Gripacold powder for oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

GRIPACOLD

effervescent powder for oral solution

Paracetamol / Phenylephrine / Chlorphenamine

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

• Keep this leaflet, as you may need to read it again. If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Gripacold is and what it is used for
2. What you need to know before taking Gripacold
3. How to take Gripacold
4. Possible side effects
5. How to store Gripacold
6. Contents of the pack and other information

1. What Gripacold is and what it is used for

It is a combination of paracetamol, an analgesic that reduces pain and fever, chlorpheniramine, an antihistamine that relieves nasal discharge, and phenylephrine, which acts to reduce nasal congestion.

It is indicated for the symptomatic relief of catarrhal and influenza-like conditions accompanied by fever, mild to moderate pain, and nasal congestion and discharge.

2. What you need to know before taking Gripacold

Do not take Gripacold

• if you are allergic (hypersensitive) to paracetamol, phenylephrine, chlorphenamine, or any of the other components of this medicine (listed in section 6)
• if you have liver disease
• if you have high blood pressure
• if you have hyperthyroidism
• if you have a serious heart or arterial disease (such as coronary artery disease or angina pectoris)
• if you have tachycardia (rapid heartbeat)
• if you are being treated with a monoamine oxidase inhibitor (MAOI) medicine (such as certain antidepressants or medicines for Parkinson’s disease, or others) (see: Taking Gripacold with other medicines)
• if you have glaucoma (increased pressure in the eye)

Warnings and precautions

Consult your doctor or pharmacist before taking Gripacold

• Do not exceed the recommended dose stated in section 3: How to take Gripacold.
• In chronic alcoholics, caution should be taken not to exceed 2 g/day of paracetamol (2 sachets/day of Gripacold).
• In patients with kidney, heart, or lung disease, and in patients with anemia, consult your doctor before taking this medicine.
• In asthmatic patients sensitive to acetylsalicylic acid, consult your doctor before taking this medicine.
• In patients sensitive (allergic) to an antihistamine, consult your doctor before taking this medicine, as they may also be sensitive to others (such as chlorphenamine).

Taking Gripacold with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, as interactions may occur with medicines used to treat: prostate enlargement, diabetes, bronchial asthma, very slow heartbeat, hypotension, cerebral arteriosclerosis, pancreatitis (inflammation of the pancreas), peptic ulcer (stenosing peptic ulcer), pyloroduodenal obstruction (between the stomach and intestine), thyroid disorders, patients sensitive to sedative effects, and epileptic patients. If you are being treated with tricyclic antidepressants or medicines with similar action and develop gastrointestinal problems, you may experience paralytic ileus (cessation of normal intestinal movements).

Please note that these instructions may also apply to medicines previously used or that may be used in the future.

Interactions due to paracetamol

In particular, if you are taking any of the following medicines, it may be necessary to adjust the dose or discontinue treatment:

• Antibiotics (chloramphenicol).
• Oral anticoagulants (acenocoumarol, warfarin).
• Oral contraceptives and estrogen treatments.
• Antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Antituberculosis medicines (isoniazid, rifampicin).
• Barbiturates (used as sleep inducers, sedatives, and anticonvulsants).
• Activated charcoal (adsorbent), used for diarrhea or gas treatment.
• Colestyramine (used to lower blood cholesterol levels).
• Medicines used to treat gout such as probenecid and sulfinpyrazone (antigout agents).
• Certain diuretics used to increase urine elimination (loop diuretics such as furosemide).
• Medicines used to relieve spasms or contractions of the stomach, intestine, and bladder (anticholinergics).
• Medicines used for the heart (digitalis glycosides).
• Metoclopramide and domperidone (used to prevent nausea and vomiting).
• Propranolol, used to treat high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias).
• Zidovudine (used in the treatment of patients infected with the human immunodeficiency virus, HIV).
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid imbalance (metabolic acidosis with high anion gap) that requires urgent treatment and may occur particularly in cases of severe renal failure, sepsis (when bacteria and their toxins circulate in the blood leading to organ damage), malnutrition, chronic alcoholism, and when maximum daily doses of paracetamol are used.

Interactions due to phenylephrine

With some of the following medicines, treatment may need to be interrupted or administration separated by at least 15 days:

• Monoamine oxidase inhibitors (MAOIs) (medicines used for depression, Parkinson’s disease, or other conditions). Gripacold administration should be separated by at least 15 days after stopping MAOI treatment.
• Alpha-adrenergic blockers (medicines for migraine or other conditions, high blood pressure, or other diseases).
• Tricyclic and tetracyclic antidepressants.
• General anesthetics.
• Antihypertensives (medicines for blood pressure) with mechanisms of action related to the sympathetic nervous system.
• Medicines that cause potassium loss (such as diuretics used to treat hypertension or other conditions).
• Medicines affecting cardiac conduction (used for heart conditions) such as cardiac glycosides and antiarrhythmics.
• Thyroid hormones.
• Alpha- and beta-adrenergic blockers such as labetalol and carvedilol (used for heart or arterial diseases).
• Atropine sulfate (for heart or digestive disorders).

