Remidol 650 mg/20 mg/4 mg granules for oral solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Remidol 650 mg/20 mg/4 mg granules for oral solution EFG

paracetamol / dextromethorphan hydrobromide / chlorphenamine maleate

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

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 adverse effects not listed in this leaflet. See section 4.
• You should consult your doctor if you worsen or do not improve after 5 days of treatment (3 days for fever and for adolescents).

Leaflet contents

1. What Remidol is and what it is used for
2. What you need to know before taking Remidol
3. How to take Remidol
4. Possible adverse effects
5. Storage of Remidol
6. Contents of the pack and other information

1. What Remidol is and what it is used for

Remidol is a medicine containing three active substances in combination: paracetamol, which reduces fever and relieves pain; dextromethorphan, which is a cough suppressant; and chlorpheniramine, which reduces nasal discharge and sneezing.

It is indicated for the symptomatic relief of cold and flu, including mild to moderate pain such as headache, fever, non-productive cough (irritant cough, nervous cough), nasal discharge, and sneezing in adults and adolescents aged 14 years and older.

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

2. What you need to know before starting to take Remidol

Do not take Remidol:

• if you are allergic (hypersensitive) to paracetamol, dextromethorphan, chlorphenamine, or to any of the other components of this medicine (listed in section 6)
• if you have respiratory failure, asthmatic cough, or cough with expectoration
• if you have severe liver disease
• if you have severe kidney disease, or are undergoing haemodialysis
• if you are being treated with a type of medicines called monoamine oxidase inhibitors (MAOIs), or within 2 weeks after stopping treatment with these medicines
• if you are or have recently been treated with other medicines, such as: medicines for depression, medicines for the treatment of Parkinson's disease, treatment with linezolid (antibiotic) or procarbazine (for cancer treatment) (see section “Other medicines and Remidol”).
• Children under 6 years of age must not take this medicine due to the dosage 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 stated in section 3, "How to take Remidol". Taking more than the recommended dose (overdose) may result in liver damage. In case of overdose, seek immediate medical help. Prompt medical attention is critical for both adults and children, even if you do not notice any signs or symptoms.

Chronic alcoholics should ask their doctor whether they can take paracetamol, other painkillers, or fever-reducing medicines. In addition, they should take care not to exceed 3 sachets per day (2 g of paracetamol).

Do not take other medicines containing paracetamol while taking this medicine, as this could lead to a paracetamol overdose that may damage the liver. Do not use more than one medicine containing 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 a patient with anemia,
• if you suffer from liver disease (with or without liver failure) or viral hepatitis, as this 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 also be sensitive to others (such as chlorpheniramine),
• if you have hypertension (high blood pressure), glaucoma (increased intraocular pressure), hyperthyroidism, bladder neck obstruction, prostate hyperplasia with urinary retention,
• if you are elderly, as you may be more sensitive to the side effects of this medicine,
• if you suffer from atopic dermatitis,
• if you are a slow metabolizer of CYP2D6 or are taking CYP2D6 inhibitors,
• if you have a chronic respiratory condition such as emphysema, chronic bronchitis, bronchial asthma, or cough with excessive secretions, glaucoma, or difficulty urinating due to prostate hyperplasia,
• in case of glucose-6-phosphate dehydrogenase (G6PD) deficiency (which may cause hemolytic anemia).

During treatment with Remidol, inform your doctor immediately if:

• you have serious conditions such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients under these circumstances when paracetamol is used at regular doses over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulty with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

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

This medicine may cause drowsiness. Avoid consuming alcoholic beverages and certain medications while being treated with this medicine, as they may enhance this effect. Refer to the sections "Other medicines and Remidol" and "Taking Remidol with food, drinks, and alcohol".

Sedated, weakened, or bedridden patients should not take this medicine.

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

Cases of abuse of medicines containing dextromethorphan have been reported in adolescents; therefore, this possibility should be considered, as it may lead to serious adverse effects (see section "If you take more Remidol than you should").

This medicine may lead to dependence. Therefore, treatment should be short-term.

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

Especially, if you are using any of the following medicines, it may be necessary to adjust the dose or discontinue treatment:

• Medicines used to treat epilepsy (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone).
• Medicines used to treat tuberculosis (isoniazid, rifampicin).
• Medicines used to prevent blood clots (oral anticoagulants) such as acenocoumarol, warfarin.
• Medicines used to increase urine elimination (loop diuretics such as furosemide, or other diuretics), and other diuretics that cause potassium loss (such as diuretics used to treat hypertension or others).
• Medicines used to prevent nausea and vomiting (metoclopramide and domperidone).
• Medicines used in the treatment of gout (probenecid).
• Medicines used to treat high blood pressure (hypertension), such as propranolol, and heart rhythm disorders (cardiac arrhythmias), such as amiodarone or quinidine.
• Medicines used to lower blood cholesterol levels (cholestyramine).
• Administration of Remidol should be separated by at least 14 days after stopping treatment with certain medicines used to treat depression (moclobemide, tranylcypromine, fluoxetine, paroxetine, bupropion); medicines used to treat Parkinson's disease (selegiline); and medicines used to treat other conditions such as cancer (procarbazine) and infections (linezolid, furazolidone).
• Medicines for depression, known as tricyclic and tetracyclic antidepressants (such as maprotiline).
• Medicines for schizophrenia (such as haloperidol).
• Medicines that cause central nervous system depression, such as those used for insomnia or anxiety, Parkinson's disease, or allergies.
• Medicines that have the adverse effect of damaging the ear (ototoxic).
• Medicines that cause photosensitivity as an adverse effect (photosensitizers).
• Medicines used for pain and inflammation relief (celecoxib, parecoxib, valdecoxib).
• Medicines used to increase mucus secretion.
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormalities (called metabolic acidosis) that must be treated urgently (see section 2).
• Metoprolol, used to treat cardiovascular conditions (hypertension, acute myocardial infarction).
• Isavuconazole, used to treat invasive aspergillosis and invasive mucormycosis.

