Rinomicine powder for oral suspension

Patient Information Leaflet

Introduction

Patient Information Leaflet

RINOMICINE powder for oral suspension

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

Always follow exactly the instructions for use provided in this leaflet or those given 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 effects not listed in this leaflet. See section 4.
• You should consult a doctor if you worsen or 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 adverse 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 chlorphenamine (relieves nasal discharge), phenylephrine (provides a decongestant effect), salicylamide and paracetamol (reduce pain and fever), caffeine (counteracts feelings of lethargy), and vitamin C (supports the body's defenses).

Rinomicine is indicated in adults and adolescents aged 16 years and older for the symptomatic relief of influenza-like conditions, catarrh, 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, to nonsteroidal anti-inflammatory drugs (NSAIDs), or to any of the other ingredients of this medicine listed in section 6.
• If you have severe kidney or liver disease.
• If you currently have or have previously had a 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 nonsteroidal anti-inflammatory drugs.
• If you suffer from asthma.
• If you have nasal polyps associated with asthma that are triggered or worsened by taking anti-inflammatory drugs, acetylsalicylic acid, or other painkillers.
• 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 linked to 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:

• You have kidney, heart, or lung disease, or you have anaemia.
• You have recently undergone or are scheduled to undergo surgery within the next 7 days, including dental surgery.
• You are taking nonsteroidal 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 (abnormal 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 suffer from rhinitis and/or urticaria.
• Do not use this medicine to prevent possible discomfort caused by vaccinations.
• You are diabetic.
• You have prostate hyperplasia.
• You are 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 lead to liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.

Children and adolescents

Children and adolescents under 16 years of age must not take this medicine.

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 nonsteroidal anti-inflammatory drugs 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 (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 rhythm disorders (propranolol, mexiletine), or arterial diseases (beta-adrenergic blocking agents).
• Medicines used to lower blood sugar levels (insulin, sulfonylureas).
• Medicines used to prevent transplant rejection (cyclosporine).
• A medicine used for certain infections (vancomycin).
• Interferon alfa, used to treat certain viral infections and tumours.
• A medicine used to treat Parkinson's disease (selegiline).
• Inhaled anaesthetic agents.
• A medicine used to treat certain psychiatric disorders (lithium).
• A medicine used to treat cancer and rheumatoid arthritis (methotrexate).
• A medicine used to treat gout (probenecid).
• Antacids (cimetidine).
• Medicines used as sedatives for sleep disorders or to treat seizures, such as barbiturates.
• A medicine used in the treatment of human immunodeficiency virus (HIV) infection, which causes AIDS (zidovudine).
• Medicines used to treat epilepsy (phenytoin and valproic acid).
• Medicines used to treat nausea and vomiting (metoclopramide).
• Medicines used 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), which requires urgent treatment and may occur particularly in cases of severe renal failure, sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, or when maximum daily doses of paracetamol are used.

Use of 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 scheduled to undergo any diagnostic tests (including blood or urine tests), inform your doctor that you are taking this medicine, as it may alter test results.

Driving and use of machines

Rinomicine may cause drowsiness, impairing mental and/or physical ability. If you experience these effects, avoid driving or operating machinery.

Rinomicine contains sucrose, fructose, and sunset yellow FCF (E110)

This medicine contains sucrose and fructose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine. Patients with diabetes mellitus should be aware that this medicine contains 8 g of sucrose per sachet.

This medicine may cause allergic reactions as it contains sunset yellow FCF (E110). It may trigger asthma, particularly in patients allergic to acetylsalicylic acid.

3. How to take Rinomicine

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

The recommended dose in adults and adolescents aged 16 years and older is: 1 sachet every 6 hours at the beginning of treatment, then continue with 1 sachet every 8 hours. Do not take more than 4 sachets in 24 hours.

Do not exceed 3 g of paracetamol in 24 hours (see section “Warnings and precautions”).

This medicine is administered orally, preferably with food.

Empty the contents of the sachet into a glass of water, stir, and drink immediately.

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 after taking the medicine.

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

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 may cause adverse effects, although not everyone experiences them. The following adverse effects have been reported during the 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 swallowing or breathing), and itching.
• Nervous system disorders: somnolence, 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 febrile illness, influenza or varicella (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: changes in pulse (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, hearing loss, 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 an allergic reaction to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs, anaphylactic or anaphylactoid reactions (generalized allergic reactions) may occur. This could also happen in patients who have not previously shown hypersensitivity to these drugs. If such a reaction occurs, stop taking the medicine and consult your doctor immediately.

In elderly patients, confusion, difficulty urinating, somnolence, dizziness, and dryness of the 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. Rinomicine Storage

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiry date indicated on the packaging after EXP. The expiry date refers to the last day of the month shown.

Do not use this medicine if you notice any change in colour or if it is clumped.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point located at pharmacies. If you have any doubts, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the package and other information

Composition of Rinomicine

• Active ingredients: 4 mg of chlorphenamine maleate, 6 mg of phenylephrine hydrochloride, 200 mg of salicylamide, 400 mg of paracetamol, 30 mg of caffeine, and 300 mg of vitamin C.

• Other components (excipients): Sucrose, fructose, orange flavor, Orange Yellow S (E-110), and sodium chloride.

Nature of the product and contents of the pack

This medicine is presented as an orange-colored powder in single-dose sachets.

Each pack contains 10 sachets.

Marketing Authorization Holder and Manufacturer

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

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

Detailed information on 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/