INTERCOLD GRANULADO FOR ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

INTERCOLDoral solution granules

Paracetamol / Phenylephrine bitartrate / Chlorphenamine maleate

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is INTERCOLD and what is it used for

It is an association of paracetamol (analgesic that reduces pain and fever), chlorphenamine (antihistamine that relieves nasal secretion), and phenylephrine (nasal decongestant).

This medicine is indicated for the relief of symptoms of catarrhal and flu-like processes that occur with fever, mild or moderate pain, congestion, and nasal secretion in adults.

You should consult your doctor if it worsens, or if it 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 take INTERCOLD

Do not take INTERCOLD

• If you are allergic to paracetamol, phenylephrine, chlorphenamine, or any of the other components of this medicine (included in section 6).
• If you have high blood pressure (arterial hypertension).

• If you have thyroid disease (hyperthyroidism).
  • If you suffer from severe liver or kidney disease.
  • If you have diabetes mellitus.
  • If you have tachycardia (rapid heartbeats).

• If you are being treated with any monoamine oxidase inhibitor (MAOI) medication (such as some antidepressants or medications for Parkinson's disease).
  • If you are being treated with sympathomimetic medications (medications used to treat asthma, or medications to accelerate heart rate).

• If you are being treated with beta-blocker medications (medications for the heart or to treat arterial diseases (see: Taking INTERCOLD with other medications).
• If you have glaucoma (elevated eye pressure).
• If you have any serious heart or arterial disease (such as coronary artery disease or angina pectoris).

Patients under 18 years of age cannot take this medicine.

Warnings and precautions

Consult your doctor or pharmacist before starting to take INTERCOLD

• Do not take more than the recommended dose of this medicine (see section 3: How to take INTERCOLD).
• Chronic alcoholics should be cautious not to take more than 2 sachets of INTERCOLD in 24 hours (2 grams/day of paracetamol).
• While taking this medicine, you cannot take other medications that contain paracetamol because paracetamol overdose can occur, which could damage the liver.

Patients in the following cases must inform their doctor before taking this medicine:

• Patient with kidney, liver, heart, or lung disease, and patients with anemia.
• Asthmatic patients sensitive to acetylsalicylic acid.
• Patient sensitive (allergic) to any antihistamine, because they may be sensitive to other antihistamines (chlorphenamine).
  • Patient being treated with medications for: prostate hypertrophy, bronchial asthma, very slow heartbeats, hypotension, obstruction of the neck of the bladder, urinary retention, cerebral arteriosclerosis, pancreatitis, peptic ulcer, pyloric-duodenal obstruction (between the stomach and intestine), anemia, thyroid disease, patient sensitive to the sedative effects of some medications.
  • Patient with glucose-6-phosphate dehydrogenase (G6PD) deficiency (can cause hemolytic anemia).

Patient being treated with tricyclic antidepressants or medications with similar effects and experience gastrointestinal problems, should stop taking this medicine and consult a doctor immediately, because paralytic ileus (stop of normal bowel movements) may occur.

Children and adolescents

Patients under 18 years of age cannot take this medicine.

Taking INTERCOLD with other medications

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medications.

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:

• Medications for treating epilepsy: Antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Medications for treating tuberculosis: (isoniazid, rifampicin). Medications for treating convulsions and depression (barbiturates), used as hypnotics, sedatives, and anticonvulsants.
• Medications to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin).
• Medications used to increase urine elimination (loop diuretics such as furosemide, or others), and other diuretics that cause potassium loss (such as diuretics for treating hypertension or others).
• Medications used to prevent nausea and vomiting (metoclopramide and domperidone).
• Medications used in the treatment of gout (probenecid and sulfinpyrazone).
• Medications used in the treatment of high blood pressure and heart rhythm disorders (arrhythmias): Propranolol.
• Medications used to lower blood cholesterol levels (cholestyramine).

