MAGNESIA LAINCO 2.4 g ORAL SUSPENSION

Introduction

PROSPECTUS: INFORMATION FOR THE USER

MAGNESIA LAINCO 2.4 g oral suspension

Magnesium hydroxide

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

Follow the administration instructions for the medication contained in this prospectus or as indicated by your doctor, pharmacist, or nurse.

• Keep this prospectus, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospectus.
• You should consult a doctor if your symptoms worsen or do not improve after 7 days of treatment.

Contents of the prospectus

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

1. What MAGNESIA LAINCO is and what it is used for

MAGNESIA LAINCO is a medication with laxative activity.

MAGNESIA LAINCO is indicated for the symptomatic and temporary 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 LAINCO

Do not take MAGNESIA LAINCO

• 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 debilitated.

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, 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 recently used, or may need to use any other medication.

The concomitant administration of MAGNESIA LAINCO 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 problems: 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 diseases: phenothiazines (especially oral chlorpromazine), chlordiazepoxide, amphetamines
• Epilepsy: phenytoin
• Diseases of the digestive system: 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: medications with enteric coating, urinary acidifiers, such as ammonium chloride, ascorbic acid or potassium or sodium phosphate.

Separate the intake of MAGNESIA LAINCO 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 LAINCO, 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 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, 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.

Important information about some of the components of MAGNESIA LAINCO

This medication contains sorbitol. 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 LAINCO

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

The recommended dose is:

• Adults and adolescents from 12 years of age: 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 lowest effective dose.

Shake the contents of the sachet well before taking the medication.

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

If your 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, generalized 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 adverse effects

Like all medications, MAGNESIA LAINCO can cause adverse effects, although not everyone experiences 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 frequency has not been established, it is the most observed adverse reaction) and abdominal pain.
• Very 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 that is not listed in this prospectus. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of MAGNESIA LAINCO

No special storage conditions are required.

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

Do not throw away medications through the sewers or in the trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist where to throw away medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

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, bromodiphenyl dimethyl ether, sorbitol (E-420), antifoam silicon (purified water, polydimethylsiloxane, sorbitan monoester, polyoxyethylene 20 sorbitan, amorphous silica, benzoic acid (E-210)), and purified water.

Appearance of the product and package contents

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

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

Marketing authorization holder and manufacturer

LAINCO, S.A.

Avda. Bizet, 8-12

08191 Rubí (Barcelona)

Date of the last revision of this prospectus: November 2017

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/