Lansoprazole Flas Qualigen 30 mg orodispersible tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Lansoprazol Flas Qualigen 30 mg orodispersible tablets

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 only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

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

Your doctor may prescribe Lansoprazol Flas Qualigen 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 Lansoprazol Flas Qualigen 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 Lansoprazol Flas Qualigen

Do not take Lansoprazol Flas Qualigen:

• If you are allergic 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 ingredient atazanavir (used in the treatment of HIV).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Lansoprazol Flas Qualigen:

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

Inform your doctor 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 Flas Qualigen, contact your doctor immediately, as Lansoprazol Flas Qualigen has been associated with a slight increase in infectious diarrhea.

If your doctor has prescribed Lansoprazol Flas Qualigen 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 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 been taking Lansoprazol Flas Qualigen 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.

Kidney inflammation may occur while taking lansoprazole. 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.

Other medicines and Lansoprazol Flas 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 Flas Qualigen 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 Flas Qualigen with food and drinks

To achieve the best results from your medication, you should take Lansoprazole Flas Qualigen at least 30 minutes before meals.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

Driving and use of machines

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

This medicine contains sucrose and sodium

If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine. It may cause dental caries.

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

3. How to Take Lansoprazole Flas Qualigen

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor again.

To properly remove the tablet, it is recommended to:

• Cut the blister along the marked cutting line.
• Separate the two aluminum layers at the indicated place and remove the tablet.

Place the tablet on the tongue and let it dissolve slowly. The tablet dissolves rapidly in the mouth, releasing microgranules which should be swallowed whole with a glass of water, without chewing.

Your doctor may give you instructions for administering the tablet using a syringe if you have serious difficulty swallowing.

Follow the instructions below for administration via syringe:

It is important to ensure that the syringe selected is appropriate.

• Remove the plunger from the syringe (at least a 5 mL syringe for the 15 mg tablet and a 10 mL syringe for the 30 mg tablet).
• Place the tablet into the barrel.
• Replace the plunger into the syringe.
• For the 15 mg tablet: fill the syringe with 4 mL of water.
• For the 30 mg tablet: fill the syringe with 10 mL of water.

Invert the syringe and pull the plunger to allow 1 mL of air to enter.

• Gently shake the syringe for 10–20 seconds until the tablet has dispersed.
• The contents can be emptied directly into the mouth.
• Refill the syringe with 2–5 mL of water to rinse any remaining residue from the syringe and empty it into the mouth.

If you take Lansoprazole Flas Qualigen once daily, try to take it at the same time every day. You may achieve better results if you take Lansoprazole Flas Qualigen in the morning.

If you take Lansoprazole Flas Qualigen twice daily, you should take the first dose in the morning and the second in the evening.

The dose of Lansoprazole Flas Qualigen depends on your general condition. The usual doses of Lansoprazole Flas Qualigen for adults are listed below. Occasionally, your doctor may prescribe a different dose and indicate a different treatment duration.

Treatment of heartburn and acid regurgitation: one orodispersible tablet of 15 mg or 30 mg 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 orodispersible tablet of 30 mg daily for 2 weeks.

Treatment of gastric ulcer: one orodispersible tablet of 30 mg daily for 4 weeks.

Treatment of inflammation of the esophagus (reflux esophagitis): one orodispersible tablet of 30 mg daily for 4 weeks.

Long-term prevention of reflux esophagitis: one orodispersible tablet of 15 mg daily; your doctor may adjust your dose to one orodispersible tablet of 30 mg daily.

Treatment of Helicobacter pylori infection: The usual dose is one orodispersible tablet of 30 mg together with two different antibiotics in the morning and one orodispersible tablet of 30 mg together with two different antibiotics in the evening. The usual treatment duration is once daily for 7 days.

The recommended antibiotic combinations are as follows:

• 30 mg Lansoprazole Flas Qualigen with 250–500 mg clarithromycin and 1,000 mg amoxicillin
• 30 mg Lansoprazole Flas 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 continuous NSAID therapy: one orodispersible tablet of 30 mg daily for 4 weeks.

Prevention of duodenal or gastric ulcer in patients requiring continuous NSAID therapy: one orodispersible tablet of 15 mg daily; your doctor may adjust your dose to one orodispersible tablet of 30 mg daily.

Zollinger-Ellison syndrome: The usual initial dose is two orodispersible tablets of 30 mg daily; thereafter, depending on your response to treatment with Lansoprazole Flas Qualigen, your doctor will determine the most appropriate dose for you.

Use in children

Lansoprazole Flas Qualigen must not be administered to children.

If you take more Lansoprazol Flas Qualigen than you should

If you take more Lansoprazol Flas Qualigen than prescribed, consult your doctor immediately or call the Toxicology Information Service right away. Telephone number: 915 620 420.

If you forget to take Lansoprazole Flas Qualigen

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 following orodispersible tablets at your usual time. Do not take a double dose to make up for the missed dose.

If you interrupt treatment with Lansoprazole Flas Qualigen

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Frequent adverse effects (occur in more than 1 in 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

• fatigue

• benign stomach polyps

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

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

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

• 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 itching sensation under the skin, bruising, redness and excessive sweating
• sensitivity to light
• 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 men, impotence
• candidiasis (fungal infection, may 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 throat, difficulty swallowing, hives, or difficulty breathing.

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

• severe hypersensitivity reactions, including anaphylactic shock. Symptoms of hypersensitivity may include fever, rash, swelling, and sometimes low blood pressure
• inflammation of the mouth (stomatitis)
• colitis (inflammation of the intestine)
• changes in laboratory values, such as sodium, cholesterol, and triglyceride levels
• very severe skin reactions with redness, blisters, severe swelling, and skin loss

In very rare cases, Lansoprazol Flas Qualigen 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 may 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 Flas Qualigen

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

Do not use Lansoprazol Flas Qualigen after the expiry date stated on the blister and carton. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Lansoprazol Flas Qualigen

The active substance is lansoprazole.

The other components are sucrose, maize starch, magnesium carbonate (E-504i), hypromellose (E-464), polysorbate 80 (E-433), polyethylene glycol 6000, triethyl citrate, talc, methacrylic acid and ethyl acrylate copolymer, methyl methacrylate copolymer, methyl acrylate, methacrylic acid, microcrystalline cellulose (E-460i), hydroxypropylcellulose (E-463), sodium saccharin (E-954ii), mannitol (E-421), tropical flavor, malic acid (E-296), magnesium stearate (E-572).

Appearance of the product and contents of the package

Greyish-white orodispersible tablets containing microgranules.

Each package contains 28 or 56 orodispersible tablets.

Only certain package sizes may be marketed.

Marketing Authorization Holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Manufacturer Responsible for Manufacturing

Laboratorios SALVAT, S.A.

Gall 30 - 36

08950 Esplugues de Llobregat

(Barcelona)

Spain

Date of the most recent revision of this leaflet:

November 2022

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