PATIENT INFORMATION LEAFLET

Opiren Flas 15 mg Buccal Tablets

Lansoprazole

Read this leaflet carefully before you start taking this medicine because 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 or pharmacist.
• This medicine has been prescribed for you only. Do 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. See section 4.

1.What is Opiren and what it is used for

2.What you need to know before you start taking Opiren

3.How to take Opiren

4.Possible side effects

5.Storage of Opiren

6.Contents of the pack and additional informationl

The active ingredient of Opiren is lansoprazol, a proton pump inhibitor. Proton pump inhibitors reduce the amount of acid produced by the stomach.

Your doctor may prescribe Opiren for the following indications in adults:

• Treatment of duodenal and gastric ulcers
• Treatment of esophagitis caused by acid reflux
• Prevention of esophagitis caused by acid reflux
• Treatment of stomach burning 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 requiring continuous treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) (NSAIDs are used for pain or inflammation)
• Treatment of Zollinger-Ellison syndrome

Your doctor may have prescribed Opiren for another indication or a different dose than the one indicated in this leaflet.Follow exactly the administration instructions for this medication as indicated by your doctor.

You should consult a doctor if you worsen or do not improve after 14 days.

Do not take Opiren

• if you are allergic to lansoprazole or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Inform your doctor if you have a serious 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 a malignant disease.

If you experience diarrhea during treatment with Opiren, contact your doctor immediately, as Opiren has been associated with a slight increase in infectious diarrhea.

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

Taking a proton pump inhibitor like Opiren, especially for a period of more than one year, may slightly increase the risk of fractures of the hip, wrist, or vertebrae. Inform your doctor if you have osteoporosis (reduced bone density) or if your doctor has told you that you are at risk of developing osteoporosis (for example, if you are taking steroids).

If you have been taking Opiren for a long time (more than 1 year), your doctor will probably perform regular checks. At your doctor's visits, you should inform them of any new or abnormal symptoms and circumstances.

Consult your doctor before starting to take lansoprazole:

• If you have reduced vitamin B12 reserves or risk factors for it and receive long-term treatment with lansoprazole. Like all medicines that reduce the amount of acid, lansoprazole may reduce vitamin B12 absorption.

• If you are scheduled to have a specific blood test (Cromogranin A).

• If you have ever had a skin reaction after treatment with a similar medicine to lansoprazole to reduce stomach acid.

• 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 lansoprazole. Remember to mention any other symptoms you may notice, such as joint pain.

• Severe skin reactions have been reported in relation to Opiren treatment [Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS)]. Stop using Opiren and call your doctor immediately if you experience any of the symptoms related to severe skin reactions described in section 4.

• Taking lansoprazole may cause inflammation in the kidneys. Signs and symptoms may include decreased urine volume or blood in the urine and/or hypersensitivity reactions such as fever, hives, and joint stiffness. Inform your doctor of such signs.

Opiren with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine, including those purchased without a prescription.

Especially, inform your doctor or pharmacist if you are taking medicines that contain any of the following active ingredients, as Opiren may affect their action:

• Protease inhibitors for HIV such as atazanavir and nelfinavir (used in HIV treatment)
• Methotrexate (used to treat autoimmune diseases and cancer)

• Ketoconazole, itraconazole, rifampicin (used to treat infections)
• Digoxin (used to treat heart problems)
• Warfarin (used to treat blood clots)
• 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)

Opiren with food and drinks

To get the best results from your medicine, take Opiren at least 30 minutes before meals with a glass of water.

Pregnancy, breastfeeding, and fertility

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

Driving and operating machinery

Patients taking Opiren 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 medicines, one of the factors that may reduce your ability to perform these operations safely is the use made of the medicines.

Read the descriptions of these effects in the following sections.

Read this leaflet carefully.

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

Opiren contains lactose

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

Opiren contains aspartame

This medicine contains 4.5 mg of aspartame in each 15 mg buccal dispersible tablet.

Aspartame contains a source of phenylalanine that may be harmful in the case of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

Opiren contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Place the tablet on the tongue and let it dissolve slowly. The tablet dissolves quickly in the mouth, releasing some microgranules that must 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 using a syringe if you have serious difficulty swallowing.

Follow the instructions below in case of administration using a syringe:

It is essential to check that the selected syringe is the right one.

• Extract the plunger from the syringe (at least a 5 ml syringe).
• Place the tablet in the reservoir.
• Replace the plunger in the syringe.
• Fill the syringe with 4 ml of water.
• Invert the syringe and pull the plunger to allow 1 ml of air to enter.
• Agitate the syringe gently for 10–20 seconds until the tablet has dispersed.
• The contents can be emptied directly into the mouth.
• Replace the syringe with 2–5 ml of water to eliminate any remaining residue in the syringe and empty it into the mouth.

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

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

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

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

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

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

Treatment of esophagitis due to reflux:one buccal dispersible tablet of 30 mg per day for 4 weeks.

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

Treatment of Helicobacter pylori infection:The normal dose is one buccal dispersible tablet of 30 mg together with two different antibiotics in the morning and one buccal dispersible tablet of 30 mg together with two different antibiotics at night. Treatment is usually daily for 7 days.

