MAALOX SUGAR-FREE CHEWABLE TABLETS 400/400 Milligram Tablets Chewable

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

ALUMINIUM OXIDE HYDRATED, MAGNESIUM HYDROXIDE

Dostopno od:

Sanofi-Aventis Ireland Limited T/A SANOFI

Koda artikla:

A02AB10

INN (mednarodno ime):

ALUMINIUM OXIDE HYDRATED, MAGNESIUM HYDROXIDE

Odmerek:

400/400 Milligram

Farmacevtska oblika:

Tablets Chewable

Pot uporabe:

Oral use

Enote v paketu:

20 or 40 tablets per box

Tip zastaranja:

Product not subject to medical prescription

Izdeluje:

sanofi-aventis

Terapevtsko območje:

COMBINATIONS

Terapevtske indikacije:

For the relief of the symptoms of dyspepsia.

Status dovoljenje:

Authorised

Datum dovoljenje:

2015-07-10

Navodilo za uporabo

Reference: 26527 1.3.1.3 - Leaflet Text - PIL - 400mg,
400mg - 2016-04-12 - 0000 - CCDSv5 tracked - 540/110/7 0.4
MAALOX® SUGAR FREE 400MG/400MG CHEWABLE TABLETS
_aluminium hydroxide_
_magnesium hydroxide_
IS THIS LEAFLET HARD TO SEE OR READ?  PHONE [phone] FOR HELP.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
-
Keep this leaflet.  You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you.  Do not pass it on to
others.  It may 
harm them, even if their symptoms are the same as yours.
-
If any side effects gets serious, or if you notice any side effect
not listed in this 
leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Maalox is and what it is used for
2. Before you take Maalox
3. How to take Maalox
4. Possible side effects
5. How to store Maalox
6. Further information
1.
WHAT MAALOX IS AND WHAT IT IS USED FOR
Maalox Sugar Free Chewable Tablets contain two different medicines.
 They are 
called Aluminium hydroxide and Magnesium hydroxide.  They belong to
a group of 
medicines called antacids.  Maalox Sugar Free Chewable Tablets are
used for:
• Heartburn or when your stomach has too much acid (indigestion)
• Lowering the amount of acid in your stomach or gut (intestine)
when you have an 
ulcer.
Maalox works by lowering the amount of acid in your stomach.
2.
BEFORE YOU USE MAALOX
DO NOT TAKE MAALOX IF:
 You are allergic (hypersensitive) to Aluminium hydroxide or
Magnesium 
hydroxide or any of the other ingredients in Maalox Tablets (see
Section 6: 
Further Information).  Signs of an allergic reaction include:
a rash, swallowing 
or breathing problems, swelling of your lips, face, throat or tongue.
 You are feeling very weak and have no energy (debilitated).
 You have kidney problems.
 You have low levels of phosphate (called ‘hypophosphataemia’.
 This is 
shown up in blood tests.
 You

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Maalox Sugar-Free 400mg/400mg Chewable Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 400 mg Aluminium Hydroxide (aluminium oxide hydrated) and 400 mg Magnesium Hydroxide.
Excipients: Each chewable tablet also contains 109.9mg of sorbitol (E420) and 632.62mg of maltitol (E965)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Chewable Tablet
Bevelled, round, engraved tablets. White to yellowish colour with lemon odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the relief of the symptoms of dyspepsia.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The route of administration is oral.
Recommended Dosage
Adults: 1-2 tablets chewed 4 times daily, taken 20 minutes to 1 hour after meals and at bedtime, or as directed by the
physician. A maximum of 8 tablets in a 24 hour period should not be exceeded, nor should the maximum dose continue
for more than 2 weeks except under the direction of the physician.
4.3 CONTRAINDICATIONS
Use in severely debilitated patients or in those suffering from kidney failure.
Use in patients who are hypersensitive to the active ingredients or to any of the excipients.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Aluminium hydroxide may cause constipation and magnesium salts overdose may cause hypomotility of the bowel;
large doses of this product may trigger or aggravate intestinal obstruction and ileus in patients at higher risk such as
those with renal impairment, infants less than 2 years, or the elderly.
Aluminium hydroxide is not well absorbed from the gastrointestinal tract, and systemic effects are therefore rare in
patients with normal renal function. However, excessive doses or long-term use, or even normal doses in patie