Maaloxan 25 MVAL suspension, 20x10 ml

Upute za korištenje Maaloxan 25 MVAL suspension, 20x10 ml

Important notes (compulsory information):

Maaloxan ® 25 MVAL suspension. Applications: To the symptomat. Treat. Of diseases in which the stomach acid is to be bound: heartburn, acid-related stomach complaints, gastric or duodenal ulcers. Note: Contains sorbitol, peppermint oil.

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


Instructions for use: Information for users
Maaloxan ® 25 MVAL suspension
oral suspension
Active ingredients: AlgelDrat, magnesium hydroxide

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

• Lift the package leaflet. You might want to read it again.
• Ask your pharmacist if you need more information or advice.
• If you notice side effects, contact your doctor or pharmacist. This also applies to side effects that are not indicated 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 before taking Maaloxan Note 25 MVAL suspension?
3. What is Maaloxan 25 MVAL suspension take?
4. Which side effects are possible?
5. How is Maaloxan Storage 25 Mval suspension?
6. Content of the pack and further information

1. What is Maaloxan 25 Mval suspension and what is she applied for?

Maaloxan 25 MVAL suspension is a means for binding excess gastric acid.
Maaloxan 25 MVAL suspension is used to symptomatic treatment of diseases in which the gastric acid is to be bound:

• Sodburn and acid-related stomach complaints,
• Stomach or duodenum ulcers (Ulcus Ventriculi or Ulcus Dodeni).

Note:
In patients with gastric or duodenal ulcers, an investigation on Helicobacter pylori (a particular bacterial type) should And, in the case of detection - a therapy with which the bacterium is completely eliminated, since then usually the ulcer healed.

2. What should you pay attention to 25 MVAL suspension before taking Maaloxan?

Maaloxan 25 MVAL suspension must not be taken,

• when they allergic against AlgelDrat or magnesium hydroxide, peppermint oil, methyl-4-hydroxybenzoate, propyl-4-hydroxybenzoate (Parabens) or one of the other ingredients of this medicine referred to in section 6,
• if you have a heavy renal failure,
• if you have a reduced phosphate blood mirror (Hypophosphatemia) is present.

Warnings and Precautions:
Long-lasting and recurring stomach complaints can be signs of a serious illness, such as: B. a stomach or duodenal ulcer. A treatment with Maaloxan 25 MVAL suspension should therefore take no longer than 14 days without a medical examination. If the teery chair occurs, blood petitions in the chair or vomiting of blood, you must immediately see a doctor.

Please talk to your doctor before you Maaloxan Take 25 MVAL suspension,

• if you suffer from kidney disease,
• if you follow a phosphatar diet.

This medicine can cause constipation and an overdose can cause a reduction in intestinal movements. High doses can trigger or aggravate or aggravate or aggravate children under 2 years or older people, children under 2 years or older people, children under 2 years or elderly people.

The active ingredients of this medicine are hardly absorbed from the digestive tract in the blood. Therefore, side effects in patients with normal kidney function are rare. However, too high doses or long-term use and even normal doses in patients who comply with a phosphatar diet can lead to a phosphate hazard or in children under 2 years (due to aluminum phosphate binding). A phosphate deficiency may be associated with increased bone resorption and increased calcium excretion in urine with the risk of osteomalacia, d. H. Increased softness and bonding tendency of the bones.

With severely limited renal function, the ingestion of magnesium and aluminum-containing medicines such as Maaloxan 25 MVAL suspension cause an increased magnesium content of the blood and an increased aluminum content of the blood (risk of poisoning!). With impaired renal function and long-term taking of high doses, the aluminum storage can come primarily in the nerve and bone tissue. This can lead to brain damage (Encephalopathy, dementia) and anemia (microcytic anemia) or a dialysic bone softening (osteomalacia) worsen. Therefore, you should avoid a long-lasting taking of high doses if you have limited kidney function.

With impaired renal function (creatinine clearance < 30 ML / min) and long-term use requires regular control of aluminum and magnesium blood levels by your doctor. The aluminum blood mirror should not exceed 40 μg / L.

In patients with porphyria (disturbance of the formation of the red blood dye), which is a hemodialysis (blood towel) undergo the taking of Maaloxan 25 MVAL suspension a risk and should therefore only be consulted with the doctor.

Application in children:
Maaloxan 25 MVAL suspension should not be used in children under 12 years, as there is no sufficient experience in this age group.