Interactions due to chlorphenamine

Concomitant use of the following medicines may increase the risk of adverse effects:

• Medicines causing central nervous system depression (such as those used for insomnia or anxiety).
• Monoamine oxidase inhibitors (MAOIs).
• Tricyclic and tetracyclic antidepressants.
• Ototoxic medicines (adverse effect damaging the ear).
• Photosensitizing medicines (adverse effect causing light allergy).

Interference with diagnostic tests:

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

Taking Gripacold with food, drinks, and alcohol

Using paracetamol in patients who habitually consume alcohol (three or more alcoholic drinks: beer, wine, liquor, etc., per day) may cause liver damage.

Do not drink alcohol during treatment with Gripacold, as symptoms of overdose such as increased sedative effects may occur.

Pregnancy, breastfeeding, and fertility

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

Do not use Gripacold during pregnancy unless your doctor decides it is necessary.

If needed, Gripacold may be used during pregnancy. Use the lowest possible dose that relieves pain or fever, and use it for the shortest possible time. Contact your doctor if pain or fever does not improve or if you need to take the medicine more frequently.

Do not use this medicine during breastfeeding, as paracetamol and chlorphenamine are known to pass into breast milk.

Children and adolescents

Do not use in children under 18 years of age.

Use in elderly people

Do not use in elderly patients without consulting a doctor.

Elderly patients may be particularly affected by certain adverse effects such as slow heartbeat (bradycardia) or reduced cardiac output due to the phenylephrine and chlorphenamine content. Blood pressure should be monitored, especially in patients with heart disease (see: Possible side effects). Elderly patients may also be 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.

Driving and use of machines

Do not drive or operate tools or dangerous machinery while taking this medicine, as it may cause drowsiness and sedation, potentially impairing reaction ability.

Gripacold contains sucrose

If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

Use in athletes

This medicine contains a component that may result in a positive analytical finding in doping controls.

3. How to take Gripacold

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

The recommended dose is:

Adults over 18 years of age: One sachet every 6–8 hours (three or four times a day). Do not exceed 4 sachets (4 grams of paracetamol) in 24 hours (one day).

Patients with liver or kidney disease: must consult their doctor.

Method of administration and route:

Gripacold is for oral use. The contents of the sachet must be completely dissolved in a small amount of liquid, preferably half a glass of water.

Duration of treatment:

This medication should be taken only as long as pain or fever symptoms persist. As symptoms subside, treatment should be discontinued.

If fever persists for more than 3 days of treatment, pain or other symptoms for more than 5 days, or if symptoms worsen or new symptoms appear, the clinical situation should be reassessed.

If you feel that the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.

If you take more Gripacold than you should

Consult your doctor or pharmacist immediately.

If an overdose of paracetamol has been ingested, seek urgent medical attention even if no symptoms are present, as symptoms often do not appear until 3 days after the overdose, even in cases of severe poisoning.

Symptoms of paracetamol overdose may include: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.

An overdose of phenylephrine causes excessive nervous stimulation: anxiety, fear, agitation, headache (which may be a sign of hypertension), seizures, insomnia, confusion, irritability, tremors; also anorexia (loss of appetite), nausea, vomiting, psychosis with hallucinations (more frequent in children), and cardiovascular effects such as hypertension, cerebral hemorrhage, pulmonary edema; peripheral vasoconstriction with possible reduction in blood flow to vital organs (serious effects are more likely in hypovolemic patients, i.e., those with reduced blood volume due to hemorrhage, dehydration, etc.), severe bradycardia (slow heartbeat), increased cardiac workload, irregular or rapid heartbeats, decreased urine output, metabolic acidosis (reduction in the blood's alkaline reserve), and paresthesia (altered sensation in body areas). With prolonged use, depletion of plasma volume (reduced blood volume) may occur.

Due to chlorpheniramine, the following may occur: unsteadiness, severe drowsiness, severe dryness of mouth, nose, or throat, facial flushing, dyspnea (difficulty breathing), cardiac arrhythmias (rapid or irregular heartbeat), nervous stimulation (hallucinations, seizures); the latter symptoms may appear later, and hypotension (feeling of fainting).

