DOLENGRIP 650 mg/15.58 mg/4 mg ORAL SOLUTION GRANULES

Introduction

Package Leaflet: Information for the User

Dolengrip650 mg/15.58 mg/4 mg Granules for Oral Solution

Paracetamol / Phenylephrine Bitartrate / Chlorphenamine Maleate

Read this package leaflet carefully before starting to take this medicine, as it contains important information for you.

Follow the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor, pharmacist, or nurse.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve or if the fever persists for more than 3 days or the pain or other symptoms persist for more than 5 days.

Package Leaflet Contents

1. What Dolengrip 650 mg/15.58 mg/4 mg Granules for Oral Solution is and what it is used for
2. What you need to know before taking Dolengrip 650 mg/15.58 mg/4 mg Granules for Oral Solution
3. How to take Dolengrip 650 mg/15.58 mg/4 mg Granules for Oral Solution
4. Possible side effects
5. Storage of Dolengrip 650 mg/15.58 mg/4 mg Granules for Oral Solution
6. Package Contents and Additional Information

1. What Dolengrip 650 mg/15.58 mg/4 mg Granules for Oral Solution is and what it is used for

It is an association of 3 active principles: paracetamol, chlorphenamine, and phenylephrine.

Paracetamol is an analgesic that reduces pain and fever.

Chlorphenamine is an antihistamine that relieves nasal secretion

Phenylephrine is a sympathomimetic that reduces nasal congestion.

It is indicated in adults and adolescents over 15 years old for the relief of symptoms of colds and flu that occur with fever or mild to moderate pain, congestion, and nasal secretion.

You should consult a doctor if your condition worsens or does not improve or if the fever persists for more than 3 days or the pain or other symptoms persist for more than 5 days.

2. What you need to know before taking Dolengrip 650 mg/15.58 mg/4 mg Granules for Oral Solution

Do not take Dolengrip650 mg/15.58 mg/4 mg Granules for Oral Solution

If you are allergic to the active principles or to any of the other components of this medicine (listed in section 6).

If you have high blood pressure.

If you have hyperthyroidism.

If you have diabetes mellitus.

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).

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 artery diseases) (see: Other medications and Dolengrip 650 mg/15.58 mg/4 mg Granules for Oral Solution).

If you have glaucoma (increased eye pressure).

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

If you have a severe liver or kidney disease.

Patients under 15 years old cannot take this medicine.

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before starting to take Dolengrip 650 mg/15.58 mg/4 mg Granules for Oral Solution.

Do not take more than the recommended dose of the medicine as stated in section 3: How to take Dolengrip 650 mg/15.58 mg/4 mg Granules for Oral Solution.

Chronic alcoholics should be cautious not to take more than 2g of paracetamol (3 sachets) per day of Dolengrip 650 mg/15.58 mg/4 mg Granules for Oral Solution.

While taking this medicine, you cannot take other medications that contain paracetamol because a paracetamol overdose may occur, which could damage the liver.

The following patients should consult their doctor before taking this medicine:

• Patient with kidney, liver, heart, or lung diseases and patients with anemia.
• Asthmatic patients sensitive to acetylsalicylic acid.
• Patient sensitive (allergic) to an antihistamine, as they may be sensitive to other antihistamines (such as chlorphenamine).
• Patient being treated with medications for: prostate hypertrophy, bronchial asthma, slow heartbeats, hypotension, cerebral arteriosclerosis, pancreatitis, peptic ulcer, pyloroduodenal obstruction, thyroid diseases, patients sensitive to the sedative effects of some medications.
• In case of glucose-6-phosphate dehydrogenase (G6PD) deficiency (may cause hemolytic anemia).

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

During treatment with Dolengrip, inform your doctor immediately:

If you have severe diseases, such as severe kidney failure or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious disease called metabolic acidosis (an anomaly in blood and fluids) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken with flucloxacillin. The symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling of discomfort (nausea) and vomiting.

Children and Adolescents

Do not use in children under 15 years old.

Interference with Laboratory Tests:

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

Other Medications and Dolengrip650 mg/15.58 mg/4 mg Granules for Oral Solution

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

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.
• Medication to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin).
• Medications used to increase urine elimination (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 to treat gout (probenecid and sulfinpyrazone).
• Medications used to treat high blood pressure and heart rhythm disorders (arrhythmias): Propranolol.
• Medications used to lower cholesterol levels in the blood (cholestyramine).
• Medications used to treat depression, Parkinson's disease, or other diseases (Monoamine Oxidase Inhibitors (MAOIs)). Dolengrip 650 mg/15.58 mg/4 mg Granules for Oral Solution and these medications should be separated by at least 15 days after finishing treatment.
• Medications used to treat migraines; medications taken for childbirth; medications taken to treat blood pressure or other diseases (alpha-adrenergic blocking medications).
• Alpha and beta-adrenergic blocking medications (labetalol and carvedilol) used for the heart or to treat artery diseases.
• Medications for treating depression (tricyclic and tetracyclic antidepressants).
• General anesthetic medications.
• Antihypertensive medications (medications to lower blood pressure).
• Medications for the heart, such as cardiac glycosides, antiarrhythmics, and beta blockers.
• Medications containing thyroid hormones (used to treat thyroid diseases).
• Medications used for heart or digestive diseases, such as atropine sulfate.
• Medications that cause depression of 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).
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid anomaly (called metabolic acidosis) that requires urgent treatment (see section 2).

