Couldina with paracetamol effervescent tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Couldina with paracetamol effervescent tablets

Paracetamol / Phenylephrine / Chlorpheniramine

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

Follow exactly the instructions for taking this medicine as described in this leaflet or as directed 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 effects not listed in this leaflet.
• You should consult your doctor if your condition worsens or does not improve, or if fever persists for more than 3 days, or if pain or other symptoms last longer than 5 days.

Contents of the 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. How to store Couldina with paracetamol
6. Contents of the pack and other information

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

It is a combination of paracetamol, chlorpheniramine, and phenylephrine.

Paracetamol is an analgesic that reduces pain and fever.

Chlorpheniramine is an antihistamine that relieves nasal discharge.

Phenylephrine is a sympathomimetic that reduces nasal congestion.

It is indicated in adults and adolescents aged 15 years and older for the relief of symptoms of colds and flu accompanied by fever or mild to moderate pain, nasal congestion, and nasal discharge.

You should consult your doctor if your condition worsens, does not improve, if fever persists for more than 3 days, or if pain or other symptoms last longer 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 medicine (listed in section 6).
• If you have high blood pressure (hypertension).
• If you have hyperthyroidism.
• If you have diabetes mellitus.
• If you have tachycardia (rapid heartbeat).
• If you are being treated with monoamine oxidase inhibitors (MAOIs) (such as certain antidepressant medicines or medicines used to treat Parkinson's disease).
• If you are being treated with sympathomimetic medicines (medicines used to treat asthma or medicines that increase heart rate).
• If you are being treated with beta-blockers (medicines for the heart or to treat arterial diseases) (see: "Taking Couldina with paracetamol with other medicines").
• If you have glaucoma (increased pressure in the eye).
• If you have a serious heart or arterial disease (such as coronary artery disease or angina pectoris).
• If you have severe liver or kidney disease.

Children under 15 years of age must not take this medicine.

Warnings and precautions

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

• Do not take more medicine than the recommended dose stated in section 3: "How to take Couldina with paracetamol".
• You should avoid taking this medicine together with other medicines containing paracetamol, as high doses may cause liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.
• Chronic alcoholics should take care not to take more than 3 tablets in 24 hours.
• Patients should consult their doctor before taking this medicine if they:
  • Have kidney, liver, heart, or lung disease, or if they have anemia.
  • Are asthmatic and sensitive to acetylsalicylic acid.
  • Are sensitive (allergic) to an antihistamine, as they may also be sensitive to other antihistamines (such as chlorphenamine).
  • Are being treated with medicines for: prostate enlargement, bronchial asthma, very slow heart rate, hypotension, cerebral arteriosclerosis, pancreatitis (inflammation of the pancreas), peptic ulcer (stenosing peptic ulcer), pyloroduodenal obstruction (blockage between the stomach and intestine), thyroid disorders, or if they are sensitive to the sedative effects of certain medicines.
• If you are being treated with tricyclic antidepressants or medicines with similar effects and develop gastrointestinal problems, you must stop taking this medicine and consult a doctor immediately, as you may develop paralytic ileus (cessation of normal intestinal movements).
• 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 in these situations 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 difficulty breathing with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.
• In case of glucose-6-phosphate dehydrogenase (G6PD) deficiency (which may cause hemolytic anemia).

Children and adolescents

Children under 15 years of age must not take this medicine.

Interference with laboratory tests:

If you are due to have any laboratory tests (including blood and urine tests, etc.), inform your doctor that you are taking/using this medicine, as it may alter test results.

