Leaflet: information for the user

magnesium citrate 200 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 for the medicine contained in this leaflet or those indicated by your doctor or pharmacist.

• 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 or pharmacist, 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 is magnesium citrate and what it is used for

2.What you need to know before starting to take magnesium citrate

3.How to take magnesium citrate

4.Possible side effects

5.Storage of magnesium citrate

6.Contents of the pack and additional information

magnesium citrate is a medication with laxative and antacid activity (neutralizes excess acid in the stomach).

It is indicated for symptomatic treatment of occasional constipation and stomach hyperacidity in adults and adolescents 12 years and older.

Consult a doctor if symptoms worsen or do not improve after 7 days of treatment.

Do not take magnesia cinfa

• 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 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 magnesia cinfa.

• 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, any symptoms indicating bleeding (such as black stools or coffee ground vomit), cramps, bloated or painful abdomen, nausea, vomiting, and diarrhea.

Children

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

Other medications and magnesia cinfa

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

The concurrent administration of magnesia 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: 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.
• Digestive system diseases: medications used for acid reflux (cimetidine, etc.), misoprostol, pancreolipase, sucralfate.
• Inflammation: indomethacin, penicillamine, salicylates, ibuprofen, flurbiprofen,fenamic acid or flufenamic acid.
• Metabolic diseases: oral phosphates, alendronate acid and tiludronate acid, polystyrene sulfonate resin, vitamin D, including calcifediol and calcitriol.
• Smoking cessation: mecamylamine.
• Others: enteric-coated medications, urinary acidifiers, such as ammonium chloride, ascorbic acid, or potassium or sodium phosphates.

Interactions of magnesium hydroxide with other medications

Some medications may be affected by magnesium hydroxide or may affect the efficacy of magnesium hydroxide. In case of doubt, ask your doctor or pharmacist – salicylates.

Separate the taking of magnesia from the taking of other medications by 2-3 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, 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.

Taking magnesia cinfa with food and drinks

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

Pregnancy and lactation

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machines

The use of this medication does not affect the ability to drive and/or operate machines.

magnesia cinfa contains sorbitol

This medication contains 50 mg of sorbitolper ml. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have a certain sugar intolerance, or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease in which the patient cannot break down fructose, consult your doctor (or your child) before taking this medication.

magnesia cinfa contains saccharose

If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medication.

magnesia cinfa contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per ml; it is essentially “sodium-free”.

Follow exactly the administration instructions of the medication contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

As a laxative, the usual recommended doses in adults and adolescents over 12 years old are: 5-10 ml (1-2 g) to 25 ml (5 g) per day, in a single dose or divided into several doses. Avoid taking the dose before bedtime or at the last hour.

As an antacid, the amount and frequency of the dose depend on the intensity and frequency of symptoms. The usual recommended dose in adults and children over 12 years old is: 1 measure of 2.5 or 5 ml as needed, up to a maximum of 12.5 ml per day. Take the dose when you notice symptoms and preferably after meals. If you take 5 ml before bedtime, it may cause a laxative effect between 3 and 6 hours after taking the medication.

This medication is taken orally.

Always take the smallest effective dose.

Shake the bottle well before taking this medication and measure the corresponding amount with the dosing cup.

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

It is recommended to drink plenty of liquid during the day.

If you do not improve or symptoms persist after 7 days of continuous treatment, you should consult a doctor.

If you take more magnesium citrate 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 overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

Like all medications,this medicationmay cause adverse effects, although not all people will experience them.

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

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:www.notificaram.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not store at a temperature above 86°F (30°C).

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.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. In this way, you will help protect the environment.

Magnesium hydroxide composition

Appearance of the product and contents of the packaging

magnesia cinfa 200 mg/ml is presented in the form of an oral suspension of white color with orange odor. It is presented in polyethylene terephthalate bottles of red color with screw cap, containing 260 ml of oral suspension. Each package contains one bottle and one dosing cup.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Park Areta

31620 Huarte (Navarra) - Spain

Last review date of this leaflet: June 2021

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 /