REMIDOL 650 mg/20 mg/4 mg ORAL SOLUTION GRANULES

2. What you need to know before taking Remidol

Do not take Remidol:

• if you are allergic (hypersensitive) to paracetamol, dextromethorphan, chlorphenamine, or any of the other components of this medication (listed in section 6)
• if you have respiratory failure, asthmatic cough, and cough accompanied by expectoration
• if you have severe liver disease
• if you have severe kidney disease or are undergoing hemodialysis
• if you are being treated with a class of medications called monoamine oxidase inhibitors (MAOIs) or after 2 weeks of finishing treatment with these medications
• if you are being treated with other medications, such as medications for depression, medications for Parkinson's disease, treatment with linezolid (antibiotic) or procarbazine (for cancer treatment) (see section "Other medications and Remidol")
• Children under 6 years old cannot take this medication due to the dose of its active ingredients.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Remidol

Do not take more than the recommended dose in section 3. "How to take Remidol". Taking more than the recommended dose (overdose) can result in liver damage. In case of overdose, seek medical help immediately. Rapid medical attention is critical for adults, as well as for children, even if you do not perceive any signs or symptoms.

Chronic alcoholics should ask their doctor if they can take paracetamol, other pain relievers, or fever-reducing medications. Additionally, they should be cautious not to take more than 3 sachets per day (2g of paracetamol).

Do not take other medications that contain paracetamol while taking this medication, as it could lead to a paracetamol overdose that could damage the liver. Do not use more than one medication that contains paracetamol without consulting your doctor.

Before starting to take Remidol, you should consult your doctor or pharmacist:

• if you have kidney, heart, or lung disease,
• if you are an anemic patient,
• if you have liver disease (with or without liver failure) or viral hepatitis, as it increases the risk of hepatotoxicity,
• if you are asthmatic and sensitive to acetylsalicylic acid,
• if you are sensitive (allergic) to an antihistamine, as you may be sensitive to others (such as chlorphenamine),
• if you have high blood pressure (hypertension), glaucoma (high eye pressure), hyperthyroidism, obstruction of the vesical neck, prostate hyperplasia with urine formation
• if you are an elderly patient, as you may be more sensitive to the side effects of this medication
• if you have atopic dermatitis
• if you are a slow metabolizer of CYP2D6 or use CYP2D6 inhibitors
• if you have a persistent respiratory condition such as emphysema, chronic bronchitis, bronchial asthma, or cough accompanied by excessive secretions, glaucoma, or difficulty urinating due to prostate hyperplasia
• in case of glucose-6-phosphate dehydrogenase (G6PD) deficiency (can cause hemolytic anemia).

During treatment with Remidol, inform your doctor immediately if:

• you have severe diseases, such as severe kidney failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you have malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious disease called metabolic acidosis (an anomaly in blood and fluids) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken with flucloxacillin. The symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

This medication may increase the sedative effects of central nervous system depressants, including alcohol, sedatives, and tranquilizers. Therefore, it is recommended to avoid drinking alcohol or taking central nervous system depressants (barbiturates, tranquilizers, MAOIs) while taking this medication.

This medication may cause drowsiness. Avoid consuming alcoholic beverages and certain medications while being treated with this medication, as they may potentiate this effect. Consult the sections "Other medications and Remidol" and "Taking Remidol with food, beverages, and alcohol"

Sedated, debilitated, or bedridden patients should not take this medication.

Very rarely, cases of severe skin reactions called acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN) have been associated with the use of paracetamol. At the first symptom of skin rash or hypersensitivity, discontinue treatment and consult your doctor.

Cases of abuse with medications containing dextromethorphan have been described in adolescents, which can cause serious side effects. (See section "If you take more Remidol than you should")

This medication may cause dependence. Therefore, treatment should be short-term.

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

Especially if you are using some of the following medications, it may be necessary to modify the dose of some of them or interrupt treatment:

• Medications for treating epilepsy (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone).
• Medications for treating tuberculosis (isoniazid, rifampicin).
• Medications for preventing blood clots (oral anticoagulants) such as acenocoumarol, warfarin.
• Medications used to increase urine elimination (loop diuretics such as furosemide, or other diuretics), and other diuretics that cause potassium loss (such as diuretics for treating hypertension or others).
• Medications used to prevent nausea and vomiting (metoclopramide and domperidone).
• Medications used for treating gout (probenecid).
• Medications used for treating high blood pressure (hypertension), such as propranolol, and heart rhythm disorders (cardiac arrhythmias), such as amiodarone or quinidine.
• Medications for reducing cholesterol levels in the blood (cholestyramine).
• The administration of Remidol should be separated by a minimum of 14 days after finishing treatment with some medications for treating depression (moclobemide, tranilcipromine, fluoxetine, paroxetine, bupropion); medications used for treating Parkinson's disease (selegiline), and medications for treating other diseases, such as cancer (procarbazine), and infections (linezolid, furazolidone).
• Medications for treating depression, called tricyclic and tetracyclic antidepressants (such as maprotiline).
• Medications for treating schizophrenia (such as haloperidol).
• Medications that have a depressant effect on the central nervous system, such as those used for insomnia or anxiety, for Parkinson's disease, or for allergies.
• Medications that have ototoxic effects (damage to the ear)
• Medications that have photosensitizing effects (allergy to light)
• Medications used for pain relief and inflammation (celecoxib, parecoxib, valdecoxib).
• Medications used to increase mucus secretion.
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid anomalies (called metabolic acidosis) that must be treated urgently (see section 2).
• Metoprolol, used for treating cardiovascular diseases (hypertension, acute myocardial infarction).
• Isavuconazole, used for treating invasive aspergillosis and invasive mucormycosis.

