Couldina with ibuprofen effervescent tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Couldina with ibuprofen effervescent tablets

Ibuprofen / Phenylephrine / Chlorpheniramine

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

Follow exactly the instructions for use of this medicine as described in this leaflet or as 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 adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4. You should consult a doctor if your condition worsens or does not improve, or:

• if this medicine is needed for longer than 5 days in adults

• if this medicine is needed for longer than 3 days in children over 12 years of age.

Contents of the leaflet

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

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

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

Ibuprofen is an anti-inflammatory and analgesic agent that reduces inflammation, pain, and fever.

Chlorpheniramine is an antihistamine that relieves nasal discharge.

Phenylephrine is a sympathomimetic agent that reduces nasal congestion.

It is indicated in adults and children aged 12 years and older for the relief of symptoms associated with colds and flu, including fever or mild to moderate pain, nasal congestion, and nasal discharge.

2. What you need to know before taking Couldina with ibuprofen

Do not take Couldina with ibuprofen

• 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 had a stomach or duodenal ulcer (last part of the small intestine), gastrointestinal bleeding, or have experienced a perforation of the digestive tract;
• If you have had allergic reactions of an asthmatic type when taking anti-inflammatory drugs, aspirin, or other painkillers;
• If you suffer or have suffered from asthma (difficulty breathing, shortness of breath, and in some cases coughing or wheezing), rhinitis (inflammation of the nasal mucosa), or urticaria (skin rash and intense itching);
• If you have severe liver, kidney, or heart disease (heart failure);
• If you have a serious heart or arterial disease (such as coronary artery disease or angina pectoris);
• If you have bleeding disorders or blood coagulation problems;
• If you vomit blood, have black stools, or diarrhea with blood;
• 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) drugs (such as certain antidepressants or medications used to treat Parkinson's disease);
• If you are being treated with sympathomimetic drugs (medications used to treat asthma or to increase heart rate);
• If you are being treated with beta-blockers (medications for heart conditions or arterial diseases) (see: Taking Couldina with ibuprofen with other medicines);
• If you have glaucoma (increased eye pressure);
• If you are in the third trimester of pregnancy;
• If you are under 12 years of age.

Warnings and precautions

Serious skin reactions such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), and acute generalized exanthematous pustulosis (AGEP) have been reported in association with ibuprofen treatment. Stop treatment with Couldina with ibuprofen and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

While taking this medicine, do not consume alcohol, as alcohol increases the likelihood of gastrointestinal adverse effects caused by ibuprofen. Additionally, alcohol may worsen chronic irritation caused by ibuprofen and may also enhance the sedative effect produced by chlorpheniramine.

If during treatment with this medicine you experience severe or persistent abdominal pain and/or black stools, stop taking the medicine immediately and consult your doctor, as you may have developed gastrointestinal bleeding or perforation of the stomach or duodenum. This risk is higher when high doses are used, treatment is prolonged, in patients with a history of peptic ulcer, and in elderly patients.

Anti-inflammatory/pain-relieving medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used at high doses. Do not exceed the recommended dose or duration of treatment.

