Package Insert: Information for the Patient

Secrepat Chewable TabletsAnise Flavor

Aluminum Glycinate, Calcium Carbonate, Aluminum Hydroxide,Magnesium Trisilicate

It is an association of 4 active principles,aluminum glycinate,calcium carbonate,aluminum hydroxide,andmagnesium trisilicate. These active principles act by reducing excess acidity in the stomach.

It is indicated for the relief and symptomatic treatment of stomach acidity and heartburn in adults andadolescents12 years of age and older.

You should consult a doctor if it worsens or does not improve after 7 days.

Do not take Secrepat:

• If you are allergic to aluminum glycinate, calcium carbonate, aluminum hydroxide, magnesium trisilicate or any of the other components of this medication (listed in section 6).
• If you have severe kidney failure.
• If you have hypermagnesemia (elevated levels of magnesium in the blood).
• If you have hypercalcemia (elevated levels of calcium in the blood).
• If you have intestinal obstruction (partial or complete blockage of the intestine that causes an interruption of the passage of intestinal contents through the same).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Secrepat.

Like other antacids, this medication may mask the symptoms of a more serious stomach disease, such as a peptic ulcer or a malignant process, so if symptoms persist or worsen after 7 days of treatment, consult your doctor.

It is not recommended to use antacids that contain aluminum in general in patients with Alzheimer's disease, as it may contribute to the development of the disease.

Before taking the medication, consult your doctor in the following cases:

• SIf you present appendicitis or symptoms of appendicitis, as the laxative or astringent effects may increase the risk of perforation or rupture;
• SIf you have undergone any ileostomy (surgery on the intestine) or colostomy (surgery on the colon);
• Si padece estreñimiento o impactación fecal (masa de heces grande,dura y seca que puededesarrollarse en elrecto debido a estreñimiento crónico);
• SIf you have pyloric obstruction (narrowing of the sphincter that connects the stomach to the small intestine);
• -SIf you have hemorrhoids;
• -Si tiene hipoparatiroidismo (enfermedad del tiroides);
• SIf you have sarcoidosis (inflammatory disease that affects multiple organs of the body, primarily lungs and lymph nodes);
• SIf you have a low-phosphorus diet, diarrhea, malabsorption, or kidney transplant, as, especially with prolonged treatments, it may cause hypophosphatemia (anorexia, muscle weakness, general discomfort) and bone diseases such as osteomalacia, osteoporosis, and fractures, especially in patients with other bone diseases;
• Si tiene insuficiencia renal (enfermedad del riñón) leve omoderada y necesita tomar este medicamento, lo hará con precaución: evitarátomar dosis altas ya que existe el riesgo de intoxicación por hipermagnesemia(aumento de los niveles de magnesio en sangre) e hiperaluminemia (aumento delos niveles de aluminio en sangre). Asimismo, evitará tratamientos crónicos ya que podrán dar lugar a encefalopatías (intoxicación por aluminio) ohipermagnesemia (aumento de los niveles de magnesio en sangre);
• Si tiene hemorragia gastrointestinal o rectal no diagnosticada,diverticulitis (inflamación de pequeños sacos o bolsas en el intestino),enfermedad inflamatoria intestinal, cálculos renales o, bien, ingiere habitualmente grandescantidades de alcohol.

The long-term use of high doses of this medication may cause adverse effects such as hypermagnesemia (elevated levels of magnesium in the blood), hypercalcemia (elevated levels of calcium in the blood), hypocalcemia (elevated levels of aluminum in the blood), and metabolic alkalosis (metabolic disorder).

Interference with diagnostic tests

Do not take antacids on the same morning as the test for evaluation of gastric acid secretion, as it may alter the results.

This medication may interfere with laboratory test values. It may increase blood levels of calcium and gastrin.

When taking Secrepat, blood levels of potassium and phosphate may decrease.

Antacids may increase blood and urine pH.

Secrepat with other medications

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

Antacids modify the absorption or elimination of many medications, so you should separate the intake of any antacid from other medications by 2-3 hours.

