GRIPACOLD POWDER FOR ORAL SOLUTION

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 medication (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 artery disease (such as coronary artery disease or angina pectoris)
• if you have tachycardia (rapid heartbeats)
• if you are being treated with a monoamine oxidase inhibitor (MAOI) medication (such as some antidepressants or medications for Parkinson's disease, or others) (see: Taking Gripacold with other medications)
• if you have glaucoma (increased eye pressure)

Warnings and precautions

Consult your doctor or pharmacist before starting to take Gripacold

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

Taking Gripacold with other medications:

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication, as they may interact or interfere with medications for treating: prostate hypertrophy, diabetes, bronchial asthma, very slow heartbeats, hypotension, cerebral arteriosclerosis, pancreatitis, peptic ulcer, pyloroduodenal obstruction, thyroid diseases, patients sensitive to sedative effects, and epileptic patients. If you are being treated with tricyclic antidepressants or medications with similar action and you experience gastrointestinal problems, paralytic ileus (stoppage of normal bowel movements) may occur.

Interactions due to paracetamol

In particular, if you are using any of the following medications, it may be necessary to modify the dose of some of them or interrupt treatment:

• Antibiotics (chloramphenicol).
• Oral anticoagulants (acenocoumarol, warfarin).
• Oral contraceptives and estrogen treatments.
• Antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Antitubercular medications (isoniazid, rifampicin).
• Barbiturates (used as sleep inducers, sedatives, and anticonvulsants).
• Activated charcoal (adsorbent), used for diarrhea or gas treatment.
• Colestyramine (used to decrease blood cholesterol levels).
• Medications used to treat gout, such as probenecid and sulfinpyrazone (anti-gout medications).
• Some medications used to increase urine elimination (loop diuretics, such as furosemide).
• Medications used to relieve stomach, intestine, or bladder spasms or contractions (anticholinergics).
• Medications used for heart conditions (digitalis glycosides).
• Metoclopramide and domperidone (used to prevent nausea and vomiting).
• Propranolol used in the treatment of high blood pressure and heart rhythm disorders (arrhythmias).
• Zidovudine (used in the treatment of patients infected with the human immunodeficiency virus, which causes AIDS).
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid alteration (metabolic acidosis with high anion gap) that must be urgently treated and may occur particularly in cases of severe renal insufficiency, sepsis, dehydration, chronic alcoholism, and if maximum daily doses of paracetamol are used.

Interactions due to phenylephrine

With some of the following medications, it may be necessary to interrupt treatment or separate administration by at least 15 days:

• Monoamine oxidase inhibitors (MAOIs) (medications used for depression, Parkinson's disease, or other conditions). Gripacold administration should be separated by at least 15 days after finishing treatment.
• Alpha-adrenergic blockers (medications for migraine or other conditions, such as childbirth, high blood pressure, or other diseases).
• Tricyclic and tetracyclic antidepressants.
• General anesthetics.
• Antihypertensive medications (blood pressure medications) with a mechanism of action related to the sympathetic nervous system.
• Medications that cause potassium loss (such as diuretics for high blood pressure or other conditions).
• Medications that affect heart conduction (used for heart conditions), such as digitalis glycosides and antiarrhythmics.
• Thyroid hormones.
• Alpha and beta-adrenergic blockers, such as labetalol and carvedilol (used for heart conditions or artery diseases).
• Atropine sulfate (for heart conditions or digestive diseases).

Interactions due to chlorphenamine

The simultaneous use of the following medications may potentiate the production of side effects:

• Medications that produce depression of the central nervous system (such as those used for insomnia or anxiety).
• Monoamine oxidase inhibitors (MAOIs).
• Tricyclic and tetracyclic antidepressants.
• Ototoxic medications (which have ear damage as a side effect).
• Photosensitizing medications (which have light allergy as a side effect).

Interference with analytical tests:

If you are going to have any analytical tests (blood tests, urine tests, skin tests using allergens, etc.), inform your doctor that you are taking this medication, as it may alter the results of these tests.

Taking Gripacold with food, drinks, and alcohol

The use of paracetamol in patients who habitually consume alcohol (three or more alcoholic beverages: 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 plan to become pregnant, consult your doctor or pharmacist before using this medication.

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

If necessary, Gripacold can be used during pregnancy. Use the lowest possible dose that reduces pain or fever and use it for the shortest possible time. Contact your doctor if pain or fever does not decrease or if you need to take the medication more frequently.

Do not use the medication 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 people without consulting a doctor.

Elderly patients may be especially affected by some side effects, such as the appearance of slow heartbeats (bradycardia) or reduced cardiac output, due to the content of phenylephrine and chlorphenamine. Blood pressure should be monitored, especially in patients with heart disease (see: Possible side effects). Elderly people are also more likely to experience side effects such as sedation, confusion, hypotension, or excitement and may be more sensitive to effects such as dry mouth and urinary retention.

Driving and using machines

Do not drive or operate hazardous tools or machines while being treated with this medication, as it may cause drowsiness and sedation, altering reaction capacity.

Gripacold contains sucrose

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

Use in athletes

This medication contains a component that may result in a positive doping test.

3. How to take Gripacold

Follow the administration instructions of this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults over 18 years: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).