Interference with diagnostic tests:

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

Taking Remidol with food, drinks, and alcohol

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

Using medicines containing paracetamol in patients who habitually consume alcohol (3 or more alcoholic drinks: beer, wine, spirits, etc., per day) may cause liver damage.

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

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.

Taking medicines during pregnancy may be harmful to the embryo or fetus and should be monitored by your doctor.

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

The active ingredients of this medicine are excreted in breast milk; therefore, women who are breastfeeding should not take Remidol.

Driving and Use of Machines

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

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

Remidol contains sucrose This medicine contains sucrose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine. Patients with diabetes mellitus should take into account that this medicine contains 4.4 g of sucrose per sachet.

Remidol contains sunset yellow FCF (E 110): This medicine may cause allergic-type reactions because it contains sunset yellow FCF (E 110). It may trigger asthma, particularly in patients allergic to acetylsalicylic acid.

3. How to take Remidol

Follow exactly the dosage instructions provided in this leaflet or those given by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Remidol is a medicine intended for oral use. Pour the contents of one sachet into half a glass of water and stir until dissolved. Sugar or honey may be added according to your preference. At night, take preferably before going to bed.

Begin treatment as soon as the first symptoms appear and discontinue as symptoms subside.

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

Always use the lowest dose that is effective.

Recommended dose:

Adults and adolescents aged 14 years and over:

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

Patients with hepatic impairment:

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

Patients with renal impairment:

You must not take this medicine due to the paracetamol dose of 650 mg.

Use in children

This medicine is contraindicated in children under 14 years of age 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 and go immediately to a medical center, or if this is not possible, call the Toxicology Information Service (telephone: 915 620 420), indicating the medicine and the amount ingested. Symptoms often do not appear until 3 days after the overdose, even in cases of severe poisoning.

The most serious effect of an overdose of this medicine is liver damage caused by paracetamol. You may experience dizziness, vomiting, confusion, excitability, restlessness, nervousness, irritability, visual disturbances, loss of appetite, yellowing of the skin and eyes (jaundice), abdominal pain, and difficulty breathing. Overdose may also cause coagulation disorders (blood clots and bleeding). In children, drowsiness or disturbances in gait may occur.

Other symptoms in cases of massive overdose may include coma, severe respiratory problems, and seizures.

Contact your doctor or hospital immediately if you experience any of the symptoms listed above.

Cases of abuse with medicines containing dextromethorphan have been reported in adolescents, which may lead to serious adverse effects such as agitation, confusion, conversion disorders, hallucinations, ataxia (incoordinated movements), coma, decreased consciousness, dysarthria (speech difficulty), apathy, dystonia, nystagmus (involuntary and uncontrollable eye movements), seizures, serotonin syndrome, tremor, depression, central nervous system stimulation, miosis and mydriasis (constriction and dilation of the eye pupil), respiratory depression, urinary retention, tachycardia, hypertension, and ischemic colitis.

Symptoms of overdose with chlorpheniramine may include central nervous system depression, hyperthermia, anticholinergic syndrome (mydriasis, flushing, fever, dry mouth, urinary retention, decreased bowel sounds), tachycardia, hypotension, hypertension, nausea, vomiting, agitation, confusion, hallucinations, psychosis, seizures, or arrhythmias. Patients with prolonged agitation, coma, or seizures may rarely develop rhabdomyolysis and renal failure.

Treatment of overdose is most effective if started within 4 hours after ingestion of the medicine. Patients undergoing treatment with barbiturates or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The following adverse 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 occurred with unknown frequency: anaphylactic reaction, hypersensitivity, insomnia, nervousness and restlessness (psychomotor hyperactivity), abdominal pain, diarrhea, nausea, vomiting, angioedema (swelling of certain areas of the skin), pruritus, urticaria, rash, pruritic rash, skin lesions after taking the medicine (fixed drug eruption), increased transaminases, and a serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness taking paracetamol (see section 2).

Concomitant consumption of alcohol during treatment may intensify the occurrence of adverse effects. Do not drink alcoholic beverages during treatment.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Remidol

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

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.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Remidol

The active substances are: paracetamol 650 mg, chlorpheniramine maleate 4 mg, and dextromethorphan hydrobromide 20 mg.

The other components (excipients) are: sucrose, sodium cyclamate, sodium citrate, sunset yellow FCF (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 sunset yellow FCF (E-110)”

Nature and content of the container

Yellow granules with lemon flavor for oral solution. 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 most recent review of this leaflet

February 2025

Other sources of information

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