Package Leaflet: Information for the User

Lansoprazol Teva 30 mg Buccal Tablets EFG

Read this 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. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

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

2.What you need to know before you start taking Lansoprazol Teva

3.How to take Lansoprazol Teva

4.Possible side effects

1. Storage of Lansoprazol Teva
2. Contents of the pack and additional information

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

Your doctor may prescribe lansoprazol for the following indications in adults:

• 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 bacteria Helicobacter 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 prescribed lansoprazol for another indication or at a different dose than indicated in this leaflet. Follow exactly the administration instructions for this medication as indicated by your doctor.

You should consult a doctor if you worsen or do not improve after 14 days.

Do not take Lansoprazol Teva:

• if you are allergic to lansoprazole or any of the other ingredients of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Lansoprazol Teva:

• if you have a severe liver disease. Your doctor may need to adjust the dose.
• if you have decreased vitamin B12 reserves or risk factors for it and receive long-term treatment with lansoprazole. Like all medications that reduce the amount of acid, lansoprazole may reduce vitamin B12 absorption.

-if you are scheduled to undergo a specific blood test (Cromogranin A).

• if you have ever had a skin reaction after treatment with a similar medication to Lansoprazol Teva for reducing stomach acid.

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

When taking lansoprazole, it may cause kidney inflammation. 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.

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

In case of experiencingdiarrheaduring treatment with Lansoprazol Teva, contact your doctorimmediately, as your medication has been associated with a slight increase in infectious diarrhea.

If your doctor has prescribed Lansoprazol Teva in addition to other medications for the treatment ofHelicobacter pyloriinfection (antibiotics) or with anti-inflammatory medications to treatpainorarthritis, read the prospectuses of these medications carefully.

The continued use of proton pump inhibitors like lansoprazole, especially for periods longer than one year, may increase the risk of hip, spine, and wrist fractures. Consult your doctor if you have osteoporosis (reduced bone density) or if your doctor has told you that you are at risk of developing osteoporosis (for example, if you are taking steroids).

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

If you take lansoprazole for more than three months, you may experience a decrease in magnesium levels in your blood. Symptoms of low magnesium levels may include fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or increased heart rate. If you experience any of these symptoms, inform your doctor immediately. Additionally, low magnesium levels may cause a decrease in potassium and calcium levels in the blood. Your doctor will decide to perform periodic blood tests to monitor magnesium levels.

Use of Lansoprazol Teva with other medications

Inform your doctor or pharmacist if you are taking/using, have taken/recently used, or may need to take/use another medication, including those purchased without a prescription.

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

• inhibitors of HIV protease such as atazanavir and nelfinavir (used in HIV treatment)
• methotrexate (used to treat autoimmune diseases and cancer)
• ketoconazole, itraconazole, rifampicin (used to treat infections)
• digoxin (used to treat heart problems)
• warfarin (used to treat blood clots)
• 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)

Pregnancy, breastfeeding, and fertility

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

Driving and operating machinery

Patients taking lansoprazole 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 fit 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 perform these operations safely is the use of medications.

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

Read this prospectus carefully.

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

Lansoprazol Teva contains lactose and sucrose

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

Lansoprazol Teva contains aspartame

Lansoprazol Teva contains 13 mg of aspartame in each tablet.

Aspartame is a source of phenylalanine. Aspartame contains a source of phenylalanine that may be harmful in the case of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

Lansoprazol Teva contains benzyl alcohol

Lansoprazol Teva contains 0.14 µg of benzyl alcohol in each tablet.

Benzyl alcohol may cause allergic reactions.

Consult your doctor or pharmacist if you are pregnant or breastfeeding, or if you have liver or kidney diseases. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

Lansoprazol Teva contains sulfur dioxide (E220)

This medication may cause severe allergic reactions and bronchospasm.

Lansoprazol Teva contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per buccal tablet; that is, it is essentially "sodium-free".

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

The tablets break easily, so handle them carefully. Do not handle the tablets with wet hands as the tablets can break.

