Monolitum Flas 30 mg orodispersible tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Monolitum Flas 30 mg orodispersible tablets

lansoprazol

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 effects, consult your doctor or pharmacist, even if they are adverse effects 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 long-term 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 at a dose 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 starting to take Monolitum Flas

Do not take Monolitum

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Monolitum:

• If you have reduced body stores 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 discontinue treatment with Monolitum. Remember to mention any other symptoms you may notice, such as joint pain.

When taking lansoprazole, inflammation of the kidneys may occur. 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 must report these signs to your doctor.

Inform 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 drugs for pain or rheumatism, please 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 hip, wrist, or vertebral fractures. 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 monitor you regularly. During visits to your doctor, you should report any new or unusual symptoms or circumstances.

Other medicines and Monolitum

Inform 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 HIV treatment)
• 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 drinks

For optimal results, you should take Monolitum 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 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, the use of medicines may be one of the factors that reduce your ability to carry out these tasks safely.

The descriptions of these effects can be found in the following sections.

Read this leaflet carefully.

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

Monolitum 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 capsule; this is essentially “sodium-free”.

3. How to take Monolitum Flas

Follow exactly the instructions for taking this medicine as 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 whole tablet may be swallowed with a glass of water.

Your doctor may give you instructions to administer 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.
• Reinsert 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 slightly to draw in 1 ml of air.
• Gently shake the syringe for 10–20 seconds until the tablet has dispersed.
• The contents can then be emptied directly into the mouth.
• Refill the syringe with 2–5 ml of water to rinse out any remaining residue and empty this into the mouth as well.

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 listed below. Occasionally, your doctor may prescribe a different dose or a different duration of treatment.

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

Long-term prevention of reflux oesophagitis: 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. Treatment is usually 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, 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 Monolitum Flas, your doctor will decide the most appropriate 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 it is almost time for your next dose. In this case, skip the missed dose and take the next tablets as usual. Do not take a double dose to make up for a missed dose.

If you stop taking Monolitum Flas

Do not stop treatment prematurely, even if your symptoms have improved. Your condition may not be completely healed and symptoms may 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 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 the mouth or throat
• skin rash, itching
• changes in liver function test values
• fatigue
• benign stomach 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 disturbances, 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 males, 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 pharynx, difficulty swallowing, urticaria, or breathing difficulties.

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 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

• very rarely, Monolitum Flas may cause a reduction in the number of white blood cells, which could 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 signs of local infection such as sore throat/pharynx/mouth or urinary problems, contact 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 adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via 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 carton after EXP. The expiry date refers to the last day of the month indicated.

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

6. Contents of the package and other information

Composition of Monolitum Flas

• The active substance is lansoprazol.
• 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 package

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

Each package 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 Health Products (AEMPS)

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