The following medications may interfere and should not be taken with Secrepat without consulting your doctor: tetracyclines and fluoroquinolones (antibiotics), phenothiazines (antipsychotics), digoxin (heart medication), isoniazid (tuberculosis medication), iron salts, and ketoconazole (antifungal). You should space the intake of Secrepat and these medications by at least 2 hours.

It is not recommended to take Secrepat with the following medications: sodium phosphate cellulose (kidney stone treatment medication), mecamilamine (hypertension medication), methenamine (antibiotic), and polystyrene sulfonate sodium (potassium level elevation treatment medication).

Secrepat with food

Due to its calcium carbonate content, the simultaneous and prolonged treatment of this medication with the consumption of milk or dairy products may lead to the "milk and alkaline" syndrome (hypercalcemia: elevated levels of calcium in the blood, and metabolic alkalosis).

Pregnancy and lactation

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

The consumption of medications during pregnancy can be hazardous to the embryo or fetus, and should be monitored by your doctor.

A certain amount of calcium, aluminum, and magnesium may pass into breast milk, but the amounts reached in the milk are not sufficient to cause effects in the newborn.

Driving and operating machinery

Secrepat tablets do not affect the ability to drive vehicles or operate machinery.

Secrepat chewable tablets with anise flavor contain lactose, sodium, and alcohol

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medication. This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

This medication contains 0.00024 mg of alcohol (ethanol) per maximum daily dose (8 tablets). The volume of this medication is equivalent to less than 0.000006 ml of beer or 0.0000024 ml of wine. The small amount of alcohol in this medication does not produce any noticeable effect.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose for adults and adolescents over 12 years old is 1 or 2 chewable tablets when symptoms appear, and preferably between 20 minutes and 1 hour after meals and before bedtime.

Do not take more than 8 chewable tablets per day.

Always use the lower effective dose.

The tablets must be chewed before swallowing.

Use in children:

Do not administer to children under 12 years old.

If symptoms do not improve in 7 days, discontinue treatment and consult a doctor.

If you take more Secrepat than you should

If you take more Secrepat than recommended, diarrhea, abdominal pain, and vomiting may appear.

In case of overdose or accidental ingestion of large quantities of Secrepat, go immediately to a medical center or call the Toxicological Information Service, phone: 915.620.420, indicating the medication and the amount ingested.

If you forgot to take Secrepat

Do not take a double dose to compensate for the missed doses.

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

Like all medications,thismedicationmay cause adverse effects, although not all people will experience them.

The adverse effects that may appear with the use ofSecrepatare generally mild and transient.

Very rare adverse effects (may affect up to 1 in 10,000 patients): constipation or diarrhea.

Adverse effects of unknown frequency:

When high doses ofSecrepatare taken or when it is taken for very long periods of time, the following adverse effects may appear:

Fecaloma (hard stool mass that obstructs defecation), lower limb edema, hypercalcemia (elevated calcium levels in blood), hyperaluminemia (elevated aluminum levels in blood), hypophosphatemia (abnormally low phosphate levels in blood), kidney stones or renal calculi, bone diseases such as osteomalacia and osteoporosis, or phosphate depletion syndrome.

Additionally, in the case of kidney disease: metabolic alkalosis, hypermagnesemia (elevated magnesium levels in blood).

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 directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

No special storage conditions are required.

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.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the Pharmacy Take-Back Point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Secrepat

• The active principles per chewable tablet are400 mg of aluminum glycinate, 150 mg of calcium carbonate, 100 mg of aluminum hydroxide, and 50 mg of magnesium trisilicate.
• The otherscomponents (excipients)are povidone, mannitol (E-421), sodium saccharin, sodium cyclamate, anise flavor (which contains lactose, sodium, and ethanol), magnesium stearate.

Appearance of the product and contents of the packaging

PVC/PVDC/Aluminum blister with 8 or 50 chewable tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder

ANGELINI PHARMA ESPAÑA, S.L.

c/ Antonio Machado, 78-80

3rd floor, module A-Edificio Australia

08840 Viladecans, Barcelona (Spain)

Responsible for manufacturing

Laboratorios ALCALÁ FARMA, S.L.

Avenida de Madrid, 82

28802 Alcalá de Henares (Madrid)

Spain

Last review date of this leaflet:January 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/