Normogrip hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Normogrip hard capsules

Paracetamol/Phenylephrine hydrochloride/Chlorphenamine maleate

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

Follow exactly the instructions for use of this medicine as described in this leaflet or as directed 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 adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve, or if fever persists for more than 3 days or pain for more than 5 days (2 days for sore throat).

Contents of the leaflet

1. What Normogrip hard capsules are and what they are used for
2. What you need to know before taking Normogrip hard capsules
3. How to take Normogrip hard capsules
4. Possible adverse effects
5. How to store Normogrip hard capsules
6. Contents of the pack and other information

1. What normogrip hard capsules are and what they are used for

Normogrip hard capsules are a combination of paracetamol (an analgesic that reduces pain and fever), chlorpheniramine (an antihistamine that relieves nasal discharge), and phenylephrine (which acts to reduce nasal congestion).

This medicine is indicated for the relief of symptoms associated with catarrhal or flu-like conditions characterized by pain (mild or moderate), fever, nasal congestion, and nasal discharge in adults and adolescents aged 12 years and older.

You should consult your doctor if your condition worsens, does not improve, or if fever persists for more than 3 days or pain for more than 5 days.

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, chlorpheniramine, or any of the other ingredients of this medicine (listed in section 6).
• If you have high blood pressure (hypertension).
• If you have a thyroid disorder (hyperthyroidism).
• If you have severe liver or kidney disease.
• If you have a serious heart or arterial disease (such as severe coronary artery disease or angina pectoris).
• 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 the heart or to treat arterial diseases) (see: Taking normogrip hard capsules with other medicines).
• If you have glaucoma (increased pressure in the eye).
• Children under 12 years of age must not take this medicine.

Warnings and precautions

Consult your doctor or pharmacist before taking normogrip hard capsules.

Do not take more medicine than the recommended dose stated in section 3 (How to take normogrip hard capsules).

Chronic alcoholics should take care not to exceed 2 g of paracetamol (4 normogrip hard capsules) per day.

Avoid using this medicine together with other medicines containing paracetamol, as high doses may cause liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.

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

• Patients with kidney, liver, heart, or lung disease, and patients with anemia.
• Asthmatic patients who are sensitive to acetylsalicylic acid.
• Patients who are sensitive (allergic) to an antihistamine, as they may also be sensitive to other antihistamines (such as chlorpheniramine).
• Patients being treated with medicines for: prostate enlargement, bronchial asthma, very 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 patients sensitive to the sedative effects of certain medicines.
• If you are taking tricyclic antidepressants or medicines with similar effects and develop gastrointestinal problems, stop taking this medicine and consult your doctor immediately, as you may develop paralytic ileus (cessation of normal intestinal movements).
• In case of glucose-6-phosphate dehydrogenase (G6PD) deficiency (which may cause hemolytic anemia).

During treatment with Normogrip hard capsules, 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 abnormality 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, feeling unwell (nausea), and vomiting.

Children and adolescents

Children under 12 years of age must not take this medicine.

Interference with diagnostic tests:

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

Taking normogrip hard capsules 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 using any of the following medicines, the dose of some of them may need to be adjusted, administration separated by at least 15 days, or treatment discontinued:

• 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.
• Medicine to prevent blood clots: oral anticoagulants (acenocoumarol, warfarin).
• Medicines used to increase urine elimination (loop diuretics such as furosemide, or other diuretics) and other diuretics causing 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 (cardiac arrhythmias) (propranolol).
• Medicines used to lower blood cholesterol levels (cholestyramine).
• Medicines used to treat depression, Parkinson's disease, or other conditions (monoamine oxidase inhibitors (MAOIs)). Administration of normogrip hard capsules must be separated by at least 15 days after stopping treatment.
• 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 blockers such as labetalol and carvedilol (used for heart conditions or arterial diseases).
• Medicines used to treat depression (tricyclic and tetracyclic antidepressants).
• General anesthetic agents.
• Antihypertensives (medicines to lower blood pressure).
• Medicines used for the heart such as cardiac glycosides and antiarrhythmics.
• Medicines containing thyroid hormones (used to treat thyroid disorders).
• Medicines used for heart or digestive disorders (e.g., atropine sulfate).
• Medicines that cause central nervous system depression (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 light allergy).

