Leaflet: information for the user

Calmagrip Forte oral powder for solution

Paracetamol/cafeine/clorfenamina maleate

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

Follow exactly the administration instructions for 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. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 5 days of treatment (3 days for fever and for adolescents).

Contents of the pack and additional information

Calmagrip Forte is a combination of paracetamol (a pain reliever that reduces pain and fever), chlorphenamine maleate (an antihistamine that relieves nasal discharge) and caffeine.

This medication is indicated for symptomatic relief of catarrhal and flu-like processes that are accompanied by fever, mild to moderate pain (such as headache), tearing, and sneezingfor adults and adolescents 14 years and older.

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

Do not take Calmagrip Forte

• If you are allergic to the active ingredients or any of the other 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

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

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

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

• In asthmatic patients sensitive to acetylsalicylic acid, consult your doctor before taking this medication.

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

• Patients with arrhythmias (heart rhythm alterations), increased thyroid function (hyperthyroidism), or anxiety syndromes, should reduce the dose of caffeine, 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 can exacerbate these situations.

• If you are diabetic, you should be aware that caffeine can 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, severe heart disease, lung disease, kidney disease, or high blood pressure (hypertension), elevated eye pressure (glaucoma), thyroid disease (hyperthyroidism), prostate enlargement (prostatic hypertrophy), urinary obstruction, or urinary retention, as well as acute asthma attacks, consult your doctor before taking this medication.

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

• This medication may cause drowsiness. Avoid using it with alcohol or barbiturates or tranquilizers.

• Children and older adults may experience a paradoxical reaction characterized by hyperexcitability (nervousness, restlessness).

• Older adults 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 taken recently, or may need to take any other medication.

Take note that these instructions may also apply to medications that have been used before or may be used afterwards.

• Disulfiram, used in the treatment of patients with alcohol dependence.

• Sympathomimetics, medications used as: anti-asthmatics, hypertensives (used to raise blood pressure), in the treatment of hyperkinetic syndrome (hyperactive child), 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 alterations.

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

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

• Anti-asthmatics (theophylline, ephedrine).

• Tricyclic antidepressants, maprotiline, lithium.

• MAO inhibitors, 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 caused by travel.

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

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

Particularly, if you are using any 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).

• Activated charcoal.

• Colestiramine, used to lower cholesterol levels in the blood.

• Medications used to treat gout (antigout medications) (probencid and sulfinpyrazone).

• Diuretics (furosemide group).

• 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 alterations.

• Zidovudine, used to treat patients infected with the human immunodeficiency virus (HIV), which causes AIDS.

• Flucloxacillin, an antibiotic, due to a serious risk of blood and fluid imbalance (metabolic acidosis with high anion gap) that must be treated urgently and may occur particularly in cases of severe renal insufficiency, sepsis, malnutrition, chronic alcoholism, and when using the maximum daily doses of paracetamol.

Interference with diagnostic tests

Inform your doctor if you are to undergo any diagnostic test (including blood, urine, etc...) as this medication 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.

Taking Calmagrip Forte with food, drinks, and alcohol

The use of Calmagrip Forte in patients who regularly consume alcohol (three or more alcoholic beverages per day) may cause liver damage.

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

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be 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. Taking medications during pregnancy can be hazardous to 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. 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 cars or operating machinery that may be hazardous, as this medication may cause drowsiness.

Important information about some components of Calmagrip Forte

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

Follow exactly the administration instructions of this medication 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 packet are taken dissolved in half a glass of water.

Adults and children over 14 years old:1 packet every 6-8 hours. Do not take more than3 gevery 24 hours (1 day).

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

Over 65 years old: 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 administration of this medication is subject to the appearance of symptoms. As these symptoms disappear, this medication should be discontinued.

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 estimate that 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, go quickly to a medical center, even if there are no symptoms, as they often do not appear until 3 days after the 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 it is initiated within 4 hours of the ingestion of the medication.

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 immediately to a medical center or call the Toxicological Information Service, Telephone: 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 compensate for the missed 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.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

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

During the period of use of chlorphenamine, the following adverse effects have been observed, whose 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 rashes.

Rarely, 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, has been observed, especially in children and elderly patients. Blood disorders, increased sweating, tachycardia.

During the period of use of caffeine, the following adverse effects have been observed, whose frequency has not been established with precision:

Nervousness, restlessness, stomach or intestinal irritation, tachycardia.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them through the national notification system Spanish System of Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es.

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 the packaging and medicines you no longer need at the SIGRE collection point(or any other medication waste collection system) at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Calmagrip Forte:

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

Sodium saccharin and sodium cyclamate contribute 18.8 mg of sodium.

Appearance of the product and contents of the packaging

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

Holder of the marketing authorization

PHARMEX ADVANCED LABORATORIES, S.L.

Ctra. A-431 Km.19

(Almodóvar del Río) -14720 -Spain

Responsible for manufacturing

ALCALÁ FARMA, S.L.

Avda. de Madrid, 82

28802 Alcalá de Henares (Madrid)

This leaflet was approved in May 2022

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