Place the tablet on your tongue and suck it slowly. The tablet dissolves quickly in your mouth, releasing microgranules that should be swallowed without chewing.

The tablet can also be swallowed whole with a glass of water.

If you have significant difficulty swallowing, your doctor may instruct you to take the tablet with a syringe.

If administered with a syringe, follow these instructions:

• Remove the plunger from the syringe (at least a 10 ml syringe)
• Place the tablet in the reservoir
• Replace the plunger in the syringe

• Fill the syringe with 10 ml of water
• Invert the syringe and pull the plunger to allow 1 ml of air
• Agitate the syringe gently for 10-20 seconds until the tablet disperses
• The contents can be emptied directly into the mouth
• Replace the syringe with 2-5 ml of water to eliminate any remaining contents from the syringe and empty it into the mouth

If you take lansoprazole once a day, try to take it at the same time every day. You may get better results if you take lansoprazole in the morning.

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

To get the best results from your medication, take lansoprazole at least 30 minutes before meals.

The dose of lansoprazole depends on your general condition. The recommended doses of lansoprazole 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

15 mg (there are other medications with this dose) or 30 mg of lansoprazole per day for 4 weeks. If symptoms do not improve after 4 weeks, consult your doctor.

Treatment of duodenal ulcer

30 mg of lansoprazole per day for 2 weeks.

Treatment of gastric ulcer

30 mg of lansoprazole per day for 4 weeks.

Treatment of esophagitis (acid reflux esophagitis)

30 mg of lansoprazole per day for 4 weeks.

Long-term prevention of acid reflux esophagitis

15 mg of lansoprazole per day (there are other medications with this dose); your doctor may adjust the dose to 30 mg of lansoprazole per day.

Treatment of Helicobacter pylori infection

The recommended dose is 30 mg of lansoprazole with two different antibiotics in the morning and 30 mg of lansoprazole with two different antibiotics at night. Treatment is usually every day for 7 days.

The recommended antibiotic combinations are as follows:

• 30 mg of lansoprazole with 250-500 mg of clarithromycin and 1,000 mg of amoxicillin
• 30 mg of lansoprazole 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

30 mg of lansoprazole per day for 4 weeks.

Prevention of duodenal or gastric ulcer in patients requiring continuous treatment with NSAIDs

15 mg of lansoprazole per day (there are other medications with this dose); your doctor may adjust the dose to 30 mg of lansoprazole per day.

Zollinger-Ellison syndrome

The recommended starting dose is 60 mg of lansoprazole per day; subsequently, based on your response to lansoprazole treatment, your doctor will decide on the best dose for you.

Use in children

Lansoprazole should not be administered to children.

If you take more Lansoprazole Teva than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the package insert and the medication packaging to the healthcare professional.

If you forget to take Lansoprazole Teva

If you forget to take a dose, take it as soon as you remember, unless the time for the next dose is near. In this case, skip the missed dose and take the buccal tablets as usual. Do not take a double dose to compensate for the missed dose.

If you interrupt treatment with Lansoprazole Teva

Do not interrupt 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, this medicine can cause side effects, although not everyone will experience them.

If you experience any of the following side effects, stop taking Lansoprazol Teva and inform your doctor immediately, or contact the nearest hospital emergency service:

• angioedema: symptoms may include facial, tongue, or pharyngeal inflammation, difficulty swallowing, urticaria, and difficulty breathing (rare side effects: may affect up to 1 in 1,000 people).
• severe hypersensitivity reactions, including anaphylactic shock: symptoms may include fever, rash, swelling, and, in some cases, decreased blood pressure (very rare side effects: may affect up to 1 in 10,000 people).
• very severe skin reactionswith redness, vesicles, severe inflammation, and skin loss: Erythema multiforme (rare side effects: may affect up to 1 in 1,000 people),Sjögren's syndrome, toxic epidermal necrolysis (very rare side effects: may affect up to 1 in 10,000 people).

liver inflammation:yellowing of the skin and the white of the eyes(rare side effects: may affect up to 1 in 1,000 people).

