Prospect: Information for the User

MAGNESIA SEID 2.4 g POWDER FOR ORAL SUSPENSION

Magnesium Hydroxide

1. What is Magnesia Seid 2.4 g and how is it used

2. What you need to know before starting to take Magnesia Seid 2.4 g

3. How to take Magnesia Seid 2.4 g

4. Possible adverse effects

5. Storage of Magnesia Seid 2.4 g

6. Contents of the package and additional information

This medication belongs to a group of medications called laxatives.

It is indicated for the symptomatic and temporary treatment of occasional constipation in adults and adolescents over 12 years old.

Consult a doctor if it worsens or does not improve after 5 days.

Do not takeMagnesia Seid:

• If you are allergic to magnesium hydroxide or any of the other components of this medication (listed in section 6).
• During the 24 hours before the acid gastric secretion test.

If you have:

• A severe kidney disease.
  Any disease that causes electrolyte imbalance (salts and water present in the body).
• Apendicitis, intestinal obstruction, undiagnosed gastrointestinal or rectal hemorrhage, 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).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Magnesia Seid.

Be especially careful if you have any kidney disease, even if it is not severe, or liver or heart diseases. Also, a special control should be performed in cases of dehydration, in the elderly, or if you have swelling of the feet or lower legs.

You should consult your doctor if you have any symptoms indicating hemorrhage, such as black stools or coffee ground vomit.Consult your doctor as soon as possible if you have any symptoms such as unknown abdominal pain, cramps, bloated and painful abdomen, nausea, vomiting, and diarrhea.

Children and adolescents

Do not administer to children under 12 years old.

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

Use of Magnesia Seid with other medications

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

Some medications may be affected by magnesium hydroxide or may affect the efficacy of magnesium hydroxide. The concurrent administration of Magnesia Seid 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 coagulation problems: dicumarol.
• Anemia: iron salts, folic acid.
• Parkinson: levodopa.
• Spasms or contractions of the stomach, intestine, 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 acidity (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 resin, sodium sulfate, 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.

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

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 Seid, as it may alter the results.

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

Taking Magnesia Seid with food and drinks

Take in the morning, fasting.

Pregnancy and lactation

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

Driving and operating machinery

No effects on the ability to drive vehicles or operate machinery have been described.

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

Oral route

The recommended dose for adults and children over 12 years old is one sachet every 24 hours taken in the morning, on an empty stomach.

Empty the powder contained in one sachet into half a glass of water and shake it before taking it.

Always take the lowest effective dose.

If there is no improvement or symptoms persist after 5 days of continuous treatment, you must consult a doctor.

If you take more Magnesia Seid than you should

Consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 5620420, indicating the medication and the amount ingested.

The symptoms of overdose that may occur are diarrhea and, less frequently, may appear hypomagnesemia, with disturbances in vision, heart rhythm, and neurological disturbances.

If you forgot to take Magnesia Seid

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

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 all people may experience them.

The adverse effects of magnesium hydroxide are generally mild and transient.

Gastrointestinal Disorders

• Frequent (may affect up to 1 in 10 people):diarrhea
• Unknown frequency: abdominal pain

Metabolism and Nutrition Disorders

• Very rare(may affect up to 1 in 10,000 people): hypermagnesemia (elevated magnesium levels in blood) after prolonged administration in patients with renal insufficiency. Initial symptoms include flushing, thirst, hypotension, nausea, vomiting, generalized fatigue, confusion, dizziness, blurred vision, discoordination, and muscle weakness.

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

Keepthis medicationout of the sight and reach of children.

No special storage conditions are required.

Do not usethis medicationafter the expiration date that appears on the packagingaftertheCAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash.Deposit the containers and medications you no longer need at the SIGREpoint of the pharmacy. If in doubt, please ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Magnesia Seid 2.4 g

• The active ingredient is magnesium hydroxide. Each sachet contains 2.4 g of magnesium hydroxide.

• The other components are: microcrystalline cellulose, sodium carmellose, sodium cyclamate, and lemon aroma (containing maltodextrin, modified tapioca starch, and butylhydroxyanisole (E 320)).

Appearance of the product and contents of the packaging

Magnesia Seid is presented in the form of an oral suspension powder, in single-dose sachets.

Each box contains 14 or 200 sachets with 2.6 g each.

Holder of the marketing authorization and responsible for manufacturing

SEID, S.A.

Carretera de Sabadell a Granollers, Km. 15

08185 - Lliçà de Vall (Barcelona)

Last review date of this leaflet:October 2017

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)

http://www.aemps.gob.es/.