KernGrip granules for oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Kerngrip granules for oral solution

paracetamol / phenylephrine bitartrate / chlorpheniramine 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of this leaflet:

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

1. What Kerngrip is and what it is used for

It is a combination of three active substances: paracetamol, chlorphenamine, and phenylephrine.

Paracetamol is an analgesic that reduces pain and fever. Chlorphenamine is an antihistamine that relieves nasal discharge, and phenylephrine works by reducing nasal congestion.

It is indicated in adults for the relief of symptoms of colds and flu accompanied by fever or mild to moderate pain, nasal congestion, and nasal discharge.

2. What you need to know before taking Kerngrip

Do not take Kerngrip

• If you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6).
• If you have hypertension (high blood pressure).
• If you have hyperthyroidism.
• If you have diabetes mellitus.
• If you have tachycardia (rapid heartbeat).
• If you are being treated with monoamine oxidase inhibitor (MAOI) medicines (such as certain antidepressants or medicines used to treat Parkinson's disease).
• If you are being treated with sympathomimetic medicines (medicines used to treat asthma or to increase heart rate).
• If you are being treated with beta-blockers (medicines for heart conditions or to treat arterial diseases) (see: Taking Kerngrip with other medicines).
• If you have glaucoma (high pressure in the eye).
• If you have a serious heart or arterial disease (such as coronary artery disease or angina pectoris).
• If you have severe liver or kidney disease.

This medicine must not be used in patients under 18 years of age.

Warnings and precautions

Consult your doctor or pharmacist before taking this medicine.

• Do not take more medicine than the recommended dose stated in section 3: How to take Kerngrip.
• Chronic alcoholics should take care not to take more than 2 sachets per day of Kerngrip.
• While taking this medicine, do not take other products containing paracetamol, as this could lead to a paracetamol overdose, which may cause liver damage.

Patients should consult their doctor before taking this medicine if they have:

• Kidney, liver, heart, or lung disease, or anemia.
• Asthma and are sensitive to acetylsalicylic acid.
• Sensitivity (allergy) to an antihistamine, as they may also be sensitive to other antihistamines (such as chlorpheniramine).
• Conditions requiring treatment with medicines for: prostate enlargement, bronchial asthma, slow heart rate, hypotension, cerebral arteriosclerosis, pancreatitis (inflammation of the pancreas), peptic ulcer (stenosing peptic ulcer), pyloroduodenal obstruction (blockage between the stomach and intestine), thyroid disorders, or if they are sensitive to the sedative effects of certain medicines.

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

During treatment with Kerngrip, inform your doctor immediately if:

You have serious conditions such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an imbalance in blood and body fluids) has been reported in patients in these situations when paracetamol is used at regular doses over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulty with deep and rapid breathing, drowsiness, malaise (nausea), and vomiting.

Children and adolescents

This medicine must not be used in patients under 18 years of age.

Taking Kerngrip with other medicines

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

In particular, if you are taking any of the following medicines, dosage adjustments or discontinuation of treatment may be necessary:

• Medicines to treat epilepsy: antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Medicines to treat tuberculosis (isoniazid, rifampicin).
• Medicines to treat 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 that cause potassium loss (such as diuretics used to treat hypertension or other conditions).
• Medicines used to prevent nausea and vomiting (metoclopramide and domperidone).
• Medicines used to treat gout (probenecid and sulfinpyrazone).
• Medicines used to treat high blood pressure (hypertension) and heart rhythm disorders (propranolol).
• Medicines used to lower blood cholesterol levels (cholestyramine).
• Medicines used to treat depression, Parkinson's disease, or other conditions (monoamine oxidase inhibitors (MAOIs)). A minimum interval of 15 days must be maintained between taking Kerngrip and 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 (labetalol and carvedilol) used for heart conditions or arterial diseases.
• Medicines used to treat depression, such as tricyclic and tetracyclic antidepressants.
• Medicines used for general anaesthesia.
• Antihypertensive medicines used to lower blood pressure.
• Medicines used for heart conditions, such as cardiac glycosides and antiarrhythmics.
• Medicines containing thyroid hormones (used to treat thyroid disorders).
• Medicines used for heart disease or digestive disorders, such as atropine sulfate.
• Medicines that depress the central nervous system, such as those used for insomnia or anxiety.
• Ototoxic medicines (those that may damage the ear as a side effect).
• Photosensitising medicines (those that may cause light allergy as a side effect).
• Flucloxacillin (an antibiotic), due to a serious risk of blood and fluid imbalance (called metabolic acidosis with high anion gap), which requires urgent treatment (see section 2).

