MONOLITUM 30 mg HARD GASTRO-RESISTANT CAPSULES

Introduction

Package Leaflet: Information for the User

Monolitum 30 mg Gastro-Resistant Hard Capsules EFG

lansoprazole

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What is Monolitum and what is it used for
2. What you need to know before you take Monolitum
3. How to take Monolitum
4. Possible side effects
5. Storage of Monolitum

1. Contents of the pack and further information

1. What is Monolitum and what is it used for

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

Your doctor may prescribe you Monolitum 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 bacteria Helicobacter pylori, in combination with antibiotics
• Treatment or prevention of duodenal or gastric ulcers in patients who require continuous treatment with non-steroidal anti-inflammatory drugs (NSAIDs) (NSAID treatment is used for pain or inflammation)
• Treatment of Zollinger-Ellison syndrome

It may be that your doctor has prescribed you Monolitum for another indication or at a different dose than stated in this leaflet. Follow your doctor's instructions regarding the taking of the medicine.

You should consult a doctor if you get worse or if you do not improve after 14 days.

2. What you need to know before you take Monolitum

Do not takeMonolitum

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Monolitum:

• If you have reduced body stores of vitamin B12 or risk factors for this and you receive long-term treatment with lansoprazole. Like all medicines that reduce acid, Monolitum may 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 to reduce stomach acidity.
• If you get a skin rash, especially in areas of the skin exposed to the sun, consult your doctor as soon as possible, as it may be necessary to interrupt treatment with Monolitum. Remember to 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 volume or the presence of blood in the urine and/or hypersensitivity reactions such as fever, skin rash, and joint stiffness. You should inform your doctor of these signs.

Tell your doctor if you have severe liver disease. It may be necessary for the doctor to adjust the dose.

Your doctor may have performed or may perform a complementary test called endoscopy to diagnose your disease and/or rule out a malignant disease.

In case 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 you Monolitum in addition to other medicines intended for the treatment of Helicobacter pylori infection (antibiotics) or together with anti-inflammatory medicines to treat pain or rheumatism, also read the package leaflets of these medicines carefully.

Taking a proton pump inhibitor like Monolitum, especially for a period of 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 probably have regular check-ups. During visits to your doctor, you should inform them of any new or abnormal symptoms and circumstances.

Other medicines and Monolitum

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

• HIV protease inhibitors such as atazanavir and nelfinavir (used to treat 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)

TakingMonolitumwith food and drinks

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 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 act with caution as your reaction ability may be reduced.

You are the only one responsible for deciding whether you are fit to drive vehicles or perform activities that require a high level of concentration. Due to its effects or adverse reactions, one of the factors that may reduce your ability to perform these operations safely is the use of medicines.

In the following sections, you will find descriptions of these effects.

Read this leaflet carefully.

If you have any further 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 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 Monolitum

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Take the capsule whole with a glass of water. If you have difficulty swallowing the capsule, your doctor will inform you of other alternative ways to take the medicine. Do not crush or chew the capsules or the contents of an emptied capsule, as this will make them not work properly.

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

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

The dose of Monolitum depends on your general condition. The recommended doses of Monolitum 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 ulcer:one 30 mg capsule per day for 2 weeks.

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

Treatment of esophagus inflammation (reflux esophagitis):one 30 mg capsule per day for 4 weeks.

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

Treatment of Helicobacter pylori infection:The recommended dose is one 30 mg capsule together with two different antibiotics in the morning and one 30 mg capsule together with two different antibiotics at night. The treatment will normally be daily for 7 days.

The recommended combinations of antibiotics are as follows:

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

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

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

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

Use in children

Monolitum should not be administered to children.

If you take moreMonolitum than you should

If you take more Monolitum than you have been told, consult your doctor immediately or contact the Toxicology Information Service, phone 915 620 420.

If you forget to take Monolitum

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 missed doses.

If you stop taking Monolitum

Do not stop treatment before time because the symptoms have improved. It is possible that your condition has not been completely cured and may come back if you do not finish all the treatment.

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

4. Possible side effects

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

Frequent side effects.

May affect up to 1 in 10 people.

• headache, dizziness
• diarrhea, 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 side effects.

May affect up to 1 in 100 people.

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

Rare side effects.

May affect up to 1 in 1,000 people.

• fever
• restlessness, drowsiness, confusion, hallucinations, insomnia, visual disturbances, vertigo
• taste disturbance, loss of appetite, tongue inflammation (glossitis)
• skin reactions such as burning sensation or itching under the skin, bruising, redness, and excessive sweating
• sensitivity to light
• hair loss
• tingling sensation (paresthesia), tremor
• anemia (pallor)
• kidney problems
• pancreatitis
• liver inflammation (may be manifested by 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, hives, and difficulty breathing.

Very rare side effects.

May affect up to 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

• mouth inflammation (stomatitis)
• colitis (inflammation of the intestine)
• changes in analytical values, such as sodium, cholesterol, and triglyceride levels
• very 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 cause a decrease in 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:

• If you have been taking Monolitum for more than three months, it is possible that the magnesium levels in your blood may decrease. Low magnesium levels can cause fatigue, muscle contractions, disorientation, convulsions, dizziness, and increased heart rate. If you notice any of these symptoms, inform your doctor immediately. Low magnesium levels can also lead to a decrease in potassium or calcium levels in the blood. Your doctor will probably ask for regular blood tests to monitor magnesium levels.
• Skin rash, possibly with joint pain
• Visual hallucinations

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Monolitum

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

Do not store above 30°C.

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

Medicines should not be disposed of via wastewater or household waste. Deposit the containers and medicines you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Monolitum

• The active substance is lansoprazole.
• The other ingredients (excipients) are: sugar spheres (sucrose and cornstarch), magnesium carbonate, hypromellose, polysorbate 80, macrogol 6000, triethyl citrate, talc, titanium dioxide (E-171), methacrylic acid and ethyl acrylate copolymer, and sodium hydroxide. The gelatin capsule is composed of: titanium dioxide (E-171), erythrosine, iron oxide red, and gelatin.

Appearance of the product and contents of the pack

Monolitum 15 mg gastro-resistant hard capsules are presented in the form of gastro-resistant hard capsules, which contain spherical gastro-resistant lansoprazole granules, in packs of 28 and 56 capsules.

Some pack sizes may only be marketed.

Marketing authorization holder

Laboratorios Salvat, S.A.

C/ Gall, 30-36 - 08950

08950 Esplugues de Llobregat

Barcelona - Spain

Manufacturer

Laboratorios Salvat, S.A.

C/Gall, 30-36 – 08950

Esplugues de Llobregat

Barcelona – Spain

or

PHARMALOOP, S.L.

C/Bolivia, 15 – Polig.Industrial Azque

28806 Alcalá de Henares,

Madrid – Spain

Date of last revision of this leaflet:November 2022

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