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

• If you have an infection. Ibuprofen, one of the components of this medicine, may mask signs of infection such as fever and pain. Therefore, Couldina with ibuprofen may delay appropriate treatment of the infection, increasing the risk of complications. This has been observed in bacterial pneumonia and skin bacterial infections related to chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, consult a doctor immediately.
• Do not take more than 3 tablets per day (1200 mg of ibuprofen per day) to avoid possible circulatory or heart problems.
• If you have had stomach or intestinal diseases (e.g., ulcer), in which case you should not take this medicine without medical supervision. Stomach or intestinal pain should not be treated with this medicine.
• If you experience stomach burning or pain when taking the medicine, stop treatment and consult your doctor.
• If you have heart problems, including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral arterial disease (poor circulation in the legs due to narrowed or blocked arteries), or any type of stroke (including "mini-stroke" or transient ischemic attack "TIA").
• Signs of allergic reaction to ibuprofen, such as breathing difficulties, facial and neck swelling (angioedema), and chest pain, have been reported. Stop using this medicine immediately and contact your doctor or emergency medical services right away if you notice any of these signs.
• Serious skin reactions such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), and acute generalized exanthematous pustulosis (AGEP) have been reported in association with treatment with ibuprofen. Discontinue treatment with Couldina with ibuprofen and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.
• If you have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker.
• If you suffer from another illness or have any type of allergy, consult your doctor or pharmacist before taking this medicine.
• If you have Crohn's disease or ulcerative colitis, as medicines containing ibuprofen may worsen these conditions.
• If you have high blood pressure, kidney, liver, or heart disease, blood coagulation disorders, or are being treated with anticoagulants, you must consult your doctor before taking this medicine.
• If you have chickenpox (a childhood infectious disease), you should not take ibuprofen.
• In case of dehydration due to severe diarrhea or vomiting, especially in children, drink plenty of fluids and seek immediate medical attention.
• If you have acute intermittent porphyria (a rare blood disorder). Patients with kidney, liver, heart, or lung disease, or anemia.
• Asthmatic patients sensitive to acetylsalicylic acid.
• Patients sensitive (allergic) to an antihistamine, as they may also be sensitive to other antihistamines (such as chlorpheniramine).
• Patients 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 stomach and intestine), thyroid diseases, or patients sensitive to the sedative effects of certain medicines.
• If you are being treated with tricyclic antidepressants or medicines with similar effects, stop taking this medicine and consult your doctor immediately, as you may develop paralytic ileus (cessation of normal intestinal movements).

Children and adolescents

Children under 12 years of age must not take this medicine.

Interference with laboratory tests:

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

Taking Couldina with ibuprofen with other medicines

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

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

• Oral anticoagulants (e.g., acetylsalicylic acid/acetylsalicylic acid, warfarin, acenocoumarol (Sintrom), ticlopidine), medicines used to thin the blood and prevent clots.
• Baclofen (used to treat involuntary and persistent muscle contractions).
• Medicines for high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan).
• Cyclosporine and tacrolimus (used to prevent organ transplant rejection).
• Medicines used for heart conditions such as digoxin and antiarrhythmics.
• Medicines used to treat epilepsy: antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Medicines used to increase urine elimination (loop diuretics such as furosemide, or other diuretics), and other diuretics causing potassium loss (such as diuretics used to treat hypertension or other conditions).
• Insulin and oral hypoglycemics (used to lower blood glucose).
• Lithium (used to treat depression).
• Methotrexate (used in the treatment of cancer and rheumatoid arthritis).
• Mifepristone (abortion-inducing agent).
• Pentoxifylline (used in circulatory disorders).
• Probenecid (used in gout patients or together with penicillin in infections).
• Quinolones (used for infections).
• Ion-exchange resins such as cholestyramine (used to lower blood cholesterol levels).
• Sulfonamides (used for infections).
• Sulfinpyrazone (used for the treatment of gout).
• Tacrine (used in the treatment of Alzheimer's disease).
• Thrombolytics (medicines that dissolve or break down blood clots).
• Zidovudine (used in the treatment of patients infected with the human immunodeficiency virus, cause of AIDS).
• Medicines for tuberculosis (isoniazid, rifampicin).
• Medicines for seizures and depression (barbiturates), used as hypnotics, sedatives, and anticonvulsants.
• Medicines used to prevent nausea and vomiting (metoclopramide and domperidone).
• Medicines used for the treatment of gout (probenecid and sulfinpyrazone).
• 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 ibuprofen should be separated by at least 15 days after stopping MAOI treatment.
• Other medicines used to treat depression (tricyclic and tetracyclic antidepressants).
• Medicines used to treat migraines; 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 or arterial diseases).
• General anesthetics.
• Medicines containing thyroid hormones (used to treat thyroid diseases).
• Medicines used for heart or digestive diseases (e.g., atropine sulfate).
• Medicines that cause central nervous system depression (such as those used for insomnia or anxiety).
• Do not use with other painkillers and anti-inflammatory drugs (non-steroidal anti-inflammatory drugs and corticosteroids) that reduce pain and inflammation, without consulting your doctor.

Other medicines may also affect or be affected by treatment with Couldina with ibuprofen. Therefore, you should always seek advice from your doctor or pharmacist before using Couldina with ibuprofen with other medicines.

If your doctor has prescribed an antiplatelet medicine (to prevent blood clots) containing acetylsalicylic acid, and you also take Couldina with ibuprofen, you should separate the administration of both medicines (see section Warnings and precautions).

