Package Insert: Information for the Patient

Rinobactil 10 mg/120 mg Modified Release Hard Capsules

Ebastina/Hydrochloride of Pseudoephedrine

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

-Keep this package insert, as you may need to read it again.

-If you have any questions, consult your doctor or pharmacist.

-This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What is Rinobactil and for what it is used

2. What you need to know before starting to take Rinobactil

3. How to take Rinobactil

4. Possible adverse effects

5. Storage of Rinobactil

6. Contents of the package and additional information

Rinobactil belongs to the group of medications known as systemic antihistamines.

Rinobactil contains an association of two active principles, ebastine which is an antihistamine (antiallergic) and pseudoephedrine which is a nasal decongestant.

Rinobactil is indicated for the treatment of symptoms of allergic rhinitis, vasomotor rhinitis, and common cold-associated rhinitis, such as nasal discharge and congestion, nasal itching, eye itching, tearing, and urge to sneeze in adults and adolescents 12 years of age and older.

Do not take Rinobactil

• if you have severe high blood pressure (hypertension) or uncontrolled high blood pressure.
• if you have severe, acute, or chronic kidney disease, or kidney failure.
• if you are allergic to ebastine, pseudoephedrine, or any other component of this medication (listed in section 6).

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

• if you have urinary retention.

•if you have severe high blood pressure (severe 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 past two weeks monoamine oxidase inhibitors (MAOIs) used to treat depression.
• if you have had a stroke (cerebral hemorrhage) or have risk factors for it.
• 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 Rinobactil:

•if you develop a generalized rash associated with fever and pustules, stop taking Rinobactil and seek medical attention immediately. See section 4.

• if you have a condition in which increased pressure in the eye (glaucoma) is present.

•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 altered potassium levels in the blood.
• if you have severe liver disease (see "How to take Rinobactil").
• if you have gastrointestinal obstruction.
• if you are being treated with azole antifungals or macrolide antibiotics (see "Use of Rinobactil with other medications").
• if you are being treated with rifampicin, a 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 Rinobactil immediately and seek medical attention if you experience symptoms that may be signs of PRES or RCVS (see section 4 "Possible side effects").

Abdominal pain or rectal bleeding may occur due to ischemic colitis with the use of Rinobactil. If these gastrointestinal symptoms appear, stop taking Rinobactil and seek medical attention immediately. See section 4.

Rinobactil may reduce blood flow to the optic nerve. If you experience sudden vision loss or decreased visual acuity, stop taking Rinobactil and seek medical attention immediately. 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 you experience high blood pressure (hypertension), rapid or strong heartbeats (tachycardia), palpitations, or arrhythmias during treatment with this medication.

Stop treatment at least 24 hours before surgery.

Use in children

Rinobactil should not be administered to children under 12 years old.

Use of Rinobactil with other medications

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

The following medications may interact with Rinobactil; in these cases, the dose may need to be changed or the treatment interrupted:

•Antidepressants called MAOIs, as it may increase blood pressure severely (see "Do not take Rinobactil").

• Levodopa (used to treat Parkinson's disease) as it may increase the risk of heart problems.
• Nitrates (used to treat angina) as it may reduce the effects of nitrates.

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

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

•The antihistamine effect of Rinobactil may be reduced in patients being treated with rifampicin, used to treat tuberculosis.

•The administration of Rinobactil with sympathomimetics, such as phenylephrine, methoxamine, phenylpropanolamine, ephedrine (sympathomimetics whose action takes place from within the body), propylhexedrine, naphazoline, oxymetazoline, tetrahydrozoline, xylometazoline, phenoxazoline, tramazoline, chlorobutanol (sympathomimetics applied to the skin or mucous membranes and have a local effect), may increase the effects of these medications, potentially increasing their toxicity.

