Intergrip powder for oral solution

Patient Information Leaflet

Introduction

Patient Information Leaflet

INTERGRIP Oral Solution Powder

Paracetamol / Chlorpheniramine / Caffeine

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

Follow exactly the instructions for use provided 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.
• You should consult a doctor if your condition worsens or if you do not improve after 5 days of treatment, or if fever persists after 3 days of treatment.

Leaflet Contents

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

1. What INTERGRIP is and what it is used for

INTERGRIP is a combination of paracetamol, chlorpheniramine, and caffeine.

This medicine is indicated for the symptomatic relief of catarrhal and influenza-like conditions associated with fever, mild to moderate pain (such as headache), lacrimation, and sneezing.

2. What you need to know before taking INTERGRIP

Do not take INTERGRIP

• If you are allergic to the active substances or to any of the components of this medicine (listed in section 6).
• If you have any liver disease.
• If you have any severe heart disease.
• If you suffer from anxiety (agoraphobia, panic attacks).
• Children under 14 years of age.

Warnings and precautions

• Do not take more medicine than the recommended dose stated in section 3: How to take INTERGRIP.
• Concomitant use of this medicine with other medicines containing paracetamol should be avoided, as high doses may lead to liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.
• In chronic alcoholics, caution should be taken not to exceed 2 g of paracetamol per day (no more than 3 sachets per day).
• In patients with asthma who are sensitive to acetylsalicylic acid, consult your doctor before taking this medicine.
• If you are sensitive to any antihistamine (a medicine used to relieve allergy symptoms, sleep difficulties, and travel-related dizziness), consult your doctor, as you may also be sensitive to other antihistamines.
• Patients with cardiac arrhythmias (heart rhythm disorders), increased thyroid function (hyperthyroidism), or anxiety syndromes should reduce their caffeine intake; the maximum recommended dose is 4 sachets per day and only under medical supervision.
• Patients with hypertension or insomnia should take this medicine with caution, as caffeine may worsen these conditions.
• If you are diabetic, you should be aware that caffeine may increase blood sugar levels.
• Patients sensitive to asthma medications such as aminophylline or theophylline may also be sensitive to caffeine and should not take this medicine.
• Patients with anemia, heart, lung, or kidney disease, high blood pressure (hypertension), increased eye pressure (glaucoma), thyroid disorders (hyperthyroidism), prostate problems (prostatic hypertrophy), bladder neck obstruction, urinary retention, or acute asthma attacks should consult their doctor before taking this medicine.
• If you have a stomach or intestinal ulcer, consult your doctor, as your condition may worsen when taking this medicine.
• This medicine may cause sedation. Concomitant use with alcoholic beverages or barbiturates or tranquilizers should be avoided.
• Children and elderly individuals may experience a paradoxical reaction characterized by hyperexcitability (nervousness, restlessness).
• Elderly individuals may be more susceptible to dizziness, sedation, confusion, hypotension, or dry mouth. These are adverse effects that may occur with chlorpheniramine.
• In case of glucose-6-phosphate dehydrogenase (G6PD) deficiency, hemolytic anemia may occur; consult your doctor before taking this medicine.

Use of INTERGRIP with other medicines

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicine.

Note that these instructions may also apply to medicines you have used previously or may use in the future.

• Disulfiram, used in the treatment of alcohol dependence.

• Sympathomimetics, medicines used as: anti-asthmatics, hypertensives (used to raise blood pressure), in the treatment of hyperkinetic (hyperactive) child syndrome, opioid withdrawal syndrome, or treatment of spasticity (muscle function disorder). Caffeine may increase the tachycardic effects (increased heart rate) of these medicines.

• Mexiletine, a medicine used to control heart rhythm disorders.

• Medicines or beverages containing caffeine or other medicines that stimulate the central nervous system.

• Cimetidine, used as an antacid and anti-ulcer agent.

• Medicines for treating asthma (theophylline, ephedrine).

• Tricyclic antidepressants, maprotiline, lithium.

• Monoamine oxidase inhibitors (MAOIs), used in the treatment of depression or Parkinson's disease. Procarbazine, used in cancer treatment.

• Iron.

• Erythromycin (antibiotic).

• Antihistamines, used to relieve allergy symptoms, sleep difficulties, and travel-related dizziness.

• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid disturbances (metabolic acidosis with high anion gap), which must be treated urgently and may occur particularly in cases of severe renal failure, sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, or when maximum daily doses of paracetamol are used.

Do not use with other analgesics (medicines that reduce pain) without consulting your doctor.

In particular, if you are taking any of the following medicines, it may be necessary to adjust the dose or discontinue treatment:

• Antibiotics (chloramphenicol).
• Oral anticoagulants (acenocoumarol, warfarin).
• Oral contraceptives and estrogen treatments.
• Antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Antituberculosis medicines (isoniazid, rifampicin).
• Barbiturates (used as hypnotics, sedatives, and anticonvulsants).
• Adsorbent (activated charcoal).
• Colestyramine (used to lower blood cholesterol levels).
• Medicines used to treat gout (antigout agents) (probenecid and sulfinpyrazone).
• Certain medicines used to increase urine output (loop diuretics, such as furosemide group).
• Medicines used to relieve spasms or contractions of the stomach, intestine, and bladder (anticholinergics, such as glycopyrronium, propantheline).
• Metoclopramide and domperidone (used to prevent nausea and vomiting).
• Propranolol, used in the treatment of high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias).
• Zidovudine (used in the treatment of patients infected with the human immunodeficiency virus or AIDS).

