Magnesia Cinfac 200 mg/ml oral suspension
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
magnesia cinfa 200 mg/ml 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 use provided in this leaflet or those given 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 effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or if you 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 side 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 medicine with laxative and antacid activity (neutralizes excess stomach acid).
It is indicated for the symptomatic treatment of occasional constipation and gastric hyperacidity in adults and adolescents aged 12 years and older.
You should consult your doctor if your condition worsens or does 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 to any of the other components of this medicine (listed in section 6).
- If you have:
- severe kidney disease,
- any condition causing a hydroelectrolytic imbalance (salts and water in the body),
- 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),
- 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 any liver or heart disease.
- you are dehydrated.
- you are over 65 years old.
- you are weakened.
If your 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, signs of 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
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
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 tiludronic acid, sodium polystyrene sulfonate resin, 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.
Interactions of magnesium hydroxide with other medicines
Some medicines may be affected by magnesium hydroxide or may affect the efficacy of magnesium hydroxide. If in doubt, consult your doctor or pharmacist – salicylates.
Separate the administration of magnesia from other medicines by 2 to 3 hours.
Interference with diagnostic tests
If you are scheduled for any diagnostic tests (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 24 hours before undergoing tests for gastric acid secretion, serum gastrin levels (gastrin is a hormone that regulates acid secretion in the stomach), 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.
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 50 mg of sorbitol per ml. Sorbitol is a source of fructose. If your doctor has diagnosed you (or your child) with intolerance to certain sugars, or 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 diagnosed you with 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 ml; therefore, it is essentially “sodium-free”.
3. How to take magnesia cinfa
Follow exactly the administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.
As a laxative, the usually recommended doses in adults and adolescents over 12 years of age are: from 5–10 ml (1–2 g) up to 25 ml (5 g) per day, taken as a single dose or divided into several doses. Avoid taking the dose immediately before bedtime or very late in the evening.
As an antacid, the amount and frequency of the dose depend on the intensity and frequency of symptoms. The usually recommended dose in adults and children over 12 years of age is: 1 measuring spoon of 2.5 or 5 ml, as needed, up to a maximum of 12.5 ml per day. Take the dose when symptoms occur, preferably after meals. If you take 5 ml before bedtime, a laxative effect may occur between 3 and 6 hours after taking the medication.
This medicine is taken orally.
Always take the smallest dose that is effective.
Shake the bottle well before taking this medicine and measure the appropriate amount using the dosing cup provided.
The dose may be taken directly, or 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 if symptoms persist after 7 days of continuous treatment, you should consult a doctor.
If you take more magnesia cinfa than you should
Symptoms of an overdose include: flushing, thirst, hypotension, nausea, vomiting, generalized fatigue, confusion, dizziness, blurred vision, lack of coordination, and muscle weakness.
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount ingested.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone 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:
- Common (may affect up to 1 in 10 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 Medicines: 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 the sight and reach of children.
Do not store above 30°C.
Do not use this medicine after the expiry date stated on the container, after EXP. The expiry date refers to the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. 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 ml of oral suspension contains 200 mg of magnesium hydroxide.
- The other components are: microcrystalline cellulose/sodium carboxymethylcellulose, sodium carboxymethylcellulose, Sinespum C (containing: sucrose, sorbitan tristearate, 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 contents of the pack
magnesia cinfa 200 mg/ml is presented as an orange-scented white oral suspension. It comes in red polyethylene terephthalate bottles with screw caps containing 260 ml of oral suspension. Each package contains one bottle and one 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 most recent revision of this package 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 Medical Devices (AEMPS) http://www.aemps.gob.es/