MAALOXAN

MAALOXAN 25 mEq Suspension

Important notes (mandatory information)

Maaloxan 25 mVal Suspension, suspension for oral use Areas of application: for the symptomatic treatment of conditions in which stomach acid should be bound: heartburn and acid-related stomach discomfort and stomach or duodenal ulcers (ulcus ventriculi or ulcus duodeni).

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


Patient information: Information for the user
Maaloxan 25 mVal Suspension, suspension for oral use
Active ingredients: alginate, magnesium hydroxide

Read the entire package leaflet carefully before you start taking this medicine, as 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 is in this leaflet
1. WHAT IS MAALOXAN 25 MVAL SUSPENSION AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING MAALOXAN 25 MVAL SUSPENSION?
3. HOW TO TAKE MAALOXAN 25 MVAL SUSPENSION?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD MAALOXAN 25 MVAL SUSPENSION BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS MAALOXAN 25 MVAL SUSPENSION AND WHAT IS IT USED FOR?
Maaloxan 25 mVal Suspension is a remedy for binding excess stomach acid.

Maaloxan 25 mVal Suspension 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).

Note

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

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING MAALOXAN 25 MVAL SUSPENSION?
Maaloxan 25 mVal Suspension must not be taken,
- if you are allergic to alginate or magnesium hydroxide, peppermint oil, methyl-4-hydroxybenzoate, propyl-4-hydroxybenzoate (parabens) 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 (hypophosphatemia).

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

Please talk to your doctor before taking Maaloxan 25 mVal Suspension,
- 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 in patients with normal kidney function are rare. 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 aluminum-phosphate bond). 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 aluminum-containing medicines such as Maaloxan 25 mVal Suspension can cause an increased magnesium level in the blood and an increased aluminum level in the blood (risk of poisoning!). In the case of impaired kidney function and long-term use of high doses, aluminum can accumulate, especially in the nervous and bone tissue. This can lead to brain damage (encephalopathy, dementia) and anemia (microcytic anemia) or worsen dialysis-related bone softening (osteomalacia). You should therefore avoid taking high doses for a long period of time if you have impaired kidney function. In the case of impaired kidney function (creatinine clearance < 30 ml/min) and long-term use, your doctor should regularly check your aluminum and magnesium blood levels. The aluminum 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 hemodialysis (blood washing), taking Maaloxan 25 mVal Suspension can pose a risk and should therefore only be taken after consulting a doctor.

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

Taking Maaloxan 25 mVal Suspension together 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 aluminum-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 the result 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 sulfonate 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 keep an interval of at least 2 hours between taking antacids and other medicines.

Taking Maaloxan 25 mVal Suspension together with food and drink
Aluminum-containing, antacid antacids increase the absorption of aluminum 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), which can increase the absorption of aluminum. This can lead to increased aluminum blood levels, especially in patients with impaired kidney function.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, 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 Suspension after consulting your doctor. In order to avoid aluminum 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.
Breast-feeding
Aluminum compounds pass into breast milk. A risk to the newborn is not to be assumed, as only very small amounts are absorbed. It is therefore possible to breast-feed, provided that the recommendations on dosage and duration of use are observed.

Driving and operating machinery
No special precautions are required.

Maaloxan 25 mVal Suspension contains sorbitol
Please only take this medicine after consulting your doctor if you are known to suffer from an intolerance to certain sugars.

Note for diabetics
Maaloxan 25 mVal Suspension contains the sugar substitutes sorbitol and mannitol. Physiological calorific value: approx. 1.32 kJ = approx. 0.32 kcal or approx. 0.0083 BE per 10 ml suspension for oral use (1 sachet).

3. HOW TO TAKE MAALOXAN 25 MVAL SUSPENSION?

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

Stomach and duodenal ulcers

Adults generally take 1-2 sachets of Maaloxan 25 mVal Suspension undiluted 1 to 2 hours after each meal and immediately before bedtime. The daily dose should not exceed 4-6 sachets of Maaloxan 25 mVal Suspension (corresponding to approx. 100-150 mVal neutralizing capacity).

