Package Insert: Information for the Patient

Rino-Ebastel 10 mg/120 mg Modified Release Hard Capsules

ebastine/pseudoephedrine hydrochloride

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

Follow exactly the administration instructions contained in this package insert or those indicated by your doctor or pharmacist.

• Keep this package insert, as you may need to refer to it again.
• For advice or more information, consult your pharmacist.
• Report any adverse effects to your doctor or pharmacist, even if they are not listed in this package insert. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 7 days.

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

2. What you need to know before starting to take Rino-Ebastel

3. How to take Rino-Ebastel

4. Possible adverse effects

5. Storage of Rino-Ebastel

6. Contents of the package and additional information

Rino-Ebastel contains a combination of 2 active principles, 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, for adults and adolescents 12 years and older.

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

Do not take Rino-Ebastel

• if you have severe high blood pressure (hypertension) or uncontrolled high blood pressure.

• if you have a severe, acute, or chronic kidney disease, or kidney failure.

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

•if you have a condition in which increased pressure within the eye can lead to blindness (narrow-angle glaucoma).

• if you have urinary retention.
• if you have severe high blood pressure (hypertension).
• if you have decreased 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 in the last two weeks a type of medication 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

Consult your doctor or pharmacist before starting to take Rino-Ebastel:

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

• if you have a condition in which increased pressure within the eye can lead to blindness (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 severe or moderate kidney disease with reduced function.

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

• if you have low potassium levels in the blood.
• if you have severe liver disease (see "How to take Rino-Ebastel").
• if you are being treated with a type of medication used to treat fungal infections called azole antifungals or with a type of medication used to treat certain infections called macrolide antibiotics (see "Use of Rino-Ebastel with other medications").
• if you are being treated with rifampicin, a type of medication used to treat tuberculosis.

•if you are over 60 years old.

Cases of reversible posterior encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported after use of pseudoephedrine-containing medications. PRES and RCVS are rare conditions that can involve reduced blood flow to the brain. Stop using Rino-Ebastel immediately and seek immediate medical attention if you experience symptoms that may be signs of PRES or RCVS (see section 4 "Possible side effects").

Rino-Ebastel may cause sudden abdominal pain or rectal bleeding due to ischemic colitis. If these gastrointestinal symptoms appear, stop taking Rino-Ebastel and contact your doctor or seek immediate medical attention. See section 4.

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

Do not take this medication if you are taking other medications that contain nasal decongestants.

Stop treatment and consult your doctor if during treatment with this medication you note or are diagnosed with high blood pressure (hypertension), rapid or strong heartbeats (tachycardia), palpitations, or arrhythmias.

Stop treatment at least 24 hours before surgery.

The use of cocaethylene with this medication may increase cardiovascular effects and the risk of adverse effects.

Use in children

Rino-Ebastel should not be administered to children under 12 years old.

Other medications and Rino-Ebastel

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication,especially if you are taking any of the medications listed below, as they may interact withRino-Ebastel; in these cases, it may be necessary to change the dose or discontinue treatment with one of them:

• Medications used to treat depressioncalled MAOIs, as they mayincrease blood pressureseverely (see "Do not take Rino-Ebastel").

• Levodopa and selegiline (medications used to treat Parkinson's disease) as they may produce severe increases in blood pressure, high fever, and headache.
• Nitrates (used to treat angina) as they may reduce the effects of nitrates.

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

•Ketoconazole and itraconazole used to treat fungal infections or with an antibiotic used to treat certain infections called erythromycin (as they may alter your electrocardiogram).

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

•The antihistamine effect of Rino-Ebastel may be reduced in patients being treated with a medication called rifampicin used to treat tuberculosis.

•The administration of Rino-Ebastel with a type of medicationused to relieve nasal congestion or increase blood pressure, among others, calledsympathomimetics, such as phenylephrine, methoxamine, phenylpropanolamine, etilefrine (sympathomimeticswhose action takes place from within the body), propylhexedrine, naphazoline, oxymetazoline, tetrahydrozoline, xylometazoline, phenoxazoline, tramazoline, chlorobutanol (sympathomimeticswith local action), produces an increase in the effectsof these medications, which may increase their toxicity.

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

• Urinary alkalizers (sodium bicarbonate, citrates) as they may make pseudoephedrine eliminate more slowly and increase its effect and toxicity.
• Inhalation anesthetics, as they may increase the risk of heart problems.
• Central nervous system stimulants (amphetamine, xanthines) as they may cause nervousness, irritability, insomnia, or possibly convulsions or arrhythmias.
• Digitalis glycosides (used for the heart) as they may produce alterations in heart rhythm.
• Thyroid hormones (used for thyroid diseases) as they may increase the effects of both hormones and pseudoephedrine.

Interference with diagnostic tests

Rino-Ebastel may interfere with the results of skin allergy tests, so it is recommended not to perform them until 5-7 days after discontinuing treatment.

Taking Rino-Ebastel with food and drinks

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

Pregnancy and breastfeeding

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

Pregnancy

Rino-Ebastel is contraindicated in the first trimester of pregnancy.As a precaution, it is recommended to avoid its use throughout pregnancy.

