MAGNESIA SAN PELLEGRINO 3.6 g POWDER FOR ORAL SUSPENSION

Introduction

Leaflet: information for the user

Magnesia San Pellegrino 3.6 g Oral Powder for Suspension

Magnesium Hydroxide

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

• Follow the administration instructions of the medication contained in this leaflet or as indicated by your doctor, pharmacist, or nurse.
• 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, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

You should consult a doctor if your symptoms worsen or do not improve after 7 days of treatment.

Contents of the leaflet:

1. What Magnesia San Pellegrino is and what it is used for.
2. What you need to know before taking Magnesia San Pellegrino
3. How to take Magnesia San Pellegrino
4. Possible side effects.
5. Storage of Magnesia San Pellegrino
6. Package contents and additional information

1. What Magnesia San Pellegrino is and what it is used for

Magnesia San Pellegrino is a medication with laxative activity.

It is indicated for the symptomatic treatment of occasional constipation in adults and adolescents from 12 years of age.

You should consult a doctor if your symptoms worsen or do not improve after 7 days of treatment.

2. What you need to know before taking Magnesia San Pellegrino

Do not take Magnesia San Pellegrino:

• If you are allergic to magnesium hydroxide or any of the other components of this medication (listed in section 6).
• If you have:
• • severe kidney disease
  • any disease that causes hydroelectrolytic imbalance (salts and water present in the body)
  • appendicitis, intestinal obstruction, gastrointestinal or rectal bleeding not diagnosed, ulcerative colitis (inflammatory disease of the colon), colostomy (surgical procedure in which the end of the large intestine is brought through the abdominal wall), diverticulitis (inflammation in the intestinal wall, forming abnormal pouches), ileostomy (surgical procedure in which the end of the small intestine is brought through the abdominal wall)
  • chronic diarrhea.

Warnings and precautions

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

• If you have any kidney disease, even if it is not severe, or liver or heart disease
• If you are dehydrated
• If you are over 65 years old
• If you are weakened.

If your symptoms worsen or persist after 7 days of continuous treatment, you should consult your doctor.

Consult your doctor as soon as possible if you have any symptoms such as abdominal pain of unknown origin, any symptoms that indicate bleeding (such as black stools or vomit like coffee grounds), cramps, bloated or painful abdomen, nausea, vomiting, and diarrhea.

Children

In young children, the use of magnesium hydroxide can cause hypermagnesemia, especially in the presence of renal insufficiency or dehydration.

Taking Magnesia San Pellegrino with other medications

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

Taking Magnesia San Pellegrino with other medications may alter the absorption or action of other medications used to treat:

• Diabetes: chlorpropamide, glibenclamide, glipizide, tolbutamide
• Infections: sulfonamides, quinolones (ciprofloxacin, ofloxacin, pefloxacin, enoxacin), tetracyclines (chloretracycline, doxycycline, tetracycline), ketoconazole, methenamine
• Blood coagulation problems: dicumarol
• Anemia: iron salts, folic acid
• Parkinson's disease: levodopa
• Stomach, intestine, and bladder spasms or contractions (anticholinergic medications)
• Cardiovascular diseases: atenolol, digoxin, captopril, quinidine
• Psychiatric diseases: phenothiazines (especially oral chlorpromazine), chlordiazepoxide, amphetamines
• Epilepsy: phenytoin
• Digestive system diseases: medications used for acidity (cimetidine, etc.), misoprostol, pancreolipase, sucralfate
• Inflammation: indomethacin, penicillamine, salicylates, ibuprofen, flurbiprofen, mefenamic acid or flufenamic acid
• Metabolic diseases: oral phosphates, alendronic acid and tiludronic acid, sodium polystyrene sulfonate resin, vitamin D, including calcifediol and calcitriol
• Smoking cessation: mecamylamine
• Others: enteric-coated medications, urinary acidifiers, such as ammonium chloride, ascorbic acid, or potassium or sodium phosphates.

Interactions of magnesium hydroxide with other medications

Some medications may be affected by magnesium hydroxide or may affect the efficacy of magnesium hydroxide. In case of doubt, ask your doctor or pharmacist – salicylates.

Separate the intake of Magnesia San Pellegrino from the intake of other medications by 2 to 3 hours.

Interference with diagnostic tests

If you are going to undergo any diagnostic test (blood test, urine test, etc.), inform your doctor or pharmacist that you are being treated with Magnesia San Pellegrino, as it may alter the results.

Do not take this medication during the 24 hours prior to the performance of the gastric acid secretion test, serum gastrin concentrations (hormone that regulates acid secretion in the stomach), serum potassium concentrations, and determination of serum and urinary pH.

Taking Magnesia San Pellegrino with food and drinks

This medication can be taken with or without food and drinks.

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 using this medication.

Driving and using machines

The use of this medication does not affect the ability to drive and/or use machines.

Magnesia San Pellegrino 3.6 g Oral Powder for Suspension in sachets 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 Magnesia San Pellegrino

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

The recommended dose for adults and adolescents from 12 years of age is 1 sachet per day.

How to take

This medication is taken orally.

Pour 200 ml of water into a glass and add the contents of the sachet. Stir with a spoon until no medication remains at the bottom of the glass and drink immediately.

It is recommended to drink plenty of liquid throughout the day.

Take preferably in the morning on an empty stomach.

If you do not improve or your symptoms persist after 7 days of continuous treatment, you should consult a doctor.

If you take more Magnesia San Pellegrino than you should

The symptoms of an overdose are: flushing, thirst, hypotension, nausea, vomiting, general fatigue, confusion, dizziness, blurred vision, disorientation, and muscle weakness.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 915620420, indicating the medication and the amount ingested.

4. Possible side effects

Like all medications, Magnesia San Pellegrino can cause side effects, although not everyone experiences them.

During the period of use of magnesium hydroxide as a laxative and antacid, the following side effects have been observed, whose frequency cannot be established with precision:

• very common: diarrhea
• unknown frequency: abdominal pain
• very rare: HyperMagnesemia HyperMagnesemia has been observed after prolonged administration in patients with renal insufficiency.

Reporting side effects:

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

5. Storage of Magnesia San Pellegrino

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 shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. 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 Magnesia San Pellegrino 3.6 g Oral Powder for Suspension in sachets

Each sachet contains 3.6 g of magnesium hydroxide as the active ingredient.

The other components (excipients) are: sucrose (0.4 g) and anise essence.

Appearance of the product and package contents

Magnesia San Pellegrino 3.6 g Oral Powder for Suspension is a fine white powder with an anise flavor and aroma, presented in boxes with 20 sachets.

Marketing authorization holder:

Anotaciones Farmacéuticas, S.L.

Calle Amposta, 14-18, planta 2 puerta 2B

08174 Sant Cugat del Vallés (Barcelona)

Manufacturer:

SINCROFARM, S.L.

C/ Mercurio, 10, Pol. Ind. Almeda

08940 Cornellà de Llobregat (Barcelona), España

or

LABIANA PHARMACEUTICALS, S.L.U.

Casanova 27- 31

Corbera de Llobregat (Barcelona), España

Date of the last revision of this leaflet: December - 2013.

Other sources of information

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/