MAGNESIA SEID 2.4 g POWDER FOR ORAL SUSPENSION

Introduction

Prospectus: Information for the User

MAGNESIA SEID 2.4 g POWDER FOR ORAL SUSPENSION

Magnesium Hydroxide

Contents of the Prospectus:

1. What is Magnesia Seid 2.4 g and what is it used for
2. What you need to know before taking Magnesia Seid 2.4 g
3. How to take Magnesia Seid 2.4 g
4. Possible side effects
5. Storage of Magnesia Seid 2.4 g
6. Package contents and additional information

1. What is Magnesia Seid 2.4 g and what is it used for

This medication belongs to the group of medications known as laxatives.

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

You should consult a doctor if your condition worsens or does not improve after 5 days.

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

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 prior to undergoing a gastric acid secretion test.

If you have:

• A severe kidney disease. Any disease that causes hydroelectrolytic imbalance (salts and water present in the body).
• Appendicitis, intestinal obstruction, gastrointestinal or rectal bleeding that has not been 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).

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 disease. You should also be under special control in cases of dehydration, in the elderly, or if you have swelling in your feet or lower legs.

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

Children and adolescents

Do not administer to children under 12 years of age.

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

Using Magnesia Seid withother medications

Tell your doctor or pharmacist if you are taking, have recently taken, 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 to treat:

• Diabetes: chlorpropamide, glibenclamide, glipizide, tolbutamide.
• Infections: sulfonamides, quinolones (ciprofloxacin, ofloxacin, pefloxacin, enoxacin), tetracyclines (chlotetracycline, doxycycline, tetracycline), ketoconazole, methenamine.
• Blood coagulation disorders: dicumarol.
• Anemia: iron salts, folic acid.
• Parkinson's disease: levodopa.
• Spasms or contractions of the stomach, intestine, and bladder (anticholinergic medications).
• Cardiovascular diseases: atenolol, digoxin, captopril, quinidine.
• Psychiatric disorders: 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 disorders: oral phosphates, alendronic acid and tiludronic acid, polystyrene resin, sodium sulfonate, vitamin D, including calcifediol and calcitriol.
• Smoking cessation: mecamylamine.
• Others: medications with enteric coating, urinary acidifiers, such as ammonium chloride, ascorbic acid, or potassium or sodium phosphate.

Separate the intake of Magnesia Seid 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 Seid, as it may alter the results.

Do not take this medication during the 24 hours prior to undergoing a 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 Seid with food and drinks

Take in the mornings, on an empty stomach.

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

It has not been described that this medication has any effect on the ability to drive vehicles or operate machinery.

3. How to take Magnesia Seid 2.4 g

Follow the administration instructions for this medication exactly as indicated in this prospectus or as directed 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 of age is one sachet every 24 hours, taken in the mornings, on an empty stomach.

Pour the powder contents of one sachet into half a glass of water and shake before taking.

Always take the smallest effective dose.

If you do not improve or symptoms persist after 5 days of continuous treatment, you should consult a doctor.If you take more Magnesia Seidthan you should

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

The symptoms of overdose that may occur are diarrhea and, more rarely, hypermagnesemia may appear, with vision disorders, cardiac rhythm disorders, and neurological disorders.

If you forget to take Magnesia Seid

Do not take a double dose to make up for forgotten doses.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone may experience them.

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

Gastrointestinal disorders

• Common (may affect up to 1 in 10 people): diarrhea
• Frequency not known: abdominal pain

Metabolism and nutrition disorders

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaRAM. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Magnesia Seid 2.4 g

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 your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Magnesia Seid 2.4 g

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

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

Appearance of the product and package contents

Magnesia Seid is presented as a powder for oral suspension, in single-dose sachets.

Each carton contains 14 or 200 sachets, each with 2.6 g.

Marketing authorization holder and manufacturer

SEID, S.A.

Carretera de Sabadell a Granollers, Km. 15

08185 - Lliçà de Vall (Barcelona)

Date of the last revision of this prospectus:October 2017

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/.