The recommended antibiotic combinations are as follows:

• 30 mg of Opiren with 250–500 mg of clarithromycin and 1,000 mg of amoxicillin
• 30 mg of Opiren 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 medication, take it at the right time anddo not miss any doses.

Treatment of duodenal or gastric ulcer in patients requiring continuous treatment with NSAIDs:one buccal dispersible tablet of 30 mg per day for 4 weeks.

Prevention of duodenal or gastric ulcer in patients requiring continuous treatment with NSAIDs:one buccal dispersible tablet of 15 mg per day; your doctor may adjust your dose to one buccal dispersible tablet of 30 mg per day.

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

Use in children:

Opiren should not be administered to children.

If you take more Opiren than you should

If you take more Opiren than prescribed, consult your doctor immediately, or contact the Toxicological Information Service, Teléfono 915 620 420

If you forget to take Opiren

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 usual tablets. Do not take a double dose to compensate for the missed dose.

If you interrupt treatment with Opiren

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

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

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

If you start to notice any of the following side effects, stop taking Opiren and contact your doctor immediately:

• round or target-shaped, slightly reddish patches on the trunk, often with blisters in the center, peeling, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin eruptions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• generalized exanthema, elevated body temperature, and lymphadenopathy (DRESS syndrome or drug hypersensitivity syndrome).

Frequent side effects (may affect up to 1 in 10 people):

• 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

Uncommon side effects (may affect up to 1 in 100 people):

• depression
• joint or muscle pain
• fluid retention or swelling
• changes in blood cell counts

Rare side effects (may affect up to 1 in 1,000 people):

• 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, hematomas, redness, and excessive sweating
• light sensitivity
• hair loss
• tingling sensation (paresthesia), tremors
• anemia (pale skin)
• renal problems
• pancreatitis
• inflammation of the liver (may manifest as 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 inflammation, difficulty swallowing, urticaria, and difficulty breathing.

Very rare side effects (may affect up to 1 in 10,000 people):

• 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)
• inflammation of the intestine (colitis)
• changes in analytical values, such as sodium, cholesterol, and triglyceride levels
• very severe skin reactions with redness, vesicles, severe inflammation, and skin loss
• in rare cases, Opiren may cause a reduction in white blood cell count, which may lead to 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 local infection symptoms such as throat, pharynx, or mouth pain, or urinary problems, consult your doctor immediately. A blood test will be performed to check for possible leukopenia (agranulocytosis).

Unknown frequency (cannot be estimated from available data):

• If you have been taking Opiren for more than three months, it is possible that magnesium levels in the blood may decrease. Low magnesium levels may cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. If you notice any of these symptoms, inform your doctor immediately. Low magnesium levels may also lead to a decrease in potassium or calcium levels in the blood. Your doctor may request regular blood tests to monitor magnesium levels.
• Low sodium levels in the blood. Common symptoms include nausea and vomiting, headache, drowsiness, and fatigue, confusion, muscle weakness or spasms, irritability, seizures, coma.
• skin rash, possibly with joint pain.
• visual hallucinations.

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging and outer carton, after CAD. The expiration date is the last day of the month indicated.

Do not store above 25°C. Store in the original packaging.

Medications should not be disposed of through drains or trash.Deposit the packaging and medications you no longer need at the SIGRE point of the pharmacy. In case of doubtask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Opiren

• The active ingredient is lansoprazol
• The other components are:Enteric-coated microgranules: Lactose monohydrate, microcrystalline cellulose, heavy magnesium carbonate, low-substituted hydroxypropylcellulose, hydroxypropylcellulose, hypromellose, titanium dioxide (E-171), talc, mannitol, copolymer of methacrylic acid and ethyl acrylate (1:1) at 30%, polyacrylate dispersion at 30%, macrogol 8000, anhydrous citric acid, glyceryl monoestearate, polysorbate 80, triethyl citrate, yellow iron oxide (E-172), red iron oxide (E-172).
• Other components: Mannitol, microcrystalline cellulose, low-substituted hydroxypropylcellulose, anhydrous citric acid, crospovidone, magnesium stearate, strawberry flavor, and aspartame (E-951).

Appearance of the product and contents of the package

Opiren Flas 15 mg is presented in the form of round, flat, bisected, white to light yellowish tablets, speckled with orange to dark brown microgranules with the mark “15” on one of the faces. Each package contains 28 or 56 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Takeda Farmacéutica España, S.A.

Paseo de la Castellana 95, 22nd floor

Edificio Torre Europa

28046 Madrid

Spain

Tel: +34 91 790 42 22

Responsible for manufacturing

Delpharm Novara S.r.l.

Via Crosa, 86

I-28065 Cerano (NO), Italy

or

TAKEDA IRELAND LIMITED

Bray Business Park

Kilruddery Bray, County Wicklow, Ireland

or

LUSOMEDICAMENTA SOCIEDADE TECNICA FARMACEUTICA S.A

RUA NORBERTO DE OLIVEIRA 1 A 5 2620-111 POVOA DE STO.ADRIAO,

Portugal

or

VIANEX S.A15th km Av. Marathonos - Pallini Attiki, Athens - GR-15351 - Greece

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

Greece: LAPRAZOL FasTab

Italy: LANSOX, LIMPIDEX, ZOTON

Portugal: OGASTO

Spain: OPIREN Flas

Last review date of this leaflet: December 2023

The detailed and updated information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)

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