Taking Dolengrip650 mg/15.58 mg/4 mg Granules for Oral Solution with Food, Drinks, and Alcohol

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

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

Taking this medicine with food does not affect its efficacy.

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 medicine.

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

This medicine cannot be taken during breastfeeding, as it may cause side 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.

Dolengrip650 mg/15.58 mg/4 mg Granules for Oral Solution contains Mannitol (E-421) and Sodium

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

This medicine contains less than 23 mg of sodium (1mmol) per sachet; it is essentially "sodium-free".

3. How to take Dolengrip 650 mg/15.58 mg/4 mg Granules for Oral Solution

Follow the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor, pharmacist, or nurse. In case of doubts, ask your doctor, pharmacist, or nurse.

If the pain persists for more than 5 days, the fever for more than 3 days, or the pain or other symptoms worsen or new symptoms appear, you should stop treatment and consult your doctor.

The recommended dose is:

Adults and adolescents over 15 years old: 1 sachet every 6-8 hours as needed (3 or 4 sachets per day). Do not take more than 3g of paracetamol (4 sachets) every 24 hours.

Patient with kidney failure: This medicine cannot be administered to these patients, as it contains 650 mg of paracetamol and its pharmaceutical form is granules. Since the maximum dose per intake for these patients is 500 mg, the sachet content cannot be divided to achieve the adequate dose.

Patient with liver failure: In case of liver failure or Gilbert's syndrome, do not exceed 3 sachets in 24 hours, and the minimum interval between doses will be 8 hours.

Use in Children

This medicine is contraindicated in children and adolescents under 15 years old.

Use in Elderly Patients

Elderly patients cannot use this medicine without consulting a doctor, as some side effects of the medicine, such as the appearance of slow heartbeats (bradycardia) or reduced cardiac output, due to the content of phenylephrine and chlorphenamine, may affect them especially. 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.

How to Take

Dolengrip 650 mg/15.58 mg/4 mg Granules for Oral Solution is taken orally.

Dissolve the sachet content completely in a little liquid, preferably half a glass of water, and then drink.

Always take the lowest effective dose.

Treatment with this medicine is subject to the appearance of symptoms. As they disappear, you should suspend treatment.

If the fever persists for more than 3 days of treatment, the pain or other symptoms persist for more than 5 days, or worsen or new symptoms appear, you should consult a doctor.

If you take more Dolengrip650 mg/15.58 mg/4 mg Granules for Oral Solution than you should

If you have ingested an overdose, you should go immediately to a medical center, 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 (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 (the latter especially in children). Dryness of 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 may cause plasma volume depletion (decrease in blood volume).

Overdose may 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 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.

4. Possible Adverse Effects

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

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

The adverse effects that may appear more frequently are: 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 discomfort (which may decrease if the medicine 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.

The adverse effects that may appear with low frequency (rare) are: Malaise, lowering of blood pressure (hypotension), and increase in blood transaminase levels. 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 (generally with high doses, and more frequent in the elderly and children), which may include symptoms such as: restlessness, insomnia, nervousness, and even convulsions. Other adverse effects that may appear with low frequency are: chest tightness, lung noises, rapid or irregular heartbeats (generally 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 blood cell formula, such as agranulocytosis, leucopenia, aplastic anemia, thrombocytopenia) with symptoms such as unusual bleeding, sore throat, or fatigue; lowering or rising blood pressure, edema (swelling), alterations in the ears, impotence, menstrual disorders.

The adverse effects that may appear with very low frequency (very rare) are:Kidney disease, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowish skin color), blood disorders (neutropenia, hemolytic anemia), and hypoglycemia (low blood sugar).

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

Very rare cases of skin reactions have been reported.

The adverse effects whose frequency of appearance is not known are: Anxiety, irritability, weakness, increase in blood pressure (hypertension, generally 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 blood vessel caliber (peripheral vasoconstriction), reduction of heart performance that affects especially the elderly and patients with poor cerebral or coronary circulation, possible production or worsening of heart disease, urinary retention, paleness, hair standing on end, increase in blood sugar (hyperglycemia), decrease in potassium in the blood, metabolic acidosis (metabolic disorder), 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. A serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

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: https://www.notificaRAM.es/. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Dolengrip 650 mg/15.58 mg/4 mg Granulate for Oral Solution

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 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 sewers or in the trash. 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. Package Contents and Additional Information

Composition ofDolengrip 650 mg/15.58 mg/4 mg Granulate for Oral Solution

Each sachet contains:

As active ingredients: 650 mg 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 cornstarch derivative), and povidone.

Appearance of the Product and Package Contents

Dolengrip 650 mg/15.58 mg/4 mg Granulate for Oral Solution is a white or yellowish-white granulate for oral solution with an orange flavor, presented in sachets packaged in cardboard boxes with 10 sachets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D. Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid). Spain

Manufacturer

Laboratorios Alcalá Farma, S.L

Avenida de Madrid, 82

28802 Alcalá de Henares (Madrid). Spain

Date of the Last Revision of this Prospectus:February 2025

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