Leaflet: information for the user

Couldina with ibuprofen effervescent tablets

Ibuprofen / 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. See section 4. You must consult a doctor if it worsens or does not improve or:

• if this medicine is needed for more than 5 days in adults
• if this medicine is needed for more than 3 days in children over 12 years old.

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

2.What you need to knowbefore starting to take 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 additional information

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

Ibuprofen is an anti-inflammatory and analgesic that reduces inflammation, 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 children 12 years and older for the relief of symptoms of colds and flu that are accompanied by fever or mild to moderate pain, congestion, and nasal secretion.

Do not take Couldina with ibuprofen

• If you are allergic to the active ingredients or any of the other components of this medication (listed in section 6).
• If you have had a stomach ulcer or bleeding in the stomach or duodenum (last part of the small intestine) or have suffered a perforation of the digestive system;
• If you have presented allergic reactions of the asthmatic type when taking anti-inflammatory, aspirin, or other analgesics;
• If you suffer from or have suffered from asthma (difficulty breathing, choking, and in some cases, coughing or wheezing when breathing), rhinitis (inflammation of the nasal mucosa), and urticaria (hives on the skin and intense itching);
• If you suffer from a severe liver, kidney, or heart disease (heart failure);
• If you suffer from any severe heart or artery disease (such as coronary disease or angina pectoris);
• If you suffer from bleeding disorders or blood clotting disorders;
• If you vomit blood, present black stools, or have diarrhea with blood;
• If you suffer from high blood pressure;
• If you suffer from hyperthyroidism;
• If you suffer from diabetes mellitus;
• If you suffer from 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-blockers (medications for the heart or to treat artery diseases) (see: Taking Couldina with ibuprofen with other medications);
• If you suffer from glaucoma (elevated eye pressure);
• If you are in the third trimester of pregnancy;
• If you are under 12 years old;

Warnings and precautions

Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), generalized acute pustular psoriasis (PEGA), have been reported in association with ibuprofen treatment. Discontinue treatment with Couldina with ibuprofen and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Do not take alcohol while taking this medication, as it increases the risk of gastrointestinal side effects caused by ibuprofen. Additionally, alcohol can potentiate the chronic irritation caused by ibuprofen and also potentiate the sedative effect caused by chlorphenamine.

If you experience intense or persistent abdominal pain and/or black stools during treatment with this medication, discontinue use and consult your doctor immediately, as it may be a sign of stomach or duodenal bleeding. This risk is higher when using high doses and prolonged treatment, especially in patients who have had a history of peptic ulcers and in elderly individuals.

Nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen may be associated with a small increase in the risk of heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or treatment duration.

Consult your doctor or pharmacist before starting treatment with this medication.

