Duomate Flas 15 mg orodispersible tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Duomate Flas 15 mg 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 questions, ask your doctor or pharmacist.
• 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 may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet.

Leaflet contents

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

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

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

Your doctor may prescribe 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 bacterium Helicobacter pylori, in combination with antibiotics
• Treatment or prevention of duodenal or gastric ulcers in patients requiring continuous treatment with non-steroidal anti-inflammatory drugs (NSAIDs) (NSAID therapy is used for pain or inflammation)
• Treatment of Zollinger-Ellison syndrome

Your doctor may have prescribed Duomate Flas for an indication or at a dose different from that stated in this leaflet. Follow your doctor's instructions regarding how to take the medicine.

2. What you need to know before taking Duomate Flas

Do not take Duomate Flas:

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

Warnings and precautions

When taking lansoprazole, inflammation of the kidney may occur. Signs and symptoms may include decreased urine volume or blood in the urine and/or hypersensitivity reactions such as fever, skin rash, and joint stiffness. You should report these signs to your doctor.

Consult your doctor before starting Duomate Flas:

• If you have ever had a skin reaction after treatment with a medicine similar to Duomate Flas used to reduce stomach acidity.
• If you are scheduled to have a specific blood test (chromogranin A).

If you develop a skin rash, especially in areas of skin exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with Duomate Flas. Remember to mention any other symptoms you may notice, such as joint pain.

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

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

If 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 along with other medicines for the treatment of Helicobacter pylori infection (antibiotics) or together with anti-inflammatory drugs for pain or rheumatism, please also read the package leaflets of these medicines carefully.

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

If you have been taking Duomate Flas for more than three months, your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, confusion, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, seek medical attention immediately. Low magnesium levels may also lead to decreased levels of potassium and calcium in the blood. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.

If you have been taking Duomate Flas for a long time (more than 1 year), your doctor will likely perform regular check-ups. During visits to your doctor, you should report any new or unusual symptoms or circumstances.

Use of Duomate Flas with other medicines

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

In particular, inform your doctor if you are taking medicines containing any of the following active substances, as Duomate Flas may affect their 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 drink

For optimal effectiveness, Duomate Flas should be taken at least 30 minutes before meals.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor 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 exercise caution, as your reaction ability may be reduced.

You are solely responsible for deciding whether you are fit to drive or perform activities requiring high concentration. Due to its effects or adverse reactions, the use of medicines may be one of the factors that reduces your ability to safely carry out these tasks.

The descriptions of these effects are provided in the following sections.

Please read this leaflet carefully.

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

Duomate Flas contains sucrose.

If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Duomate Flas

Follow exactly the dosing instructions for this medicine as given by your doctor. If in doubt, consult your doctor again.

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

Alternatively, you may swallow the whole tablet with a glass of water.

Your doctor may give you instructions for administering the tablet using a syringe if you have serious difficulty swallowing.

Follow the instructions below for administration via nasogastric tube (with a diameter of 12F or 18F):

• Remove the plunger from the syringe (use at least a 5 ml syringe for the 15 mg tablet and a 10 ml syringe for the 30 mg tablet).
• Place the tablet into the barrel.
• Reinsert the plunger into 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 draw in 1 ml of air.
• Gently shake the syringe for 10–20 seconds until the tablet has dispersed.
• Attach the syringe to the tube and empty the contents into the nasogastric tube.
• Refill the syringe with 2–5 ml of water to flush any remaining residue from the syringe and administer into the tube.

Follow the instructions below for oral administration using a syringe:

It is important to ensure that the syringe selected is appropriate.

• Remove the plunger from the syringe (use at least a 5 ml syringe for the 15 mg tablet and a 10 ml syringe for the 30 mg tablet).
• Place the tablet into the barrel.
• Reinsert the plunger into 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 draw in 1 ml of air.
• Gently shake the syringe for 10–20 seconds until the tablet has dispersed.
• The contents can be emptied directly into the mouth.
• Refill the syringe with 2–5 ml of water to flush any remaining residue from the syringe and empty it into the mouth.
• Repeat the preceding step if necessary.

If you take Duomate Flas once daily, try to take it at the same time each day. You may achieve better results if you take Duomate Flas in the early morning.

If you take Duomate Flas twice daily, take the first dose in the morning and the second in the evening.

