Intercold granules for oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

INTERCOLD Granules for oral solution

Paracetamol / Phenylephrine bitartrate / Chlorpheniramine maleate

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 reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

1. What INTERCOLD 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 (a nasal decongestant).

This medicine is indicated for the relief of symptoms associated with colds and influenza, including fever, mild to moderate pain, nasal congestion, and nasal discharge in adults.

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

2. What you need to know before taking INTERCOLD

Do not take INTERCOLD

• If you are allergic to paracetamol, phenylephrine, chlorpheniramine, or any of the other ingredients of this medicine (listed in section 6).

• If you have high blood pressure (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 heartbeat).

• If you are being treated with monoamine oxidase inhibitors (MAOIs) (such as certain antidepressants or medicines for Parkinson's disease).

  • If you are being treated with sympathomimetic drugs (medicines used to treat asthma, or medicines to increase heart rate).

• If you are being treated with beta-blockers (medicines for the heart or to treat arterial diseases) (see: Taking INTERCOLD with other medicines).

• If you have glaucoma (increased intraocular pressure).

• If you have severe heart or arterial disease (such as coronary artery disease or angina pectoris).

Patients under 18 years of age must not take this medicine.

Warnings and precautions

Consult your doctor or pharmacist before taking INTERCOLD

• Do not take more medicine than recommended in section 3: How to take INTERCOLD.
• Chronic alcoholics should take care not to take more than 2 sachets of INTERCOLD in 24 hours (2 g/day of paracetamol).
• While taking this medicine, do not take other medicines containing paracetamol, as this could lead to paracetamol overdose, which may damage the liver.

Patients falling into any of the following categories should inform their doctor before taking this medicine:

• Patients with kidney, liver, heart, or lung disease, and patients with anemia.
• Asthmatic patients sensitive to acetylsalicylic acid.
• Patients who are sensitive (allergic) to any antihistamine, as they may also be sensitive to other antihistamines (chlorpheniramine).
  • Patients being treated with medicines for: prostate hypertrophy, bronchial asthma, very slow heart rate, hypotension, bladder neck obstruction, urinary retention, cerebral arteriosclerosis, inflammation of the pancreas (pancreatitis), peptic ulcer (stenosing peptic ulcer), pyloro-duodenal obstruction (between stomach and intestine), anemia, thyroid disorders, or patients sensitive to the sedative effects of certain medicines.
  • Patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency (which may cause hemolytic anemia).

Patients being treated with tricyclic antidepressants or medicines with similar effects who develop gastrointestinal problems should stop taking this medicine and consult a doctor immediately, as they may develop paralytic ileus (cessation of normal intestinal movements).

Children and adolescents

Patients under 18 years of age must not take this medicine.

Taking INTERCOLD with other medicines

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

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

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

• Medicines to treat tuberculosis: (isoniazid, rifampicin). Medicines used for seizures and depression (barbiturates), used as hypnotics, sedatives, and anticonvulsants.

• 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 in the treatment of gout (probenecid and sulfinpyrazone).

• Medicines used to treat high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias): Propranolol.

• Medicines used to lower blood cholesterol levels (cholestyramine).

• Medicines used to treat depression, Parkinson's disease, or other conditions (monoamine oxidase inhibitors (MAOIs)). INTERCOLD must be taken at least 15 days after stopping treatment with these medicines.

• Medicines used to treat migraine; medicines taken during childbirth; medicines used to treat blood pressure or other conditions (alpha-adrenergic blocking agents).

• Alpha- and beta-adrenergic blocking agents used for heart conditions or arterial diseases (labetalol and carvedilol).

• Medicines used to treat depression (tricyclic and tetracyclic antidepressants).

• General anesthetics.

• Medicines for the heart such as cardiac glycosides, antiarrhythmics, and beta-adrenergic blockers.

• Medicines containing thyroid hormones (used to treat thyroid disorders).

• Medicines used for heart disease and digestive disorders such as atropine sulfate.

• Medicines that cause central nervous system depression (such as those used for insomnia or anxiety).

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

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

• Antibiotics, specifically flucloxacillin, due to a serious risk of blood and fluid imbalance (metabolic acidosis with high anion gap), which requires urgent treatment and may occur particularly in cases of severe renal failure, sepsis (when bacteria and their toxins circulate in the blood causing organ damage), malnutrition, chronic alcoholism, or when maximum daily doses of paracetamol are used.

Interference with laboratory tests:

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

Taking INTERCOLD with food, drinks, and alcohol

While being treated with this medicine, you must not drink alcoholic beverages, as this may increase the risk of adverse effects of this medicine.

In addition, the use of paracetamol-containing medicines in patients who habitually consume alcohol (3 or more alcoholic drinks: 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 are planning 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 must not be used during breastfeeding, as it may cause adverse effects in the baby.

