Lansoprazole Qualigen 15 mg gastro-resistant capsules EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Lansoprazol Qualigen 15 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 only and must not be given to other people, even if they have the same symptoms as you, as it may harm them.

• If you experience serious side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

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

Your doctor may prescribe lansoprazole 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 lansoprazole 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 Lansoprazol Qualigen

Do not take Lansoprazol Qualigen

• if you are allergic (hypersensitive) to lansoprazol or to any of the other ingredients of this medicine (listed in section 6).
• if you are taking another medicine containing the active substance atazanavir (used in the treatment of HIV).

Warnings and precautions

Talk to your doctor or pharmacist before starting Lansoprazol Qualigen:

• If you have severe liver disease. Your doctor may need to adjust your dose.

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

• If you experience diarrhea during treatment with lansoprazol, contact your doctor immediately, as lansoprazol has been associated with a slight increase in infectious diarrhea.

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

• If you have been taking lansoprazol 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.

• If you are taking proton pump inhibitors such as Lansoprazol Qualigen, especially for more than one year, there may be a slight increase in the risk of fractures 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).

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

• Kidney inflammation may occur while taking lansoprazol. Signs and symptoms may include reduced urine volume or blood in the urine and/or hypersensitivity reactions such as fever, rash, and joint stiffness. You should report these signs to your doctor.

Other medicines and Lansoprazol Qualigen

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 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 Lansoprazol Qualigen with food and drink

For best results, take lansoprazol at least 30 minutes before meals.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before taking this medicine.

Driving and using machines

Lansoprazol Qualigen is unlikely to affect your ability to drive or use tools or machinery. However, adverse effects such as dizziness and visual disturbances may occur (see section 4). If these occur, you should not drive or use machines.

This medicine contains sucrose and sodium

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

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

3. How to take Lansoprazole Qualigen

Follow exactly the administration instructions for this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor 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. You must not crush or chew the capsules or the contents of an emptied capsule, as this will prevent them from working properly.

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

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

The dose of lansoprazole depends on your general condition. The usual doses of lansoprazole for adults are given below. Occasionally, your doctor may prescribe you 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 Lansoprazole Qualigen with 250–500 mg clarithromycin and 1,000 mg amoxicillin
• 30 mg Lansoprazole Qualigen 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 ongoing NSAID therapy: one 30 mg capsule daily for 4 weeks.

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

Use in children

Lansoprazole must not be given to children.

If you take more Lansoprazole Qualigen than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take Lansoprazole Qualigen

If you forget to take a dose, take it as soon as possible unless the time for your next dose is approaching.

In that case, skip the missed dose and take the next capsules as usual. Do not take a double dose to make up for a missed dose.

If you stop taking Lansoprazole Qualigen

Do not stop treatment prematurely because symptoms have improved. Your condition may not have been completely cured and may recur 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, this medicine can cause adverse effects, although not everyone experiences them.

Frequent (occur in more than 1 in 100 patients):

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

Uncommon (occur in less than 1 in 100 patients):

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

Rare (occur in less than 1 in 1,000 patients):

• fever
• restlessness, drowsiness, confusion, hallucinations, insomnia, visual disturbances, dizziness
• taste disturbances, loss of appetite, tongue inflammation (glossitis)
• skin reactions such as burning or itching sensation under the skin, bruising, redness and excessive sweating
• light sensitivity
• hair loss
• tingling sensation (paraesthesia), tremor
• anaemia (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 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.

Very rare (occur in less than 1 in 10,000 patients):

• severe hypersensitivity reactions, including anaphylactic shock. Symptoms of hypersensitivity reactions may include fever, rash, swelling, and sometimes a drop in 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, severe swelling and skin loss
• in very rare cases, lansoprazole 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 local infection symptoms 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).

Frequency not known (cannot be estimated from available data):

• Skin rash, possibly with joint pain.
• Visual hallucinations
• If you are taking lansoprazole for more than three months, your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, 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 your magnesium levels.

Reporting of adverse effects:

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Lansoprazol Qualigen

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

Store below 30ºC.

Do not use lansoprazole after the expiry date stated on the packaging, after the abbreviation for the expiry date. 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 empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lansoprazol Qualigen 15 mg

The active substance is lansoprazole.

The other components are: sugar spheres (sucrose and maize starch), sodium carboxymethyl starch from potato, sodium lauryl sulfate, povidone (E-1201), trisodium phosphate, hypromellose (E-464), methacrylic acid and ethyl acrylate copolymer, triethyl citrate, titanium dioxide (E-171), talc (E-553b).

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

Components of the printing ink: shellac (E-904), anhydrous ethanol, isopropyl alcohol, propylene glycol (E-1520), n-butyl alcohol, ammonium hydroxide, potassium hydroxide, and black iron oxide (E-172).

Appearance of the product and contents of the pack

Lansoprazol Qualigen 15 mg is presented as white-beige, hard gastro-resistant capsules. Each pack contains 28 capsules.

Marketing Authorization Holder and Manufacturer

The Marketing Authorization Holder is:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

The manufacturer is:

Teva Pharma, S.L.U.

Polígono Malpica c/C 4.

50016 (Zaragoza)

Spain

Date of the most recent review of this leaflet: 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/.