Package Insert: Information for the User

RINOMICINE Powder for Oral Suspension

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

Follow exactly the administration instructions contained in this package insert or those provided by your doctor or pharmacist.

• Keep this package insert, as you may need to refer to 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 not listed in this package insert. 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).

This medication is an association of chlorphenamine (relieves nasal secretion), phenylephrine (provides a decongestant effect), salicylamide and paracetamol (reduce pain and fever), caffeine (counteracts lethargy) and vitamin C (helps the body's defenses).

Rinomicine is indicated in adults and adolescents from 16 years old for symptomatic relief of influenza-like states, catarrhal and common cold that are accompanied by mild or moderate pain, headache, fever, congestion and nasal secretion.

Consult a doctor if it worsens or does not improve after 5 days of treatment or if fever persists for more than 3 days.

Do not take Rinomicine:

• If you are allergic to the active ingredients of this medication or to nonsteroidal anti-inflammatory drugs or to any of the other components of this medication listed in section 6.
• If you have a serious kidney or liver disease.
• If you have a stomach ulcer, intestinal ulcer, or recurring stomach discomfort.
• If you have a history of stomach or intestinal bleeding or perforation after treatment with acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs.
• If you have asthma.
• If you have nasal polyps associated with asthma that are produced or increased by taking anti-inflammatory drugs, acetylsalicylic acid, or other analgesics.
• If you have hemophilia or other bleeding disorders that predispose you to internal bleeding.
• If you are under 16 years old, as the use of acetylsalicylic acid has been associated with 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:

• Patients with kidney, heart, or lung diseases and patients with anemia.
• Have recently undergone or will undergo surgery, including dental surgery, within the next 7 days.
• Are taking nonsteroidal anti-inflammatory drugs or other medications that may increase the risk of bleeding, such as corticosteroids, selective serotonin reuptake inhibitors, anticoagulants.
• Have hypertension (elevated blood pressure), glaucoma (elevated intraocular pressure), or pheochromocytoma (a type of adrenal gland tumor).
• Have cardiac arrhythmias (heart rhythm disorders), hyperthyroidism, or anxiety states.
• Are allergic to other anti-inflammatory or antirheumatic drugs.
• Have glucose-6-phosphate dehydrogenase deficiency.
• Have rhinitis and/or urticaria.
• Do not use this medication to prevent discomfort caused by vaccinations.
• Are diabetic.
• Have benign prostatic hyperplasia.
• Patients sensitive to aminophylline or theophylline.

Older people may be more sensitive to the side effects of this medication.

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

Avoid taking this medication with other medications that contain paracetamol, as high doses may cause liver damage. Do not take more than one medication containing paracetamol without consulting your doctor.

Children and adolescents:

Children under 16 years old cannot take this medication.

Taking Rinomicine with other medications:

Inform your doctor or pharmacist if you are taking, have taken recently, 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 discontinue treatment:

• Analgesics and nonsteroidal anti-inflammatory drugs, which are used to treat pain and/or muscle inflammation, as it increases the risk of gastrointestinal bleeding.
• Corticosteroids (used to treat inflammation), as it may potentiate the risk of gastrointestinal bleeding.
• Diuretics (used to increase urine elimination).
• Some medications used to treat depression, such as selective serotonin reuptake inhibitors (fluoxetine, paroxetine, sertraline) and monoamine oxidase inhibitors (IMAO) (moclobemide, tranylcypromine).
• Medications used to thin the blood and prevent clotting, such as oral anticoagulants (acenocoumarol, warfarin).
• Some 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 vascular diseases (beta-blockers).
• Medications used to lower blood sugar levels (insulin, sulfonylureas).
• Medications used to prevent transplant rejection (ciclosporin).
• Medication used to treat some infections (vancomycin).
• Interferon alfa, used to treat some viral infections and tumors.
• Medication used to treat Parkinson's disease (selegiline).
• Anesthetic medications by inhalation.
• Medication used to treat some psychiatric disorders (lithium).
• Medication used to treat cancer and rheumatoid arthritis (methotrexate).
• Medication used to treat gout (probenecid).
• Antacids (cimetidine).
• Medications used as sedatives for sleep disorders and to treat seizures, such as barbiturates.
• Medication used to treat HIV infections (zidovudine).
• Medications used to treat epilepsy (phenytoin and valproic acid).
• Medications used to treat nausea and vomiting (metoclopramide).
• Medications used to lower cholesterol levels in the blood (colestiramine).
• Medications used to treat alcohol withdrawal in alcoholic patients (disulfiram).
• Adrenergic bronchodilators (theophylline).
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid imbalance (metabolic acidosis with high anion gap) that must be treated urgently and may occur particularly in cases of severe renal insufficiency, sepsis (when bacteria and their toxins circulate in the blood causing organ damage), malnutrition, chronic alcoholism, and when using maximum daily doses of paracetamol.

