Couldina Instant with acetylsalicylic acid effervescent granules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Couldina Instant with Acetylsalicylic Acid effervescent granules

Acetylsalicylic acid/Chlorpheniramine maleate/Phenylephrine hydrochloride

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

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet.
• You should consult your doctor if your condition worsens or does not improve, or if fever persists for more than 3 days or pain for more than 5 days of treatment.

Contents of the leaflet

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

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

Couldina Instant with Acetylsalicylic Acid is a combination of acetylsalicylic acid, chlorpheniramine, and phenylephrine.

Acetylsalicylic acid is an anti-inflammatory agent that acts against pain and fever.

Chlorpheniramine is an antihistamine that relieves nasal discharge.

Phenylephrine is a sympathomimetic that reduces nasal congestion.

It is indicated in adults and adolescents aged 16 years and older for the relief of symptoms associated with colds and flu that present with fever, mild to moderate pain, nasal congestion, and nasal discharge.

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

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

Do not take Couldina Instant with Acetylsalicylic Acid if:

• You are allergic to acetylsalicylic acid (aspirin), chlorpheniramine maleate, phenylephrine hydrochloride, or any of the other components of this medicine (listed in section 6).
• You have experienced allergic-type asthma reactions (difficulty breathing, suffocation, bronchospasms, and in some cases coughing or wheezing) when taking anti-inflammatory drugs, acetylsalicylic acid (aspirin), other painkillers, tartrazine dye, or other allergy medications, as cross-sensitivity may occur.
• You suffer from gastric or duodenal ulcers or recurrent stomach discomfort.
• You have previously experienced stomach bleeding or perforation caused by acetylsalicylic acid or other anti-inflammatory drugs.
• You have hemophilia or other blood clotting disorders.
• You suffer from asthma.
• You have nasal polyps associated with asthma that are caused or worsened by acetylsalicylic acid (aspirin).
• You have a serious heart condition (severe coronary disease or angina pectoris) or a serious arterial disease.
• You have tachycardia (rapid heartbeat).
• You have poorly controlled high blood pressure (hypertension).
• You have severe kidney or liver disease (severe renal or hepatic insufficiency).
• You have thyroid disease (hyperthyroidism).
• You are being treated with oral anticoagulant medications (e.g., Sintrom).
• You have glaucoma (increased eye pressure).
• 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 medicines”).
• You are being treated with beta-blockers (medications for heart conditions or arterial diseases) (see section “Taking Couldina Instant with Acetylsalicylic Acid with other medicines”).
• The patient is under 16 years of age, as the use of acetylsalicylic acid has been linked to Reye's syndrome, a rare but serious illness occurring in children under 16.
• You have diabetes mellitus.
• You are in the third trimester of pregnancy.

Warnings and precautions

Do not take more medicine than the recommended dose stated in section 3 “How to take Couldina Instant with Acetylsalicylic Acid”.

While being treated with this medicine, do not consume alcohol, as alcohol increases the likelihood of gastrointestinal adverse effects caused by acetylsalicylic acid. Additionally, alcohol may worsen the chronic irritation caused by acetylsalicylic acid and 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 this may indicate gastrointestinal bleeding or perforation of the stomach or duodenum. This risk is greater when high doses are used, with prolonged treatment, in patients with a prior history of peptic ulcer, and in elderly patients.

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

• If you suffer from bladder neck obstruction or urinary retention, as these conditions may worsen.
• If you have glucose-6-phosphate dehydrogenase deficiency (an inherited condition causing a type of anemia).
• If you suffer from or have previously suffered from 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 hypertension.
• If you have pheochromocytoma, cardiovascular diseases such as slow heart rate, kidney, liver, or lung diseases, or if you suffer from anemia.
• If you are being treated with tricyclic antidepressants or medications with similar effects and develop gastrointestinal problems, you should stop taking this medicine and consult your doctor immediately, as paralytic ileus (cessation of normal intestinal movements) may occur.
• If you are being treated with monoamine oxidase inhibitors (MAOIs) for depression or Parkinson’s disease, you must separate the administration of Couldina Instant with Acetylsalicylic Acid from these medications by at least 15 days.

Children and adolescents

This medicine is contraindicated in individuals under 16 years of age and must not be taken by them.

Elderly patients

Elderly patients should not take this medicine without consulting their doctor, as they are more prone to experiencing adverse effects.

Taking Couldina Instant with Acetylsalicylic Acid with other medicines

Inform your doctor or pharmacist if you are currently using, have recently used, or may need to use any other medicines, including those obtained without a prescription, homeopathic remedies, herbal medicines, or other health-related products, as it may be necessary to interrupt treatment or adjust the dosage of one or more of these medicines.