Symptomatic treatment of heartburn and acid-related stomach discomfort

Take one sachet of Maaloxan 25 mVal Suspension several times a day as needed.

Method of administration
For oral use. Knead the sachet vigorously before use and then tear it open at the marked point. Either pour the contents of the sachet onto a spoon and then take it undiluted or empty it directly from the sachet into the mouth.

Note

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

Duration of use
The duration of treatment depends on the type, severity and 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 Suspension than you should
Poisoning by Maaloxan 25 mVal Suspension is unlikely due to the low absorption of aluminum 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 Suspension 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 Suspension
Do not take more Maaloxan 25 mVal Suspension next time, but continue taking the prescribed or recommended dose.

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

If you have any further questions about 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 (affects 1 to 10 out of 100 treated patients)

- soft stools.

Uncommon (affects 1 to 10 out of 1,000 treated patients)

- Diarrhea or constipation (see section 2. "Warnings and precautions

"). Talk to your doctor if you get diarrhea while taking Maaloxan 25 mVal Suspension. A reduction in the dose will usually improve the symptoms. Frequency not known (frequency cannot be estimated from the available data)

- Hypersensitivity reactions such as itching, hives (urticaria), severe allergic reactions including so-called angioedema, in which swelling of the lips, face, throat or tongue and difficulty swallowing or breathing may occur.
- increased magnesium blood level, increased aluminum 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").

Other possible side effects
Methyl-4-hydroxybenzoate and propyl-4-hydroxybenzoate (parabens) can cause hypersensitivity reactions, including delayed reactions. In appropriately sensitized patients, peppermint oil 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 about the safety of this medicine.

5. HOW SHOULD MAALOXAN 25 MVAL SUSPENSION BE STORED?
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 sachet after "Use by". The expiry date refers to the last day of the month indicated.
Storage conditions: Store protected from frost. Do not store above 25 oC.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Maaloxan 25 mVal Suspension contains
The active ingredients are alginate and magnesium hydroxide. 10 ml suspension for oral use (1 sachet) contains: Alginate from aluminum hydroxide gel, corresponding to 230 mg aluminum oxide, and 400 mg magnesium hydroxide (corresponding to a neutralizing capacity of approx. 25 mVal hydrochloric acid). The other ingredients are: methyl-4-hydroxybenzoate (Ph. Eur.), propyl-4-hydroxybenzoate (Ph. Eur.), citric acid monohydrate, saccharin sodium, mannitol (Ph. Eur.), sorbitol solution 70% (non-crystallizing) (Ph. Eur.), peppermint oil, hydrogen peroxide solution 30%, purified water, hydrochloric acid 10%.

What Maaloxan 25 mVal Suspension looks like and contents of the pack
White suspension, which is homogeneous after shaking.
Original packs of 10, 20 or 50 sachets each containing 10 ml suspension for oral use.

Pharmaceutical entrepreneur and manufacturer

Winthrop Arzneimittel GmbH
65927 Frankfurt am Main
Telephone: (01 80) 2 02 00 10*
Telefax: (01 80) 2 02 00 11*
*0.06 EUR/call (German landline); max. 0.42 EUR/min (mobile)

Co-distributor

Zentiva Pharma GmbH
65927 Frankfurt am Main

Or

Manufacturer

A. Nattermann & Cie. GmbH
Nattermannallee 1
50829 Cologne
Or
Sanofi-Aventis S.p.A.
Viale Europa 11
21040 Origgio (VA)
Italy

This leaflet was last revised in November 2014.

Source: Information from the package leaflet
Status: 02/2015
Areas of application: for the symptomatic treatment of conditions in which stomach acid should be bound: heartburn and acid-related stomach discomfort and stomach or duodenal ulcers (ulcus ventric