Use of Rinomicine with food, drinks, and alcohol:

Take this medication after meals or with food.

While taking this medication, do not consume alcoholic beverages, as it may potentiate the appearance of adverse effects of this medication.

Additionally, the use of medications containing paracetamol by patients who regularly consume alcohol (3 or more alcoholic beverages: beer, wine, liquor, etc. per day) may cause liver damage.

Pregnancy, breastfeeding, and fertility:

If you are pregnant or breastfeeding, or if you 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 has not been established during the rest of pregnancy.

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

Interference with diagnostic tests:

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

Driving and operating machinery:

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

Rinomicine contains saccharose, fructose, and yellow S (E110):

This medication contains saccharose and fructose. If your doctor has indicated that you have a sensitivity to certain sugars, consult with him before taking this medication. Patients with diabetes mellitus should note that this medication contains 8 g of saccharose per tablet.

This medication may cause allergic reactions because it contains yellow S (E110). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

Follow exactly the administration instructions for this medication contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose in adults and adolescents 16 years and older is: 1 tablet every 6 hours at the start of treatment and continue with 1 every 8 hours. Do not take more than 4 tablets in 24 hours.

Do not take more than 3 g of paracetamol every 24 hours (see section “Warnings and precautions”).

This medication is administered orally, preferably with food.

Empty the contents of the packet into a glass of water, shake and drink afterwards.

Use in children and adolescents

Children and adolescents under 16 years cannot take this medication

Use in elderly patients

Elderly patients should not take this medication without consulting their doctor, as they are more prone to experiencing adverse 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 appear until several days after ingestion, even in cases of severe poisoning.

The treatment of overdose is more effective if initiated within 4 hours of medication ingestion.

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

If you forgot to take Rinomicine

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

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

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

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

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

Rare side effects (can affect up to 1 in 100 patients):

• Reye's syndrome in patients under 16 years with febrile, flu, or chickenpox processes (see section 2. What you need to know before starting to take Rinomicine).
• Liver 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, strange behavior.
• CARDIOVASCULAR EFFECTS: alterations in pulse (palpitations, tachycardia), elevated blood pressure (hypertension), which can sometimes be severe (hypertensive crises), chest tightness.
• Difficulty urinating.
• Dry mouth, nose, or throat.
• Blurred vision.
• Decreased gastrointestinal motility.

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

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

In long-term treatments and high doses, the following may occur: dizziness, ear noises, hearing loss, sweating, headache, confusion, and kidney problems.

The treatment should be stopped immediately if the patient notices any episode of hearing loss, ear noises, or dizziness.

In patients who have had an allergic reaction to acetylsalicylic acid and other nonsteroidal 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 medications. If this type of reaction occurs, stop taking the medication and consult your doctor immediately.

In elderly patients, it is more likely to occur confusion, difficulty urinating, drowsiness, dizziness, and dry mouth, nose, or throat.

In children and elderly patients, it is more likely to occur 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 that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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 that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not use this medication if you notice it has changed color or become discolored.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and unused medication at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medication. By doing so, you will help protect the environment.

Composition of Rinomicine

• As 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.

• The other components (excipients) are: sucrose, fructose, orange essence, yellow orange S (E-110), and sodium chloride.

Appearance of the product and contents of the packaging

This medication is presented in the form of orange-colored powder in single-dose sachets.

Each package contains 10 sachets.

Holder of the marketing authorization and responsible for manufacturing

Laboratorio de Aplicaciones Farmacodinámicas, S.A. Grassot, 16 – 08025 Barcelona

Date of the last review of this leaflet:September 2022

The detailed information about this medication 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 Medical Devices (AEMPS)http://www.aemps.gob.es/