MAALOXAN

MAALOXAN 25 mVal Chewable Tablets

Important notes (mandatory information)

Maaloxan 25 mVal chewable tablets. Indications: for the symptomatic treatment of conditions in which stomach acid should be bound: heartburn and acid-related stomach discomfort, stomach or duodenal ulcers (ulcus ventriculi or ulcus duodeni).

For risks and side effects, read the package leaflet and consult your doctor or pharmacist!


PACKAGE LEAFLET: INFORMATION FOR THE USER

Maaloxan 25 mVal chewable tablets
Active ingredients: algedrate, magnesium hydroxide

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information. Always take this medicine exactly as described in this leaflet or exactly as directed by your doctor or pharmacist.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet.
• If you do not feel better or even worse after 14 days, contact your doctor.

What this leaflet contains

1. WHAT IS MAALOXAN 25 MVAL1 AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING MAALOXAN 25 MVAL?
3. HOW TO TAKE MAALOXAN 25 MVAL?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE MAALOXAN 25 MVAL?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS MAALOXAN 25 MVAL1 AND WHAT IS IT USED FOR?

Maaloxan 25 mVal is a medicine for binding excess stomach acid and consists of the two active ingredients algedrate (aluminium hydroxide gel) and magnesium hydroxide. Maaloxan 25 mVal neutralises excess stomach acid and thus relieves pain and discomfort. Maaloxan 25 mVal is used for the symptomatic treatment of conditions in which stomach acid should be bound: heartburn and acid-related stomach discomfort, stomach or duodenal ulcers (ulcus ventriculi or ulcus duodeni).

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING MAALOXAN 25 MVAL?

Maaloxan 25 mVal must not be taken:

• if you are allergic to algedrate or magnesium hydroxide, mint flavouring or any of the other ingredients of this medicine listed in section 6.
• if you have severe kidney failure.
• if you have a low phosphate level in your blood (hypophosphataemia).

Warnings and precautions

Prolonged and recurring stomach discomfort can be a sign of a serious condition, such as a stomach or duodenal ulcer. Treatment with Maaloxan 25 mVal should therefore not last longer than 14 days without a medical examination. If you experience tarry stools, blood in your stools or vomiting blood, you must see a doctor immediately.

Please talk to your doctor before taking Maaloxan 25 mVal:

• if you have kidney disease,
• if you are on a low-phosphate diet.

This medicine can cause constipation and an overdose can cause a reduction in bowel movements. High doses can trigger or worsen a disturbance of the intestinal passage and intestinal obstruction in patients who are particularly at risk, such as patients with impaired kidney function, children under 2 years of age or the elderly. The active ingredients of this medicine are hardly absorbed from the digestive tract into the blood. Therefore, side effects are rare in patients with normal kidney function. However, excessively high doses or long-term use and even normal doses in patients on a low-phosphate diet or in children under 2 years of age can lead to phosphate depletion (due to the aluminium-phosphate binding). A phosphate deficiency can be associated with increased bone resorption and increased urinary calcium excretion with the risk of osteomalacia, i.e. increased softness and tendency of the bones to bend. In the case of severely impaired kidney function, taking magnesium- and aluminium-containing medicines such as Maaloxan 25 mVal can cause an increased magnesium level in the blood and an increased aluminium level in the blood (risk of poisoning!). In the case of impaired kidney function and long-term use of high doses, regular monitoring of the aluminium and magnesium blood levels by your doctor is necessary. The aluminium blood level should not exceed 40 µg/l. In patients with porphyria (a disorder of the formation of the red blood pigment) who are undergoing haemodialysis (blood washing), taking Maaloxan 25 mVal can pose a risk and should therefore only be taken after consulting a doctor.

Note

In patients with stomach or duodenal ulcers, an examination for Helicobacter pylori (a certain type of bacteria) and - if detected - therapy to completely eliminate the bacteria should be considered, as this usually also heals the ulcer.

Use in children

Maaloxan 25 mVal should not be used in children under 12 years of age, as there is insufficient experience in this age group.

