Couldina Instant with paracetamol effervescent granules

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Couldina instant with paracetamol effervescent granules

Paracetamol / Phenylephrine / Chlorphenamine

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 effects not listed in this leaflet.
• You should consult your doctor if your condition worsens, 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 instant with paracetamol is and what it is used for
2. What you need to know before taking Couldina instant 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 instant 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 from 15 years of age 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. What you need to know before taking Couldina instant with paracetamol

Do not take Couldina instant with paracetamol

• If you are allergic to the active substances or to any of the other ingredients 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 inhibitor (MAOI) medicines (such as certain antidepressants 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 heart conditions or to treat arterial diseases) (see: "Taking Couldina instant with paracetamol with other medicines").
• If you have glaucoma (increased pressure in the eye).
• If you have severe 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 taking this medicine.

• Do not take more medicine than the recommended dose stated in section 3: "How to take Couldina instant with paracetamol".
• Avoid using this medicine simultaneously 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 sachets in 24 hours.
• The following patients should consult their doctor before taking this medicine:
  • Patients with kidney, liver, heart, or lung disease, and patients with anaemia.
  • Asthmatic patients who are sensitive to acetylsalicylic acid.
  • Patients who are sensitive (allergic) to an antihistamine, as they may also be sensitive to other antihistamines (such as chlorphenamine).
  • Patients who 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 (between the stomach and intestine), thyroid disorders, or patients 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 have 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 conditions 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.
• In case of glucose-6-phosphate dehydrogenase (G6PD) deficiency (which may cause haemolytic anaemia).

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 or urine tests, etc.), inform your doctor that you are taking/using this medicine, as it may alter test results.

Taking Couldina instant 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, as it may be necessary to adjust the dose or discontinue treatment:

• Medicines for epilepsy: Antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Medicines for tuberculosis: (isoniazid, rifampicin).
• Medicines for 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 other conditions).
• Medicines used to prevent nausea and vomiting: Metoclopramide and domperidone.
• Medicines used in the treatment of gout (probenecid and sulfinpyrazone).
• Medicines used for high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias): Propranolol.
• Medicines to reduce cholesterol levels in the blood: (cholestyramine).
• Medicines used to treat depression, Parkinson's disease, or other conditions (monoamine oxidase inhibitors (MAOIs)). Couldina instant with paracetamol must not be taken until 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 medicines).
• Alpha- and beta-adrenergic blockers such as labetalol and carvedilol (used for heart conditions or arterial diseases).
• Medicines for depression (tricyclic and tetracyclic antidepressants).
• General anaesthetic medicines.
• Antihypertensives (medicines to lower blood pressure).
• Medicines for the heart such as cardiac glycosides, antiarrhythmics, and beta-adrenergic blockers.
• Medicines containing thyroid hormones (used to treat thyroid disorders).
• Medicines used for heart disease or digestive disorders (sulphated atropine).
• Medicines that cause central nervous system depression (such as those used for insomnia or anxiety).
• Ototoxic medicines (which have the adverse effect of damaging the ear).
• Photosensitising medicines (which 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 instant with paracetamol with food, drinks and alcohol

While being treated with this medicine, you must not consume alcoholic beverages, as they may increase the risk of adverse effects of this medicine.

In addition, using medicines containing paracetamol in 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 using machines

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

Couldina instant 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 sachets daily for a prolonged period, especially if you have been advised to follow a low-salt (low-sodium) diet.

3. How to take Couldina instant with paracetamol

Follow exactly the dosage instructions 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 sachet (650 mg paracetamol) every 6–8 hours as needed (3 or 4 sachets per day).

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

Patients with renal impairment:

This medicine must not be taken due to the paracetamol dose.

Patients with hepatic impairment:

Consult your doctor.

In cases of hepatic impairment or Gilbert’s syndrome, do not exceed 3 sachets/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 should 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 the development of slow heartbeats (bradycardia) or reduced cardiac output, due to the presence of phenylephrine and chlorpheniramine. 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 instant with paracetamol is taken orally. Completely dissolve the sachet 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 are present. Treatment should be discontinued as symptoms resolve.

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 instant with paracetamol than you should:

If you have ingested an overdose, you must immediately go to a medical center even if you do not have symptoms, as symptoms often do not appear until up to 3 days after ingestion, 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 (possibly a sign of high blood pressure), seizures, insomnia (or intense drowsiness), clumsiness, fainting sensation, instability, confusion, irritability, tremors, anorexia; psychosis with hallucinations (the latter especially in children). Dry mouth, nose, or throat. Effects such as high blood pressure, arrhythmias (rapid or irregular heartbeats), 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 if 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, go immediately to a medical center 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 instant with paracetamol may cause adverse effects, although not everyone experiences them.

During the period of use of the combination of paracetamol, phenylephrine and chlorphenamine, the following adverse effects have been reported, the frequency of which has not been precisely 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 with 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, sweating, blurred vision or other visual disturbances.

-Adverse effects that may occur infrequently (rare):

Malaise, drop in blood pressure (hypotension), and increased blood transaminase levels. 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 excitement (generally with high doses, and more frequent in elderly patients and children), which may include symptoms such as restlessness, insomnia, nervousness, and even convulsions. Other adverse effects that may occur infrequently 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 drugs 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.

-Adverse effects that may occur very infrequently (very rare):

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 in high doses or during prolonged treatment.

Very rare cases of serious skin reactions have been reported.

-Adverse effects with unknown frequency:

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 heartbeat (severe bradycardia), reduction in blood vessel diameter (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 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, reduction 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 of these adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You may 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 instant with paracetamol

Keep out of the sight and reach of children.

Do not use Couldina instant with paracetamol after the expiry date stated on the packaging, 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.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Couldina instant with paracetamol

Each sachet contains:

• Active substances: Each sachet contains 650 mg of paracetamol, 4 mg of chlorpheniramine maleate, and 10 mg of phenylephrine hydrochloride.
• Other components (excipients): polyvinylpyrrolidone K30 (E-1201), sodium docusate, anhydrous citric acid (E-330), sodium hydrogen carbonate (sodium bicarbonate) (E-500ii), anhydrous sodium carbonate (E-500i), sodium saccharin (E-954), and lemon flavour.

Appearance of the medicinal product and contents of the container

This medicine is packaged in monodose heat-sealed sachets made from a composite sheet consisting of a layer of paper, an adhesive layer, an aluminium film, and a thermosoldable ethylene-acrylic acid copolymer film. Pack contents: 10 and 20 sachets.

Marketing Authorization Holder and Manufacturer

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

Date of latest review of this 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/