Magnesia Cinfa 2,4 g oral suspension
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
magnesia cinfa 2.4 g oral suspension
Magnesium hydroxide
Read the entire 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 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 adverse reactions, consult your doctor or pharmacist, 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
- What magnesia cinfa is and what it is used for
- What you need to know before taking magnesia cinfa
- How to take magnesia cinfa
- Possible adverse effects
- How to store magnesia cinfa
- Contents of the pack and other information
1. What magnesia cinfa is and what it is used for
magnesia cinfa is a medicinal product with laxative activity.
It is indicated for the symptomatic treatment of occasional constipation in adults and adolescents aged 12 years and older.
You should consult a doctor if 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
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If you are allergic to magnesium hydroxide or to any of the other components of this medicine (listed in section 6).
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If you have:
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severe kidney disease,
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any condition causing a hydroelectrolytic imbalance (salts and water in the body),
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appendicitis, intestinal obstruction, undiagnosed gastrointestinal or rectal bleeding, ulcerative colitis (inflammatory 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),
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chronic diarrhea.
Warnings and precautions
Talk to your doctor or pharmacist before taking magnesia cinfa.
- If you have any kidney disease, even if not severe, or 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, any sign indicating bleeding (for example, black stools or coffee-ground-like vomit), cramps, bloated or painful abdomen, nausea, vomiting, or diarrhea.
Children
In young children, the use of magnesium hydroxide may 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 might need to take any other medicines.
The concomitant administration of magnesia with other medicines may 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 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, polystyrene resin, sodium sulfonate, vitamin D, including calcifediol and calcitriol.
- Smoking cessation: mecamylamine.
- Others: enteric-coated medicines, urinary acidifying agents such as ammonium chloride, ascorbic acid, or potassium or sodium phosphates.
Separate the administration of magnesia from other medicines by 2 to 3 hours.
Interference with diagnostic tests
If you are scheduled for any diagnostic test (blood, urine, etc.), inform your doctor or pharmacist that you are taking magnesia, as it may alter test results.
Do not take this medicine within the 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 cinfa with food and drinks
This medicine may be taken with or without food and drinks.
Interactions of magnesium hydroxide with other medicines
Some medicines may be affected by magnesium hydroxide or may affect the effectiveness of magnesium hydroxide. If in doubt, consult 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 medicine.
Driving and using machines
This medicine does not affect your ability to drive or operate machinery.
magnesia cinfa contains sorbitol
This medicine contains 600 mg of sorbitol per sachet. Sorbitol is a source of fructose. If your doctor has advised you (or your child) that you have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic condition in which the patient cannot break down fructose, consult your doctor (or your child's doctor) before taking this medicine.
magnesia cinfa contains sucrose
If your doctor has advised you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.
magnesia cinfa contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per sachet; therefore, it is essentially "sodium-free".
3. How to take magnesia cinfa
Follow exactly the administration instructions for this medicine provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult 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), taken either as a single dose or divided into two doses. Avoid taking the dose immediately before going to bed or late in the evening.
This medicine is taken orally.
Always take the lowest effective dose.
Squeeze the sachet to properly mix the contents before taking the medicine.
The dose may be taken directly, but it 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).
It is advisable to drink plenty of fluids throughout the day.
If you do not improve or 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 sometimes even earlier, it is recommended not to take magnesia cinfa right before bedtime or late in the day.
If you take more magnesia cinfa 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, immediately consult your doctor or pharmacist or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.
4. Possible adverse effects
Like all medicines, this medicine may produce adverse effects, although not everyone experiences them.
During the period of use of magnesium hydroxide as a laxative, the following adverse effects have been observed with the frequency described below:
- Common (may affect up to 1 in 100 patients): diarrhoea.
- Very rare (may affect up to 1 in 10,000 patients): hypermagnesaemia. Hypermagnesaemia has been observed after prolonged administration in patients with renal insufficiency.
- Frequency not known (cannot be estimated from available data): abdominal pain.
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 via 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 cinfa
Keep this medicine out of sight and reach of children.
This medicine does not require special storage conditions.
Do not use this medicine after the expiry date stated on the packaging, after EXP.
The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point at your pharmacy. If 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 cinfa
- The active substance is magnesium hydroxide. Each 12 ml sachet contains 2.4 g of magnesium hydroxide.
- The other components are: microcrystalline cellulose/sodium carboxymethylcellulose, sodium carmellose, Sinespum C (composed of: sucrose, sorbitan tristearate, PEG 40 stearate, dimethicone, silicon dioxide and 2-Bromo-2-nitropropanediol-1,3), domiphen bromide, sorbitol (E-420), sodium saccharin, xanthan gum, orange flavor, and purified water.
Nature of the product and contents of the container
magnesia cinfa 2.4 g is presented as a homogeneous white oral suspension with an orange odor. It is supplied in single-dose sachets of 12 ml.
Each pack contains 14 or 500 (hospital pack) single-dose sachets.
Only certain pack 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 most recent revision of this leaflet: June 2021
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) https://www.aemps.gob.es/