COULDINA INSTANT with Acetylsalicylic Acid Effervescent Granules

Introduction

Package Leaflet: Information for the User

Couldina Instant with Acetylsalicylic Acid Effervescent Granules

Acetylsalicylic Acid/Chlorphenamine Maleate/Phenylephrine Hydrochloride

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

Follow the instructions for administration of the medicine contained 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.
• You should consult your doctor if your condition worsens or does not improve, or if the fever persists for more than 3 days or the pain for more than 5 days of treatment.

Contents of the Package Leaflet

1. What is Couldina Instant with Acetylsalicylic Acidand what is it used for
2. What you need to know before you start taking Couldina Instant with Acetylsalicylic Acid
3. How to take Couldina Instantwith Acetylsalicylic Acid
4. Possible side effects
5. Storage of Couldina Instant with Acetylsalicylic Acid
6. Package Contents and Additional Information

1. What is Couldina Instant with Acetylsalicylic Acid and what is it used for

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 occur with fever, mild or moderate pain, congestion, and nasal secretion.

You should consult your doctor if your condition worsens or does not improve, or if the fever persists for more than 3 days or the pain for more than 5 days.

2. What you need to know before you start taking Couldina Instant with Acetylsalicylic Acid

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 medicine (listed in section 6).
• If you have experienced allergic reactions of an asthmatic type (difficulty breathing, shortness of breath, bronchospasm, and in some cases cough or wheezing when breathing) when taking anti-inflammatory drugs, acetylsalicylic acid (aspirin), other analgesics, tartrazine dye, or other allergy medications, as cross-hypersensitivity may occur.
• If you have a stomach ulcer, duodenal ulcer, or recurring stomach discomfort.
• If you have had any bleeding or perforation of the stomach caused by acetylsalicylic acid or other anti-inflammatory drugs.
• If you have hemophilia or other blood coagulation problems.
• If you have asthma.
• If you have nasal polyps associated with asthma that are produced or increased by acetylsalicylic acid (aspirin).
• If you have 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 (MAOI) (see section "Taking Couldina Instant with Acetylsalicylic Acid with other medications").
• If you are taking beta-blocker medications (medications for the heart or to treat 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 linked to 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 than the recommended dose of this medicine as stated in section 3 "How to take Couldina Instant with Acetylsalicylic Acid".

While taking this medicine, do not consume alcohol, as it may increase 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 produced by chlorphenamine.

If during treatment with this medicine you experience intense or persistent abdominal pain and/or black stools, stop taking this medicine and consult your doctor immediately, as you may have a stomach or duodenal bleeding or perforation. This risk is higher when using high doses and prolonged treatments, in patients who have previously had peptic ulcers, and in elderly individuals.

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

• If you have obstruction of the neck of the bladder or urinary retention, as it may worsen.
• If you have a deficiency of glucose-6-phosphate dehydrogenase (a hereditary disease that causes a type of anemia).
• If you have or have had rhinitis or urticaria.
• If you have recently undergone or are scheduled to undergo surgery or dental procedures, including tooth extraction, within the next 7 days.
• If you have controlled high blood pressure.
• If you have pheochromocytoma, cardiovascular diseases such as slow heart movement, kidney, liver, or lung diseases, or if you suffer from anemia.
• If you are taking tricyclic antidepressants or medications with similar effects and experience gastrointestinal problems, you should stop taking this medicine and consult your doctor immediately, as you may develop paralytic ileus (stoppage of normal movements of a part of the intestine).
• If you are taking monoamine oxidase inhibitor (MAOI) medications for the treatment of depression or Parkinson's disease, you should 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 should not take this medicine, as it is contraindicated in them.

Elderly

Elderly individuals should not take this medicine without consulting their doctor, as they are more prone to its side effects.

Taking Couldina Instant with Acetylsalicylic Acid with other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription, homeopathic products, herbal remedies, and other health-related products, as it may be necessary to interrupt treatment or adjust the dose of one of them.

In particular, if you are using 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 one of them or interrupt treatment.

