Prospect: information for the user

Rhinocort 64 micrograms nasal spray

Budesonide

1.What is Rhinocort 64 micrograms and what it is used for.

2.What you need to know before starting to use Rhinocort 64 micrograms.

3.How to use Rhinocort 64 micrograms.

4.Possible side effects.

5.Storage of Rhinocort 64 micrograms.

6. Contents of the pack and additional information.

Rhinocort 64 micrograms contains budesonide as its active ingredient, which belongs to a group of medicines called glucocorticoids and is used to reduce inflammation. Rhinocort 64 micrograms reduces nasal mucosa inflammation (the inner part of the nose).

Rhinocort 64 micrograms is used for the relief of nasal symptoms (such as sneezing, itching, runny nose, congestion) of allergic rhinitis caused by pollen and other airborne allergens, such as dust mites, fungal spores, or animal hair, in adults.

The maximum level of protection may not be achieved during the first few days, so it is essential to continue regular use to ensure complete therapeutic benefit.

Consult a doctor if symptoms do not improve or worsen after 7 days.

This medicine should not be used continuously for more than 3 months unless your doctor advises otherwise.

Do not use Rhinocort 64 micrograms:

• If you are allergic to the active ingredient or to any of the other components of this medicine (listed in section 6).
• If you present symptoms or signs of a localized infection in the nasal passages.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Rhinocort 64 micrograms if:

• You suffer from severe or frequent nasal bleeding.
• If you have recently had nasal ulcers, have undergone nasal surgery, or have had a nasal wound that has not healed well.
• You suffer from tuberculosis, a chest infection, chickenpox, or measles, or have been in contact with someone who suffers from tuberculosis, chickenpox, or measles.
• You have ever had glaucoma (increased eye pressure) or cataracts.
• You have an eye infection.
• You have diabetes.
• You have liver problems.

Consult your doctor or pharmacist if you suffer from any of the following conditions while using Rhinocort 64 micrograms:

• Blurred visionor othervisual disturbances
• Any sign ofinfection, such as persistent fever

If symptoms persist or worsen, or if new symptoms appear, stop using Rhinocort 64 micrograms and consult your doctor.

Children and adolescents

The long-term effects in children are unknown, but it may cause growth retardation. If growth is observed to be delayed, consult your doctor to assess treatment.

Use of Rhinocort 64 micrograms with other medicines:

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine. This includes medicines obtained without a prescription and herbal medicines. Some medicines may increase the effects of Rhinocort. In particular, inform your doctor or pharmacist if you are taking the following medicines:

• For treatingfungus infections(such as itraconazole or ketoconazole).
• You are taking antibiotics (such as clarithromycin).
• You are taking HIV medicines (such as saquinavir, atazanavir, indinavir, nelfinavir, ritonavir, or medicines containing cobicistat).
• You are taking cimetidine (medicine for stomach acid).

• You are takingestrogenssuch ashormone replacement therapyorbirth control pills.
• You are taking anothermedicine with corticosteroids(such as creams for eczema, inhalers for asthma, tablets, injections, nasal sprays, eye or nasal drops).
• You have recently stopped takingtablets with corticosteroidssuch asprednisoloneorinjections of corticosteroids.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine. You must contact your doctor as soon as possible if you become pregnant during treatment with Rhinocort 64 micrograms.

Driving and operating machinery

There is no indication thatRhinocort 64 microgramsmay affect your ability to drive or operate machinery.

Rhinocort 64 micrograms contains potassium sorbate.

Since Rhinocort 64 micrograms contains potassium sorbate as an excipient, it may cause local skin reactions (e.g., contact dermatitis)

Warning to athletes:This medicine contains a component that may produce a positive result in doping control tests.

Follow exactly the administration instructions for Rhinocort 64 micrograms contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Adults:

The recommended initial daily dose is two sprays in each nasal passage.

This dose can be administered as two applications (2 x 64 micrograms) in each nasal cavity once a day in the morning or one application (1 x 64 micrograms) in each nasal cavity, in the morning and in the evening.

Once total symptom relief is achieved, administration can be reduced to one spray in each nasal passage once a day, preferably in the morning.

Do not administer more than four applications in a day.

You should consult a doctor or pharmacist if symptoms worsen or do not improve after 7 days.

Do not use it continuously for more than 3 months.

You may experience symptom relief from the first day of treatment, however, several days of treatment may be necessary for the full effect to occur (in some cases up to 2 weeks).

Do not share the sprayer with other people due to the risk of contagion.

Avoid contact of the product with the eyes. In case of eye contact, rinse them immediately with plenty of water.

