NORMOGRIP hard capsules

2. What you need to know before taking Normogrip hard capsules

Do not take Normogrip hard capsules

• If you are allergic (hypersensitive) to paracetamol, phenylephrine, chlorphenamine, or any of the other components of the medicine (listed in section 6)
• If you have high blood pressure (arterial hypertension).
• If you have 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) medicine (such as some antidepressants or medicines for Parkinson's disease).
• If you are being treated with sympathomimetic medicines (medicines used to treat asthma or to accelerate heart rate).
• If you are being treated with beta-blocker medicines (medicines for the heart or to treat artery diseases) (see: Taking Normogrip hard capsules with other medicines).
• If you have glaucoma (elevated eye pressure).
• Children under 12 years of age cannot take this medicine.

Warnings and Precautions

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

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

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

Avoid simultaneous use of this medicine with other medicines that contain paracetamol, as high doses can cause liver damage. Do not use more than one medicine that contains paracetamol without consulting your doctor.

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 medicines for: prostate hypertrophy, bronchial asthma, very slow heartbeats, hypotension, cerebral arteriosclerosis, pancreatitis, peptic ulcer, pyloroduodenal obstruction, thyroid diseases, patients sensitive to the sedative effects of some medicines.
• If being treated with tricyclic antidepressants or medicines with similar effects and experience gastrointestinal problems, stop taking this medicine and consult a doctor immediately, as ileus (stop of normal bowel movements) may occur.
• In case of glucose-6-phosphate dehydrogenase (G6PD) deficiency (can cause hemolytic anemia).

During treatment with Normogrip hard capsules, inform your doctor immediately if:

If you have severe 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

Children under 12 years of age cannot take this medicine.

Interference with laboratory tests:

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

Taking Normogrip hard capsules with other medicines

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

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

• Medicines for treating epilepsy: Antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).

Medicines for treating tuberculosis (isoniazid, rifampicin).

• Medicines for treating convulsions and depression (barbiturates), used as hypnotics, sedatives, and anticonvulsants.
• Medicine to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin).

Medicines used to increase urine elimination (diuretics such as furosemide, or other diuretics) and other diuretics that cause potassium loss (such as diuretics for treating hypertension or other).

• 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 and heart rhythm disorders (arrhythmias) (Propranolol).
• Medicines to lower cholesterol levels in the blood (cholestyramine).
• Medicines used to treat depression, Parkinson's disease, or other diseases (monoamine oxidase inhibitors (MAOIs)). The administration of Normogrip hard capsules should be separated by at least 15 days after finishing treatment.
• Medicines used to treat migraines; medicines taken for childbirth; medicines taken to treat blood pressure or other diseases (alpha-adrenergic blocking medicines).
• Alpha and beta-adrenergic blockers such as labetalol and carvedilol (used for the heart or to treat artery diseases).
• Medicines for treating depression (tricyclic and tetracyclic antidepressants).
• General anesthetic medicines.
• Antihypertensive medicines (medicines to lower blood pressure).
• Medicines used for the heart, such as cardiac glycosides and antiarrhythmics.
• Medicines containing thyroid hormones (used to treat thyroid diseases).
• Medicines used for heart or digestive diseases (atropine sulfate).
• Medicines that cause depression of the central nervous system (such as those used for insomnia or anxiety).
• Ototoxic medicines (which have the adverse effect of damaging the ear).
• Photosensitizing medicines (which have the adverse effect of causing allergy to light).

Inform your doctor or pharmacist if you are taking:

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

Taking Normogrip hard capsules with food and drinks

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

In chronic alcoholics, caution should be taken not to take more than 4 capsules of Normogrip hard capsules per day (2g of paracetamol) divided into several doses.

The medicine can be taken with or without food.

Pregnancy and Breastfeeding

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 used 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.

3. How to Take Normogrip Hard Capsules

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

Dosage

Adults and adolescents over 12 years: 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.

Patient with liver or kidney disease: Should consult their doctor (see section 2 (What you need to know before taking this medicine).

.

Use in Children Under 12 Years:

Children under 12 years of age cannot take this medicine.

Use in Elderly:

Elderly people should not use this medicine without consulting their doctor, as some side effects of the medicine, such as the appearance of slow heartbeats (bradycardia) or reduction of cardiac output, due to the content of phenylephrine and chlorphenamine, may affect them especially. They are also more likely to present side effects such as sedation, confusion, hypotension, or excitement, and may be more sensitive to effects such as dry mouth and urinary retention.

Method of Administration

This medicine is taken orally.

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

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

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 your doctor consulted.

If You Take More Normogrip Hard Capsules Than 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 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 (can be a symptom of high blood pressure), convulsions, insomnia (or intense drowsiness), clumsiness, feeling of fainting, instability, confusion, irritability, tremors, anorexia; psychosis with hallucinations (especially in children). Dry 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 alkaline reserve). In prolonged use, it can cause depletion of plasma volume (decrease in blood volume). Overdose can also cause: coagulation disorders (blood clots and bleeding).

Treatment of overdose is more effective if started within 4 hours of 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 to a medical center immediately or call the Toxicological Information Service, phone 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 everyone 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 medicine is administered with food), nausea, vomiting, diarrhea, constipation, stomach pain, urinary retention, dry nose and throat, thickening of mucus, sweating, blurred vision or other vision disorders.

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

Malaise, low blood pressure (hypotension), and increased transaminase levels 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 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 (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) with medicines 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).

Very rare cases of severe skin reactions have been reported.

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

• 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 (vasoconstriction), reduction of heart performance that especially affects the elderly and patients with poor cerebral or coronary circulation, possible production or worsening of 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 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 not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Normogrip Hard Capsules

Keep this medicine 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 medicine after the expiration date stated on the packaging and blister (after "EXP"). The expiration date is the last day of the indicated month.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and unused medicines at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Packaging Contents and Additional Information

Composition of Normogrip Capsules

• The active ingredients 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 corn starch, stearic acid, and povidone.

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

Appearance of the Product and Packaging Contents

Normogrip hard capsules are presented in packaging containing 14 capsules.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

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

Date of the Last Revision of this Leaflet: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.