Leaflet: information for the user

INTERGRIP Powder for oral solution

Paracetamol / Chlorphenamine / Caffeine

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.
• You should consult a doctor if you get worse or do not improve after 5 days of treatment, or if the fever persists after 3 days of treatment.

1. What is INTERGRIP and what it is used for

2. What you need to know before starting to take INTERGRIP

3. How to take INTERGRIP

4. Possible side effects

5. Storage of INTERGRIP

6. Contents of the pack and additional informationl

INTERGRIP is an association of paracetamol, chlorphenamine, and caffeine.

This medication is indicated for the symptomatic relief of catarrhal and flu-like processes that are accompanied by fever, mild to moderate pain (such as headache), tearing, and sneezing.

Do not take INTERGRIP

- If you are allergic to the active ingredients or any of the components of this medication (listed in section 6).

- If you have any liver disease.

- If you have any severe heart disease.

- If you have anxiety (agoraphobia, panic attacks).

- Children under 14 years old.

Warnings and precautions

- Do not take more medication than recommended in section 3: How to take INTERGRIP.

- Avoid simultaneous use of this medication with other medications containing paracetamol, as high doses may cause liver damage. Do not take more than one medication containing paracetamol without consulting your doctor.

- In chronic alcoholics, be careful not to take more than 2g of paracetamol per day (not more than 3 packets per day).

- In patients with asthma sensitive to acetylsalicylic acid, consult your doctor before taking this medication.

- If you are sensitive to any antihistamine (medication used to relieve allergy symptoms, sleep problems, and motion sickness), consult your doctor because you may be sensitive to other antihistamines.

- Patients with arrhythmias (heart rhythm disorders), increased thyroid function (hyperthyroidism), or anxiety disorders, should reduce their caffeine dose, so the maximum they should take is 4 packets and under medical supervision.

- Patients with hypertension or insomnia will take this medication with caution, as caffeine may exacerbate these conditions.

- If you are diabetic, be aware that caffeine may increase blood sugar levels.

- Patients sensitive to asthma medications such as aminophylline, theophylline, may also be sensitive to caffeine, so they should not take this medication.

- In patients with anemia, heart disease, lung disease, kidney disease, or high blood pressure (hypertension), consult your doctor before taking this medication.

- If you have stomach ulcers or intestinal ulcers, consult your doctor because your condition may worsen when taking this medication.

- This medication may cause drowsiness. Avoid concurrent use with alcoholic beverages or barbiturates or tranquilizers.

- Children and the elderly may experience a paradoxical reaction characterized by hyperexcitability (nervousness, restlessness).

- The elderly may be more susceptible to experiencing dizziness, sedation, confusion, hypotension, or dry mouth. These are adverse effects that may occur with chlorphenamine.

Use of INTERGRIP with other medications

Inform your doctor or pharmacist that you are using, have used recently, or may need to use any other medication.

Be aware that these instructions may also apply to medications you have used before or may use afterwards.

• Disulfiram, used in the treatment of alcoholics.

• Sympathomimetics, medications used as: antiasthmatics, antihypertensives (used to raise blood pressure), in the treatment of hyperactive child syndrome (hyperkinetic syndrome), in opioid withdrawal syndrome, in the treatment of spasticity (muscle function alteration). Caffeine may increase the effects of these medications.
• Mexiletine, used to control heart rhythm disorders.
• Medications or beverages containing caffeine or other medications that stimulate the nervous system.
• Cimetidine, used as an antacid and antiulcer medication.
• Medications used to treat asthma (theophylline, ephedrine).
• Tricyclic antidepressants, maprotiline, lithium.
• Monamine 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 problems, and motion sickness.
• Flucloxacillin (antibiotic), due to a severe risk of blood and fluid imbalance (metabolic acidosis with high anion gap) that must be treated urgently and may occur particularly in severe renal failure, sepsis (when bacteria and their toxins circulate in the blood causing organ damage), malnutrition, chronic alcoholism, and if maximum daily doses of paracetamol are used.

Do not use with other analgesics (pain-relieving medications) without consulting your doctor.

Particularly, if you are using some of the following medications, you may need to modify the dose of some of them or discontinue treatment:

• Antibiotics (chloramphenicol).
• Oral anticoagulants (acenocoumarol, warfarin).
• Oral contraceptives and hormone replacement therapy.
• Antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Antituberculars (isoniazid, rifampicin).
• Barbiturates (used as hypnotics, sedatives, and anticonvulsants).
• Adsorbent (activated charcoal).
• Colestiramine (used to lower cholesterol levels in the blood).
• Medications used to treat gout (antigout medications) (probencid and sulfinpyrazone).
• Some medications used to increase urine elimination (diuretics, such as furosemide).
• Medications used to relieve spasms or contractions of the stomach, intestines, and bladder (anticholinergics, such as glycopyrrolate, propanteline).
• Metoclopramide and domperidone (used to prevent nausea and vomiting).
• Propranolol, used to treat high blood pressure and heart rhythm disorders.
• Zidovudine (used to treat patients infected with the human immunodeficiency virus or HIV).