Interference with analytical tests:

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

Taking Remidol with food, beverages, and alcohol

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

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

Do not take the medication with grapefruit or bitter orange juice, as it may potentiate the effects of one of its components (dextromethorphan).

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.

Taking medications during pregnancy can be hazardous to the embryo or fetus and should be monitored by your doctor.

This medication should not be taken during pregnancy unless your doctor considers it strictly necessary.

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

Driving and using machines

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

Remidol contains sodiumThis medication contains 26.3 mg of sodium (main component of table salt/cooking salt) per sachet. This is equivalent to 1.18% of the maximum recommended daily sodium intake for an adult.

Remidol contains sucroseThis medication contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication. Patients with diabetes mellitus should be aware that this medication contains 4.4 g of sucrose per sachet

Remidol contains orange yellow S(E 110)):This medication may cause allergic reactions because it contains orange yellow S (E110). It can cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Remidol

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

Remidol is a medication intended for oral use. Pour the contents of one sachet into a half glass of water and stir until dissolved. You can add sugar or honey according to your preferences. At night, take preferably before bedtime.

Start treatment when the first symptoms appear and suspend as they disappear

If your condition worsens or does not improve after 5 consecutive days of treatment (3 days for fever or in adolescents), you should consult your doctor. (See section 1. "What is Remidol and what is it used for")

Always use the lowest effective dose

The recommended dose is:

Adults and adolescents from 14 years old:

1 sachet every 6 or 8 hours (3 or 4 times a day), as needed. Preferably take 1 sachet before bedtime. Do not take more than 4 sachets (equivalent to 2.6 g of paracetamol) per day. See section "Warnings and precautions".

Patient with liver failure:

1 sachet every 8 hours. Do not take more than 3 sachets (equivalent to 1.95 g of paracetamol) per day. Consult your doctor.

Patient with kidney failure:

You cannot take this medication due to the dose of paracetamol 650 mg.

Use in children

This medication is contraindicated in children under 14 years old due to the dose of its active ingredients.

If you take more Remidol than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist, go immediately to a medical center, or, if not possible, consult the Toxicology Information Service (telephone: 915 620 420), indicating the medication and the amount ingested. The symptoms often do not appear until 3 days after ingestion of the overdose, even in case of severe poisoning.

The most serious effect of an overdose of this medication is liver damage caused by paracetamol. You may feel dizzy, vomit, confused, excited, restless, nervous, irritable, visual disturbances, loss of appetite, yellowing of the skin and eyes (jaundice), abdominal pain, and difficulty breathing. The overdose can also cause coagulation disorders (blood clots and bleeding). In children, states of drowsiness or alterations in gait.

Other symptoms in case of massive overdose may be: coma, severe respiratory problems, and convulsions.

Contact your doctor or hospital immediately if you experience any of the mentioned symptoms

Cases of abuse with medications containing dextromethorphan have been reported in adolescents, which can cause serious side effects, such as agitation, confusion, conversion disorders, hallucinations, ataxia (uncoordinated movements), coma, decreased consciousness, dysarthria (difficulty speaking), apathy, dystonia, nystagmus (involuntary eye movement), convulsions, serotonin syndrome, tremor, depression, and central nervous system excitement, miosis, and mydriasis (pupillary constriction and dilation), respiratory depression, urinary retention, tachycardia, hypertension, and ischemic colitis.

The symptoms of an overdose of chlorphenamine may be central nervous system depression, hyperthermia, anticholinergic syndrome (mydriasis, flushing, fever, dry mouth, urinary retention, decreased intestinal sounds), tachycardia, hypotension, hypertension, nausea, vomiting, agitation, confusion, hallucinations, psychosis, convulsions, or arrhythmias. Patients with prolonged agitation, coma, or convulsions may rarely develop rhabdomyolysis and renal failure.

Treatment of overdose is more effective if started within 4 hours of taking the medication. Patients treated with barbiturates or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone may experience them.

The following side effects were reported in at least 1 in 100 subjects during clinical trials with chlorphenamine: drowsiness, dry mouth, dizziness, restlessness, pharyngitis, and dyspepsia.

The following adverse reactions were reported with an unknown frequency: anaphylactic reaction, hypersensitivity, insomnia, nervousness, and restlessness (psychomotor hyperactivity), abdominal pain, diarrhea, nausea, vomiting, angioedema (swelling of certain skin areas), pruritus, urticaria, rash, pruritic rash, skin lesions after taking the medication (fixed drug eruption), increased transaminases, and a serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

Concurrent consumption of alcohol during treatment may accentuate the appearance of side effects. Do not ingest alcoholic beverages during the same

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Remidol

Keep this medicine out of sight and reach of children. Do not store at a temperature above 30 ºC

Do not use this medicine after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

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

6. Package Contents and Additional Information

Composition of Remidol

The active ingredients are: paracetamol 650 mg, chlorphenamine maleate 4 mg, and dextromethorphan hydrobromide 20 mg.

The other components (excipients) are: sucrose, sodium cyclamate, sodium citrate, orange yellow S (E-110), sodium saccharin, anhydrous citric acid, polysorbate 80, povidone K 30, titanium dioxide (E-171), lemon flavor, quinoline yellow (E-104).

See Section 2 "Remidol contains sodium, sucrose, and orange yellow S (E-110)"

Appearance of the Product and Package Contents

Oral solution granulate of yellow color and lemon flavor. Each package contains 10 sachets.

Marketing Authorization Holder

Farmasierra Laboratorios, S.L.

Ctra de Irún, km 26,200

28706, San Sebastián de los Reyes Madrid.

Spain

Manufacturer

Farmasierra Manufacturing SL

Ctra de Irún km 26,200

San Sebastián de los Reyes 28706 Madrid.

Spain

Date of the Last Revision of this Leaflet

February 2025

Other Sources of Information

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