Lansoprazole Normon 15 mg gastro-resistant capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Lansoprazol Normon 15 mg gastro-resistant capsules EFG

Lansoprazole

Read the entire 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you; do not give it 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 effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Lansoprazol Normon is and what it is 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 Lansoprazol Normon for the following indications:

• Treatment of duodenal and gastric ulcers.
• Treatment of inflammation of the oesophagus (reflux oesophagitis).
• Prevention of reflux oesophagitis.
• 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 Normon 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 Lansoprazole Normon

Do not take Lansoprazole Normon

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

If you are taking another medicine containing atazanavir (used in the treatment of HIV).

Warnings and precautions

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

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

When taking Lansoprazole Normon, 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.

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

If you experience diarrhea during treatment with Lansoprazole Normon, contact your doctor immediately, as Lansoprazole Normon has been associated with a slight increased risk of infectious diarrhea.

If your doctor has prescribed Lansoprazole Normon together with other medicines for the treatment of Helicobacter pylori infection (antibiotics) or together with anti-inflammatory drugs for pain or rheumatism, please 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 likely carry out regular check-ups. During your visits, you must inform your doctor of any new or unusual symptoms or 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 used to reduce stomach acid.

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

Other medicines and Lansoprazole Normon

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

In particular, inform your doctor if you are taking medicines containing any of the following active substances, as Lansoprazole Normon may affect their 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 drink

For best results, Lansoprazole Normon should be taken at least 30 minutes before meals.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using 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 exercise caution, as your reaction capacity may be reduced.

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

Descriptions of these effects can be found in the following sections.

Please read this leaflet carefully.

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

Lansoprazole Normon 15 mg contains sucrose and sodium

This medicine contains sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per capsule; therefore, it is essentially “sodium-free”.

3. How to take Lansoprazol Normon

Follow exactly the instructions for taking Lansoprazol Normon as given by your doctor or pharmacist. If in 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 alternative ways to take the medicine. Do not crush or chew the capsules or the contents of an emptied capsule, as this will prevent them from working properly.

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

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

The dose of Lansoprazol Normon depends on your general condition. The usual doses of Lansoprazol Normon for adults are given 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 esophagus (reflux esophagitis): one 30 mg capsule daily for 4 weeks.

Long-term prevention of reflux esophagitis: 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. The usual treatment duration is once daily for 7 days.

The recommended antibiotic combinations are as follows:

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

If you are receiving anti-infective treatment for an ulcer, the ulcer is unlikely to recur if the infection is successfully treated. To achieve the best results with your medicine, take it at the correct time and do not miss any doses.

Treatment of duodenal or gastric ulcer in patients requiring ongoing NSAID treatment: one 30 mg capsule daily for 4 weeks.

Prevention of duodenal or gastric ulcer in patients requiring ongoing NSAID treatment: 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 Normon, your doctor will decide the best dose for you.

Use in children

Lansoprazol Normon must not be given to children.

If you take more Lansoprazol Normon than you should

If you take more Lansoprazol Normon than prescribed, contact your doctor immediately or call the Toxicology 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 possible unless it is almost time for your next dose. In that case, skip the missed dose and take the next capsules at your usual time. Do not take a double dose to make up for a missed dose.

If you stop taking Lansoprazol Normon

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

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

4. Possible adverse effects

Like all medicines, Lansoprazol Normon may cause adverse effects, although not everyone experiences them.

The following adverse 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 mouth or throat
• benign gastric polyps
• skin rash, itching
• changes in liver function test values
• fatigue.

The following adverse effects are uncommon (occur in less than 1 in 100 people):

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

If you are taking proton pump inhibitors such as Lansoprazol Normon, especially for a period longer than one year, the risk of hip, wrist, and spine fractures may be slightly increased. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).

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

• fever
• restlessness, drowsiness, confusion, hallucinations, insomnia, visual disturbances, dizziness
• altered taste, loss of appetite, inflammation of the tongue (glossitis)
• skin reactions such as burning or itchy sensation under the skin, bruising, redness, and excessive sweating
• sensitivity to light
• hair loss
• tingling sensation (paresthesia), tremor
• anemia (pallor)
• kidney problems
• pancreatitis
• liver inflammation (may present as yellowing of the skin or eyes)
• breast swelling in males, impotence
• candidiasis (fungal infection, may affect skin or mucosa)
• angioedema; contact your doctor immediately if you experience symptoms of angioedema, such as swelling of the face, tongue or pharynx, difficulty swallowing, urticaria, or breathing difficulties.

The following adverse 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 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
• very severe skin reactions with redness, blisters, serious swelling, and skin loss
• in very rare cases, Lansoprazol Normon 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 a significant deterioration in your general condition, or fever with signs of localized 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).

The following adverse effects have unknown frequency (cannot be estimated from available data):

• if you are taking Lansoprazol Normon 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, seek medical advice 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 magnesium levels.

• skin rash, possibly with joint pain.

• Visual hallucinations

Reporting of adverse effects

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

5. Storage of Lansoprazole Normon

Keep out of 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 refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their packaging. 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 (composed of corn starch, sucrose and purified water), sodium lauryl sulfate, N-methylglucamine, mannitol, hypromellose, macrogol 6000, talc, polysorbate 80, titanium dioxide (E171), 30% dispersion of methacrylic acid copolymer and ethyl acrylate (1:1). The capsule shell components are: quinoline yellow (E104), titanium dioxide (E171), water and gelatin.

Appearance of the medicine and contents of the pack

Lansoprazole Normon 15 mg is presented as yellow, opaque, hard gastro-resistant capsules containing enteric-coated lansoprazole microgranules. Each pack contains 28 or 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 most recent review of this leaflet: December 2022

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You may also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/66428/P_66428.html