LANSOPRAZOLO 15 mg Enteric-Coated Hard Capsule

Зміст інструкції

1. LANSOPRAZOLO PENSA 15 mg hard gastro-resistant capsules, 30 mg hard gastro-resistant capsules
   1. WHAT LANSOPRAZOLO PENSA IS AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LANSOPRAZOLO PENSA
   3. HOW TO TAKE LANSOPRAZOLO PENSA
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE LANSOPRAZOLO PENSA
   6. PACKAGE CONTENTS AND OTHER INFORMATION

LANSOPRAZOLO PENSA 15 mg hard gastro-resistant capsules, 30 mg hard gastro-resistant capsules

Generic medicine
Read this leaflet carefully before taking this medicinebecause 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. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Lansoprazolo Pensa is and what it is used for
• 2. What you need to know before you take Lansoprazolo Pensa
• 3. How to take Lansoprazolo Pensa
• 4. Possible side effects
• 5. How to store Lansoprazolo Pensa
• 6. Contents of the pack and other information

1. WHAT LANSOPRAZOLO PENSA IS AND WHAT IT IS USED FOR

The active ingredient of LANSOPRAZOLO PENSA is lansoprazole, which is a proton pump inhibitor.
Proton pump inhibitors reduce the amount of acid that your stomach produces.
Your doctor may prescribe LANSOPRAZOLO PENSA for the following indications:

• Treatment of duodenal and stomach ulcers
• Treatment of esophageal inflammation (reflux esophagitis)
• Prevention of reflux esophagitis
• Treatment of heartburn and acid regurgitation
• Treatment of infections caused by the bacterium Helicobacter pyloriwhen administered in combination with antibiotic therapy
• Treatment or prevention of duodenal or stomach ulcers in patients who require continuous treatment with non-steroidal anti-inflammatory drugs (NSAIDs, used against pain or inflammation)
• Treatment of Zollinger-Ellison syndrome

Your doctor may have prescribed LANSOPRAZOLO PENSA for another indication or with a
different way to take the medicine.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LANSOPRAZOLO PENSA

Do not take LANSOPRAZOLO PENSA:

• if you are allergic (hypersensitive) to lansoprazole or any of the other ingredients of this medicine (listed in section 6).
• If you are taking a medicine containing the active substance atazanavir (used in the treatment of HIV).

Warnings and precautions
Talk to your doctor before taking Lansoprazolo Pensa:

• if you have ever had a skin reaction after treatment with a medicine similar to Lansoprazolo Pensa that reduces stomach acid. If you notice the appearance of a skin rash, especially in areas exposed to sunlight, contact your doctor as soon as possible, as you may need to stop therapy with Lansoprazolo Pensa. Remember to report any other undesirable effects such as joint pain.
• if you are to undergo a specific blood test (Chromogranin A)

Be careful with LANSOPRAZOLO PENSA
Tell your doctor if you have a serious liver disease. The doctor may need to adjust the dosage.
The doctor may have performed or is performing a further examination called an endoscopy to
diagnose your condition and/or exclude a malignant disease.
If you experience diarrhea during treatment with LANSOPRAZOLO PENSA, contact
your doctor immediately, as LANSOPRAZOLO PENSA has been associated with a small
increase in infectious diarrhea.
If your doctor has prescribed LANSOPRAZOLO PENSA in addition to other medicines for the
treatment of Helicobacter pyloriinfection (antibiotics) or together with anti-
inflammatory medicines to treat pain or rheumatic diseases: please read carefully also the
If you take LANSOPRAZOLO PENSA for a long time (for more than 1 year) your doctor
will probably keep you under regular observation. You must report any new exceptional
symptom and circumstance whenever you see your doctor.

Other medicines and LANSOPRAZOLO PENSA
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, even those available without a prescription.
In particular, tell your doctor if you are taking medicines containing one of the following active
substances, as LANSOPRAZOLO PENSA can affect their mechanism of action:

• Ketoconazole, itraconazole, rifampicin (used to treat infections)
• digoxin (used to treat heart problems)
• 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 reflux)
• sucralfate (used to heal ulcers)
• St. John's wort (hypericum perforatum) (used to treat mild depression)

LANSOPRAZOLO PENSA with food and drink
To obtain the best results you should take LANSOPRAZOLO PENSA at least 30 minutes before
taking food.

Pregnancy, breastfeeding and fertility
“Ask your doctor or pharmacist for advice before taking any medicine”.
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor for advice before taking this medicine.

