Lansoprazole Tecnigen 15 mg gastro-resistant hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Lansoprazol TecniGen 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 must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet.

Leaflet contents:

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

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

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

Your doctor may prescribe Lansoprazol 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 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 Lansoprazol TecniGen for an indication or at a dosage different from that stated in this leaflet. Follow your doctor's instructions regarding how to take the medicine.

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

Do not take Lansoprazole TecniGen:

• 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 TecniGen.

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

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

Inform your doctor if you have severe liver disease. Your doctor may need to adjust your dose.

Your doctor may perform or may have already performed an additional test called an endoscopy to diagnose your condition and/or rule out cancer.

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

If your doctor has prescribed Lansoprazole TecniGen 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 TecniGen for a long time (more than 1 year), your doctor will likely carry out regular check-ups. During visits to your doctor, you must report any new or unusual symptoms or circumstances.

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

Taking Lansoprazole TecniGen with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

In particular, inform your doctor if you are taking medicines containing any of the following active substances, as Lansoprazole TecniGen may affect their 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, Lansoprazole TecniGen should be taken at least 30 minutes before meals.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might 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, 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. One of the factors that may reduce your ability to carry out these tasks safely is the use of medicines, due to their effects or adverse reactions.

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

Read the information in this leaflet carefully.

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

Lansoprazole TecniGen contains sucrose

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

3. How to take Lansoprazol TecniGen

Follow exactly the instructions for administering this medicine as given by your doctor. If you are unsure, 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 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 the medicine from working properly.

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

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

The dose of Lansoprazol TecniGen depends on your general condition. The recommended doses of Lansoprazol TecniGen for adults are listed below. Occasionally, your doctor may prescribe 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 persist, inform your doctor. If symptoms do not improve after 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. The usual treatment duration is once daily for 7 days.

The recommended antibiotic combinations are as follows:

• 30 mg of Lansoprazol TecniGen with 250–500 mg of clarithromycin and 1,000 mg of amoxicillin
• 30 mg of Lansoprazol TecniGen with 250 mg of clarithromycin and 400–500 mg of metronidazole

If you are receiving anti-infective treatment due to 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 30 mg capsule daily for 4 weeks.

Prevention of duodenal or gastric ulcer in patients requiring ongoing NSAID therapy: one 15 mg capsule daily; your doctor may adjust the dose to one 30 mg capsule daily.

Zollinger-Ellison syndrome: The usual initial dose is two 30 mg capsules daily; subsequently, depending on your response to treatment with Lansoprazol TecniGen, your doctor will decide the best dose for you.

Use in children

Lansoprazol TecniGen must not be given to children.

If you take more Lansoprazol TecniGen than you should

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

In case of overdose or accidental ingestion, contact the Toxicology Information Service at telephone number 91 562 04 20.

If you forget to take Lansoprazol TecniGen

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

If you stop taking Lansoprazol TecniGen

Do not stop treatment prematurely, even if your symptoms have improved. Your condition may not be completely 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, Lansoprazol TecniGen may cause adverse effects, although not everyone experiences them.

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

• headache, dizziness
• diarrhea, constipation, stomach pain, nausea and vomiting, flatulence, dryness or pain in mouth or throat
• skin rash, itching
• changes in liver function test values
• fatigue
• benign polyps in the stomach

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

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

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

• 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 under the skin, bruising, redness and excessive sweating
• light sensitivity
• hair loss
• tingling sensation (paresthesia), tremor
• anemia (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 the skin or mucous membranes)
• angioedema; contact your doctor immediately if you experience symptoms of angioedema such as swelling of the face, tongue or throat, difficulty swallowing, urticaria, or difficulty breathing.

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

• severe hypersensitivity reactions, including anaphylactic shock. Symptoms of hypersensitivity reactions may include fever, rash, swelling, and occasionally low blood pressure
• inflammation of the mouth (stomatitis)
• colitis (inflammation of the intestine)
• changes in laboratory 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 TecniGen 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 localized 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).

The following adverse effect has unknown frequency (cannot be estimated from available data):

Visual hallucinations.

If you are taking Lansoprazol TecniGen 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 experience any of these symptoms, consult 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 your magnesium levels.

If you are taking proton pump inhibitors such as Lansoprazol TecniGen, 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 are taking corticosteroids (which may increase the risk of osteoporosis).

Skin rash, possibly with joint pain.

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects 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 stated on the blister pack, bottle label, and 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. Unused medicines and their containers should be handed over to the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.

6. Contents of the package and other information

Composition of Lansoprazole TecniGen

• 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)

15 mg:

Capsule shell: gelatin, titanium dioxide (E171), quinoline yellow (E104)

Nature of the product and contents of the container

15 mg:

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

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

The Marketing Authorization Holder is:

Tecnimede España Industria Farmacéutica, S.A.

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

28108 Alcobendas (Madrid)

The manufacturer is:

LABORATORIOS LICONSA, S.A.

Avda. Miralcampo, Nº 7, Polígono Industrial Miralcampo,

19200 Azuqueca de Henares (Guadalajara)

Spain

Date of the most recent revision of this leaflet: October 2022.

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