LANSOPRAZOL CINFAMED 30 mg GASTRO-RESISTANT CAPSULES

Introduction

Package Leaflet: Information for the User

Lansoprazole Cinfamed 30 mg Hard Gastro-Resistant Capsules 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 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 get 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 Lansoprazole Cinfamed and what is it used for
2. What you need to know before you take Lansoprazole Cinfamed
3. How to take Lansoprazole Cinfamed
4. Possible side effects
5. Storage of Lansoprazole Cinfamed
6. Contents of the pack and other information

1. What is Lansoprazole Cinfamed 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 Lansoprazole Cinfamed for the following indications in adults:

• Treatment of duodenal 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 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

You may have been prescribed lansoprazole for another indication or at a different dose than stated in this leaflet. Follow your doctor's instructions exactly.

You should consult a doctor if your symptoms worsen or do not improve after 14 days.

2. What you need to know before you take Lansoprazole Cinfamed

Do not take Lansoprazole Cinfamed

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

Warnings and precautions

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

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

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

If your doctor has prescribed lansoprazole in addition to other medicines for the treatment of Helicobacter pyloriinfection (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 lansoprazole, especially over a period of more than one year, may slightly increase the risk of hip, wrist, or spine fractures. Tell your doctor if you have osteoporosis (reduced bone density) or if your doctor has told you that you are at risk of osteoporosis (for example, if you are taking steroids).

If you have been taking lansoprazole for a long time (more than 1 year), your doctor will probably monitor you regularly. During your visits to the doctor, you should report any new or abnormal symptoms and circumstances.

Consult your doctor before starting to take lansoprazole:

• 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, lansoprazole may reduce the absorption of vitamin B12.
• If a specific blood test (Chromogranin A) is planned.
• If you have ever had a skin reaction after treatment with a medicine similar to lansoprazole to reduce stomach acid.
• If you get a rash, especially in areas of the skin exposed to the sun, contact your doctor as soon as possible, as it may be necessary to interrupt treatment with lansoprazole. Remember to mention any other symptoms you may notice, such as joint pain.
• There have been reports of serious skin reactions with lansoprazole (Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug rash with eosinophilia and systemic symptoms (DRESS)). Stop using lansoprazole and contact your doctor immediately if you experience any of the symptoms related to serious skin reactions described in section 4.
• When taking lansoprazole, kidney inflammation may occur. The signs and symptoms may include decreased urine output or the presence of blood in the urine and/or hypersensitivity reactions such as fever, rash, and joint stiffness. You should report these signs to your doctor.

Other medicines and Lansoprazole Cinfamed

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 or pharmacist if you are taking medicines that contain any of the following active substances, as lansoprazole may affect their 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)

Taking Lansoprazole Cinfamed with food and drinks

To get the best results from your medicine, you should take lansoprazole at least 30 minutes before meals with a glass of water.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Lansoprazole is unlikely to affect your ability to drive or use tools or machines. However, side effects such as dizziness and visual disturbances (see section 4) may occur. If this happens, do not drive or use machines.

You are responsible for deciding whether you are fit to drive or perform tasks that require a high level of attention. Due to its effects or side effects, one of the factors that can reduce your ability to perform these tasks safely is the use of medicines.

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

Read the information in this leaflet carefully.

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

Lansoprazole Cinfamed contains sucrose

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

Lansoprazole Cinfamed contains sodium

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

3. How to take Lansoprazole Cinfamed

Follow the instructions for administration of this medicine exactly as told by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.

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

If you take lansoprazole once a day, try to take it at the same time every day. You may get better results if you take this medicine in the morning.

If you take lansoprazole twice a day, take the first dose in the morning and the second dose in the evening.

The dose of lansoprazole depends on your general condition. The recommended doses of lansoprazole 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 do not improve after 4 weeks, consult your doctor.

Treatment of duodenal ulcers:one 30 mg capsule per day for 2 weeks.

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

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

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

Treatment of Helicobacter pyloriinfection: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 in the evening. The recommended treatment is once a day for 7 days.

