Leaflet: information for the user

Duomate Flas 15 mg buccal dispersible tablets

Lansoprazol

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

1. What Duomate Flas is and for what it is used

2. What you need to know before starting to take Duomate Flas

3. How to take Duomate Flas

4. Possible side effects

5. Storage of Duomate Flas

6. Contents of the pack and additional informationl

TheactiveingredientofDuomateFlasislansoprazol,aprotonpumpinhibitor.Protonpumpinhibitorsdecreasetheamountofacidproducedbythestomach.

YourdoctormayprescribeDuomateFlasforthefollowingindications:

• Treatmentofduodenalandgastriculcers
• Treatmentofinflammationoftheesophagus(acidrefluxesophagitis)
• Preventionofacidrefluxesophagitis
• Treatmentofheartburnandacidregurgitation
• TreatmentofinfectionscausedbythebacteriaHelicobacter pylori,incombinationwithantibiotics
• Treatmentorpreventionofduodenalorgastriculcersinpatientsrequiringlong-termtreatmentwithnonsteroidalanti-inflammatorydrugs(NSAIDs)(NSAIDsareusedtotreatpainorinflammation)
• TreatmentofZollinger-Ellisonsyndrome

YourdoctormayhaveprescribedDuomateFlasforanotherindicationoratadifferentdosethanthatindicatedinthisleaflet.Followyourdoctor'sinstructionsregardingtheuseofthismedicine.

Do not take Duomate Flas:

• If you are allergic to lansoprazole or any of the other ingredients of this medication (listed in section 6).
• If you are taking another medication whose active ingredient is atazanavir (used to treat HIV).

Warnings and precautions

Taking lansoprazole may cause inflammation in the kidneys. Signs and symptoms may include decreased urine volume or the presence of blood in the urine and/or hypersensitivity reactions such as fever, skin rash, and joint stiffness. You should inform your doctor of these signs.

Consult your doctor before starting to take Duomate Flas:

• If you have ever had a skin reaction after treatment with a similar medication to Duomate Flas to reduce stomach acid.
• If you are scheduled to have a specific blood test (Cromogranin A).

If you suffer from a skin rash, especially in sun-exposed areas, consult your doctor as soon as possible, as it may be necessary to interrupt treatment with Duomate Flas. Remember to mention any other symptoms you may notice, such as joint pain.

Inform your doctor if you have a severe liver disease. Your doctor may need to adjust the dose.

Your doctor may perform or have performed a diagnostic test called endoscopy to diagnose your condition and/or rule out cancer.

In case of diarrhea during treatment with Duomate Flas, contact your doctor immediately, as Duomate Flas has been associated with a slight increase in infectious diarrhea.

If your doctor has prescribed Duomate Flas in addition to other medications for the treatment of Helicobacter pylori infection (antibiotics) or together with anti-inflammatory medications to treat pain or rheumatism, read the leaflets for these medications carefully.

If you are taking proton pump inhibitors such as Duomate Flas, especially for a period of more than one year, it may slightly increase the risk of hip, wrist, and spinal fractures. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).

If you are taking Duomate Flas for more than three months, it is possible that blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, and increased heart rate. If you experience any of these symptoms, see your doctor immediately. Low magnesium levels can also produce a decrease in blood potassium and calcium levels. Your doctor may decide to perform regular blood tests to monitor magnesium levels.

If you have been taking Duomate Flas for a long time (over 1 year), your doctor will likely perform regular checks. During your doctor's visits, you should inform them of any new or abnormal symptoms and circumstances.

Use of Duomate Flas with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Especially, inform your doctor if you are using medications containing any of the following active ingredients, as Duomate Flas may affect their mode of action:

• ketoconazole, itraconazole, rifampicin (used to treat infections)
• digoxin (used to treat heart problems)
• theophylline (used to treat asthma)
• tacrolimus (used to prevent transplant rejection)
• fluvoxamine (used to treat depression and other psychiatric disorders)
• antacids (used to treat stomach burning or acid regurgitation)
• sucralfate (used to heal ulcers)
• St. John's Wort (Hypericum perforatum) (used to treat mild depression)

Taking Duomate Flas with food and drinks

To get the best results from your medication, you should take Duomate Flas at least 30 minutes before meals.

Pregnancy, breastfeeding, and fertility

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

Driving and operating machinery

Patients taking Duomate Flas may occasionally experience side effects such as dizziness, vertigo, fatigue, and visual disturbances. If you experience any of these side effects, you should exercise caution as your reaction time may be reduced.

You are the only one responsible for deciding whether you are fit to drive vehicles or perform activities that require a high level of concentration. Due to the effects or adverse reactions of the medication, one of the factors that may reduce your ability to carry out these operations safely is the use of the medication.

