LACTEST 0.45 g ORAL SOLUTION POWDER
How to use LACTEST 0.45 g ORAL SOLUTION POWDER
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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.
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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/
- Country of registration
- Dosage formORAL SOLUTION/SUSPENSION, 0.45 g
- Average pharmacy price70.25 EUR
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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