Rino-Ebastel 10 mg/120 mg modified-release hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Rino-Ebastel 10 mg/120 mg modified-release hard capsules

ebastine/pseudoephedrine hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Always follow exactly the instructions for use of this medicine as described in this leaflet or as given 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 any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 7 days.

Contents of this leaflet:

1. What Rino-Ebastel is and what it is used for
2. What you need to know before taking Rino-Ebastel
3. How to take Rino-Ebastel
4. Possible side effects
5. How to store Rino-Ebastel
6. Contents of the pack and other information

1. What Rino-Ebastel is and what it is used for

Rino-Ebastel contains a combination of two active substances, ebastine and pseudoephedrine.

Ebastine is an antihistamine (antiallergic) and pseudoephedrine is a nasal decongestant. Antihistamines help reduce allergy symptoms by preventing the effects of histamine release. Decongestants help reduce nasal congestion.

Rino-Ebastel is indicated for the relief of nasal and ocular symptoms associated with seasonal allergic rhinitis when accompanied by nasal congestion, in adults and adolescents from 12 years of age.

You should consult a doctor if your condition worsens or does not improve after 7 days of treatment.

2. What you need to know before taking Rino-Ebastel

Do not take Rino-Ebastel

• if you have very high blood pressure (severe hypertension) or uncontrolled hypertension due to your medication.

• if you have severe acute (sudden) or chronic (long-term) kidney disease, or kidney failure.

• if you are allergic to ebastine, pseudoephedrine, or any of the other components of this medicine (listed in section 6).

• if you suffer from a serious eye condition in which pressure inside the eye increases and may lead to blindness (narrow-angle glaucoma).

  • if you have urinary retention.
  • if you have very high blood pressure (severe hypertension).
  • if you have reduced blood flow to the heart through the coronary arteries (coronary insufficiency).
  • if you have a condition in which the thyroid gland produces too much thyroid hormone (hyperthyroidism).
  • if you are taking or have taken within the last two weeks certain medicines used to treat depression called monoamine oxidase inhibitors (MAOIs).
  • if you are in the first trimester of pregnancy.

• if you are breastfeeding

Warnings and precautions

Talk to your doctor or pharmacist before taking Rino-Ebastel:

• if you develop a generalized feverish rash with pustules, stop taking Rino-Ebastel and contact your doctor or seek immediate medical attention. See section 4.

  • if you suffer from a condition in which pressure inside the eye is increased (glaucoma).

• if you have high blood pressure (hypertension).

• if you have a condition in which blood sugar levels are very high (diabetes).

• if you have an enlarged prostate (prostatic hypertrophy).

• if you have any heart disease.

  • if you have moderate or severe kidney disease with reduced function.

• if your electrocardiogram results are abnormal (prolongation of the QT interval).

  • if you have low potassium levels in the blood.
  • if you suffer from severe liver disease (see section “How to take Rino-Ebastel”).
  • if you are being treated with a type of medicine used to treat fungal infections called azole antifungals, or with medicines used to treat certain infections called macrolide antibiotics (see section “Taking Rino-Ebastel with other medicines”).
  • if you are being treated with rifampicin, a medicine used to treat tuberculosis.

• if you are over 60 years old.

Cases of reversible posterior encephalopathy syndrome (RPES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported after using medicines containing pseudoephedrine. RPES and RCVS are rare conditions that may involve reduced blood flow to the brain. Stop using Rino-Ebastel immediately and seek urgent medical help if you experience symptoms that could indicate RPES or RCVS (see section 4 "Possible side effects" for symptoms).

Sudden abdominal pain or rectal bleeding may occur while taking Rino-Ebastel due to inflammation of the colon (ischemic colitis). If these gastrointestinal symptoms appear, stop taking Rino-Ebastel and contact your doctor or seek immediate medical attention. See section 4.

With Rino-Ebastel, blood flow to the optic nerve may be reduced. If you experience sudden vision loss, stop taking Rino-Ebastel and contact your doctor or seek immediate medical attention. See section 4.

If you are taking other medicines containing nasal decongestants, you should not take this medicine.

You must stop treatment and consult your doctor if, during treatment with this medicine, you notice or are diagnosed with high blood pressure (hypertension), rapid or strong heartbeat (tachycardia), palpitations, or irregular heart rhythm (arrhythmias).

You must stop treatment at least 24 hours before undergoing surgery.

Concomitant use of cocaine with this medicine may increase cardiovascular effects and the risk of adverse reactions.

Use in children

Rino-Ebastel must not be given to children under 12 years of age.