In the following sections, you will find descriptions of these side effects.

Read this prospectus carefully.

If you have any doubts, ask your doctor, nurse, or pharmacist.

Duomate Flas contains saccharose.

If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

Followexactlytheadministrationinstructionsforthismedicationasindicatedbyyourdoctor.Incaseofdoubt,consultyourdoctoragain.

Placethetabletonthetongueandswallowitslowly.Thetabletwillrapidlydissolveinthemouth,releasingmicrogranulesthatmustbeswallowedwithoutchewing.

Youcanalsoswallowthetabletwholewithaglassofwater.

Yourdoctormaygiveyouinstructionstoadministerthetabletusingasyringe,ifyouhaveseriousdifficultyswallowing.

Followtheinstructionsbelowforadministrationusinganasogastrictube(withadiameterof12For18F):

• Removetheplungerfromthesyringe(atleastonesyringeof5mlfora15mgtabletandonesyringeof10mlfora30mgtablet).
• Placethetabletinthecontainer.
• Replacetheplungerinthesyringe.
• Fora15mgtablet:fillthesyringewith4mlofwater.
• Fora30mgtablet:fillthesyringewith10mlofwater.
• Invertthesyringeandpulltheplungertoallow1mlofairtoenter.
• Agitatethesyringegentlyfor10–20secondsuntilthetablethasdissolved.
• Connectthesyringetothenasogastrictubeandemptythecontentsofthesyringeintothenasogastrictube.
• Fillthesyringewith2–5mlofwatertoremoveanyremainingcontentsfromthesyringeandadministerthecontentsintothenasogastrictube.

Followtheinstructionsbelowfororaladministrationusingasyringe:

Itisimportantthatyoucheckthatthesyringeselectedisthecorrectone.

• Removetheplungerfromthesyringe(atleastonesyringeof5mlfora15mgtabletandonesyringeof10mlfora30mgtablet).
• Placethetabletinthecontainer.
• Replacetheplungerinthesyringe.
• Fora15mgtablet:fillthesyringewith4mlofwater.
• Fora30mgtablet:fillthesyringewith10mlofwater.
• Invertthesyringeandpulltheplungertoallow1mlofairtoenter.
• Agitatethesyringegentlyfor10–20secondsuntilthetablethasdissolved.
• Thecontentscanbeemptieddirectlyintothemouth.
• Fillthesyringewith2–5mlofwatertoremoveanyremainingcontentsfromthesyringeandemptythecontentsintothemouth.
• Repeatthepreviousstepifnecessary.

Togetthebestresultsfromthismedication,takeitattherighttimeanddonotmissanydoses.

Treatmentofheartburnandacidregurgitation:one15mgor30mgbuccaltabletperdayfor4weeks.Ifsymptomspersist,informyourdoctor.Ifsymptomsdonotimproveafter4weeks,consultyourdoctor.

Treatmentofduodenalulcer:one30mgbuccaltabletperdayfor2weeks.

Treatmentofgastriculcer:one30mgbuccaltabletperdayfor4weeks.

Treatmentofesophagitisduetogastroesophagealreflux:one30mgbuccaltabletperdayfor4weeks.

Long-termpreventionofgastroesophagealrefluxesophagitis:one15mgbuccaltabletperday;yourdoctormayadjustyourdosetoone30mgbuccaltabletperday.

TreatmentofHelicobacterpyloriinfection:Theusualdoseisone30mgbuccaltablettogetherwithtwodifferentantibioticsinthemorningandone30mgbuccaltablettogetherwithtwodifferentantibioticsintheevening.Theusualtreatmentdurationisonedayperweekfor7days.

Therecommendedantibioticcombinationsare:

• 30mgofDuomateFlaswith250-500mgofclarithromycinand1,000mgofamoxicillin
• 30mgofDuomateFlaswith250mgofclarithromycinand400-500mgofmetronidazole

Ifyoureceiveantibiotictreatmentforanulcer,itisunlikelythattheulcerwillreappeariftheinfectionistreatedsatisfactorily.Togetthebestresultsfromthismedication,takeitattherighttimeanddonotmissanydoses.

Treatmentofduodenalorgastriculcerinpatientsrequiringlong-termtreatmentwithNSAIDs:one30mgbuccaltabletperdayfor4weeks.

Preventionofduodenalorgastriculcerinpatientsrequiringlong-termtreatmentwithNSAIDs:one15mgbuccaltabletperday;yourdoctormayadjustyourdosetoone30mgbuccaltabletperday.

