PATIENT INFORMATION LEAFLET

Opiren15 mg Capsules

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 pass it on 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

1. Storage of Opiren
2. Contents of the pack and additional information

The active ingredient of Opiren is lansoprazole, 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 severe liver disease. Your doctor may need to adjust the dose.

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

In case 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 medicines for the treatment of Helicobacter pylori infection (antibiotics) or together with anti-inflammatory drugs to treat pain or rheumatism, read the leaflets of these medicines carefully.

The fact of 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. 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 must 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 undergo 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 refer 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, rash, 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 mode of 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 stomach burning 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 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 exercise caution as your reaction time may be reduced.

You are the only one responsible for deciding whether you are in a condition 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 may reduce your ability to carry out these operations safely is the use of medicines.

Find the descriptions of these effects in the following sections.

Read this prospectus carefully.

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

Opiren contains saccharose

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

Opiren contains sodium

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

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

Take the entire capsule with a glass of water. If you have difficulty swallowing the capsule, your doctor will inform you of alternative ways to take the medication. Do not crush or chew the capsules or the contents of an empty capsule, as this will make them ineffective.

If you take Opiren once a day, try to take it at the same time every day. You may get better results by taking 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 normal doses of Opiren for adults are indicated below. In some cases, your doctor may prescribe a different dose and a different duration of treatment.

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

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

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

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

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

Treatment of Helicobacter pylori infection:The normal dose is one 30 mg capsule with two different antibiotics in the morning and one 30 mg capsule 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 successfully. 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 30 mg capsule per day for 4 weeks.

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

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

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 Toxicology 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 next dose is almost due. In this case, skip the missed dose and take the capsules as usual. Do not take a double dose to make up 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 can 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 spots 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 gastric polyps

• 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
• 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 (pallor)
• 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, tongue, or pharyngeal swelling, 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 the number of white blood cells, which may lead to a decrease in your 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, convulsions, 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, convulsions, coma.
• skin rash, possibly with joint pain.
• visual hallucinations.

Reporting 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.

Store below 25°C. Store in the original packaging to protect it from moisture.

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

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

Medications should not be disposed of through drains or in the trash.Deposit the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubtask your pharmacist how to dispose of the containers 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: heavy magnesium carbonate, sugar spheres, saccharose, cornstarch, hydroxypropylcellulose, low-substitution hydroxypropylcellulose, dispersion of methacrylic acid copolymer and ethyl acrylate (1:1) at 30%, talc, macrogol 8000, titanium dioxide (E-171), polisorbate 80, and anhydrous colloidal silica.

The capsule components are: titanium dioxide (E-171), gelatin, and ink formed by shellac lacquer (E-904), potassium hydroxide (E-525), propylene glycol (E-1520), ammonium hydroxide (E-527), and iron oxide black (E-172).

Appearance of the product and contents of the package

Opiren 15 mg is presented in the form of hard, gastro-resistant white capsules with "Opiren 15" printed on them. Each package contains 28 or 56 capsules.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

TAKEDA FARMACÉUTICA ESPAÑA, S.A.

Paseo de la Castellana 95, floor 22

Edificio Torre Europa

28046 Madrid

Spain

Tel: +34 91 790 42 22

Responsible for manufacturing

Delpharm Novara S.r.l.

Via Crosa, 86 - Cerano (No) - I-28065 - Italy

or

Lusomedicamenta – Sociedade Técnica Farmacêutica, S.A.

Rua Norberto de Oliveira, 1 to 5 2620-111, Póvoa de Sto. Adrião, Portugal.

or

Lusomedicamenta – Sociedade Técnica Farmacêutica, S.A.

Estrada Consiglieri Pedroso, 66, 69-B, Queluz de Baixo – 2730-055 Barcarena – Portugal.

or

Opella Healthcare International SAS

56, Route de Choisy

60200 Compiègne

FRANCE

or

Vianex S.A

15th km Marathonos Ave, 15351 Pallini Attiki, Greece.

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

Trade names:

Austria: AGOPTON

France: LANZOR, OGAST

Germany: AGOPTON

Greece: LAPRAZOL

Italy: LANSOX, LIMPIDEX, ZOTON

Portugal: OGASTO

Spain: OPIREN

Last review date of this prospectus: December 2023

The 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/