Breastfeeding

Pseudoephedrine is excreted inbreast milk, sothis medicationshould not be used duringbreastfeeding.

Use in athletes

Inform athletes that this medication contains a component that may produce a positive result in doping control tests.

Driving and operating machines

If you experience drowsiness, dizziness, or vertigo during treatment with this medication, do not drive or operate machines.

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

This medication contains saccharose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication..

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

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

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

Dosage

The recommended dose inadolescents (between 12-17 years)is 1 capsule, once a day, preferably with breakfast.

The recommended doseinadultsis 1 capsule, once a day, preferably with breakfast. If necessary, it can be taken 1 capsule every 12 hours.

In patients with severe liver diseasedo not exceed a dose of 1 capsule per day.

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

You should consult your doctor if you worsen, if symptoms persist for more than 7 days of treatment or if accompanied by high fever.

Administration Form

This medication is taken orally.

Take the entire capsule, without opening or crushing it, with the help of 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 notice: rapid breathing, excitement, nervousness, irritability, restlessness, tremors, convulsions, palpitations, increased blood pressure, arrhythmias, difficulty urinating. In more severe cases, you may experience: decreased potassium levels in the blood (hypokalemia), altered perception of reality (psychosis), convulsions, coma, and hypertensive crisis.

In case of overdose or accidental ingestion, immediately go to a medical center or call the Toxicological Information Service (phone: 915 620 420), indicating the medication and the amount ingested..

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

In clinical trials and post-marketing experience, the following side effects have been observed:

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

• Headache

Common: may affect up to 1 in 10 people:

• Drowsiness
• 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
• Inflammation of the liver (hepatitis), cholestasis, abnormal liver function tests (elevated transaminases, gamma-GT, alkaline phosphatase, and bilirubin)
• Urticaria, skin rash, dermatitis
• Menstrual disorders
• Swelling (edema) 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 pseudoephedrine usage period, the following side effects have been observed, whose frequency could not be established with precision:

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

Less frequently: hyperactivity, hyperexcitability, dizziness and vertigo, headache, uncoordinated movements, dilated pupils, rapid heartbeats, elevated blood pressure. Nausea, vomiting, bloody diarrhea. Dermatitis, urticaria, skin rash. Painful urination. Increased sweating, pallor, and weakness.

In rare cases: hypersensitivity reactions, hallucinations, nightmares, screaming, and confusion in children. Alterations in heart rhythm and slow heartbeats. In very rare cases, myocardial infarction, and at very high doses, convulsions, confusion, and headache.

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

• Sudden onset of fever, skin redness, or many small pustules (possible symptoms of generalized acute pustular exanthema – PEGA) that may occur in the first 2 days of treatment with Rino-Ebastel. See section 2.
• 1. Stop taking Rino-Ebastel if these symptoms appear and contact your doctor or seek medical attention immediately.
• Ischemic colitis due to inadequate blood supply.
• Decreased blood flow to the optic nerve (ischemic optic neuropathy).
• Severe diseases affecting the brain's blood vessels known as reversible posterior leukoencephalopathy syndrome (RPLS) and reversible cerebral vasoconstriction syndrome (RCVS).

Stop using Rino-Ebastel immediately and seek urgent medical assistance if you experience symptoms that may be signs of reversible posterior leukoencephalopathy syndrome (RPLS) and reversible cerebral vasoconstriction syndrome (RCVS). These include:

• Sudden onset of severe headache

• Malaise

• Vomiting

• Confusion

• Seizures

• Changes in vision

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 the 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.

Do not store at a temperature above 86°F (30°C).

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.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and medicines you no longer need at the SIGRE collection pointat the pharmacy. If in doubtask your pharmacist how to dispose of the packaging and medicines you no longer need.By doing so, you will help protect the environment.

Composition of Rino-Ebastel

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

The other components are: sucrose, cornstarch, hypromellose, microcrystalline cellulose (E-460i), 8-polioxyl stearate, macrogol, glyceryl oleate polyethylene glycol, glyceryl oleate, polioxyethylen sorbitan triestearate (E-436), methylcellulose (E-461), stearoyl polyethylene glycol, glyceryl monoestearate (E-471), xanthan gum (E-415), benzoic acid (E-210), sulfuric acid (E-513), and sorbic acid (E-200). The components of the capsule are: erythrosine (E-127), iron oxide red (E-172), iron oxide yellow (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 content of the container

Rino-Ebastel is presented in the form of hard capsules for oral administration.The hard capsules are red in color and have the text EBA PSE printed in white.

Each container contains 7 hard capsules.

Holder of the marketing authorization and responsible for manufacturing

Holderof the marketing authorization

Almirall, S.A.

General Mitre, 151

08022 - Barcelona

Spain

Responsible for manufacturing

Industrias Farmacéuticas Almirall, S.A.

Ctra. de Martorell, 41-61

08740 Sant Andreu de la Barca – Barcelona

Spain

Last review date of this leaflet:April 2024

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/)