Package Insert: Information for the User

Couldina Instant with Aspirin Granulated Effervescent

Aspirin/Chlorphenamine Maleate/Phenylephrine Hydrochloride

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

Follow exactly the medication administration instructions contained in this package insert or those indicated by your doctor or pharmacist.

• Keep this package insert, as you may need to refer to 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 not listed in this package insert.
• You should consult your doctor if your condition worsens or does not improve, or if fever persists after more than 3 days or pain after more than 5 days of treatment.

Couldina Instant with Acetylsalicylic Acidis an association of acetylsalicylic acid, chlorphenamine, and phenylephrine.

Acetylsalicylic acid is an anti-inflammatory that acts on 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 adolescents from 16 years old for the relief of symptoms of colds and flu that are accompanied by fever, mild or moderate pain, congestion, and nasal secretion.

Consult a doctor if it worsens or does not improve or if the fever persists for more than 3 days or the pain for more than 5 days.

Do not take Couldina Instant with Acetylsalicylic Acid:

• If you are allergic to acetylsalicylic acid (aspirin), chlorphenamine maleate, phenylephrine hydrochloride, or any of the other components of this medication (listed in section 6).
• If you have had allergic reactions of the asthmatic type (difficulty breathing, choking, bronchospasm, and in some cases, coughing or ringing in the ears) when taking anti-inflammatory medications, acetylsalicylic acid (aspirin), other analgesics, tartrazine dye, or other allergy medications, because cross-reactivity may occur.
• If you have a gastric ulcer, duodenal ulcer, or recurring stomach discomfort.
• If you have had a hemorrhage or perforation of the stomach caused by acetylsalicylic acid or other anti-inflammatory medications.
• If you have hemophilia or other bleeding disorders.
• If you have asthma.
• If you have nasal polyps associated with asthma that are produced or increased by acetylsalicylic acid (aspirin).
• If you have a severe heart disease (severe coronary artery disease or angina pectoris) or severe arterial disease.
• If you have tachycardia (rapid heartbeats).
• If you have uncontrolled high blood pressure (hypertension).
• If you have severe kidney or liver disease (severe renal or hepatic insufficiency).
• If you have thyroid disease (hyperthyroidism).
• If you are taking oral anticoagulant medications (e.g., Sintrom).
• If you have glaucoma (increased eye pressure).
• If you are taking or have taken within the last 15 days any medication for depression or Parkinson's disease that inhibits monoamine oxidase (MAO) (see section "Taking Couldina Instant with Acetylsalicylic Acid with other medications").
• If you are taking beta-blocker medications (heart medications or medications for arterial diseases) (see section "Taking Couldina Instant with Acetylsalicylic Acid with other medications").
• If the patient is under 16 years old, as the use of acetylsalicylic acid has been associated with Reye's syndrome, a rare but serious disease that occurs in children under 16 years old.
• If you have diabetes mellitus.
• If you are in the third trimester of pregnancy.

Warnings and precautions

Do not take more medication than recommended in section 3 "How to take Couldina Instant with Acetylsalicylic Acid".

While taking this medication, do not consume alcohol, as alcohol increases the risk of gastrointestinal side effects caused by acetylsalicylic acid. Additionally, alcohol may cause chronic irritation caused by acetylsalicylic acid and potentiate the sedative effect of chlorphenamine.

If you experience severe or persistent abdominal pain and/or black stools during treatment with this medication, discontinue taking it and consult your doctor immediately, as it may be a sign of a stomach or duodenal hemorrhage or perforation. This risk is higher with high doses and prolonged treatment, especially in patients with a history of peptic ulcers and in the elderly.

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

• If you have urinary retention or bladder neck obstruction, as it may worsen.
• If you have glucose-6-phosphate dehydrogenase deficiency (a hereditary disease that causes a type of anemia).
• If you have or have had rhinitis or urticaria.
• If you have undergone or are scheduled to undergo surgery or dental procedures, including tooth extraction, within the next 7 days.
• If you have controlled hypertension.
• If you have phaeochromocytoma, cardiovascular diseases such as bradycardia, kidney, liver, or lung diseases, or anemia.
• If you are taking tricyclic antidepressants or medications with similar effects and experience gastrointestinal problems, discontinue taking this medication and consult your doctor immediately, as it may cause paralytic ileus (detention of normal intestinal movements).
• If you are taking monoamine oxidase inhibitors (MAOIs) for depression or Parkinson's disease, separate the intake of Couldina Instant with Acetylsalicylic Acid from these medications by at least 15 days.

