LANSOPRAZOL NORMON 15 mg GASTRO-RESISTANT CAPSULES

Introduction

Package Leaflet: Information for the User

Lansoprazole Normon 15 mg Gastro-Resistant Capsules EFG

Lansoprazole

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Lansoprazole Normon and what is it used for
2. What you need to know before you take Lansoprazole Normon
3. How to take Lansoprazole Normon
4. Possible side effects
5. Storing Lansoprazole Normon
6. Contents of the pack and other information

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

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

Your doctor may prescribe you Lansoprazole Normon for the following indications:

• Treatment of duodenal and gastric ulcers.
• Treatment of inflammation of the esophagus (reflux esophagitis).
• Prevention of reflux esophagitis.
• Treatment of heartburn 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 who require continuous treatment with non-steroidal anti-inflammatory drugs (NSAIDs) (NSAID treatment is used for pain or inflammation).
• Treatment of Zollinger-Ellison syndrome.

It is possible that your doctor has prescribed you Lansoprazole Normon for another indication or at a different dose than indicated in this leaflet. Follow your doctor's instructions regarding the administration of the medicine.

2. What you need to know before you take Lansoprazole Normon

Do not take Lansoprazole Normon

If you are allergic (hypersensitive) to lansoprazole or any of the other components of this medicine (listed in section 6).

If you are taking another medicine whose active substance is atazanavir (used to treat HIV).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Lansoprazole Normon:

Tell your doctor if you have a severe liver disease. It is possible that the doctor may need to adjust the dose.

When taking Lansoprazole Normon, kidney inflammation 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, rash, and joint stiffness. You should report these signs to your doctor.

Your doctor may have performed or may perform a complementary test called endoscopy to diagnose your disease and/or rule out cancer.

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

If your doctor has prescribed you Lansoprazole Normon in addition to other medicines intended for the treatment of Helicobacter pyloriinfection (antibiotics) or together with anti-inflammatory drugs to treat pain or rheumatism, also read the package leaflets of these medicines carefully.

If you have been taking Lansoprazole Normon for a long time (more than 1 year), your doctor will probably have you checked regularly. During your visits to the doctor, you should report any new or abnormal symptoms and circumstances.

• If you are scheduled to have a specific blood test (Chromogranin A).

If you have ever had a skin reaction after treatment with a medicine similar to Lansoprazole Normon: to reduce stomach acidity.

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

Other medicines and Lansoprazole Normon

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

In particular, tell your doctor if you are using medicines that contain any of the following active substances, as Lansoprazole Normon 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 heartburn or acid regurgitation)
• sucralfate (used to heal ulcers)
• St. John's Wort (Hypericum perforatum) (used to treat mild depression).

Taking Lansoprazole Normon with food and drinks

To get the best results from your medicine, you should take Lansoprazole Normon at least 30 minutes before meals.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Patients taking Lansoprazole Normon may occasionally experience side effects, such as dizziness, vertigo, fatigue, and visual disturbances. If you experience any of these side effects, you should act with caution as your reaction ability may be reduced.

You are the only one responsible for deciding whether you are in a fit state 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 can reduce your ability to perform these operations safely is the use of medicines.

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

Read this leaflet carefully.

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

Lansoprazole Normon 15 mg contains sugar and sodium

This medicine contains sugar. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

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

3. How to take Lansoprazole Normon

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

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

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

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

The dose of Lansoprazole Normon depends on your general condition. The normal doses of Lansoprazole Normon for adults are indicated below. Sometimes, your doctor may prescribe you a different dose and indicate a different duration of treatment.

Treatment of heartburn and acid regurgitation:one 15 mg or 30 mg capsule 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 30 mg capsule per day for 2 weeks.

Treatment of gastric ulcer:one 30 mg capsule per day for 4 weeks.

Treatment of esophageal inflammation (reflux esophagitis):one 30 mg capsule per day for 4 weeks.

Long-term prevention of reflux esophagitis:one 15 mg capsule per day; your doctor may adjust the dose to one 30 mg capsule per day.

Treatment of Helicobacter pyloriinfection:The normal dose is one 30 mg capsule together with two different antibiotics in the morning and one 30 mg capsule together 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 Lansoprazole Normon with 250-500 mg of clarithromycin and 1000 mg of amoxicillin
• 30 mg of Lansoprazole 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 medicine, take it at the right time and do not miss any dose.

Treatment of duodenal or gastric ulcers in patients who require continuous treatment with NSAIDs:one 30 mg capsule per day for 4 weeks.

Prevention of duodenal or gastric ulcers in patients who require continuous treatment with NSAIDs:one 15 mg capsule per day; your doctor may adjust the dose to one 30 mg capsule per day.

Zollinger-Ellison syndrome:The initial normal dose is two 30 mg capsules per day; subsequently, based on your response to treatment with Lansoprazole Normon, the doctor will decide the best dose for you.

Use in children

Lansoprazole Normon should not be administered to children.

If you take more Lansoprazole Normon than you should

If you take more Lansoprazole Normon than you have been prescribed, consult your doctor immediately or contact the Toxicology Information Service, Telephone 915 620 420.

If you forget to take Lansoprazole Normon

If you forget to take a dose, take it as soon as possible unless the time for the next dose is near. 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 taking Lansoprazole Normon

Do not stop treatment prematurely because the symptoms have improved. It is possible that your condition has not been completely cured and may recur if you do not finish the entire treatment.

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

4. Possible side effects

Like all medicines, Lansoprazole Normon can cause side effects, although not everybody gets them.

The following side effects are common (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 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 people):

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

If you are taking proton pump inhibitors like Lansoprazole Normon, especially for a period of more than one year, you may have a slightly increased risk of fracture of the hip, wrist, or spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which 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
• altered taste, loss of appetite, inflammation of the tongue (glossitis)
• skin reactions such as a burning sensation or itching under the skin, bruising, redness, and excessive sweating
• sensitivity to light
• hair loss
• tingling sensation (paresthesia), tremors
• anemia (pallor)
• kidney problems
• pancreatitis
• inflammation of the liver (which can manifest as yellowing of the skin or eyes)
• breast swelling in males, impotence
• candidiasis (fungal infection, can 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, 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. The symptoms of a hypersensitivity reaction 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, blisters, severe inflammation, and skin loss.

In very rare cases, Lansoprazole Normon may cause a reduction in the number of white blood cells, which can lead to a decrease in 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. You will have a blood test to check for a possible reduction in white blood cells (agranulocytosis).

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

skin rash, possibly with joint pain.

• Visual hallucinations

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Lansoprazole Normon

Keep out of the sight and reach of children.

Do not store above 30°C.

Do not use Lansoprazole Normon after the expiry date stated on the packaging after "EXP". The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and medicines you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lansoprazole Normon 15 mg

The active substance is lansoprazole. Each capsule contains 15 mg of lansoprazole.

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

Appearance of the product and packaging contents

Lansoprazole Normon 15 mg is presented in the form of hard gastro-resistant capsules of opaque yellow color that contain lansoprazole microgranules with enteric coating. Each pack contains 28 and 56 capsules.

Marketing authorization holder and manufacturer

The marketing authorization holder is:

LABORATORIOS NORMON, S.A.

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

The manufacturer is:

LICONSA, S.A.

Avda. Miralcampo, Nº 7, Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara), SPAIN

Other presentations

Lansoprazole Normon 30 mg gastro-resistant capsules EFG

Date of the last revision of this leaflet:December 2022