DUOMATE FLAS 30 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

Duomate Flas 30mg Orodispersible Tablets

Lansoprazole

Read all of 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack

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

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

The active substance of Duomate Flas is lansoprazole, a proton pump inhibitor. Proton pump inhibitors reduce the amount of acid produced by the stomach.

Your doctor may prescribe you Duomate Flas for the following indications:

• Treatment of duodenal and gastric ulcers
• Treatment of inflammation of the esophagus (reflux esophagitis)
• Prevention of reflux esophagitis
• Treatment of heartburn and acid regurgitation
• Treatment of infections caused by the bacteria Helicobacter pylori, in combination with antibiotics
• Treatment or prevention of duodenal or gastric ulcers in patients who require continuous treatment with non-steroidal anti-inflammatory drugs (NSAIDs) (NSAID treatment is used for pain or inflammation)
• Treatment of Zollinger-Ellison syndrome

It may be that your doctor has prescribed Duomate Flas for another indication or at a different dose than indicated in this leaflet. Follow your doctor's instructions regarding the taking of the medicine.

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

Do not take Duomate Flas:

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

Warnings and precautions

When taking lansoprazole, kidney inflammation may occur. The 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 medicine similar to Duomate Flas to reduce stomach acidity.
• If you are scheduled to have a specific blood test (Chromogranin A).

If you experience a skin rash, especially in areas of the skin exposed to the sun, 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 serious liver disease. It may be necessary for the doctor to adjust the dose.

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

In case you experience 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 medicines intended for the treatment of Helicobacter pyloriinfection (antibiotics) or together with anti-inflammatory drugs to treat pain or rheumatism, also read the package leaflets of these medicines carefully.

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

If you have been taking Duomate Flas for more than three months, it is possible that your 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, go to the doctor immediately. Low magnesium levels can also cause a decrease in blood potassium and calcium levels. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.

If you have been taking Duomate Flas for a long time (more than 1 year), your doctor will probably have you checked regularly. During visits to your doctor, you should inform them of any new or abnormal symptoms and circumstances.

Using Duomate Flas with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

In particular, inform your doctor if you are using medicines that contain any of the following active substances, 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 heartburn 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 medicine, 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 are planning to have a baby, ask your doctor for advice before taking this medicine.

Driving and using machines

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 act with caution as your reaction ability may be reduced.

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

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

Read the information in this leaflet carefully.

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

Duomate Flas contains sucrose.

If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

3. How to take Duomate Flas

Follow the instructions for administration of this medicine indicated by your doctor. In case of doubt, consult your doctor again.

Place the tablet on the tongue and suck it slowly. The tablet dissolves quickly in the mouth, releasing microgranules that should be swallowed without chewing.

You can also swallow the tablet whole with a glass of water.

Your doctor may give you instructions to administer the tablet through a syringe, in case you have serious difficulties swallowing.

Follow the following instructions in case of administration through a nasogastric tube (with a diameter of 12F or 18F):

• Remove the plunger from the syringe (at least a 5 ml syringe for the 15mg tablet and a 10 ml syringe for the 30mg tablet).
• Place the tablet in the reservoir.
• Put the plunger back in the syringe.
• For the 15 mg tablet: fill the syringe with 4 ml of water.
• For the 30 mg tablet: fill the syringe with 10 ml of water.
• Invert the syringe and pull the plunger to allow 1 ml of air to enter.
• Gently shake the syringe for 10-20 seconds until the tablet is dispersed.
• Connect the syringe to the tube and empty the contents of the syringe into the nasogastric tube.
• Refill the syringe with 2-5 ml of water to remove any remaining residue from the syringe and administer the contents into the tube.

Follow the following instructions in case of oral administration through a syringe:

It is important that you check that the selected syringe is suitable.

• Remove the plunger from the syringe (at least a 5 ml syringe for the 15mg tablet and a 10 ml syringe for the 30mg tablet).
• Place the tablet in the reservoir.
• Put the plunger back in the syringe.
• For the 15 mg tablet: fill the syringe with 4 ml of water.
• For the 30 mg tablet: fill the syringe with 10 ml of water.
• Invert the syringe and pull the plunger to allow 1 ml of air to enter.
• Gently shake the syringe for 10-20 seconds until the tablet is dispersed.
• The contents can be poured directly into the mouth.
• Refill the syringe with 2-5 ml of water to remove any remaining residue from the syringe and pour it into the mouth.
• Repeat the previous step if necessary.

If you take Duomate Flas once a day, try to take it always at the same time. You may get better results if you take Duomate Flas in the morning.

If you take Duomate Flas twice a day, you should take the first dose in the morning and the second dose at night.

The dose of Duomate Flas depends on your general condition. The normal doses of Duomate Flas for adults are indicated below. Sometimes, your doctor may prescribe a different dose and indicate a different duration of treatment.