Taking Maaloxan 25 MVAL suspension together with other medicines:
Tell your doctor or pharmacist if you take other medicines, recently taken or intend to take other medicines.
The simultaneous intake of quinidine (medicines against cardiac arrhythmias) can increase the quinidine blood levels and thereby lead to overdose of quinidine.

The simultaneous intake of aluminum-containing gastric agents with other medicines may affect their recording. Significant recovery reductions are described for certain antibiotics such as tetracycline, fluoroquinolones (eg ciprofloxacin, norfloxacin, pefloxacin) and cephalosporins (e.g., cefpodoxime). They can be up to 90% and are consequence of the formation of non-absorbable compounds of these medicines. Therefore, during a therapy with these antibiotics, it is advised by taking gastric acid-binding medicament. If necessary, other gastric acid inhibiting medicines should be applied.

The recording of the following medicines can also be reduced: Chloroquine, allopurinol, non-steroidal anti-rheumatics (eg. B. Diclofenac, acetylsalicylic acid, naproxen, indometacin, diflunisal, Penicillamine, digoxin, isoniazide, captopril, atenolol, metoprolol, propranolol, dicumarol, levothyroxine, ketoconazole, gabapentin, H2 receptor blocker, bisphosphonates, ethambutol, lincosamide antibiotics (eg clindamycin), sodium fluoride, rosuvastatin, glucocorticoids, iron compounds and neuroleptics From the phenothiazin type (eg chlorpromazine).

Caution is required while taking polystyrene sulfonate ion exchange resins. It is possible that the potassium binding effectiveness of the resin is reduced, at Patothed with impaired renal function of pH in the blood increases (alkalosis) and that it comes to a colon closure.

With regard to possible recording impairment, you should generally follow a distance of at least 2 hours between the intake of acid-binding gastric agents and other medicinal products.

Taking Maaloxan 25 MVAL suspension along with food and beverages:
Aluminum, acid-binding gastric agent increase with simultaneous ingestion with acidic drinks (fruit juices, wine u. A.) The aluminum absorption from the intestine. Also effervescent tablets contain fruit acids (eg citrates), which can increase the aluminum intake. This can lead to increased aluminum blood levels, especially in patients with renal impairment.

Pregnancy and breast feeding period:
If you are pregnant or breastfeeding or if you suspect to be pregnant, or intend to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy:
If you are pregnant, you are allowed to Maaloxan 25 MVAL suspension only after consultation with your doctor. In order to avoid aluminum loading and thus a possible damage to your child, you may only take this medicine during pregnancy at short notice in the lowest possible dosage.

Latving:
Aluminum compounds go into breast milk. A risk for the newborn can not be assumed because only very small quantities are absorbed. Therefore, it is possible to breastfeed, provided that the recommendations for dosing and application time are observed.

Driving and ability to operate machines:
There are no special precautions required.

Maaloxan 25 MVAL suspension contains sorbitol
Please take this medicine only after consulting your doctor if you are familiar with any intolerance to certain sugars.

Note for diabetics:
Maaloxan 25 MVAL suspension contains the sugar replacement sorbitol and mannitol. Physiological condensing value: approx. 1.32 kJ = approx. 0.32 kcal or approx. 0.0083 BE per 10 ml suspension to take (1 Bag).

3. How is Maaloxan to take 25 Mval suspension?

Always take this medicine as described in this leaflet, or just according to the agreement made with your doctor. Ask your doctor or pharmacist if you are not sure.

Unless otherwise prescribed by the doctor, the usual dose is:
Stomach and duodenal ulcers:
Adults generally take 1 to 2 hours after each meal and immediately before going to bed 1 - 2 bags Maaloxan 25 MVAL suspension undiluted. The daily dose should 4 - 6 bags Maaloxan 25 MVAL suspension (corresponding to approx. 100 - 150 MVAL neutralization capacity not exceed.

Symptomatic treatment of heartburn and acid-related stomach complaints:
If necessary several times a day a bag Maaloxan 25 MVAL suspension.

type of application
To take.
Before use, knead the bag strongly and then tear on the marked spot. Put the bag content either on a spoon and then take undiluted or empty straight out of the bag in the mouth.

Note:
The taking of other medicines should basically at least two hours before or after taking Maaloxan 25 MVAL suspension occur. During treatment with antibiotics such as tetracyclines and quinolons, the ingestion of gastric acid-binding medicines is not recommended (see "Taking Maaloxan 25 MVAL suspension together with other medicines").

Duration of application:
The duration of the treatment depends on the type and severity as well as the course of the disease. If the complaints remain under treatment for more than 2 weeks, a doctor should be visited.