• If you have an infection. Ibuprofen, one of the components of this medication, may mask the signs of an infection such as fever and pain. Therefore, it is possible that Couldina with ibuprofen may delay the appropriate treatment of the infection, which may increase the risk of complications. This has been observed in pneumonia caused by bacteria and skin infections related to varicella. If you take this medication while having an infection and the symptoms persist or worsen, consult a doctor without delay.
• Do not take more than 3 tablets per day (1200 mg of ibuprofen per day) to avoid the possible appearance of circulatory or heart problems.
• If you have had stomach or intestinal diseases (e.g., ulcers), you should not consume this medication without medical supervision. Abdominal or intestinal pain should not be treated with this medication.
• If you experience heartburn or abdominal pain while taking the medication, discontinue treatment and consult your doctor.
• You have heart problems, including heart failure, angina (chest pain), or have had a heart attack, coronary bypass surgery, peripheral artery 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").
• Severe allergic reactions to ibuprofen, such as respiratory problems, swelling of the face and neck region (angioedema), and chest pain, have been reported. Stop using this medication immediately and contact your doctor or emergency medical services if you notice any of these symptoms.
• Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), generalized acute pustular psoriasis (PEGA), have been reported in association with ibuprofen treatment. Discontinue treatment with Couldina with ibuprofen and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.
• You have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker.
• If you have any other disease or suffer from any type of allergy, consult your doctor or pharmacist before taking this medication.
• If you suffer from Crohn's disease or ulcerative colitis, as ibuprofen-containing medications may worsen these conditions.
• If you suffer from hypertension, kidney, liver, or heart disease, blood clotting disorders, or are being treated with anticoagulants, consult your doctor before taking this medication.
• If you suffer from varicella (childhood infection), do not take ibuprofen.
• In case of dehydration, severe diarrhea, or vomiting, especially in children, take plenty of fluids and seek medical attention immediately.
• If you suffer from intermittent acute porphyria (rare blood disorder). Patients with kidney, liver, heart, or lung diseases and patients with anemia.
• Asthmatic patients sensitive to acetylsalicylic acid.
• Patients sensitive (allergic) to antihistamines, as they may be sensitive to other antihistamines (such as chlorphenamine).
• Patients being treated with medications for: prostate hypertrophy, bronchial asthma, slow heart rate, hypotension, cerebral arteriosclerosis, pancreatitis, peptic ulcer (peptic ulcer stenosing), pyloric obstruction (between the stomach and 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, discontinue this medication and consult a doctor immediately, as you may experience paralytic ileus (detention of normal movements in a part of the intestine).

Children and adolescents

Children under 12 years old should not take this medication.

Interference with laboratory tests:

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

Taking Couldina with ibuprofen with other medications

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

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

• Oral anticoagulants (e.g., acetylsalicylic acid, warfarin, acenocoumarol (Sintrom), ticlopidine) medications that make blood less thick and prevent clots.
• Baclofen (used to treat involuntary and persistent muscle contractions).
• Antihypertensive medications (inhibitors of the ECA like captopril, beta-blockers like atenolol, angiotensin II receptor antagonists like losartan).
• Ciclosporin and tacrolimus (used to prevent rejection in organ transplants).
• Medications used for the heart, such as digoxin and antiarrhythmics.
• Antiepileptic medications: Lamotrigine, phenytoin, or other hydantoins, phenobarbital, methyphenobarbital, primidone, carbamazepine.
• Diuretics of the loop (e.g., furosemide) or other diuretics that cause potassium loss (e.g., diuretics for hypertension or other conditions).
• Insulin and oral hypoglycemic agents (used to reduce blood glucose levels).
• Lithium (used to treat depression).
• Methotrexate (used to treat cancer and rheumatoid arthritis).
• Mifepristone (inducer of abortion).
• Pentoxifylline (used in circulatory disorders).
• Probenecid (used in patients with gout or with penicillin in infections).
• Quinolones (used in infections).
• Ion exchange resins like cholestyramine (used to reduce blood cholesterol levels).
• Sulfonamides (used in infections).
• Sulfinpyrazone (used to treat gout).
• Tacrine (used to treat Alzheimer's disease).
• Thrombolytics (medications that dissolve or break down blood clots).
• Zidovudine (used to treat patients infected with the human immunodeficiency virus, causing AIDS).
• Medications used to treat tuberculosis (isoniazid, rifampicin).
• Medications used to treat seizures and depression (barbiturates), used as hypnotics, sedatives, and anticonvulsants.
• Medications used to prevent nausea and vomiting (metoclopramide and domperidone).
• Medications used to treat gout (probenecid and sulfinpyrazone).
• Medications used to reduce blood cholesterol levels (cholestyramine).
• Medications used to treat depression, Parkinson's disease, or other conditions (monoamine oxidase inhibitors (MAOIs)). Discontinue treatment with Couldina with ibuprofen at least 15 days after completing treatment.
• Other medications used to treat depression (tricyclic and tetracyclic antidepressants).
• Medications used to treat migraines; medications taken for childbirth; medications taken for hypertension or other conditions (alpha and beta-adrenergic blockers).
• Alpha and beta-adrenergic blockers like labetalol and carvedilol (used for the heart or to treat artery diseases).
• General anesthetics.
• 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 (e.g., used for insomnia or anxiety).
• Do not use with other analgesics and anti-inflammatory medications (nonsteroidal anti-inflammatory drugs and corticosteroids) that reduce pain and inflammation, without consulting your doctor.

