Package Insert: Information for the User

Magnesia San Pellegrino 3.6 g Powder for Oral Suspension

Magnesium Hydroxide

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

• Follow exactly the administration instructions for the medication contained in this package insert or those indicated by your doctor, pharmacist, or nurse.
• Keep this package insert, as you may need to refer to it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

You should consult a doctor if your condition worsens or does not improve after 7 days of treatment.

Magnesia San Pellegrino is a laxative medication.

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

Consult a doctor if symptoms worsen or do not improve after 7 days of treatment.

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 electrolyte imbalance (salts and water present in the body)
  • Apendicitis, intestinal obstruction, undiagnosed gastrointestinal or rectal bleeding, ulcerative colitis (inflammatory disease of the colon), colostomy (surgical procedure in which the end of the large intestine is removed through the abdominal wall), diverticulitis (inflammation of the intestinal wall, forming abnormal pouches), ileostomy (surgical procedure in which the end of the small intestine is removed 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 diseases
• If you are dehydrated
• If you are over 65 years old
• If you are weakened.

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

Consult your doctor as soon as possible if you have any symptoms such as unknown abdominal pain, any symptom indicating bleeding (such as black stools or coffee ground vomit), cramps, swollen or painful abdomen, nausea, vomiting, and diarrhea.

Children

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

Taking Magnesia San Pellegrino with other medications

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

The concurrent administration of Magnesia San Pellegrino with other medications may alter the absorption or action of other medications used for the treatment of:

• Diabetes: chlorpropamide, glibenclamide, glipizide, tolbutamide
• Infections: sulfonamides, quinolones (ciprofloxacin, ofloxacin, pefloxacin, enoxacin), tetracyclines (chlor tetracycline, doxycycline, tetracycline), ketoconazole, methenamine
• Blood clotting problems: dicumarol
• Anemia: iron salts, folic acid
• Parkinson's disease: levodopa
• Spasms or contractions of the stomach, intestines, and bladder (anticholinergic medications)
• Cardiovascular diseases: atenolol, digoxin, captopril, quinidine
• Psychiatric diseases: phenothiazines (especially oral chlorpromazine), chlordiazepoxide, amphetamines
• Epilepsy: phenytoin
• Digestive system diseases: medications used for acid reflux (cimetidine, etc.), misoprostol, pancreolipase, sucralfate
• Inflammation: indomethacin, penicillamine, salicylates, ibuprofen, flurbiprofen, mefenamic acid or flufenamic acid
• Metabolic diseases: oral phosphates, alendronate acid and tiludronic acid, polystyrene sulfonate resin, vitamin D, including calcifediol and calcitriol
• Smoking cessation: mecamylamine
• Other: 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.

Take Magnesia San Pellegrino 2 to 3 hours apart from other medications.

Interference with diagnostic tests

If you are to undergo any diagnostic test (blood, urine, 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 before undergoing a test for gastric acid secretion, serum gastrin concentrations (hormone that regulates acid secretion in the stomach), serum potassium concentrations, and serum and urine pH determination.

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, or think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

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

Magnesia San Pellegrino 3.6 g Powder for oral suspension in sachets contains saccharose. If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose for adults and adolescents 12 years and older is 1 tablet per day.

How to Take

This medication is taken orally.

Put 200 ml of water in a glass and add the contents of the packet. Stir with a spoon until there is no medication left at the bottom of the glass and drink immediately.

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

Take preferably in the morning on an empty stomach.

If there is no improvement or 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, discoordination, and muscle weakness.

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

Like all medications, Magnesia San Pellegrino may cause adverse effects, although not everyone will experience them.

During the period of use of magnesium hydroxide as a laxative and as an antacid, the following adverse effects have been observed, although their frequency has not been established with precision:

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

Reporting Adverse Effects:

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

Medicines should not be disposed of through the drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Magnesia San Pellegrino 3.6 g Powder for oral suspension in sachets

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

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

Appearance of the product and contents of the packaging

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

Holder of the marketing authorization:

Anotaciones Farmacéuticas, S.L.

Ctra de Rubí to Sant Cugat, km 1, nº 40-50, 6th floor

08174 Sant Cugat del Vallés (Barcelona)

Responsible for manufacture:

SINCROFARM, S.L.

C/ Mercurio, 10, Pol. Ind. Almeda

08940 Cornellà de Llobregat (Barcelona), Spain

or

LABIANA PHARMACEUTICALS, S.L.U.

Casanova 27- 31

Corbera de Llobregat (Barcelona), Spain

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

Other sources of information

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/