LANSOPRAZOL QUALIGEN 30 mg GASTRO-RESISTANT CAPSULES

Introduction

PATIENT INFORMATION LEAFLET

Lansoprazole Qualigen 30 mg hard gastro-resistant capsules EFG

Read all of this leaflet carefully before you start taking this medicine.

• 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, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

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

• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack and other information:

1. What is Lansoprazole Qualigen and what is it used for
2. What you need to know before you take Lansoprazole Qualigen 30 mg
3. How to take Lansoprazole Qualigen
4. Possible side effects
5. Storing Lansoprazole Qualigen
6. Contents of the pack and other information

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

The active substance of Lansoprazole 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 oesophagitis)
• Prevention of reflux oesophagitis
• 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

ongoing 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 another indication or at a different dose than stated in this leaflet. Follow your doctor's instructions for taking the medicine.

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

Do not take Lansoprazole Qualigen

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

Warnings and precautionsConsult your doctor or pharmacist before taking Lansoprazole Qualigen:

• If you have severe liver disease. Your doctor may need to adjust the 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 diarrhoea during treatment with lansoprazole, contact your doctor immediately, as lansoprazole has been associated with a slight increase in infectious diarrhoea.

• If your doctor has prescribed lansoprazole in addition to other medicines for the treatment of Helicobacter pyloriinfection (antibiotics) or together with anti-inflammatory medicines to treat pain or rheumatism, also read the patient information leaflets for these medicines carefully.

• If you have been taking lansoprazole for a long time (more than 1 year), your doctor will probably monitor you regularly. During your visits to the doctor, you should report any new or unusual symptoms or circumstances.

• If you are taking proton pump inhibitors like Lansoprazole Qualigen, especially for a period of more than one year, you may have a slightly increased risk of fractures of the hip, wrist, and spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

• If you have ever had a skin reaction after treatment with a medicine similar to lansoprazole to reduce stomach acid.

• A specific blood test (Chromogranin A) is planned

• If you get a skin rash, especially in areas of the skin exposed to the sun, contact your doctor as soon as possible, as it may be necessary to interrupt treatment with lansoprazole. Also, mention any other symptoms you may notice, such as joint pain.

• When taking lansoprazole, kidney inflammation may occur. The signs and symptoms may include decreased urine output 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.

Other medicines and Lansoprazole Qualigen

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

In particular, tell your doctor if you are using medicines that contain 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

To get the best results from your 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 use tools or machines. However, side effects such as dizziness and visual disturbances (see section 4) may occur. If this happens, do 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 some sugars, consult 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 Qualigen

Follow the instructions for administration of this medicine exactly as prescribed by your doctor or pharmacist. 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. Do not crush or chew the capsules or the contents of an empty capsule, as this will prevent them from working properly.

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

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

The dose of lansoprazole depends on your general condition. The usual doses of lansoprazole for adults are indicated below. Sometimes, your doctor may prescribe 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 ulcers:one 30 mg capsule per day for 2 weeks.

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

Treatment of inflammation of the oesophagus (reflux oesophagitis):one 30 mg capsule per day for 4 weeks.

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

Treatment of Helicobacter pyloriinfection: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. The treatment is usually taken daily for 7 days.

The recommended combinations of antibiotics are as follows:

• 30 mg of Lansoprazole Qualigen with 250-500 mg of clarithromycin and 1000 mg of amoxicillin
• 30 mg of Lansoprazole Qualigen with 250 mg of clarithromycin and 400-500 mg of metronidazole

If you are receiving anti-infective treatment due to an ulcer, it is unlikely that the ulcer will come back if the infection is treated successfully. To get the best results from your medicine, take it at the right time and do not miss any doses.

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

Prevention of duodenal or gastric ulcers in patients who require ongoing 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 usual initial dose is two 30 mg capsules per day; subsequently, based on your response to treatment with lansoprazole, the doctor will decide on the best dose for you.

Use in children

Lansoprazole should not be given to children.

If you take more Lansoprazole Qualigen than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Lansoprazole Qualigen

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 Qualigen

Do not stop treatment early because your symptoms have improved. It is possible that your condition has not been completely cured and may come back if you do not complete the full treatment.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common (affect more than 1 in 100 people):

• 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 polyps in the stomach

Uncommon (affect less than 1 in 100 people):

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

Rare (affect 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
• anaemia (pallor)
• kidney problems
• pancreatitis
• inflammation of the liver (which may be indicated by yellowing of the skin or eyes)
• breast swelling in men, impotence
• candidiasis (fungal infection, which 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.

Very rare (affect 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
• severe skin reactions with redness, blisters, severe inflammation, and skin loss
• in very rare cases, lansoprazole may cause a reduction in the number of white blood cells, which can lead to a decreased 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).

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

• skin rash, possibly with joint pain.
• visual hallucinations
• If you are taking lansoprazole for more than three months, it is possible that your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you have any of these symptoms, see your doctor immediately. Low magnesium levels can also lead to a decrease in blood potassium and calcium levels. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency's Pharmacovigilance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Lansoprazole Qualigen

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

Store below 30°C.

Do not use lansoprazole after the expiry date stated on the packaging, after the expiry date abbreviation. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to the pharmacy's SIGRE point. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lansoprazole Qualigen 30 mg

The active substance is lansoprazole.

The other ingredients are: sugar spheres (sucrose and corn starch), sodium starch glycollate, sodium lauryl sulfate, povidone (E-1201), hypromellose (E-464), methacrylic acid - ethyl acrylate copolymer, triethyl citrate, titanium dioxide (E-171), talc (E-553b).

The ingredients of the capsule are: gelatine, titanium dioxide (E-171).

The ingredients of the ink are: 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

Lansoprazole Qualigen 30 mg is presented in the form of hard gastro-resistant capsules, white-beige in colour. Each pack contains 14 or 28 capsules.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

The marketing authorisation 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 last revision of this leaflet:November 2022

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.