FORTMYL GRANULADO FOR ORAL SOLUTION EFG

2. What you need to know before taking Fortmyl

Do not take Fortmyl

• If you are allergic to paracetamol, phenylephrine, chlorphenamine, or any of the other components of this medication (listed in section 6).
• If you have high blood pressure (arterial hypertension).
• If you have any thyroid disease (hyperthyroidism).
• If you have any severe liver or kidney disease.
• If you have any severe heart or artery disease (severe coronary disease or angina pectoris).
• If you have diabetes mellitus.
• If you have tachycardia (rapid heartbeats).
• If you are being treated with any monoamine oxidase inhibitor (MAOI) medication (such as some antidepressants or medications for Parkinson's disease).
• If you are being treated with sympathomimetic medications (medications used to treat asthma or to accelerate heart rate).
• • If you are being treated with beta-blocker medications (medications for the heart or to treat artery diseases (see: "Other medications and Fortmyl").
  • If you have glaucoma (elevated ocular pressure).
  • Children under 14 years of age cannot take this medication due to the paracetamol content.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take this medication.

The following patients should consult their doctor before taking this medication:

• Patient with kidney, liver, heart, or lung disease, and patients with anemia.
• Asthmatic patients sensitive to acetylsalicylic acid.
• Patient sensitive (allergic) to an antihistamine, as they may be sensitive to other antihistamines (such as chlorphenamine).
• Patient being treated with medications for: prostate hypertrophy, bronchial asthma, slow heart rate, hypotension, cerebral arteriosclerosis, pancreatitis, peptic ulcer, pyloroduodenal obstruction, anemia, thyroid disease, patients sensitive to the sedating effects of some medications.
• In case of glucose-6-phosphate dehydrogenase (G6PD) deficiency (may cause hemolytic anemia).

If you are being treated with tricyclic antidepressants or medications with similar effects and you experience gastrointestinal problems, you should stop taking this medication and consult a doctor immediately, as you may develop paralytic ileus (stop of normal intestinal movements).

Chronic alcoholics should be cautious not to take more than 2 g (3 sachets) of paracetamol per day.

Do not take more medication than recommended in section 3 ("How to take Fortmyl").

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

During treatment with Fortmyl, inform your doctor immediately:

If you have severe diseases, such as severe renal insufficiency or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you have malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A severe disease called metabolic acidosis (a blood and fluid anomaly) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken with flucloxacillin. The symptoms of metabolic acidosis may include: severe respiratory distress with deep and rapid breathing, drowsiness, feeling of discomfort (nausea) and vomiting.

Children

Due to the paracetamol content of this medication, children under 14 years of age cannot take this medication.

Interference with analytical tests:

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

Chlorphenamine may interfere with the results of allergy tests. If you are going to undergo any, it is recommended to stop taking the medication at least 3 days in advance.

Other medications and Fortmyl

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

In particular, if you are using any of the following medications, it may be necessary to modify the dose of some of them or separate the administration by a minimum of 15 days or interrupt treatment:

• Medications for treating epilepsy: Antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Medications for treating tuberculosis (isoniazid, rifampicin).
• Medications for treating convulsions and depression (barbiturates), used as hypnotics, sedatives, and anticonvulsants.
• Medication to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin).
• Medications used to increase urine elimination (loop diuretics such as furosemide, or other diuretics) and other diuretics that cause potassium loss (such as diuretics for treating hypertension or other conditions).
• Medications used to prevent nausea and vomiting (metoclopramide and domperidone).
• Medications used to treat gout (probenecid and sulfinpyrazone).
• Medications used to treat high blood pressure and heart rhythm disorders (arrhythmias) (propranolol).
• Medications used to lower cholesterol levels in the blood (cholestyramine).
• Medications used to treat depression, Parkinson's disease, or other diseases (Monoamine Oxidase Inhibitors (MAOIs). The administration of this medication should be separated by a minimum of 15 days after finishing treatment.
• Medications used to treat migraines; medications taken for childbirth; medications taken to treat blood pressure or other diseases (alpha-adrenergic blocking medications).
• Alpha and beta-adrenergic blockers such as labetalol and carvedilol (used for the heart or to treat artery diseases).
• General anesthetics.
• Antihypertensives (medications to lower blood pressure).
• Medications used for the heart, such as cardiac glycosides and antiarrhythmics.
• Medications containing thyroid hormones (used to treat thyroid diseases).
• Medications used for heart or digestive diseases (atropine sulfate).
• Medications that cause depression of the central nervous system (such as those used for insomnia or anxiety).
• Ototoxic medications (which have the adverse effect of damaging the ear).
• Photosensitizing medications (which have the adverse effect of producing light allergy).

