LANSOPRAZOL TECNIGEN 15 mg HARD GASTRORESISTENT CAPSULES

Introduction

Package Leaflet: Information for the Patient

Lansoprazole TecniGen 15 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.

Contents of the pack and other information:

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

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

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

Your doctor may prescribe you Lansoprazole TecniGen for the following indications:

• Treatment of duodenal and gastric ulcers
• Treatment of inflammation of the esophagus (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 who require continuous treatment with non-steroidal anti-inflammatory drugs (NSAIDs) (NSAID treatment is used for pain or inflammation)
  • Treatment of Zollinger-Ellison syndrome

It may be that your doctor has prescribed Lansoprazole TecniGen for another indication or at a different dose than indicated in this leaflet. Follow your doctor's instructions regarding the administration of the medicine.

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

Do not take Lansoprazole TecniGen:

• 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 whose active substance is atazanavir (used in the treatment of HIV).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Lansoprazole TecniGen.

• if you have ever had a skin reaction after treatment with a medicine similar to Lansoprazole TecniGen to reduce stomach acidity.
• if you are scheduled to have a specific blood test (Chromogranin A)

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

Inform your doctor if you have a severe liver disease. It is possible that the doctor may need 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 cancer.

In case you experience diarrhea during treatment with Lansoprazole TecniGen, contact your doctor immediately, as Lansoprazole TecniGen has been associated with a slight increase in infectious diarrhea.

If your doctor has prescribed you Lansoprazole TecniGen in addition to other medicines intended for the treatment of Helicobacter pylori infection (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 TecniGen for a long time (more than 1 year), your doctor will probably have you checked regularly. During your visits to the doctor, you must inform him of any new or abnormal symptoms and circumstances.

When taking lansoprazole, kidney inflammation may occur. The signs and symptoms may include decreased urine volume or the presence of 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 TecniGen with other medicines

Tell your doctor or pharmacist that you are taking, have recently taken, or may take any other medicine.

In particular, inform your doctor if you are using medicines that contain any of the following active substances, as Lansoprazole TecniGen may affect their mode of action:

• ketoconazole, itraconazole, rifampicin (used to treat infections)
• digoxin (used to treat heart problems)
• 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 TecniGen with food and drinks

To get the best results from your medicine, you should take Lansoprazole TecniGen at least 30 minutes before meals.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Driving and using machines

Patients taking Lansoprazole TecniGen 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 the information in this leaflet carefully.

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

Lansoprazole TecniGen contains sucrose

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

3. How to take Lansoprazole TecniGen

Follow your doctor's instructions for the administration of this medicine exactly. If in doubt, consult your doctor 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 Lansoprazole TecniGen once a day, try to take it always at the same time. You may get better results if you take Lansoprazole TecniGen in the morning.

If you take Lansoprazole TecniGen twice a day, you should take the first dose in the morning and the second dose at night.

The dose of Lansoprazole TecniGen depends on your general condition. The recommended doses of Lansoprazole TecniGen 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 persist, inform your doctor. 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 pylori infection: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 normal treatment is once a day for 7 days.

The recommended combinations of antibiotics are as follows:

• 30 mg of Lansoprazole TecniGen with 250-500 mg of clarithromycin and 1000 mg of amoxicillin
• 30 mg of Lansoprazole TecniGen 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 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, based on your response to treatment with Lansoprazole TecniGen, the doctor will decide the best dose for you.

Use in children

Lansoprazole TecniGen should not be administered to children.

If you take more Lansoprazole TecniGen than you should

If you take more Lansoprazole TecniGen than you have been prescribed, consult your doctor immediately or call the Toxicology Information Service immediately.

In case of overdose or accidental ingestion, consult the Toxicology Information Service, phone 91 562 04 20.

If you forget to take Lansoprazole TecniGen

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 the missed doses.

If you stop taking Lansoprazole TecniGen

Do not stop treatment prematurely because the 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 TecniGen can cause side effects, although not everybody gets them.

The following side effects are common (occur in more than 1 in 100 patients):

• 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.

The following side effects are uncommon (occur in less than 1 in 100 patients):

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

The following side effects are rare (occur in less than 1 in 1,000 patients):

• fever
• restlessness, drowsiness, confusion, hallucinations, insomnia, visual disturbances, dizziness
• taste alteration, loss of appetite, tongue inflammation (glossitis)
• skin reactions such as burning sensation or itching under the skin, bruising, redness, and excessive sweating
• sensitivity to light
• hair loss
• tingling sensation (paresthesia), tremor
• anemia (pallor)
• kidney problems
• pancreatitis
• liver inflammation (may manifest as yellowing of the skin or eyes)
• breast swelling in males, impotence
• candidiasis (fungal infection, can 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.

The following side effects are very rare (occur in less than 1 in 10,000 patients):

• 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)
• 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 TecniGen may cause a reduction in the number of white blood cells, which can cause 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. You will have a blood test to check for possible reduction of white blood cells (agranulocytosis).

The following side effects have an unknown frequency (cannot be estimated from the available data):

Visual hallucinations.

If you are taking Lansoprazole TecniGen 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 have any of these symptoms, go to the doctor immediately. Low magnesium levels can also cause a decrease in blood potassium and calcium levels. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.

If you are taking proton pump inhibitors like Lansoprazole TecniGen, 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.

If you experience side effects, consult your doctor or pharmacist, even if it is a side effect not listed in this leaflet.

5. Storage of Lansoprazole TecniGen

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 indicated.

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. Place the packaging and unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Lansoprazole TecniGen

• The active substance is lansoprazole
• The other ingredients are:

Contents of the capsules:sugar spheres (sucrose and cornstarch), 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)

15 mg:

Coating of the capsules:gelatin, titanium dioxide (E171), quinoline yellow (E104)

Appearance of the product and contents of the pack

15 mg:

These gastro-resistant capsules are available in blister packs containing: 28 capsules, clinical pack of 500 capsules. They are also available in bottles containing: 28 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

The marketing authorization holder is:

Tecnimede España Industria Farmacéutica, S.A.

Avenida de Bruselas, 13. Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid)

The manufacturer is:

LABORATORIOS LICONSA, S.A.

Avenida Miralcampo, Nº 7, Polígono Industrial Miralcampo,

19200 Azuqueca de Henares (Guadalajara)

Spain

Date of the last revision of this leaflet:October 2022.

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