Lansoprazole Flas Viatris 15 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Lansoprazol Flas Viatris 15 mg orodispersible tablets EFG

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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you. It may 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.

Contents of the leaflet

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

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

The active substance in Lansoprazol Flas Viatris is lansoprazole, which is a proton pump inhibitor.

Proton pump inhibitors reduce the amount of acid produced by the stomach.

Your doctor may have prescribed lansoprazole for the following:

• Treatment of duodenal (intestinal) 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 bacterium Helicobacter pylori, when given in combination with an antibiotic.
• Treatment or prevention of duodenal (intestinal) or gastric ulcers in patients who require ongoing treatment with non-steroidal anti-inflammatory drugs or NSAIDs (NSAID therapy is used to reduce pain or inflammation).
• Treatment of Zollinger-Ellison syndrome.

Your doctor may have prescribed lansoprazole for a different condition or at a different dose than those listed 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 Viatris

Do not take Lansoprazol Flas Viatris:

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

Warnings and precautions

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

• If you have liver problems. Your doctor may need to adjust your dose.
• If you have ever had a skin allergic reaction after treatment with a medicine similar to Lansoprazol Flas Viatris used to reduce stomach acid.
• If you are scheduled to have a specific blood test (chromogranin A).
• If you have low levels of vitamin B12 or risk factors for this and are receiving treatment with these medicines for a long period of time. As with all medicines that reduce acid levels, lansoprazol may reduce the absorption of vitamin B12.

This medicine may affect how your body absorbs vitamin B12, particularly if you need to take it for a long time. Please contact your doctor if you notice any of the following symptoms, as they could indicate low vitamin B12 levels:

• Extreme tiredness or lack of energy.
• Pins and needles.
• Red or sore tongue, mouth ulcers.
• Muscle weakness.
• Blurred vision.
• Memory problems, confusion, depression.

Cases of serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with lansoprazol treatment. Stop taking lansoprazol and contact your doctor immediately if you experience any symptoms related to the serious skin reactions described in section 4.

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 lansoprazol. Remember to mention any other symptoms you may notice, such as joint pain.

If your doctor has prescribed Lansoprazol Flas Viatris along with other medicines for treating infection caused by the bacterium Helicobacter pylori (antibiotics) or together with anti-inflammatory medicines to treat pain or rheumatism, please also read the package leaflets of these medicines carefully.

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

Kidney inflammation may occur while taking lansoprazol. Signs and symptoms may include reduced 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.

If you take lansoprazol for more than three months, your blood magnesium levels may become very low. If you feel tired, confused, dizzy, or experience muscle spasms, seizures (fits), or a rapid heartbeat, contact your doctor immediately, as you may have very low blood magnesium levels (see section 4 “Possible side effects”). Low blood magnesium levels can lead to low calcium and potassium levels. Therefore, your doctor may monitor your blood magnesium levels.

The use of a proton pump inhibitor such as lansoprazol, especially for more than one year, may slightly increase the risk of hip, wrist, or spine fracture. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

If you take lansoprazol for a prolonged period (more than 1 year), your doctor will likely schedule periodic check-ups. You should inform your doctor of any new or unusual symptoms or circumstances.

During treatment

If you experience severe or persistent diarrhea during treatment with lansoprazol, contact your doctor immediately, as lansoprazol has been associated with a small increased risk of infectious diarrhea.

Other medicines and Lansoprazol Flas Viatris

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 the following:

• HIV protease inhibitors such as atazanavir and nelfinavir (used in the treatment of HIV).
• Methotrexate (used to treat autoimmune diseases and cancer).
• Ketoconazole (used to treat Cushing's syndrome—when the body produces excess cortisol).
• Itraconazole (used to treat fungal infections).
• Rifampicin (used to treat tuberculosis).
• 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, such as aluminium hydroxide or magnesium carbonate).
• Sucralfate (used to heal ulcers).
• St. John's wort (Hypericum perforatum) (used to treat mild depression).

Pregnancy and breastfeeding

Lansoprazol is not recommended during pregnancy, as there are no available data.

It is unknown whether lansoprazol is present in breast milk. Talk to your doctor to determine whether the benefit of continuing this medicine outweighs the benefit of breastfeeding.

