OPIREN FLAS 15 mg ORALLY DISINTEGRATING TABLETS

2. What you need to know before you take Opiren

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

Tell your doctor if you have a severe liver disease. The doctor may need 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 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 you Opiren 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 carefully the package leaflets of these medicines.

Taking a proton pump inhibitor like Opiren, especially for a period of more than one year, may slightly increase the risk of hip, wrist, or vertebral fractures. Tell your doctor if you have osteoporosis (reduced bone density) or if your doctor has told you that you are at risk of 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 monitor you regularly. During your visits to the doctor, you should inform him of any new or abnormal symptoms and circumstances.

Consult your doctor before starting to take lansoprazole:

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

• If a specific blood test (Chromogranin A) is scheduled.

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

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

• Severe skin reactions have been reported in relation to treatment with Opiren [Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug rash 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.

• Kidney inflammation can occur when taking lansoprazole. Signs and symptoms may include decreased urine volume or blood in the urine and/or hypersensitivity reactions such as fever, rash, and joint stiffness. You should inform your doctor of such signs.

Taking Opiren with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

In particular, tell your doctor or pharmacist if you are taking medicines that contain any of the following active substances, as Opiren may affect their action:

• HIV protease inhibitors such as atazanavir and nelfinavir (used to treat HIV)
• 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)

Taking Opiren with food and drinks

To get the best results from your medicine, you should 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

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 act with caution as your reaction ability may be reduced.

You are the only one responsible for deciding whether you are in a fit state 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 carefully the information in this leaflet.

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

Opiren contains lactose

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

Opiren contains aspartame

This medicine contains 4.5 mg of aspartame in each 15 mg orally disintegrating tablet.

Aspartame is a source of phenylalanine, which may be harmful in cases of phenylketonuria (a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it properly).

Opiren contains sodium

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

3. How to take Opiren

Follow your doctor's instructions exactly. If you are in doubt, consult your doctor or pharmacist again.

Place the tablet on your 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 these instructions in case of administration through a syringe:

It is important that you check that the selected syringe is the right one.

• Remove 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.
• Turn the syringe upside down 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 emptied directly into the mouth.
• Refill the syringe with 2-5 ml of water to remove any remaining contents from 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 dose at night.

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

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

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

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

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

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

Treatment of Helicobacter pyloriinfection:The usual dose is one 30 mg orally disintegrating tablet together with two different antibiotics in the morning and one 30 mg orally disintegrating tablet together with two different antibiotics in the evening. The treatment is usually taken daily for 7 days.

The recommended combinations of antibiotics are as follows:

• 30 mg of Opiren with 250-500 mg of clarithromycin and 1000 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 come back if the infection is successfully treated. 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 orally disintegrating tablet per day for 4 weeks.

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

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

Use in children:

Opiren should not be administered to children.

If you take more Opiren than you should

If you take more Opiren than you should, consult your doctor immediately, or consult the Toxicology Information Service, Telephone 915 620 420

If you forget to take Opiren

If you forget to take a dose, take it as soon as possible unless the time for the next dose is near. In this case, skip the missed dose and take the next orally disintegrating tablets as usual. Do not take a double dose to make up for forgotten doses.

If you stop taking Opiren

Do not stop treatment prematurely because the symptoms have improved. It is possible that your condition has not been completely cured and may come back if you do not finish 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.

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

• round or target-like red spots on the trunk, often with blisters in the center, peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• generalized rash, high body temperature, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome).

Common 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 count

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

• fever
• restlessness, drowsiness, confusion, hallucinations, insomnia, visual disturbances, vertigo
• altered taste, loss of appetite, tongue inflammation (glossitis)
• skin reactions such as burning sensation or itching, bruising, redness, and excessive sweating
• sensitivity to light
• hair loss
• tingling sensation (paresthesia), tremor
• anemia (pallor)
• kidney problems
• pancreatitis
• liver inflammation (may manifest as 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 swelling of the face, tongue, or pharynx, difficulty swallowing, hives, and difficulty breathing.

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

• 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)
• inflammation of the intestine (colitis)
• 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, Opiren may cause a reduction in the number of white blood cells, which can 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 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 a possible reduction in white blood cells (agranulocytosis).

Frequency not known (cannot be estimated from the available data):

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

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Opiren

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 packaging and outer carton, after EXP. The expiry date is the last day of the month indicated.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Opiren

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

Appearance of the Product and Package Contents

Opiren Flas 15 mg is presented in the form of round, flat, beveled, white to off-white buccal dispersible tablets, speckled with orange to dark brown microgranules, with the mark "15" on one face. Each package contains 28 or 56 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Takeda Pharmaceutical Spain, S.A.

Albacete Street, 5, 9th floor,

Los Cubos Building

28027 Madrid

Spain

Tel: +34 91 790 42 22

Manufacturer

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

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

PORTUGAL

or

VIANEX S.A 15th km Av. Marathonos - Pallini Attiki, Athens - GR-15351 - Greece

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

European Economic Area with the following names:

Greece: LAPRAZOL FasTab

Italy: LANSOX, LIMPIDEX, ZOTON

Portugal: OGASTO

Spain: OPIREN Flas

Date of the last revision of this leaflet: December 2023

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

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