Zollinger-Ellisonsyndrome:Theusualinitialdoseistwo30mgbuccaltabletsperday;subsequently,yourdoctorwilldeterminethebestdoseforyoubasedonyourresponsetoDuomateFlas.

Useinchildren:

DuomateFlasshouldnotbeadministeredtochildren.

IfyoutakemoreDuomateFlasthanyoushould:

IfyoutakemoreDuomateFlasthanyoushould,consultyourdoctorimmediatelyorcalltheToxicologicalInformationServiceimmediately.Telephone915620420.

Ifyoumissadose:

Ifyoumissadose,takeitassoonaspossibleunlessyournextdoseisduesoon.

Donottakeadoubledosetomakeupforamisseddose.

IfyoustoptakingDuomateFlas:

DonotstoptakingDuomateFlasbeforetimebecauseyoursymptomshaveimproved.Itispossiblethatyourconditionhasnotbeencompletelycuredandmayreappearifyoudonotcompletethetreatment.

Ifyouhaveanyotherquestionsabouttheuseofthismedication,askyourdoctororpharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The following side effects are frequent (occur in more than 1 in 100 patients):

• headache, dizziness
• diarrhea, constipation, stomach pain, nausea and vomiting, flatulence, dryness or pain in the mouth or throat
• skin rash, itching
• changes in liver function test values
• fatigue
• benign polyps in the stomach

The following side effects are infrequent (occur in less than 1 in 100 patients):

• depression
• joint or muscle pain
• fluid retention or swelling
• changes in blood cell count
• increased risk of hip, wrist, and spinal fracture

The following side effects are rare (occur in less than 1 in 1,000 patients):

• fever
• restlessness, drowsiness, confusion, hallucinations, insomnia, visual disturbances, vertigo
• alteration of taste, loss of appetite, inflammation of the tongue (glossitis)
• skin reactions such as burning or itching under the skin, bruises, redness, and excessive sweating
• light sensitivity
• hair loss
• tingling sensation (paresthesia), tremor
• anemia (pale skin)
• kidney problems
• pancreatitis
• inflammation of the liver (may be manifested by yellow skin or eyes)
• chest swelling in men, impotence
• candidiasis (fungal infection, may affect the skin or mucous membranes)
• angioedema; contact your doctor immediately if you experience symptoms of angioedema, such as facial swelling, tongue, or throat swelling, difficulty swallowing, hives, and difficulty breathing.

The following side effects are very rare (occur in less than 1 in 10,000 patients):

• severe hypersensitivity reactions, including anaphylactic shock. Symptoms of hypersensitivity reactions may include fever, rash, swelling, and, in some cases, a drop in blood pressure
• inflammation of the mouth (stomatitis)
• colitis (inflammation of the intestine)
• changes in analytical values, such as sodium, cholesterol, and triglyceride levels
• very severe skin reactions with redness, vesicles, severe inflammation, and skin loss
• in very rare cases, lansoprazole may cause a reduction in the number of white blood cells, which can cause a decrease in resistance to infections. If you experience an infection with symptoms such as fever and severe deterioration of your general condition, or fever with symptoms of local infection such as sore throat/pharynx/mouth or urinary problems, consult your doctor immediately. A blood test will be performed to check for possible reduction in white blood cells (agranulocytosis).

Unknown frequency

• hypomagnesemia
• skin rash, possibly with joint pain
• visual hallucinations

If you notice side effects not mentioned in this leaflet or if you experience one of the side effects described severely, inform your doctor or pharmacist.

If you experience side effects, consult your doctor, even if they are side effects that do not appear in this leaflet.

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

Do not use this medication after the expiration date that appears on the blister and the box. The expiration date is the last day of the month indicated.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Duomate Flas

• The active ingredient is lansoprazol.

• The other components are sugar spheres (sacarosa and cornstarch); magnesium carbonate; hypromellose; polisorbate 80; macrogol 6000; triethyl citrate; talc; methacrylic acid copolymer and ethyl acrylate copolymer; methyl methacrylate and methacrylic acid copolymer; microcrystalline cellulose; hydroxypropyl cellulose; sodium saccharin; mannitol (E-421); tropical flavor; maleic acid; magnesium stearate.

Appearance of the product and contents of the packaging

Duomate Flas 15 mg are white-gray colored tablets containing microgranules.

Duomate Flas 15 mg are presented in packaging of 14, 28, or 56 tablets.

Holder of the marketing authorization and manufacturer

Laboratorios Salvat, S.A.

Gall 30-36

08950 Esplugues de Llobregat

Barcelona - Spain

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

Duomate 15 mg orodispersible tabletsItaly

Last review date of this leaflet:December 2022

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)

http://www.aemps.gob.es/