The recommended antibiotic combinations are:

• 30 mg of Lansoprazole Cinfamed with 250-500 mg of clarithromycin and 1000 mg of amoxicillin
• 30 mg of Lansoprazole Cinfamed 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 successfully. 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 ulcers in patients who require continuous treatment with NSAIDs:one 30 mg capsule per day for 4 weeks.

Prevention of duodenal or gastric ulcers 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 lansoprazole, the doctor will decide the best dose for you.

Use in children

Lansoprazole should not be administered to children.

If you take more Lansoprazole Cinfamed than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Lansoprazole Cinfamed

If you forget to take a dose, take it as soon as you remember, unless it is nearly time for your next dose. In this case, skip the missed dose and take the next capsules as usual. Do not take a double dose to make up for forgotten doses.

If you stop taking Lansoprazole Cinfamed

Do not stop treatment prematurely because your symptoms have improved. It is possible that your condition has not been completely cured and may come back if you do not complete the entire 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.

If you start to feel any of the following side effects, stop taking lansoprazole and contact your doctor immediately:

• round or ring-shaped red patches on the trunk, often with blisters in the centre, peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis)
• generalized rash, high body temperature, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome).

Common side 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 side effects (may affect up to 1 in 100 people):

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

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

• fever,
• restlessness, drowsiness, confusion, hallucinations, insomnia, visual disturbances, vertigo,
• altered taste, loss of appetite, inflammation of the tongue (glossitis),
• skin reactions such as burning sensation or itching, bruising, redness, and excessive sweating,
• sensitivity to light,
• hair loss,
• tingling sensation (paraesthesia), tremors,
• anaemia (pallor),
• kidney problems,
• pancreatitis,
• inflammation of the liver (may be indicated by yellowing of the skin or eyes),
• breast swelling in men, impotence,
• candidiasis (fungal infection, can 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, 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,
• 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 lead to 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. A blood test will be performed to check for a possible reduction in white blood cells (agranulocytosis).

Side effects with frequency not known (cannot be estimated from the available data):

• skin rash, possibly with joint pain.
• visual hallucinations.
• low sodium levels in the blood. Common symptoms include nausea and vomiting, headache, drowsiness, and fatigue, confusion, weakness, or muscle spasms, irritability, convulsions, coma.

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 Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Lansoprazole Cinfamed

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

Store below 30°C.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Container Contents and Additional Information

Composition of Lansoprazol cinfamed

• The active ingredient is lansoprazole. Each hard gastro-resistant capsule contains 30 mg of lansoprazole.
• The other components are: sugar spheres (containing sucrose and corn starch), sodium lauryl sulfate, povidone, sodium carboxymethyl starch (type A) (from potato), dodecahydrate disodium phosphate, hypromellose, methacrylic acid and ethyl acrylate copolymer (1:1), triethyl citrate, titanium dioxide (E-171), and talc.

The gelatin capsule is composed of: gelatin and titanium dioxide (E-171).

The printing ink of the capsules contains shellac, anhydrous ethyl alcohol, isopropyl alcohol, propylene glycol, n-butyl alcohol, ammonium hydroxide, potassium hydroxide, and black iron oxide (E-172).

Appearance of the Product and Container Contents

Lansoprazol cinfamed 30 mg hard gastro-resistant capsules EFG are hard gelatin capsules with a white opaque cap and body. The capsules have been marked with black ink with the letter “L” on the cap and the number “30” on the body.

Packaging in HDPE bottles with 14 or 28 gastro-resistant capsules.

Packaging in Aluminum/Aluminum blisters of 14 or 28 gastro-resistant capsules.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer

TEVA PHARMA, S.L.U.

Polígono Malpica c/C, 4

50016 Zaragoza.

or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the Last Revision of this Prospectus:July 2025

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

You can access detailed and updated information about this medication by scanning the QR code included in the prospectus and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/66350/P_66350.html

QR code to: https://cima.aemps.es/cima/dochtml/p/66350/P_66350.html