LANSOPRAZOL STADA 30 mg HARD GASTRO-RESISTANT CAPSULES

Introduction

Package Leaflet: Information for the Patient

Lansoprazole Stada 30 mg Hard Gastro-Resistant Capsules EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What is Lansoprazole Stada and what is it used for
2. What you need to know before you take Lansoprazole Stada
3. How to take Lansoprazole Stada
4. Possible side effects
5. Storing Lansoprazole Stada
6. Contents of the pack and other information

1. What is Lansoprazole Stada and what is it used for

The active substance of Lansoprazole Stada is lansoprazole, a proton pump inhibitor. Proton pump inhibitors reduce the amount of acid produced by the stomach.

Your doctor may prescribe you lansoprazole for the following indications in adults:

• Treatment of duodenal and gastric ulcers

• Treatment of inflammation of the oesophagus (reflux oesophagitis)

• Prevention of reflux oesophagitis

• Treatment of heartburn 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 who require continuous treatment with non-steroidal anti-inflammatory drugs (NSAIDs) (NSAID treatment is used for pain or inflammation)
• Treatment of Zollinger-Ellison syndrome

You may have been prescribed lansoprazole for another indication or at a different dose than stated in this leaflet. Follow your doctor's instructions exactly.

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

2. What you need to know before you take Lansoprazole Stada

Do not take Lansoprazole Stada:

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

• If you are taking another medicine containing the active substance atazanavir (used to treat HIV).

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with lansoprazole.

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 an additional test called endoscopy to diagnose your condition and/or rule out cancer.

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

If your doctor has prescribed you lansoprazole in addition to other medicines for the treatment of Helicobacter pyloriinfection (antibiotics) or together with anti-inflammatory drugs to treat pain or rheumatism, also read the package leaflets of these medicines carefully.

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

Consult your doctor before starting treatment with lansoprazole:

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

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

• If you have low levels of vitamin B12 or risk factors for this and receive treatment with these medicines for a long period. Like all acid-reducing medicines, lansoprazole may reduce the absorption of vitamin B12.

• If you experience 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 association with lansoprazole treatment [Stevens-Johnson syndrome, toxic epidermal necrolysis and drug rash with eosinophilia and systemic symptoms (DRESS)]. Stop using lansoprazole and contact your doctor immediately if you experience any of the symptoms related to severe skin reactions described in section 4.

• When taking lansoprazole, kidney inflammation may occur. The signs and symptoms may include decreased urine output or blood in the urine and/or hypersensitivity reactions such as fever, rash and joint stiffness. You should report these signs to your doctor.

Taking Lansoprazole Stada with other medicines

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

In particular, inform your doctor or pharmacist if you are using medicines that contain any of the following active substances, as lansoprazole may affect their mode of 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 Lansoprazole Stada with food and drinks

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

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, 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 lansoprazole 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 may 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 the information in this leaflet carefully.

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

Lansoprazole Stada contains sucrose

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

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

3. How to take Lansoprazole Stada

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

Swallow the capsule whole with a glass of water. If you have difficulty swallowing the capsule, your doctor will inform you of 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 lansoprazole once a day, try to take it at the same time every day. You may get better results if you take lansoprazole in the morning.

If you take lansoprazole twice a day, you should take the first dose in the morning and the second dose in the evening.

The dose of lansoprazole depends on your general condition. The recommended doses 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 capsule per day for 4 weeks. If symptoms do not improve after 4 weeks, consult your doctor.

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

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

Treatment of oesophageal inflammation (reflux oesophagitis):one 30 mg capsule per day for 4 weeks

Long-term prevention of reflux oesophagitis: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 in the evening. The treatment will normally be daily for 7 days.

The recommended combinations of antibiotics are as follows:

• 30 mg of lansoprazole with 250 - 500 mg of clarithromycin and 1,000 mg of amoxicillin
• 30 mg of lansoprazole 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 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 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 recommended starting dose is two 30 mg capsules per day; subsequently, based on your response to lansoprazole treatment, the doctor will decide on the best dose for you.

Use in children

Lansoprazole should not be given to children.

If you take more Lansoprazole Stada than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, telephone: 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to bring the package leaflet and the medicine packaging to the healthcare professional.

If you forget to take Lansoprazole Stada

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 capsules as usual. Do not take a double dose to make up for forgotten doses.

If you stop taking Lansoprazole Stada

Do not stop treatment prematurely because your symptoms have improved. It is possible that your condition has not been completely cured and may recur if you do not complete 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, lansoprazole can cause side effects, although not everybody gets them.

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

• round or ring-shaped red spots on the trunk, often with blisters in the centre, 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

• diarrhoea, 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, inflammation of the tongue (glossitis)

• skin reactions such as burning sensation or itching under the skin, bruising, redness and excessive sweating

• sensitivity to light

• hair loss

• tingling sensation (paraesthesia), tremor

• anaemia (pallor)

• kidney problems

• pancreatitis

• inflammation of the liver (may be indicated by yellowing of the skin or eyes)

• breast swelling in men, impotence

• candidiasis (fungal infection, can 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, 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

• inflammation of the mouth (stomatitis)

• colitis (inflammation of the intestine)
• 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, lansoprazole 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. A blood test will be performed to check for a possible reduction in white blood cells (agranulocytosis).

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

• If you are taking lansoprazole 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, increased heart rate. If you experience any of these symptoms, see your doctor immediately. Low magnesium levels can also lead to a decrease in blood potassium and calcium levels. Your doctor may decide to perform periodic 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.

• If you are taking proton pump inhibitors like lansoprazole, especially for a period of more than one year, you may have a slightly increased risk of hip, wrist and spine fractures. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).
• 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 via the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Lansoprazole Stada

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 blister, label of the bottle and carton. The expiry date is the last day of the month stated.

Blister: Do not store above 30°C. Store in the original package to protect from moisture.

Bottle: Do not store above 30°C. Keep the bottle tightly closed to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy for proper disposal. If you have any doubts, ask your pharmacist how to dispose of the packaging and unused medicine. This will help protect the environment.

6. Container Content and Additional Information

Composition of Lansoprazol Stada

• The active ingredient is lansoprazole
• The other components are:

Content of the capsules:sugar spheres (sucrose and corn starch), sodium lauryl sulfate, meglumine, mannitol (E421), hypromellose, macrogol, talc, polysorbate 80, titanium dioxide (E171), 30% dispersion of methacrylic acid and ethyl acrylate copolymer (1:1)

Capsule coating:gelatin, titanium dioxide (E171)

Appearance of the Product and Container Content

These gastro-resistant capsules are available in blister packs, with 14, 28, 56 or 500 (clinical package) capsules.

They are also available in bottles, with 14 or 28 capsules.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960- Sant Just Desvern

Barcelona - Spain

[email protected]

Manufacturer

Laboratorios Liconsa, S.A.

Avda. Miralcampo, Nº 7,

Polígono Industrial Miralcampo,

19200 Azuqueca de Henares, Guadalajara

Spain

Date of the Last Revision of this Prospectus:June 2024

Detailed information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/