingling, dry mouth, loss of appetite, alterations in taste or smell, stomach and intestinal problems (gastrointestinal) such as nausea, vomiting, diarrhea, constipation, stomach pain, as well as urinary retention, nasal and throat dryness, thickening of mucus, sweating, blurred vision, or other vision disorders.

The side effects that can occur rarely 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) usually with overdose, liver disorders (which can be presented with stomach pain or abdominal pain, dark urine, or other symptoms), allergic reactions, some of which can be serious (cough, difficulty swallowing, rapid heartbeat, itching, swelling of the eyelids or around the eyes, face, tongue, difficulty breathing, etc.), sun sensitivity (photosensitivity), allergy to other medicines related to chlorphenamine (cross-sensitivity), rarely blood alterations such as changes in blood cell levels such as agranulocytosis, leucopenia, hemolytic anemia, thrombocytopenia, and pancytopenia; low or high blood pressure, swelling (edema), ear disorders, impotence, menstrual disorders.

If you think any of the side effects you are suffering from is serious or if you notice any side effect not mentioned in this leaflet, 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 listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of respibien antiallergic

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

This medicine does not require special storage conditions.

Do not use this medicine after the expiration date that appears on the container after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through wastewater or household waste. Deposit the containers and medicines you no longer need in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of respibien antiallergic

• The active ingredients are oxymetazoline hydrochloride and chlorphenamine maleate.

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

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

Appearance of the product and package contents

This medicine is a clear, slightly viscous aqueous nasal spray solution.

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

Each container contains 15 ml of nasal spray solution.

Marketing authorization holder and manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Date of the last revision of this leaflet:December 2021

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