RINOMICINE COMPRESSES

Introduction

Package Leaflet: Information for the User

RINOMICINE Tablets

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

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist exactly.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 5 days of treatment (3 days for fever).

Contents of the Package Leaflet:

1. What Rinomicine is and what it is used for
2. What you need to know before taking Rinomicine
3. How to take Rinomicine
4. Possible side effects
5. Storage of Rinomicine
6. Package Contents and Additional Information

1. What Rinomicine is and what it is used for

This medication is an association of chlorphenamine (relieves nasal secretion), phenylephrine (provides a decongestant effect), salicylamide, and paracetamol (reduce pain and fever), and caffeine (counteracts the state of depression).

Rinomicine is indicated for adults and adolescents from 16 years of age for the symptomatic relief of flu-like, catarrhal, and common cold conditions that present with mild or moderate pain, headache, fever, congestion, and nasal secretion.

You should consult a doctor if your condition worsens or does not improve after 5 days of treatment or if the fever persists for more than 3 days.

2. What you need to know before taking Rinomicine

Do not take Rinomicine:

• If you are allergic to the active substances of this medication or to non-steroidal anti-inflammatory drugs or to any of the other components of this medication listed in section 6.
• If you have a severe kidney or liver disease.
• If you have or have had stomach ulcers, intestinal ulcers, or recurring gastric discomfort.
• If you have a history of bleeding or stomach perforation after treatment with acetylsalicylic acid or other non-steroidal anti-inflammatory drugs.
• If you have asthma.
• If you have nasal polyps associated with asthma that are produced or increased by taking non-steroidal anti-inflammatory drugs, acetylsalicylic acid, or other analgesics.
• If you have hemophilia or other blood coagulation problems that predispose you to internal bleeding.
• If you are under 16 years of age, as the use of acetylsalicylic acid has been linked to Reye's syndrome, a rare but serious disease.
• If you are in the third trimester of pregnancy.

Warnings and Precautions:

Consult your doctor or pharmacist before starting to take this medication if you are in any of the following situations:

• Patient with kidney, heart, or lung disease and patients with anemia.
• You have recently undergone or are to undergo surgery in the next 7 days, including dental surgery.
• You are taking non-steroidal anti-inflammatory drugs or other types of medications that may increase the risk of bleeding, such as corticosteroids, antidepressants of the selective serotonin reuptake inhibitor type, and anticoagulants.
• You have high blood pressure, glaucoma, or pheochromocytoma.
• You have cardiac arrhythmias, hyperthyroidism, or anxiety states.
• You are allergic to other anti-inflammatory or anti-rheumatic medications.
• You have a glucose-6-phosphate dehydrogenase deficiency.
• You have rhinitis and/or urticaria.
• Do not use this medication to prevent possible discomfort caused by vaccinations.
• You are diabetic.
• You have prostate hypertrophy.
• Patient sensitive to aminophylline or theophylline.

Elderly people may be more sensitive to the secondary effects of this medication.

Do not take more medication than recommended in section 3. How to take Rinomicine.

Avoid simultaneous use of this medication with other medications that contain paracetamol, as high doses can lead to liver damage. Do not use more than one medication that contains paracetamol without consulting your doctor.

Children and Adolescents

Children under 16 years of age cannot take this medication.

Taking Rinomicine with other medications

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

This is especially important if you are using any of the following medications, as it may be necessary to modify the dose of some of them or interrupt treatment:

• Pain relievers and non-steroidal anti-inflammatory drugs, medications used to treat pain and/or muscle inflammation, as they increase the risk of gastrointestinal bleeding.
• Corticosteroids, as they can potentiate the risk of gastrointestinal bleeding.
• Medications used to increase urine elimination (diuretics).
• Certain medications for the treatment of depression, such as selective serotonin reuptake inhibitors (fluoxetine, paroxetine, sertraline) and monoamine oxidase inhibitors (moclobemide, tranylcypromine).
• Medications used to thin the blood and prevent clot formation, such as oral anticoagulants (acenocoumarol, warfarin).
• Certain medications used to treat high blood pressure (methyldopa, reserpine, guanethidine, rauwolfia alkaloids).
• Medications used for the heart (digoxin) and cardiac rhythm disorders (propranolol, mexiletine) or to treat arterial diseases (beta-adrenergic blocking agents).
• Medications to lower blood sugar levels (insulin, sulfonylureas).
• Medications used to prevent transplant rejection (cyclosporine).
• Medication used in certain infections (vancomycin).
• Interferon alpha, used to treat certain viral infections and tumors.
• Medication used to treat Parkinson's disease (selegiline).
• Anesthetic medications for inhalation.
• Medication used to treat certain psychiatric disorders (lithium).
• Medication used for the treatment of cancer and rheumatoid arthritis (methotrexate).
• Medications used for the treatment of gout (probenecid).
• Antacids (cimetidine).
• Medications used as sedatives for sleep problems and to treat convulsions, such as barbiturates.
• Medication used in the treatment of HIV infections (zidovudine).
• Medications used to treat epilepsy (phenytoin and valproic acid).
• Medications used to treat nausea and vomiting (metoclopramide).
• Medications to lower cholesterol levels in the blood (cholestyramine).
• Medications used to treat withdrawal syndrome in alcoholic patients (disulfiram).
• Bronchodilator medications (theophylline).
• Flucloxacillin (antibiotic), due to a serious risk of alteration of blood and fluids (metabolic acidosis with high anion gap) that must be treated urgently and that can occur particularly in cases of severe renal insufficiency, sepsis, malnutrition, chronic alcoholism, and if the maximum daily doses of paracetamol are used.