If you have a larger amount of Maaloxan 25 MVAL suspension taken as they should:
Poisoning by Maaloxan 25 MVAL suspension are unlikely due to the low recording of aluminum and magnesium.
For overdose, it can change of stool behavior such as chair softening, increase in chair frequency, abdominal pain and vomiting. Special measures are generally not required here.

In patients with impaired renal function, due to the increased poison risk is suspected of overdose with larger quantities of Maaloxan 25 MVAL suspension immediately to notify a doctor. In such cases, a disturbance of the intestinal passage and a colon closure can be triggered or aggravated.

If you are taking Maaloxan 25 MVAL suspension forgot:
Take no longer than the next time Maaloxan 25 MVAL suspension, but put the intake with the prescribed or Recommended dose away.

If you are taking Maaloxan Cancel 25 MVAL suspension:
In any case, talk to your doctor before you, z. B. Due to the occurrence of side effects, a doctor prescribed by the doctor with Maaloxan 25 MVAL suspension interrupt or end prematurely.

If you have further questions about the application of this medicine, contact your doctor or pharmacist.

4. Which side effects are possible?

Like all medicines, this medicine can also have side effects, but they do not have to occur each other.
possible side effects
Frequently (concerns 1 to 10 treated from 100):

• soft chair.

Occasionally (concerns 1 to 10 treated by 1,000):

• Diarrhea or constipation (see section 2. "Warnings and Precautions2). Talk to your doctor if you get under treatment with Maaloxan 25 Mval suspension diame. As a rule, a reduction of the dose will improve the complaints.

Frequency unknown (frequency based on the available data not estimable):

• Hypersensitivity reactions such as itching, hives (Urticaria), severe allergic reactions including so-called angioedema, where swelling of lips, face, throat or tongue and hiccups or breathing difficulties can occur.
• increased magnesium blood mirror, increased aluminum blood mirrors, reduced phosphate blood levels, increased bone resorption, increased calcium excretion in urine, increased softness and bonding tendency of the bones (osteomalacia) (see section 2. "Warnings and Precautions").

Other possible side effects:
Methyl-4-hydroxybenzoate and propyl-4-hydroxybenzoate (parabenses) can cause hypersensitivity reactions, even late reactions.
In the case of correspondingly sensitized patients, hypersensitivity reactions (including respiratory distress) can be triggered by peppermint oil.

Message of side effects:
If you notice side effects, contact your doctor or pharmacist. This also applies to side effects that are not indicated in this leaflet. You can also share effects directly
Federal Institute for Pharmaceuticals and Medical Products
Dept. Pharmacovigilance Kurt-Georg-Kiesinger-Allee 3
D-53175 Bonn
Website: www.bfarm.de
Show. By reporting side effects, you can help to provide more information about the security of this medicine.

5. How to keep Maaloxan 25 MVAL suspension?

Keep this medicine inaccessible to children.
You must not use this medicine after the expiry date specified on the folding box and the bag according to "until". The expiry date refers to the last day of the specified month.
Storage conditions:
Store protected from frost. Do not store over 25 OC.

6. Content of the pack and further information

What Maaloxan 25 MVAL suspension contains
The active ingredients are AlgelDrat and Magnesiumydroxide.
10 ml suspension to take (1 bag) included:
AlgelDrat made of aluminum hydroxide gel, corresponding to 230 mg of alumina, and 400 mg of magnesium hydroxide (corresponding to a neutralization capacity of about 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% (not crystallizing) (Ph. EUR.), Peppermint oil, hydrogen peroxide solution 30%, purified water, hydrochloric acid 10 %.

Like Maaloxan 25 MVAL suspension looks and content of the pack:
White suspension that is homogeneous after shaking.
Original packs with 10, 20 or 50 bags each with 10 ml suspension to take.

Pharmaceutic entrepreneur:
Winthrop Arzneimittel GmbH
65927 Frankfurt am Main
Telephone: (01 80) 2 02 00 10*
Fax: (01 80) 2 02 00 11*

Co-sales:
Zentiva Pharma GmbH
65927 Frankfurt am Main
Sanofi-Aventis Deutschland GmbH
65926 Frankfurt am Main

or
Manufacturer
A. Nattermann & Cie. GmbH
Nattermannallee 1
50829 Cologne

or
Sanofi S.P.A.
Viale Europe 11
21040 Origgio (VA)
Italy

This leaflet was recently revised in December 2015.

Pharmacy-only.
*0.06 EUR / call (dt. Landline); Max. 0.42 EUR / min (mobile radio).

Source: Information of the leaflet
Status: 01/2018