Leaflet: information for the user

Couldina with paracetamol effervescent tablets

Paracetamol / Phenylephrine / Chlorphenamine

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

Follow exactly the administration instructions for the medicine contained in this leaflet or those indicated 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.
• You should consult a doctor if you worsen, or if you do not improve, or if the fever persists for more than 3 days or the pain or other symptoms persist for more than 5 days.

It is an association of paracetamol, chlorphenamine and phenylephrine.

Paracetamol is an analgesic that reduces pain and fever.

Chlorphenamine is an antihistamine that relieves nasal secretion.

Phenylephrine is a sympathomimetic that reduces nasal congestion.

It is indicated in adults and adolescents from 15 years old for the relief of symptoms of colds and flu that are accompanied by fever or mild to moderate pain, congestion and nasal secretion.

Consult a doctor if it worsens or does not improve or if the fever persists for more than 3 days or the pain or other symptoms persist for more than 5 days.

Do not take Couldina with paracetamol

• If you are allergic to the active ingredients or any of the other components of this medication (listed in section 6).
• If you have high blood pressure.
• If you have hyperthyroidism.
• If you have diabetes mellitus.
• If you have tachycardia (rapid heartbeats).
• If you are being treated with any monoamine oxidase inhibitor (MAOI) medication (such as certain antidepressants or medications for Parkinson's disease).
• If you are being treated with sympathomimetic medications (medications used to treat asthma or medications to accelerate heart rate).
• If you are being treated with beta-blocker medications (medications for the heart or to treat arterial diseases) (see: “Taking Couldina with paracetamol with other medications”).
• If you have glaucoma (elevated eye pressure).
• If you have severe heart or arterial disease (such as coronary disease or angina pectoris).
• If you have severe liver or kidney disease.

Patients under 15 years old cannot take this medication.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication.

• Do not take more medication than recommended in section 3: “How to take Couldina with paracetamol”.
• You should avoid taking this medication with other medications that contain paracetamol, as high doses can cause liver damage. Do not use more than one medication that contains paracetamol without consulting your doctor.
• Chronic alcoholics should be careful not to take more than 3 tablets in 24 hours.
• You should consult your doctor before taking this medication:

• Patients with kidney, liver, heart, or lung diseases and patients with anemia.
• Patients with asthma who are sensitive to acetylsalicylic acid.
• Patients who are sensitive (allergic) to an antihistamine, as they may be sensitive to other antihistamines (such as chlorphenamine).
• Patients who are being treated with medications for: prostate hypertrophy, bronchial asthma, very slow heartbeats, hypotension, cerebral arteriosclerosis, pancreatitis, peptic ulcer (peptic ulcer stenosis), pyloric obstruction (between the stomach and the intestine), thyroid diseases, patients sensitive to the sedative effects of some medications.
• If you are being treated with tricyclic antidepressants or medications with similar effects and you experience gastrointestinal problems, stop taking this medication and consult your doctor immediately, as you may develop paralytic ileus (detention of normal movements in a part of the intestine).
• If you have severe diseases, such as severe renal insufficiency or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). A severe disease called metabolic acidosis (a blood and fluid anomaly) has been reported in patients in these situations when using paracetamol at regular doses for a prolonged period or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe respiratory distress with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

• In case of glucose-6-phosphate dehydrogenase deficiency (G6PD) (may cause hemolytic anemia).

Children and adolescents

Patients under 15 years old cannot take this medication.

Interference with laboratory tests:

Inform your doctor that you are taking/using this medication, as it may alter the results.