Taking Couldina with paracetamol with other medicines

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

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

• Medicines to treat epilepsy: Antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Medicines to treat tuberculosis: (isoniazid, rifampicin).
• Medicines to treat seizures and depression (barbiturates), used as hypnotics, sedatives, and anticonvulsants.
• Medicine to prevent blood clots: Oral anticoagulants (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 and sulfinpyrazone).
• Medicines used to treat high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias): Propranolol.
• Medicines to lower blood cholesterol levels: (cholestyramine).
• Medicines used to treat depression, Parkinson's disease, or other conditions (monoamine oxidase inhibitors (MAOIs)). Administration of Couldina with paracetamol must be separated by at least 15 days after stopping MAOI treatment.
• Medicines used to treat migraine; medicines taken during childbirth; medicines used to treat blood pressure or other conditions (alpha-adrenergic blocking agents).
• Alpha- and beta-adrenergic blockers such as labetalol and carvedilol (used for heart conditions or arterial diseases).
• Medicines used to treat depression (tricyclic and tetracyclic antidepressants).
• General anesthetics.
• Antihypertensives (medicines to lower blood pressure).
• Medicines used for heart conditions such as cardiac glycosides, antiarrhythmics, and beta-adrenergic blockers.
• Medicines containing thyroid hormones (used to treat thyroid disorders).
• Medicines used for heart or digestive disorders (atropine sulfate).
• Medicines that cause central nervous system depression (such as those used for insomnia or anxiety).
• Ototoxic medicines (those that have the adverse effect of damaging the ear).
• Photosensitizing medicines (those that have the adverse effect of causing light allergy).
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormalities (called metabolic acidosis) requiring urgent treatment (see section 2).

Taking Couldina with paracetamol with food, drinks, and alcohol

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

In addition, the use of medicines containing paracetamol by patients who regularly consume alcohol (3 or more alcoholic drinks: beer, wine, spirits, etc., per day) may cause liver damage.

Taking this medicine with food does not affect its efficacy.

Pregnancy and breastfeeding

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.

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

This medicine must not be used during breastfeeding, as it may cause adverse effects in the infant.

Driving and use of machines

This medicine may cause drowsiness, affecting mental and/or physical ability. If you experience these effects, avoid driving vehicles or operating machinery.

Couldina with paracetamol contains sodium

This medicine contains 460.9 mg of sodium (the main component of table/cooking salt) per tablet. This corresponds 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 advised to follow a low-salt (sodium) diet.

3. How to take Couldina with paracetamol

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Recommended dose:

Adults and adolescents aged 15 years and older:

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

Do not exceed 3 grams of paracetamol in any 24-hour period (see section “Warnings and precautions”).

Patients with renal impairment:

This medicine must not be used due to the paracetamol content.

Patients with hepatic impairment:

Consult your doctor.

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

Use in children

This medicine is contraindicated in children and adolescents under 15 years of age.

Use in elderly patients

Elderly patients must not use this medicine without consulting a doctor.

This is because they may be particularly affected by certain adverse effects of the medicine, such as slow heart rate (bradycardia) or reduced cardiac output, due to the presence of phenylephrine and chlorphenamine. They may also be more likely to experience adverse effects such as sedation, confusion, hypotension, or agitation, 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 small amount of liquid, preferably half a glass of water, and then drink.

Always take the lowest effective dose.

This medicine should only be taken when symptoms occur. Treatment should be discontinued as symptoms subside.

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

If you take more Couldina with paracetamol than you should

If you have ingested an overdose, seek immediate medical attention even if you do not experience symptoms, as symptoms often do not appear until 3 days after the overdose, even in cases of severe poisoning.

Symptoms of overdose may include: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain. Anxiety, fear, agitation, headache (which may indicate high blood pressure), seizures, insomnia (or intense drowsiness), clumsiness, feeling faint, instability, confusion, irritability, tremors, anorexia; psychosis with hallucinations (especially in children). Dry mouth, nose, or throat. Effects such as high blood pressure, arrhythmias (rapid or irregular heartbeat), palpitations, reduced urine output. Metabolic acidosis (decrease in the blood's alkaline reserve). With prolonged use, depletion of plasma volume (reduction in blood volume) may occur.

Treatment for overdose is most effective when initiated within 4 hours of ingestion.

Patients undergoing treatment with barbiturates or chronic alcoholics may be more susceptible to paracetamol overdose toxicity. Overdose may also cause coagulation disorders (blood clots and hemorrhages).

In case of overdose or accidental ingestion, seek immediate medical attention or call the Toxicology Information Service (Telephone 91 562 04 20), indicating the medicine and the amount ingested.

