Prospect: information for the patient

Lansoprazol TecniGen 30 mg hard-gastroresistent EFG capsules

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only to you and should not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect.

1.Lansoprazol TecniGen and its use

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

3.How to take Lansoprazol TecniGen

4.Possible adverse effects

5.Storage of Lansoprazol TecniGen

6.Contents of the package and additional informationadditional

The active ingredient of Lansoprazol TecniGen is lansoprazol, 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 esophagus inflammation (acid reflux esophagitis)

-Prevention of acid reflux esophagitis

-Treatment of stomach burning and acid regurgitation

-Treatment of infections caused by the bacteriaHelicobacter pylori, in combination with antibiotics

-Treatment or prevention of duodenal or gastric ulcers in patients requiring continuous treatment with non-steroidal anti-inflammatory drugs (NSAIDs) (NSAIDs are used for pain or inflammation)

• Treatment of Zollinger-Ellison syndrome

Your doctor may have prescribed Lansoprazol TecniGen for another indication or at a different dose than indicated in this leaflet. Follow your doctor's instructions regarding the medication intake.

Do not take Lansoprazol TecniGen:

-If you are allergic to lansoprazol or to any of the other components of this medication (listed in section 6)..

-If you are taking another medication whose active ingredient is atazanavir (used in the treatment of HIV).

Warnings and precautions

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

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If you suffer from a skin rash,especiallyin areas of the skin exposed to the sun, consult your doctor as soon as possible,as it may be necessary to interrupt treatment with Lansoprazol TecniGen.Remember to mention any other symptoms you may notice, such as joint pain.

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

Your doctor may have performed or will perform a supplementary test called endoscopy to diagnose your condition and/or rule out cancer.

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

If your doctor has prescribed Lansoprazol TecniGen in addition to other medications for the treatment of Helicobacter pylori infection (antibiotics) or together with anti-inflammatory medications to treat pain or rheumatism, read the prospectuses of these medications carefully.

If you have been taking Lansoprazol TecniGen for a long time (over 1 year), your doctor will probably schedule regular check-ups. During your visits to your doctor, you must inform them of any new or abnormal symptoms and circumstances.

When taking lansoprazol, it may cause inflammation in the kidneys. The signs and symptoms may include decreased urine volume or the presence of blood in the urine and/or hypersensitivity reactions such as fever, skin rash, and joint stiffness. You must inform your doctor of these signs.

Taking Lansoprazol TecniGen with other medications

Inform your doctor or pharmacist that you are taking, have taken recently, or may need to take any other medication.

Especially, inform your doctor if you are using medications containing any of the following active ingredients, as Lansoprazol TecniGen may affect their mode of action:

-ketoconazol, itraconazol, rifampicina (used to treat infections)

-digoxina (used to treat heart problems)

-teofilina (used to treat asthma)

-tacrolimús (used to prevent transplant rejection)

-fluvoxamina (used to treat depression and other psychiatric disorders)

-anti-acids (used to treat stomach burning or acid regurgitation)

-sucralfato (used to heal ulcers)

-St. John's Wort (Hypericum perforatum) (used to treat mild depression)

Taking Lansoprazol TecniGen with food and drinks

To get the best results from your medication, you must take Lansoprazol TecniGen at least 30 minutes before meals.

Pregnancy and breastfeeding

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

Driving and operating machinery

Patients taking Lansoprazol TecniGen may occasionally experience side effects such as dizziness, vertigo, fatigue, and visual disturbances. If you experience any of these side effects, you must act with caution as your reaction time may be reduced.

You are the only one responsible for deciding whether you are fit to drive vehicles or perform activities that require a high level of concentration. Due to their effects or adverse reactions, one of the factors that may reduce your ability to carry out these operations safely is the use of medications.

In the following sections, you will find the descriptions of these side effects.

Read this prospectus carefully.

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

Lansoprazol TecniGen contains saccharose

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

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor again.

Take the entire capsule with a glass of water. If you have difficulty swallowing the capsule, your doctor will inform you of alternative ways to take the medication. Do not crush or chew the capsules or the contents of an empty capsule, as this will make them ineffective.

