Monolitum Flas 15 mg orodispersible tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Monolitum Flas 15 mg orodispersible tablets

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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people even if they have the same symptoms as you, because it could harm them.
• If you experience any 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 Monolitum Flas is and what it is used for
2. What you need to know before taking Monolitum Flas
3. How to take Monolitum Flas
4. Possible side effects
5. How to store Monolitum Flas
6. Contents of the pack and other information

1. What Monolitum Flas is and what it is used for

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

Your doctor may prescribe Monolitum Flas for the following indications:

• Treatment of duodenal and gastric ulcers
• Treatment of inflammation of the esophagus (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 ongoing 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 Monolitum Flas for an indication or dosage different from that stated in this leaflet. Follow your doctor's instructions regarding how to take the medicine.

You should consult a doctor if your condition worsens or does not improve after 14 days.

2. What you need to know before taking Monolitum

Do not take Monolitum

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Monolitum:

• If you have low body reserves of vitamin B12 or risk factors for this and are receiving long-term treatment with lansoprazole. Like all medicines that reduce acid levels, Monolitum could reduce the absorption of vitamin B12.
• 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 Monolitum used to reduce stomach acidity.
• 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 Monolitum. Remember to mention any other symptoms you may notice, such as joint pain.

When taking lansoprazole, 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.

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

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

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

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

Taking a proton pump inhibitor such as Monolitum, especially for more than one year, may slightly increase 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 Monolitum for a long time (more than 1 year), your doctor will likely perform regular check-ups. During visits to your doctor, you should report any new or unusual symptoms or circumstances.

Other medicines and Monolitum

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take 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 Monolitum may affect their action:

• HIV protease inhibitors such as atazanavir and nelfinavir (used in the treatment of HIV)
• methotrexate (used to treat autoimmune diseases and cancer)
• ketoconazole, itraconazole, rifampicin (used to treat infections)
• digoxin (used to treat heart problems)
• warfarin (used to treat blood clots)
• 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 Monolitum with food and drink

To get the best results from your medicine, you should take Monolitum at least 30 minutes before meals.

Pregnancy and breastfeeding

If you are pregnant, 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 Monolitum 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 ability 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, one of the factors that may reduce your ability to safely carry out these activities is the use of medicines.

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

Read this leaflet carefully.

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

Monolitum contains sucrose and sodium

This medicine contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with him 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 Monolitum Flas

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

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

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 using a 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 back 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 out any remaining residue and empty it into the mouth.

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

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

The dose of Monolitum Flas depends on your general condition. The usual doses of Monolitum Flas 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 orodispersible tablet daily for 4 weeks. If symptoms persist, inform your doctor. If symptoms do not improve after 4 weeks, consult your doctor.

Treatment of duodenal ulcer: one 30 mg orodispersible tablet daily for 2 weeks.

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

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

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

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

The recommended antibiotic combinations are as follows:

• 30 mg Monolitum Flas with 250–500 mg clarithromycin and 1,000 mg amoxicillin
• 30 mg Monolitum Flas 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 NSAID treatment: one 30 mg orodispersible tablet daily for 4 weeks.

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

Zollinger-Ellison syndrome: The usual initial dose is two 30 mg orodispersible tablets daily; subsequently, depending on your response to Monolitum Flas treatment, your doctor will decide the optimal dose for you.

Use in children and adolescents

Monolitum Flas must not be administered to children and adolescents.

If you take more Monolitum Flas than you should

If you take more Monolitum Flas than prescribed, contact your doctor immediately or contact the Toxicology Information Service immediately at telephone number 915 620 420.

If you forget to take Monolitum Flas

If you forget to take a dose, take it as soon as possible unless the next dose is due soon. In this case, skip the missed dose and take the next tablets as usual. Do not take a double dose to make up for missed doses.

If you stop taking Monolitum Flas

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

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

4. Possible adverse effects

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

Frequent adverse effects.

May affect up to 1 in 10 people.

• 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 gastric polyps

Uncommon adverse effects.

May affect up to 1 in 100 people.

• depression
• joint or muscle pain
• fluid retention or swelling
• changes in blood cell counts
• risk of hip, wrist, and spinal fractures

Rare adverse effects.

May affect up to 1 in 1,000 people.

• 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 pharynx, difficulty swallowing, urticaria, and difficulty breathing.

Very rare adverse effects.

May affect up to 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, severe swelling, and skin loss

• in very rare cases, Monolitum Flas may cause a reduction in the number of white blood cells, which may lead to decreased 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:

• If you have been taking Monolitum Flas 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 notice any of these symptoms, inform your doctor immediately. Low magnesium levels may also lead to decreased levels of potassium or calcium in the blood. Your doctor will likely request regular blood tests to monitor your magnesium levels.
• Skin rash, possibly with joint pain
• Visual hallucinations

Reporting of adverse effects:

If you experience any type of 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 Monolitum Flas

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the blister and packaging after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their containers to the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Monolitum Flas

• The active substance is lansoprazole.
• The other components (excipients) are sucrose, corn starch, magnesium carbonate, hypromellose; polysorbate 80, polyethylene glycol 6000, triethyl citrate, talc, methacrylic acid and ethyl acrylate copolymer, methyl acrylate, methyl methacrylate and methacrylic acid copolymer, microcrystalline cellulose, hydroxypropylcellulose, sodium saccharin, mannitol, tropical flavor (contains corn maltodextrin (releases glucose), gum arabic (E-414), propylene glycol (E-1520), malic acid and magnesium stearate).

Appearance of the product and contents of the pack

Monolitum Flas is presented as buccodispersible tablets of white-greyish color containing microgranules.

Each pack contains 28 or 56 buccodispersible tablets.

Marketing Authorization Holder and Manufacturer

Laboratorios Salvat, S.A.

C/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 medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS):

http://www.aemps.gob.es/