Taking Rinomicine with food, drinks, and alcohol

Take this medication after meals or with some food.

While taking this medication, you cannot consume alcoholic beverages, as it may potentiate the appearance of side effects of this medication.

Additionally, the use of medications containing paracetamol by patients who habitually consume alcohol (3 or more alcoholic beverages per day) can cause liver damage.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

This medication cannot be used during the third trimester of pregnancy.

The safety of this product during the rest of the pregnancy has not been established.

The active ingredients of this medication are excreted in breast milk, so breastfeeding women should not take Rinomicine.

Interference with Laboratory Tests

If you are to undergo any diagnostic tests (including blood tests, urine tests, etc.), inform your doctor that you are taking this medication, as it may alter the results.

Driving and Using Machines:

This medication can cause drowsiness, altering mental and/or physical ability. If you notice these effects, avoid driving vehicles or using machines.

3. How to take Rinomicine

Follow the administration instructions for this medication contained in this package leaflet or as indicated by your doctor or pharmacist exactly. In case of doubt, ask your doctor or pharmacist.

The recommended dose in adults and adolescents over 16 years of age is: 1 tablet every 6 hours.

Do not take more than 3 grams of paracetamol every 24 hours (see "Warnings and Precautions" section).

This medication is administered orally, preferably with food. It should be taken with a glass of water.

Use in Children and Adolescents

Children and adolescents under 16 years of age cannot take this medication.

Use in Elderly Patients

Elderly patients should not take this medication without consulting their doctor, as they are more likely to suffer from its side effects.

Patients with Reduced Liver or Kidney Function

They should consult their doctor before taking this medication.

If you take more Rinomicine than you should

The main symptoms of overdose are: headache, dizziness, ringing in the ears, blurred vision, drowsiness, sweating, nausea, vomiting, and occasionally diarrhea.

Go immediately to a medical center, even if there are no symptoms, as they often do not manifest until a few days after ingestion, even in cases of severe poisoning.

Treatment of overdose is more effective if started within 4 hours of taking the medication.

If you have taken more of this medication than you should, consult your doctor or pharmacist immediately or the Toxicology Information Service, telephone 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Rinomicine

Do not take a double dose to make up for forgotten doses.

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them. During the use of this association, the following side effects have occurred:

Frequent side effects (may affect up to 1 in 10 patients):

• Gastrointestinal disorders, such as gastric ulcers, duodenal ulcers, gastrointestinal bleeding, abdominal pain, gastric discomfort, nausea, vomiting.
• Respiratory disorders, such as difficulty breathing, bronchospasm, rhinitis.
• Urticaria, skin rashes, angioedema, and itching.
• Nervous system disorders: drowsiness, vertigo, dizziness.
• Blood and lymphatic system disorders: hypoprothrombinemia when administered in high doses.

Uncommon side effects (may affect up to 1 in 100 patients):

• Reye's syndrome in children under 16 years of age with febrile, flu-like, or chickenpox processes (see section 2. What you need to know before taking Rinomicine).
• Hepatic disorders, especially in patients with juvenile arthritis.
• Anemia
• Nervous system disorders: confusion (especially in elderly patients), euphoria, nervousness, restlessness (especially in children and elderly patients), insomnia, headache, abnormal behavior.
• Cardiovascular effects: alterations in pulse (palpitations, tachycardia), elevation of blood pressure (hypertension), which can sometimes be severe (hypertensive crises), chest tightness.
• Difficulty urinating.
• Dryness of the mouth, nose, or throat.
• Blurred vision.
• Decreased gastric motility.

Rare side effects (may affect up to 1 in 1,000 patients):

• Malaise, low blood pressure (hypotension).
• Coagulation disorders.
• Increased liver transaminase levels.

In long-term treatments and with high doses, the following may appear: dizziness, ringing in the ears, deafness, sweating, headache, confusion, and kidney problems.

Treatment should be suspended immediately if the patient notices any episode of deafness, ringing in the ears, or dizziness.

In patients who have presented an allergic reaction to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs, anaphylactic or anaphylactoid reactions may occur. This could also happen in patients who have not previously shown hypersensitivity to these medications.

In elderly patients, it is more likely to produce confusion, difficulty urinating, drowsiness, dizziness, and dryness of the mouth, nose, or throat.

In children and elderly patients, it is more likely to produce nightmares, unusual excitement, nervousness, restlessness, or irritability.

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 not listed in this package leaflet. You can also report them directly through the Spanish Medicines Agency's website: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Rinomicine

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

No special storage conditions are required.

Do not use this medication after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not use this medication if you notice that the color has darkened or it shows any signs of deterioration.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Rinomicine Composition

• As active ingredients: 4 mg of chlorphenamine maleate, 10 mg of phenylephrine hydrochloride, 150 mg of salicylamide, 150 mg of paracetamol, and 30 mg of caffeine.

• Other components (excipients) are: microcrystalline cellulose, cornstarch, magnesium stearate, sodium starch glycolate, silicon dioxide, and stearic acid.

Product Appearance and Package Contents

This medication is presented in the form of circular, scored tablets, white in color. Each package contains 10 tablets.

Marketing Authorization Holder and Manufacturer

LABORATORIO DE APLICACIONES FARMACODINÁMICAS, S.A.

Grassot, 16 - 08025- Barcelona

Date of the last revision of this package leaflet:September 2022

Detailed information about this medication is available on the European Medicines Agency's website: http://www.ema.europa.eu/ and on the Spanish Agency for Medicines and Health Products (AEMPS) website: http://www.aemps.gob.es/