Coughgrip 300 mg/15 mg/2 mg powder for oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Coughgrip 300 mg/15 mg/2 mg powder for oral solution

Paracetamol / Dextromethorphan hydrobromide / Chlorphenamine maleate

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

Follow exactly the instructions for use provided in this leaflet or as directed 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 adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or if you do not improve after 3 days.

Contents of the leaflet

1. What Coughgrip is and what it is used for

2. What you need to know before taking Coughgrip

3. How to take Coughgrip

4. Possible adverse effects

5. How to store Coughgrip

6. Contents of the pack and other information

1. What Coughgrip is and what it is used for

Paracetamol / Dextromethorphan / Chlorpheniramine is a combination of paracetamol, an analgesic that reduces pain and fever; dextromethorphan, a cough suppressant; and chlorpheniramine, which helps reduce nasal secretions.

This medicine is indicated for the symptomatic relief of colds and influenza characterized by mild to moderate pain such as headache, fever, non-productive cough (irritant cough, nervous cough), and nasal discharge in children over 6 years of age and adolescents.

You should consult a doctor if your condition worsens or does not improve after 3 days of treatment.

2. What you need to know before taking Coughgrip

Do not take Coughgrip

• If you are allergic to the active substances or to any of the other components of this medicine (listed in section 6)
• If you have severe liver or kidney disease
• If you have respiratory failure or a serious lung disease
• If you have asthmatic cough or cough with abundant secretions
• If you are currently or have recently (within the last two weeks) been treated with other medicines, such as those used to treat depression, Parkinson’s disease, or other conditions (monoamine oxidase inhibitors [MAOIs], serotonin reuptake inhibitors such as fluoxetine or paroxetine), or also with bupropion (a medication used to stop smoking), or with linezolid (an antibiotic) (see section “Other medicines and Coughgrip”)
• Children under 6 years of age must not take this medicine.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Coughgrip

• Do not take more medicine than recommended in section 3, How to take Coughgrip
• Chronic alcoholics should take care not to exceed 6 sachets per day (2 g of paracetamol)
• Avoid using this medicine simultaneously with other medicines containing paracetamol, as high doses may cause liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.
• In case of glucose-6-phosphate dehydrogenase (G6PD) deficiency (which may cause hemolytic anemia)

The following patients should consult their doctor or pharmacist before starting treatment with this medicine:

• Patients with persistent or chronic cough, such as that caused by smoking. Particularly in children, chronic cough could be an early symptom of asthma
• Patients with kidney, heart, or lung diseases, and patients with anemia
• Patients with liver diseases (with or without hepatic insufficiency) or viral hepatitis, because the risk of hepatotoxicity due to paracetamol is increased
• Asthmatic patients sensitive to acetylsalicylic acid
• Patients sensitive (allergic) to an antihistamine, as they may also be sensitive to other antihistamines (such as chlorphenamine)
• Patients with hypertension (high blood pressure), glaucoma (increased intraocular pressure), hyperthyroidism, vesical neck obstruction, symptomatic prostatic hypertrophy, or urinary retention
• Elderly patients, who may be more sensitive to the side effects of this medicine
• Patients who are sedated, debilitated, or bedridden
• Patients with atopic dermatitis (an inflammatory skin disease characterized by erythema, itching, exudation, crusting, and scaling, beginning in childhood in individuals with hereditary predisposition to allergy)

During treatment with Coughgrip, inform your doctor immediately:

• If you have serious conditions such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients in these situations when paracetamol is used at regular doses over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulty with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

This medicine causes drowsiness. Avoid consuming alcoholic beverages and certain medicines while taking this medicine, as they may enhance this effect. See sections “Other medicines and Coughgrip” and “Taking Coughgrip with food, drinks, and alcohol”.

Cases of abuse of medicines containing dextromethorphan have been reported in adolescents; therefore, this possibility should be considered, as it may lead to serious adverse effects (see section: If you take more Coughgrip than you should).

This medicine may also be addictive, so its use at high doses or for prolonged periods may lead to tolerance and mental and physical dependence. In patients with a tendency to abuse or dependence, it should only be administered under strict medical supervision and for short periods.

This medicine may lead to dependence. Therefore, treatment should be short-term.