Taking Couldina with paracetamol with other medications

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

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

• Medications for treating epilepsy: Antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Medications for treating tuberculosis: (isoniazid, rifampicin).
• Medications for treating seizures and depression (barbiturates), used as hypnotics, sedatives, and anticonvulsants.
• Medication to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin).
• Medications used to increase urine elimination (diuretics of the loop, such as furosemide, or other diuretics), and other diuretics that cause potassium loss (such as diuretics for hypertension or others).
• Medications used to prevent nausea and vomiting: Metoclopramide and domperidone.
• Medications used to treat gout (probencid and sulfinpyrazone).
• Medications used to treat high blood pressure and heart rhythm disorders (arrhythmias): Propranolol.
• Medications to lower cholesterol levels in the blood: (colestiramine).
• Medications used to treat depression, Parkinson's disease, or other diseases (Monoamine oxidase inhibitors (MAOIs)). You should separate the administration of Couldina with paracetamol by at least 15 days after completing treatment.
• Medications used to treat migraines; medications taken for childbirth; medications taken to treat high blood pressure, or other diseases (alpha-blockers).
• Alpha and beta-blockers such as labetalol and carvedilol (used for the heart or to treat arterial diseases).
• Medications for treating depression (tricyclic antidepressants and tetracyclic antidepressants).
• General anesthetics.
• Anti-hypertensives (medications to lower blood pressure).
• Medications used for the heart, such as cardiac glycosides, anti-arrhythmics, and beta-blockers.
• Medications containing thyroid hormones (used to treat thyroid diseases).
• Medications used for heart or digestive diseases (atropine sulfate).
• Medications that cause depression of the central nervous system (such as those used for insomnia or anxiety).
• Ototoxic medications (that have as an adverse effect that they damage the ear).
• Phototoxic medications (that, as an adverse effect, produce allergy to light).
• Flucloxacillin (antibiotic), due to a severe risk of blood and fluid anomaly (called metabolic acidosis) that requires urgent treatment (see section 2).

Taking Couldina with paracetamol with food, drinks, and alcohol

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 habitually consume alcohol (3 or more alcoholic beverages: beer, wine, liquor, etc. per day) may cause liver damage.

The taking of this medication with food does not affect its efficacy.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

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

This medication cannot be used during breastfeeding, as it may cause adverse effects in the baby.

Driving and operating machinery

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

Couldina with paracetamol contains sodium

This medication contains 460.9 mg of sodium (main component of table salt/for cooking) in each tablet. This is equivalent to 24% of the recommended daily maximum sodium intake for an adult.

Consult your doctor or pharmacist if you need 1 or more tablets per day for a prolonged period, especially if you have been recommended a low-sodium diet.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.

The recommended dose is:

Adults and adolescents 15 years of age and older:

1 tablet (650 mg of paracetamol) every 6-8 hours as needed (3 or 4 tablets per day).

Do not take more than3 grams of paracetamolper 24 hours(see“Warnings and precautions” section).

Patients with renal insufficiency:

This medication cannot be taken due to the paracetamol dose.

Patients with liver insufficiency:

Consult a doctor

In cases of liver insufficiency or Gilbert’s syndrome, do not exceed 3 tablets/24 hours and the minimum interval between doses will be 8 hours.

Use in children

This medication is contraindicatedin children and adolescents under 15 years of age.

Use in elderly patients

Elderly patients cannot use this medication without consulting a doctor.

Because they may be especially affected by some medication side effects such as the appearance of slow heartbeats (bradycardia) or reduced cardiac output, due to the content of phenylephrine and chlorphenamine. They may also be more likely to experience side effects such as sedation, confusion, hypotension, or excitement, and may be more sensitive to effects such as dry mouth and urinary retention.

How to take

Couldina with paracetamol is taken orally. Dissolve the tablet completely in a little liquid, preferably half a glass of water, and then drink.

Always take the smallest effective dose.

The use of this medication is subject to the appearance of symptoms. As they disappear, treatment should be discontinued.

If feverpersists for more than 3 days of treatment, pain or other symptoms persist for more than 5 days, worsen or new ones appear, consult a doctor.

If you take more Couldina with paracetamol than you should

If you have ingested an overdose, go immediately to a medical center, even if you do not feel symptoms, as they often do not appear until 3 days after ingestion of the overdose, even in cases of severe poisoning.

Overdose symptoms may include: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain. Anxiety, fear, agitation, headache (may be a symptom of high blood pressure), seizures, insomnia (or intense drowsiness), clumsiness, feeling of fainting, instability, confusion, irritability, tremors, anorexia; psychosis with hallucinations (this last one especially in children). Dry mouth, nose, or throat. Effects such as high blood pressure, arrhythmias (rapid or irregular heartbeats), palpitations, reduced urine production. Metabolic acidosis (decrease in blood alkalinity reserve). In prolonged use, depletion of plasma volume (decrease in blood volume) may occur.

The treatment of an overdose is more effective if initiated within 4 hours of taking the overdose medication.

Patients undergoing barbiturate treatment or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.The overdose may also cause: coagulation disorders (blood clots and bleeding).

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicological Information Service (Telephone 91 562 04 20), indicating the medication and the amount ingested.

Like all medications, Couldina with paracetamol may cause side effects, although not everyone will experience them.

