Package Insert: Information for the Patient

LacTEST 0.45 g Powder for Oral Solution

Gaxilosa

Read this entire package insert carefully before using this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor.
• This medication has been prescribed only for you, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, even if they are not listed in this package insert. See section 4.

1. What is LacTEST and what is it used for

2. What you need to know before starting to use LacTEST

3. How to use LacTEST

4. Possible adverse effects

5. Storage of LacTEST

6. Contents of the package and additional information

This medication is only for diagnostic use.

LacTESTis indicated for the non-invasive diagnosis of intestinal lactase deficiency in children and adolescents aged 6 years and above, adults, and elderly patients.

You should not use LacTEST:

• if you are allergic (hypersensitive) to xylitol
• if you have galactosemia or pentosuria
• if you have severe kidney disease, portal hypertension (ascites, cirrhosis), myxedema (severe hypothyroidism) or a history of total gastrectomy and/or vagotomy, as the safety studies have not been conducted in these conditions.

Warnings and precautions

Consult your doctor before starting to use LacTEST:

• if you have abnormal kidney function, as the safety and efficacy of LacTEST in patients with renal insufficiency have not been established. Your kidney function may be evaluated before administering LacTEST.
• if you have abnormal liver function, as the safety and efficacy of LacTEST in patients with liver insufficiency have not been established.

Children and adolescents

LacTEST can be administered to children and adolescents aged 6 years and above with normal kidney function.

The safety and efficacy of LacTEST in children aged 0 to 5 years have not been established. .

Use of LacTEST with other medications

Inform your doctor if you are using, have used recently or may need to use any other medication.

You should not take aspirin or indometacin 48 hours before the test with LacTEST and until the test has been completed, as aspirin and indometacin have been described to decrease the excretion of xylitol in the urine.

The possibility of interaction between LacTEST 0.45 g and arabinose contained in some foods cannot be ruled out, therefore patients will be advised to avoid taking foods containing arabinose at least 10 hours (maximum 24 hours) before ingesting LacTEST 0.45 g and until the completion of the test.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant or plan to become pregnant, consult your doctor before using this medication.

No effects are expected during pregnancy and breastfeeding.

Driving and operating machinery

The influence of LacTEST on the ability to drive and operate machinery is negligible or insignificant.

Follow exactly the administration instructions of this medication contained in this leaflet or those indicated by your doctor. In case of doubt, consult your doctor.

The recommended dose in adults and the elderly is 0.45 g dissolved in 100 ml of water.

The test must be performed following the following sequence:

1. It must be fasting for 10 hours before the test, preferably overnight.
2. It must urinate two hours before the test and again 15-30 minutes before the test.
3. It must ingest the contents of the package dissolved in water.
4. You must collect the urine in an appropriate container that will be provided for this purpose during the 5 hours that the test lasts and you must urinate immediately before completing it. During this time, you must drink up to a maximum of 500 ml of water to increase the desire to urinate.

For children aged 6 to 11 years, the test must follow the following sequence:

1. It must be fasting for 10 hours before the test, preferably overnight.

2. Three hours before taking LacTEST, you can have breakfast with one or some of the following foods: a fried egg, grilled chicken breast, white rice, and 2 slices of serrano ham. The cured/serrano ham must be obtained fresh to minimize the amount of additives.

3. It must urinate before the test.

4. It must ingest the contents of the package dissolved in water.

5. You must collect the urine in an appropriate container that will be provided for this purpose during the 5 hours that the test lasts and you must urinate immediately before completing it. During this time, you must drink up to a maximum of 500 ml of water to increase the desire to urinate.

This medication is not authorized for use in children aged 0 to 5 years.

Use in children and adolescents

LacTEST can be administered to children and adolescents from 6 years old with normal renal function.

No dose adjustment is necessary.

This medication is not authorized for use in children aged 0-5 years.

If you take moreLacTESTthan you should

Since only 0.45 g of gaxilosa is administered, a overdose is not expected.

Like all medications, LacTEST may produce adverse effects, although not all people will experience them.

The following adverse effects have been reported:

Rare (observed in 1 to 10 of every 1,000 patients)

Headache, abdominal distension, abdominal pain, nausea, diarrhea, vomiting, pruritus, urticaria

Unknown frequency (cannot be estimated from available data)

Dizziness, syncope, flatulence, abdominal discomfort, epigastric pain, gastrointestinal sounds, skin rash.

Reporting Adverse Effects

If you experience any adverse effect, consult your doctor, even if it is an adverse effect not listed in this prospectus.You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keepthis medicationout of sightand out ofreach of children.

Do not use thismedicationafter the expiration date that appears on the box.Theexpiration date is the last day of the month indicated.

Do not use this medication if you observevisible signs of deterioration.

This medicationis stored in blisters, its pharmaceuticalform; it does not require specialtemperature conditions for itsconservation.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGREcollection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofLacTEST

• The active ingredient is gaxilosa. Each sachet contains 0.45 g of gaxilosa.
• It does not contain other ingredients.

Appearance of the product and content of the packaging.

LacTESTis presented as a white or almost white powder for oral solution contained in a sachet.

Holder of the medicinal product authorization and responsible for manufacturing

Holder of the medicinal product authorization

Venter Pharma S.L.

Almagro 1, 1st floor

28010 Madrid

Spain

Responsible for the manufacture of the medicinal product

Infarmade, S.L.

Industrial Park La Isla

C/ Torre de los Herberos, 35

41703 Dos Hermanas. Sevilla

Spain

Local Representative

Juste Farma, S.L.U.

Avda. De San Pablo, 27.

28823 Coslada (Madrid)

Spain

This medicinal product is authorized in the member states of the European Economic Area with the following names:

SpainLacTEST 0.45 g powder for oral solution

PortugalLacTEST 0.45 g powder fororal solution

Last review date of this leaflet:February 2025

Other sources of information

The detailed information of this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/