In particular, if you are taking any of the following medicines, it is important to consult your doctor before taking Couldina Instant with Acetylsalicylic Acid, as it may be necessary to adjust the dose or discontinue treatment:

• Analgesics or non-steroidal anti-inflammatory drugs (medicines used to treat pain and/or muscle inflammation, such as ibuprofen or others) and corticosteroids, as concomitant use may cause ulcers, intestinal bleeding, and may reduce the effectiveness of these medicines.
• Anesthetics (inhaled hydrocarbons): if you are scheduled for surgery, you should discontinue this medicine several days beforehand due to the possible risk of arrhythmias.
• Antacids may reduce the effectiveness of Couldina Instant with Acetylsalicylic Acid.
• Anticoagulants (medicines used to prevent blood clots), such as Sintrom, heparin, or warfarin, as the risk of bleeding increases.
• Antidepressants (medicines used for depression), such as selective serotonin reuptake inhibitors, tricyclic and tetracyclic antidepressants, and monoamine oxidase inhibitors (MAOIs), as the risk of bleeding increases and reduced effectiveness or serious adverse effects may occur. If you are being treated with monoamine oxidase inhibitors (MAOIs) for depression or Parkinson’s disease, you must separate the administration of Couldina Instant with Acetylsalicylic Acid from these medicines by at least 15 days, as serious adverse effects such as severe headache, increased blood pressure, and sudden rise in body temperature may occur. If you are being treated with lithium, you must not take this medicine, as it may increase lithium levels in the blood to toxic levels.
• Antiepileptics such as phenytoin and valproic acid, as they may reduce effectiveness or increase adverse effects of antiepileptic drugs.
• Antihypertensives (medicines to lower blood pressure), as kidney failure and reduced effectiveness of antihypertensive drugs may occur.
• Medicines used to lower blood sugar levels (oral antidiabetics, insulin, and sulfonylureas), as taking Couldina Instant with Acetylsalicylic Acid while on these treatments increases the blood sugar-lowering effect and may cause hypoglycemia.
• Medicines used to treat seizures (such as barbiturates), as taking them together increases barbiturate blood levels and thus their adverse effects.
• Cyclosporine and tacrolimus (used to prevent transplant rejection), as taking Couldina Instant with Acetylsalicylic Acid while on cyclosporine increases cyclosporine-induced kidney toxicity.
• Cimetidine and ranitidine (used for stomach acidity), as they increase the adverse effects of Couldina Instant with Acetylsalicylic Acid.
• Digoxin (a heart medication): Couldina Instant with Acetylsalicylic Acid should not be taken while on digoxin, as digoxin may reach toxic blood levels.
• Interferon alfa (used to treat certain viral infections and tumors), as interferon effectiveness may be reduced.
• Methotrexate (used to treat cancer and rheumatoid arthritis), as methotrexate toxicity may increase.
• Medicines used to treat gout (probenecid and sulfinpyrazone), as Couldina Instant with Acetylsalicylic Acid toxicity may increase and the effectiveness of gout medications may decrease.
• Medicines used to lower high blood pressure (diuretics and ACE inhibitors).
• Other analgesics or non-steroidal anti-inflammatory drugs (medicines used to treat pain and/or muscle inflammation).
• The antibiotic vancomycin (used to treat infections). Taking Couldina Instant with Acetylsalicylic Acid while on vancomycin increases the risk of vancomycin-induced ototoxicity.
• Zidovudine (used in the treatment of patients infected with human immunodeficiency virus, HIV, which causes AIDS). Taking Couldina Instant with Acetylsalicylic Acid while on zidovudine reduces zidovudine elimination, increasing the risk of its adverse effects.
• Medicines affecting heart conduction, such as antiarrhythmics: taking this medicine while on such treatments must be monitored by a doctor.
• Medicines containing thyroid hormones (used to treat thyroid diseases): taking this medicine while on thyroid treatments must be monitored by a doctor.
• Medicines used for heart conditions or digestive diseases (e.g., atropine sulfate): taking Couldina Instant with Acetylsalicylic Acid while on these medicines may reduce their effectiveness and increase their adverse effects.
• Medicines causing central nervous system depression (such as those used for insomnia or anxiety, or antihistamines), as symptoms of overdose of these medicines may occur.
• Ototoxic medicines (those with adverse effects damaging the ear). When Couldina Instant with Acetylsalicylic Acid is taken with ototoxic medicines, symptoms of ototoxicity such as tinnitus, dizziness, and vertigo may not be noticed.
• Photosensitizing medicines (those causing light allergy as an adverse effect), as taking Couldina Instant with Acetylsalicylic Acid with photosensitizing medicines may increase their photosensitizing effects.
• Nasal decongestants, as adverse central nervous system stimulation effects such as nervousness, irritability, insomnia, and possible convulsive seizures may increase. Increased blood pressure may also occur.
• Medicines containing caffeine, as Couldina Instant with Acetylsalicylic Acid enhances the effects and adverse effects of caffeine.