Other medications may also affect or be affected by treatment with Couldina with ibuprofen. Therefore, always consult your doctor or pharmacist before using Couldina with ibuprofen with other medications.

If your doctor has prescribed an antiplatelet medication (to prevent blood clots) containing acetylsalicylic acid, and you are also taking Couldina with ibuprofen, separate the intake of both medications (see: Advertencias y precauciones).

Taking Couldina with ibuprofen with food, drinks, and alcohol

Take this medication after meals or with food.

Do not take alcoholic beverages while taking this medication, as it may potentiate the appearance of side effects of this medication.

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

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

Pregnancy, breastfeeding, and fertility

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

Do not take Couldina with ibuprofen if you are in the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery.It may cause kidney and heart problems in your fetus. It may affect your predisposition and that of your baby to bleeding and delay or prolong delivery more than expected. Do not take Couldina with ibuprofen during the first 6 months of pregnancy unless absolutely necessary and indicated by your doctor. If you need treatment during this period or while trying to become pregnant, you should take the lowest 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 fetus, which may cause low amniotic fluid levels surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for a period longer than a few days, your doctor may recommend additional monitoring.

Women breastfeeding should consult their doctor or pharmacist before taking this medication.

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

Ibuprofen belongs to a group of medications that may decrease a woman's fertility (ability to become pregnant). This effect is reversible when the medication is discontinued.

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 ibuprofen contains sodium

This medication contains 501.6 mg of sodium (main component of table salt/for cooking) in each tablet. This is equivalent to 26% 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.

Couldina with ibuprofen contains aspartame

This medication may be harmful to individuals with phenylketonuria, as it contains aspartame, which is a source of phenylalanine.

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 children 12 years of age and older

1 effervescent tablet every 8-12 hours as needed. Do not take more than 3 tablets in 24 hours and leave a minimum of 6 hours between each dose.

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 medication is contraindicated in children under 12 years of age.

Use in elderly patients

Elderly patients should not use this medication without consulting a doctor because they may be especially affected by certain side effects of the medication, such as the appearance of slow heartbeats (bradycardia) or reduced cardiac output, due to the presence 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.

Take Couldina with ibuprofen after meals or with food or milk (especially if digestive discomfort is noted).

Do not take on an empty stomach.

Couldina with ibuprofenis taken orally. Dissolve the tablet completely in a small amount of liquid, preferably half a glass of water, and then drink. If there is any remaining white residue in the glass, add water, shake until dissolved, and take

Always take the smallest effective dose.

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

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

If you take more Couldina with ibuprofen than you should

If you have taken more Couldina with ibuprofen than you should, or if a child has accidentally ingested the medication, consult a doctor immediately or go to the nearest hospital to inform yourself about the risk and ask for advice on the measures to be taken.

The symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-tinged mucus), gastrointestinal bleeding, diarrhea, headache, ringing in the ears, confusion, and involuntary eye movement. Agitation, drowsiness, disorientation, or coma may also occur. Occasionally, patients develop seizures. At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been reported. Blood in the urine, low potassium levels in the blood, chills, and breathing difficulties may also occur.

Additionally, the prothrombin time/INR may be prolonged, probably due to interference with the actions of circulating coagulation factors. Acute renal failure and liver damage may occur. It is possible that asthma may be exacerbated in asthmatics. Low blood pressure and breathing difficulties may also occur.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

Like all medications,this medicationmay cause side effects, although not everyone will experience them.