4. Possible adverse effects

Like all medicines, Couldina with paracetamol may produce adverse effects, although not everyone will experience them.

The following adverse effects have been reported during the period of use of the combination of paracetamol, phenylephrine, and chlorphenamine. The frequency of these effects has not been accurately established:

• The adverse effects that may occur more frequently are:

Mild drowsiness, dizziness, muscle weakness: these adverse effects may disappear after 2–3 days of treatment. Difficulty in facial movements, clumsiness, tremor, disturbances in sensation and tingling, dry mouth, loss of appetite, disturbances in taste or smell, gastrointestinal discomfort (which may decrease if the medicine is taken with food), nausea, vomiting, diarrhoea, constipation, stomach pain, urinary retention, dryness of the nose and throat, thickening of mucus secretions, sweating, blurred vision or other visual disturbances.

• The adverse effects that may occur less frequently (rare) are:

Malaise, drop in blood pressure (hypotension), and increased levels of transaminases in the blood. Myocardial infarction, ventricular arrhythmia (irregular heartbeat), pulmonary oedema (increased fluid volume in the lungs), and cerebral haemorrhage (at high doses or in sensitive patients).

Nervous excitation (generally with high doses, and more frequent in elderly patients and children), which may include symptoms such as restlessness, insomnia, nervousness, and even seizures. Other adverse effects that may occur less frequently are: chest tightness, lung sounds, rapid or irregular heartbeat (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 heartbeat, itching, swelling of eyelids or around the eyes, face, tongue, breathing difficulties, etc.), photosensitivity (sensitivity to sunlight), cross-sensitivity (allergy) to medicines related to chlorphenamine. Blood disorders (changes in blood cell count, such as agranulocytosis, leucopenia, aplastic anaemia, thrombocytopenia) with symptoms such as unusual bleeding, sore throat, or fatigue; low or high blood pressure, oedema (swelling), ear disturbances, impotence, menstrual disorders.

• The adverse effects that may occur very infrequently (very rare) are:

Kidney disorders, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (neutropenia, haemolytic anaemia), and hypoglycaemia (low blood sugar).

Paracetamol may damage the liver when taken at high doses or during prolonged treatment.

Very rare cases of serious skin reactions have been reported.

• Adverse effects for which the frequency is not known are:

Anxiety, irritability, weakness, increased blood pressure (hypertension, generally with high doses and in sensitive patients), headache (with high doses and may be a symptom of hypertension), very slow heartbeat (severe bradycardia), reduction in the diameter of blood vessels (peripheral vasoconstriction), reduced cardiac performance particularly affecting elderly patients and those with poor cerebral or coronary circulation, possible onset or worsening of heart disease, urinary retention, pallor, piloerection (goosebumps), increased blood sugar (hyperglycaemia), low potassium levels in the blood, metabolic acidosis (metabolic disturbance), coldness in the extremities (legs or arms), flushing, feeling of faintness (hypotension). At high doses, the following may occur: vomiting, palpitations, psychotic states with hallucinations; with prolonged use, a decrease in blood volume may occur.

A serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness who are using paracetamol (see section 2).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Couldina with paracetamol

Keep out of the sight and reach of children.

Do not use Couldina with paracetamol after the expiry date stated on the container, after EXP or Expiry. The expiry date refers to the last day of the month indicated.

Keep the container tightly closed. Store in the original packaging.

Do not store above 30°C.

Period of validity after first opening: 3 months

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to 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 Couldina with paracetamol

Each tablet contains:

• Active substances: Each tablet contains 650 mg of paracetamol, 4 mg of chlorpheniramine maleate, and 10 mg of phenylephrine hydrochloride.
• Other components (excipients): polyvidone 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).

Appearance of the product and contents of the container

This medicine is presented as effervescent tablets, flat cylindrical, bright white in colour. It is packaged in aluminium tubes coated with an epoxy paint layer, closed with a polyethylene cap containing silica gel, in packs of 20 tablets.

Marketing Authorization Holder and Manufacturer

Laboratorios Alter, S.A.
C/Mateo Inurria, 30
28036, Madrid
Spain

Date of the most recent review of this package leaflet: February 2025

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