Children and adolescents

Children under 16 years old cannot take this medication, as it is contraindicated in them.

Older adults

Older adults should not take this medication without consulting their doctor, as they are more prone to experiencing its side effects.

Using Couldina Instant with Acetylsalicylic Acid with other medications

Inform your doctor or pharmacist if you are taking or have taken recently any other medications, including over-the-counter medications, homeopathic medications, herbal remedies, and other health-related products, as it may be necessary to interrupt treatment or adjust the dose of one or more medications.

In particular, if you are taking any of the following medications, it is essential to consult your doctor before taking Couldina Instant with Acetylsalicylic Acid, as it may be necessary to modify the dose of some medications or discontinue treatment.

• Analgesics or nonsteroidal anti-inflammatory drugs (NSAIDs) (medications used to treat pain and/or inflammation) and corticosteroids, as concurrent treatment may cause ulcers, intestinal hemorrhages, and may reduce the effectiveness of these medications.
• Anesthetics (inhalation hydrocarbons) in cases where you are scheduled to undergo surgery, discontinue treatment with this medication a few days before the procedure, as it may pose a risk of arrhythmias.
• Antacids may reduce the effectiveness of Couldina Instant with Acetylsalicylic Acid.
• Anticoagulants (medications used to prevent blood clotting) such as Sintrom, heparin, or warfarin, as it increases the risk of bleeding.
• Antidepressants (medications used to treat depression), such as selective serotonin reuptake inhibitors, tricyclic antidepressants, and tetracyclic antidepressants, and monoamine oxidase inhibitors (MAOIs), as it increases the risk of bleeding and may cause severe side effects. If you are taking medications that inhibit monoamine oxidase (MAOIs) for depression or Parkinson's disease, separate the intake of Couldina Instant with Acetylsalicylic Acid from these medications by at least 15 days, as it may cause severe side effects such as severe headache, increased blood pressure, and sudden fever. If you are taking liti, you cannot take this medication, as it may increase the amount of lithium in your blood and reach toxic levels.
• Antiepileptic medications such as phenytoin and valproic acid, as it may reduce their effectiveness or increase their side effects.
• Antihypertensive medications (medications used to lower blood pressure), as it may cause kidney failure and reduce the effectiveness of the antihypertensive medication.
• Medications used to lower blood sugar levels (oral antidiabetic medications, insulin, and sulfonylureas), as concurrent treatment with Couldina Instant with Acetylsalicylic Acid may increase the effect of lowering blood sugar levels and cause hypoglycemia.
• Medications used to treat seizures (such as barbiturates), as concurrent treatment with Couldina Instant with Acetylsalicylic Acid may increase the amount of barbiturates in your blood and their side effects.
• Ciclosporin and Tacrolimus (used to prevent transplant rejection), as concurrent treatment with Couldina Instant with Acetylsalicylic Acid may increase the toxicity of ciclosporin to the kidneys.
• Cimetidine and ranitidine (used to treat stomach acid), as it may increase the side effects of Couldina Instant with Acetylsalicylic Acid.
• Digoxin (used to treat heart disease), do not take Couldina Instant with Acetylsalicylic Acid when taking these medications, as digoxin may reach toxic levels in your blood.
• Interferon-alpha (used to treat certain viral and tumor diseases), as it may reduce the effectiveness of interferon.
• Metotrexate (used to treat cancer and rheumatoid arthritis), as it may increase the toxicity of metotrexate.
• Medications used to treat gout (probencid and sulfinpyrazone), as it may increase the toxicity of Couldina Instant with Acetylsalicylic Acid and reduce the effectiveness of medications used to treat gout.
• Diuretics and angiotensin-converting enzyme (ACE) inhibitors (used to lower blood pressure), as it may cause kidney failure and reduce the effectiveness of the antihypertensive medication.
• Other analgesics or nonsteroidal anti-inflammatory drugs (NSAIDs) (medications used to treat pain and/or inflammation).
• Vancomycin (used to treat infections), as concurrent treatment with Couldina Instant with Acetylsalicylic Acid may increase the risk of ototoxicity.
• Zidovudine (used to treat HIV-infected patients), as concurrent treatment with Couldina Instant with Acetylsalicylic Acid may reduce the elimination of zidovudine, increasing the risk of its side effects.
• Medications that affect heart conduction, such as antiarrhythmics, as concurrent treatment with Couldina Instant with Acetylsalicylic Acid may require close monitoring by your doctor.
• Medications containing thyroid hormones (used to treat thyroid diseases), as concurrent treatment with Couldina Instant with Acetylsalicylic Acid may require close monitoring by your doctor.
• Medications used to treat heart or digestive diseases (atropine sulfate), as concurrent treatment with Couldina Instant with Acetylsalicylic Acid may reduce their effectiveness and increase their side effects.
• Medications that cause central nervous system depression (such as those used to treat insomnia or anxiety or antihistamines), as concurrent treatment with Couldina Instant with Acetylsalicylic Acid may cause symptoms of overdose of these medications.
• Medications that are ototoxic (may damage the ear), as concurrent treatment with Couldina Instant with Acetylsalicylic Acid may mask the symptoms of ototoxicity, such as ringing in the ears, dizziness, and vertigo.
• Medications that are photosensitizing (may cause an allergic reaction to light), as concurrent treatment with Couldina Instant with Acetylsalicylic Acid may increase the photosensitizing effects of these medications.
• Decongestant nasal sprays, as concurrent treatment with Couldina Instant with Acetylsalicylic Acid may increase the side effects of central nervous system stimulation, such as nervousness, irritability, insomnia, and possible seizures. It may also increase blood pressure.
• Caffeine-containing medications, as Couldina Instant with Acetylsalicylic Acid may increase the effects of caffeine and its side effects.

