INTERGRIP POWDER FOR ORAL SOLUTION

2. What you need to know before taking INTERGRIP

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 of age.

Warnings and Precautions

• Do not take more medication than recommended in section 3: How to take INTERGRIP.
• The simultaneous use of this medication with other medications containing paracetamol should be avoided, as high doses can lead to liver damage. Do not use more than one medication containing paracetamol without consulting your doctor.
• In chronic alcoholics, caution should be exercised not to take more than 2 grams of paracetamol per day (no more than 3 sachets per day).
• In asthmatic patients sensitive to acetylsalicylic acid, consultation with the doctor is recommended before taking this medication.
• In case you are sensitive to any antihistamine (medication used to relieve allergy symptoms, sleep problems, and travel sickness); you should consult your doctor because you may be sensitive to other antihistamines.
• Patients with cardiac arrhythmias (heart rhythm disorders), increased thyroid function (hyperthyroidism), or anxious syndromes should reduce the dose of caffeine, so the maximum they should take is 4 sachets and under medical control.
• Patients with hypertension or insomnia should take this medication with caution, as caffeine can exacerbate these situations.
• If you are diabetic, you should be aware that caffeine can increase blood sugar levels.
• Patients sensitive to medications for treating asthma, such as aminophylline or theophylline, may also be sensitive to caffeine, so they should not take this medication.
• In patients with anemia, heart, lung, kidney, or high blood pressure (hypertension), elevated eye pressure (glaucoma), any thyroid disease (hyperthyroidism), prostate disorders (prostatic hypertrophy), obstruction of the neck of the bladder, or urinary retention, as well as acute asthma attacks, should consult their doctor before taking this medication.
• If you have stomach or intestinal ulcers, you should consult your doctor because your situation may worsen when taking this medication.
• This medication can cause sedation. The concomitant use with alcoholic beverages or barbiturate or tranquilizing medications should be avoided.
• 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 appear with chlorphenamine.
• In case of glucose-6-phosphate dehydrogenase (G6PD) deficiency, it can cause hemolytic anemia; consultation with the doctor is recommended before taking this medication.

Using INTERGRIP with Other Medications

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

Note that these instructions may also apply to medications you have used before or may use after.

• Disulfiram, used in the treatment of alcohol detoxification.

• Sympathomimetics, medications used as: anti-asthmatics, hypertensives (used to raise blood pressure), in the treatment of hyperactive syndrome (hyperkinetic syndrome), in withdrawal syndrome from opium derivatives, in the treatment of spasticity (muscle function disorder). Caffeine can increase the tachycardic effects (increased heart rate) of these medications.
• Mexiletine, a medication 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 anti-ulcer medication.
• Medications 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 problems, and travel sickness.
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid alteration (metabolic acidosis with high anionic imbalance) that must be treated urgently and may occur particularly in cases of severe renal insufficiency, sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), malnutrition, chronic alcoholism, and if the maximum daily doses of paracetamol are used.

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

In particular, if you are using any of the following medications, it may be necessary to modify the dose of some of them or interrupt treatment:

• Antibiotics (chloramphenicol).
• Oral anticoagulants (acenocoumarol, warfarin).
• Oral contraceptives and estrogen treatments.
• Antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Antitubercular medications (isoniazid, rifampicin).
• Barbiturates (used as hypnotics, sedatives, and anticonvulsants).
• Adsorbent (activated charcoal).
• Colestyramine (used to decrease blood cholesterol levels).
• Medications used for gout treatment (anti-gout medications) (probenecid and sulfinpyrazone).
• Certain medications used to increase urine elimination (loop diuretics, such as furosemide).
• Medications used for relief of stomach, intestine, and bladder spasms or contractions (anticholinergics, such as glycopyrrolate, propantheline).
• Metoclopramide and domperidone (used to prevent nausea and vomiting).
• Propranolol, used in the treatment of high blood pressure and heart rhythm disorders.
• Zidovudine (used in the treatment of patients infected with the human immunodeficiency virus or AIDS).

Interference with Analytical Tests

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

It may interfere with the results of blood uric acid analysis.

This medication can interfere with skin tests using allergens. It is recommended to suspend the intake of this medication at least three days before starting the tests and inform the doctor.

Using INTERGRIP with Food, Beverages, and Alcohol

The use of INTERGRIP in patients who habitually consume alcohol (three or more alcoholic beverages 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 produce an interaction with the antihistamine it contains (chlorphenamine), enhancing its sedative effects.

Use in Children and Adolescents

It should 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 medication. The consumption of medications during pregnancy can be dangerous for the embryo or fetus and should be monitored by your doctor.

Breastfeeding

Consult your doctor or pharmacist before taking a medication.

The active ingredients of INTERGRIP pass into breast milk. Breastfeeding women should avoid taking this medication without first consulting their doctor.

Driving and Using Machines

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

Important Information about Some Components of INTERGRIP

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

3. How to Take INTERGRIP

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist. INTERGRIP is taken orally.

Adults and children over 14 years: 1 sachet (650 mg of 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 every 24 hours (see "Warnings and Precautions" section).

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

Patients over 65 years: Before taking this medication, consult your doctor, as you may need lower doses due to increased sensitivity to the adverse effects of chlorphenamine.

The contents of the sachet 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 should be suspended.

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 your doctor.

Always use the lowest effective dose.

If you think 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, consult your doctor or pharmacist immediately.

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

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

Overdose can also cause coagulation disorders (blood clots and bleeding).

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

Patients treated with barbiturates or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

In case of overdose or accidental ingestion, immediately go to a medical center or call the Toxicology Information Service, Phone: 91 562 04 20, indicating the medication and the amount ingested.

4. Possible Side Effects

Like all medications, INTERGRIP can 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 can occur:

• Kidney disorders, cloudy urine.
• Skin rash (allergic dermatitis).
• Jaundice (yellowing 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 in prolonged treatments.

Side Effects Due to Chlorphenamine:

The following side effects have been observed, whose frequency cannot be established with precision:

• Drowsiness, sedation.
• Dry mouth and throat (more likely to occur in elderly patients).
• Gastrointestinal discomfort, nausea, vomiting, diarrhea, constipation (these effects can be avoided by taking the medication 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 excitement, nervousness, nightmares may also occur, which has been observed more frequently in children and elderly patients. Blood disorders, increased sweating, tachycardias.

Side Effects Due to Caffeine:

The following side effects have been observed, whose frequency cannot be established with precision:

• Nervousness, restlessness.
• Stomach or intestine irritation.
• Tachycardias.

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

5. Storage of INTERGRIP

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

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

Do not store above 30°C.

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

6. Package Contents and Additional Information

Composition of INTERGRIP

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

Appearance of the Product and Package Contents

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

INTERPHARMA, S.A.

C/Santa Rosa 6

08921 Santa Coloma de Gramenet

Phone: 93 466 37 52

Fax: 93 386 91 44

Manufacturer:

Laboratorios Alcalá Farma, S.L.

Ctra. M-300, Km. 29,920

28802 Alcalá de Henares (Madrid)

Date of the Last Revision of this Package Leaflet: February 2025

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/