Gelatum Aluminii phosphorici Aflofarm

INFORMATION PLACED ON OUTER AND DIRECT PACKAGING

PACKAGING

Leaflet

1. NAME OF THE MEDICINAL PRODUCT

Gelatum Aluminii Phosphorici Aflofarm

45 mg/g, oral suspension
Aluminii phosphatis liquamen

2. CONTENT OF ACTIVE SUBSTANCE

Composition:

100 g of the product contains:
4.5 g of aluminum phosphate gel (Aluminii phosphatis liquamen)

3. LIST OF EXCIPIENTS

and excipients: sucrose, sodium benzoate, peppermint essential oil
with reduced menthol content, sodium bicarbonate, purified water.

4. PHARMACEUTICAL FORM AND PACKAGING CONTENT

Oral suspension
250 g Code: 5909990053711

5. METHOD AND ROUTE OF ADMINISTRATION

Oral administration.
You should read the contents of the leaflet before using the medicine, to do this,
you should peel off the label in the top right corner where indicated by an arrow.

6. WARNING ABOUT STORAGE OF THE MEDICINAL PRODUCT

IN A PLACE INVISIBLE AND INACCESSIBLE TO CHILDREN

Store in a place invisible and inaccessible to children.

7. OTHER SPECIAL WARNINGS, IF NECESSARY

8. EXPIRY DATE

Expiry date
Do not use after the expiry date.
Shelf life after first opening of the medicine: 28 days.

9. SPECIAL STORAGE CONDITIONS

Store at a temperature below 25°C. Do not store in the refrigerator or freeze.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED

MEDICINAL PRODUCT OR WASTE DERIVED FROM IT, IF APPROPRIATE

APPLICABLE

11. NAME AND ADDRESS OF THE RESPONSIBLE ENTITY

Responsible entity

Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
Tel. (42) 22-53-100

12. NUMBER OF THE MARKETING AUTHORIZATION

Authorization number R/0537

13. BATCH NUMBER

Batch number

14. GENERAL CATEGORY OF AVAILABILITY

OTC - Medication available without a prescription.

15. INSTRUCTIONS FOR USE

Indications:Supporting treatment of symptoms of gastric acid hypersecretion in the course of:
gastroesophageal reflux disease, gastritis, gastric and duodenal ulcer disease.
Contraindications:Hypersensitivity to aluminum phosphate or excipients. Chronic
renal failure, especially in dialyzed patients.
Interactions:The medicine reduces the effect of the following medicines:

• tetracyclines (the medicine should be taken 3 to 4 hours after their administration);
• ciprofloxacin, norfloxacin (antibacterial medicines);
• phenytoin (a medicine used to treat epilepsy);
• iron compounds;
• cardiac glycosides (used in heart diseases);
• ketoconazole (an antifungal medicine);
• salicylates;
• quinidine (an antiarrhythmic medicine);
• levothyroxine (a medicine used to treat hypothyroidism);
• histamine H2 receptor antagonists (cimetidine, ranitidine, famotidine);
• sucralfate (used in ulcer disease). The medicine may change the site of action of medicines in the form of enteric-coated tablets (instead of in the intestines, the special coating of the medicine dissolves in the stomach). Therefore, these medicines should be taken 1 hour before or 1 hour after taking the medicine. If the patient is not sure whether they are taking any of the above-mentioned medicines, they should consult a doctor or pharmacist.

Pregnancy and breastfeeding:Before using the medicine, you should consult a doctor.
Driving and operating machinery:The medicine has no effect or a negligible effect
on the ability to drive vehicles and operate machinery.
Precautions related to use:The medicine should not be used without consulting a doctor: in children under 6 years of age, people with bone system diseases, with kidney function disorders, and in patients with Alzheimer's disease.
The medicine should not be used for a long time. If symptoms worsen or do not improve during treatment with the medicine, you should consult a doctor.

The medicine contains sucrose, sodium benzoate, and sodium

Sucrose

The medicine contains 7.350 g of sucrose in 15 ml of suspension. This should be taken into account in patients with
diabetes.
If the patient has previously been diagnosed with intolerance to some sugars, the patient should
consult a doctor before taking the medicine.

Sodium benzoate

The medicine contains 73.5 mg of sodium benzoate in 15 ml of suspension.

Sodium

The medicine contains 17.474 mg of sodium (the main component of table salt) in 15 ml of suspension.
The medicine contains 35 mg of sodium (the main component of table salt) in 30 ml of suspension, which corresponds to
1.75% of the maximum recommended daily intake of sodium in the diet for adults.

Method of administration and route of administration:

Oral administration.
To dose the medicine, use the measuring cup attached to the packaging. This allows for accurate dosing.
The medicine should be taken between meals from 5 ml to 15 ml, 3 to 5 times a day.
At night, it is recommended to take a double dose. The maximum daily dose should not exceed 100 ml.

Shake vigorously before use.

This medicine should always be used in accordance with the description on the label or as directed by a doctor or pharmacist. In case of doubts, you should consult a doctor or pharmacist.
Overdose:No data available.
In case of a missed dose, take the missed dose as soon as possible.
Adverse reactions:The following adverse reactions may occur: constipation, increased
aluminum levels in the blood, decreased phosphate levels (hypophosphatemia) manifested by: lack of
appetite, poor well-being, muscle weakness, softening of bones; kidney function disorders, encephalopathy (brain damage manifested by behavioral disorders), hypersensitivity reactions.
In elderly patients, there is a risk of occurrence or worsening of Alzheimer's disease symptoms.

Reporting adverse reactions

If any adverse reactions occur, including any adverse reactions not listed in this leaflet, you should inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring of Adverse Reactions to 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
Adverse reactions can also be reported to the responsible entity.
By reporting adverse reactions, more information can be gathered on the safety of the medicine.

16. INFORMATION PROVIDED IN BRAILLE SYSTEM

Gelatum Aluminii Phosphorici Aflofarm

17. UNIQUE IDENTIFIER – 2D CODE

Not applicable.

18. UNIQUE IDENTIFIER – HUMAN-READABLE DATA

Not applicable.