Other medicines and Coughgrip

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

You must not take this medicine if you are being treated with the following medicines, or within 2 weeks after stopping them, as they may cause excitement, high blood pressure, and fever above 40°C (hyperpyrexia):

• Antidepressant monoamine oxidase inhibitors (MAOIs) (moclobemide, tranylcypromine)
• Antidepressant serotonin reuptake inhibitors (paroxetine, fluoxetine)
• Bupropion (used to stop smoking)
• Linezolid (used as an antibacterial)
• Procarbazine (used to treat cancer)
• Selegiline (used to treat Parkinson’s disease)

If you are using any of the following medicines, consult your doctor before starting this medicine, as it may be necessary to adjust the dose or discontinue treatment:

• Medicines to treat epilepsy: antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone)

• Medicines to treat tuberculosis: (isoniazid, rifampicin)

• Medicines to prevent blood clots: oral anticoagulants (acenocoumarol, warfarin)

• Medicines used to increase urine elimination (loop diuretics such as furosemide, or others), and other diuretics causing potassium loss (such as diuretics used to treat hypertension or others)

• Medicines used to prevent nausea and vomiting (metoclopramide and domperidone)

• Medicines used to treat gout (probenecid)

• Medicines used to treat high blood pressure (hypertension), such as propranolol, and heart rhythm disorders (cardiac arrhythmias), such as amiodarone or quinidine

• Medicines used to lower blood cholesterol levels (cholestyramine)

• Medicines used to treat depression (moclobemide, tranylcypromine, fluoxetine, paroxetine, bupropion), Parkinson’s disease (selegiline), or other conditions such as cancer (procarbazine), infections (linezolid, furazolidone). Administration of Coughgrip should be separated by at least 14 days after stopping treatment

• Other medicines used to treat depression, known as tricyclic and tetracyclic antidepressants (such as maprotiline)

• Medicines for schizophrenia (such as haloperidol)

• Medicines that cause depression of the central nervous system (such as those used for insomnia or anxiety, Parkinson’s disease, or allergies)

• Ototoxic medicines (which have the adverse effect of damaging the ear)

• Photosensitizing medicines (which have the adverse effect of causing light allergy)

• Medicines used to relieve pain and inflammation (celecoxib, parecoxib, valdecoxib)

• Medicines used to increase mucus secretion

• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormalities (called metabolic acidosis) requiring urgent treatment (see section 2)

Interference with diagnostic tests:

If you are scheduled to undergo any diagnostic tests (including blood and urine tests, skin tests using allergens, etc.), inform your doctor that you are taking this medicine, as it may alter test results.

Consult your doctor or pharmacist before taking Coughgrip:

If you are taking other medicines such as antidepressants or antipsychotics, Coughgrip may interact with these medicines and you may experience changes in your mental state (e.g., agitation, hallucinations, coma) and other effects such as body temperature above 38°C, increased heart rate, high blood pressure, exaggerated reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, and diarrhea).

Taking Coughgrip with food, drinks, and alcohol

While taking this medicine, you must not consume alcoholic beverages, as they may enhance the occurrence of adverse effects of this medicine.

Additionally, using medicines containing paracetamol in patients who habitually consume alcohol (3 or more alcoholic drinks: beer, wine, spirits, etc., per day) may cause liver damage.

Do not take the medicine with grapefruit juice or bitter orange juice, as they may enhance the effects of one of its components (dextromethorphan).

All other foods and drinks may be consumed with this medicine, as they do not affect its efficacy.

Pregnancy and breastfeeding

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

This medicine should not be taken during pregnancy or breastfeeding without medical advice.

Driving and using machines

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

Coughgrip contains sucrose and sodium:

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

This medicine contains less than 23 mg of sodium (1 mmol) per sachet; this is essentially “sodium-free”.

3. How to take Coughgrip

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

Paediatric population

Serious adverse effects may occur in children in case of overdose, including neurological disturbances. Caregivers must not exceed the recommended dose.

The powder contained in Coughgrip sachets is for oral administration.

The recommended dose is:

Children aged 6 to 12 years (weight between 21.5 kg and 43 kg): 1 sachet every 6–8 hours as needed (3 or 4 times daily).

Individuals over 12 years of age (weight over 44 kg): 2 sachets every 6–8 hours as needed (3 or 4 times daily).

It is preferable to take one dose before going to bed. Do not exceed 4 doses.

This medicine is contraindicated in children under 6 years of age.

Always use the lowest effective dose.

Begin treatment at the first sign of symptoms and discontinue as symptoms resolve.