Also, inform your doctor or pharmacist if you are taking:

flucloxacillin (antibiotic), due to a serious risk of alteration of blood and fluids (called metabolic acidosis) that requires urgent treatment (see section 2).

Taking Fortmyl with food, drinks, and alcohol

While being treated with this medication, you should not consume alcoholic beverages, as it may enhance the appearance of side effects of this medication.

Additionally, the use of medications containing paracetamol by patients who habitually consume alcohol (3 or more alcoholic beverages: beer, wine, liquor, etc. per day) may cause liver damage.

In chronic alcoholics, caution should be taken not to take more than 2 g of paracetamol (3 sachets per day) divided into several doses.

The medication can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medication.

This medication should not be taken during pregnancy unless your doctor considers it strictly necessary.

This medication cannot be taken during breastfeeding, as it may cause side effects in the baby.

Driving and using machines

This medication may cause drowsiness, so if it occurs, avoid driving vehicles or using machines.

Fortmyl contains mannitol (E-421)

This medication may have a mild laxative effect because it contains mannitol.

Fortmyl contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per sachet; it is essentially "sodium-free"

3. How to take Fortmyl

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

Dosage

Adults: The usual dose is 1 sachet every 6-8 hours (3-4 sachets per day). The maximum daily dose will be 4 sachets in 24 hours.

Adolescents from 14 years of age: The usual dose is 1 sachet every 6-8 hours (3-4 sachets per day).

Do not take more than 3 g of paracetamol (4 sachets) every 24 hours.

Patient with liver disease: in case of hepatic insufficiency, do not exceed 2 g of paracetamol (3 sachets per day) and the minimum interval between doses will be 8 hours.

Patient with kidney disease: this medication is not indicated for patients with renal insufficiency due to the paracetamol content (see section 2 "What you need to know before taking Fortmyl").

Use in children and adolescents under 14 years:

Children under 14 years of age cannot take this medication due to the paracetamol content.

Use in elderly people:

Elderly people should not use this medication without consulting a doctor, as some side effects of the medication, such as the appearance of slow heartbeats (bradycardia) or reduced cardiac output, due to the phenylephrine and chlorphenamine content, may affect them especially. They are also more likely to experience side effects such as dizziness, sedation, confusion, hypotension, or excitement, and may be more sensitive to effects such as dry mouth and urinary retention.

Method of administration

This medication is taken orally.

Pour the entire contents of the sachet into approximately half a glass of water. Stir and drink.

Duration of treatment:

Taking this medication is subject to the appearance of symptoms. As they disappear, treatment should be suspended.

If your condition worsens, or if the fever persists for more than 3 days of treatment, the pain or other symptoms persist for more than 5 days, or new ones appear, you should consult a doctor.

If you take more Fortmyl than you should

If you have ingested an overdose, you should go to a medical center immediately, even if you do not notice symptoms, as they often do not appear until 3 days after ingestion of the overdose, even in cases of severe poisoning.

The symptoms of overdose may be: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain. Anxiety, fear, agitation, headache (may be a symptom of high blood pressure), convulsions, insomnia (or intense drowsiness), clumsiness, feeling of fainting, instability, confusion, irritability, tremors, anorexia; psychosis with hallucinations (especially in children). Dryness of the mouth, nose, or throat. Effects such as high blood pressure, arrhythmias (rapid or irregular heartbeats), palpitations, reduced urine production. Metabolic acidosis (decrease in blood alkaline reserve). Prolonged use may cause plasma volume depletion (decrease in blood volume).

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

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

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

4. Possible Adverse Effects

Like all medications, this medication can produce adverse effects, although not all people suffer from them.

