CALMAGRIP FORTE ORAL SOLUTION POWDER

Introduction

Leaflet: information for the user

Calmagrip Forte powder for oral solution

Paracetamol/caffeine/chlorphenamine maleate

Read the entire leaflet carefully before starting to take this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this leaflet or as 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 side effects, consult your doctor or pharmacist, even if they are side effects that do not appear in this leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 5 days of treatment (3 days for fever and for adolescents).

Contents of the leaflet:

1. What Calmagrip Forte is and what it is used for
2. What you need to know before taking Calmagrip Forte
3. How to take Calmagrip Forte
4. Possible side effects
5. Storage of Calmagrip Forte

Package contents and additional information

1. What Calmagrip Forte is and what it is used for

Calmagrip Forte is an association of paracetamol (an analgesic that reduces pain and fever), chlorphenamine maleate (an antihistamine that relieves nasal secretion) and caffeine.

This medication is indicated for the symptomatic relief of catarrhal and flu-like processes that occur with fever, mild or moderate pain (such as headache) runny nose and sneezing for adults and adolescents from 14 years old.

You should consult a doctor if your symptoms worsen or do not improve after 5 days of treatment (3 days for fever and for adolescents).

2. What you need to know before taking Calmagrip Forte

Do not take Calmagrip Forte

• If you are allergic to the active ingredients or to any of the other components of this medication (included in section 6).
• If you have any liver disease.
• If you have any serious heart disease.
• If you have anxiety (agoraphobia, panic attacks).
• Children under 14 years old.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Calmagrip Forte.

• Do not take more than the recommended dose in section 3, how to take Calmagrip Forte.

• In chronic alcoholics, precautions should be taken 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 (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 potentiate 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, 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 with the doctor before taking this medication.

• If you have a stomach or intestinal ulcer, you should consult your doctor because your situation may worsen when taking this medication.

• This medication can produce 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.

Use in children

Do not use in children under 14 years old.

Other medications and Calmagrip Forte

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

Keep in mind that these instructions may also apply to medications that have been used before or may be used 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 hyperkinetic syndrome (hyperactivity), in the syndrome of withdrawal from opium derivatives, in the treatment of spasticity (alteration of muscle function). Caffeine can increase the tachycardic effects (increase in heart rate) of these medications.

• Mexiletine, used to control heart rhythm disorders.

• Medications or beverages with caffeine or other medications that stimulate the nervous system.

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

• Anti-asthmatics (theophylline, ephedrine).

• Tricyclic antidepressants, maprotiline, lithium.

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

• Procarbazine, used in the treatment of cancer.

• Iron.

• Erythromycin (antibiotic).

• Antihistamines, used to relieve allergy symptoms, sleep problems, and travel sickness.

Concomitant use of this medication with other medications that contain paracetamol should be avoided, as high doses can lead to liver damage. Do not use more than one medication that contains paracetamol without consulting your doctor.

• 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).

• Antituberculars (isoniazid, rifampicin).

• Barbiturates (used as hypnotics, sedatives, and anticonvulsants).

• Adsorbent (activated charcoal).

• Colestyramine (used to decrease blood cholesterol levels).

• Medications used to treat gout (anti-gout medications) (probenecid and sulfinpyrazone).

• Certain medications used to increase urine elimination (diuretics such as furosemide).

• Medications used to relieve 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, the cause of AIDS).

• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid alteration (metabolic acidosis with high anionic imbalance) that must be treated urgently and that can occur particularly in cases of severe renal insufficiency, sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, and if the maximum daily doses of paracetamol are used.

Interference with analytical tests

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

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

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

Taking Calmagrip Forte with food, beverages, and alcohol

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

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

The simultaneous use of this medication with alcoholic beverages may produce an interaction with the antihistamine (chlorphenamine) it contains, potentiating the sedative effects.

Pregnancy, breastfeeding, and fertility

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.

IMPORTANT FOR WOMEN

If you are pregnant or think you may be pregnant, consult your doctor before taking 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 Calmagrip Forte pass into breast milk. Breastfeeding women should avoid taking this medication, unless advised by their doctor.

Driving and using machines

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

Important information about some of the components of Calmagrip Forte

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.

3. How to take Calmagrip Forte

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Calmagrip Forte is taken orally.

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

Adults and children over 14 years old: 1 sachet every 6-8 hours. Do not take more than 3 grams every 24 hours (1 day).

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

Over 65 years old: Before taking this medication, consult your doctor, as you may need lower doses due to being more sensitive to the adverse effects of chlorphenamine.

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, or the symptoms worsen or do not improve after 5 days, or other symptoms appear, interrupt the treatment and consult your doctor.

Always use the lowest effective dose.

If you think the action of Calmagrip Forte is too strong or too weak, inform your doctor or pharmacist.

If you take more Calmagrip Forte than you should

If you have taken more Calmagrip Forte than you should, consult your doctor or pharmacist immediately.

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

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

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

Patients 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 immediately to a medical center or call the Toxicology Information Service, Phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Calmagrip Forte

Do not take a double dose to make up for forgotten doses.

If you interrupt treatment with Calmagrip Forte

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not all people experience them.

Due to its paracetamol content, in rare cases (in more than 1 in 10,000 patients but in less than 1 in 1,000 patients), the following can occur: kidney disorders, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood alterations (agranulocytosis, leucopenia, neutropenia, thrombocytopenia, hemolytic anemia), and hypoglycemia (low blood sugar). Paracetamol can damage the liver when taken in high doses or in prolonged treatments. Very rare cases of severe skin reactions have been reported.

During the period of use of chlorphenamine, the following side effects have been observed, whose frequency cannot be established with accuracy:

Drowsiness, sedation.

Dry mouth and throat (it is more likely that these effects appear 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, cases of blurred vision, confusion, urinary retention, difficulty or pain during urination (especially in elderly patients), loss of appetite have been observed. A paradoxical effect of excitement, nervousness, nightmares can also occur, which has been observed more frequently in children and elderly patients. Blood alterations, increased sweating, tachycardias.

During the period of use of caffeine, the following side effects have been observed, whose frequency cannot be established with accuracy:

Nervousness, restlessness, stomach or intestine irritation, tachycardias.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them through the national reporting system, Spanish Medication Surveillance System for Human Use: www.notificaRAM.es.

5. Storage of Calmagrip Forte powder for oral solution

Keep this medication out of 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 above 30°C.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need in the SIGRE Point (or any other medication waste collection system) at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Calmagrip Forte:

• The active ingredients are: 650 mg of paracetamol, 25 mg of caffeine, and 4 mg of chlorphenamine maleate.
• The other components (excipients) are: colloidal anhydrous silica, anhydrous citric acid, sodium saccharin, sucrose (3.9 g), sodium cyclamate, and orange flavor.

Sodium saccharin and sodium cyclamate provide 18.8 mg of sodium.

Appearance of the product and package contents

Calmagrip Forte is a powder for oral solution, white-yellowish in color with an orange flavor. It is presented in packages of 10 sachets.

Marketing authorization holder

PHARMEX ADVANCED LABORATORIES, S.L.

Ctra. A-431 Km.19

(Almodóvar del Río) -14720 -Spain

Manufacturer

ALCALÁ FARMA, S.L.

Avda. de Madrid, 82

28802 Alcalá de Henares (Madrid)

This leaflet was approved in May 2022

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