Label: information for the user

INTERCOLDoral granule solution

Paracetamol / Fenilefrina bitartrate / Chlorphenamine maleate

Read this label carefully before starting to take this medication, as it contains important information for you.

- Keep this label, as you may need to read it again.

- If you have any questions, consult your doctor or pharmacist.

- This medication has been prescribed only to you, and you should not give it to others who have the same symptoms as you, as it may harm them.

- If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1. What is INTERCOLD and for what it is used

2. What you need to know before starting to take INTERCOLD

3. How to take INTERCOLD

4. Possible adverse effects

5. Storage of INTERCOLD

6. Contents of the package and additional information

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

This medication is indicated for the relief of symptoms of catarrhal and flu-like processes that are accompanied by fever, mild or moderate pain, congestion, and nasal secretion in adults.

Consult a doctor if symptoms worsen, do not improve, or if fever persists for more than 3 days, or pain for more than 5 days.

Do not take INTERCOLD

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

-If you have a thyroid disease (hyperthyroidism).

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

- If you are being treated with a monoamine oxidase inhibitor (MAOI) (such as some antidepressants or Parkinson's disease medications).

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

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

- If you have glaucoma (elevated eye pressure).

- If you have severe heart or blood vessel disease (such as coronary artery disease or angina pectoris).

Patients under 18 years old cannot take this medication.

Warnings and precautions

Consult your doctor or pharmacist before starting to take INTERCOLD

• Do not take more medication than recommended in section 3: How to take INTERCOLD.
• Chronic alcoholics should be careful not to take more than 2 packets of INTERCOLD in 24 hours (2 g / day of paracetamol).
• While taking this medication, do not take other medications that contain paracetamol, as it may cause a paracetamol overdose that could damage the liver.

Patients included in the following cases should inform their doctor before taking this medication:

- Patients with kidney, liver, heart, or lung diseases, and patients with anemia.

- Patients with asthma who are sensitive to acetylsalicylic acid.

- Patients who are sensitive (allergic) to some antihistamines, as they may be sensitive to other antihistamines (chlorphenamine).

• Patients being treated with medications for: benign prostatic hyperplasia, bronchial asthma, slow heartbeats, hypotension, urinary retention, cerebral arteriosclerosis, pancreatitis, peptic ulcer disease, pyloric obstruction, anemia, thyroid diseases, patients sensitive to the sedative effects of some medications.

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

Children and adolescents

Patients under 18 years old cannot take this medication.

Taking INTERCOLD with other medications

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

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

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

• Medications used to treat depression, Parkinson's disease, or other conditions: Monoamine oxidase inhibitors (MAOIs). It is recommended to separate the intake of INTERCOLD and these medications for at least 15 days after completing treatment.
• Medications used to treat migraines; medications taken for childbirth; medications taken to treat high blood pressure, or other conditions: Alpha-adrenergic blockers.
• Medications used to treat depression: Tricyclic antidepressants and tetracyclic antidepressants.

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

• Medications containing thyroid hormones (used to treat thyroid diseases).
• Medications used to treat heart and digestive diseases, such as atropine sulfate.
• Medications that cause depression of the central nervous system, such as those used for insomnia or anxiety.
• Medications ototoxic (that can damage the ear).
• Medications photosensitizing (that can cause an allergic reaction to light).
• Antibiotics, specifically flucloxacillin, due to a serious risk of blood and fluid imbalance (metabolic acidosis with high anion gap) that must be treated urgently and may occur particularly in cases of severe renal insufficiency, sepsis, malnutrition, chronic alcoholism, and when using the maximum daily doses of paracetamol.

Interference with laboratory tests:

If you are to undergo any laboratory tests (including blood, urine, etc…), inform your doctor that you are taking/using this medication, as it may alter the results.

Taking INTERCOLD with food, drinks, and alcohol

While taking this medication, do not consume alcoholic beverages, as it may potentiate the appearance of adverse effects of this medication.

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

Pregnancy, breastfeeding, and fertility

If you are pregnant, or in the breastfeeding period, believe you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before taking this medication.