Other medicines and Rino-Ebastel

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, especially if you are taking any of the following, as they may interact with Rino-Ebastel; in such cases, it may be necessary to adjust the dose or discontinue treatment with one of the medicines:

• Medicines used to treat depression called MAOI-type antidepressants, as they may cause a severe increase in blood pressure (see section “Do not take Rino-Ebastel”)

  • Levodopa and selegiline (medicines used to treat Parkinson's disease), as they may cause a severe increase in blood pressure, very high fever, and headache.
  • Nitrates (used to treat angina pectoris), as they may reduce the effectiveness of nitrates.

• Rino-Ebastel may enhance the effect of other medicines used to treat allergies (antihistamines).

• Ketoconazole and itraconazole (used to treat fungal infections) or the antibiotic erythromycin (used to treat certain infections), as they may cause changes in your electrocardiogram.

• Some medicines used to lower blood pressure (methyldopa, mecamylamine, reserpine, and veratrum alkaloids).

• The antihistamine effect of Rino-Ebastel may be reduced in patients taking rifampicin, a medicine used to treat tuberculosis.

• Concomitant administration of Rino-Ebastel with a group of medicines known as sympathomimetics, used to relieve nasal congestion or increase blood pressure, among other uses—such as phenylephrine, methoxamine, phenylpropanolamine, ethylnorepinephrine (sympathomimetics acting from within the body), propylhexedrine, naphazoline, oxymetazoline, tetrahydrozoline, xylometazoline, phenoxazoline, tramazoline, chlorobutanol (topical sympathomimetics applied to skin or mucous membranes with local effect)—may increase the effects of these medicines and potentially increase their toxicity.

• Some medicines used to lower blood pressure or promote urine elimination (such as beta-blockers, ACE inhibitors, rauwolfia alkaloids such as reserpine, methyldopa, mecamylamine, guanethidine, and veratrum alkaloids), as they may cause a decrease in heart rate or a sudden rise in blood pressure.

  • Urinary alkalinizers (sodium bicarbonate, citrates), as they may slow down the elimination of pseudoephedrine, thereby increasing its effect and toxicity.
  • Inhaled anesthetics, as they may increase the risk of heart problems.
  • Central nervous system stimulants (amphetamines, xanthines), as they may cause nervousness, irritability, insomnia, or possibly seizures or irregular heart rhythm (arrhythmias).
  • Cardiac glycosides (used for heart conditions), as they may cause disturbances in heart rhythm.
  • Thyroid hormones (used for thyroid disorders), as they may increase the effects of both the hormones and pseudoephedrine.

Interference with diagnostic tests

Rino-Ebastel may interfere with skin allergy test results; therefore, such tests should not be performed until at least 5–7 days after stopping treatment.

Taking Rino-Ebastel with food and drink

The capsules can be taken with or without food. Taking this medicine with meals or drinks does not affect its efficacy.

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.

Pregnancy

Rino-Ebastel is contraindicated during the first trimester of pregnancy. As a precautionary measure, it is preferable to avoid using this medicine throughout pregnancy.

Lactation

Pseudoephedrine is excreted in breast milk; therefore, this medicine should not be used during breastfeeding.

Use in athletes

Athletes are advised that this medicine contains a component that may result in a positive doping test.

Driving and using machines

If you experience drowsiness, dizziness, or vertigo while taking this medicine, you should not drive or operate machinery.

Rino-Ebastel contains sucrose, benzoic acid (E-210), and sodium

This medicine contains sucrose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains 0.00016 mg of benzoic acid (E-210) (contained in the simethicone emulsion) per capsule.

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; hence, it is essentially “sodium-free”.

3. How to take Rino-Ebastel

Follow exactly the administration instructions for Rino-Ebastel provided in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Dosage

The recommended dose in adolescents (aged 12–17 years) is 1 capsule once daily, preferably with breakfast.

The recommended dose in adults is 1 capsule once daily, preferably with breakfast. If necessary, 1 capsule every 12 hours may be taken.

In patients with severe liver disease, the dose should not exceed 1 capsule per day.

The duration of treatment should be as short as possible and should be discontinued as symptoms resolve.

Consult your doctor if your condition worsens, if symptoms persist for more than 7 days of treatment, or if they are accompanied by high fever.

Method of administration

This medicine is taken orally.

Swallow the capsule whole, without opening or chewing it, with a liquid (preferably a glass of water).

If you take more Rino-Ebastel than you should

If you take more Rino-Ebastel than you should, you may experience: rapid breathing, excitement, nervousness, irritability, restlessness, tremors, seizures, palpitations, increased blood pressure, changes in heart rhythm (arrhythmias), difficulty urinating. In more severe cases, the following may occur: low blood potassium levels (hypokalaemia), mental disorder with altered perception of reality (psychosis), seizures, coma, and hypertensive crises.