Treatment of heartburn and acid regurgitation:one 15 mg or 30 mg orodispersible tablet per day for 4 weeks. If symptoms persist, inform your doctor. If symptoms do not improve after 4 weeks, consult your doctor.

Treatment of duodenal ulcer:one 30 mg orodispersible tablet per day for 2 weeks.

Treatment of gastric ulcer:one 30 mg orodispersible tablet per day for 4 weeks.

Treatment of inflammation of the esophagus (reflux esophagitis):one 30 mg orodispersible tablet per day for 4 weeks.

Long-term prevention of reflux esophagitis:one 15 mg orodispersible tablet per day; your doctor may adjust the dose to one 30 mg orodispersible tablet per day.

Treatment of Helicobacter pyloriinfection:The normal dose is one 30 mg orodispersible tablet together with two different antibiotics in the morning and one 30 mg orodispersible tablet together with two different antibiotics in the evening. The normal treatment is once a day for 7 days.

The recommended combinations of antibiotics are as follows:

• 30 mg of Duomate Flas with 250-500 mg of clarithromycin and 1000 mg of amoxicillin
• 30 mg of Duomate Flas with 250 mg of clarithromycin and 400-500 mg of metronidazole

If you receive anti-infective treatment due to an ulcer, it is unlikely that the ulcer will recur if the infection is treated satisfactorily. To get the best results from your medicine, take it at the right time and do not miss any dose.

Treatment of duodenal or gastric ulcers in patients who require continuous treatment with NSAIDs: one 30 mg orodispersible tablet per day for 4 weeks.

Prevention of duodenal or gastric ulcers in patients who require continuous treatment with NSAIDs:one 15 mg orodispersible tablet per day; your doctor may adjust the dose to one 30 mg orodispersible tablet per day.

Zollinger-Ellison syndrome:The initial normal dose is two 30 mg orodispersible tablets per day; subsequently, based on your response to treatment with Duomate Flas, the doctor will decide the best dose for you.

Use in children

Duomate Flas should not be administered to children.

If you take more Duomate Flas than you should

If you take more Duomate Flas than you have been told, consult your doctor immediately or call the Toxicology Information Service. Phone 915 620 420.

If you forget to take Duomate Flas

If you forget to take a dose, take it as soon as you remember, unless the time for the next dose is near.

In this case, skip the missed dose and take the next orodispersible tablets as usual. Do not take a double dose to make up for the missed dose.

If you stop taking Duomate Flas

Do not stop treatment early because the symptoms have improved. It is possible that your condition has not been completely cured and may recur if you do not complete the entire treatment.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects are common (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 stomach polyps

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

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

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

• fever
• restlessness, drowsiness, confusion, hallucinations, insomnia, visual disturbances, vertigo
• taste disturbance, loss of appetite, tongue inflammation (glossitis)
• skin reactions such as burning sensation or itching under the skin, bruising, redness, and excessive sweating
• sensitivity to light
• hair loss
• tingling sensation (paresthesia), tremor
• anemia (pallor)
• kidney problems
• pancreatitis
• liver inflammation (may be manifested by yellowing of the skin or eyes)
• breast swelling in males, impotence
• candidiasis (fungal infection, can affect the skin or mucous membranes)
• angioedema; contact your doctor immediately if you experience symptoms of angioedema, such as facial swelling, tongue or pharynx 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. The symptoms of a hypersensitivity reaction may include fever, rash, swelling, and, in some cases, a drop in blood pressure
• mouth inflammation (stomatitis)
• colitis (inflammation of the intestine)
• changes in analytical values, such as sodium, cholesterol, and triglyceride levels
• very severe skin reactions with redness, blisters, 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. You will have a blood test to check for possible reduction of white blood cells (agranulocytosis).

Frequency not known

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

If you notice side effects not mentioned in this leaflet or if you suffer from one of the side effects described in a severe way, inform your doctor or pharmacist.

If you experience side effects, consult your doctor, even if it is a side effect not listed in this leaflet.

5. Storing Duomate Flas

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

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

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Packaging Content and Additional Information

Duomate Flas Composition

• The active ingredient is lansoprazole.

• The other components are sugar spheres (sucrose and corn starch); magnesium carbonate; hypromellose; polysorbate 80; macrogol 6000; triethyl citrate; talc; methacrylic acid and ethyl acrylate copolymer; methyl methacrylate, methacrylic acid, and methyl acrylate copolymer; microcrystalline cellulose; hydroxypropylcellulose; sodium saccharin; mannitol (E-421); tropical flavor; malic acid; magnesium stearate.

Product Appearance and Packaging Content

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

Duomate Flas 15 mg is available in packs of 14, 28, or 56 tablets.

Marketing Authorization Holder and Manufacturer

LABORATORIOS SALVAT, S.A.

Gall 30-36

08950 Esplugues de Llobregat

Barcelona - Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Duomate 15 mg compresse orodispersibili Italy

Date of Last Revision of this Leaflet:December 2022

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)

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