Interference with diagnostic tests

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

It may interfere with blood uric acid test results.

This medicine may interfere with skin tests using allergens. It is recommended to stop taking this medicine at least three days before starting the tests and to inform your doctor.

Use of INTERGRIP with food, drinks, and alcohol

Using INTERGRIP in patients who habitually consume alcohol (three or more alcoholic drinks—beer, wine, spirits—per day) may cause liver damage.

Concurrent use of this medicine with beverages containing caffeine may cause nervousness, irritability, or insomnia.

Concurrent use of this medicine with alcoholic beverages may result in an interaction with the antihistamine it contains (chlorpheniramine), increasing sedative effects.

Use in children and adolescents

This medicine must not be used in children under 14 years of age.

Pregnancy and breastfeeding

IMPORTANT FOR WOMEN

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. Taking medicines during pregnancy may be harmful to the embryo or fetus and should be monitored by your doctor.

Breastfeeding

Consult your doctor or pharmacist before taking any medicine.

The active substances in INTERGRIP pass into breast milk. Women who are breastfeeding should avoid taking this medicine without first consulting their doctor.

Driving and use of machines

Avoid performing activities requiring high concentration, such as driving vehicles or operating potentially dangerous machinery, as this medicine may cause drowsiness.

Important information about some components of INTERGRIP

This medicine contains sucrose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

3. How to take INTERGRIP

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. INTERGRIP is taken orally.

Adults and children over 14 years: 1 sachet (650 mg paracetamol) every 6 - 8 hours (3 or 4 sachets per day). Do not take more than 4 sachets in 24 hours (1 day).

Do not take more than 3 grams of paracetamol in any 24-hour period (see section “Warnings and precautions”).

Patients with kidney or liver disease: Should consult their doctor.

Patients over 65 years: Should consult their doctor before taking this medicine, as they may require lower doses due to increased sensitivity to the adverse effects of chlorpheniramine.

The contents of the sachet should be dissolved in half a glass of water.

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

If fever lasts more than 3 days, symptoms worsen or do not improve after 5 days, or new symptoms appear, stop treatment and consult your doctor.

Always use the lowest effective dose.

If you feel that the effect of INTERGRIP is too strong or too weak, inform your doctor or pharmacist.

If you take more INTERGRIP than you should

If you have taken more INTERGRIP than you should, contact your doctor or pharmacist immediately.

In case of overdose, seek urgent medical attention at a healthcare facility even if there are no symptoms, as symptoms often do not appear until 3 days after the overdose has occurred, even in cases of severe poisoning.

Symptoms of overdose may include: dizziness, vomiting, loss of appetite, dry mouth, difficulty urinating, drowsiness, insomnia, restlessness (nervous overstimulation), yellowing of the skin and eyes (jaundice), and abdominal pain.

Overdose may also cause coagulation disorders (blood clots and hemorrhages).

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

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 centre or call the Toxicology Information Service, Telephone: 91 562 04 20, stating the name of the medicine and the amount ingested.

4. Possible adverse effects

Like all medicines, INTERGRIP may have adverse effects.

Adverse effects due to paracetamol:

Because of its paracetamol content, the following may occur rarely (may affect up to 1 in 1,000 people):

• Kidney disorders, cloudy urine.
• Skin rash (allergic dermatitis).
• Jaundice (yellowing of the skin).
• Blood disorders (agranulocytosis, leucopenia, neutropenia, thrombocytopenia, haemolytic anaemia) and low blood sugar (hypoglycaemia).

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

Adverse effects due to chlorpheniramine:

The following adverse effects have been observed, although their frequency cannot be precisely determined:

• Drowsiness, sedation.
• Dryness of mouth and throat (these effects are more likely to occur in elderly patients).
• Gastrointestinal discomfort, nausea, vomiting, diarrhoea, constipation (these effects may be avoided by taking the medicine with milk or food).
• Skin rashes.

Rarely (may affect up to 1 in 1,000 people), the following have been observed:

• Blurred vision.
• Confusion.
• Urinary retention, difficulty or pain during urination (especially in elderly patients).
• Loss of appetite.

A paradoxical effect of excitation, nervousness, and nightmares may also occur, which has been observed more frequently in children and elderly patients. Blood disorders, increased sweating, tachycardia.

Adverse effects due to caffeine:

The following adverse effects have been observed, although their frequency cannot be precisely determined:

• Nervousness, restlessness.
• Stomach or intestinal irritation.
• Tachycardia.

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

5. Storage of INTERGRIP

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

Do not use this medicine after the expiry date stated on the packaging after EXP.... The expiry date is the last day of the month indicated.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and their packaging. This helps protect the environment.

6. Package contents and additional information

Composition of INTERGRIP

• The active substances are: 650 mg of paracetamol, 25 mg of caffeine, and 4 mg of chlorpheniramine.
• The other components (excipients) are: anhydrous colloidal silica, anhydrous citric acid, sodium saccharin, sucrose, sodium cyclamate, and orange flavour.

Appearance of the product and contents of the package

Yellowish-white oral solution powder with an orange flavour. It is supplied in packs of 10 sachets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

INTERPHARMA, S.A.

C/Santa Rosa 6

08921 Santa Coloma de Gramenet

Tel.: 93 466 37 52

Fax: 93 386 91 44

Manufacturer:

Laboratorios Alcalá Farma, S.L.

Avenida de Madrid 82

28802 Alcalá de Henares (Madrid)

Date of the most recent review of this leaflet: 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/