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

Interference with laboratory tests:

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

Taking Couldina Instant with Acetylsalicylic Acid 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 enhance the occurrence of adverse effects of this medicine.

Pregnancy and breastfeeding

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

This medicine is contraindicated during the third trimester of pregnancy.

In addition, it should not be taken during the remainder of pregnancy unless your doctor considers it strictly necessary.

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

Driving and operating machinery

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

Codeine Instant with Acetylsalicylic Acid contains sodium, sucrose, aspartame (E-951), and sunset yellow FCF (E110):

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

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

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

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

This medicine may cause allergic reactions, as it contains sunset yellow FCF (E110).

It may trigger asthma, particularly in patients allergic to acetylsalicylic acid.

3. How to take Couldina Insatant with Acetylsalicylic Acid

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and adolescents aged 16 years and over:

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

In any case, no more than 4 sachets should be taken within 24 hours, and a minimum interval of 6 hours must be left between each dose.

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

These patients must not take this medicine without consulting their doctor, as the dose may need to be reduced.

Use in children

This medicine is contraindicated in individuals under 16 years of age.

Use in elderly people

Elderly individuals must not use this medicine without consulting their doctor, as some adverse effects of the medicine may particularly affect them, such as slow heartbeats (bradycardia) or reduced cardiac output due to the presence of phenylephrine and chlorphenamine. 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.

Method of administration

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

Do not take on an empty stomach.

This medicine is taken orally.

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

Always use the lowest effective dose.

The administration of this medicine should only occur when all symptoms are present—pain or fever, nasal congestion, and nasal discharge. As these symptoms resolve, treatment should be discontinued.

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

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

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, go to a medical center immediately, or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested.

4. Possible adverse effects

Like all medicines, Couldina Instant with Acetylsalicylic Acid may cause adverse effects, although not everyone will experience them.

The following adverse effects have been reported during the use of acetylsalicylic acid, phenylephrine, chlorpheniramine, and vitamin C, although their frequency has not been accurately established:

• The adverse effects that may occur more frequently are:

Mild drowsiness, dizziness, muscle weakness; these adverse effects may disappear after 2–3 days of treatment. Difficulty in facial movements, clumsiness, tremor, disturbances in sensation and tingling, dry mouth, nose, and throat, loss of appetite, disturbances in taste or smell, gastrointestinal discomfort (which may decrease if the medicine is taken with food), nausea, vomiting, diarrhoea, constipation, stomach pain, thickening of mucus secretions, sweating, blurred vision or other visual disturbances, gastric ulcer, duodenal ulcer, gastrointestinal bleeding. Hypoprothrombinemia (a coagulation disorder) when high doses are taken.

• The adverse effects that may occur less frequently (rare):

Reye's syndrome in patients under 16 years of age with fever, influenza, or varicella (see section “What you need to know before taking Couldina Instant”). Hepatic disorders, especially in patients with juvenile arthritis. Confusion (particularly in elderly patients), euphoria, nervousness, restlessness (especially in children and elderly patients), insomnia, headache, unusual behaviour; disturbances in pulse (palpitations, tachycardia), elevation of blood pressure (hypertension), which may sometimes be severe (hypertensive crisis). Difficulty in urination. Anaemia.

• The adverse effects that may occur very rarely (very rare):

Chronic post-haemorrhagic anaemias/iron deficiency (due to occult bleeding) presenting with typical symptoms such as fatigue and pallor. Cerebral haemorrhage, particularly in patients with uncontrolled hypertension and who are concurrently taking anticoagulant medicines. Anaphylactic shock and hyperglycaemia (increased blood sugar).

If taken for a prolonged period: dizziness, tinnitus, hearing loss, sweating, headache, confusion, renal failure, and acute interstitial nephritis (inflammation at the kidney level).

If you notice any of the following:

• Stomach discomfort or pain, gastric or intestinal bleeding, or black stools.
• Skin disorders such as rashes or redness.
• Difficulty breathing.
• Unexpected changes in the amount or appearance of urine.
• Swelling of the face, feet, or legs.
• Hearing loss, ringing in the ears, or dizziness.

Stop taking the medicine and consult your doctor immediately, as these may indicate adverse effects requiring urgent medical attention.

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

5. Storage of Couldina Instant with Acetylsalicylic Acid

Keep out of the sight and reach of children.

Do not store above 25°C.

Keep the container tightly closed. Store in the original packaging.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

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

6. Contents of the pack and other information

Composition of Couldina Instant with Acetylsalicylic Acid effervescent sachets

• The active substances 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 flavour (flavour preparation, natural flavouring substance), and sunset yellow FCF (E-110).

Nature of the product and pack contents

This medicine is an effervescent granulate, orange-coloured, supplied in sachets packed in boxes containing 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 leaflet was last approved in October 2018

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