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

Driving and using machines

Sometimes, patients taking lansoprazol may experience adverse effects such as dizziness, vertigo (a sensation of rotational movement when sitting or standing up), drowsiness, and vision problems. If you experience any of these adverse effects, you should exercise caution, as your reaction capabilities may be reduced.

You are solely responsible for deciding whether you are fit to drive or perform other activities requiring a high level of concentration. One of the factors that may impair your ability to safely carry out these activities is your use of medicines.

Descriptions of these effects can be found in the following sections. Please read this leaflet carefully. If in doubt, consult your doctor or pharmacist.

Lansoprazol Flas Viatris contains sucrose, aspartame, and sodium

This medicine contains 5.97 mg of aspartame per tablet.

Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

This medicine contains sucrose.

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially “sodium-free”.

3. How to take Lansoprazol Flas Viatris

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

The dose of lansoprazole depends on your general condition. The recommended doses of lansoprazole for adults are indicated 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 once daily for 4 weeks. If symptoms persist, inform your doctor. If symptoms do not improve within 4 weeks, consult your doctor.

Treatment of duodenal ulcers (intestine): one orodispersible tablet of 30 mg once daily for 2 weeks.

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

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

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

Treatment of infection caused by Helicobacter pylori: the recommended 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 daily for 7 days.

The recommended antibiotic combinations are as follows:

• 30 mg of lansoprazole with 250–500 mg of clarithromycin and 1,000 mg of amoxicillin.
• 30 mg of lansoprazole 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 recur if the infection is successfully treated. To achieve the best results with your medicine, take it at the correct time and do not miss any doses.

Treatment of duodenal (intestine) or gastric ulcers in patients requiring ongoing treatment with non-steroidal anti-inflammatory drugs (NSAIDs): one orodispersible tablet of 30 mg once daily for 4 weeks.

Prevention of duodenal (intestine) or gastric ulcers in patients requiring ongoing treatment with NSAIDs: one orodispersible tablet of 15 mg once daily; your doctor may adjust your dose to one orodispersible tablet of 30 mg once daily.

Zollinger-Ellison syndrome: the recommended initial dose is two orodispersible tablets of 30 mg once daily; subsequently, depending on your response to lansoprazole treatment, your doctor will decide the best dose for you.

Use in patients with liver problems

If you have moderate or severe liver problems, your doctor may prescribe half the recommended dose.

Use in elderly patients

Your doctor may prescribe a lower than the recommended dose if you are elderly. The maximum recommended dose for elderly patients is 30 mg per day.

Use in children

Lansoprazole must not be given to children.

How to take it

To achieve the best results with the medicine, take lansoprazole at least 30 minutes before eating.

If you take lansoprazole once daily, try to take it at the same time each day. You may achieve the best results if you take lansoprazole on an empty stomach in the morning.

If you take lansoprazole twice daily, take the first dose in the morning and the second in the afternoon.

Lansoprazole tablets break easily, so handle them carefully. Do not handle the tablets with wet hands, as they may break.

Lansoprazol Viatris in peelable or push-through blisters.

1. For peelable blisters only, hold the blister strip by the edges and separate one blister from the rest of the strip by gently tearing along the perforations around the blister.
2. Carefully peel back the backing. For non-perforated blisters, take care not to peel the backing from adjacent tablets.
3. Gently push the tablet out.
4. Place the tablet in your mouth. The tablet will dissolve directly in your mouth and can be swallowed more easily.

The tablet may also be swallowed whole with a glass of water.

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

If using an oral syringe:

• Remove the plunger from the syringe (use 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: pull the plunger to draw 4 ml of tap water into the syringe.
• For the 30 mg tablet: pull the plunger to draw 10 ml of tap water into the syringe.
• Turn the syringe upside down and pull the plunger to draw 1 ml of air into the syringe.
• Gently shake the syringe for 10–20 seconds until the tablet is dispersed.
• The contents can be emptied directly into the mouth.
• Refill the syringe with 2–5 ml of tap water to rinse out any residue and empty into the mouth.
• Repeat this last step if necessary.

If using a nasogastric tube:

It is important that the suitability of the selected tube is carefully evaluated. The recommended diameter of the nasogastric tube to be used is 3.3 mm (French size 10) or larger.

