KERNGRIP GRANULADO FOR ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Kerngrip Granules for Oral Solution

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 Package Leaflet:

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

1. What is Kerngrip and what is it 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, and phenylephrine acts by reducing nasal congestion.

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

2. What you need to know before you take Kerngrip

Do not take Kerngrip

• If you are allergic to the active substances 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 to accelerate heart rate).
• If you are being treated with beta-blocker medications (medications for the heart or to treat arterial diseases) (see: Taking Kerngrip with other medications).
• If you have glaucoma (high eye pressure).
• If you have a serious heart or arterial disease (such as coronary disease or angina pectoris).
• If you have a serious liver or kidney disease.

Patients under 18 years of age cannot take this medicine.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take this medicine.

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

The following patients should consult 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 an antihistamine, as they may be sensitive to other antihistamines (such as chlorphenamine).
• Patient being treated with medications for: prostate hypertrophy, bronchial asthma, very slow heartbeats, hypotension, cerebral arteriosclerosis, pancreatitis, peptic ulcer, pyloroduodenal obstruction, thyroid diseases, patient sensitive to sedative effects of some medications.

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 movements of a part of the intestine).

During treatment with Kerngrip, inform your doctor immediately if:

If you have serious diseases, such as severe renal 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 unwell (nausea) and vomiting.

Children and Adolescents

Patients under 18 years of age cannot take this medicine.

Taking Kerngrip with other medications

Tell your doctor or pharmacist if you are taking or have recently taken or may 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 (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 for treating gout (probenecid and sulfinpyrazone).
• Medications used for treating high blood pressure and heart rhythm disorders (propranolol).
• Medications used to lower blood cholesterol levels (cholestyramine).
• Medications used for treating depression, Parkinson's disease, or other diseases (monoamine oxidase inhibitors (MAOIs)). Kerngrip and these medications should be taken at least 15 days apart.
• Medications used for treating migraines; medications taken for childbirth; medications taken for treating 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 arterial diseases.
• Medications for treating depression of the tricyclic and tetracyclic type.
• Medications used for general anesthesia.
• Antihypertensive medications used to lower blood pressure.
• Medications for the heart of the type of cardiac glycosides and antiarrhythmics.
• Medications containing thyroid hormones (used to treat thyroid diseases).
• Medications used for heart diseases or digestive diseases of the type of 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 allergy to light).
• Flucloxacillin (antibiotic), due to a serious risk of alteration of blood and fluids (called metabolic acidosis with high anion imbalance) that should be treated urgently (see section 2).

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 this medicine, as it may alter the results.

Taking Kerngrip with food, drinks, and alcohol

While being treated with this medicine, you should not drink alcoholic beverages, as it may increase 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, wine, liquor, ... per day) may cause liver damage.

The medication can be taken with or without food.

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 taking this medicine.

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

This medicine should not be taken by breastfeeding mothers, as it may cause adverse effects in the baby.

Driving and Using Machines

This medicine may cause drowsiness. If you experience drowsiness while taking this medicine, avoid driving vehicles or using machines.

Kerngrip contains Mannitol (E-421)

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

3. How to Take Kerngrip

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

The recommended dose is:

Adults from 18 years: 1 sachet every 6-8 hours as needed (3 or 4 sachets per day). Do not take more than 4 sachets in 24 hours.

Patient with liver or kidney disease: Should consult a doctor (see section 2. What you need to know before you take Kerngrip).

Use in Children

This medicine is contraindicated in children under 18 years.

Use in Elderly

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

How to take

Kerngrip is taken orally.

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

Always take the lowest effective dose.

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

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

If you take more Kerngrip 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 manifest 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). Dry mouth, nose, or throat. You may also notice 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, a decrease in blood volume may occur.

Treatment of overdose is most 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 Toxicological Information Service (Telephone 91 562 04 20), indicating the medicine and the amount ingested.

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, tremor, alterations in sensations and tingling, dry mouth, loss of appetite, alterations in taste or smell, gastrointestinal disorders (which 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.

• 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 (generally 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 (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 the eyelids or around the eyes, face, tongue, difficulty breathing, etc.), photosensitivity (sensitivity to sunlight), cross-sensitivity (allergy) with 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, 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 peripheral 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 a 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; in 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 who use paracetamol (see section 2).

Reporting of Side Effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects that are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines (Website: www.notificaRAM.es). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Kerngrip

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

Do not use this medicine after the expiry date which is stated on the packaging, after EXP. The expiry 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. Dispose of the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Kerngrip Composition

Each sachet contains:

• As active ingredients: 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).
• 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.

Product Appearance and Package Contents

Kerngrip is a white or yellowish-white granulate for oral solution with an orange flavor, presented in sachets packaged in cardboard boxes containing 10 sachets.

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

Laboratorios Alcalá Farma, S.L.

Avenida de Madrid, 82

28802 Alcalá de Henares (Madrid)

This leaflet was approved inFebruary 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/