Magaldrate Mylan

Patient Information Leaflet

Magaldrate Mylan 800 mg chewable tablets, mg/10 ml oral suspension

Magaldrate
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Magaldrate Mylan is and what it is used for
2. What you need to know before taking Magaldrate Mylan
3. How to take Magaldrate Mylan
4. Possible side effects
5. How to store Magaldrate Mylan
6. Contents of the pack and other information

1. What Magaldrate Mylan is and what it is used for

Magaldrate Mylan contains the active substance magaldrate, which belongs to a group of medicines called antiacids and anti-ulcer agents used to protect the stomach wall from the action of acids and to prevent damage caused by stress or by certain medicines used to relieve pain and inflammation (non-steroidal anti-inflammatory drugs).

This medicine is indicated for the treatment of:

• lesions of the stomach or intestine (duodenal and gastric ulcers);
• inflammation of the oesophagus caused by the backflow of stomach contents into the oesophagus (reflux oesophagitis);
• inflammations of the stomach and intestine (gastritis and gastroduodenitis) of various origins, characterized by increased acidity (hyperacidity).

2. What you need to know before taking Magaldrate Mylan

Do not take Magaldrate Mylan

• if you are allergic to magaldrate or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Magaldrate Mylan.
Take Magaldrate Mylan with caution and only under strict medical supervision if you have kidney problems
(renal impairment). If you have severe kidney problems (severe renal impairment), avoid taking this
medicine.
Other medicines and Magaldrate Mylan
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
Avoid taking Magaldrate Mylan together with any of the following medicines, as magaldrate may
affect their absorption:

• medicines used to treat infections (tetracyclines);
• digoxin, a medicine used to treat heart disorders;
• medicines used to treat anxiety and sleep disorders (benzodiazepines);
• dicoumarol, a medicine used to make the blood more fluid;
• indomethacin, a medicine used to treat inflammation;
• medicines used to treat biliary tract disorders (cheto- and ursodesoxycholic acid);
• medicines used to treat iron deficiency in the body (iron derivatives).

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding,
please consult your doctor or pharmacist before taking this medicine.
Driving and using machines
No effects on the ability to drive or operate machinery are known.
Magaldrate Mylan 800 mg chewable tablets contain sorbitol and sodium
Sorbitol
This medicine contains 146.8 mg of sorbitol per chewable tablet, equivalent to 3.27 mg/kg.
Sorbitol is a source of fructose. If your doctor has told you that you are intolerant to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic condition in which patients cannot metabolize fructose, speak with your doctor before taking this medicine.
Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per chewable tablet of Magaldrate Mylan, i.e. essentially 'sodium-free'.
Magaldrate Mylan 800 mg/10 ml oral suspension contains sorbitol, sodium benzoate, ethanol, and sodium
Sorbitol
This medicine contains 840 mg of sorbitol per 10 ml of oral suspension.
Sorbitol is a source of fructose. If your doctor has told you that you are intolerant to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic condition in which patients cannot metabolize fructose, speak with your doctor before taking this medicine.
Sodium benzoate
This medicine contains 50 mg of sodium benzoate per 10 ml of Magaldrate Mylan.
Ethanol 96%
This medicine contains 500 mg of alcohol (ethanol) in 10 ml of Magaldrate Mylan, equivalent to 1.11 mg/kg/ml. The amount in 10 ml of this medicine is equivalent to less than 13 ml of beer or 5 ml of wine.
The small amount of alcohol in this medicine will not produce significant effects.
Sodium
This medicine contains 9.8 mg of sodium (the main component of table salt) per 10 ml of Magaldrate Mylan. This corresponds to 0.49% of the maximum recommended daily dietary intake for an adult.

3. How to take Magaldrate Mylan

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Magaldrate Mylan 800 mg chewable tablets
The recommended dose is 1 tablet, 4 times a day, one hour after meals and one hour before going to bed.
The tablets should be chewed or sucked.
Magaldrate Mylan 800 mg/10 ml oral suspension
Bottle: The recommended dose is 10 ml of suspension (2 teaspoons), 4 times a day, one hour after
meals and one hour before going to bed.
Shake the bottle well before use.
Packets: The recommended dose is 1 packet, 4 times a day, one hour after meals and one hour before
going to bed.
Before opening the packet, knead it so that its contents become homogeneous.
You may take higher doses than recommended only if prescribed by your doctor and under their close
supervision. In any case, reduce the dose to the lowest effective dose needed to control symptoms as soon as possible.
If you take more Magaldrate Mylan than you should
Cases of overdose are not known.
After taking an excessive dose of this medicine, intestinal problems may occur (See section “Possible side effects”).
If you or someone else accidentally takes an excessive dose of Magaldrate Mylan, inform your doctor immediately or go to the nearest hospital.
If you forget to take Magaldrate Mylan
Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The following side effects may occur:
Frequency not known (frequency cannot be estimated from the available data)

• intestinal disturbances (changes in bowel habits), such as increased frequency of faecal elimination (defecation) and/or soft stools (reduced stool consistency) following the ingestion of very high doses of Magaldrate Mylan;
• stomach and intestinal disorders (gastrointestinal transit alterations) such as mild and temporary diarrhoea or constipation (stipsis).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/web/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Magaldrate Mylan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after "Exp.". The expiry date refers to the last day of that month and to the product in its original unopened packaging, properly stored.
This medicine requires no special storage conditions.
Do not dispose of medicines 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 Magaldrato Mylan contains
Magaldrato Mylan 800 mg chewable tablets

• The active substance is magaldrate. Each tablet contains 800 mg of magaldrate.
• The other components are: sorbitol, mannitol, maize starch, magnesium stearate, sodium saccharin, caramel flavour.

Magaldrato Mylan 800 mg/10 ml oral suspension

• The active substance is magaldrate. 10 ml of suspension contain 800 mg of magaldrate.
  The other components are: sorbitol 70%, hydroxyethylcellulose, citric acid monohydrate, sodium cyclamate, sodium saccharin, simethicone emulsion, sodium benzoate, potassium sorbate, ethanol (96%), cream flavour, passion fruit flavour, purified water.

Description of the appearance of Magaldrato Mylan and contents of the pack
Magaldrato Mylan 800 mg chewable tablets
Box containing 40 chewable tablets.
Magaldrato Mylan 800 mg/10 ml oral suspension
Bottle of 250 ml.
Pack containing 40 sachets of 10 ml each.

Marketing Authorization Holder
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milan
Italy

Manufacturers
Magaldrato Mylan 800 mg chewable tablets
Doppel Farmaceutici S.r.l. – Quinto de’ Stampi – Rozzano (MI) – Italy
Magaldrato Mylan 800 mg/10 ml oral suspension
Zeta Farmaceutici S.p.A. – Sandrigo (VI) – Italy