Leaflet: information for the user

Normogrip hard capsules

Paracetamol/Fenilefrine hydrochloride/Chlorphenamine maleate

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this leaflet or those indicated by your doctor, or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any side effects, consult your doctor or pharmacist even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve, or if the fever persists for more than 3 days or the pain for more than 5 days (2 days for throat pain).

1. What is normogrip hard capsules and what it is used for

2. What you need to know before starting to take normogrip hard capsules

3. How to take normogrip hard capsules

4. Possible side effects

5. Storage of normogrip hard capsules

6. Contents of the pack and additional information

Normogrip hard capsules are an association of paracetamol (an analgesic that reduces pain and fever), chlorphenamine (an antihistamine that relieves nasal secretion) and phenylephrine (which acts by reducing nasal congestion).

This medication is indicated for the relief of symptoms of catarrhal or flu-like processes that are accompanied by pain (mild or moderate), fever, congestion, and nasal secretion in adults and adolescents aged 12 years and above.

You should 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 Normogrip hard capsules

- If you are allergic (hypersensitive) to paracetamol, pheniramine, chlorphenamine, or any of the other components of the 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 severe heart or artery disease (such as severe coronary disease or angina pectoris)

- 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 medications for Parkinson's disease)

- 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 artery diseases) (see: Taking Normogrip hard capsules with other medications)

- If you have glaucoma (elevated eye pressure)

- Children under 12 years old cannot take this medication

Warnings and precautions

Consult your doctor or pharmacist before starting to take Normogrip hard capsules

Do not take more medication than recommended in section 3 (How to take Normogrip hard capsules)

Chronic alcoholics should be careful not to take more than 2 g of paracetamol (4 Normogrip hard capsules)

Avoid taking this medication with other medications that contain paracetamol, as high doses may cause liver damage. Do not use more than one medication that contains paracetamol without consulting your doctor

Consult your doctor before taking this medication:

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

- Asthmatic patients sensitive to acetylsalicylic acid

- Patients sensitive (allergic) to an antihistamine, as they may be sensitive to other antihistamines (such as chlorphenamine)

- Patients being treated with medications for: prostate hypertrophy, bronchial asthma, slow heartbeats, hypotension, cerebral arteriosclerosis, pancreatitis, peptic ulcer (peptic ulcer stenosis), pyloric obstruction (between the stomach and the intestine), thyroid diseases, patients sensitive to the sedative effects of some medications

- If you are being treated with tricyclic antidepressants or medications with similar effects and you experience gastrointestinal problems, stop taking this medication and consult your doctor immediately, as you may develop paralytic ileus (detention of normal movements in a part of the intestine).- In case of glucose-6-phosphate dehydrogenase deficiency (G6PD) (may cause hemolytic anemia)

Inform your doctor immediately if you experience:

Severe diseases, such as severe renal insufficiency or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). A severe disease called metabolic acidosis (a blood and fluid anomaly) has been reported in patients in these situations when using paracetamol at regular doses for a prolonged period or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe respiratory difficulty with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting

Children and adolescents

Children under 12 years old cannot take this medication

Interference with laboratory tests:

Inform your doctor that you are taking/using this medication, as it may alter test results

Taking Normogrip hard capsules with other medications

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

Particularly, if you are using any of the following medications, as it may be necessary to modify the dose of some of them or separate the administration by at least 15 days or interrupt the treatment:

- Medications for epilepsy: Antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)

- Medications for tuberculosis (isoniazid, rifampicin)

- Medications for seizures 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 of the loop, such as furosemide, or other diuretics) and other diuretics that cause potassium loss (such as diuretics for hypertension or others)

- Medications used to prevent nausea and vomiting (metoclopramide and domperidone)

- Medications used to treat gout (probencid and sulfinpyrazone)

- Medications used to treat high blood pressure and heart rhythm disorders (arritmias) (Propranolol)

- Medications to lower cholesterol levels in the blood (cholestyramine)

- Medications used to treat depression, Parkinson's disease, or other diseases (monoamine oxidase inhibitors (MAOIs)). It is necessary to separate the administration of Normogrip hard capsules by at least 15 days after completing the treatment

- Medications used to treat migraines; medications taken for childbirth; medications taken to treat high blood pressure or other diseases (alpha-adrenergic blockers)

- Alpha and beta-adrenergic blockers such as labetalol and carvedilol (used for the heart or to treat artery diseases)

- Medications for depression (tricyclic antidepressants and tetracyclic antidepressants)

- General anesthetics

- Anti-hypertensives (medications to lower blood pressure)

- Medications used for the heart, such as cardiac glycosides and anti-arrhythmics

