PROSPECTO: INFORMATION FOR THE USER

MAGNESIA LAINCO 2.4 g oral suspension

Magnesium hydroxide

Read this prospect carefully beforestarting totakethis medicationbecause it contains important information for you.

Follow exactly the medication administration instructions contained in this prospect or those indicated by your doctor, pharmacist, or nurse.

• Keep this prospect, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult yourdoctor,pharmacistor nurse,even if they are not listed in this prospect.
• You should consult a doctor if you worsen or do not improveafter7 days of treatment.

1. What isMAGNESIA LAINCOand what is it used for

2. What you need to knowbefore starting to takeMAGNESIA LAINCO

3. Howto takeMAGNESIA LAINCO

4. Possible adverse effects

5. Storage ofMAGNESIA LAINCO

6. Contents of the package and additional information

MAGNESIA LAINCO is a laxative medication.

MAGNESIA LAINCO is indicated for the symptomatic and temporary 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 LAINCO

-If you are allergic to magnesium hydroxide or any of the other components of thismedication (listed in section 6).

-If you have:

-severe kidney disease

-any disease that causes electrolyte imbalance (salts and water present in the body)

-appendicitis, 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, cramps, bloated or painful abdomen, nausea, vomiting, and diarrhea.

Taking MAGNESIA LAINCO with other medications

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

The simultaneous administration of MAGNESIA LAINCO 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's disease: levodopa

-Spasms or contractions of the stomach, intestines, and bladder (anticholinergic medications)

-Cardiovascular diseases: atenolol, digoxin, captopril, quinidine

-Mental health disorders: phenothiazines (especially oral chlorpromazine), chlordiazepoxide, anphetamines

-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 disorders: 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.

Separate the taking of MAGNESIA LAINCO from the taking 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 LAINCO, as it may alter the results.

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

Taking MAGNESIA LAINCO 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, 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.

Important information about some of the components of MAGNESIA LAINCO

This medication contains sorbitol. If your doctor has told you that you have a certain sugar intolerance, consult with them 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 is:

-Adults and adolescents 12 years and older:1 or 2 sachets per day as needed, in a single dose or divided into 2 doses.

This medication is taken orally.

Always take the lower effective dose.

Shake the sachet well before taking the medication.

It can be taken directly from the sachet, or it can be mixed with water, juices, or infusions. It is recommended to take each sachet with plenty of liquid (200 ml, a full glass).

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

If you take more MAGNESIA LAINCO 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

Toxicology Information Service, phone 915620420 indicating the medication and the

amount ingested.

Like all medications, MAGNESIA LAINCO may cause adverse effects, although not everyone will experience them.

During the period of use of magnesium hydroxide as a laxative, the following adverse effects have been observed with the frequency described below:

-Unknown frequency: diarrhea (although its exact frequency has not been established) and abdominal pain.

-Rare adverse reactions (may affect up to 1 in 10,000 people): hypermagnesemia (elevated magnesium levels in the blood). 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 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 about the safety of this medication.

No requires special conditions for conservation.

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

Do not use this medication after the expiration date that appears on the packaging afterthe CAD. The expiration date is the last day of the month indicated.

Do not throw the medications down the drains or in the trash. Deposit the packaging and themedications that you no longer need at the SIGRE collection point of the pharmacy. In case of doubt, askyour pharmacist where to dispose of the medications that you no longer need. In this way, you will help toprotect the environment.

Composition of MAGNESIA LAINCO

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

-The other components (excipients) are: microcrystalline cellulose-carmellose sodium, xanthan gum, carmellose sodium, sodium saccharin, orange flavor, domifen bromide, sorbitol (E-420), silicon antifoaming agent (purified water, polymethylsiloxane, sorbitan monoestearate, polyethylene oxide 20 sorbitan, amorphous silica, benzoic acid (E-210)), and purified water.

Appearance of the product and contents of the packaging

MAGNESIA LAINCO is presented in boxes with 14 sachets and clinical packaging with 200 sachets, each sachet containing 12 ml of oral suspension.

The suspension is white, viscous, sweet-tasting, and has an orange odor.

Holder of the marketing authorization and responsible for manufacturing

LAINCO, S.A.

Avda. Bizet, 8-12

08191 Rubí (Barcelona)

Date of the last review of this leaflet: November 2017

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/