OPIREN 15 mg CAPSULES

2. What you need to know before you take Opiren

Do not take Opiren

• if you are allergic to lansoprazole or to 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. It may be that the doctor needs 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.

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 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 perform regular checks. During your visits to the doctor, you should inform him of any new or abnormal symptoms or circumstances.

Consult your doctor before starting to take lansoprazole:

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

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

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

• If you suffer from 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.

• There have been reports of serious skin reactions 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 refer to any of the symptoms related to serious skin reactions described in section 4.

• When taking lansoprazole, kidney inflammation can occur. The 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 mode of action:

• HIV protease inhibitors such as atazanavir and nelfinavir (used in the treatment of 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, drowsiness, 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 sucrose

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

Opiren contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; this is, essentially “sodium-free”.

3. How to take Opiren

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

Take the capsule whole with a glass of water. If you have difficulty swallowing the capsule, your doctor will inform you of other alternative ways to take the medicine. Do not crush or chew the capsules or the contents of an emptied capsule, as this will make them not work properly.

If you take Opiren once a day, try to take it always at the same time. 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. 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 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 esophagus inflammation (reflux esophagitis):one 30 mg capsule per day for 4 weeks.

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

Treatment of Helicobacter pyloriinfection:The normal dose is one 30 mg capsule together with two different antibiotics in the morning and one 30 mg capsule together with two different antibiotics at night. The treatment will normally be 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 treated satisfactorily. To get the best results from your medicine, take it at the right time and do not forget any dose.

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

Prevention of duodenal or gastric ulcers in patients who require 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, depending 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 have been prescribed, consult your doctor immediately or contact 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 of the next dose is near. In this case, skip the missed dose and take the next capsules as usual. Do not take a double dose to make up for missed doses.

If you stop taking Opiren

Do not stop treatment before time 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 all the 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 serious 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, dizziness
• taste alteration, loss of appetite, tongue inflammation (glossitis)
• skin reactions such as burning or itching sensation, bruising, redness, and excessive sweating
• photosensitivity
• hair loss
• tingling sensation (paresthesia), tremor
• anemia (pallor)
• kidney problems
• pancreatitis
• liver inflammation (may be manifested by yellowish skin or eyes)
• breast swelling in males, 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 pharynx swelling, 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 hypersensitivity reaction may include fever, rash, swelling, and, occasionally, a drop in blood pressure
• mouth inflammation (stomatitis)
• intestine inflammation (colitis)
• changes in analytical values, such as sodium, cholesterol, and triglyceride levels
• very serious 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 cause 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 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 (cannot be estimated from the available data):

• If you have been taking Opiren for more than three months, it is possible that the magnesium levels in your blood may decrease. Low magnesium levels can 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 can also lead to a decrease in potassium or calcium levels in the blood. Your doctor will probably ask for 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 of side effects:

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them 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

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

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.

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

6. Container Content and Additional Information

Composition of Opiren

The active ingredient is lansoprazole.

The other components are: heavy magnesium carbonate, sugar spheres, sucrose, corn starch, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, dispersion of methacrylic acid and ethyl acrylate copolymer (1:1) at 30%, talc, macrogol 8000, titanium dioxide (E-171), polysorbate 80, and anhydrous colloidal silica.

The components of the capsule 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 black iron oxide (E-172).

Appearance of the Product and Container Content

Opiren 15 mg is presented in the form of hard gastro-resistant capsules of white color that are printed with “Opiren 15”. Each container contains 28 or 56 capsules.

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 - Cerano (No) - I-28065 - Italy

or

Lusomedicamenta – Technical Pharmaceutical Company, S.A.

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

or

Lusomedicamenta – Technical Pharmaceutical Company, S.A.

Consiglieri Pedroso Highway, 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 Avenue, 15351 Pallini Attiki, Greece.

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

European Economic Area with the following names:

Austria: AGOPTON

France: LANZOR, OGAST

Germany: AGOPTON

Greece: LAPRAZOL

Italy: LANSOX, LIMPIDEX, ZOTON

Portugal: OGASTO

Spain: OPIREN

Date of the last revision of this leaflet: December 2023

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/