Treatment of paracetamol overdose is most effective if started within 4 hours after ingestion of the medicine.

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

Treatment of phenylephrine and chlorpheniramine overdose is symptomatic and supportive.

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service (Telephone 91 562 04 20), indicating the medicine and the amount ingested.

If you forget to take Gripacold

Do not take a double dose to make up for missed doses.

If you forget a dose, take it as soon as possible, but if it is almost time for your next dose, return to your regular schedule.

If you stop taking Gripacold

Ask your doctor or pharmacist.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Gripacold may produce adverse effects, although not everyone experiences them.

Adverse effects due to phenylephrine:

• Frequency not known: anxiety, nervousness, irritability, weakness, dizziness, tremors, insomnia, increased blood pressure (hypertension, usually with high doses and in sensitive patients), headache (with high doses and may be a symptom of hypertension), chest pain or discomfort, very slow heartbeats (severe bradycardia), reduction in the diameter of blood vessels (peripheral vasoconstriction), reduced cardiac performance particularly affecting elderly patients and those with poor cerebral or coronary circulation, possible onset or worsening of heart disease, urinary retention, breathing difficulty, pallor, piloerection, increased sweating, elevated blood sugar (hyperglycemia), decreased potassium levels in the blood, metabolic acidosis, coldness in the extremities (arms or legs), flushing, feeling of faintness (hypotension); with high doses: vomiting, palpitations, psychotic states with hallucinations; with prolonged use: reduction in blood volume.
• Myocardial infarction, ventricular arrhythmia, pulmonary edema, and cerebral hemorrhage (at high doses or in sensitive patients) may occur rarely.

Adverse effects due to chlorpheniramine:

• More commonly occurring effects: mild drowsiness, dizziness, muscle weakness; these adverse effects may disappear after 2–3 days of treatment, facial movement difficulties, clumsiness, tremor, sensory disturbances and tingling, dry mouth, loss of appetite, taste or smell disturbances, gastrointestinal discomfort which may decrease if the medicine is taken with food (nausea, vomiting, diarrhea, constipation, stomach pain), urinary retention, dryness of nose and throat, thickening of mucus secretions, sweating, blurred vision or other visual disturbances.
• Less frequent or rare: occasional nervous excitation (generally with high doses and more frequent in elderly patients and children) with symptoms such as restlessness, insomnia, nervousness, and even seizures; other adverse effects: chest tightness, lung sounds, rapid or irregular heartbeat (usually with overdose), liver disorders (which may present with stomach or abdominal pain, dark urine, or other symptoms), allergic reaction, severe hypersensitivity reactions (cough, difficulty swallowing, rapid heartbeat, itching, swelling of eyelids or around eyes, face, tongue, breathing difficulty, etc.), photosensitivity (sensitivity to sunlight), cross-sensitivity (allergy) to drugs related to chlorpheniramine, rarely blood disorders (changes in blood cell count, such as agranulocytosis, leucopenia, aplastic anemia, thrombocytopenia) with symptoms such as unusual bleeding, sore throat or fatigue; low or high blood pressure, edema (swelling), ear disturbances, impotence, menstrual disorders.

Adverse effects due to paracetamol:

• Very rare (at least 1 in 10,000 patients): kidney disorders, cloudy urine, skin rash (allergic dermatitis), yellowing of the skin (jaundice), blood disorders (agranulocytosis, leucopenia, neutropenia, thrombocytopenia, hemolytic anemia), and low blood sugar (hypoglycemia). Paracetamol may damage the liver when taken at high doses or during prolonged treatment.
• 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 severe illness who use paracetamol (see section 2).

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Gripacold

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

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.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines and packaging that you no longer need. This will help
to protect the environment.

6. Contents of the pack and other information

Composition of Gripacold

• The active substances are: paracetamol, phenylephrine hydrochloride and chlorphenamine maleate.

Each sachet contains: Paracetamol: 1,000 mg; Phenylephrine hydrochloride: 10 mg; Chlorphenamine maleate: 4 mg.

• The other components are: anhydrous colloidal silica, anhydrous citric acid, sodium saccharin, sucrose (3.994 mg/sachet), anhydrous sodium cyclamate, orange flavour.

Nature of the product and pack contents

Gripacold is a powder for oral solution, supplied in packs of 10 sachets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

MEDICAL, S.A.

Pol. Ind. Las Quemadas, Parcela 87

14014 - Córdoba.

SPAIN

Manufacturer:

LABORATORIOS ALCALÁ FARMA, S.L.

Avenida de Madrid, 82

28802 Alcalá de Henares (Madrid)

Spain

This leaflet was approved in June 2009

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