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

Interference with laboratory tests:

If you are scheduled to undergo 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 Instant with Acetylsalicylic Acid with food, beverages, and alcohol

Take this medication after meals or with food.

While taking this medication, do not consume alcoholic beverages, as it may potentiate the appearance of side effects of this medication.

Pregnancy and lactation

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

This medication is contraindicated during the third trimester of pregnancy.

Additionally, do not take it during the rest of pregnancy unless your doctor considers it strictly necessary.

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

Driving and operating machinery

This medication may cause drowsiness, altering mental or physical ability. If you experience these effects, avoid driving vehicles or operating machinery.

Couldina Instant with Acetylsalicylic Acid contains sodium, saccharose, aspartame (E-951), and yellow orange S (E110):

This medication contains 337 mg of sodium (main component of table salt/cooking salt) in each tablet. This represents 17% of the recommended daily maximum sodium intake for an adult.

Consult your doctor or pharmacist if you need 2 or more packets per day for an extended period, especially if you have been recommended a low-sodium diet.

This medication contains saccharose. If your doctor has recommended that you have an intolerance to certain sugars, consult with them before taking this medication.

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

This medication may cause allergic reactions, as it contains yellow orange S (E110).

It may cause asthma, especially in patients allergic to acetylsalicylic acid.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and adolescents 16 years of age and older:

Take 1 tablet every 8 hours. If necessary, it could be taken every 6 hours (3 or 4 times in 24 hours).

In any case, no more than 4 tablets can be taken in 24 hours, and a minimum of 6 hours should be left between each dose.

Use in patients with reduced liver, kidney, or heart function

These patients cannot take this medication without consulting a doctor, as the dose must be reduced.

Use in children

This medication is contraindicated in children under 16 years of age.

Use in elderly individuals

Elderly individuals cannot use this medication without consulting a doctor, as it may affect them especially, causing some adverse effects of the medication, such as the appearance of slow heartbeats (bradycardia) or reduced cardiac output, due to the content of phenylephrine and chlorphenamine. It is also more likely that they may experience adverse effects such as sedation, confusion, hypotension, or excitement, and may be more sensitive to effects such as dry mouth and urinary retention.

Administration form

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

Do not take on an empty stomach.

This medication is taken orally.

Dissolve the tablet in a small amount of liquid, preferably half a glass of water, and wait until the bubbling or effervescence has completely disappeared and then drink.

Always use the smallest effective dose.

The administration of this medication is subject to the appearance of all symptoms, pain, or fever, congestion, and nasal secretion. As these symptoms disappear, treatment should be discontinued.