Driving and operating machinery
Undesirable effects such as dizziness, vertigo, fatigue and visual disturbances occur sometimes in
patients taking LANSOPRAZOLO PENSA.
If you experience undesirable effects like these, you must be careful because your ability to
pay attention may decrease.
You alone are responsible for deciding whether you are fit to drive a motor vehicle or to
perform other tasks that require increased concentration. The use of medicines
represents one of the factors that can reduce the ability to perform these actions safely, due to
their undesirable effects.
Descriptions of these effects can be found in other paragraphs.
Read all the information contained in this leaflet as a guide.
If you are not sure about something, discuss it with your doctor, nurse or pharmacist.

LANSOPRAZOLO PENSA contains sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking
this medicine.

LANSOPRAZOLO PENSA contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially
‘sodium-free’.

3. HOW TO TAKE LANSOPRAZOLO PENSA

Swallow the capsule whole with a glass of water. If you find it difficult to swallow the capsules, your doctor may advise an alternative way to take the medicine. Do not crush or chew these capsules or the contents of emptied capsules, because the medicine would not work correctly.
If you take LANSOPRAZOLO PENSA once a day, try to take it at the same time each day. You may get better results if you take LANSOPRAZOLO PENSA first thing in the morning.
If you take LANSOPRAZOLO PENSA twice a day, you must take the first dose in the morning and the second dose in the evening.
The dose of LANSOPRAZOLO PENSA depends on your condition. The usual doses of LANSOPRAZOLO PENSA for adults are given below. Your doctor may sometimes prescribe a different dose and will tell you how long the treatment should last.

Treatment of heartburn and acid reflux:one 15 mg or 30 mg capsule every day for 4 weeks. If symptoms persist, you should tell your doctor. If symptoms are not relieved within 4 weeks, contact your doctor.

Treatment of duodenal ulcer:one 30 mg capsule every day for 2 weeks.

Treatment of stomach ulcer:one 30 mg capsule every day for 4 weeks.

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

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

Treatment of infection byHelicobacter pylori:the usual dose is one 30 mg capsule in combination with two different antibiotics in the morning and one 30 mg capsule in combination with two different antibiotics in the evening. The treatment will be every day for 7 days.
The recommended antibiotic combinations are:
30 mg of LANSOPRAZOLO PENSA together with 250-500 mg of clarithromycin and 1g of amoxicillin
30 mg of LANSOPRAZOLO PENSA together with 250 mg of clarithromycin and 400-500 mg of metronidazole
If you are treating your infection because you have an ulcer, it is likely that the ulcer will not recur if the infection is treated successfully. To get the best results from this therapy, take the medicine at the scheduled times and never miss a dose.
Treatment of duodenal or stomach ulcer in patients requiring continuous treatment with NSAIDs:one 30 mg capsule every day for 4 weeks.

Prevention of duodenal or stomach ulcer in patients requiring continuous treatment with NSAIDs:one 15 mg capsule every day, your doctor may adjust the dosage up to one 30 mg capsule every day.

Zollinger-Ellison syndrome:the usual initial dose is two 30 mg capsules every day, then based on your response to LANSOPRAZOLO PENSA your doctor will decide the most suitable dose for you.
Take the medicine exactly as your doctor has told you. If you have any doubts about how to take the medicine, you should consult your doctor.

Children:
The use of LANSOPRAZOLO PENSA is not recommended in children as clinical data are limited. Treatment of children under one year of age should be avoided as available data have not demonstrated benefit in the treatment of gastro-esophageal reflux disease.

If you take more LANSOPRAZOLO PENSA than you should

“In case of accidental ingestion/intake of an excessive dose of Lansoprazolo Pensa

immediately notify your doctor or go to the nearest hospital”.

If you forget to take LANSOPRAZOLO PENSA
If you forget to take a dose, take it as soon as you remember unless it is too close to the next dose. If this happens do not take the forgotten dose and take the rest of the capsules normally. Do not take a double dose to make up for the forgotten capsule.

If you stop taking LANSOPRAZOLO PENSA
Do not stop taking the treatment prematurely if your symptoms have improved. Your condition may not be completely healed and may recur if you do not complete the treatment period.

“If you have any doubts about the use of LANSOPRAZOLO PENSA, ask your doctor or pharmacist

4. POSSIBLE SIDE EFFECTS

Like all medicines, LANSOPRAZOLO PENSA can cause side effects, although not everyone gets them.
The following side effects are common (affect more than 1 in 100 patients)

• headache, dizziness
• diarrhoea, constipation, stomach pain, feeling unwell, intestinal gas (flatulence), dry or inflamed mouth or throat
• skin rash, itching
• changes in liver function tests
• fatigue
• benign polyps in the stomach

The following side effects are uncommon (affect less than 1 in 100 patients)

