RINOBACTIL 10 mg/120 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Rinobactil 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.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet:

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

1. What is Rinobactil and what is it used for

Rinobactil belongs to a group of medicines called systemic antihistamines.

Rinobactil contains a combination of two active substances, ebastine which is an antihistamine (anti-allergic) and pseudoephedrine which is a nasal decongestant.

Rinobactil is indicated for the treatment of symptoms of allergic rhinitis, vasomotor rhinitis and rhinitis associated with the common cold, such as nasal discharge and congestion, itching of the nose, itching of the eyes, tearing and sneezing in adults and adolescents from 12 years of age.

2. What you need to know before you take Rinobactil

Do not take Rinobactil

• if you have very high blood pressure (severe hypertension) or uncontrolled hypertension.
• if you have severe kidney disease, acute (sudden) or chronic (long-term), or kidney failure.
• if you are allergic to ebastine, pseudoephedrine or any of the other ingredients of this medicine (listed in section 6).

• if you have an eye disease that causes increased pressure inside the eye and can lead to blindness (narrow-angle glaucoma).
  • if you suffer from urinary retention.

• if you have very high blood pressure (severe arterial hypertension).
• if you have reduced blood flow to the heart through the coronary arteries (coronary insufficiency).
• if you have a condition where the thyroid gland produces too much thyroid hormone (hyperthyroidism).
  • if you are taking or have taken in the last two weeks certain medicines used to treat depression called monoamine oxidase inhibitors (MAOIs).
  • if you have had strokes (cerebral hemorrhage) or have risk factors for having them.
  • 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 blisters (small cavities in the skin filled with pus), stop taking Rinobactil and contact your doctor or seek medical attention immediately. See section 4.
  • if you have a disease where the pressure inside the eye is increased (glaucoma).

• if you have high blood pressure (arterial hypertension).
• if you have a disease where 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 suffer from severe liver disease (see "How to take Rinobactil").
  • if you suffer from gastrointestinal obstruction.
  • 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 "Using Rinobactil with other medicines").
  • if you are being treated with rifampicin, a type of medicine used to treat tuberculosis.

• if you are over 60 years old.

There have been reports of cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) after the use of medicines containing pseudoephedrine. PRES and RCVS are rare diseases that can involve a reduction in blood flow to the brain. Stop using Rinobactil immediately and seek immediate medical attention if you present symptoms that may be signs of PRES or RCVS (to know the symptoms, see section 4 "Possible side effects").

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

With Rinobactil, blood flow to the optic nerve may be reduced. If you suffer a sudden loss of vision or a decrease in visual acuity, stop taking Rinobactil and contact your doctor or seek medical attention immediately. See section 4.

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

You should interrupt treatment and consult your doctor if during treatment with this medicine you notice or are diagnosed with high blood pressure (hypertension), rapid or strong heartbeats (tachycardia), palpitations or alteration of the heart rhythm (arrhythmias).

You should suspend treatment at least 24 hours before surgery.

Use in children

Rinobactil should not be administered to children under 12 years of age.

Using Rinobactil with other medicines

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

The following medicines may interfere with Rinobactil; in these cases, it may be necessary to change the dose or interrupt treatment with one of them:

• Medicines used to treat depression called tricyclic antidepressants, because they can seriously increase blood pressure (see "Do not take Rinobactil").
  • Levodopa (medicine used to treat Parkinson's disease) as it may increase the risk of heart problems.
  • Nitrates (used to treat angina pectoris) as they may reduce the effects of nitrates.

