MAGNESIA CINFA 2.4 g ORAL SUSPENSION

Introduction

Package Leaflet: Information for the User

magnesia cinfa 2.4 g Oral Suspension

Magnesium Hydroxide

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

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist exactly.

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

Contents of the Package Leaflet

1. What is magnesia cinfa and what is it used for
2. What you need to know before taking magnesia cinfa
3. How to take magnesia cinfa
4. Possible side effects
5. Storage of magnesia cinfa
6. Package Contents and Additional Information

1. What is magnesia cinfa and what is it used for

magnesia cinfa is a medication with laxative activity.

It is indicated for the symptomatic 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 cinfa

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:

• a 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 magnesia cinfa.

• 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, any symptoms that indicate bleeding (such as black stools or vomit like coffee grounds), 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 recently taken, or may need to take any other medication.

The concomitant administration of magnesia 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 (chlortetracycline, doxycycline, tetracycline), ketoconazole, methenamine.
• Blood Coagulation Disorders: 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 disorders: 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 disorders: oral phosphates, alendronic acid and tiludronic acid, polystyrene resin, sodium sulfonate, 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.

Separate the intake of magnesia from the intake of other medications by 2 to 3 hours.

Interference with Diagnostic Tests

If you are going to have any diagnostic tests (blood tests, urine tests, 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 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 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 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.

magnesia cinfa contains Sorbitol

This medication contains 600 mg of sorbitol in each sachet. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have 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 before taking this medication.

magnesia cinfa contains Sucrose

If your doctor has told you that you have 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 sachet; it is essentially "sodium-free".

3. How to Take magnesia cinfa

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

The recommended dose as a laxative, in adults and adolescents over 12 years of age, is 1 to 2 sachets per day (2.4 to 4.8 g of magnesium hydroxide), in a single dose or divided into 2 doses. Avoid taking the dose before bedtime or late at night.

This medication is taken orally.

Always take the smallest effective dose.

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

The dose can be taken 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 throughout the day.

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

Since the laxative effect usually occurs between 3 and 6 hours after administration and even before, it is recommended not to take magnesia at bedtime or late at night.

If you take more magnesia cinfa than you should

The symptoms of an overdose are: flushing, thirst, hypotension, nausea, vomiting, general fatigue, confusion, dizziness, blurred vision, disorientation, and muscle weakness.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone gets them.

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

• Frequent (may affect up to 1 in 100 patients): diarrhea.
• Very rare (may affect up to 1 in 10,000 patients): hypermagnesemia. Hypermagnesemia has been observed after prolonged administration in patients with renal insufficiency.
• Frequency not known (cannot be estimated from available data): abdominal pain.

Reporting Side Effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of magnesia cinfa

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 stated on the packaging, after CAD.

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of magnesia cinfa

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

Appearance of the Product and Package Contents

magnesia cinfa 2.4 g is presented as 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 marketed.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the Last Revision of this Package Leaflet:June 2021

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