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

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

Driving and operating machinery

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

INTERCOLD contains mannitol (E-421)

This medication may cause a mild laxative effect due to the presence of mannitol.

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

The recommended dose is:

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

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

Patients with liver diseases: These patients cannot take more than 2 tablets a day (2 grams of paracetamol per day), every 8-12 hours as needed.

Consult with your doctor.

Patients with kidney diseases:This medication cannot be taken due to the amount of paracetamol in each tablet.

Use in children and adolescents

Children under 18 years old cannot take this medication.

Use in elderly people

Elderly people cannot take this medication without consulting a doctor. This is because they may be especially affected by some side effects of the medication, such as the appearance of slow heartbeats (bradycardia), or the reduction of cardiac output, due to the content of phenylephrine and chlorphenamine.

They 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.

Form of use and route of administration:

INTERCOLD is taken orally.

Empty the contents of the tablet into approximately half a glass of water. Shake and drink afterwards.

The medication can be taken with or without food.

Always take the lower dose that is effective.

The use of this medication 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, the pain or other symptoms for more than 5 days, or worsens or new symptoms appear, you should consult with your doctor.

If you take more INTERCOLD than you should

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

The symptoms of an overdose may be: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice) and abdominal pain. Anxiety, fear, agitation, headache (may be a symptom of high blood pressure), convulsions, insomnia (or intense drowsiness), clumsiness, feeling of fainting, instability, confusion, irritability, tremors, anorexia; psychosis with hallucinations (this last one 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 alkalinity reserve). In case of prolonged use, depletion of plasma volume (decrease in blood volume) may occur.

The treatment of an overdose is more effective if it is initiated within 4 hours of taking the overdose of the medication.

Patients undergoing barbiturate treatment 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 Toxicological Information Service (Telephone 91 562 04 20), indicating the medication and the amount ingested.

If you forgot to take INTERCOLD

Do not take a double dose to compensate for the missed doses.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience 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 appearmost frequently are:

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

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

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

Nervous excitement (usually at high doses, and 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 sounds, rapid or irregular heartbeats (usually with overdose), liver disturbances (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 eyelids or around the eyes, face, tongue, difficulty breathing, etc.), photosensitivity (sensitivity to sunlight), cross-sensitivity (allergy) with related chlorphenamine medications. Blood disorders (changes in the formula of blood cells, such as agranulocytosis, leukopenia, aplastic anemia, thrombocytopenia) with symptoms such as unusual bleeding, sore throat, or fatigue; low or high blood pressure, edema (swelling), ear disturbances, impotence, menstrual disturbances.

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

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

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

Very rarely, severe skin reactions have been reported.

• The side effects whose frequency of appearance is unknown, are:

Anxiety, irritability, weakness, high blood pressure (hypertension, usually at high doses and in sensitive patients), headache (at high doses and may be a symptom of hypertension), very slow heartbeats (bradycardia), reduction in the diameter of blood vessels (peripheral vasoconstriction), reduction in heart function that affects the elderly and patients with poor cerebral or coronary circulation, possible production or worsening of a heart disease, urinary retention, pallor, goosebumps, high blood sugar (hyperglycemia), low potassium in the blood, metabolic acidosis (metabolic disturbance), coldness in the extremities (legs or arms), flushing, sensation of fainting (hypotension). At high doses, vomiting, palpitations, psychotic states with hallucinations may occur; in 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 prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaRAM.es/. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the 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.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE point of your pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of INTERCOLD

Each blister pack contains:

- As active principles: 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, a cornstarch derivative) and povidone K30.

Appearance of the product and content of the packaging:

INTERCOLD is an oral granule solution of white/ light yellow color.

Orange flavor.

It is presented in cardboard packaging with 10 blister packs.

Holder of the marketing authorization:

INTERPHARMA, S.A.

C/ Santa Rosa Nº 6

08921 Santa Coloma de Gramenet (Barcelona)

Responsible for manufacturing:

Laboratorios Alcalá Farma, S.L

Avenida de Madrid, 82

28802 Alcalá de Henares (Madrid)

Last review date of this leaflet: June 2022

The detailed and updated information of this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/