• Pain relievers or non-steroidal anti-inflammatory drugs (medications used to treat pain and/or muscle inflammation, such as ibuprofen or others) and corticosteroids, as concurrent treatment may cause ulcers, intestinal bleeding, and decreased efficacy of these medications.
• Anesthetics (inhalation hydrocarbons) in case of surgery; treatment with this medicine should be interrupted a few days before the intervention due to the possible risk of arrhythmias.
• Antacids may decrease the efficacy of Couldina Instant with Acetylsalicylic Acid.
• Anticoagulants (medications used to prevent blood clot formation) such as Sintrom, heparin, or warfarin, as they increase the risk of bleeding.
• Antidepressants (medications used for depression), such as selective serotonin reuptake inhibitors, tricyclic and tetracyclic antidepressants, and monoamine oxidase inhibitors (MAOIs), as they increase the risk of bleeding and may decrease the efficacy of some of these medications or cause severe side effects. If you are taking MAOI medications for the treatment of depression or Parkinson's disease, you should separate the intake of Couldina Instant with Acetylsalicylic Acid from these medications by at least 15 days, as severe side effects may occur, including severe headache, increased blood pressure, and sudden increase in temperature.
• Antiepileptics such as phenytoin and valproic acid, as they may decrease the efficacy or increase the side effects of antiepileptic medications.
• Antihypertensives (medications to lower blood pressure), as they may cause kidney failure and decrease the efficacy of antihypertensive medications.
• Medications used to lower blood sugar levels (oral antidiabetics, insulins, and sulfonylureas), as taking Couldina Instant with Acetylsalicylic Acid while using these medications may increase the effect of lowering blood sugar levels and cause hypoglycemia.
• Medications used to treat seizures (such as barbiturates), as taking them together may increase the amount of barbiturates in the blood and their side effects.
• Cyclosporine and Tacrolimus (used to prevent transplant rejection), as taking Couldina Instant with Acetylsalicylic Acid while using cyclosporine may increase the toxicity of cyclosporine to the kidneys.
• Cimetidine and ranitidine (used for stomach acidity), as they may increase the side effects of Couldina Instant with Acetylsalicylic Acid.
• Digoxin (medication for the heart), as it should not be taken with Couldina Instant with Acetylsalicylic Acid, as digoxin may reach toxic levels in the blood.
• Interferon alfa (used for the treatment of certain viral and tumor infections), as it may decrease the efficacy of interferon.
• Methotrexate (used for the treatment of cancer and rheumatoid arthritis), as it may increase the toxicity of methotrexate.
• Medications used to treat gout (probenecid and sulfinpyrazone), as they may increase the toxicity of Couldina Instant with Acetylsalicylic Acid and decrease the efficacy of medications used to treat gout.
• Medications used to lower high blood pressure (diuretics and ACE inhibitors).
• Other pain relievers or non-steroidal anti-inflammatory drugs (medications used to treat pain and/or muscle inflammation).
• The antibiotic vancomycin (used to treat infections), as taking Couldina Instant with Acetylsalicylic Acid while using vancomycin may increase the risk of vancomycin-induced ototoxicity.
• Zidovudine (used in the treatment of patients infected with the human immunodeficiency virus, HIV, which causes AIDS), as taking Couldina Instant with Acetylsalicylic Acid while using zidovudine may decrease the elimination of zidovudine, increasing the risk of its side effects.
• Medications that affect heart conduction, such as antiarrhythmics: taking this medicine while using medications that affect heart conduction should be controlled by the doctor.
• Medications that contain thyroid hormones (used to treat thyroid diseases), as taking this medicine while using medications for thyroid diseases should be controlled by the doctor.
• Medications used for heart or digestive diseases (atropine sulfate), as taking Couldina Instant with Acetylsalicylic Acid while using these medications may decrease their efficacy and increase their side effects.
• Medications that produce depression of the central nervous system (such as those used for insomnia or anxiety or antihistamines), as they may cause symptoms of overdose of these medications.
• Ototoxic medications (which have the side effect of damaging the ear), as taking Couldina Instant with Acetylsalicylic Acid while using ototoxic medications may not cause noticeable symptoms of ototoxicity, such as ringing in the ears, dizziness, and vertigo.
• Photosensitizing medications (which have the side effect of causing allergy to light), as taking Couldina Instant with Acetylsalicylic Acid with photosensitizing medications may increase the photosensitizing effects of these medications.
• Nasal decongestants, as they may increase the stimulating effects on the central nervous system, such as nervousness, irritability, insomnia, and possible convulsive crises. They may also increase blood pressure.
• Medications that contain caffeine, 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 recently taken, or may need to take any other medication.