Frequent side effects(may affect up to 1 in 10 people):

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

Uncommon side effects(may affect up to 1 in 100 people):

• depression
• joint or muscle pain
• fluid retention or swelling
• changes in blood cell counts
• fracture of the hip, wrist, or spine (see section 2 “Warnings and precautions”)

Rare side effects(may affect up to 1 in 1,000 people)

• fever
• restlessness, drowsiness, confusion, hallucinations, difficulty sleeping (insomnia), visual disturbances, vertigo
• alteration of taste, loss of appetite, inflammation of the tongue (glossitis)
• skin reactions such as burning or itching, hematomas, redness, and sweatingexcessive
• sensitivity to light
• hair loss
• tingling sensation (paresthesia), tremors
• anemia (pale skin)
• renal problems
• pancreatitis
• swelling of the chest in men, impotence
• candidiasis (fungal infection, may affect the skin or mucous membranes)

Very rare side effects(may affect up to 1 in 10,000 people):

• inflammation of the mouth (stomatitis)
• inflammation of the intestine (colitis)
• changes in analytical values, such as sodium, cholesterol, and triglyceride levels
• very rarely may cause a reduction in the number of white blood cells, which may decrease 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).
• Abnormal coexisting reduction in the number of red blood cells and white blood cells, as well as platelets (pancytopenia).

Unknown frequency(cannot be estimated based on available data):

• low levels of magnesium in the blood (hypomagnesemia) (See section 2 “Warnings and precautions.”) Reduction of magnesium levels may produce a reduction of potassium and calcium in the blood (hypocalcemia, hypokalemia)
• low levels of sodium in the blood. Common symptoms include nausea and vomiting, headache, drowsiness, and fatigue, confusion, muscle weakness or spasms, irritability, convulsions, coma.
• skin rash, probably with joint pain.
• visual hallucinations

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use website:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not store at a temperature above 25°C. Store in the original packaging to protect it from moisture.

Do not use this medication after the expiration date shown on the blister pack and the container after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash.Deposit the containers and medicines you no longer need at the SIGRE collection pointat the pharmacy. If in doubtask your pharmacist how to dispose of the containers and medicines you no longer need.By doing so, you will help protect the environment.

Lansoprazol Teva 30 mg Bucodispersable Tablets Composition

• The active ingredient is lansoprazol. Each bucodispersable tablet contains 30 mg of lansoprazol.

• The other components are:sugar spheres (sacarosa and cornstarch), hypromellose, talc, magnesium carbonate, copolymer of methacrylic acid and ethyl acrylate (1:1), triethyl citrate, titanium dioxide (E171), colloidal anhydrous silica, lactose monohydrate, cornstarch, aspartame (E951), strawberry flavor (maltodextrin, arabic gum, triethyl citrate, lactose, sulfur dioxide (E220), benzyl alcohol, and flavorings), and magnesium stearate.

Product Appearance and Packaging Content

Round, flat, bisected, white to off-white tablets with “30” engraved on one face and smooth on the other face. Each bucodispersable tablet contains white to grayish granules.

Lansoprazol Teva 30 mg is available in aluminum-aluminum blister packs of 1, 2, 7, 14, 28, 30 (3x10), 50, 56, 98, and 100 bucodispersable tablets..

Only some packaging sizes may be commercially available.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1st floor

28108 Alcobendas, Madrid, Spain

Responsible Manufacturer

Pharmachemie B.V.

Swensweg 5, Postbus 552,

2003 RN Haarlem

Netherlands

Teva Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen

Hungary

Teva Czech Industries, s.r.o.

Ostravská 29, c.p. 305, 747 70 Opava -Komárov

Czech Republic

Balkan Pharma -Dupnitsa AD

3-Samokovsko Shosse Street,

Dupnitsa 2600, Bulgaria

Merckle GmbH,

Graf-Arco-Strasse 3,

89079 Ulm,

Germany

This medicine is authorized in the member states of the European Economic Area with the following names:

Last reviewed date of this leaflet:August 2023

For detailed information about this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http:/www.aemps..gob.es/