If you take Lansoprazol TecniGen once a day, try to take it at the same time every day. You may get 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 dose at night.

The dose of Lansoprazol TecniGen depends on your general condition. The recommended doses of Lansoprazol TecniGen for adults are indicated below. In some cases, your doctor may prescribe a different dose and a different duration of treatment.

Treatment of heartburn and acid regurgitation:one capsule of 15 mg or 30 mg 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 capsule of 30 mg per day for 2 weeks.

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

Treatment of esophagitis caused by acid reflux:one capsule of 30 mg per day for 4 weeks.

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

Treatment of Helicobacter pylori infection:The usual dose is one capsule of 30 mg with two different antibiotics in the morning and one capsule of 30 mg with two different antibiotics at night. The usual treatment is once a day 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 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 medication, take it at the right time anddo not miss any doses.

Treatment of duodenal or gastric ulcer in patients requiring continuous treatment with NSAIDs:one capsule of 30 mg per day for 4 weeks.

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

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

Use in children:

Lansoprazol TecniGen should not be administered to children.

If you take more Lansoprazol TecniGen than you should:

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

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

If you forget to take Lansoprazol TecniGen:

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

If you interrupt treatment with Lansoprazol TecniGen:

Do not stop treatment before time because symptoms have improved. It is possible that your condition has not been fully cured and may recur if you do not complete the entire treatment.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, Lansoprazol TecniGen can cause side effects, although not everyone will experience them.

The following side effects are frequent (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 polyps in the stomach.

The following side effects are infrequent (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, vertigo

-alteration of taste, loss of appetite, inflammation of the tongue (glossitis)

-skin reactions such as burning or itching under the skin, bruises, redness and excessive sweating

-sensitivity to light

-hair loss

-tingling sensation (paresthesia), tremors

-anemia (pale skin)

-kidney problems

-pancreatitis

-inflammation of the liver (may be manifested by yellow skin or eyes)

-swelling of the chest 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 facial swelling, tongue or throat swelling, difficulty swallowing, urticaria 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. Symptoms of hypersensitivity reactions 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, vesicles, severe inflammation and skin loss

-in very rare cases, Lansoprazol TecniGen may cause a reduction in the number of white blood cells, which may cause a decrease in your 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 possible reduction in white blood cells (agranulocytosis).

The following side effects have an unknown frequency

(cannot be estimated from available data):

Visual hallucinations

If you are taking Lansoprazol TecniGen for more than three months, it is possible that blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you experience any of these symptoms, see your doctor immediately. Low magnesium levels may also cause a decrease in potassium and calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.

If you are taking proton pump inhibitors such as Lansoprazol TecniGen, especially for a period of more than one year, you may slightly increase the risk of hip, wrist and spinal fractures. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (they may increase the risk of osteoporosis).

Skin rash, possibly with joint pain.

If you experience side effects, consult your doctor or pharmacist, even if they are side effects that do not appear in this prospectus.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister pack, bottle label, and box. The expiration date is the last day of the month indicated.

Blister pack:Do not store at a temperature above 30°C. Store in the original packaging to protect it from moisture.

Bottle:Do not store at a temperature above 30°C. Keep the bottle perfectly closed to protect it from moisture.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Lansoprazol TecniGen

- The active ingredient is lansoprazol

- The other components are:

Contents of the capsules:sugar spheres (sucrose and cornstarch), sodium lauryl sulfate, meglumine, mannitol (E421), hypromellose, Macrogol, talc, polisorbate 80, titanium dioxide (E171), dispersion at 30% of methacrylic acid copolymer and ethyl acrylate (1:1)

30 mg:

Capsule coating:gelatin, titanium dioxide (E171)

Appearance of the product and contents of the packaging

30 mg:

These gastro-resistant capsules are available in blister packs containing: 14, 28 capsules, clinical packaging of 500 capsules. They are also available in bottles containing: 14, 28 capsules.

Only some packaging sizes may be commercially available.

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, Industrial Park Miralcampo,

19200 Azuqueca de Henares (Guadalajara)

Spain

Last review date of this leaflet: October 2022.

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