Interference with laboratory tests:

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

Taking Couldina Instant with Acetylsalicylic Acid with food, beverages, and alcohol

Take this medicine after meals or with some food.

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

Pregnancy and Breastfeeding

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 medicine.

This medicine is contraindicated during the third trimester of pregnancy.

Additionally, it should not be taken during the rest of pregnancy unless your doctor considers it strictly necessary.

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

Driving and Using Machines

This medicine may cause drowsiness, altering mental or physical ability. If you experience these effects, avoid driving vehicles or using machines.

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

This medicine contains 337 mg of sodium (main component of table salt) per tablet. This is equivalent to 17% of the maximum recommended daily intake of sodium for an adult.

Consult your doctor or pharmacist if you need to take 2 or more sachets per day for a prolonged period, especially if you have been advised to follow a low-sodium diet.

This medicine contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

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

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

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

3. How to take Couldina Instant with Acetylsalicylic Acid

Follow the administration instructions of the medication contained in this prospectus or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and adolescents from 16 years old:

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

In any case, no more than 4 sachets can be taken in 24 hours, and a minimum time of 6 hours must be left between each intake.

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 old.

Use in elderly people

Elderly people cannot use this medication without consulting a doctor, because they may be especially affected by 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. They are also more likely to experience adverse effects such as sedation, confusion, hypotension, or excitement, and may be more sensitive to effects such as dry mouth and urinary retention.

Method of administration

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

Do not take on an empty stomach.

This medication is taken orally.

Dissolve the sachet in a little liquid, preferably half a glass of water, and wait until the bubbling or effervescence has completely disappeared before drinking.

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 disappear, treatment should be suspended.

If the 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, altered 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

4. Possible adverse effects

Like all medications, Couldina Instantwith Acetylsalicylic Acid may produce adverse effects, although not all people experience them.

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

• Adverse effects that may appear more frequently are:

Mild drowsiness, dizziness, muscle weakness, these adverse effects may disappear after 2-3 days of treatment. Difficulty in facial movements, clumsiness, tremors, alterations in sensations and tingling, dry mouth, nose, and throat, loss of appetite, alterations in taste or smell, gastrointestinal discomfort (which may decrease if the medication is administered with food), nausea, vomiting, diarrhea, constipation, stomach pain, thickening of mucus, sweating, blurred vision, or other vision disorders, gastric ulcer, duodenal ulcer, gastrointestinal bleeding. Hypoprothrombinemia (coagulation disorder) when high doses are taken.

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

Reye's syndrome in children under 16 years old with febrile processes, flu, or chickenpox (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), elevated blood pressure (hypertension), which can sometimes be severe (hypertensive crises). Difficulty urinating. Anemia.

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

If taken for a long period:dizziness, ringing in the ears, deafness, sweating, headache, confusion, renal insufficiency, and acute interstitial nephritis (kidney inflammation).

If you observe the appearance of:

• Discomfort or stomach pain, gastric or intestinal bleeding, or black stools.
• Skin disorders, such as rashes or redness.
• Difficulty breathing.
• Unforeseen change in the amount or appearance of urine.
• Swelling of the face, feet, or legs.
• Deafness, ringing in the ears, or dizziness.

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

If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus.

5. Conservation of Couldina Instant with Acetylsalicylic Acid

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.

Medications should not be thrown down the drain or into the trash. Deposit the containers and medications that are no longer needed in the SIGRE Point (or any other system for collecting medication waste) at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and medications that are no longer needed. This will help protect the environment.

6. Container content and additional information

Composition of Couldina Instant with Acetylsalicylic Acid effervescent sachets

• The active ingredients are: acetylsalicylic acid, chlorphenamine maleate, phenylephrine hydrochloride. Each sachet contains 500 mg of acetylsalicylic acid, 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 flavor (flavor preparation, natural flavoring substance), and orange yellow S (E-110).

Appearance of the product and container content

This medication is an effervescent granulate, orange in color, presented in sachets that are packaged in boxes with 10 and 20 sachets.

Marketing authorization holder

Laboratorios Alter, S.A.

C/ Mateo Inurria, 30

28036 Madrid

Spain

Manufacturer

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

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es