Taking Maaloxan 25 mVal with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or intend to take any other medicines. Taking quinidine (a medicine for heart rhythm disorders) at the same time can increase quinidine blood levels and thus lead to an overdose of quinidine. Taking aluminium-containing antacids at the same time as other medicines can impair their absorption. Significant reductions in absorption have been described for certain antibiotics such as tetracyclines, fluoroquinolones (e.g. ciprofloxacin, norfloxacin, pefloxacin) and cephalosporins (e.g. cefpodoxime). They can be up to 90% and are a consequence of the formation of non-absorbable compounds of these medicines. Therefore, taking antacids is not recommended during therapy with these antibiotics. If necessary, other antacids should be used.

The absorption of the following medicines may also be reduced

Chloroquine, allopurinol, non-steroidal anti-inflammatory drugs (e.g. diclofenac, acetylsalicylic acid, naproxen, indomethacin, diflunisal), penicillamine, digoxin, isoniazid, captopril, atenolol, metoprolol, propranolol, dicumarol, levothyroxine, ketoconazole, gabapentin, H2-receptor blockers, bisphosphonates, ethambutol, lincosamide antibiotics (e.g. clindamycin), sodium fluoride, rosuvastatin, glucocorticoids, iron compounds and phenothiazine neuroleptics (e.g. chlorpromazine).

Caution is advised when taking polystyrene sulphonate ion exchange resins at the same time. It is possible that the potassium-binding effect of the resin will be reduced, that the pH value in the blood will rise (alkalosis) in patients with impaired kidney function and that intestinal obstruction will occur.

In view of a possible impairment of absorption, you should generally observe an interval of at least 2 hours between taking antacids and other medicines. Some medicines can be affected by magnesium hydroxide, or they can affect how well magnesium hydroxide will work. Please tell your doctor or pharmacist if you are already taking the following: Salicylates.

Taking Maaloxan 25 mVal with food and drink

Aluminium-containing antacids increase the absorption of aluminium from the intestine when taken at the same time as acidic drinks (fruit juices, wine, etc.). Effervescent tablets also contain fruit acids (e.g. citrates) that can increase aluminium absorption. This can lead to increased aluminium blood levels, especially in patients with impaired kidney function.

Pregnancy and

breastfeeding

If you are pregnant or breastfeeding, or if you suspect you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

If you are pregnant, you should only take Maaloxan 25 mVal after consulting your doctor. In order to avoid aluminium exposure and thus possible harm to your child, you should only take this medicine during pregnancy for a short period of time and at the lowest possible dose.

Breastfeeding

Aluminium compounds pass into breast milk. A risk to the newborn is not to be assumed, as only very small amounts are absorbed. Therefore, it is possible to breastfeed, provided that the recommendations on dosage and duration of use are observed.

Driving and operating machinery

No special precautions are required.

Maaloxan 25 mVal chewable tablets contain sorbitol and sucrose

Please only take Maaloxan 25 mVal chewable tablets after consulting your doctor if you are known to suffer from an intolerance to certain sugars. Maaloxan 25 mVal chewable tablets can be harmful to the teeth (caries).

3. HOW TO TAKE MAALOXAN 25 MVAL?

Always take this medicine exactly as described in this leaflet or exactly as agreed with your doctor. Check with your doctor or pharmacist if you are not sure.

Unless otherwise prescribed by your doctor, the usual dose is:

• Gastric and duodenal ulcers: Unless otherwise prescribed, adults generally take 1 to 2 Maaloxan 25 mVal chewable tablets 1 to 2 hours after each meal and immediately before bedtime. The daily dose should not exceed 4 – 6 Maaloxan 25 mVal chewable tablets (corresponding to 100 – 150 mVal neutralisation capacity).
• Symptomatic treatment of heartburn and acid-related stomach discomfort: Take one Maaloxan 25 mVal chewable tablet several times a day as needed.

Method of administration

The tablets should be chewed as thoroughly as possible.

Note

Other medicines should generally be taken at least two hours before or after taking Maaloxan 25 mVal chewable tablets. Taking antacids is not recommended during treatment with antibiotics such as tetracyclines and quinolones (see "Taking Maaloxan 25 mVal with other medicines").