Before using Rhinocort 64 micrograms for the first time, you should read the "Administration Form" section, which explains how the pump sprayer works. Follow the instructions carefully.

Use in children

This medication should not be used in children or adolescents under 18 years old.

If you use more Rhinocort 64 micrograms than you should

The administration of an occasional dose of more than the recommended dose usually does not cause adverse effects. If this occurs over a long period (months), it is possible for adverse effects to appear, so you should consult your doctor or pharmacist.

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service, phone +34915620420, indicating the medication and the amount ingested.

If you forgot to use Rhinocort 64 micrograms:

In case of forgetting a dose of Rhinocort 64 micrograms, wait for the next one. Do not take a double dose to compensate for the missed doses. Simply apply the next dose as needed.

Administration Form

Read the following use instructions carefully and follow them carefully.

Before using the nasal sprayer of Rhinocort 64 micrograms for the first time, shake the container, remove the protective cap, and, holding the container in a vertical position, press several times (5-10 times) into the air until a uniform spray of the product appears (see Figure 1). If it is not used daily, it is necessary to recharge the pump. In this case, a single (1) air press will be sufficient.

1.Blow your nose. Shake the container and remove the cap.

2.Hold the container in a vertical position as shown in the figures.

3.Insert the tip of the applicator into one nasal passage and direct it to the side of the nose in the direction opposite the nasal center (the "septum"). Press one or two times, depending on the dose needed. Repeat the action in the other nasal passage.

4.Replace the cap. Do not use the Rhinocort 64 micrograms nasal sprayer more times than recommended in this leaflet.

Cleaning

Clean the upper plastic parts regularly. To do this, remove the cap and the nasal applicator. Wash the plastic parts with warm water. Let them dry completely in the air before replacing them.

Do not attempt to clean the nasal applicator with a pin or any sharp object.

When you no longer need this medication, it is recommended to dispose of the remainder, even if it has not been consumed in its entirety.

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.

If you experience any of the following symptoms, stop using this nasal spray and consult a doctor immediately:

• Sudden signs of allergic reaction such as hives, itching, rashes, or skin redness, facial swelling, lip, mouth, tongue, or other body part swelling, difficulty breathing, wheezing, or difficulty swallowing or breathing, or feeling of fainting.

Other side effectsinclude:

Frequent (may affect 1 in 10 patients):

• Nasal, throat, or sinus infections:
• Nasal bleeding (epistaxis) or nasal irritation.
• Mouth and/or throat pain.
• Ears infection.
• Headache.
• Abdominal discomfort.
• Fever.

Less frequent (may affect up to 1 in 100 patients):

- Muscle cramps.

Rare (may affect up to 1 in 1,000 patients):

- Effects on the adrenal glands (small glands located near the kidneys).

- Nasal ulcers or perforation of the nasal septum.

- Voice change.

- Hematomas.

- Blurred vision.

Other side effects of unknown frequency include:

- Cataracts (loss of transparency of the crystalline lens in the eye).

- Glaucoma (increased intraocular pressure).

- Angioedema.

- Dermatitis.

- Erythema.

- Eruption.

- Urticaria.

Other side effects in children

There has been reported reduced growth in children treated with nasal corticosteroids.

In children, the following side effects have been frequently reported: abdominal discomfort, headache, cough, fever or high temperature, inflammation, and infections of the ears, tonsils, sinuses, or lungs, or skin rash.

There have been reported rare occasions (especially in children) of mental or behavioral disorders, such as hyperactivity, sleep disorders, nervousness, depression, or aggression.

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 that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Replace the protective cap after using Rhinocort 64 micrograms.

Do not store at a temperature above 30 °C. Do not freeze.

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.

Medications should not be disposed of through drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Rhinocort 64 micrograms

• The active ingredient is budesonide.

• The other components (excipients) are:sodium edetate, potassium sorbate (E 202), anhydrous glucose, microcrystalline cellulose (E 460) and sodium carboxymethyl cellulose (E 466), polisorbate 80 (E 433), hydrochloric acid and purified water.

Appearance of the product and contents of the packaging

Rhinocort 64 micrograms is presented in abrown glass vial of 10 ml (120 sprays) provided with a spray pump and a nasal applicator. The liquid it contains is a nasal spray suspension. Each spray contains 64 micrograms of the active ingredient.

Holder of the marketing authorization and responsible for manufacturing

The holder is:

JNTL Consumer Health (Spain), S.L.

C/ Vía de los Poblados 1, Edificio E, planta 3

28033-Madrid

Spain

The manufacturer is:

McNeil AB

Norrbroplatsen 2

251 09 Helsingborg

Sweden

Last review date of this leaflet: March 2022

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