During the period of use of paracetamol, phenylephrine, and chlorphenamine, the following adverse effects have been reported, whose frequency has not been established with precision:

• Adverse effects that may appear more frequently are:

Mild drowsiness, dizziness, muscle weakness, which may disappear after 2-3 days of treatment. Difficulty in facial movements, clumsiness, tremors, alterations in sensations and tingling, dry mouth, loss of appetite, alterations in taste or smell, gastrointestinal discomfort (which may decrease if the medication is administered with food), nausea, vomiting, diarrhea, constipation, stomach pain, urinary retention, or difficulty urinating, dryness of the nose and throat, thickening of mucus, sweating, blurred vision or other vision disorders.

• Adverse effects that may appear with low frequency (rare) are:

Discomfort, low blood pressure (hypotension), and increased levels of transaminases in the blood. Myocardial infarction, ventricular arrhythmia (irregular heartbeats), pulmonary edema (increased fluid volume in the lungs), and cerebral hemorrhage (at high doses or in sensitive patients).

Nervous excitement (generally with high doses and more frequently in elderly patients and children), which may include symptoms such as: restlessness, insomnia, nervousness, tremors, delirium, palpitations, and even convulsions. Other adverse effects that may appear with low frequency are: chest tension, lung noises, rapid or irregular heartbeats (generally with overdose), liver disorders (which may present with stomach pain or abdominal pain, dark urine, or other symptoms), allergic reaction, severe hypersensitivity reactions, anaphylactic reaction (cough, difficulty swallowing, rapid heartbeats, itching, swelling of eyelids or around the eyes, face, tongue, difficulty breathing, fatigue, etc.), photosensitivity (sensitivity to sunlight), cross-sensitivity (allergy) to medications related to chlorphenamine. Blood disorders (changes in the formula of blood cells, such as agranulocytosis, leukopenia, aplastic anemia, thrombocytopenia) with symptoms such as unusual bleeding, sore throat, or fatigue; low or high blood pressure, edema (swelling), alterations in the ears, impotence, menstrual disorders.

• Adverse effects that may appear with very low frequency (very rare) are:

Kidney disease, cloudy urine, allergic reaction (skin rash or anaphylactic shock), jaundice (yellowish skin color), blood disorders (neutropenia, hemolytic anemia), and hypoglycemia (low blood sugar).

Very rare cases of severe skin reactions have been reported.

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

• Adverse effects whose frequency of appearance is not known (cannot be estimated from available data) are:

Restlessness, anxiety, nervousness, irritability, weakness, dizziness, tremors, insomnia, high blood pressure (hypertension, generally with high doses and in sensitive patients), headache (with high doses and may be a symptom of hypertension),

Chest pain or discomfort, very slow heartbeats (severe bradycardia), reduction of blood vessel caliber (peripheral vasoconstriction), reduction of heart performance that affects especially elderly patients and patients with poor cerebral or coronary circulation, possible production or worsening of a heart disease.

Urinary retention, paleness, goosebumps, sweating, high blood pressure, high blood sugar (hyperglycemia), low potassium levels in the blood, metabolic acidosis (metabolic disorder), coldness in the extremities (legs or arms), flushing, feeling of fainting (hypotension). With high doses, the following may occur: vomiting, palpitations, psychotic states with hallucinations; with prolonged use, a decrease in blood volume may occur.

A serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaRAM.es/. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Fortmyl

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.

No special storage conditions are required.

Medications should not be thrown away through the sewers or in the trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. In case of 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 Fortmyl

Each sachet contains:

• As active ingredients: 650 mg of paracetamol, 15.58 mg of phenylephrine bitartrate (equivalent to 8.21 mg of phenylephrine), and 4 mg of chlorphenamine maleate (equivalent to 2.8 mg of chlorphenamine)

• The other components (excipients) are: mannitol (E-421), sodium saccharin, anhydrous colloidal silica, orange flavor, and povidone.

Appearance of the Product and Package Contents

Fortmyl is a granulate for oral solution, white or yellowish in color, and orange in flavor, presented in paper sachets coated with clay/aluminum, which are packaged in cardboard boxes with 10 sachets.

Marketing Authorization Holder

Viamoalta, S.L.

AV. Santuario de Valverde, 11 Puerta B

28049 Madrid

Spain

Manufacturer

Laboratorios Alcalá Farma, S.L

Avenida de Madrid, 82

28802 Alcalá de Henares (Madrid)

Spain

Date of the Last Revision of this Prospectus: February 2025

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