Inform your doctor or pharmacist if you are taking:

• flucloxacillin (antibiotic), due to a serious risk of blood and fluid imbalance (called metabolic acidosis) that requires urgent treatment (see section 2).

Taking normogrip hard capsules with food and drinks

While taking this medicine, do not consume alcoholic beverages, as they may increase the risk of adverse effects of this medicine.

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.

In chronic alcoholics, care should be taken not to exceed 4 normogrip hard capsules per day (2 g of paracetamol), divided into several doses.

This 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 must not be used during breastfeeding, as it may cause adverse effects in the infant.

Driving and using machines

This medicine may cause drowsiness, affecting mental and/or physical ability. If you experience these effects, avoid driving or operating machinery.

3. How to take normogrip hard capsules

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Dosage

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

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

Patients with liver or kidney disease: Must consult their doctor. (See section 2, "What you need to know before taking this medicine.")

Use in children under 12 years of age:

Children under 12 years of age must not take this medicine.

Use in elderly people:

Elderly individuals should not use this medicine without consulting their doctor, as they may be particularly susceptible to certain adverse effects of the medicine, such as slow heartbeats (bradycardia) or reduced cardiac output due to the presence of phenylephrine and chlorpheniramine. 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.

Method of administration

This medicine is taken orally.

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

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

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

If you take more normogrip hard capsules than you should

You must consult your doctor or pharmacist immediately:

If you have ingested an overdose, you must go immediately to a medical center even if you do not have 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 (possibly a sign of high blood pressure), seizures, insomnia (or excessive drowsiness), clumsiness, fainting sensation, 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, reduced urine output. Metabolic acidosis (decreased blood alkaline reserve). With prolonged use, depletion of plasma volume (decreased blood volume) may occur. Overdose may also cause: coagulation disorders (blood clots and bleeding).

Treatment of overdose is most effective if initiated within 4 hours after ingestion of the overdose.

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, go immediately to a medical center or call the Toxicology Information Service at telephone number 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 period of use of paracetamol, phenylephrine and chlorphenamine, whose frequency has not been precisely 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, low blood pressure (hypotension), and increased blood transaminase levels. Myocardial infarction, ventricular arrhythmia (irregular heartbeat), pulmonary edema (increased fluid volume in the lungs), and cerebral hemorrhage (at high doses or in sensitive patients).

Nervous excitation (generally with high doses and more frequently 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 are: chest tightness, lung sounds, rapid or irregular heartbeat (generally 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 chlorphenamine. 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, edema (swelling), ear disturbances, impotence, menstrual disorders.

• The adverse effects that may occur very rarely (very rare) are:

Kidney diseases, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (neutropenia, haemolytic anaemia), and hypoglycaemia (low blood sugar).

Very rare cases of severe skin reactions have been reported.

Paracetamol may damage the liver when taken at high doses or during prolonged treatment.

• 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 heartbeats (severe bradycardia), reduction in the diameter of blood vessels (peripheral vasoconstriction), reduced cardiac performance especially affecting 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 potassium levels in the blood, metabolic acidosis (metabolic disturbance), coldness in the extremities (legs or arms), flushing, sensation of fainting (hypotension). At 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) in patients with severe illness who are using paracetamol (see section 2).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide 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 blisters: No special storage conditions required.

Do not use this medicine after the expiry date stated on the packaging and on the blister (after "EXP"). The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Normogrip capsules

• The active substances are paracetamol 500 mg, phenylephrine hydrochloride 10 mg (equivalent to 8.21 mg of phenylephrine) and chlorpheniramine maleate 4 mg (equivalent to 2.8 mg of chlorpheniramine).
• The other components are: pregelatinized maize starch, stearic acid and povidone.

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

Appearance of the medicine and contents of the pack

Normogrip hard capsules are supplied in a pack containing 14 capsules.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the most recent revision of this leaflet: February 2025

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