Package Insert: Information for the User

Lansoprazol Normon 15 mg gastro-resistant capsules EFG

Lansoprazol

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

• Keep this package insert, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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

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

3. How to take Lansoprazol Normon

4. Possible adverse effects

5. Storage of Lansoprazol Normon

6. Contents of the package and additional information

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

Your doctor may prescribe Lansoprazol Normon for the following indications:

• Treatment of duodenal and gastric ulcers.
• Treatment of esophagitis caused by acid reflux.
• Prevention of esophagitis caused by acid reflux.
• 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) (NSAIDs are used for pain or inflammation).
• Treatment of Zollinger-Ellison syndrome.

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

Do not take Lansoprazol Normon

If you are allergic (hypersensitive) 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 Normon:

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

When taking Lansoprazol Normon, an inflammation in the kidney may occur. 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. Inform your doctor of these signs.

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

In case of experiencing diarrhea during treatment with Lansoprazol Normon, contact your doctor immediately, as Lansoprazol Normon has been associated with a slight increase in infectious diarrhea.

If your doctor has prescribed Lansoprazol Normon 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 also carefully the leaflets of these medications.

If you have been taking Lansoprazol Normon 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 and circumstances.

- If a specific blood test (Cromogranina A) is planned.

-If you have ever had a skin reaction after treatment with a similar medication to Lansoprazol Normon: to reduce stomach acidity.

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

Other medications and Lansoprazol Normon

Inform your doctor or pharmacist if 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 Normon 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 (Hypericurn perforatum) (used to treat mild depression).

Taking Lansoprazol Normon with food and drinks

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

Pregnancy and breastfeeding

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

Driving and operating machines

Patients taking Lansoprazol Normon 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.

Lansoprazol Normon 15 mg contains saccharose and sodium

This medication contains saccharose. If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

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

Follow exactly the administration instructions for Lansoprazol Normon indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Swallow 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 ineffective.

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

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

The dose of Lansoprazol Normon depends on your general condition. The normal doses of Lansoprazol Normon 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 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. The normal treatment is once a day for 7 days.

The recommended antibiotic combinations are as follows:

- 30 mg of Lansoprazol Normon with 250-500 mg of clarithromycin and 1,000 mg of amoxicillin

- 30 mg of Lansoprazol Normon 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 and do 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 initial normal 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 Normon.

Use in children:

Lansoprazol Normon should not be administered to children.

If you take more Lansoprazol Normon than you should:

If you take more Lansoprazol Normon than indicated, consult your doctor immediately or contact the Toxicological Information Service, Telephone 915 620 420.

If you forget to take Lansoprazol Normon:

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 capsules as usual. Do not take a double dose to make up for the missed dose.

If you interrupt treatment with Lansoprazol Normon:

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 doubts about the use of this medication, ask your doctor or pharmacist.

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

The following side effects are frequent (occur in more than 1 in 100 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.

The following side effects are infrequent (occur in less than 1 in 100 people):

• depression
• joint or muscle pain
• fluid retention or swelling
• changes in blood cell count.

If you are taking proton pump inhibitors such as Lansoprazol Normon, 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 (may increase the risk of osteoporosis)

The following side effects are rare (occur in less than 1 in 1,000 people):

• 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, hematomas, redness, and excessive sweating
• light sensitivity
• hair loss
• tingling sensation (paresthesia), tremor
• anemia (pale skin)
• renal problems
• pancreatitis
• inflammation of the liver (may manifest as yellow 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, 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 people):

• 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 Normon 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 throat, pharynx, or mouth pain or urinary problems, consult your doctor immediately. A blood test will be performed to check for possible leukopenia (agranulocytosis).

The following side effects occur with an unknown frequency (cannot be estimated with the available data):

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

skin rash, possibly 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 not listed in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for human use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine..

Keep out of the sight and reach of children.

Do not store at a temperature above 30 °C.

Do not use Lansoprazol Normon after the expiration date that appears on the packaging 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. Dispose of the packaging and medicines you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Lansoprazol Normon 15 mg

The active ingredient is lansoprazol. Each capsule contains 15 mg of lansoprazol.

The other components are: sugar spheres (constituted by cornstarch, sucrose, and purified water), sodium lauryl sulfate, N-methylglucamine, mannitol, hypromellose, macrogol 6000, talc, poloxamer 80, titanium dioxide (E171), dispersion at 30% of methacrylic acid copolymer and ethyl acrylate (1:1). The capsule components are: quinoline yellow (E104), titanium dioxide (E171), water, and gelatin.

Appearance of the product and content of the packaging

Lansoprazol Normon 15 mg is presented in the form of hard, gastro-resistant yellow opaque capsules containing microgranules of lansoprazol with enteric coating. Each package contains 28 and 56 capsules.

Holder of the marketing authorization and responsible for manufacturing

The holder of the marketing authorization is:

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

The responsible for manufacturing is:

Liconsa, S.A.

Avda. Miralcampo, Nº 7, Industrial Estate Miralcampo

19200 Azuqueca de Henares (Guadalajara), SPAIN

Other presentations

Lansoprazol Normon 30 mg gastro-resistant capsules EFG

Last review date of this leaflet:December 2022