Gelatum aluminii phosphorici aflofarm

INFORMATION ON OUTER PACKAGING AND IMMEDIATE PACKAGING
Package Leaflet

1. NAME OF THE MEDICINAL PRODUCT

Gelatum Aluminii phosphorici Aflofarm
45 mg/g, oral suspension
Aluminii phosphatis liquamen

2. ACTIVE SUBSTANCE CONTENT

Composition:
100 g of 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 hydrogen carbonate, purified water.

4. PHARMACEUTICAL FORM AND PACKAGE CONTENTS

Oral suspension
250 g Code: 5909990053711

5. METHOD AND ROUTE OF ADMINISTRATION

Oral administration.
Read the contents of the label insert before using the medicine. To do so, peel off the label in the upper right corner at the place marked with an arrow.

6. WARNING ON STORAGE OF THE MEDICINAL PRODUCT

KEEP OUT OF SIGHT AND REACH OF CHILDREN
Store in a place out of sight and reach of children.
7. OTHER SPECIAL WARNINGS, IF NECESSARY
8. EXPIRY DATE
Expiry date
Do not use after the expiry date.
Period of validity after first opening of the medicinal product: 28 days.

9. SPECIAL STORAGE CONDITIONS

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

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED

MEDICINAL PRODUCT OR WASTE DERIVING FROM ITS USE, IF
APPLICABLE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

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

12. MARKETING AUTHORISATION NUMBER

Authorisation number: R/0537

13. BATCH NUMBER

Batch number

14. GENERAL AVAILABILITY CATEGORY

OTC - Medicinal product available without a prescription.

15. INSTRUCTIONS FOR USE

Indications: Adjunctive treatment of symptoms of gastric acid hyperacidity in the course of:
gastroesophageal reflux disease, gastric mucosal inflammation, peptic ulcer disease of the stomach
and duodenum.

Contraindications: Hypersensitivity to aluminium phosphate or excipients. Chronic
renal failure, particularly in dialysed patients.

Interactions: The medicinal product reduces the effect of the following drugs:

• tetracyclines (the medicinal product should be taken 3 to 4 hours after these drugs);
• ciprofloxacin, norfloxacin (antibacterial agents);
• phenytoin (used in epilepsy treatment);
• iron compounds;
• cardiac glycosides (used in heart diseases);
• ketoconazole (antifungal agent);
• salicylates;
• quinidine (antiarrhythmic agent);
• levothyroxine (used in hypothyroidism);
• H-receptor antagonists (cimetidine, ranitidine, famotidine);
• sucralfate (used in peptic ulcer disease).

The medicinal product may alter the site of action of enteric-coated tablets (the special coating dissolves in the stomach instead of the intestines). Therefore, these drugs should be taken 1 hour before or 1 hour after taking the medicinal product. If the patient is unsure whether they are taking any of the above-mentioned drugs, they should consult a physician or pharmacist.

Pregnancy and breastfeeding: Consult a physician before using the medicinal product.

Driving and operating machinery: The medicinal product has no effect or has negligible effect
on the ability to drive and operate machinery.

Precautions related to use: Do not use the medicinal product without consulting a physician: in children under 6 years of age, patients with bone disorders, renal function disorders, and in patients with Alzheimer's disease.
Do not use the medicinal product long-term. If symptoms worsen or do not improve during treatment, consult a physician.

The medicinal product contains sucrose, sodium benzoate and sodium

Sucrose
The medicinal product contains 7.350 g of sucrose in 15 ml of suspension. This should be taken into account in diabetic patients.
If a patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a physician before taking the medicinal product.

Sodium benzoate
The medicinal product contains 73.5 mg of sodium benzoate in 15 ml of suspension.

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

Method of administration and dosage:
Oral administration.
Use the measuring cup provided in the package for dosing. This ensures accurate dose measurement.
Take 5 ml to 15 ml of the medicinal product between meals, 3 to 5 times daily.
A double dose is recommended at bedtime. The maximum daily dose should not exceed 100 ml.

Shake well before use.

Always use this medicinal product as directed on the label or as advised by a physician or pharmacist. In case of doubt, consult a physician or pharmacist.

Overdose: No data available.
If a dose is missed, take the missed dose as soon as possible.

Adverse reactions: The following adverse effects may occur: constipation, increased aluminium concentration in blood, decreased phosphate concentration (hypophosphatemia) manifested by: loss of appetite, malaise, muscle weakness, bone softening; renal function disorders, encephalopathy (brain damage manifested by behavioral disturbances), hypersensitivity reactions.
In elderly patients, there is a risk of occurrence or worsening of symptoms of Alzheimer's disease.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed on this label, inform a physician or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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 marketing authorization holder.
Reporting adverse reactions helps to gather more information on the safety of the medicinal product.

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.