• Medications used to treat depression, Parkinson's disease, or other diseases (Monoamine Oxidase Inhibitors (MAOIs)). INTERCOLD and these medications should be taken at least 15 days apart after finishing treatment.
• Medications used to treat migraines; medications taken for childbirth; medications taken for high blood pressure or other diseases (alpha-adrenergic blocking medications).
• Alpha and beta-adrenergic blocking medications used for the heart or to treat arterial diseases (labetalol and carvedilol).
• Medications for treating depression (tricyclic and tetracyclic antidepressants).

• General anesthetic medications.
• Medications for the heart, such as cardiac glycosides, anti-arrhythmics, and beta-adrenergic blockers.

• Medications containing thyroid hormones (used to treat thyroid diseases).
• Medications used for heart diseases and digestive diseases, such as atropine sulfate.
• Medications that depress the central nervous system (such as those used for insomnia or anxiety).
• Ototoxic medications (which have the adverse effect of damaging the ear).
• Photosensitizing medications (which have the adverse effect of causing light allergy).
• Antibiotics, specifically flucloxacillin, due to a serious risk of blood and fluid alteration (metabolic acidosis with high anionic imbalance) that must be treated urgently and may occur particularly in cases of severe kidney failure, sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, and if the maximum daily doses of paracetamol are used.

Interference with analytical tests

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

Taking INTERCOLD with food, drinks, and alcohol

While being treated with this medicine, you should not drink alcoholic beverages, as it may enhance the appearance of adverse effects of this medicine.

Additionally, the use of medications containing paracetamol by patients who habitually consume alcohol (3 or more alcoholic beverages: beer, liquor, wine, etc. per day) may cause liver damage.

Pregnancy, breastfeeding, and fertility

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

This medicine should not be taken during pregnancy unless your doctor considers it strictly necessary.

This medicine cannot be used during breastfeeding, as it may cause adverse effects in the baby.

Driving and using machines

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

INTERCOLD contains mannitol (E-421)

This medicine may have a mild laxative effect because it contains mannitol.

3. How to take INTERCOLD

Follow the administration instructions of this medicine indicated by your doctor. In case of doubt, consult your doctor again.

The recommended dose is:

Adults over 18 years: 1 sachet every 6-8 hours (3 or 4 times a day) as needed.

No more than 4 sachets (4 grams of paracetamol) should be taken in 24 hours (1 day).

Patient with liver disease: These patients should not take more than 2 sachets per day (2 grams of paracetamol per day), every 8-12 hours as needed.

Consult your doctor.

Patient with kidney disease: This medicine should not be taken due to the amount of paracetamol it contains in each sachet.

Use in children and adolescents

Patients under 18 years of age cannot take this medicine.

Use in elderly

Elderly patients should not take this medicine without consulting their doctor. This is because they may be especially affected by some adverse effects of the medicine, such as the appearance of slow heartbeats (bradycardia), or reduction of cardiac output, due to the content of phenylephrine and chlorphenamine.

It is also more likely that they may experience adverse effects such as sedation, confusion, hypotension, or excitement, and may be more sensitive to effects such as dry mouth and urinary retention.

Form of use and administration route:

INTERCOLD is taken orally.

Pour all the contents of the sachet into approximately half a glass of water. Shake and drink immediately.

The medicine can be taken with or without food.

Always take the lowest effective dose.

Taking this medicine is subject to the appearance of symptoms. As they 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, you should consult your doctor.

If you take more INTERCOLD than you should

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

The symptoms of overdose may be: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain. Anxiety, fear, agitation, headache (can be a symptom of high blood pressure), convulsions, insomnia (or intense drowsiness), clumsiness, feeling of fainting, instability, confusion, irritability, tremors, anorexia; psychosis with hallucinations (the latter especially in children). Dry mouth, nose, or throat. Effects such as high blood pressure, arrhythmias (rapid or irregular heartbeats), palpitations, decreased urine output, metabolic acidosis (decrease in blood alkaline reserve). In case of prolonged use, it can cause depletion of plasma volume (decrease in blood volume).

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

Treatment of overdose is more effective if started within 4 hours after taking the overdose of the medicine.

Patient being treated with barbiturates or chronic alcoholics may be more susceptible to paracetamol toxicity.

