Rinobactil 10 mg/120 mg modified-release hard capsules

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Rinobactil 10 mg/120 mg modified-release hard capsules

ebastine/pseudoephedrine hydrochloride

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Rinobactil is and what it is used for

Rinobactil belongs to the group of medicines known as 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 runny nose, nasal congestion, nasal itching, eye itching, tearing, and sneezing, in adults and adolescents aged 12 years and older.

2. What you need to know before taking Rinobactil

Do not take Rinobactil

• 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 have a condition of the eye in which there is increased pressure inside the eye that may 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 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 have suffered strokes (cerebral hemorrhage) or have risk factors for them.
  • if you are in the first trimester of pregnancy.
  • if you are breastfeeding.

Warnings and precautions

Talk to your doctor or pharmacist before taking Rinobactil:

• if you develop a widespread red rash associated with fever and pustules (small pus-filled skin lesions), stop taking Rinobactil and contact your doctor or seek immediate medical attention. See section 4.

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

• if you have high blood pressure (arterial 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 (ECG) results are abnormal (prolongation of the QT interval).

  • if you have abnormal blood potassium levels.
  • if you have severe liver disease (see section “How to take Rinobactil”).
  • if you have 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 section “Taking Rinobactil with other medicines”).
  • if you are being treated with rifampicin, a medicine used to treat tuberculosis.

• if you are over 60 years of age.

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 Rinobactil immediately and seek immediate medical help if you experience symptoms that could be signs of RPES or RCVS (for symptoms, see section 4 "Possible side effects").

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

With Rinobactil, blood flow to the optic nerve may be reduced. If you experience sudden vision loss or decreased visual acuity, stop taking Rinobactil 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 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 heartbeat (tachycardia), palpitations, or irregular heart rhythm (arrhythmias).

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

Use in children

Rinobactil must not be given to children under 12 years of age.

Taking Rinobactil with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

The following medicines may interact with Rinobactil; in such cases, it may be necessary to adjust the dose or discontinue treatment with one of them:

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

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

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

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

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

• The administration of Rinobactil together with a group of medicines used to relieve nasal congestion or increase blood pressure, among other effects, called sympathomimetics—such as phenylephrine, methoxamine, phenylpropanolamine, etilefrine (sympathomimetics acting from within the body), propylhexedrine, naphazoline, oxymetazoline, tetrahydrozoline, xylometazoline, phenoxazoline, tramazoline, and chlorobutanol (topical or mucosal sympathomimetics with local action)—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, reserpine, methyldopa, guanethidine, and veratrum alkaloids), as Rinobactil may reduce their effects.
  • Inhalational anesthetics, as they may increase the risk of heart problems.
  • Central nervous system stimulants (such as amphetamines), as they may cause nervousness or irregular heart rhythm (arrhythmias).
  • Digitalis glycosides (used for heart conditions), as they may cause cardiac rhythm disturbances. No interactions between ebastine and theophylline, warfarin, cimetidine, diazepam, or alcohol have been described.

Interference with diagnostic tests

Rinobactil may interfere with the results of skin allergy tests. Therefore, it is advisable not to perform such tests until 5–7 days after stopping treatment.

Rinobactil with food and drinks

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

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

Rinobactil is contraindicated during the first trimester of pregnancy. As a precautionary measure, it is preferable to avoid its use throughout pregnancy.

Breastfeeding

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 confusion while taking this medicine, you should not drive or operate machinery.

Rinobactil contains sucrose and benzoic acid (E-210)

This medicine contains sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, consult with him or her 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 exactly the administration instructions for Rinobactil provided by your doctor. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

Dosage

Use in adolescents (12-17 years of age): 1 capsule once daily, preferably with breakfast.

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

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

Duration of treatment should be limited to the acute phase, when symptoms (itching, tearing) are most intense; generally not exceeding 10 days in allergic and vasomotor rhinitis, or 3 days in cold-associated rhinitis.

Method of administration

This medicine is for oral use.

The capsule should be taken whole, without opening or chewing it.

If you take more Rinobactil than you should

If you take more Rinobactil 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: decreased potassium levels in blood (hypokalemia), mental disturbances with altered perception of reality (psychosis), seizures, coma, and hypertensive crises.

In case of overdose or accidental ingestion, seek immediate medical attention or call the Toxicology Information Service at phone number 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 missed doses. Take the missed dose as soon as you remember, then continue with your regular schedule. However, if it is almost time for your next dose, do not take the missed dose and wait to take the next dose at the scheduled time.

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

4. Possible adverse effects

Like all medicines, Rinobactil may cause adverse effects, although not everyone experiences 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):

• 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 (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 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 Rinobactil. See section 2.

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

• Weight gain.
• Increased appetite.
• Inflammation of the colon due to insufficient blood supply (ischemic colitis).
• Decreased blood flow to the optic nerve (ischemic optic neuropathy).
• Hallucinations
• Seizures
• Arrhythmia
• Hypertension
• Dyspnea
• Dysuria
• Serious conditions affecting the brain's blood vessels known as reversible posterior encephalopathy syndrome (RPES) and reversible cerebral vasoconstriction syndrome (RCVS).

Stop using Rinobactil immediately and seek urgent medical assistance if you experience symptoms that could be signs of 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, pharmacist, or nurse, 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 Medicinal Products: https://www.notificaram.es. By reporting adverse 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 stated on the packaging after 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 collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This 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 components are: sucrose, corn starch, hypromellose, microcrystalline cellulose (E-460i), stearate 8-polyoxyl, macrogol, polyethylene glycol glyceryl oxyestearate, simethicone emulsion (purified water, simethicone, polyoxyethylene sorbitan triesterate (E-436), methylcellulose (E-461), polyethylene glycol stearate, glyceryl 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 and methyl methacrylate copolymer (1:2), dibutyl sebacate and talc.

Components of the capsule shell: 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 pack contents

Rinobactil 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 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 latest review of this leaflet: April 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/