Magnesia Lainco 200 mg/ml oral suspension

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Magnesia Lainco 200 mg/ml oral suspension

Magnesium hydroxide

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

Follow exactly the instructions for administration 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 adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.
• You should consult a doctor if you worsen or do not improve after 7 days of treatment.

Contents of the leaflet:

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 side effects

5. Storage of Magnesia Lainco

6. Contents of the pack and other information

1. What Magnesia Lainco is and what it is used for

It is a medication with laxative activity.

It is indicated for the symptomatic and short-term treatment of occasional constipation in adults and adolescents aged 12 years and older.

You should consult a doctor if your condition worsens or does not improve after 7 days of treatment.

2. What you need to know before starting to take Magnesia Lainco

Do not take Magnesia Lainco

• If you are allergic to magnesium hydroxide or any of the other components of this medicine (listed in section 6).
• If you have:
  • severe kidney disease
  • any condition causing hydroelectrolytic imbalance (salts and water in the body)
  • appendicitis, intestinal obstruction, undiagnosed gastrointestinal or rectal bleeding, ulcerative colitis (inflammatory bowel disease of the colon), colostomy (a surgical procedure in which the end of the large intestine is brought through the abdominal wall), diverticulitis (inflammation of the intestinal wall forming abnormal pouches), ileostomy (a 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 Magnesia Lainco:

• If you have any kidney disease, even if not severe, or any liver or heart disease.

• If you are dehydrated.

• If you are over 65 years of age.

• If you are weakened.

If symptoms worsen or persist after 7 days of continuous treatment, consult your doctor.

Contact your doctor as soon as possible if you experience any symptoms such as abdominal pain of unknown origin, cramps, bloated or painful abdomen, nausea, vomiting, or diarrhea.

Taking Magnesia Lainco with other medicines

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

Concomitant administration of Magnesia Lainco with other medicines may alter the absorption or action of other medicines used to treat:

• Diabetes: chlorpropamide, glyburide, glipizide, tolbutamide
• Infections: sulfonamides, quinolones (ciprofloxacin, ofloxacin, pefloxacin, enoxacin), tetracyclines (chlortetracycline, doxycycline, tetracycline), ketoconazole, methenamine
• Blood coagulation disorders: dicoumarol
• Anemia: iron salts, folic acid
• Parkinson's disease: levodopa
• Stomach, intestinal, and bladder spasms or contractions (anticholinergic medicines)
• Cardiovascular diseases: atenolol, digoxin, captopril, quinidine
• Psychiatric disorders: phenothiazines (especially oral chlorpromazine), chlordiazepoxide, amphetamines
• Epilepsy: phenytoin
• Digestive disorders: medicines used for acidity (cimetidine, etc.), misoprostol, pancreolipase, sucralfate
• Inflammation: indomethacin, penicillamine, salicylates, ibuprofen, flurbiprofen, mefenamic acid or flufenamic acid
• Metabolic disorders: oral phosphates, alendronate acid and tiludronate acid, sodium polystyrene sulfonate resin, vitamin D, including calcifediol and calcitriol
• Smoking cessation: mecamylamine
• Others: enteric-coated medicines, urinary acidifiers such as ammonium chloride, ascorbic acid or potassium or sodium phosphates.

Separate the administration of Magnesia Lainco from other medicines by 2 to 3 hours.

Interference with diagnostic tests

If you are scheduled for any diagnostic tests (blood, urine, etc.), inform your doctor or pharmacist that you are being treated with Magnesia Lainco, as it may alter test results.

Do not take this medicine within 24 hours prior to undergoing tests for gastric acid secretion, serum gastrin levels (a hormone regulating stomach acid secretion), serum potassium levels, or serum and urinary pH determination.

Taking Magnesia Lainco with food and drinks

This medicine may be taken with or without food and drinks.

Pregnancy, breastfeeding and fertility

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

Driving and use of machines

This medicine does not affect the ability to drive and/or operate machinery.

Magnesia Lainco contains sorbitol

This medicine contains sorbitol. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Magnesia Lainco

Follow exactly the instructions for use provided in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

• Adults and adolescents aged 12 years and older: 5–10 ml (1–2 g), up to 25 ml (5 g) per day, taken as a single dose or divided into 2 doses, as needed.

This medicine is taken orally.

Always take the lowest effective dose.

Shake the bottle well before taking the medicine.

It can be taken directly, but may also be mixed with water, juices, or infusions. It is advisable 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 more Magnesia Lainco than you should

Symptoms of overdose include: flushing, thirst, hypotension, nausea, vomiting, general fatigue, confusion, dizziness, blurred vision, lack of coordination, and muscle weakness.

In case of overdose or accidental ingestion, consult your doctor or pharmacist, or call the Toxicology Information Service at telephone number 915620420, indicating the medicine and the amount ingested.

If you forget to take Magnesia Lainco

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

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

4. Possible adverse effects

Like all medicines, Magnesia Lainco can produce 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:

• Frequency not known: diarrhoea (although its exact frequency has not been established, it is the most commonly observed adverse reaction) and abdominal pain.
• Very rare adverse reactions (may affect up to 1 in 10,000 people): hypermagnesaemia (elevated magnesium levels in blood). Hypermagnesaemia has been observed after prolonged administration in patients with renal insufficiency.

Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Magnesia Lainco

No special storage conditions are required.

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

Do not use this medicine after the expiry date indicated on the packaging after EXP. The expiry date refers to the last day of the month shown.

Validity period after first opening: 2 months; no special storage conditions required.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point located at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Magnesia Lainco

• The active substance is magnesium hydroxide. Each ml of oral solution contains 200 mg of magnesium hydroxide.
• The other components (excipients) are: microcrystalline cellulose-sodium carmellose, xanthan gum, sodium carmellose, sodium saccharin, orange flavor, domiphen bromide, sorbitol (E-420), antifoaming agent silicon (purified water, polydimethylsiloxane, sorbitan monostearate, polyoxyethylene 20 sorbitan, amorphous silica, benzoic acid (E-210)) and purified water.

Appearance of the product and contents of the container

Magnesia Lainco is a white, viscous suspension with a sweet taste and orange odor.

It is presented in a 220 ml amber glass bottle containing oral suspension, fitted with a polyethylene and polypropylene cap, and accompanied by a polypropylene dosing cup.

Marketing Authorization Holder and Manufacturer

LAINCO, S.A.

Avda. Bizet, 8-12. 08191 Rubí (Barcelona) Spain

Date of the most recent revision of this leaflet: November 2017

Other sources of information

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS*): http://www.aemps.gob.es/*