COULDINA WITH PARACETAMOL EFFERVESCENT TABLETS

Introduction

Package Leaflet: Information for the User

Couldina with Paracetamol Effervescent Tablets

Paracetamol / Phenylephrine / Chlorphenamine

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

Follow the administration instructions for the medication contained in this leaflet or as indicated by your doctor or pharmacist exactly.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet.
• You should consult your doctor if your condition 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.

Contents of the Package Leaflet

1. What Couldina with Paracetamol is and what it is used for
2. What you need to know before taking Couldina with Paracetamol
3. How to take Couldina with Paracetamol
4. Possible side effects
5. Storage of Couldina with Paracetamol
6. Contents of the pack and further information

1. What Couldina with Paracetamol is and what it is used for

It is an association of paracetamol, chlorphenamine, and phenylephrine.

Paracetamol is a pain reliever that reduces pain and fever.

Chlorphenamine is an antihistamine that relieves nasal secretion.

Phenylephrine is a sympathomimetic that reduces nasal congestion.

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

You should consult your doctor if your condition 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.

2. Couldina with Paracetamol

Do not take Couldina with Paracetamol

• If you are allergic to the active substances or to 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 a monoamine oxidase inhibitor (MAOI) medication (such as some antidepressants or medications for Parkinson's disease).
• If you are being treated with sympathomimetic medications (medications used to treat asthma or to accelerate heart rate).
• If you are being treated with beta-blocker medications (medications for the heart or to treat artery diseases) (see: "Taking Couldina with Paracetamol with other medications").
• If you have glaucoma (increased eye pressure).
• If you have a serious heart or artery disease (such as coronary artery disease or angina pectoris).
• If you have a serious liver or kidney disease.

Children 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 simultaneously 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 cautious not to take more than 3 tablets in 24 hours.
• You should consult your doctor before taking this medication:

• Patient with kidney, liver, heart, or lung diseases, and patients with anemia.
• Asthmatic patients sensitive to acetylsalicylic acid.
• Patient sensitive (allergic) to an antihistamine, as they may be sensitive to other antihistamines (such as chlorphenamine).
• Patient being treated with medications for: prostate hypertrophy, bronchial asthma, slow heart rate, hypotension, cerebral arteriosclerosis, pancreatitis, peptic ulcer, pyloroduodenal obstruction, 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, you should stop taking this medication and consult your doctor immediately, as you may develop paralytic ileus (stop of normal intestinal movements).
• If you have severe diseases, such as severe renal insufficiency 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 (a blood and fluid anomaly) 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 respiratory distress with deep and rapid breathing, drowsiness, feeling of discomfort (nausea) and vomiting.

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

Children and Adolescents

Children under 15 years old cannot take this medication.

Interference with Laboratory Tests

If you are going to have any laboratory tests (including blood, urine, etc...), 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 recently taken or may need to take any other medication.

In particular, if you are using any of the following medications, 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 convulsions and depression (barbiturics), used as hypnotics, sedatives, and anticonvulsants.
• Medication to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin).
• Medications used to increase urine elimination (diuretics such as furosemide, or other diuretics), and other diuretics that cause potassium loss (such as diuretics for treating hypertension or other conditions).
• Medications used to prevent nausea and vomiting: Metoclopramide and domperidone.
• Medications used to treat gout (probenecid and sulfinpyrazone).
• Medications used to treat high blood pressure and heart rhythm disorders (arrhythmias): Propranolol.
• Medications to lower cholesterol levels in the blood: (cholestyramine).
• 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 finishing the treatment.
• Medications used to treat migraines; medications taken for childbirth; medications taken to treat blood pressure or other diseases (alpha-adrenergic blocking medications).
• Alpha and beta-adrenergic blockers such as labetalol and carvedilol (used for the heart or to treat artery diseases).
• Medications for treating depression (tricyclic and tetracyclic antidepressants).
• General anesthetic medications.
• Antihypertensive medications (medications to lower blood pressure).
• Medications used for the heart, such as cardiac glycosides, antiarrhythmics, 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 (which have the adverse effect of damaging the ear).
• Photosensitizing medications (which have the adverse effect of causing light allergy).
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid anomalies (called metabolic acidosis) that requires urgent treatment (see section 2).

Taking Couldina with Paracetamol with Food, Drinks, and Alcohol

While being treated with this medication, you should not consume alcoholic beverages, as it may enhance the appearance of side 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, ... per day) may cause liver damage.

Taking this medication with food does not affect its efficacy.

Pregnancy and Breastfeeding

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.

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 side effects in the baby.

Driving and Using Machines

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

Couldina with Paracetamol Contains Sodium

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

Consult your doctor or pharmacist if you need to take 1 or more tablets daily for a prolonged period, especially if you have been recommended a low-salt diet (sodium).

3. How to Take Couldina with Paracetamol

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

The recommended dose is:

Adults and Adolescents from 15 Years Old:

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

Do not take more than 3 grams of paracetamol every 24 hours (see "Warnings and Precautions" section).

Patient with Renal Insufficiency:

This medication cannot be taken due to the paracetamol dose.