During the period of use of the association of paracetamol, phenylephrine, and chlorphenamine, the following side effects have been reported, whose frequency has not been established with precision:

-The side effects that may appear most frequently are::

Mild drowsiness, dizziness, muscle weakness: these side effects may disappear after 2-3 days of treatment. Difficulty moving the face, clumsiness, tremors, alterations in sensations and paresthesias, dry mouth, loss of appetite, alterations in taste or smell, gastrointestinal discomfort (which may decrease if the medication is taken with food), nausea, vomiting, diarrhea, constipation, stomach pain, urinary retention, dryness of the nose and throat, thickening of mucosities, sweating, blurred vision, or other visual disturbances.

-The side effects that may appear with low frequency (rare) are::

Unpleasantness, low blood pressure, and increased levels of transaminases in the blood. Myocardial infarction, ventricular arrhythmia (irregular heartbeats), pulmonary edema (increased volume of fluid in the lungs), and cerebral hemorrhage (at high doses or in sensitive patients).

Nervous excitement (usually at high doses, and more frequent in the elderly and children), which may include symptoms such as: restlessness, insomnia, nervousness, and even convulsions. Other side effects that may appear with low frequency are: chest tightness, lung sounds, rapid or irregular heartbeats (usually with overdose), liver disorders (which may present with stomach or abdominal pain, dark urine, or other symptoms), allergic reaction, severe hypersensitivity reactions (cough, difficulty swallowing, rapid heartbeats, itching, swelling of eyelids or around the eyes, face, tongue, difficulty breathing, etc.), photosensitivity (sensitivity to sunlight), cross-sensitivity (allergy) with related chlorphenamine medications. Blood disorders (changes in the formula of blood cells, such as agranulocytosis, leukopenia, aplastic anemia, thrombocytopenia) with symptoms such as unusual bleeding, sore throat, or fatigue; low or high blood pressure, edema (swelling), ear alterations, impotence, menstrual alterations.

-The side effects that may appear with very low frequency (very rare) are:

Renal diseases, cloudy urine, allergic dermatitis (skin rash), jaundice (yellow discoloration of the skin), blood disorders (neutropenia, hemolytic anemia), and hypoglycemia (low blood sugar).

Paracetamol may damage the liver when taken in high doses or with prolonged treatment.

Very rarely, severe skin reactions have been reported.

-The side effects whose frequency of appearance is unknown are::

Anxiety, irritability, weakness, high blood pressure (hypertension, usually at high doses and in sensitive patients), headache (at high doses and may be a symptom of hypertension), very slow heartbeats (bradycardia), peripheral vasoconstriction, reduced heart function that affects the elderly and patients with poor cerebral or coronary circulation, possible production or worsening of a heart disease, urinary retention, pallor, goosebumps, high blood sugar (hyperglycemia), low potassium in the blood, metabolic acidosis (metabolic disorder), coldness in the extremities (legs or arms), flushing, sensation of fainting (hypotension). At high doses, vomiting, palpitations, psychotic states with hallucinations may occur; in prolonged use, a decrease in blood volume may occur.

A severe disease that may make the blood more acidic (denominated metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

Reporting of side effects

If you experience any of the side effects, consult your doctor or pharmacist, even if they are side effects that do not appear in this leaflet. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep out of sight and reach of children.

Do not use Couldina with paracetamol after the expiration date that appears on the packaging, after CAD or Expiration. The expiration date is the last day of the month indicated.

Keep the packaging perfectly closed. Store in the original packaging.

Do not store at a temperature above 30°C.

Shelf lifeonceopened:3months

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medicines you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Couldina with paracetamol

Each tablet contains:

-Active ingredients: Each tablet contains 650 mg of paracetamol, 4 mg of chlorpheniramine maleate and 10 mg of phenylephrine hydrochloride.

-The other components (excipients) are: polyvinylpyrrolidone K30 (E-1201), sodium docusate, anhydrous citric acid (E-330), sodium hydrogen carbonate (bicarbonate of soda) (E-500ii), anhydrous sodium carbonate (E-500i) and sodium saccharin (E-954).

Appearance of the product and contents of the packaging

This medicine is presented in the form of effervescent tablets, flat cylindrical tablets of bright white color, packaged in aluminum tubes coated with an epoxy paint layer, closed with a polyethylene plug containing silica gel, in packs of 20 tablets.

Holder of the marketing authorization and responsible manufacturer

Laboratorios Alter, S.A.

C/Mateo Inurria, 30

28036, Madrid

Spain

Last review date of this leaflet: February 2025

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es/