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

If you take more Couldina Instant with Acetylsalicylic Acid than you should

The main symptoms of overdose are: headache, dizziness, ringing in the ears, blurred vision, drowsiness, sweating, rapid breathing, low or high blood pressure, alteration of the pulse (cardiac arrhythmias), nervousness, hallucinations, confusion, nausea, vomiting, and occasionally diarrhea.

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

Like all medications,Couldina Instantwith Acetylsalicylic Acid may cause side effects, although not everyone will experience them.

During the period of use of acetylsalicylic acid, phenylephrine, chlorphenamine, and vitamin C, the following side effects have been reported, whose frequency has not been established with precision:

• The side effects that may appear most frequently are:

Mild drowsiness, dizziness, muscle weakness, these side effects may disappear after 2-3 days of treatment. Difficulty moving the face, clumsiness, tremors, alterations in sensations and paresthesias, dryness of the mouth, nose, and throat, loss of appetite, alterations in taste or smell, gastrointestinal discomfort (which may decrease if the medication is taken with food), nausea, vomiting, diarrhea, constipation, stomach pain, thickening of mucosities, sweating, blurred vision or other visual disturbances, gastric ulcer, duodenal ulcer, gastrointestinal bleeding. Hypoprothrombinemia (coagulation alteration) when high doses are taken.

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

Reye's syndrome in children under 16 years with febrile, flu, or varicella processes (see section “What you need to know before starting to take Couldina Instant”). Hepatic disorders, especially in patients with juvenile arthritis. Confusion (especially in elderly patients), euphoria, nervousness, restlessness (especially in children and elderly patients), insomnia, headache, strange behavior; alterations in pulse (palpitations, tachycardia), elevation of blood pressure (hypertension), which can sometimes be severe (hypertensive crises). Difficulty urinating. Anemia.

• The side effects that may appear with very low frequency (very rare) are:Anemia due to chronic post-hemorrhagic blood loss/iron deficiency (due to occult bleeding) presenting typical symptoms, such as fatigue and pallor. Cerebral hemorrhage, especially in patients with uncontrolled hypertension and taking anticoagulant medications at the same time. Anaphylactic shock and hyperglycemia (elevated blood sugar).

If taken for a long period:dizziness, ear noises, hearing loss, sweating, headache, confusion, renal insufficiency, and acute interstitial nephritis (inflammation at the kidney level).

If you observe the appearance of:

• Abdominal discomfort or stomach pain, gastrointestinal bleeding, or black stools.
• Dermatological disorders, such as rashes or redness.
• Difficulty breathing.
• Unpredictable change in the amount or appearance of urine.
• Swelling of the face, feet, or legs.
• Hearing loss, tinnitus, or dizziness.

Stop taking the medication and consult your doctor immediately, as they may indicate the appearance of side effects that require urgent medical attention.

If you experience side effects, consult your doctor or pharmacist, even if they are side effects that do not appear in this prospectus.

Keep out of sight and reach of children.

Do not store at a temperature above 25°C.

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

Do not use this medication after the expiration date that appears on the container after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point (or any other medication waste collection system) at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Couldina Instant with Aspirin Effervescent Tablets

• The active ingredients are: aspirin, chlorphenamine maleate, and phenylephrine hydrochloride. Each tablet contains 500 mg of aspirin, 2 mg of chlorphenamine maleate, and 7.5 mg of phenylephrine hydrochloride.
• The other components (excipients) are: anhydrous citric acid (E-330), sodium hydrogen carbonate (E-500ii), anhydrous sodium carbonate (E-500i), mannitol (E-421), povidone K 30 (E-1201), glycine (E-640), sodium docusate, aspartame (E-951), sucrose, sodium saccharin (E-954ii), orange aroma (prepared aroma, natural flavoring substance), and yellow-orange S (E-110).

Appearance of the product and content of the packaging

This medication is an effervescent granule, orange in color, which is presented in tablets that are packaged in boxes with 10 and 20 tablets.

Holder of the marketing authorization

Laboratorios Alter, S.A.

C/ Mateo Inurria, 30

28036 Madrid

Spain

Responsible for manufacturing

Laboratorios Alter, S.A.

C/ Mateo Inurria, 30

28036, Madrid

Spain

or

Laboratorios Alter, S.A.

C/ Zeus, 6

Polígono Industrial R2

28880, Meco (Madrid)

Spain

This prospectus was approved in October 2018

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es