Rinomicine tablets

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

RINOMICINE tablets

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

Follow exactly the instructions for taking this medicine as contained in this leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• 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.
• You should consult a doctor if your condition worsens or if you do not improve after 5 days of treatment (3 days for fever).

Contents of the 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. How to store Rinomicine
6. Contents of the pack and other information

1. What Rinomicine is and what it is used for

This medicine is a combination of chlorpheniramine (relieves nasal discharge), phenylephrine (provides a decongestant effect), salicylamide and paracetamol (reduce pain and fever), and caffeine (counteracts drowsiness).

Rinomicine is indicated for symptomatic relief in adults and adolescents aged 16 years and older with influenza-like conditions, catarrhal states, and the common cold associated with mild to moderate pain, headache, fever, nasal congestion, and nasal discharge.

You should consult a doctor if your condition worsens or does not improve after 5 days of treatment, or if 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 in this medicine or to non-steroidal anti-inflammatory drugs (NSAIDs), or to any of the other components of this medicine listed in section 6.
• If you have severe kidney or liver disease.
• If you have or have had stomach or intestinal ulcer, or recurrent gastric discomfort.
• If you have a history of gastrointestinal bleeding or perforation following 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 caused or worsened by taking anti-inflammatory drugs, acetylsalicylic acid, or other analgesics.
• If you have haemophilia or other blood coagulation disorders that predispose you to internal bleeding.
• If you are under 16 years of age, as the use of acetylsalicylic acid has been associated with Reye's syndrome, a rare but serious illness.
• If you are in the third trimester of pregnancy.

Warnings and precautions:

Consult your doctor or pharmacist before taking this medicine if any of the following apply to you:

• Patients with kidney, heart, or lung disease, or patients with anaemia.
• You have recently undergone or are scheduled to undergo surgery within the next 7 days, including dental surgery.
• You are taking non-steroidal anti-inflammatory drugs (NSAIDs) or other medicines that may increase the risk of bleeding, such as corticosteroids, selective serotonin reuptake inhibitors (SSRIs), or anticoagulants.
• You have hypertension (high blood pressure), glaucoma (increased intraocular pressure), or phaeochromocytoma (a type of tumour in the adrenal gland).
• You have cardiac arrhythmias (irregular heart rhythm), hyperthyroidism, or anxiety states.
• You are allergic to other anti-inflammatory or anti-rheumatic drugs.
• You have glucose-6-phosphate dehydrogenase deficiency.
• You have rhinitis and/or urticaria.
• Do not use this medicine to prevent possible discomfort caused by vaccinations.
• You are diabetic.
• You have prostate hypertrophy.
• Patients sensitive to aminophylline or theophylline.

Elderly people may be more sensitive to the side effects of this medicine.

Do not take more medicine than the recommended dose stated in section 3. How to take Rinomicine.

Concomitant use of this medicine with other medicines containing paracetamol should be avoided, as high doses may cause liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.

Children and adolescents

This medicine must not be taken by children under 16 years of age.

Taking Rinomicine with other medicines

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

This is especially important if you are taking any of the following medicines, as it may be necessary to adjust the dose or discontinue treatment:

• Analgesics and non-steroidal anti-inflammatory drugs (NSAIDs), medicines used to treat pain and/or muscle inflammation, as they increase the risk of gastrointestinal bleeding.
• Corticosteroids (used for inflammation), as they may increase the risk of gastrointestinal bleeding.
• Medicines used to increase urine output (diuretics).
• Certain antidepressants such as selective serotonin reuptake inhibitors (SSRIs) (fluoxetine, paroxetine, sertraline) and monoamine oxidase inhibitors (MAOIs) (moclobemide, tranylcypromine).
• Medicines used to thin the blood and prevent clot formation, such as oral anticoagulants (acenocoumarol, warfarin).
• Certain medicines used to treat high blood pressure (methyldopa, reserpine, guanethidine, rauwolfia alkaloids).
• Medicines used for heart conditions (digoxin), cardiac arrhythmias (propranolol, mexiletine), or arterial diseases (beta-adrenergic blocking agents).
• Medicines to lower blood sugar levels (insulin, sulfonylureas).
• Medicines used to prevent transplant rejection (cyclosporine).
• Medicine used for certain infections (vancomycin).
• Interferon alfa, used to treat certain viral infections and tumours.
• Medicine used to treat Parkinson's disease (selegiline).
• Inhalational anaesthetic agents.
• Medicine used to treat certain psychiatric disorders (lithium).
• Medicine used to treat cancer and rheumatoid arthritis (methotrexate).
• Medicines used to treat gout (probenecid).
• Antacids (cimetidine).
• Medicines used as sedatives for sleep disorders and to treat seizures, such as barbiturates.
• Medicine used in the treatment of human immunodeficiency virus (HIV) infection causing AIDS (zidovudine).
• Medicines used to treat epilepsy (phenytoin and valproic acid).
• Medicines used to treat nausea and vomiting (metoclopramide).
• Medicines to lower blood cholesterol levels (cholestyramine).
• Medicines used to treat alcohol withdrawal syndrome (disulfiram).
• Adrenergic bronchodilators (theophylline).
• Flucloxacillin (an antibiotic), due to a serious risk of blood and fluid disturbances (metabolic acidosis with high anion gap) requiring urgent treatment, particularly in cases of severe renal failure, sepsis (when bacteria and their toxins circulate in the blood causing organ damage), malnutrition, chronic alcoholism, or when maximum daily doses of paracetamol are used.

