Gelatum Aluminii phosphorici

Leaflet included in the packaging: patient information

Gelatum Aluminii Phosphorici, 45 mg/g oral suspension

( Aluminum phosphate)
You should carefully read the contents of the leaflet before using the medicine, as it contains
important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• If the patient experiences any undesirable effects, including any undesirable effects not mentioned in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Gelatum Aluminii Phosphorici and what is it used for
• 2. Important information before using Gelatum Aluminii Phosphorici
• 3. How to use Gelatum Aluminii Phosphorici
• 4. Possible undesirable effects
• 5. How to store Gelatum Aluminii Phosphorici
• 6. Contents of the packaging and other information

1. What is Gelatum Aluminii Phosphorici and what is it used for

Gelatum Aluminii Phosphorici is a medicine that neutralizes gastric acid and also has a protective and adsorbing effect. The aluminum phosphate contained in the medicine has a protective effect on the mucous membrane of the esophagus, stomach, and duodenum by creating a protective layer. The suspension form facilitates even distribution of the medicine on the mucous membrane, which facilitates its healing. The aluminum chloride formed as a result of the neutralization reaction has an adsorbing and anti-inflammatory effect. The addition of peppermint oil provides a mild antispasmodic effect in digestive disorders.
Indications for use:
In the treatment of symptoms occurring in the course of the following diseases:

• gastric and duodenal ulcer disease (supportive or symptomatic in case of symptoms)
• gastric acid hypersecretion,
• gastroesophageal reflux disease,
• heartburn.

2. Important information before using Gelatum Aluminii Phosphorici

When not to use Gelatum Aluminii Phosphorici:

• if the patient is allergic to the active substances or any of the other ingredients of this medicine (listed in section 6);
• in case of: severe renal impairment.

Warnings and precautions

Before starting to use Gelatum Aluminii Phosphorici, you should discuss it with your doctor or pharmacist.
ParticularcautionshouldbeexercisedwhenusingGelatumAluminiiPhosphoriciinpatientswithimpairedrenalfunctionduetothecontentofaluminumandthepossibilityofitsaccumulation. Long-term use in dialyzed patients may increase the risk of encephalopathy. The medicine should not be used for a long time. If symptoms persist, the diagnosis should be verified.

Children

The medicine should be used with caution in children under 6 years of age, especially dehydrated or with renal impairment.

Gelatum Aluminii Phosphorici and other medicines

Due to the possibility of absorption disorders of other medicines (especially tetracyclines, non-steroidal anti-inflammatory drugs, iron, oral anticoagulants, digoxin - a medicine used in heart diseases, vitamins), they should be administered at least 1 hour before taking the aluminum phosphate suspension or 2 hours after its administration.
You should tell your doctor or pharmacist about all medicines that the patient is currently taking or has recently taken, as well as about medicines that the patient plans to take.

Gelatum Aluminii Phosphorici with food and drink

The medicine should be taken before meals or 1-2 hours after each meal and immediately before bedtime

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects that she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before using this medicine.
During pregnancy, the medicine should be used with caution, in accordance with the indications. The recommended doses should not be exceeded, and the medicine should not be used for a long time.
During breastfeeding, the medicine should be used with caution, in accordance with the indications. The recommended doses should not be exceeded, and the medicine should not be used for a long time.

Driving and operating machinery

The medicine does not affect the ability to drive and operate machinery.

Gelatum Aluminii Phosphorici contains sucrose

The medicine contains 40 g of sucrose in 100 g of suspension. This should be taken into account in patients with diabetes. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

Gelatum Aluminii Phosphorici contains ethyl hydroxybenzoate, propyl hydroxybenzoate

The medicine may cause allergic reactions (possible reactions of the delayed type).
The medicine contains 12.2 mg of benzene acid salt in 5 ml of suspension (teaspoon).
The medicine contains less than 1 mmol (23 mg) of sodium per dose (tablespoon), which means that the medicine is considered "sodium-free".

The medicine contains peppermint oil

The medicine contains a flavoring and fragrant substance with limonene (a component of peppermint oil). Limonene may cause allergic reactions. An allergic reaction may occur in patients who are allergic and in patients who have not been allergic before.

3. How to use Gelatum Aluminii Phosphorici

Before use, shake the bottle.
Orally: usually 3 times a day, 1 teaspoon (in severe cases, 1 tablespoon) before meals or 1-2 hours after each meal and immediately before bedtime.
You should not take more than 100 ml per day.
If you feel that the effect of the medicine is too strong or too weak, you should consult your doctor.
This medicine should always be used exactly as described in the patient information leaflet or according to the doctor's or pharmacist's instructions. In case of doubts, you should consult your doctor or pharmacist.

Missing a dose of Gelatum Aluminii Phosphorici

You should not take a double dose to make up for a missed dose.

Stopping the use of Gelatum Aluminii Phosphorici

In case of any further doubts related to the use of this medicine, you should consult your doctor or pharmacist.

4. Possible undesirable effects

Like all medicines, this medicine can cause undesirable effects, although not everybody gets them.
During the use of the medicine, constipation may occur. Increased aluminum concentration in the blood, decreased phosphate concentration (hypophosphatemia). Symptoms of hypophosphatemia include: loss of appetite, malaise, muscle weakness, osteomalacia (softening of bones caused by loss of calcium and phosphorus from bone tissue, leading to bone fragility).
In elderly patients, there is a risk of occurrence or exacerbation of Alzheimer's disease symptoms.

Reporting undesirable effects

If any undesirable effects occur, including any undesirable effects not mentioned in the leaflet, you should inform your doctor or pharmacist. Undesirable effects can be reported directly to the Department of Monitoring of Undesirable Effects of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: + 48 22 49 21 301
fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Undesirable effects can also be reported to the marketing authorization holder.
Thanks to the reporting of undesirable effects, more information can be collected on the safety of the use of the medicine.

5. How to store Gelatum Aluminii Phosphorici

Store in a temperature below 25°C.
Shelf life after first opening of the medicinal product: 21 days .
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Gelatum Aluminii Phosphorici contains

100 g of suspension contains:

• active substance: aluminum phosphate 4.5 g
• excipients: sucrose, sodium benzoate, ethyl hydroxybenzoate, propyl hydroxybenzoate, glycerol 85%, peppermint oil, purified water.

What Gelatum Aluminii Phosphorici looks like and what the packaging contains

A 250 g bottle containing a white-blue, homogeneous suspension with a minty smell, in a cardboard box.

Marketing authorization holder and manufacturer

Pharmaceutical Company "Ziołolek" Sp. z o.o.
ul. Starołęcka 189
61-341 Poznań
tel. 61 8352363
fax 61 8352363
e-mail: [email protected]

Date of the last update of the leaflet:

(company logo)