PROSPECTO: INFORMATION FOR THE USER

Lansoprazol Tarbis 15 mg hard-gastrorresistant EFG capsules

1. Before taking Lansoprazol Tarbis 15 mg capsules
2. How to take Lansoprazol Tarbis 15 mg capsules
3. Possible adverse effects
4. Storage of Lansoprazol Tarbis 15 mg capsules
5. Additional information

The active ingredient ofLansoprazol Tarbisis lansoprazol, a proton pump inhibitor. Proton pump inhibitors reduce the amount of acid produced by the stomach.

Your doctor may prescribeLansoprazol Tarbisfor the following indications:

• Treatment of duodenal and gastric ulcers
• Treatment of inflammation of the esophagus (gastroesophageal reflux esophagitis)
• Prevention of gastroesophageal 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 nonsteroidal anti-inflammatory drugs (NSAIDs) (NSAID treatment is used for pain or inflammation)
• Treatment of Zollinger-Ellison syndrome

Your doctor may have prescribedLansoprazol Tarbisfor another indication or a different dose than indicated in this leaflet. Follow your doctor's instructions for taking the medication.

Do not take Lansoprazol Tarbis 15 mg capsules:

-If you are allergic (hypersensitive) to lansoprazol or to any of the other components of Lansoprazol Tarbis.

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

Be especially careful with Lansoprazol Tarbis 15 mg capsules

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

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

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

If your doctor has prescribed Lansoprazol Tarbis 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 leaflets of these medications carefully.

If you have been taking Lansoprazol Tarbis for a long time (over 1 year), your doctor will probably perform regular checks. At your doctor's visits, you must inform him of any new or abnormal symptoms.

Warnings and precautions

Consult your doctor before starting to take Lansoprazol Tarbis:

• If you have ever had a skin reaction after treatment with a similar medication to Lansoprazol Tarbis for reducing stomach acid.
• If you are scheduled to have a specific blood test (Cromogranin A).

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

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 should inform your doctor of these signs.

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

Especially, inform your doctor if you are using medications containing any of the following active ingredients, as Lansoprazol Tarbis 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 stomach burning or acid regurgitation)

-sucralfate (used to heal ulcers)

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

Take Lansoprazol Tarbis 15 mg capsules with food and beverages

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

Pregnancy and breastfeeding

If you are pregnant, or think you may be pregnant, or are breastfeeding, consult your doctor before using any medication.

Driving and operating machinery

Patients taking Lansoprazol Tarbis 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 time may be reduced.

You are the only one responsible for deciding whether you are in a condition 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 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.

Important information about some of the components of Lansoprazol Tarbis 15 mg capsules

Lansoprazol Tarbis 15 mg capsules contain sucrose. If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

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 medication. Do not crush or chew the capsules or the contents of an empty capsule, as this will make them not work properly.

If you takeLansoprazol Tarbisonce a day, try to take it at the same time every day. You may get better results if you takeLansoprazol Tarbisin the morning.

If you takeLansoprazol Tarbistwice a day, take the first dose in the morning and the second at night.

The dose ofLansoprazol Tarbisdepends on your general condition. The normal doses ofLansoprazol Tarbisfor adults are indicated below. Occasionally, your doctor may prescribe a different dose and indicate 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 due to reflux:one capsule of 30 mg per day for 4 weeks.

Long-term prevention of esophagitis due to reflux: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 normal 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. Treatment is usually daily for 7 days.

The recommended antibiotic combinations are as follows:

• 30 mg ofLansoprazol Tarbiswith 250–500 mg of clarithromycin and 1,000 mg of amoxicillin
• 30 mg ofLansoprazol Tarbiswith 250 mg of clarithromycin and 400–500 mg of metronidazole

If you receive antibiotic 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 forget any dose.

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 initial normal dose is two capsules of 30 mg per day; subsequently, your doctor will decide the best dose for you based on your response to treatment withLansoprazol Tarbis.

Lansoprazol Tarbisshould not be administered to children.

Follow exactly the administration instructions given by your doctor. Consult your doctor if you have any doubts.

If you take moreLansoprazol Tarbis15 mg capsules than you should

If you take moreLansoprazol Tarbisthan you have been told to, consult your doctor immediately or contact the Toxicology Information Service, Teléfono 915 620 420.

If you forget to takeLansoprazol Tarbis15 mg capsules

If you forget to take a dose, take it as soon as you remember, unless the time for 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 stop takingLansoprazol Tarbis15 mg capsules

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 product, ask your doctor or pharmacist.

Like all medicines, Lansoprazol Tarbis can cause side effects, although not everyone will experience 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, benign polyps in the stomach
• skin rash, itching
• changes in liver function test values
• fatigue

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 counts

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 sensation under the skin, bruises, redness and excessive sweating
• light sensitivity
• hair loss
• tingling sensation (paresthesia), tremor
• anemia (pale skin)
• kidney problems
• pancreatitis
• inflammation of the liver (may be manifested by yellowish 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 laboratory 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 Tarbis may cause a reduction in the number of white blood cells, which may lead to 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 are of unknown frequency (cannot be estimated from available data):

• skin rash, possibly with joint pain.
• Visual hallucinations.

If you are taking Lansoprazol Tarbis for more than three months, it is possible that your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, increased heart rate. If you experience any of these symptoms, see your doctor immediately. Low magnesium levels can 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 Tarbis, especially for a period of more than one year, it 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).

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Store below 30°C.

Keep the productout of the reach and sight of children.

Do not useLansoprazol Tarbisafter the expiration date that appears on the packaging, after the expiration date abbreviation. The expiration date is the last day of the month indicated.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Lansoprazol Tarbis15 mg capsules

The active ingredient is lansoprazol.

The other components are: Sugar spheres (saccharose and cornstarch), sodium carboxymethylstarch, sodium laurylsulfate, povidone, trisodium dodecyl phosphate dodecahydrate, hypromellose, copolymer of methacrylic acid and ethyl acrylate, triethyl citrate, titanium dioxide, talc.

The capsule components are: Gelatin, titanium dioxide (E-171)

Appearance of the product and content of the packaging

Lansoprazol Tarbis15 mg gastro-resistant capsules are white opaque cap and body capsules filled with beige micropellets. The capsules have been marked with black ink with the letter “L” on the cap and the number “15” on the body.

Packaging in HDPE bottles with 28 gastro-resistant capsules.

Packaging in aluminum/aluminum blisters of 28 gastro-resistant capsules.

Holder of the marketing authorization and responsible for manufacturing:

The holder of the marketing authorization is:

Tarbis Farma, S.L.

Gran Via Carlos III, 94

08028 Barcelona

The responsible for manufacturing is:

Teva Pharma, S.L.U.

Polígono Malpica c/C 4.

50016 Zaragoza.

This leaflet was approved in October 2008

Last review November 2022

The detailed and updated information of this medicine is available on the webpage of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.