Gelatum aluminii phosphorici

Package leaflet: Information for the patient

Gelatum Aluminii Phosphorici, 45 mg/g oral suspension
(Aluminii phosphas)
Please read all of this leaflet carefully before taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If your symptoms do not improve or if you feel worse, consult your doctor.

Contents of the leaflet

1. What is Gelatum Aluminii Phosphorici and what is it used for
2. Important information before taking Gelatum Aluminii Phosphorici
3. How to take Gelatum Aluminii Phosphorici
4. Possible side effects
5. How to store Gelatum Aluminii Phosphorici
6. Contents of the package and other information

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

Gelatum Aluminii Phosphorici is a medicine that neutralizes hydrochloric acid in gastric juice and also has protective and astringent properties. The aluminium phosphate contained in the medicine protects the mucous membranes of the oesophagus, stomach and duodenum by forming a protective layer. The suspension formulation facilitates even distribution of the medicine over the mucous membrane, thereby supporting tissue healing. The aluminium chloride formed during the neutralization reaction exerts an astringent and anti-inflammatory effect. The addition of peppermint oil provides mild antispasmodic action in gastrointestinal disorders.

Indications:
For the treatment of symptoms occurring in the course of the following conditions:

• Peptic ulcer disease of the stomach and duodenum (as supportive treatment or on-demand relief of symptoms)
• Gastric hyperacidity
• Gastro-oesophageal reflux
• 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 to any of the other ingredients of this medicine (listed in section 6);
• in case of severe renal insufficiency.

Warnings and precautions
Before starting treatment with Gelatum Aluminii Phosphorici, discuss it with your doctor or pharmacist.
Exercise special caution when using Gelatum Aluminii Phosphorici in patients with impaired kidney function due to the aluminium content and the possibility of its accumulation. Long-term use in dialysed patients may increase the risk of developing encephalopathy. The medicine should not be used for prolonged periods. If symptoms persist, the diagnosis should be re-evaluated.
Children
Use with caution in children under 6 years of age, especially in dehydrated children or those with renal insufficiency.
Gelatum Aluminii Phosphorici and other medicines
Due to the possibility of impaired absorption of other medicinal products (especially tetracyclines, non-steroidal anti-inflammatory drugs, iron, oral anticoagulants, digoxin – a medicine used in heart diseases, vitamins), these should be administered at least one hour before or two hours after taking aluminium phosphate suspension.
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines planned for use.
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 she might be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
During pregnancy, the medicine should be used cautiously and only as indicated. Recommended doses should not be exceeded, nor should the medicine be used for prolonged periods.
During breastfeeding, the medicine should be used cautiously and only as indicated. Recommended doses should not be exceeded, nor should the medicine be used for prolonged periods.
Driving and operating machinery
This medicine does not affect the ability to drive or operate machinery.
Gelatum Aluminii Phosphorici contains sucrose
The medicine contains 40 g of sucrose per 100 g of suspension. This should be taken into account in patients with diabetes. If a patient has previously been diagnosed with intolerance to certain sugars, the patient should contact a doctor before taking this medicine.
Gelatum Aluminii Phosphorici contains ethyl hydroxybenzoate, propyl hydroxybenzoate
The medicine may cause allergic reactions (including delayed-type reactions).
The medicine contains 12.2 mg of benzoic acid salt per 5 ml of suspension (teaspoon).
The medicine contains less than 1 mmol (23 mg) of sodium per dose (tablespoon), meaning the medicine is considered "sodium-free".
The medicine contains peppermint oil
The medicine contains a flavouring agent containing limonene (a component of peppermint oil). Limonene may cause allergic reactions. Allergic reactions may occur in both sensitized patients and in patients not previously sensitized.

3. How to use Gelatum Aluminii Phosphorici

Shake the bottle before use.
Orally: Usually, a teaspoonful is taken 3 times daily into tea (in more severe cases, a tablespoonful)
before meals or 1–2 hours after each meal and immediately before bedtime.
Do not use more than 100 ml per day.
If you feel that the effect of the medicine is too strong or too weak, consult your doctor.
This medicine should always be used exactly as described in the patient information leaflet or as directed by
your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Missed dose of Gelatum Aluminii Phosphorici
Do not take a double dose to make up for a missed dose.
Stopping Gelatum Aluminii Phosphorici
If you have any further questions regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like any medicinal product, this medicine may cause adverse effects, although not everyone experiences them.
Constipation may occur during treatment. Increased aluminium concentration in blood, decreased phosphate levels (hypophosphataemia). Symptoms of hypophosphataemia include: loss of appetite, malaise, muscle weakness, osteomalacia (softening of bones caused by loss of calcium and phosphate from bone tissue, leading to reduced bone strength).
In elderly patients, there is a risk of occurrence or worsening of symptoms of Alzheimer's disease.
Reporting of adverse effects
If any adverse symptoms occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects may also be reported to the marketing authorisation holder.
Reporting of adverse effects allows collection of further information on the safety of using the medicine.

5. How to store Gelatum Aluminii Phosphorici

Store below 25°C.
Shelf-life after first opening of the medicinal product: 21 days.
Keep this medicine out of the 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 stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such action 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: aluminium 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 contents of the pack
A 250 g bottle containing a white-blue, homogeneous suspension with a minty odour, in a cardboard box.
Marketing Authorisation 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]
(company logo)