In case of overdose or accidental ingestion, go immediately to a medical centre or call the Toxicology Information Service (telephone: 915 620 420), indicating the medicine and the amount ingested.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The following adverse effects have been observed in clinical trials and post-marketing experience:

Very common: may affect more than 1 in 10 people:

• Headache

Common: may affect up to 1 in 10 people:

• Somnolence
• Dry mouth

Rare: may affect up to 1 in 1,000 people:

• Hypersensitivity reactions: allergic reactions (such as anaphylaxis and angioedema)
• Nervousness, insomnia
• Dizziness, decreased sensation of touch or sensitivity, decreased or altered taste
• Palpitations, tachycardia
• Abdominal pain, vomiting, nausea, digestive problems
• Liver inflammation (hepatitis), cholestasis, abnormal liver function tests (increased transaminases, gamma-GT, alkaline phosphatase, and bilirubin)
• Urticaria, skin rash, dermatitis
• Menstrual disorders
• Edema (swelling due to fluid accumulation), fatigue

Very rare: may affect up to 1 in 10,000 people:

• Anxiety, agitation, tremor
• Excitability
• Hypertension
• Urinary retention

Frequency not known (cannot be estimated from available data):

• Weight gain
• Increased appetite

During the period of pseudoephedrine use, the following adverse effects have been observed, whose frequency could not be accurately determined:

More frequently: nervousness, restlessness, difficulty sleeping, anxiety, tremor, altered taste.

Less frequently: hyperactivity, hyperexcitability, dizziness and vertigo, headache, uncoordinated movements, pupil dilation, rapid heartbeat, elevated blood pressure. Nausea, vomiting, bloody diarrhea. Dermatitis, urticaria, skin rash. Pain during urination. Increased sweating, pallor, and weakness.

Occasionally: hypersensitivity reactions, hallucinations, nightmares, shrieking, and confusion in children. Heart rhythm disturbances and slow heartbeats. In very rare cases, myocardial infarction; at very high doses, seizures, confusion, and headache.

Frequency not known (cannot be estimated from available data):

• Sudden onset of fever, skin redness, or numerous small pustules (possible symptoms of acute generalized exanthematous pustulosis – AGEP) that may occur within the first 2 days of treatment with Rino-Ebastel. See section 2.
  1. Stop taking Rino-Ebastel immediately if these symptoms appear and contact your doctor or seek immediate medical attention.
• Inflammation of the colon due to insufficient blood supply (ischemic colitis).
• Reduced blood flow to the optic nerve (ischemic optic neuropathy).
• Serious conditions affecting the blood vessels in the brain, known as reversible posterior encephalopathy syndrome (RPES) and reversible cerebral vasoconstriction syndrome (RCVS).

Stop using Rino-Ebastel immediately and seek urgent medical assistance if you experience symptoms that could indicate reversible posterior encephalopathy syndrome (RPES) or reversible cerebral vasoconstriction syndrome (RCVS). These include:

• Sudden, severe headache
• Malaise
• Vomiting
• Confusion
• Seizures
• Changes in vision

Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Rino-Ebastel

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

Do not store at temperatures above 30°C.

Do not use this medicine after the expiry date stated on the container, following EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their packaging at the SIGRE Point located at the pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This way, you will help protect the environment.

6. Package contents and other information

Composition of Rino-Ebastel

• The active substances are ebastine and pseudoephedrine hydrochloride. Each capsule contains 10 mg of ebastine and 120 mg of pseudoephedrine hydrochloride.

The other components are: sucrose, corn starch, hypromellose, microcrystalline cellulose (E-460i), stearyl polyoxyl-8, macrogol, polyethylene glycol glyceryl oxiystearate, simethicone emulsion (purified water, simethicone, polyoxyethylene sorbitan tristearate (E-436), methylcellulose (E-461), polyethylene glycol stearate, glycerol monostearate (E-471), xanthan gum (E-415), benzoic acid (E-210), sulfuric acid (E-513) and sorbic acid (E-200)), ammonium methacrylate copolymer, methacrylic acid-methyl methacrylate copolymer (1:2), dibutyl sebacate and talc. The components of the capsule shell are: erythrosine (E-127), red iron oxide (E-172), yellow iron oxide (E-172), titanium dioxide (E-171), gelatin and ink (shellac lacquer, propylene glycol (E-1520), sodium hydroxide (E-524), povidone (E-1201) and titanium dioxide (E-171)).

Appearance of the product and contents of the pack

Rino-Ebastel is presented as hard capsules for oral administration. The hard capsules are red in colour and bear the white printed text "EBA PSE".

Each pack contains 7 hard capsules.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Almirall, S.A.

General Mitre, 151

08022 - Barcelona

Spain

Manufacturer

Industrias Farmacéuticas Almirall, S.A.

Ctra. de Martorell, 41-61

08740 Sant Andreu de la Barca – Barcelona

Spain

Date of the most recent review of this leaflet: April 2024

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