Taking Rinomicine with food, drinks and alcohol

Take this medicine after meals or with food.

While taking this medicine, you must not consume alcoholic beverages, as they may increase the risk of adverse effects.

In addition, the use of medicines containing paracetamol in patients who regularly consume alcohol (3 or more alcoholic drinks per day: beer, wine, spirits, etc.) may cause liver damage.

Pregnancy, breastfeeding and fertility

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

This medicine must not be used during the third trimester of pregnancy.

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

The active substances in this medicine are excreted in breast milk; therefore, women who are breastfeeding should not take Rinomicine.

Interference with diagnostic tests

If you are due to have any diagnostic tests (including blood or urine tests, etc.), inform your doctor that you are taking this medicine, as it may alter test results.

Driving and use of machines:

This medicine may cause drowsiness, affecting mental and/or physical abilities. If you experience these effects, avoid driving vehicles or operating machinery.

3. How to take Rinomicine

Follow exactly the administration instructions for this medicine provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

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

Do not take more than 3 g of paracetamol in any 24-hour period (see section “Warnings and precautions”).

This medicine 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 must not take this medicine.

Use in elderly patients

Elderly patients should not take this medicine without consulting their doctor, as they are more likely to experience adverse effects.

Patients with impaired liver or kidney function

Must consult their doctor before taking this medicine.

If you take more Rinomicine than you should

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

Seek immediate medical attention at a healthcare facility, even if there are no symptoms, as symptoms often do not appear until several days after ingestion, even in cases of severe poisoning.

Treatment of overdose is most effective if started within 4 hours of taking the medicine.

If you have taken more than the prescribed amount of this medicine, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine taken and the amount ingested.

If you forget to take Rinomicine

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. The following adverse effects have been reported during use of this combination:

Common adverse effects (may affect up to 1 in 10 patients):

• Gastrointestinal disorders, such as gastric ulcer, duodenal ulcer, gastrointestinal bleeding, abdominal pain, gastric discomfort, nausea, vomiting.
• Respiratory disorders, such as difficulty breathing, bronchospasm, rhinitis.
• Urticaria, skin rashes, angioedema (inflammation and swelling affecting the face, lips, mouth, tongue or throat, which may cause difficulty in swallowing or breathing), and itching.
• Nervous system disorders: drowsiness, dizziness, vertigo.
• Blood and lymphatic system disorders: hypoprothrombinemia (coagulation disorder) when administered at high doses.

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

• Reye's syndrome in patients under 16 years of age with fever, influenza or chickenpox (see section 2. What you need to know before taking Rinomicine).
• Hepatic disorders, especially in patients with juvenile arthritis.
• Anaemia.
• Nervous system disorders: confusion (especially in elderly patients), euphoria, nervousness, restlessness (especially in children and elderly patients), insomnia, headache, unusual behaviour.
• Cardiovascular effects: pulse disturbances (palpitations, tachycardia), elevated blood pressure (hypertension), which may sometimes be severe (hypertensive crises), chest tightness.
• Difficulty urinating.
• Dryness of mouth, nose or throat.
• Blurred vision.
• Decreased gastrointestinal motility.

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

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

With long-term treatment and high doses, dizziness, tinnitus, deafness, sweating, headache, confusion, and kidney problems may occur.

Treatment must be stopped immediately if the patient experiences any episode of hearing loss, tinnitus, or dizziness.

In patients who have previously shown allergic reactions to acetylsalicylic acid or 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 drugs.

In elderly patients, confusion, difficulty urinating, drowsiness, dizziness, and dryness of mouth, nose or throat are more likely to occur.

In children and elderly patients, nightmares, unusual excitement, nervousness, restlessness, or irritability are more likely to occur.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, 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 Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Rinomicine

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

No special storage conditions are required.

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.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of unused medicines and packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rinomicine

• Active substances: 4 mg of chlorpheniramine maleate, 10 mg of phenylephrine hydrochloride, 150 mg of salicylamide, 150 mg of paracetamol, and 30 mg of caffeine.

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

Appearance of the medicine and contents of the pack

This medicine is presented as white, circular tablets, scored on one side. Each pack contains 10 tablets.

Marketing Authorization Holder and Manufacturer

LABORATORIO DE APLICACIONES FARMACODINÁMICAS, S.A.
Grassot, 16 - 08025- Barcelona

Date of the most recent review of this leaflet: September 2022

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