Lansoprazole Tarbis 30 mg gastro-resistant hard capsules EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Lansoprazol Tarbis 30 mg gastro-resistant hard capsules EFG

Read the entire leaflet carefully before you start taking this medicine

• 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 and should not be given to other people, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

1. What Lansoprazol Tarbis 30 mg capsules are and what they are used for

2. Before you take Lansoprazol Tarbis 30 mg capsules

3. How to take Lansoprazol Tarbis 30 mg capsules

4. Possible side effects

5. How to store Lansoprazol Tarbis 30 mg capsules

6. Further information

1. What Lansoprazol Tarbis 30 mg capsules are and what they are used for

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

Your doctor may prescribe Lansoprazol Tarbis for the following indications:

• Treatment of duodenal and gastric ulcers
• Treatment of inflammation of the oesophagus (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 continuous 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 Tarbis for an indication or at a dose 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 Lansoprazol Tarbis 30 mg capsules

Do not take Lansoprazol Tarbis 30 mg capsules:

• If you are allergic (hypersensitive) to lansoprazole or to any of the other components of Lansoprazol Tarbis.
• If you are taking another medicine containing the active substance atazanavir (used in the treatment of HIV).

Take special care with Lansoprazol Tarbis 30 mg capsules

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

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

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

If your doctor has prescribed Lansoprazol Tarbis together with other medicines for the treatment of Helicobacter pylori infection (antibiotics) or together with anti-inflammatory medicines for pain or rheumatism, also read carefully the package leaflets of these medicines.

If you have been taking Lansoprazol Tarbis for a long time (more than 1 year), your doctor will likely monitor you regularly. During visits to your doctor, you must report any new or unusual symptoms or circumstances.

Warnings and precautions

Talk to your doctor before starting Lansoprazol Tarbis:

• If you have ever had a skin reaction after treatment with a medicine similar to Lansoprazol Tarbis 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 stop treatment with Lansoprazol Tarbis. Remember to mention any other symptoms you may notice, such as joint pain.

When taking lansoprazole, inflammation of the kidney may occur. Signs and symptoms may include decreased urine volume or blood in the urine and/or hypersensitivity reactions such as fever, skin rash, and joint stiffness. You should report these signs to your doctor.

Use of other medicines

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

In particular, inform your doctor if you are taking medicines containing any of the following active substances, as Lansoprazol Tarbis may affect their way 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 Lansoprazol Tarbis 30 mg capsules with food and drink

For optimal effectiveness, Lansoprazol Tarbis should be taken at least 30 minutes before meals.

Pregnancy and breastfeeding

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

Driving and using machines

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 capabilities may be reduced.

You are solely responsible for deciding whether you are fit to drive or perform activities requiring high concentration. Due to its side effects or adverse reactions, the use of this medicine may be one of the factors that reduces your ability to safely carry out these activities.

Descriptions of these effects are provided in the following sections.

Please read the information in this leaflet carefully.

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

Important information about some of the components of Lansoprazol Tarbis 30 mg capsules

Lansoprazol Tarbis 30 mg capsules contain sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Lansoprazol Tarbis 30 mg capsules

Swallow 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. 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 Tarbis once daily, try to take it at the same time each day. You may achieve better results if you take Lansoprazol Tarbis in the morning.

If you take Lansoprazol Tarbis twice daily, you should take the first dose in the morning and the second in the evening.

The dose of Lansoprazol Tarbis depends on your general condition. The usual doses of Lansoprazol Tarbis 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 within 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 oesophagitis): one 30 mg capsule daily for 4 weeks.

Long-term prevention of reflux oesophagitis: 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 taken in the morning together with two different antibiotics, and one 30 mg capsule taken in the evening together with two different antibiotics. Treatment is usually given daily for 7 days.

The recommended antibiotic combinations are as follows:

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

If you are receiving anti-infective treatment for an ulcer, it is unlikely that the ulcer will 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 continuous NSAID therapy: one 30 mg capsule daily for 4 weeks.

Prevention of duodenal or gastric ulcer in patients requiring continuous 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 Tarbis, your doctor will decide the most appropriate dose for you.

Lansoprazol Tarbis must not be administered to children.

Follow your doctor's instructions exactly. Consult your doctor if you have any doubts.

If you take more Lansoprazol Tarbis 30 mg capsules than you should

If you take more Lansoprazol Tarbis than prescribed, consult your doctor immediately or contact the Toxicology Information Service, Telephone 915 620 420.

If you forget to take Lansoprazol Tarbis 30 mg capsules

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 Tarbis 30 mg capsules

Do not stop treatment prematurely, even if symptoms have improved. Your condition may not be completely healed and symptoms may return if you do not complete the full course of treatment.

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

4. Possible adverse effects

Like all medicines, Lansoprazol Tarbis can cause adverse effects, although not everyone experiences them.

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

• fever
• restlessness, drowsiness, confusion, hallucinations, insomnia, visual disturbances, dizziness
• taste disturbances, 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 enlargement 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 pharynx, difficulty swallowing, hives, or breathing difficulties.

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

• severe hypersensitivity reactions, including anaphylactic shock. Symptoms of hypersensitivity 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
• severe skin reactions with redness, blisters, severe swelling, and skin loss
• in very rare cases, Lansoprazol Tarbis may cause a reduction in the number of white blood cells, which can 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/pharyngitis/mouth sores 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 effects have 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, magnesium levels in the blood may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, contact 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 Tarbis, 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 if you are taking corticosteroids (which may increase the risk of osteoporosis).

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

5. Storage of Lansoprazol Tarbis 30 mg capsules

Store below 30°C.

Keep the medicine out of the reach and sight of children.

Do not use Lansoprazol Tarbis after the expiry date stated on the packaging, following the expiration abbreviation. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lansoprazole Tarbis 30 mg capsules

The active substance is lansoprazole.

The other components are: Sugar spheres (sucrose and maize starch), sodium carboxymethyl starch from potato, sodium lauryl sulphate, povidone, trisodium phosphate dodecahydrate, hypromellose, methacrylic acid-ethyl acrylate copolymer, triethyl citrate, titanium dioxide, talc.

Components of the capsule shell: gelatin, titanium dioxide (E-171).

Appearance of the product and contents of the pack

Lansoprazole Tarbis 30 mg gastro-resistant capsules are capsules with an opaque white cap and body, filled with beige micropellets. The capsules are marked with black ink, with the letter “L” on the cap and the number “30” on the body.

Pack sizes: HDPE bottles containing 14 and 28 gastro-resistant capsules.

Aluminum/Aluminum blister packs containing 14 and 28 gastro-resistant capsules.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer:

The Marketing Authorization Holder is:

Tarbis Farma, S.L.

Gran Via Carlos III, 94

08028 Barcelona, Spain

The manufacturer is:

Teva Pharma, S.L.U.

Polígono Malpica c/C 4

50016 Zaragoza, Spain

This leaflet was approved in October 2008.

Latest revision: November 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/.