Lansoprazole Qualigen 30 mg gastro-resistant capsules EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Lansoprazol Qualigen 30 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 it could harm them.
• If you experience serious adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions 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 30 mg
3. How to take Lansoprazol Qualigen
4. Possible side effects
5. How to store Lansoprazol Qualigen
6. Contents of the pack and other information

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 have prescribed lansoprazole 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
  long-term treatment with non-steroidal anti-inflammatory drugs (NSAIDs) (NSAID treatment 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 to take Lansoprazole Qualigen

Do not take Lansoprazole Qualigen

• if you are allergic (hypersensitive) to lansoprazole 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 to take Lansoprazole 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 lansoprazole, contact your doctor immediately, as lansoprazole has been associated with a slight increase in infectious diarrhea.

• If your doctor has prescribed lansoprazole along 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 for a long time (more than 1 year), your doctor will likely monitor you regularly. During visits to your doctor, you should report any new or unusual symptoms or circumstances.

• If you are taking proton pump inhibitors such as Lansoprazole Qualigen, especially for more than one year, there may be a slight increase in the risk of fractures of the hip, wrist, and 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 lansoprazole used to reduce stomach acid.

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

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

• Kidney inflammation may occur during treatment with lansoprazole. Signs and symptoms may include decreased urine volume or 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.

Other medicines and Lansoprazole Qualigen

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, even those obtained without a prescription.

In particular, inform your doctor if you are taking medicines containing any of the following active substances, as lansoprazole 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 Qualigen with food and drinks

For optimal effectiveness of this medicine, you should take lansoprazole at least 30 minutes before meals.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before taking this medicine.

Driving and using machines

Lansoprazole Qualigen is unlikely to affect your ability to drive or operate 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 operate machinery.

This medicine 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 tablet; thus, it is essentially “sodium-free”.

3. How to take Lansoprazol Qualigen

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

If you take lansoprazole once a day, try to take it at the same time every 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 dose in the evening.

The dose of lansoprazole depends on your overall condition. The usual doses of lansoprazole 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 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 together with two different antibiotics in the morning and one 30 mg capsule together with two different antibiotics in the evening. Treatment is normally given daily for 7 days.

The recommended antibiotic combinations are as follows:

• 30 mg Lansoprazol Qualigen with 250–500 mg clarithromycin and 1,000 mg amoxicillin
• 30 mg Lansoprazol Qualigen 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 from your medicine, take it at the correct time and do not miss any doses.

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

Prevention of duodenal or gastric ulcer in patients requiring continuous treatment with NSAIDs: 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 determine the most appropriate dose for you.

Use in children

Lansoprazole must not be given to children.

If you take more Lansoprazol 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 number: 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take Lansoprazol Qualigen

If you forget to take a dose, take it as soon as possible unless the next dose is due soon.

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

If you stop taking Lansoprazol Qualigen

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

Frequent (occurs in more than 1 out of every 100 patients):

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

Uncommon (occurs in less than 1 out of every 100 patients):

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

Rare (occurs in less than 1 out of every 1,000 patients):

• fever
• restlessness, drowsiness, confusion, hallucinations, insomnia, visual disturbances, dizziness
• taste disturbance, loss of appetite, inflammation of the tongue (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 mucosa)
• angioedema; contact your doctor immediately if you experience symptoms of angioedema, such as swelling of the face, tongue or throat, difficulty swallowing, hives, or breathing difficulties.

Very rare (occurs in less than 1 out of every 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, serious 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 a severe deterioration in your general condition, or fever with signs 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 a 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, and increased heart rate. If you experience any of these symptoms, see your doctor 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 adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: 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 sight and reach of children.

Store below 30ºC.

Do not use lansoprazole after the expiry date stated on the packaging, which follows the abbreviation for the expiration 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 a SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly discard 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 30 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), copolymer of methacrylic acid and ethyl acrylate, triethyl citrate, titanium dioxide (E-171), talc (E-553b).

Components of the capsule shell: 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).

Nature of the product and pack contents

Lansoprazol Qualigen 30 mg is presented as white-beige, hard gastro-resistant capsules. Each pack contains 14 or 28 capsules.

Only certain pack sizes may be marketed.

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 for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.