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

If you forget to take INTERCOLD

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

During the period of use of paracetamol, phenylephrine, and chlorphenamine, the following side effects have been reported, whose frequency has not been established with precision:

• The side effects that may appear more frequently are

Mild drowsiness, dizziness, muscle weakness: these side effects may disappear after 2-3 days of treatment. Difficulty in facial movements, clumsiness, tremors, alterations in sensations and paresthesia, dry mouth, loss of appetite, alterations in taste or smell, gastrointestinal disorders (which may decrease if the medicine is administered with food), nausea, vomiting, diarrhea, constipation, stomach pain, urinary retention, dry nose and throat, thickening of mucus, sweating, blurred vision or other vision disorders.

• The side effects that may appear with low frequency (rare) are

Discomfort, low blood pressure (hypotension), and increased levels of transaminases in the blood. Myocardial infarction, ventricular arrhythmia (irregular heartbeats), pulmonary edema (increase in lung fluid volume), and cerebral hemorrhage (at high doses or in sensitive patients).

Nervous excitement (usually with high doses, and is more frequent in the elderly and children), which may include symptoms such as: restlessness, insomnia, nervousness, and even convulsions. Other side effects that may appear with low frequency are: chest tightness, lung noises, rapid or irregular heartbeats (usually with overdose), liver disorders (which may present with stomach pain or abdominal pain, dark urine, or other symptoms), allergic reaction, severe hypersensitivity reactions (cough, difficulty swallowing, rapid heartbeats, itching, swelling of eyelids or around the eyes, face, tongue, difficulty breathing, etc.), photosensitivity (sensitivity to sunlight), cross-sensitivity (allergy) to medications related to chlorphenamine. Blood disorders (changes in the formula of blood cells, 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 disorders, impotence, menstrual disorders.

• The side effects that may appear with very low frequency (very rare) are:

Kidney disease, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (neutropenia, hemolytic anemia), and hypoglycemia (low blood sugar).

Paracetamol may damage the liver when taken in high doses or in prolonged treatments.

Very rare cases of severe skin reactions have been reported.

• The side effects whose frequency of appearance is not known are

Anxiety, irritability, weakness, high blood pressure (hypertension, usually with high doses and in sensitive patients), headache (with high doses and may be a symptom of hypertension), very slow heartbeats (severe bradycardia), reduction of peripheral blood vessel caliber (peripheral vasoconstriction), reduction of cardiac output that especially affects the elderly and patients with poor cerebral or coronary circulation, possible production or worsening of heart disease, urinary retention, paleness, hair standing on end, high blood sugar (hyperglycemia), low potassium levels in the blood, metabolic acidosis (alteration of metabolism), cold in the extremities (legs or arms), flushing, feeling of fainting (hypotension). With high doses, the following may occur: vomiting, palpitations, psychotic states with hallucinations; with prolonged use, a decrease in blood volume may occur.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaRAM.es/. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of INTERCOLD

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

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

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Packaging Content and Additional Information

INTERCOLD Composition

Each sachet contains:

• As active ingredients: 1g of paracetamol, 15.58 mg of phenylephrine bitartrate (equivalent to 8.21 mg of phenylephrine) and 4 mg of chlorphenamine maleate (equivalent to 2.8 mg of chlorphenamine).

• The other components (excipients) are: Mannitol (E-421), sodium saccharin, anhydrous colloidal silica, orange flavor (containing maltodextrin, which is a corn starch derivative) and povidone K30.

Product Appearance and Packaging Content:

INTERCOLD is a white/white-yellowish granulate for oral solution.

Orange flavor.

It is presented in cardboard boxes with 10 sachets.

Marketing Authorization Holder:

INTERPHARMA, S.A.

C/ Santa Rosa Nº 6

08921 Santa Coloma de Gramenet (Barcelona)

Manufacturer:

Laboratorios Alcalá Farma, S.L

Avenida de Madrid, 82

28802 Alcalá de Henares (Madrid)

Date of the Last Revision of this Leaflet: February 2025

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/