• depression
• joint and muscle pain
• fluid retention or swelling
• changes in red blood cell count
• fracture of the hip, wrist or spine If you take a proton pump inhibitor like LANSOPRAZOLO PENSA, especially for a period longer than one year, there may be a slight increase in the risk of fractures

of the hip, wrist or spine. If you suffer from osteoporosis or are taking
corticosteroids (which can increase the risk of osteoporosis) consult your doctor.
The following side effects are rare (affect less than 1 in 1,000 patients)

• fever
• restlessness, drowsiness, confusion, hallucination, insomnia, vision disturbances, vertigo
• change in taste, loss of appetite, inflammation of the tongue (glossitis)
• skin reactions such as a burning or tingling sensation under the skin, bruising, redness and excessive sweating
• sensitivity to light
• hair loss
• tingling sensation on the skin (paresthesia), tremor
• anaemia (pallor)
• kidney problems
• pancreatitis
• inflammation of the liver (may cause yellowing of the skin or eyes)
• breast enlargement in men, impotence
• candidiasis (fungal infection, can affect the skin or mucous membranes)
• angioedema; you should immediately go to the doctor if you experience symptoms of angioedema such as swelling of the face, tongue or pharynx, difficulty swallowing, hives and difficulty breathing.

The following side effects are very rare (affect less than 1 in 10,000 patients)

• severe hypersensitivity reactions including shock. Symptoms of hypersensitivity reactions may include fever, rash, swelling and sometimes a drop in blood pressure
• inflammation of the mouth (stomatitis)
• colitis (inflammation of the colon)
• changes in laboratory values such as sodium, cholesterol and triglyceride levels
• very severe skin reactions with redness, blisters, severe inflammation and loss of skin
• very rarely LANSOPRAZOLO PENSA can cause a reduction in the number of white blood cells and resistance to infections may therefore decrease. If you develop an infection with symptoms such as fever and a severe worsening of your general condition, or fever with symptoms of a local infection such as an inflamed throat/pharynx/mouth or urinary problems, go to your doctor immediately. A blood test will be performed to check for a possible reduction in white blood cells (agranulocytosis).

Frequency not known

• hypomagnesemia If you take LANSOPRAZOLO PENSA for more than three months, your blood magnesium levels may decrease. Low magnesium levels can manifest with fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you have any of these symptoms, consult your doctor immediately. Low magnesium levels can also lead to a decrease in blood potassium or calcium levels. The doctor should decide whether to regularly check magnesium levels in the blood.
• cutaneous lupus erythematosus
• erythema, possible joint pain.

Reporting of side effects
If you get any side effect, even if not listed in this leaflet,
tell your doctor or pharmacist. Side effects can also be reported
directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .. Reporting of side
effects helps to provide more information on the safety of this medicine.

5. HOW TO STORE LANSOPRAZOLO PENSA

Keep LANSOPRAZOLO PENSA out of sight and reach of children.
Do not use LANSOPRAZOLO PENSA after the expiry date which is stated on the packaging. The
expiry date refers to the last day of the month.
The expiry date indicated refers to the product in intact packaging, correctly
stored.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What LANSOPRAZOLO PENSA contains
LANSOPRAZOLO PENSA 15 mg hard capsules:
One hard capsule contains: Active ingredient: Lansoprazole 15 mg.
Excipients: Gastro-resistant granules: hypromellose (E-464), talc (E-553b), titanium dioxide (E-171),
methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30%, triethyl citrate (E-1505), sucrose
spheres.
Capsule: gelatin, titanium dioxide (E171), black ink, purified water.

LANSOPRAZOLO PENSA 30 mg hard capsules:
One hard capsule contains: Active ingredient: Lansoprazole 30 mg.
Excipients: Gastro-resistant granules: hypromellose (E-464), talc (E-553b), titanium dioxide (E-171),
methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30%, triethyl citrate (E-1505), sucrose
spheres.
Capsule: gelatin, titanium dioxide (E171), black ink, purified water.

Description of the appearance of LANSOPRAZOLO PENSA and contents of the pack
HDPE bottle
LANSOPRAZOLO PENSA 15 mg hard capsules: 14 and 28 hard capsules for oral use.
LANSOPRAZOLO PENSA 30 mg hard capsules: 14 and 28 hard capsules for oral use.
Blister
LANSOPRAZOLO PENSA 15 mg hard capsules: 14, 28 and 56 hard capsules for oral use.
LANSOPRAZOLO PENSA 30 mg hard capsules: 14, 28 and 56 hard capsules for oral use.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Pensa Pharma S.p.A.
Via Ippolito Rosellini, 12
20124 Milano
Italy

Manufacturer:
Towa Pharmaceutical Europe, S.L.
C/ de Sant Martì 75-97
08107 Martorelles, Barcelona
Spain