Opiren Flas 15 mg orodispersible tablets

Patient Information Leaflet

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Opiren Flas 15 mg Orodispersible Tablets

lansoprazol

Read the entire leaflet carefully before you start taking this medicine, as 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 and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if the effects are not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Opiren is and what it is used for

The active substance in 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 inflammation of the oesophagus (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 ongoing 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 Opiren for an indication or at a dosage different from that stated in this leaflet. Follow exactly the instructions for taking this medicine as given by your doctor.

Consult a doctor if you worsen or do not improve after 14 days.

2. What you need to know before taking 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

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 malignant disease.

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

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

Taking a proton pump inhibitor such as Opiren, especially for 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 osteoporisis (for example, if you are taking steroids).

If you have been taking Opiren for a long time (more than 1 year), your doctor will likely monitor you regularly. During visits to your doctor, you should report any new or unusual symptoms or circumstances.

Consult your doctor before starting lansoprazole:

• If you have reduced body stores of vitamin B12 or risk factors for this, and you are to receive long-term treatment with lansoprazole. Like all medicines that reduce acid levels, 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 used to reduce stomach acidity.

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

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

• 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, rash, and joint stiffness. You must report such signs to your treating doctor.

Taking Opiren with other medicines

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

In particular, inform your doctor or pharmacist if you are taking medicines containing any of the following active substances, as Opiren may affect their 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

For optimal effectiveness of this medicine, take Opiren at least 30 minutes before meals with a glass of water.

Pregnancy, breast-feeding and fertility

If you are pregnant, breast-feeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist 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 exercise caution, as your reaction capabilities may be reduced.

You are solely responsible for deciding whether you are fit to drive or perform activities requiring a high level of concentration. One of the factors that may impair your ability to perform these tasks safely is the use of medicines.

Descriptions of these effects can be found in the following sections.

Please read the information in this leaflet carefully.

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

Opiren contains lactose

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

Opiren contains aspartame

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

Aspartame contains a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

Opiren contains sodium

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

3. How to take Opiren

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

Place the tablet on your 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 using a syringe:

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

• Remove the plunger from the syringe (at least a 5 ml syringe).
• Place the tablet into the barrel.
• Replace the plunger into the syringe.
• Fill the syringe with 4 ml of water.
• Invert the syringe and pull the plunger back 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 rinse any remaining residue from the syringe and empty it into the mouth.

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

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

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

Treatment of heartburn and acid regurgitation: one orodispersible tablet of 15 mg or 30 mg daily for 4 weeks. 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 esophagitis): one orodispersible tablet of 30 mg daily for 4 weeks.

Long-term prevention of reflux esophagitis: 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. Treatment is normally given 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 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 ongoing NSAID therapy: one orodispersible tablet of 30 mg daily for 4 weeks.

Prevention of duodenal or gastric ulcer in patients requiring ongoing 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 treatment with Opiren, your doctor will decide the best dose for you.

Use in children:

Opiren must not be given 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, Telephone 915 620 420.

If you forget to take Opiren

If you forget to take a dose, take it as soon as possible unless it is almost time for your next dose. In that case, skip the missed dose and take the next tablet at the usual time. Do not take a double dose to make up for a missed dose.

If you stop taking Opiren

Do not stop treatment prematurely, even if symptoms have improved. Your condition may not be fully healed and 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 will experience them.

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

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

Common adverse effects (may affect up to 1 in 10 people):

• headache, dizziness
• diarrhoea, constipation, stomach pain, nausea and vomiting, flatulence, dryness or soreness in mouth or throat
• skin rash, itching
• changes in liver function test results
• tiredness
• benign polyps in the stomach

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

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

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

• fever
• restlessness, drowsiness, confusion, hallucinations, insomnia, visual disturbances, dizziness
• altered taste, loss of appetite, inflammation of the tongue (glossitis)
• skin reactions such as burning or itching sensation, 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 males, 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 pharynx, difficulty swallowing, urticaria, or breathing difficulties.

Very rare adverse 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 sometimes low blood pressure
• inflammation of the mouth (stomatitis)
• inflammation of the intestine (colitis)
• changes in laboratory values, such as levels of sodium, cholesterol, and triglycerides
• very severe skin reactions with redness, blisters, severe swelling, and skin loss
• very rarely, Opiren may cause a reduction in the number of white blood cells, which can 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 local infection symptoms such as sore throat/pharynx/mouth or urinary problems, consult your doctor immediately. A blood test will be performed to check for possible reduction in white blood cells (agranulocytosis).

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

• If you have been taking Opiren for more than three months, your blood magnesium levels 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 decreased levels of potassium or calcium in the blood. Your doctor will likely 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 adverse effects:

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish System for Pharmacovigilance of Human Medicines: https://www.notificaram.es. By reporting adverse 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 stated on the container and outer carton, after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25°C. Keep in the original container.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Opiren

• The active substance is lansoprazole.
• The other components are: Gastro-resistant 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) 30% dispersion, 30% polacrylate dispersion, macrogol 8000, anhydrous citric acid, glyceryl monostearate, 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 pack

Opiren Flas 15 mg is presented as round, flat, bevelled orodispersible tablets, white to yellowish-white in color, speckled with orange to dark brown microgranules, marked "15" on one side. Each pack contains 28 or 56 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Takeda Farmacéutica España, S.A.
Calle Albacete, 5, 9th floor,
Edificio Los Cubos
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
RUA NORBERTO DE OLIVEIRA 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 medicinal product is authorized in the Member States of the European Economic Area under the following names:

Greece: LAPRAZOL FasTab
Italy: LANSOX, LIMPIDEX, ZOTON
Portugal: OGASTO
Spain: OPIREN Flas

Date of the most recent review of this leaflet: December 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS):
http://www.aemps.gob.es/