This medication should not be used for more than 3 consecutive days without consulting a doctor (see section 1, "What Coughgrip is and what it is used for").

How to take:

This medicine is taken orally.

Pour the contents of one sachet into half a glass of water and stir vigorously. Take immediately.

If you take more Coughgrip than you should

Seek immediate medical attention even if there are no symptoms, as symptoms often do not appear until 3 days after the overdose has occurred, even in cases of severe poisoning.

The most serious effect of overdose is liver damage caused by paracetamol. You may experience dizziness, vomiting, confusion, excitability, restlessness, nervousness, irritability, visual disturbances, loss of appetite, yellowing of the skin and eyes (jaundice), abdominal pain, and difficulty breathing. In children, symptoms may include drowsiness, nervousness, nausea, vomiting, or disturbances in gait.

Treatment for overdose is most effective if initiated within 4 hours of ingestion.

Patients undergoing treatment with barbiturates or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

Cases of abuse have occurred with medications containing dextromethorphan, potentially leading to serious adverse effects such as: anxiety, panic, memory loss, tachycardia (rapid heartbeat), lethargy, hypertension or hypotension (high or low blood pressure), mydriasis (pupil dilation), agitation, dizziness, gastrointestinal discomfort, slurred speech, nystagmus (involuntary, uncontrolled eye movements), fever, tachypnea (rapid, shallow breathing), brain damage, ataxia (uncoordinated movements), seizures, respiratory depression, loss of consciousness, arrhythmias (irregular heartbeat), and death.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the medicine’s packaging and leaflet to the healthcare professional.

If you take more Coughgrip than indicated, you may experience the following symptoms: nausea and vomiting, involuntary muscle contractions, agitation, confusion, drowsiness, disturbances in consciousness, involuntary and rapid eye movements, cardiac disorders (increased heart rate), coordination disorders, psychosis with visual hallucinations, and hyperexcitability.

Other symptoms in cases of massive overdose may include: coma, severe breathing problems, and seizures.

Overdose may also cause: coagulation disorders (blood clots and bleeding).

Contact your doctor or hospital immediately if you experience any of the symptoms listed above.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

The most frequent adverse effects are drowsiness and somnolence.

During the period of use of the combination of paracetamol, dextromethorphan and chlorpheniramine, the following adverse effects have occurred, although their frequency cannot be precisely determined.

Nightmares, insomnia, excitation, nervousness or restlessness (psychomotor hyperactivity) may rarely occur, more commonly in children and elderly patients. Dizziness and hypotension, especially in the elderly.

Very rarely, gastrointestinal discomfort such as abdominal pain, diarrhoea, nausea, vomiting and indigestion (dyspepsia), confusion, dizziness, visual disturbances, increased sensitivity to sunlight, dry mouth, sore throat and difficulty urinating. Skin rashes, serious skin reactions and severe allergic reactions such as anaphylactic reaction, hypersensitivity, angioedema (swelling of certain areas of the skin), pruritus, urticaria, rash, allergic dermatitis, as well as increased transaminases have also been reported. High doses or prolonged treatments are hepatotoxic.

Frequency not known (cannot be estimated from available data): A serious condition that may make the blood more acidic (called metabolic acidosis) in patients with serious illness using paracetamol (see section 2).

Other adverse effects in children

Taking very high amounts of this medicine may cause in children a state of drowsiness, nervousness, nausea, vomiting or disturbances in walking pattern.

Concomitant consumption of alcohol during treatment may increase the occurrence of adverse effects. Do not consume alcoholic beverages during treatment.

Reporting of adverse effects

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

5. Coughgrip Storage

Keep this medicine out of the sight and reach of children.

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

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly discard medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Coughgrip

Each sachet contains:

• The active substances are: 300 mg of paracetamol, 15 mg of dextromethorphan (as hydrobromide), and 2 mg of chlorpheniramine (as maleate).
• The other components (excipients) are: anhydrous colloidal silica, anhydrous citric acid, sucrose, sodium saccharin, anhydrous sodium cyclamate, orange flavouring.

Appearance of the medicinal product and contents of the pack

Coughgrip is a white or yellowish-white powder for oral solution with an orange flavour, supplied in sachets packed in cardboard boxes containing 10 sachets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13. 3º D

28108 Alcobendas (Madrid)

Spain

Manufacturer

Laboratorios Alcalá Farma, S.L.

Avenida de Madrid, 82

28802 Alcalá de Henares, Madrid

Spain

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

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/