Driving and using machines

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

INTERCOLD contains mannitol (E-421)

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

3. How to take INTERCOLD

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

The recommended dose is:

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

Do not take more than 4 sachets (4 grams of paracetamol) in 24 hours (1 day).

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

Consult your doctor.

Patients with kidney disease: This medicine must not be taken due to the amount of paracetamol contained in each sachet.

Use in children and adolescents

This medicine must not be taken by individuals under 18 years of age.

Use in elderly patients

Elderly patients must not take this medicine without consulting a doctor. This is because certain adverse effects of the medicine may particularly affect them, such as the occurrence of slow heartbeats (bradycardia) or reduced cardiac output, due to the phenylephrine and chlorphenamine content.

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 and route:

INTERCOLD is taken orally.

Empty the entire contents of the sachet into approximately half a glass of water. Stir and drink immediately.

The medicine may be taken with or without food.

Always take the lowest effective dose.

This medicine should only be taken when symptoms occur. Treatment should be discontinued as symptoms resolve.

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

If you take more INTERCOLD than you should

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

Symptoms of overdose may include: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain. Anxiety, fear, agitation, headache (which may be a sign of high blood pressure), seizures, insomnia (or intense drowsiness), clumsiness, fainting sensation, instability, confusion, irritability, tremors, anorexia; psychosis with hallucinations (especially in children). Dryness of mouth, nose, or throat. Effects such as high blood pressure, arrhythmias (rapid or irregular heartbeats), palpitations, reduced urine output, metabolic acidosis (decreased blood alkaline reserve). With prolonged use, depletion of plasma volume (decreased blood volume) may occur.

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

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

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

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 INTERCOLD

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

During the period of use of paracetamol, phenylephrine, and chlorphenamine, the following adverse effects have been reported, the frequency of which has not been precisely established:

• The adverse effects that may occur most frequently are:

Mild drowsiness, dizziness, muscle weakness: these adverse effects may disappear after 2–3 days of treatment. Difficulty with facial movements, clumsiness, tremor, disturbances in sensation and tingling, dry mouth, 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, urinary retention, dryness of the nose and throat, thickening of mucus secretions, sweating, blurred vision, or other visual disturbances.

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

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

Nervous excitement (generally with high doses, and more common in elderly patients and children), which may include symptoms such as restlessness, insomnia, nervousness, and even seizures. Other adverse effects that may occur less frequently are: 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 the eyes, face, tongue, breathing difficulties, etc.), photosensitivity (sensitivity to sunlight), cross-sensitivity (allergy) to medicines related to chlorphenamine. Blood disorders (changes in blood cell count, such as agranulocytosis, leucopenia, aplastic anaemia, thrombocytopenia) with symptoms such as unusual bleeding, sore throat, or fatigue; low or high blood pressure, edema (swelling), ear disturbances, impotence, menstrual disorders.

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

Kidney disorders, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (neutropenia, haemolytic anaemia), and hypoglycaemia (low blood sugar).

Paracetamol can damage the liver when taken in high doses or during prolonged treatment.

Very rare cases of severe skin reactions have been reported.

• Adverse effects with unknown frequency are:

Anxiety, irritability, weakness, increased blood pressure (hypertension, generally with high doses and in sensitive patients), headache (with high doses and may be a symptom of hypertension), very slow heartbeat (severe bradycardia), reduction in the diameter of blood vessels (peripheral vasoconstriction), reduced cardiac performance especially affecting elderly patients and those with poor cerebral or coronary circulation, possible onset or worsening of heart disease, urinary retention, pallor, piloerection (goosebumps), increased blood sugar (hyperglycaemia), low potassium levels in the blood, metabolic acidosis (metabolic disturbance), coldness in the extremities (legs or arms), flushing, feeling of faintness (hypotension). With high doses, vomiting, palpitations, and psychotic states with hallucinations may occur; with prolonged use, a decrease in blood volume may occur.

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 Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es/. By reporting adverse effects, you can help provide 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 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. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of INTERCOLD

Each sachet contains:

• Active substances: 1 g 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).

• Other components (excipients): Mannitol (E-421), sodium saccharin, anhydrous colloidal silica, orange flavour (containing maltodextrin, a derivative of maize starch), and povidone K30.

Appearance of the medicine and contents of the pack:

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

Orange flavour.

It is presented in cardboard packs containing 10 sachets.

Marketing Authorization Holder:

INTERPHARMA, S.A.
C/ Santa Rosa No. 6
08921 Santa Coloma de Gramenet (Barcelona)

Manufacturer responsible:

Laboratorios Alcalá Farma, S.L
Avenida de Madrid, 82
28802 Alcalá de Henares (Madrid)

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

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