• Remove the plunger from the syringe (use at least a 25 ml syringe for the 15 mg tablet and a 50 ml syringe for the 30 mg tablet).
• Place the tablet into the barrel.
• Replace the plunger into the syringe.
• For the 15 mg tablet: pull the plunger to draw 10 ml of tap water into the syringe.
• For the 30 mg tablet: pull the plunger to draw 25 ml of tap water into the syringe.
• Turn the syringe upside down and pull the plunger to draw 5 ml of air into the syringe.
• Gently shake the syringe for 10–20 seconds until the tablet is dispersed.
• Attach the syringe to the nasogastric tube and empty the syringe contents into the tube.
• For the 15 mg tablet: refill the syringe with 10 ml of tap water and flush into the tube.
• For the 30 mg tablet: refill the syringe with 25 ml of tap water and flush into the tube.

If you take more Lansoprazol Flas Viatris than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number: 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take Lansoprazol Flas Viatris

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, do not take the missed dose and continue taking lansoprazole as usual.

Do not take a double dose to make up for forgotten doses.

If you stop taking Lansoprazol Flas Viatris

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 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 everybody will experience them.

Stop taking this medicine and contact your doctor immediately or go to the nearest hospital if you think you may be experiencing any of the following adverse effects:

• Very rarely, lansoprazole may cause severe hypersensitivity (allergic) reactions. Symptoms of a hypersensitivity reaction may include fever, skin rash, facial swelling, swollen lymph nodes, swelling of the tongue or pharynx, difficulty swallowing, hives, difficulty breathing, and sometimes a drop in blood pressure.
• Very rarely, serious and potentially life-threatening skin reactions have been reported with lansoprazole. Symptoms include reddish spots on the trunk, which may appear as target-shaped or circular lesions, often with central blisters, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms [Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN)].
• Widespread skin rash, high body temperature, and swollen lymph nodes [Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS, frequency unknown)].
• If you have been taking lansoprazole for more than three months, your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, confusion, seizures, dizziness, and increased heart rate. If you notice any of these symptoms, inform your doctor immediately. Low magnesium levels may also lead to reduced levels of potassium or calcium in the blood. Your doctor will likely request regular blood tests to monitor your magnesium levels.
• Very rarely, lansoprazole may cause a reduction in the number of white blood cells (agranulocytosis), which may reduce your resistance to infections, or may coexist with abnormal reductions in red blood cells, white blood cells, and platelets (pancytopenia). If you develop an infection with symptoms such as fever and severe deterioration in your general condition, or fever with localized infection symptoms such as sore throat/pharynx/mouth or urinary problems, or if you experience fatigue, pale skin, unexplained bruising, or prolonged bleeding, contact your doctor immediately. A blood test will be performed to check for possible reduction in white blood cells.
• Rarely, lansoprazole may cause inflammation of the pancreas (pancreatitis). Symptoms include sudden, severe pain in the upper abdomen, which may radiate to the back, and may be accompanied by nausea and vomiting.
• If you develop severe or persistent diarrhoea during treatment with lansoprazole, contact your doctor immediately, as lansoprazole has been associated with a small increased risk of infectious diarrhoea.

Other possible adverse effects:

Common (may affect up to 1 in 10 people):

• Headache, dizziness.
• Diarrhoea, constipation, stomach pain, discomfort (nausea) or vomiting, flatulence, dry mouth, or mouth or throat pain.
• Skin rash, itching.
• Changes in liver function test values.
• Fatigue.
• Benign polyps in the stomach.

Uncommon (may affect up to 1 in 100 people):

• Depression.
• Muscle or joint pain.
• Risk of hip, wrist, or spine fracture.
• Fluid retention or swelling.
• Changes in blood cell counts.

Rare (may affect up to 1 in 1,000 people):

• Fever.
• Restlessness, drowsiness.
• Confusion, seeing, feeling, or hearing things that are not real (hallucinations), difficulty sleeping (insomnia).
• Vision disturbances.
• Sensation of body rotation while standing (vertigo).
• Taste disturbances, loss of appetite, swollen tongue (glossitis).
• Skin reactions such as burning or itching sensation under the skin, bruising, redness, and excessive sweating.
• Light sensitivity.
• Alopecia (hair loss).
• Tingling sensation (paraesthesia), tremor.
• Anaemia (pallor).
• Kidney inflammation (tubulointerstitial nephritis); possible symptoms include changes in urine output, blood in urine.
• Liver inflammation (may present as yellowing of the skin or eyes).
• Breast enlargement in males, impotence.
• Candidiasis (fungal infection, may affect the oesophageal mucosa).

