PROCESOL 15 mg HARD GASTRO-RESISTANT CAPSULES

Introduction

Package Leaflet: Information for the User

Procesol 15 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 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 pack:

1. What is Procesol and what is it used for
2. What you need to know before you take Procesol
3. How to take Procesol
4. Possible side effects
5. Storage of Procesol
6. Contents of the pack and further information

1. What is Procesol and what is it used for

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

Your doctor may prescribe this medicine 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 this medicine 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 Procesol

Do not take Procesol:

• 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 a 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 disease and/or rule out a malignant disease.

If you experience diarrhoea during treatment with this medicine, contact your doctor immediately, as this medicine 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 or if you are taking corticosteroids (which can increase the risk of osteoporosis).

If you have been taking this medicine 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 or circumstances.

Consult your doctor before starting to take lansoprazole:

- If you have reduced body stores of vitamin B12 or risk factors for this

and you 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 scheduled.

- If you have ever had a skin reaction after treatment with a medicine similar to lansoprazole to reduce stomach acid.

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

When taking lansoprazole, kidney inflammation may occur. The signs and symptoms can include decreased urine output or the presence of blood in the urine and/or hypersensitivity reactions such as fever, skin rash, and joint stiffness. You should report these signs to your doctor.

Other medicines and Procesol

Tell your doctor or pharmacist if you are taking or 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 using medicines that contain any of the following active substances, as Procesol 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)

Taking Procesol with food, drinks, and alcohol

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

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

Patients taking lansoprazole 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 in a fit state 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 can 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 the information in this leaflet carefully. If you have any further questions, ask your doctor, nurse, or pharmacist.

Procesol contains sucrose

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

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

3. How to take Procesol

Follow your doctor's instructions exactly. If you are unsure, consult your doctor or pharmacist again.

Swallow 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 an empty capsule, as this will prevent them from working properly.

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

The dose of Procesol depends on your general condition. The usual doses of this medicine 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 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 usual 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 treatment will normally be for 7 days.

The recommended combinations of antibiotics are as follows:

• 30 mg of Procesol with 250-500 mg of clarithromycin and 1000 mg of amoxicillin
• 30 mg of Procesol 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 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 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 usual initial dose is two 30 mg capsules per day; subsequently, your doctor may decide to adjust the dose based on your response to treatment with Procesol.

Use in children

Procesol should not be administered to children.

If you take more Procesol than you should

If you take more Procesol than you have been prescribed, consult your doctor immediately or contact the Toxicology Information Service, Telephone 915 620 420.

If you forget to take Procesol

If you forget to take a dose, take it as soon as you remember, unless it is almost 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 Procesol

Do not stop treatment early 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 product, ask your doctor or pharmacist.

4. Possible side effects

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

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 polyps in the stomach

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

• depression
• muscle or joint 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 (paresthesia), tremor
• anaemia (pallor)
• kidney problems
• pancreatitis
• inflammation of the liver (which can be indicated by yellowing of the skin or eyes)
• breast swelling in men, impotence
• candidiasis (fungal infection that 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, 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
• inflammation of the mouth (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, Procesol 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. You will have a blood test to check for a possible reduction in white blood cells (agranulocytosis)

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

• If you have been taking Procesol for more than three months, it is possible that your blood magnesium levels 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 blood potassium or calcium levels. Your doctor will probably ask for regular blood tests to monitor your 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, even if they are not listed in this leaflet. You can also report them directly through the national reporting system, Spanish Medicines Monitoring System for Human Use. Website: www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Procesol

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

Blisters

Do not store above 30°C.

Store in the original packaging to protect from moisture.

Bottles:

Do not store above 30°C.

Keep the bottle tightly closed to protect from moisture.

Do not use this medicine after the expiry date which is stated on the packaging and outer 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. Return any unused medicine to a pharmacy for proper disposal. If you are unsure, ask your pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Contents of the pack and further information

Composition of Procesol

The active substance is lansoprazole.

Contents:

Sugar spheres (contain sucrose and corn starch)

Hypromellose

Talc

Titanium dioxide (E-171)

Methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30% (sodium lauryl sulfate, polysorbate 80, and methacrylic acid-ethyl acrylate copolymer)

Triethyl citrate

Capsule:

Gelatine, Purified water

Titanium dioxide (E-171)

Printing ink (shellac and iron oxide black (E-172))

Appearance of the product and contents of the pack

Procesol 15 mg is presented in the form of hard gastro-resistant capsules, white opaque, with "LAN 15" printed on them. Each capsule contains lansoprazole granules with a gastro-resistant coating. Available in blister packs of 28 and 56 capsules and a bottle of 28 capsules.

Marketing authorisation holder and manufacturer

Towa Pharmaceutical Europe, S.L.

C/ de Sant Martí, 75-97,

Martorelles, 08107 Barcelona,

Spain

Date of last revision of the leaflet: December 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/