Magnesium effervescent Sella

Package leaflet: Information for the user

Magnesia effervescente Sella 40 g

Magnesium hydroxide
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If any adverse reactions occur, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement or if your symptoms worsen after a few days of treatment.

Contents of this leaflet:

1. What MAGNESIA EFFERVESCENTE SELLA is and what it is used for
2. What you need to know before using MAGNESIA EFFERVESCENTE SELLA
3. How to use MAGNESIA EFFERVESCENTE SELLA
4. Possible side effects
5. How to store MAGNESIA EFFERVESCENTE SELLA
6. Contents of the pack and other information

1. What MAGNESIA EFFERVESCENTE SELLA is and what it is used for

This medicinal product contains the active substance magnesium hydroxide, which belongs to the classes of antacids and laxatives. MAGNESIA EFFERVESCENTE SELLA works by promoting bowel evacuation and controlling stomach acidity.
Consult your doctor if you do not feel better or if you feel worse after a few days.

2. What you need to know before using MAGNESIA EFFERVESCENTE SELLA

Do not use MAGNESIA EFFERVESCENTE SELLA:

• if you are allergic to magnesium hydroxide or to any of the other ingredients of this medicine (listed in section 6);
• if you have acute abdominal pain or abdominal pain of unknown cause (acute surgical abdomen);
• if you have kidney problems (impaired renal function, severe renal failure);

Warnings and precautions
Talk to your doctor or pharmacist before using MAGNESIA EFFERVESCENTE SELLA.
Do not use MAGNESIA EFFERVESCENTE SELLA if you have heart failure.
If you have mild renal insufficiency, inform your doctor, as monitoring of serum magnesium levels (magnesemia) is necessary.
If you use this medicine excessively or incorrectly, you may develop dependence or other adverse effects.
Do not use MAGNESIA EFFERVESCENTE SELLA if you experience abdominal pain, nausea or vomiting.
If constipation persists over time, consult your doctor.
Avoid prolonged use of this medicine.
If you do not experience improvement after using this medicine, consult your doctor.

Children
In young children, the use of magnesium hydroxide may cause hypermagnesemia, particularly if renal impairment or dehydration is present.

Other medicines and MAGNESIA EFFERVESCENTE
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Magnesium hydroxide may affect or be affected by certain drugs. Inform your doctor or pharmacist if you are taking salicylates.
Laxatives may reduce intestinal transit time, and therefore the absorption, of other medicines taken simultaneously by oral route. Avoid taking laxatives and other medicines at the same time: after taking any medicine, wait at least 2 hours before taking the laxative.
Magnesium salts reduce the absorption of certain active substances (indometacrine, nitrofurantoin, aminophylline, chlordiazepoxide), increase the absorption of others (dicoumarol agents), reduce the absorption and oral bioavailability of tetracyclines, anticholinergics, cimetidine, digoxin, and enhance the effect of peripheral muscle relaxants.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
There are no adequate and well-controlled studies on the use of this medicine during pregnancy or breastfeeding. Therefore, the medicine should be used only under direct medical supervision, after carefully weighing the expected benefit to the mother against the potential risk to the fetus or nursing infant.

Driving and using machines
It is not known whether this medicine may affect the ability to drive vehicles or operate machinery.

MAGNESIA EFFERVESCENTE SELLA contains sucrose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
This medicine contains 0.82 g of sodium (a main component of table salt) per spoonful. This corresponds to 41% of the maximum daily recommended dietary intake of sodium for an adult.

3. How to use MAGNESIA EFFERVESCENTE SELLA

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
As a laxative: one tablespoon of MAGNESIA EFFERVESCENTE SELLA in a glass of water.
As a mild laxative: one teaspoon of MAGNESIA EFFERVESCENTE SELLA in a glass of water.
As an antacid: half a teaspoon in a small amount of water.
Pour MAGNESIA EFFERVESCENTE SELLA into water, stir and drink after effervescence has subsided.
In children, doses should be halved or reduced further according to age.
Do not exceed the recommended doses.
Administration is preferably recommended in the evening, or alternatively in the morning.
Consult your doctor if the condition occurs repeatedly or if you notice any recent changes in its characteristics.
If you take more MAGNESIA EFFERVESCENTE SELLA than you should
If you have taken or ingested an excessive dose of this medicine, contact your doctor immediately or go to the nearest hospital.
If you forget to take MAGNESIA EFFERVESCENTE SELLA
Do not take a double dose to make up for the forgotten dose.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
The following side effects may occur:
Frequency not known:

• Abdominal pain

Very rare frequency:

• Hypermagnesaemia. This has been observed after prolonged administration in patients with renal impairment.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store MAGNESIA EFFERVESCENTE SELLA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Store this medicine in its tightly closed container, protected from moisture and at a temperature not exceeding 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What MAGNESIA EFFERVESCENTE SELLA contains

• The active substance is magnesium hydroxide. 100 g of product contain 40 g of magnesium hydroxide.
• The other components are: sucrose, sodium bicarbonate, tartaric acid, lemon or mint flavouring.

Description of the appearance of MAGNESIA EFFERVESCENTE SELLA and contents of the pack
MAGNESIA EFFERVESCENTE SELLA is presented as an effervescent powder for oral use.
Pack contents:
Bottle of 115 g (Lemon flavour)
Bottle of 115 g (Mint flavour)

Marketing Authorization Holder and Manufacturer
Laboratorio Chimico Farmaceutico A. Sella s.r.l., Via Vicenza, 67 - 36015 Schio (VI)

Health education notes
If you use this medicine excessively, frequently or incorrectly, you may experience persistent diarrhoea, resulting in loss of water, mineral salts (especially potassium) and other essential nutrients. In more severe cases, dehydration and low blood potassium levels (hypokalaemia) may occur, potentially causing problems with the heart, nerves and muscles, particularly if you are also taking medicines to stimulate heart function (cardiac glycosides), increase urine production (diuretics), or medicines known as corticosteroids.

If you use this medicine excessively or incorrectly, you may develop dependence (leading to a progressive need to increase the dose), chronic constipation and loss of normal bowel function (intestinal atony).

If you suffer from constipation, first correct your dietary habits by consuming an adequate amount of fibre and water and engaging in physical activity. In most cases, a balanced diet rich in water and fibre (bran, vegetables and fruit) can permanently resolve constipation. Many people mistakenly believe they are constipated if they do not defecate every day; in fact, this condition is often completely normal. True constipation occurs when bowel movements are reduced compared to your usual pattern and are associated with the passage of hard stools.

If episodes of constipation recur frequently, consult your doctor. The treatment of chronic or recurrent constipation always requires medical supervision for diagnosis, prescription of medicines and monitoring during therapy. Consult your doctor when the need for a laxative arises from a sudden change in previous bowel habits (frequency and characteristics of evacuations) lasting for more than two weeks, or when use of the laxative fails to produce an effect. It is also advisable for elderly individuals or those in poor health to consult a doctor before using this medicine.