Patient with liver or kidney disease: should consult their doctor.

Method of use and administration route:

Gripacold should be taken orally. The contents of the sachet should be completely dissolved in a small amount of liquid, preferably in half a glass of water.

Duration of treatment:

Administration of the preparation is subject to the appearance of painful or febrile symptoms. As these symptoms disappear, this medication should be discontinued.

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

If you think the effect of this medication is too strong or too weak, tell your doctor or pharmacist.

If you take more Gripacold than you should

Consult your doctor or pharmacist immediately.

If you have ingested an overdose of paracetamol, go to a medical center immediately, even if you do not have symptoms, as they may not appear until 3 days after ingestion, even in cases of severe poisoning.

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

Phenylephrine overdose produces excessive nervous stimulation: anxiety, fear, agitation, headache (may be a symptom of hypertension), convulsions, insomnia, confusion, irritability, tremors; also anorexia (loss of appetite), nausea, vomiting, psychosis with hallucinations (more frequent in children), and effects on the cardiovascular system such as hypertension, cerebral hemorrhage, pulmonary edema; peripheral vasoconstriction with possible reduction of blood flow to vital organs (severe effects may appear more probably in hypovolemic patients, i.e., with decreased blood volume, due to hemorrhage, dehydration, etc.), severe bradycardia (slow heartbeats), increased heart workload, irregular or rapid heartbeats, decreased urine output, metabolic acidosis (decrease in blood alkaline reserve), paresthesias (sensitivity alterations in body areas). With prolonged use, plasma volume depletion (decrease in blood volume) may occur.

Due to chlorphenamine, the following may appear: instability, intense drowsiness, severe dryness of the mouth, nose, or throat, facial flushing, dyspnea (breathing difficulty), cardiac arrhythmias (rapid or irregular heartbeats), nervous stimulation (hallucinations, convulsions), these latter symptoms may appear late, hypotension (feeling of fainting).

Treatment of paracetamol overdose is more effective if started within 4 hours after ingestion of the medication.

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

Treatment of phenylephrine and chlorphenamine 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 medication and the amount ingested.

If you forget to take Gripacold

Do not take a double dose to make up for forgotten 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 interrupt treatment with Gripacold

Ask your doctor or pharmacist.

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

4. Possible Adverse Effects

Like all medicines, Gripacold can cause adverse effects, although not all people suffer from them.

Adverse effects due to phenylephrine:

• Frequency not known: anxiety, nervousness, irritability, weakness, dizziness, tremors, insomnia, increase in 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 of blood vessel caliber (peripheral vasoconstriction), reduction of heart performance that especially affects the elderly and patients with poor cerebral or coronary circulation, possible production or worsening of heart disease, urinary retention, breathing difficulties, paleness, goosebumps, increased sweating, increase in blood sugar (hyperglycemia), decrease in potassium in the blood, metabolic acidosis, coldness in the extremities (legs or arms), flushing, feeling of fainting (hypotension); with high doses, vomiting, palpitations, psychotic states with hallucinations may occur; with prolonged use, a decrease in blood volume may occur.
• Rarely, the following may appear: myocardial infarction, ventricular arrhythmia, pulmonary edema, and cerebral hemorrhage (with high doses or in sensitive patients).

Adverse effects due to chlorphenamine:

• Those that may appear more frequently: 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, loss of appetite, alterations in taste or smell, gastrointestinal disorders that may decrease if the medication is administered with food (nausea, vomiting, diarrhea, constipation, stomach pain), urinary retention, dryness of the nose and throat, thickening of mucus, sweating, blurred vision or other vision disorders.
• Less frequently or rarely: occasionally nervous excitement (usually with high doses and more frequent in the elderly and children) with symptoms such as restlessness, insomnia, nervousness, and even convulsions; other adverse effects: chest tension, lung noises, rapid or irregular heartbeats (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 heartbeats, itching, swelling of the eyelids or around the eyes, face, tongue, breathing difficulties, etc.), photosensitivity (sensitivity to sunlight), cross-sensitivity (allergy) to medications related to chlorphenamine, rarely blood alterations (changes in the blood cell formula, such as agranulocytosis, leucopenia, aplastic anemia, thrombocytopenia) with symptoms such as unusual bleeding, sore throat or fatigue; decrease or increase in blood pressure, edema (swelling), alterations in the ears, impotence, menstrual alterations.

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 alterations (agranulocytosis, leucopenia, neutropenia, thrombocytopenia, hemolytic anemia), and decrease in blood sugar (hypoglycemia). Paracetamol may damage the liver when taken in high doses or with prolonged treatment.
• Frequency not known (cannot be estimated from available data): a serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

If you consider that any of the adverse effects you suffer from is serious or if you notice any adverse effect not mentioned in this prospectus, 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 it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Gripacold

Keep this medication out of sight and reach of children.

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

No special storage conditions are required.

Medicines should not be thrown away through the drains or into the trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition ofGripacold

• The active ingredients 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 flavor.

Appearance of the Product and Package Contents

Gripacold is a powder for oral solution, presented in packages 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 prospectus was approved in June 2009

Date of the last revision of this prospectus:February 2025