The dose of Duomate Flas depends on your general condition. The usual doses of Duomate Flas for adults are listed below. Occasionally, your doctor may prescribe a different dose or treatment duration.

Treatment of heartburn and acid regurgitation: one orodispersible tablet of 15 mg or 30 mg daily 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 orodispersible tablet of 30 mg daily for 2 weeks.

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

Treatment of inflammation of the oesophagus (reflux oesophagitis): one orodispersible tablet of 30 mg daily for 4 weeks.

Long-term prevention of reflux oesophagitis: one orodispersible tablet of 15 mg daily; your doctor may adjust your dose to one orodispersible tablet of 30 mg daily.

Treatment of Helicobacter pylori infection: The usual dose is one orodispersible tablet of 30 mg together with two different antibiotics in the morning and one orodispersible tablet of 30 mg together with two different antibiotics in the evening. The usual treatment duration is once daily for 7 days.

The recommended antibiotic combinations are as follows:

• 30 mg Duomate Flas with 250–500 mg clarithromycin and 1,000 mg amoxicillin
• 30 mg Duomate Flas with 250 mg clarithromycin and 400–500 mg metronidazole

If you are receiving anti-infective treatment for an ulcer, the ulcer is unlikely to recur if the infection is successfully treated. To achieve the best results from your medicine, take it at the correct time and do not miss any doses.

Treatment of duodenal or gastric ulcer in patients requiring continuous NSAID therapy: one orodispersible tablet of 30 mg daily for 4 weeks.

Prevention of duodenal or gastric ulcer in patients requiring continuous NSAID therapy: one orodispersible tablet of 15 mg daily; your doctor may adjust your dose to one orodispersible tablet of 30 mg daily.

Zollinger-Ellison syndrome: The usual initial dose is two orodispersible tablets of 30 mg daily; subsequently, depending on your response to Duomate Flas treatment, your doctor will determine the optimal dose for you.

Use in children

Duomate Flas must not be given to children.

If you take more Duomate Flas than you should

If you take more Duomate Flas than prescribed, consult your doctor immediately or call the Toxicology Information Service immediately at telephone number 915 620 420.

If you forget to take Duomate Flas

If you forget to take a dose, take it as soon as possible unless the next dose is due soon.

In that case, skip the missed dose and take the next 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 prematurely, even if symptoms have improved. Your condition may not be fully healed, and symptoms may return if you do not complete the full course of treatment.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

The following adverse 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 mouth or throat
• skin rash, itching
• changes in liver function test values
• tiredness
• benign polyps in the stomach

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

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

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

• fever
• restlessness, drowsiness, confusion, hallucinations, insomnia, visual disturbances, dizziness
• taste disturbances, loss of appetite, inflammation of the tongue (glossitis)
• skin reactions such as burning or itching sensation under the skin, bruising, redness, and excessive sweating
• sensitivity to light
• hair loss
• tingling sensation (paraesthesia), tremor
• anaemia (pallor)
• kidney problems
• pancreatitis
• liver inflammation (may present as yellowing of the skin or eyes)
• breast swelling in men, impotence
• candidiasis (fungal infection, may affect skin or mucous membranes)
• angioedema; contact your doctor immediately if you experience symptoms of angioedema, such as swelling of the face, tongue or throat, difficulty swallowing, hives, or breathing difficulties.

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

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

Frequency not known

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

If you notice adverse effects not listed in this leaflet, or if you experience any of the listed adverse effects severely, inform your doctor or pharmacist.

If you experience any adverse effects, consult your doctor, even if they are adverse effects not mentioned in this leaflet.

5. Storage of Duomate Flas

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the blister pack and carton. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and empty containers at the SIGRE Point located at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.

6. Contents of the pack and other information

Composition of Duomate Flas

• The active substance 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 acrylate, methyl methacrylate and methacrylic acid copolymer; microcrystalline cellulose; hydroxypropylcellulose; sodium saccharin; mannitol (E-421); tropical flavor; malic acid; magnesium stearate.

Appearance of the medicinal product and contents of the pack

Duomate Flas 15 mg are white to greyish-white 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 medicine is authorized in the Member States of the European Economic Area under the following names:

Duomate 15 mg compresse orodispersibili Italy

Date of the most recent revision of this leaflet: December 2022

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS):

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