Duration of use

The duration of treatment depends on the type and severity as well as the course of the disease. If the symptoms persist for more than 2 weeks during treatment, a doctor should be consulted.

If you have taken more Maaloxan 25 mVal than you should

Poisoning by Maaloxan 25 mVal is unlikely due to the low absorption of aluminium and magnesium. In case of overdose, changes in bowel movements such as stool softening, increased stool frequency, abdominal pain and vomiting may occur. Special measures are generally not necessary in this case. In patients with impaired kidney function, a doctor should be notified immediately in case of suspected overdose with larger amounts of Maaloxan 25 mVal due to the increased risk of poisoning. In such cases, a disturbance of the intestinal passage and intestinal obstruction can be triggered or worsened.

If you forget to take Maaloxan 25 mVal

Do not take more Maaloxan 25 mVal chewable tablets the next time, but continue taking the prescribed or recommended dose.

If you stop taking Maaloxan 25 mVal

In any case, talk to your doctor before interrupting or prematurely ending a treatment with Maaloxan 25 mVal prescribed by your doctor, e.g. due to the occurrence of side effects.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Possible side effects

Common (may affect up to 1 in 10 people):

• soft stools.

Uncommon (may affect up to 1 in 100 people):

• diarrhoea or constipation (see section 2. "Warnings and precautions").

Talk to your doctor if you get diarrhoea while taking Maaloxan 25 mVal. Usually, reducing the dose will improve the symptoms.

Very rare (may affect up to 1 in 10,000 people):

• hypermagnesaemia (pathologically elevated magnesium level

Not known (frequency cannot be estimated from the available data):

• hypersensitivity reactions such as itching, hives
• increased aluminium blood level, decreased phosphate blood level, increased bone resorption, increased urinary calcium excretion, increased softness and tendency of the bones to bend (osteomalacia) (see section 2. "Warnings and precautions").
• abdominal pain.

Other possible side effects

In appropriately sensitised patients, mint flavouring can trigger hypersensitivity reactions (including shortness of breath).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE MAALOXAN 25 MVAL?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the folding box and the blister pack after "Use by". The expiry date refers to the last day of the month indicated. Storage conditions: Store in the original package to protect the contents from moisture. After opening the HDPE bottle, the medicine can be stored for 6 months.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What a Maaloxan 25 mVal chewable tablet contains

The active ingredients are algedrate and magnesium hydroxide. 1 chewable tablet contains 400 mg algedrate, corresponding to 200 mg aluminium oxide, and 400 mg magnesium hydroxide (corresponding to a neutralisation capacity of approx. 25 mVal hydrochloric acid). The other ingredients are: mannitol (Ph. Eur.), sorbitol (Ph. Eur.), saccharin sodium, potato starch, mint flavouring, magnesium stearate (Ph. Eur.) [vegetable], sucrose.

What Maaloxan 25 mVal chewable tablets look like and contents of the pack

White, round tablets with bevelled edges and an imprint.

Type of containers

PVC/aluminium blisters, folding boxes or white HDPE bottles with a white plastic (LDPE) closure with desiccant.

Pack sizes

PVC/aluminium blisters: 12, 20, 50 and 100 chewable tablets.

HDPE bottle

40 chewable tablets.

Pharmaceutical entrepreneur

Sanofi-Aventis Deutschland GmbH
65926 Frankfurt am Main

Postal address

Postfach 80 08 60
65908 Frankfurt am Main

Telephone: 0800 56 56 010
Telefax: 0800 56 56 011

Manufacturer

Sanofi S.p.A.
Viale Europa 11
21040 Origgio (VA)
Italy

or

Sanofi S.p.A.
Strada Statale 17, km 22
67019 Scoppito (AQ)
Italy

This leaflet was last revised in September 2018.

Source: Information from the package leaflet
Status: 10/2019
Indications: for the symptomatic treatment of conditions in which stomach acid should be bound: heartburn and acid-related stomach discomfort, stomach or duodenal ulcers (ulcus ventriculi or ulcus duodeni).