Patient with Hepatic Insufficiency:

Consult your doctor.

In case of hepatic 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 contraindicated in children and adolescents under 15 years old.

Use in Elderly Patients

Elderly people cannot use this medication without consulting their doctor.

Because they may be especially affected by some side effects of the medication, such as the appearance of slow heartbeats (bradycardia) or reduction of cardiac output, due to the content of phenylephrine and chlorphenamine. They are also more likely to present 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.

Taking this medication is subject to the appearance of symptoms. As they disappear, treatment should be suspended.

If the fever persists for more than 3 days of treatment, the pain or other symptoms persist for more than 5 days, or worsen, or new ones appear, you should consult your doctor.

If You Take More Couldina with Paracetamol Than You Should

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

The symptoms of overdose may be: 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), convulsions, insomnia (or intense drowsiness), clumsiness, feeling of fainting, instability, confusion, irritability, tremors, anorexia; psychosis with hallucinations (the latter especially in children). Dryness of the mouth, nose, or throat. Effects such as high blood pressure, arrhythmias (rapid or irregular heartbeats), palpitations, reduced urine production. Metabolic acidosis (decrease in blood alkaline reserve). In prolonged use, it can cause plasma volume depletion (decrease in blood volume).

Treatment of an overdose is more effective if started within 4 hours after taking the overdose of the medication.

Patient being treated with barbiturics or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose. The overdose can also cause: coagulation disorders (blood clots and hemorrhages).

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

4. Possible Adverse Effects

Like all medicines, Couldina with paracetamol can produce adverse effects, although not all people suffer from them.

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

• The adverse effects that may appear more frequently are:

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

• The adverse effects that may appear with low frequency (rare) are:

Discomfort, lowering of blood pressure (hypotension), and increase in blood transaminase levels. Myocardial infarction, ventricular arrhythmia (irregular heartbeats), pulmonary edema (increase in lung fluid volume), and cerebral hemorrhage (at high doses or in sensitive patients).

Nervous excitement (generally with high doses, and more frequent in the elderly and children), which may include symptoms such as: restlessness, insomnia, nervousness, and even convulsions. Other adverse effects that may appear with low frequency are: chest tightness, lung noises, rapid or irregular heartbeats (generally 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) to medications related to chlorphenamine. Blood alterations (changes in blood cell formula, such as agranulocytosis, leucopenia, aplastic anemia, thrombocytopenia) with symptoms such as unusual bleeding, sore throat, or fatigue; lowering or rising blood pressure, edema (swelling), alterations in the ears, impotence, menstrual alterations.

• The adverse effects that may appear with very low frequency (very rare) are:

Kidney diseases, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowish skin color), blood alterations (neutropenia, hemolytic anemia), and hypoglycemia (low blood sugar).

Paracetamol can damage the liver when taken in high doses or in prolonged treatments.

Very rare cases of severe skin reactions have been reported.

• The adverse effects whose frequency of appearance is not known are:

Anxiety, irritability, weakness, increase in blood pressure (hypertension, generally with high doses and in sensitive patients), headache (with high doses and may be a symptom of hypertension), very slow heartbeats (severe bradycardia), reduction of blood vessel caliber (peripheral vasoconstriction), reduction of heart performance that affects especially the elderly and patients with poor cerebral or coronary circulation, possible production or worsening of a heart condition, urinary retention, paleness, hair standing on end, increase in blood sugar (hyperglycemia), decrease in potassium in the blood, metabolic acidosis (metabolism alteration), cold in the extremities (legs or arms), flushing, feeling of fainting (hypotension). With high doses, the following may occur: vomiting, palpitations, psychotic states with hallucinations; with prolonged use, a decrease in blood volume may occur.

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

Reporting of Adverse Effects

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

5. Conservation of Couldina with Paracetamol

Keep out of sight and reach of children.

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

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

Do not store at a temperature above 30°C.

Validity period once opened: 3 months

Medicines should not be thrown away through the sewers or in the trash. Deposit the containers and medications you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. This way, you will help protect the environment.

6. Container Content and Additional Information

Composition of Couldina with Paracetamol

Each tablet contains:

• As active ingredients: Each tablet contains 650 mg of paracetamol, 4 mg of chlorphenamine maleate, and 10 mg of phenylephrine hydrochloride.
• The other components (excipients) are: povidone K30 (E-1201), sodium docusate, anhydrous citric acid (E-330), sodium hydrogen carbonate (sodium bicarbonate) (E-500ii), anhydrous sodium carbonate (E-500i), and sodium saccharin (E-954).

Product Appearance and Container Content

This medication is presented in the form of effervescent tablets, flat cylindrical, white, and shiny. It is packaged in aluminum tubes coated with an epoxy paint layer, closed with a polyethylene plug that contains silica gel, in containers of 20 tablets.

Marketing Authorization Holder and Manufacturer

Laboratorios Alter, S.A.

C/Mateo Inurria, 30

28036, Madrid

Spain

Date of the Last Revision of this Prospectus: February 2025

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