Very rare (may affect up to 1 in 10,000 people):

• Inflammation of the mouth (stomatitis).
• Inflammation of the intestine (colitis).
• Low sodium levels in blood; symptoms include nausea and vomiting, headache, drowsiness and fatigue, confusion, muscle weakness or spasms, irritability, seizures, coma. Your doctor may decide to perform periodic blood tests to monitor your sodium levels.
• Increased blood cholesterol or triglyceride levels.

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

• Skin-related forms of lupus or lupus-like skin rash.
• Skin rash, possibly with joint pain.
• Visual hallucinations.
• .

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Lansoprazole Flas Viatris

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

Store in the original packaging to protect it from moisture.

Bottles: Once opened, use within 100 days. Keep the bottle tightly closed to protect the contents from moisture.

Do not use this medicine after the expiry date stated on the blister, the carton, and the bottle after CAD or EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE point located at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lansoprazol Flas Viatris

The active substance is lansoprazole.

The other components are: sugar spheres, light magnesium carbonate (E-504), crospovidone (E-1202), hydroxypropylcellulose (E-463), methacrylic acid and ethyl acrylate copolymer (1:1), triethyl citrate (E-1505), sodium hydroxide (E-524), talc (E-553b), polysorbate (E-433), macrogol, red iron oxide (E-172), yellow iron oxide (E-172), mannitol (E-421), microcrystalline cellulose (E-460), sodium carboxymethylstarch type A (derived from potato starch), aspartame (E-951), sodium lauryl sulfate, sodium bicarbonate (E-500), citric acid monohydrate (E-330), strawberry flavour [flavouring, corn maltodextrin and propylene glycol (E-152)] and magnesium stearate. (See section 2 “Lansoprazol Flas Viatris contains sucrose, aspartame and sodium”).

Appearance of the product and contents of the pack

The medicine is presented as orodispersible tablets (solid oral formulation) which dissolve to release gastro-resistant microgranules.

Lansoprazol Flas Viatris 15 mg are round, white to yellowish tablets with orange to dark brown specks, flat with bevelled edges, marked with “LP1” on one side and “M” on the other.

Orodispersible tablets of Lansoprazol Flas Viatris 15 mg are available in:

• Peelable blisters of 7, 14, 28, 30, 56, 90 or 98 tablets.
• Single-dose peelable perforated blisters of 28 x1 tablet.
• Press-through blisters of 7, 14, 28, 30, 56, 90 or 98 tablets.
• Single-dose perforated press-through blisters of 28 x1 tablet.
• Single-dose perforated press-through blisters of 14 x1 tablet.
• Plastic bottles with absorbent cotton and screw cap containing 30, 100 or 500 tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer

Generics [UK] Ltd
Station Close, Potters Bar, Hertfordshire, EN6 1TL
United Kingdom

or

McDermott Laboratories Limited trading as Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13
Ireland

or

Mylan Hungary Kft.
H-2900, Komárom Mylan utca 1
Hungary

or

Viatris UK Healthcare Limited
Building 20, Station Close, Potters Bar, EN6 1TL
United Kingdom

For further information about this medicine, contact the local representative of the Marketing Authorisation Holder:

Viatris Pharmaceuticals, S.L.U.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicine is authorised in the Member States of the European Economic Area and the United Kingdom (Northern Ireland) under the following names:

Spain: Lansoprazol Flas Viatris 15 mg orodispersible tablets EFG
France: Lansoprazole Viatris 15 mg orodispersible tablet
Italy: Lansoprazolo Mylan Generics Italia
Malta: Lansoprazole 15 mg orodispersible tablets
Portugal: Lansoprazole Mylan
United Kingdom: Lansoprazole 15 mg Orodispersible tablets
Sweden: Lansoprazol Viatris 15 mg muns?nderfallande tablett

Date of the most recent review of this leaflet: May 2025

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