Package Insert: Information for the User

magnesium oxide 2.4 g oral suspension

Magnesium Hydroxide

Read this package insert carefully before starting to take this medication, as it contains important information for you.

Follow exactly the medication administration instructions contained in this package insert or those indicated by your doctor or pharmacist.

• Keep this package insert, as you may need to refer to it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 7 days of treatment.

magnesium citrate is a laxative medication.

It is indicated for the symptomatic 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 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),
• Apendicitis, 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 symptom 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 can 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 clotting 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.
• Mental health 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, mefenamic acid or flufenamic acid.
• Metabolic diseases: oral phosphates, alendronate acid and tiludronate acid, polystyrene resin, sodium sulfate, 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 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, 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 the secretion of acids 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.

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

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 600 mg of sorbitol in each packet. Sorbitol is a source of fructose. If your doctor has indicated that you (or your child) suffer from an intolerance to certain sugars, 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 sucrose

If your doctor has indicated that you suffer from an intolerance to certain sugars, consult with him before taking this medication.

magnesia cinfa contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per packet; this is, essentially "sodium-free".

Follow exactly the 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 as a laxative, in adults and adolescents over 12 years old is 1 to 2 sachets per day (2.4 to 4.8 g of magnesium hydroxide), in 1 single dose or divided into 2 doses. Avoid taking the dose before bedtime or at the last hour.

This medication is taken orally.

Always take the lower effective dose.

Press the sachet to agitate the contents well before taking this medication.

You can take the dose directly, although 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 it does not improve or symptoms persist after 7 days of continuous treatment, you must consult a doctor.

Since the laxative effect usually manifests itself between 3 and 6 hours after administration and even before, it is recommended not to take magnesium at bedtime or at the last hour of the day.

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 medicationcan cause side effects, although not everyone will experience them.

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting side 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.

This medication does not require special storage conditions.

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.

Medications should not be disposed of through drains or in the trash. Dispose of 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. By doing so, you will help protect the environment.

Magnesium hydroxide composition

• The active ingredient is magnesium hydroxide. Each 12 ml sachet contains 2.4 g of magnesium hydroxide.
• The other components are: microcrystalline cellulose/sodium carboxymethylcellulose,sodium caramel,Sinespum C (a compound consisting of: sucrose, sorbitan trioleate, PEG 40 stearate, dimethicone, silica dioxide, and 2-Bromo-2-nitropropane-1,3-diol), domifen bromide, sorbitol (E- 420), sodium saccharin, xanthan gum, orange flavor, and purified water.

Appearance of the product and contents of the packaging

magnesia cinfa 2.4 gis presented in the form of a homogeneous oral suspension of white color with an orange odor. It is presented in single-dose sachets of 12 ml.

Each package contains 14 or 500 (clinical package) single-dose sachets.

Only some package sizes may be commercially marketed.

Marketing authorization holder and responsible manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) - Spain

Last review date of this leaflet:June 2021

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