- Medications containing thyroid hormones (used to treat thyroid diseases)

- Medications used for heart or digestive diseases (atropine sulfate)

- Medications that cause depression of the central nervous system (such as those used for insomnia or anxiety)

- Ototoxic medications (that have as an adverse effect that they damage the ear)

- Photosensitizing medications (that, as an adverse effect, produce an allergy to light)

Inform your doctor or pharmacist if you are taking:

- Flucloxacillin (antibiotic), due to a serious risk of alteration of the blood and fluids (called metabolic acidosis) that must be treated urgently (see section 2)

Taking Normogrip hard capsules with food and drinks

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, wine, liquor, etc. per day) may cause liver damage

Chronic alcoholics should be careful not to take more than 4 Normogrip hard capsules per day (2 g of paracetamol) divided into several doses

The medication can be taken with or without food

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using 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

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

Dosage

Adults and adolescents over 12 years old: The usual dose is 1 capsule every 6 or 8 hours (3 or 4 capsules per day). The maximum daily dose will be 6 capsules.

Do not take more than 3 grams of paracetamol in 24 hours.

Patients with liver or kidney disease: They must consult their doctor. (See section 2 (What you need to know before taking this medication).

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Use in children under 12 years old:

Children under 12 years old cannot take this medication.

Use in elderly people:

Elderly people should not use this medication without consulting their doctor because they may be especially affected by some side effects of the medication such as the appearance of slow heartbeats (bradycardia) or a reduction in cardiac output, due to the content of phenylephrine and chlorphenamine. They may also be 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.

Administration form

This medication is taken orally.

Take 1 capsule with a little liquid, preferably half a glass of water.

The taking of this medication is subject to the appearance of symptoms. As they disappear, treatment should be discontinued.

If the pain persists for more than 5 days, the fever for more than 3 days, or the pain or fever worsen or other symptoms appear, treatment should be interrupted and the doctor consulted.

If you take more Normogrip hard capsules than you should

You should consult your doctor or pharmacist immediately:

If you have ingested an overdose, you should go to a medical center immediately, even if you do not feel the 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 (this last especially in children). Dryness of the mouth, nose, or throat. Effects such as high blood pressure, arrhythmias (rapid or irregular heartbeats), palpitations, reduction of urine production. Metabolic acidosis (decrease in blood alkalinity reserve). In prolonged use, it may cause depletion of plasma volume (decrease in blood volume). Overdose can also cause: coagulation disorders (blood clots and bleeding).

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

Patients on 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, phone 91 562 04 20, indicating the medication and the amount ingested.

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 appear most 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, hypotension, and increased levels of transaminases in the blood. Myocardial infarction, ventricular arrhythmia (irregular heartbeats), pulmonary edema (increase in lung volume) and cerebral hemorrhage (at high doses or in sensitive patients).

Nervous excitement (usually with high doses and more frequently 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 (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 alterations (changes in the formula of blood cells, such as agranulocytosis, leukopenia, aplastic anemia, thrombocytopenia) with symptoms such as unusual bleeding, sore throat, or fatigue; hypotension, edema, ear alterations, impotence, menstrual alterations.

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

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

Very rarely, severe skin reactions have been reported

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

-The side effects whose frequency of appearance is unknown are:

Anxiety, irritability, weakness, hypertension (usually with high doses and in sensitive patients), headache (with high doses and may be a symptom of hypertension), very slow heartbeats (bradycardia), peripheral vasoconstriction, reduced 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), cold extremities (legs or arms), flushing, sensation of fainting (hypotension). With high doses, vomiting, palpitations, psychotic states with hallucinations may occur; with prolonged use, a decrease in blood volume may occur. A severe disease that may make the blood more acidic (metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

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 for the 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.

Aluminum/PVC Blister: Store below 30°C

Aluminum /PVDC-PE and Aluminum /PVC-PVDC Blister: No special storage conditions are required.

Do not use this medication after the expiration date appearing on the packaging and in the blister (after “CAD”). The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Normogrip capsules

- The active principles are paracetamol 500 mg, phenylephrine hydrochloride 10 mg (equivalent to 8.21 mg of phenylephrine) and chlorphenamine maleate 4 mg (equivalent to 2.8 mg of chlorphenamine).

- The other components are: pregelatinized cornstarch, stearic acid and povidone.

The gelatin capsule is composed of: gelatin, titanium dioxide (E-171), indigo carmine (E-132) and quinoline yellow (E-104).

Appearance of the product and contents of the packaging

Normogrip hard capsules are presented in packaging containing 14 capsules.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the last review of this leaflet:February 2025

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