• Rinobactil may increase the effect of other medicines 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 produce an alteration in your electrocardiogram).
• The antihistamine effect of Rinobactil may be decreased in patients being treated with a medicine called rifampicin used to treat tuberculosis.
• The administration of Rinobactil together with a type of medicine used to relieve nasal congestion or increase blood pressure, among others, called sympathomimetics, such as phenylephrine, methoxamine, phenylpropanolamine, ethylephrine (sympathomimetics whose action takes place from inside the body), propylhexedrine, naphazoline, oxymetazoline, tetrahydrozoline, xylometazoline, phenoxazoline, tramazoline, chlorobutanol (sympathomimetics for application on the skin or mucous membranes and have a local effect), produces an increase in the effects of these medicines, which can increase their toxicity.
  • Certain medicines used to lower blood pressure or to facilitate the elimination of urine (such as beta-blockers, reserpine, methyldopa, guanethidine and veratrum alkaloids) as Rinobactil may reduce the effects of these medicines.
  • Inhaled anesthetics, as they may increase the risk of heart problems.
  • Stimulants of the nervous system (such as amphetamines) as they may cause nervousness or alteration of the heart rhythm (arrhythmias).
  • Digitalis glycosides (used for the heart) as they may produce alterations in the heart rhythm. No interactions have been described between ebastine and theophylline, warfarin, cimetidine, diazepam and alcohol.

Interference with diagnostic tests

Rinobactil may interfere with the results of skin allergy tests, so it is recommended not to perform them until 5-7 days have passed since the treatment was interrupted.

Rinobactil with food and drinks

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, or think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

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

Breastfeeding

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

Use in athletes

Athletes are informed that this medicine contains a component that can produce a positive result in doping tests.

Driving and using machines

If you feel drowsy, dizzy or confused during treatment with this medicine, do not drive or use machines.

Rinobactil contains sucrose and benzoic acid (E-210)

This medicine contains sucrose. If your doctor has told you that you have an intolerance to some sugars, consult with them 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 23 mg of sodium (1 mmol) per capsule; this is essentially "sodium-free".

3. How to take Rinobactil

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

Remember to take your medicine.

Dosage

Use in adolescents (between 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 can be administered every 12 hours.

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

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

Method of administration

This medicine is for oral administration.

It is recommended to swallow the capsule whole, without opening or chewing 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, alteration of the heart rhythm (arrhythmias), difficulty urinating. In more severe cases, it can cause: decreased potassium in the blood (hypokalemia), mental disorder with altered perception of reality (psychosis), convulsions, coma and hypertensive crises.

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

If you forget to take Rinobactil

Do not take a double dose to make up for forgotten doses. Take the forgotten dose when you remember and then follow your regular schedule. However, if there are only a few hours left until the next dose, do not take the forgotten dose and wait until it is time to take the next dose.

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

4. Possible side effects

Like all medicines, Rinobactil can cause side effects, although not everybody gets them.

The following side 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):

• 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 sense 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 (increased 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 the available data):

• Sudden onset of fever, skin redness, or many small blisters (possible symptoms of acute generalized exanthematous pustulosis - AGEP) that may occur within 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.
• Inflammation of the colon due to insufficient blood irrigation (ischemic colitis).
• Decreased blood flow to the optic nerve (ischemic optic neuropathy).
• Hallucinations
• Convulsions
• Arrhythmia
• Hypertension
• Dyspnea
• Dysuria
• Severe diseases that affect the blood vessels of the brain known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS).

Stop using Rinobactil immediately and seek urgent medical attention if you present symptoms that may be signs of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). These include:

• sudden severe headache
• malaise
• vomiting
• confusion
• convulsions
• changes in vision

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Rinobactil

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

Do not store above 30°C.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Rinobactil

• The active substances are ebastine and pseudoephedrine hydrochloride. Each capsule contains 10 mg of ebastine and 120 mg of pseudoephedrine hydrochloride.
• The other ingredients are: sucrose, corn starch, hypromellose, microcrystalline cellulose (E-460i), polyoxyethylene stearate, macrogol, polyethylene glycol oxi stearate, simethicone emulsion (purified water, simethicone, polyoxyethylene sorbitan trioleate (E-436), methylcellulose (E-461), polyethylene glycol stearate, glycerol monooleate (E-471), xanthan gum (E-415), benzoic acid (E-210), sulfuric acid (E-513) and sorbic acid (E-200)), ammonium methacrylate copolymer, methacrylic acid copolymer and methyl methacrylate (1:2), dibutyl sebacate and talc.

The components of the capsule 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

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

Each pack contains 10 hard capsules.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Almirall, S.L.

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 last revision of this leaflet:April 2024

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