Lansoprazole Stada 15 mg gastro-resistant hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Lansoprazol Stada 15 mg gastro-resistant hard capsules EFG

Read the entire 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, and you should not give it 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 these are effects not listed in this leaflet. See section 4.

Leaflet contents:

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

2. What you need to know before taking Lansoprazol Stada

3. How to take Lansoprazol Stada

4. Possible side effects

5. How to store Lansoprazol Stada

6. Contents of the pack and other information

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

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

Your doctor may prescribe lansoprazole 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 long-term 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 lansoprazole for a different indication or at a dosage different from that stated in this leaflet. Follow exactly the administration instructions given by your doctor.

You should consult a doctor if your condition worsens or does not improve after 14 days.

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

Do not take Lansoprazole Stada:

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

• If you are taking another medicine containing the active substance atazanavir (used in the treatment of HIV).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take lansoprazole.

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 to 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 lansoprazole together with other medicines for the treatment of Helicobacter pylori infection (antibiotics) or together with anti-inflammatory medicines for 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 likely monitor you regularly. During visits to your doctor, you should report any new or unusual symptoms or circumstances.

Talk to your doctor before starting to take lansoprazole:

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

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

• If you have low levels of vitamin B12 or risk factors for this and are receiving long-term treatment with these medicines. As with all medicines that reduce acid levels, lansoprazole may reduce the absorption of vitamin B12.

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

• Kidney inflammation may occur while taking lansoprazole. Signs and symptoms may include decreased urine volume or blood in the urine and/or hypersensitivity reactions such as fever, skin rash, and joint stiffness. You should report these signs to your doctor.

Taking Lansoprazole Stada with other medicines

Tell 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 lansoprazole 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 Lansoprazole Stada with food and drinks

To get the best results from your medicine, take lansoprazole 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 become pregnant, consult your doctor or pharmacist before using 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 exercise caution, as your reaction ability may be reduced.

You are solely responsible for deciding whether you are fit to drive or perform activities requiring a high level of concentration. Due to its effects or adverse reactions, the use of medicines may be one of the factors that reduces your ability to carry out these tasks safely.

Descriptions of these effects can be found in the following sections. Please read the information in this leaflet carefully.

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

Lansoprazole Stada contains sucrose

If your doctor has diagnosed you with an intolerance to certain sugars, consult him or her before taking this medicine.

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

3. How to take Lansoprazol Stada

Follow exactly the instructions for use of this medicine as given by your doctor. If in 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 alternative ways to take the medicine. You must not crush or chew the capsules or the contents of an emptied capsule, as this will prevent them from working properly.

If you take lansoprazole once a day, try to take it at the same time every day. You may achieve 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 in the evening.

The dose of lansoprazole depends on your condition. The recommended doses for adults are indicated below. Occasionally, your doctor may prescribe you a different dose and indicate a different treatment duration.

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

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

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

Treatment of inflammation of the oesophagus (reflux esophagitis): one 30 mg capsule daily for 4 weeks.

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

Treatment of Helicobacter pylori infection: the usual 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. Treatment is normally given daily for 7 days.

The recommended antibiotic combinations are as follows:

• 30 mg lansoprazole with 250–500 mg clarithromycin and 1,000 mg amoxicillin
• 30 mg lansoprazole with 250 mg clarithromycin and 400–500 mg metronidazole

If you are receiving anti-infective treatment for an ulcer, the ulcer is unlikely to recur if the infection is successfully treated. To obtain 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 continuous treatment with NSAIDs: one 30 mg capsule daily for 4 weeks.

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

Zollinger-Ellison syndrome: the recommended starting dose is two 30 mg capsules daily; subsequently, depending on your response to lansoprazole treatment, your doctor will decide the best dose for you.

Use in children

Lansoprazole must not be given to children.

If you take more Lansoprazol Stada than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, stating the medicine and the amount ingested. It is recommended to bring the package leaflet and the medicine container to the healthcare professional.

If you forget to take Lansoprazol Stada

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

If you stop taking Lansoprazol Stada

Do not stop treatment prematurely because symptoms have improved. Your condition may not have been completely cured and may recur 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, lansoprazol may cause adverse effects, although not everyone experiences them.

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

• circular or target-shaped slightly reddish spots on the trunk, often with blisters in the center, peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These severe 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 of mouth or throat

• skin rash, itching

• changes in liver function test values

• fatigue

• benign gastric polyps

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

• taste disturbances, loss of appetite, inflammation of the tongue (glossitis)

• skin reactions such as burning or itching sensation under the skin, 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 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 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 may include fever, rash, swelling, and occasionally low blood pressure

• inflammation of the mouth (stomatitis)

• colitis (inflammation of the intestine)

• changes in laboratory test values, such as levels of sodium, cholesterol, and triglycerides

• very severe skin reactions with redness, blisters, severe swelling, and skin loss

• in very rare cases, lansoprazol may cause a reduction in the number of white blood cells, which may decrease your resistance to infections. If you develop an infection with symptoms such as fever and severe deterioration in your general condition, or fever with signs 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 possible reduction in white blood cells (agranulocytosis).

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

• If you are taking lansoprazol for more than three months, your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, see your doctor immediately. Low magnesium levels may also lead to decreased levels of potassium and calcium in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.

• Low levels of sodium in the blood. Common symptoms include nausea and vomiting, headache, drowsiness and fatigue, confusion, muscle weakness or spasms, irritability, seizures, coma.

• If you are taking proton pump inhibitors such as lansoprazol, especially for a period longer than one year, there may be a slight increase in the risk of fractures of the hip, wrist, and spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).

• 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 Pharmacovigilance System for 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 Lansoprazole Stada

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the blister pack, the label of the bottle, and the outer carton. The expiry date refers to the last day of the month indicated.

Blister pack: Do not store above 30°C. Keep in the original packaging to protect from moisture.

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

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

6. Contents of the pack and other information

Composition of Lansoprazol Stada

• The active substance is lansoprazole.
• The other components are:

Capsule contents: sugar spheres (sucrose and maize 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), quinoline yellow (E104)

Appearance of the product and contents of the pack

These gastro-resistant capsules are available in blister packs containing 28, 56 or 500 (hospital pack) capsules.

They are also available in bottles containing 28 capsules.

Only certain pack 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 most recent review of this leaflet: June 2024

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