PATIENT INFORMATION LEAFLET

Lansoprazol Tarbis 30 mg Hard Gastroresistant Capsules EFG

1. Before taking Lansoprazol Tarbis 30 mg Capsules
2. How to take Lansoprazol Tarbis 30 mg Capsules
3. Possible side effects
4. Storage of Lansoprazol Tarbis 30 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 regarding the use of the medication.

Do not takeLansoprazol Tarbis30 mg capsules:

• If you are allergic (hypersensitive) to lansoprazol or to any of the other components ofLansoprazol Tarbis.
• If you are taking another medicine whose active ingredient is atazanavir (used in the treatment of HIV).

Be especially careful withLansoprazol Tarbis 30 mg capsules

Inform your doctor if you have a serious 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 rule out cancer.

In case you experience diarrhea during treatment withLansoprazol Tarbis, contact your doctor immediately, asLansoprazol Tarbishas been associated with a slight increase in infectious diarrhea.

If your doctor has prescribedLansoprazol Tarbisin addition to other medicines for the treatment of Helicobacter pylori infection (antibiotics) or together with anti-inflammatory drugs to treat pain or rheumatism, read the leaflets of these medicines carefully.

If you have been takingLansoprazol Tarbisfor a long time (over 1 year), your doctor will probably perform regular checks. At your doctor's visits, you must inform them of any new or abnormal symptoms and circumstances.

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 medicine to Lansoprazol Tarbis for reducing stomach acid.
• If you are scheduled to have a specific blood test (Cromogranina 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. Symptoms and signs 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.

Use of other medicines

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

Especially, inform your doctor if you are using medicines containing any of the following active ingredients, asLansoprazol Tarbismay 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 heartburn or acid regurgitation)
• sucralfato (used to heal ulcers)
• St. John's Wort (Hypericum perforatum) (used to treat mild depression)

TakingLansoprazol Tarbis30 mg capsules with food and drinks

To get the best results from your medicine, you must takeLansoprazol Tarbisat 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 medicine.

Driving and operating machinery

Patients takingLansoprazol Tarbismay 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 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 medicines.

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 ofLansoprazol Tarbis 30 mg capsules

Lansoprazol Tarbis30 mg capsules contain sacarose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medicine.

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 usual doses ofLansoprazol Tarbisfor adults are listed 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 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 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. 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 usual initial 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 your doctor's administration instructions exactly. Consult your doctor if you have any doubts.

If you take moreLansoprazol Tarbis30mg 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 Tarbis30mg 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 next capsules as usual. Do not take a double dose to make up for the missed dose.

If you stop takingLansoprazol Tarbis30mg 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.t

Like all medicines, Lansoprazol Tarbis 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, benign polyps in the stomach
• skin rash, itching
• changes in liver function test values
• fatigue

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 sensation under the skin, hematomas, redness and excessive sweating
• light sensitivity
• hair loss
• tingling sensation (paresthesia), tremor
• anemia (pale skin)
• renal problems
• pancreatitis
• inflammation of the liver (may be manifested by yellowish skin or eyes)
• chest 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 facial swelling, tongue or throat inflammation, 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 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 of 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 any of the side effects you are experiencing to be 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 into the drains or 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 Tarbis 30 mg capsules

The active ingredient is lansoprazol.

The other components are: Sugar spheres (saccharose and cornstarch), sodium carboxymethylstarch from potato, sodium laurylsulfate, povidone, trisodium dodecahydrogenephosphate, hypromellose, copolymer of methacrylic acid and ethyl acrylate, triethylcitrate, titanium dioxide, talc.

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

Appearance of the product and contents of the packaging

Lansoprazol Tarbis 30 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 “30” on the body.

Packaging in HDPE bottles with 14 and 28 gastro-resistant capsules.

Packaging in aluminum/aluminum blisters of 14 and 28 gastro-resistant capsules.

Only some packaging sizes may be commercially available.

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 manufacturer is responsible for:

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