• Some medications used to lower blood pressure or promote urine elimination (such as beta-blockers, reserpine, methyldopa, guanethidine, and veratrum alkaloids) as Rinobactil may reduce the effects of these medications.
• Inhaled anesthetics, as they may increase the risk of heart problems.
• Stimulants of the nervous system (such as amphetamines) as it may cause nervousness or arrhythmias.
• Digitalis glycosides (used for the heart) as they may produce arrhythmias.No interactions have been described between ebastine and theophylline, warfarin, cimetidine, diazepam, and alcohol.

Interference with diagnostic tests

Rinobactil may interfere with skin allergy test results, so it is recommended not to perform them until 5-7 days after stopping treatment.

Rinobactil with food and drinks

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

Pregnancy and breastfeeding

Inform your doctor or pharmacist if you are pregnant, breastfeeding, or may become pregnant, or if you intend to become pregnant.

Pregnancy

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

Breastfeeding

Pseudoephedrine is excreted in breast milk, so this medication should not be used during breastfeeding.

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 confusion during treatment with this medication, do not drive or operate machines.

Rinobactil contains saccharose and benzoic acid (E-210)

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

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

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

Follow exactly the administration instructions for Rinobactil as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medication.

Dosage

Use in adolescents (12-17 years):1 capsule, once a day, preferably with breakfast.

Use in adults:1 capsule, once a day, preferably with breakfast. In severe cases, 1 capsule may be administered every 12 hours.

Use in patients with severe liver disease:Do not exceed a dose of 10 mg of ebastine per day (1 capsule).

The duration of treatment should be limited to the acute phase, when symptoms (itching, tearing) are more intense, and not prolonged, in general, for more than 10 days in allergic and vasomotor rhinitis, or 3 days in rhinitis associated with the common cold.

Administration Form

This medication is for oral administration.

It is recommended to ingest the capsule whole, without opening or crushing it.

If you take more Rinobactil than you should

If you take more Rinobactil 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 mental perception (psychosis), convulsions, coma, and hypertensive crises.

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).

If you forgot to take Rinobactil

Do not take a double dose to compensate for the missed dose.Take the missed dose as soon as you remember and then continue with your regular schedule. However, if there are only a few hours left before the next dose, do not take the missed dose and wait for the next dose at the scheduled time.

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

Like all medications, Rinobactil 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):

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

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

• Anxiety, agitation, tremor
• Excitability
• Urinary retention

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 Rinobactil. See section 2.

Stop taking Rinobactil if these symptoms appear and contact your doctor or seek medical attention immediately.

• Weight gain.
• Increased appetite.
• Colitis due to inadequate blood supply (ischemic colitis).
• Decreased blood flow to the optic nerve (ischemic optic neuropathy).
• Hallucinations
• Seizures
• Arrhythmia
• Hypertension
• Dyspnea
• Disuria
• Severe diseases affecting the blood vessels of the brain known as reversible posterior leukoencephalopathy syndrome (RPLS) and reversible cerebral vasoconstriction syndrome (RCVS).

Stop using Rinobactil 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, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

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 pointof the pharmacy. If in doubt, please ask 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 Rinobactil

• The active principles are ebastina and pseudoefedrine hydrochloride. Each capsule contains 10 mg of ebastina and 120 mg of pseudoefedrine hydrochloride.
• The other components are:sucrose, cornstarch, hypromellose, microcrystalline cellulose (E-460i), 8-polioxyl stearate, macrogol, oxiestearate of glycerol polyethyleneglycol, emulsion of simeticona (purified water, simeticona, polioxietilen sorbitan triestearate (E-436), methylcellulose (E-461),stearate of polyethyleneglycol, glycerol monoestearate (E-471), xanthan gum (E-415), benzoic acid (E-210), sulfuric acid (E-513) and sorbic acid (E-200)), copolymer of amonio metacrylate, copolymer of metacrylic acid and methacrylate of methilo (1:2), sebacate of dibutilo and talc.

The capsule components 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 content of the container

Rinobactil 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 10 hard capsules.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Almirall, S.L.

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)

Date of the last review of this leaflet:April 2024

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