MAGNESIA CINFA 200 mg/ml ORAL SUSPENSION

Introduction

Leaflet: Information for the user

magnesia cinfa 200 mg/ml oral suspension

magnesium hydroxide

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

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

• Keep this 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 not listed in this 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 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 medicine with laxative and antiacid activity (neutralizes excess stomach acid).

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

You should consult your 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 medicine (listed in section 6).
• If you have:
• • severe kidney disease,
  • any disease that causes hydroelectrolytic imbalance (salts and water present in the body),
  • appendicitis, intestinal obstruction, gastrointestinal or rectal bleeding that has not been 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 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 medicines and magnesia cinfa

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

Taking magnesia with other medicines can alter the absorption or action of other medicines used to treat:

• Diabetes: chlorpropamide, glibenclamide, glipizide, tolbutamide.
• Infections: sulfonamides, quinolones (ciprofloxacin, ofloxacin, pefloxacin, enoxacin), tetracyclines (chlortetracycline, doxycycline, tetracycline), ketoconazole, methenamine.
• Blood coagulation problems: dicumarol.
• Anemia: iron salts, folic acid.
• Parkinson's disease: levodopa.
• Stomach, intestine, and bladder spasms or contractions (anticholinergic medicines)
• Cardiovascular diseases: atenolol, digoxin, captopril, quinidine.
• Psychiatric diseases: phenothiazines (especially oral chlorpromazine), chlordiazepoxide, amphetamines.
• Epilepsy: phenytoin.
• Digestive system diseases: medicines used for acidity (cimetidine, etc.), misoprostol, pancreolipase, sucralfate.
• Inflammation: indomethacin, penicillamine, salicylates, ibuprofen, flurbiprofen, mefenamic acid or flufenamic acid.
• Metabolic diseases: oral phosphates, alendronic acid and tiludronic 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.

Interactions of magnesium hydroxide with other medicines

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

Take magnesia at least 2 to 3 hours apart from other medicines.

Interference with diagnostic tests

If you are going to have any diagnostic tests (blood tests, urine tests, etc.), tell your doctor or pharmacist that you are being treated with magnesia, as it may alter the results.

Do not take this medicine 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 medicine can be taken with or without food and drinks.

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 medicine.

Driving and using machines

Taking this medicine does not affect your ability to drive or use machines.

magnesia cinfa contains sorbitol

This medicine contains 50 mg of sorbitol per ml. 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 medicine.

magnesia cinfa contains sucrose

If your doctor has told you that you have an intolerance to certain sugars, consult him before taking this medicine.

magnesia cinfa contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per ml; that is, it is essentially "sodium-free".

3. How to take magnesia cinfa

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

As a laxative, the usual recommended doses in adults and adolescents over 12 years of age are: from 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 late at night.

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

This medicine is taken orally.

Always take the smallest effective dose.

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

The dose can be taken 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 throughout the day.

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

If you take more magnesia cinfa than you should

The symptoms of an overdose are: flushing, thirst, hypotension, nausea, vomiting, generalized 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 medicine and the amount ingested.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

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

• Common(may affect up to 1 in 10 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 that is not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of magnesia cinfa

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

Do not store above 30°C.

Do not use this medicine after the expiration date stated on the packaging, after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the pharmacy's SIGRE point. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines 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 ml of oral suspension contains 200 mg of magnesium hydroxide.
• The other ingredients are: microcrystalline cellulose/carboxymethylcellulose sodium, carboxymethylcellulose sodium, 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 200 mg/ml is presented as a white oral suspension with an orange odor. It is presented in red polyethylene terephthalate bottles with a screw cap, which contain 260 ml of oral suspension. Each package contains a bottle and a dosing cup.

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 leaflet:June 2021

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