During the period of use with each of the drugs found in the association of Couldina with ibuprofen, the following side effects have been reported, whose frequency has not been established with precision:

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

Fatigue, headache, burning and stomach pain, skin disorders (skin eruptions, itching), ear buzzing, mild drowsiness, dizziness, muscle weakness, these side effects may disappear after 2-3 days of treatment. Dry mouth, nose, and throat, nausea, vomiting, diarrhea, constipation, and thickening of mucous secretions.

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

Allergic reactions, asthma, rhinitis (inflammation of the nasal mucosa) and urticaria (skin rashes and intense itching), difficulty moving the face, clumsiness, tremors, alterations in sensations and paresthesia, loss of appetite, alterations in taste or smell, bleeding and gastric ulcers, sleep disturbances and mild restlessness, blurred vision, decreased visual acuity or changes in color perception, auditory alterations and coagulation disorders when taking high doses.

• 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 consisting of: acute interstitial nephritis with hematuria (blood in urine), proteinuria (protein elimination through urine) and occasionally nephrotic syndrome (a set of symptoms that appear as a result of kidney damage); depression, vision disorders (obscuration of vision), neck stiffness and bronchospasm (sudden sensation of suffocation), dyspnea (difficulty breathing) and angioedema (inflammation of the deep layers of the skin, which can cause facial, lip, tongue, or throat swelling, potentially causing difficulty swallowing or breathing). Uncomfortable feeling, low blood pressure (hypotension). Myocardial infarction, ventricular arrhythmia (irregular heartbeats), pulmonary edema (increase in lung volume) and cerebral hemorrhage (at high doses or in sensitive patients).

Nervous excitement (usually with 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: rapid or irregular heartbeats (usually with overdose), cross-sensitivity (allergy) with related chlorphenamine medications. Low or high blood pressure.

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

Asymptomatic meningitis, blood disorders (aplastic anemia and hemolytic anemia) and coagulation disorders, hypertension and heart failure, severe skin, eye, and mucous membrane disorders such as Stevens-Johnson syndrome (severe skin disease) and toxic epidermal necrolysis (skin and mucous membrane lesions that cause skin detachment) and erythema multiforme (inflammation of the skin) and hypoglycemia (low blood sugar).

• Unknown frequency (frequency cannot be estimated from available data):

Anxiety, irritability, weakness, high blood pressure (hypertension, usually with high doses and in sensitive patients), headache (with high doses and may be a symptom of hypertension), very slow heartbeats (severe bradycardia), peripheral vasoconstriction, reduced heart function affecting the elderly and patients with poor cerebral or coronary circulation, possible production or worsening of heart disease, urinary retention, pallor, goosebumps, high blood sugar (hyperglycemia), low potassium levels in the blood, metabolic acidosis (metabolic disorder), cold extremities (legs or arms), flush, sensation of fainting (hypotension), chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome. With high doses, the following may occur: vomiting, palpitations, psychotic states with hallucinations; in prolonged use, a decrease in blood volume may occur.

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

• Flat, red, circular spots on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital, and eye ulcers. These severe skin eruptions may be preceded by fever and symptoms similar to the flu [dermatitis exfoliativa, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Generalized skin eruption, elevated body temperature, and hypertrophied lymph nodes (DRESS syndrome).
• Generalized, red, scaly eruption with protuberances under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized pustular exanthema).

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Usehttp://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 useCouldina with ibuprofenafter the expiration date that appears on the box, after CAD or expiration. The expiration date is the last day of the month indicated.

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

Do not store at a temperature above 30°C.

Shelf life once opened: 6 months

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

Couldina with ibuprofen composition

• The active principles are ibuprofen, phenylephrine, and chlorphenamine. Each tablet contains 400 mg of ibuprofen (as ibuprofen lysinate), 7.5 mg of phenylephrine (as phenylephrine hydrochloride), and 2 mg of chlorphenamine (as chlorphenamine 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 aroma.

Product appearance and packaging contents

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 containers of 20 tablets.

Marketing authorization holder and responsible manufacturer

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid

Spain

Last review date of this leaflet: March 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.gob.es /

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