Interference with laboratory tests:

If you are scheduled for any laboratory tests (including blood or urine tests), inform your doctor that you are taking this medicine, as it may alter test results.

Taking Kerngrip with food, drinks, and alcohol

Do not drink alcoholic beverages while taking this medicine, as this may increase the risk of adverse effects.

In addition, using medicines containing paracetamol in patients who habitually consume alcohol (3 or more alcoholic drinks: beer, wine, spirits, etc., per day) may cause liver damage.

This medicine can be taken with or without food.

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 used during pregnancy unless your doctor considers it strictly necessary.

Breastfeeding mothers must not take this medicine, as it may cause adverse effects in the infant.

Driving and using machines

This medicine may cause drowsiness. If you experience drowsiness during treatment, avoid driving or operating machinery.

Kerngrip contains mannitol (E-421)

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

3. How to take Kerngrip

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Recommended dose:

Adults aged 18 years and over: 1 sachet every 6–8 hours as needed (3 or 4 sachets per day). Do not exceed 4 sachets in 24 hours.

Patients with liver or kidney disease: Must consult a doctor (see section 2. What you need to know before taking Kerngrip).

Use in children

This medicine is contraindicated in individuals under 18 years of age.

Use in elderly people

Elderly patients should not use this medicine without consulting a doctor, as they may be particularly affected by certain adverse effects of the medicine such as slow heart rate (bradycardia) or reduced cardiac output due to phenylephrine and chlorphenamine. 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.

How to take

Kerngrip is taken orally.

Completely dissolve the contents of the sachet in a small amount of liquid, preferably half a glass of water, and then drink.

Always take the lowest effective dose.

This medicine should only be taken when symptoms appear. As symptoms subside, treatment should be discontinued.

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

If you take more Kerngrip than you should

If you have ingested an overdose, you must immediately go to a medical center even if you do not feel 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, feeling faint, instability, confusion, irritability, tremors, anorexia; psychosis with hallucinations (especially in children). Dryness of the mouth, nose, or throat. You may also experience effects such as high blood pressure, arrhythmias (rapid or irregular heartbeat), palpitations, reduced urine output, metabolic acidosis (decreased blood alkaline reserve). With prolonged use, a reduction in blood volume may occur.

Treatment of overdose is most effective if started within 4 hours after the overdose has been taken.

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, immediately go 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 everyone experiences them.

The following adverse effects have been reported during the use of paracetamol, phenylephrine, and chlorpheniramine, although their frequency has not been accurately established:

• The adverse effects that may occur more frequently are:

Mild drowsiness, dizziness, muscle weakness: these adverse effects may disappear after 2–3 days of treatment. Difficulty in 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, sweating, blurred vision, or other visual disturbances.

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

Malaise, drop in blood pressure (hypotension), and increased blood transaminase levels. Myocardial infarction, ventricular arrhythmia (irregular heartbeat), pulmonary oedema (increased fluid volume in the lungs), and cerebral haemorrhage (at high doses or in sensitive patients).

Nervous excitation (generally with high doses, and more common in elderly patients and children), which may include symptoms such as restlessness, insomnia, nervousness, and even convulsions. Other adverse effects that may occur less frequently include: 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 chlorpheniramine. 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, oedema (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 cause liver damage when taken in high doses or during prolonged treatment.

Very rare cases of serious skin reactions have been reported.

• Adverse effects for which the frequency of occurrence is unknown 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 blood vessel diameter (peripheral vasoconstriction), reduced cardiac performance affecting especially 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 blood potassium, 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. A serious condition that may cause the blood to become more acidic (called metabolic acidosis) has been reported in severely ill patients taking paracetamol (see section 2).

Reporting of adverse effects

If you experience any 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 (Website: www.notificaRAM.es). By reporting adverse 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 stated on the container, after EXP. The expiry date is 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 containers and medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Kerngrip

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, which is a derivative of maize starch) and povidone.

Nature of the product and pack contents

Kerngrip is a white or slightly yellowish granulate for oral solution with an orange flavour, supplied in sachets. The sachets are packed in cardboard packs containing 10 sachets.

Marketing Authorisation 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 patient information leaflet was last approved in February 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS):

http://www.aemps.gob.es/