Lactest 0.45 g powder for oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

LacTEST 0,45 g powder for oral solution

Gaxilose

Read all of this leaflet carefully before using this medicine, as 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.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of this leaflet

1. What LacTEST is and what it is used for
2. What you need to know before taking LacTEST
3. How to take LacTEST
4. Possible side effects
5. How to store LacTEST
6. Contents of the pack and other information

1. What LacTEST is and what it is used for

This medicine 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 using LacTEST

Do not use LacTEST:

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

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 impairment have not been established. Your kidney function may be evaluated before administration of LacTEST.
• If you have abnormal liver function, as the safety and efficacy of LacTEST in patients with hepatic impairment have not been established.

Children and adolescents

LacTEST may be administered to children and adolescents aged 6 years and older who have normal renal function.

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

Use of LacTEST with other medicines

Inform your doctor if you are taking, have recently taken, or might need to take any other medicines.

Do not take aspirin or indomethacin from 48 hours before undergoing the LacTEST test until the test is completed, as aspirin and indomethacin have been reported to reduce urinary excretion of xylitol.

A potential interaction between LacTEST 0.45 g and arabinose contained in certain foods cannot be completely ruled out. Therefore, patients should be advised to avoid consuming foods containing arabinose for at least 10 hours (up to 24 hours) before ingesting LacTEST 0.45 g and until completion of the test.

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.

Effects during pregnancy and breastfeeding are not expected.

Driving and using machines

The influence of LacTEST on the ability to drive and operate machinery is negligible or none.

3. How to use LacTEST

Follow exactly the administration instructions for this medicine provided in this leaflet or those indicated by your doctor. If in doubt, consult your doctor.

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

The test must be performed according to the following sequence:

1. You must fast for 10 hours before the test, preferably overnight.
2. You must urinate 2 hours before the test and again 15–30 minutes prior to the test.
3. You must ingest the contents of the sachet dissolved in water.
4. You must collect your urine into an appropriate container, which will be provided for this purpose, over the 5-hour duration of the test, and you must urinate immediately before the test ends. During this time, you should drink up to a maximum of 500 ml of water to increase the urge to urinate.

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

1. You must fast for 10 hours before the test, preferably overnight.
2. Three hours before taking LacTEST, you may have breakfast consisting of one or more of the following foods: one fried egg, grilled chicken breast, white rice, and 2 slices of serrano ham. The cured/serrano ham must be freshly obtained to minimize the amount of additives.
3. You must urinate before the test.
4. You must ingest the contents of the sachet dissolved in water.
5. You must collect your urine into an appropriate container, which will be provided for this purpose, over the 5-hour duration of the test, and you must urinate immediately before the test ends. During this time, you should drink up to a maximum of 500 ml of water to increase the urge to urinate.

Use of this medicine is not authorized in children aged 0 to 5 years.

Use in children and adolescents

LacTEST may be administered to children and adolescents from 6 years of age onwards who have normal renal function.

Dose adjustment is not necessary.

Use of this medicine is not authorized in children aged 0–5 years.

If you use more LacTEST than you should

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

4. Possible adverse effects

Like all medicines, LacTEST can produce adverse effects, although not everyone will experience them.

The following adverse effects have been reported:

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

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

Frequency unknown (cannot be estimated from available data)

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

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, even if it is an effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse 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 packaging. The expiry date refers to the last day of the month indicated.

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

This medicine is supplied in sachets, its pharmaceutical form; it does not require special temperature conditions for storage.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Pack contents and additional information

Composition of LacTEST

• The active substance is gaxilose. Each sachet contains 0.45 g of gaxilose.
• 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, 1st floor, right-hand side
28010 Madrid
Spain

Manufacturer of the medicinal product

Infarmade, S.L.
Industrial Estate La Isla
C/ Torre de los Herberos, 35
41703 Dos Hermanas, Seville
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 most recent review of this leaflet: February 2025

Other sources of information

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