Taking Couldina with ibuprofen with food, drinks, and alcohol

Take this medicine after meals or with food.

While being treated with this medicine, do not consume alcoholic beverages, as they may increase the likelihood of adverse effects from this medicine.

If you regularly consume alcohol (3 or more alcoholic drinks – beer, wine, spirits – per day), taking Couldina with ibuprofen may cause stomach bleeding.

Taking this medicine with food does not affect its efficacy.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Do not take Couldina with ibuprofen during the last 3 months of pregnancy, as it may harm the fetus or cause complications during delivery. It may cause kidney and heart problems in your unborn baby, affect your or your baby's ability to bleed normally, and delay or prolong labor beyond the expected time. You should not take Couldina with ibuprofen during the first 6 months of pregnancy unless absolutely necessary and specifically advised by your doctor. If treatment is needed during this period or while trying to conceive, you should take the lowest possible dose for the shortest possible time. If taken for more than a few days after week 20 of pregnancy, Couldina with ibuprofen may cause kidney problems in your unborn baby, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is needed for longer than a few days, your doctor may recommend additional monitoring.

Breastfeeding women should consult their doctor or pharmacist before taking this medicine.

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

Ibuprofen belongs to a group of medicines that may reduce female fertility (ability to become pregnant). This effect is reversible upon discontinuation of the medicine.

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 with ibuprofen contains sodium

This medicine contains 501.6 mg of sodium (the main component of table/cooking salt) per tablet. This corresponds to 26% of the maximum recommended daily sodium intake 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.

Couldina with ibuprofen contains aspartame

This medicine may be harmful to people with phenylketonuria, as it contains aspartame, a source of phenylalanine.

3. How to take Couldina with ibuprofen

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

The recommended dose is:

Adults and children aged 12 years and older

1 effervescent tablet every 8–12 hours as needed. Do not exceed 3 tablets in 24 hours, and leave a minimum interval of 6 hours between doses.

Patients with kidney, liver, or heart disease

Reduce the dose and consult your doctor.

The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If you have an infection, consult a doctor immediately if symptoms (fever and pain) persist or worsen (see section 2).

Use in children

This medicine is contraindicated in children under 12 years of age.

Use in elderly patients

Elderly patients should not take this medicine without consulting a doctor, as 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 chlorpheniramine. They are also 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.

Take Couldina with ibuprofen after meals or with food or milk (especially if gastrointestinal discomfort occurs).

It is not recommended to take it on an empty stomach.

Couldina with ibuprofen is taken orally. Completely dissolve the tablet in a small amount of liquid, preferably half a glass of water, and then drink it. If any white residue remains in the glass, add more water, stir until fully dissolved, and drink.

Always use the lowest dose that is effective.

This medicine should be taken only when symptoms appear. As symptoms subside, treatment should be discontinued.

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

If you take more Couldina with ibuprofen than you should

If you have taken more Couldina with ibuprofen than recommended, or if a child has accidentally ingested the medicine, contact a doctor immediately or go to the nearest hospital to assess the risk and obtain advice on necessary measures.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-stained sputum), gastrointestinal bleeding, diarrhea, headache, tinnitus, confusion, and involuntary eye movements. Restlessness, drowsiness, disorientation, or coma may also occur. Occasionally, patients may develop seizures. At high doses, symptoms such as drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness, dizziness, blood in the urine, low blood potassium levels, chills, and breathing difficulties have been reported.

In addition, prothrombin time/INR may be prolonged, likely due to interference with circulating coagulation factors. Acute renal failure and liver damage may occur. Asthma may worsen in asthmatic patients. Low blood pressure and difficulty breathing may also occur.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

4. Possible adverse effects

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

During the period of use of each of the drugs contained in the Couldina with ibuprofen combination, the following adverse effects have been reported, the frequency of which has not been precisely established:

• Common (may affect up to 1 in 10 people):

Fatigue, headache, stomach burning and pain, skin disorders (skin rashes, itching), tinnitus (ringing in the ears), mild drowsiness, dizziness, muscle weakness; these adverse effects may disappear after 2–3 days of treatment. Dryness of mouth, nose, and throat, nausea, vomiting, diarrhoea, constipation, and thickening of mucus secretions.

