Leaflet: information for the user

Magnesia Lainco200 mg/ml oral suspension

Magnesium hydroxide

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this leaflet or those indicated by your doctor, pharmacist or nurse.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if you get worse or do not improve after 7 days of treatment.

1.What isMagnesia Laincoand what is it used for

2.What you need to know before you start takingMagnesia Lainco

3.How to takeMagnesia Lainco

4.Possible side effects

5Storage ofMagnesia Lainco

6.Contents of the pack and additional information

It is a laxative medication.

It 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 takeMagnesia 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 electrolyte imbalance (salts and water present in the body)
  • appendicitis, 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)
  • chronic diarrhea.

Warnings and precautions

Consult your doctor, pharmacist before starting to takeMagnesia Lainco:

• 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.

TakingMagnesia Laincowith 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 ofMagnesia Laincowith 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
• Mental health disorders: 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 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 ofMagnesia Laincofrom 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 withMagnesia Lainco, 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.

TakingMagnesia Laincowith food and drinks

This medication can be taken with or without food and drinks.

Pregnancy, breastfeeding, and fertility

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 operating machinery

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

Magnesia Laincocontains sorbitol

This medication contains sorbitol. If your doctor has indicated 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:5-10 ml (1-2 g) up to 25 ml (5 g) per day in a single dose or divided into 2 doses, as needed.

This medication is taken orally.

Always take the lower effective dose.

Shake the bottle well before taking the medication.

You can take it directly, or mix it with water, juices, or infusions. It is recommended to take each dose 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 moreMagnesia Laincothan 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 overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 915620420, indicating the medication and the amount ingested.

If you forgot to takeMagnesia Lainco

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

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

Like all medications,Magnesia Laincomay cause adverse effects, although not everyone will experience them.

During the period of use of magnesium hydroxide as a laxative, the following adverse effectshave 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 observedafter 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 does not appear 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 after CAD. The expiration date is the last day of the month indicated.

Shelf life after the first opening: 2 months, no special conditions for conservation are required.

Medications should not be disposed of through drains or in the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point at 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 ofMagnesia Lainco

Appearance of the product and contents of the packaging

Magnesia Laincois presented in a case with a amber-colored glass bottle with a polyethylene stopper, containing 220 ml of oral suspension, accompanied by a polystyrene dosing cup. 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

Other sources of information

The detailed and updated information on this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS):http://www.aemps.gob.es/