Interference with diagnostic tests

If you are to undergo any diagnostic test (including blood, urine, etc.) inform your doctor that you are taking this medication, as it may alter the results.

This medication may interfere with uric acid levels in the blood.

This medication may interfere with skin tests that use allergens. It is recommended to discontinue taking this medication at least three days before starting the tests and inform your doctor.

Use of INTERGRIP with food, beverages, and alcohol

The use of INTERGRIP in patients who regularly consume alcohol (three or more alcoholic beverages -beer, wine, liquor...- per day) may cause liver damage.

The simultaneous use of this medication with beverages containing caffeine may cause nervousness, irritability, or insomnia.

The simultaneous use of this medication with alcoholic beverages may potentiate the sedative effects of the antihistamine it contains (chlorphenamine).

Use in children and adolescents

Do not use in children under 14 years old.

Pregnancy and lactation

IMPORTANT FOR WOMEN

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.The consumption of medications during pregnancy may be hazardous to the embryo or fetus and should be monitored by your doctor.

Lactation

Consult your doctor or pharmacist before taking a medication.

The active ingredients of INTERGRIP pass into breast milk. Women breastfeeding should avoid taking this medication without consulting their doctor.

Driving and operating machinery

Avoid performing activities that require great attention, such as driving or operating machinery that may be hazardous, as this medication may cause drowsiness.

Important information about some components of INTERGRIP

This medication contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist. INTERGRIP is taken orally.

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

Do not take more than 3 grams of paracetamol each 24 hours (see "Warnings and precautions").

Patients with kidney or liver disease::They must consult their doctor.

Patients over 65 years:Before taking this medication, they must consult their doctor because they may need lower doses due to being more sensitive to the adverse effects of chlorphenamine.

The contents of the tablet are taken dissolved in half a glass of water.

The administration of this medication is subject to the appearance of symptoms. As they disappear, this medication must be discontinued.

If the fever lasts more than 3 days, symptoms worsen or do not improve after 5 days, or other symptoms appear, interrupt treatment and consult a doctor.

Always use the lowest effective dose.

If you estimate that the action 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, consult your doctor or pharmacist immediately.

If an overdose has been ingested, go to a medical center immediately, even if there are no symptoms, as symptoms often do not appear until 3 days after ingestion of the overdose, even in cases of severe poisoning.

The symptoms of an overdose may be: dizziness, vomiting, loss of appetite, dry mouth, difficulty urinating, drowsiness, insomnia, restlessness (nervous overexcitement), yellowing of the skin and eyes (jaundice), and abdominal pain.

The treatment of an overdose is more effective if initiated within 4 hours of the medication ingestion.

Patients undergoing barbiturate treatment 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, Telephone: 91 562 04 20, indicating the medication and the amount ingested.

Like all medicines, INTERGRIP may have side effects.

Side effects due to paracetamol:

Due to its paracetamol content, in rare cases (may affect up to 1 in 1,000 people) the following may occur:

-Renal disorders, cloudy urine.

-Dermatitis (allergic skin rash).

-Icterus (yellow discoloration of the skin).

-Blood disorders (agranulocytosis, leucopenia, neutropenia, thrombocytopenia, hemolytic anemia) and low blood sugar (hypoglycemia).

Paracetamol can damage the liver when taken in high doses or for prolonged periods.

Side effects due to chlorphenamine:

The following side effects have been observed, but their frequency has not been established with precision:

-Drowsiness, sedation.

-Dry mouth and throat (these effects are more likely to occur in elderly patients).

-Gastrointestinal discomfort, nausea, vomiting, diarrhea, constipation (these effects can be prevented by taking the medication with milk or food).

-Skin eruptions.

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

-Blurred vision.

-Confusion.

-Urinary retention, difficulty or pain during urination (especially in elderly patients),

-Loss of appetite.

A paradoxical effect of excitement, nervousness, nightmares, has been observed, particularly in children and elderly patients. Blood disorders, increased sweating, tachycardia.

Side effects due to caffeine:

The following side effects have been observed, but their frequency has not been established with precision:

-Nervousness, restlessness.

-Stomach or intestinal irritation.

-Tachycardia.

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this prospectus.

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

Do not use this medication after the expiration date that appears on the packaging after CAD... The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of INTERGRIP

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

Appearance of the product and contents of the packaging

Oral solution powder, yellowish white in color with an orange flavor. It is presented in 10 sachets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

INTERPHARMA, S.A.

C/Santa Rosa 6

08921 Santa Coloma de Gramenet

Tel:93 466 37 52

Fax:93 386 91 44

Responsible for manufacturing:

Laboratorios Alcalá Farma, S.L.

Ctra. M-300, Km. 29,920

28802 Alcalá de Henares (Madrid)

Last review date of this leaflet: June 2022

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