• Uncommon (may affect up to 1 in 100 people):

Allergic reactions, asthma, rhinitis (inflammation of the nasal mucosa), and urticaria (skin rash and intense itching), difficulty with facial movements, clumsiness, tremor, disturbances in sensation and tingling, loss of appetite, disturbances in taste or smell, gastrointestinal bleeding and ulcers, sleep disturbances and mild restlessness, blurred vision, decreased visual acuity, or changes in color perception, auditory disturbances, and impaired blood coagulation when high doses are taken.

• Rare (may affect up to 1 in 1,000 people):

Edema (swelling due to fluid retention), blood disorders (leukopenia), stomach and intestinal perforation, liver disorders (including jaundice, i.e., yellowing of the skin and eyes), kidney disorders such as acute interstitial nephritis with hematuria (blood in urine), proteinuria (excretion of proteins in urine), and occasionally nephrotic syndrome (a group of symptoms resulting from kidney damage); depression, visual disturbances (blurred vision), neck stiffness, bronchospasm (sudden sensation of suffocation), dyspnea (difficulty breathing), and angioedema (swelling of the deep layers of the skin, manifesting as swelling of the face, lips, tongue, or throat, which may cause difficulty in swallowing or breathing). Malaise, low blood pressure (hypotension). Myocardial infarction, ventricular arrhythmia (irregular heartbeats), pulmonary edema (increased fluid volume in the lungs), and cerebral hemorrhage (at high doses or in sensitive patients).

Nervous excitation (usually at 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 include: rapid or irregular heartbeat (usually in cases of overdose), cross-sensitivity (allergy) to drugs related to chlorpheniramine, and low or high blood pressure.

• Very rare (may affect up to 1 in 10,000 people):

Aseptic meningitis (inflammation of the meninges not caused by bacteria), blood disorders (aplastic anemia and hemolytic anemia) and coagulation disorders, hypertension and heart failure, severe skin reactions (cutaneous erythema), and disorders affecting the eyes and mucous membranes such as Stevens-Johnson syndrome (a serious skin condition), toxic epidermal necrolysis (skin and mucosal lesions leading to skin detachment), erythema multiforme (skin inflammation), and hypoglycemia (low blood sugar).

• Frequency not known (frequency cannot be estimated from available data):

Anxiety, irritability, weakness, increased blood pressure (hypertension, usually with high doses and in sensitive patients), headache (with high doses, and may be a symptom of hypertension), very slow heartbeat (severe bradycardia), reduced 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 (hyperglycemia), low potassium levels in blood, metabolic acidosis (metabolic disturbance), cold extremities (legs or arms), flushing, feeling of faintness (hypotension), chest pain, which may be a sign of a potentially serious allergic reaction known as Kounis syndrome. At high doses, vomiting, palpitations, and psychotic states with hallucinations may occur; with prolonged use, reduction in blood volume may occur.

Stop treatment with Couldina with ibuprofen and seek immediate medical attention if you notice any of the following symptoms:

• Non-elevated red spots, target-shaped or circular, on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital, or eye ulcers. These severe skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Generalized skin rash, high body temperature, and enlarged lymph nodes (DRESS syndrome).
• Widespread, red, and scaly rash, with subcutaneous bumps and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

Reporting of adverse effects:

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

5. Storage of Couldina with ibuprofen

Keep out of sight and reach of children.

Do not use Couldina with ibuprofen 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.

Validity period after opening: 6 months

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 properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Couldina with ibuprofen

• The active substances are ibuprofen, phenylephrine, and chlorpheniramine. Each tablet contains 400 mg of ibuprofen (as ibuprofen lysinate), 7.5 mg of phenylephrine (as phenylephrine hydrochloride), and 2 mg of chlorpheniramine (as chlorpheniramine maleate).
• The other components (excipients) are: povidone K 30 (E1201), sodium docusate, crospovidone, meglumine, anhydrous citric acid (E330), sodium bicarbonate, glycine (E640), mannitol (E421), sodium saccharin (E954ii), aspartame (E951), lemon flavor.

Appearance of the medicine and pack contents

This medicine is presented as effervescent tablets, flat cylindrical white shiny tablets, packed in aluminum 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.

Mateo Inurria, 30

28036 Madrid

Spain

Date of the most recent revision of this leaflet: March 2025

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/