This page is for general information. Consult a doctor for personal advice. Call emergency services if symptoms are severe.

How to use LACTEST 0.45 g ORAL SOLUTION POWDER

Introduction

Package Leaflet: Information for the Patient

LacTEST 0.45 g Powder for Oral Solution

Gaxilosa

Read this package leaflet carefully before using this medicine, as it contains important information for you.

Keep this package leaflet, as you may need to read it again.
If you have any further questions, ask your doctor.
This medicine has been prescribed for you only. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
If you experience any side effects, talk to your doctor, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

What is LacTEST and what is it used for
What you need to know before taking LacTEST
How to take LacTEST
Possible side effects
Storage of LacTEST
Contents of the pack and further information

1. What is LacTEST and what is it used for

This medicinal product is for diagnostic use only.

LacTEST is indicated for the non-invasive diagnosis of intestinal lactase deficiency in children and adolescents from 6 years of age, adults, and elderly patients.

2. What you need to know before taking LacTEST

Do not useLacTEST:

If you are allergic (hypersensitive) to gaxilosa
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 safety studies have not been conducted in these conditions.

Warnings and precautions

Consult your doctor before taking LacTEST:

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

Children and adolescents

LacTEST can be administered to children and adolescents from 6 years of age with normal kidney function.

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

Using LacTEST with other medicines

Tell your doctor if you are using, have recently used, or might use any other medicines.

Do not take aspirin or indomethacin from 48 hours before the LacTEST test and until the test is completed, as aspirin and indomethacin have been reported to decrease the excretion of xylose in the urine.

It cannot be completely ruled out that there may be an interaction between LacTEST 0.45 g and arabinose contained in some foods. Therefore, patients should be advised to avoid taking foods containing arabinose at least 10 hours (maximum 24 hours) before ingesting LacTEST 0.45 g and until the test is completed.

Pregnancy and breastfeeding

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

No effects are expected during pregnancy and breastfeeding.

Driving and using machines

The influence of LacTEST on the ability to drive and use machines is negligible or non-existent.

3. How to take LacTEST

Follow the instructions for administration of this medicine exactly as described in this package leaflet or as directed by your doctor. If you are unsure, consult your doctor.

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

The test should be performed in the following sequence:

You must be fasting for 10 hours before the test, preferably during the previous night.
You must urinate 2 hours before the test and again 15-30 minutes before the test.
You must ingest the contents of the sachet dissolved in water.
You will need to collect your urine in a suitable container provided for this purpose during the 5 hours that the test lasts, and you must urinate immediately before completing the test. During this time, you should drink up to a maximum of 500 ml of water to increase the desire to urinate.

For children from 6 to 11 years of age, the test should be performed in the following sequence:

You must be fasting for 10 hours before the test, preferably during the previous night.
Three hours before taking LacTEST, you can have breakfast with one or more of the following foods: a fried egg, grilled chicken breast, white rice, and 2 slices of cured ham. The cured ham must be fresh to minimize the amount of additives.
You must urinate before the test.
You must ingest the contents of the sachet dissolved in water.
You will need to collect your urine in a suitable container provided for this purpose during the 5 hours that the test lasts, and you must urinate immediately before completing the test. During this time, you should drink up to a maximum of 500 ml of water to increase the desire to urinate.

This medicinal product is not authorized for use in children from 0 to 5 years of age.

Use in children and adolescents

LacTEST can be administered to children and adolescents from 6 years of age with normal kidney function.

No dose adjustment is necessary.

This medicinal product is not authorized for use in children from 0-5 years of age.

If you use moreLacTESTthan you should

As only 0.45 g of gaxilosa is administered, an overdose is not expected.

4. Possible side effects

As with all medicines, LacTEST can cause side effects, although not everybody gets them.

The following side effects have been reported:

Uncommon (affects 1 to 10 users in 1,000)

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

Frequency not known (cannot be estimated from the available data)

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

Reporting of side effects

If you experience any side effects, talk to your doctor, even if they are not listed in this package leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of LacTEST

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton. The expiry date is the last day of the month stated.

Do not use this medicine if you notice visible signs of deterioration.

This medicine is stored in sachets; it does not require special temperature conditions for storage.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition ofLacTEST

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

Appearance of the product and contents of the pack.

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

Marketing authorization holder and manufacturer

Marketing authorization holder

Venter Pharma S.L.

Almagro 1, 1º dcha

28010 Madrid

Spain

Manufacturer of the medicinal product

Infarmade, S.L.

Polígono Industrial 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 under the following names:

Spain LacTEST 0.45 g powder for oral solution

Portugal LacTEST 0.45 g powder for oral solution

Date of the last revision of this package leaflet:February 2025

Other sources of information

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/

How much does LACTEST 0.45 g ORAL SOLUTION POWDER cost in Spain ( 2025)?

The average price of LACTEST 0.45 g ORAL SOLUTION POWDER in December, 2025 is around 70.25 EUR. Prices may vary depending on the region, pharmacy, and whether a prescription is required. Always check with a local pharmacy or online source for the most accurate information.

Dr Tomasz Grzelewski is an MD, PhD specialist in allergy, paediatrics, general practice and sports medicine, with a clinical focus on dermatology, endocrinology, allergology and sports-related health. He has more than 20 years of clinical experience and completed his medical training at the Medical University of Łódź, where he defended his PhD thesis with distinction. His doctoral research was recognised by the Polish Society of Allergology for its innovative contribution to the field. Throughout his career, he has gained extensive expertise in diagnosing and managing a wide range of allergic and paediatric conditions, including modern allergen desensitisation techniques.

For five years, Dr Grzelewski served as the Head of two paediatric departments in Poland, managing complex clinical cases and leading multidisciplinary teams. He also worked in medical centres in the United Kingdom, gaining experience across both primary care and specialist environments. With over a decade of telemedicine experience, he has provided online consultations across Europe and is valued for his clear, structured and evidence-based medical guidance.

Dr Grzelewski is actively involved in clinical programmes focused on modern anti-allergic therapies. As a Principal Investigator, he leads research projects on sublingual and oral allergen desensitisation, supporting evidence-based progress in allergy treatment for both children and adults.

In addition to his background in allergology and paediatrics, he completed dermatology studies through the Cambridge Education Group (Royal College of Physicians of Ireland) and a Clinical Endocrinology course at Harvard Medical School. This advanced training enhances his ability to manage skin manifestations of allergies, atopic conditions, urticaria, endocrine-related symptoms and complex immunological reactions.

Patients commonly seek his care for:

seasonal and perennial allergies
allergic rhinitis and chronic nasal symptoms
asthma and breathing difficulties
food and medication allergies
urticaria, atopic dermatitis and skin reactions
recurrent infections in children
sports-related health questions
general family medicine concerns

Dr Tomasz Grzelewski is known for his clear communication style, structured medical approach and ability to explain treatment options in a concise and accessible way. His multidisciplinary background across allergy, paediatrics, dermatology and endocrinology allows him to provide safe, up-to-date and comprehensive care for patients of all ages.

LACTEST 0.45 g ORAL SOLUTION POWDER

Nuno Tavares Lopes

Duarte Meneses

Nuno Tavares Lopes

Duarte Meneses