Lansoprazole PensA

PACKAGE LEAFLET

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

Generic medicine
Please read this leaflet carefully before 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. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. WHAT IS LANSOPRAZOLE PENSA AND WHAT IS IT USED FOR?

The active substance of LANSOPRAZOLE PENSA is lansoprazole, which is a proton pump
inhibitor. Proton pump inhibitors reduce the amount of acid produced by your stomach.
Your doctor may prescribe LANSOPRAZOLE PENSA for the following indications:

• 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 bacterium Helicobacter pylori, when administered in combination with antibiotic therapy
• Treatment or prevention of duodenal or gastric ulcers in patients requiring ongoing treatment with non-steroidal anti-inflammatory drugs (NSAIDs, used for pain or inflammation)
• Treatment of Zollinger-Ellison syndrome

Your doctor may have prescribed LANSOPRAZOLE PENSA for another indication or at a
different dosage than that stated in this leaflet. Follow your doctor's instructions when taking this medicine.

2. WHAT YOU SHOULD KNOW BEFORE TAKING LANSOPRAZOLE PENSA

Do not take LANSOPRAZOLE PENSA:

• if you are allergic (hypersensitive) to lansoprazole or to 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 LANSOPRAZOLE PENSA:

• if you have ever had a skin reaction after treatment with a medicine similar to LANSOPRAZOLE PENSA that reduces gastric acidity. If you notice the appearance of a skin rash, especially in areas exposed to sunlight, contact your doctor as soon as possible, as it may be necessary to stop treatment with LANSOPRAZOLE PENSA. Remember to also report any other adverse effects such as joint pain.
• if you need to undergo a specific blood test (Chromogranin A).

Be careful with LANSOPRAZOLE PENSA
Tell your doctor if you have severe liver disease. Your doctor may need to adjust the dosage.
Your doctor may perform or may have already performed an additional examination called endoscopy to diagnose your condition and/or exclude malignant disease.
If you develop diarrhoea during treatment with LANSOPRAZOLE PENSA, contact your doctor immediately, as LANSOPRAZOLE PENSA has been associated with a slightly increased risk of infectious diarrhoea.
If your doctor has prescribed LANSOPRAZOLE PENSA in addition to other medicines for the treatment of Helicobacter pylori infection (antibiotics) or together with anti-inflammatory medicines for treating pain or rheumatic diseases: please read carefully the package leaflet of these medicines as well.
If you take LANSOPRAZOLE PENSA long-term (for more than 1 year), your doctor will likely monitor you regularly. You must report any new or unusual symptoms and circumstances at every visit to your doctor.

Other medicines and LANSOPRAZOLE PENSA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
In particular, tell your doctor if you are taking medicines containing any of the following active substances, as LANSOPRAZOLE PENSA may 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 regurgitation)
• sucralfate (used to heal ulcers)
• St. John’s wort (Hypericum perforatum) (used to treat mild depression)

LANSOPRAZOLE PENSA with food and drinks
To achieve the best results, you must take LANSOPRAZOLE PENSA at least 30 minutes before eating.

Pregnancy, breastfeeding and fertility
“Ask your doctor or pharmacist for advice before taking any medicine.”
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.

Driving and using machines
Adverse effects such as dizziness, vertigo, fatigue, and visual disturbances may occasionally occur in patients taking LANSOPRAZOLE PENSA.
If you experience effects like these, you should be cautious, as your ability to concentrate may be reduced.
Only you are responsible for deciding whether you are fit to drive a motor vehicle or perform other tasks requiring heightened concentration. The use of medicines is one of the factors that may impair your ability to safely perform these activities due to their adverse effects.
Descriptions of these effects can be found in other sections.
Read all the information contained in this leaflet carefully.
If you are unsure about anything, discuss it with your doctor, nurse, or pharmacist.

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

LANSOPRAZOLE 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 LANSOPRAZOLE PENSA

Swallow the capsule whole with a glass of water. If you have difficulty swallowing the capsules, your doctor may recommend an alternative way to take the medicine. Do not crush or chew these capsules or the contents of emptied capsules, as the medicine would not work properly.
If you take LANSOPRAZOLE PENSA once daily, try to take it at the same time every day. You may achieve better results if you take LANSOPRAZOLE PENSA first thing in the morning.
If you take LANSOPRAZOLE PENSA twice daily, you should take the first dose in the morning and the second dose in the evening.

The dose of LANSOPRAZOLE PENSA depends on your condition. The usual doses of LANSOPRAZOLE PENSA for adults are listed below. Your doctor may sometimes prescribe a different dose and will inform you how long the treatment should last.

Treatment of heartburn and acid regurgitation: one 15 mg or 30 mg capsule daily for 4 weeks. If symptoms persist, inform your doctor. If symptoms are not relieved within 4 weeks, contact your doctor.

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

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

Treatment of inflammation of the oesophagus (reflux oesophagitis): one 30 mg capsule daily for 4 weeks.

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

Treatment of Helicobacter pylori infection: the usual dose is one 30 mg capsule in the morning in combination with two different antibiotics, and one 30 mg capsule in the evening in combination with two different antibiotics. The treatment lasts for 7 days.

The recommended antibiotic combinations are:

• 30 mg of LANSOPRAZOLE PENSA together with 250–500 mg of clarithromycin and 1 g of amoxicillin
• 30 mg of LANSOPRAZOLE PENSA together with 250 mg of clarithromycin and 400–500 mg of metronidazole

If you are being treated for H. pylori infection because you have an ulcer, the ulcer is unlikely to recur if the infection is successfully treated. To achieve the best results from this therapy, take the medicine at the scheduled times and never miss a dose.

Treatment of duodenal or gastric ulcer in patients requiring ongoing NSAID treatment: one 30 mg capsule daily for 4 weeks.

Prevention of duodenal or gastric ulcer in patients requiring ongoing NSAID treatment: one 15 mg capsule daily; your doctor may adjust the dose up to one 30 mg capsule daily.

Zollinger-Ellison syndrome: the usual initial dose is two 30 mg capsules daily; thereafter, depending on your response to LANSOPRAZOLE PENSA, your doctor will decide the most appropriate dose for you.

Take the medicine exactly as prescribed by your doctor. If you have any doubts about how to take the medicine, consult your doctor.

Children:
The use of LANSOPRAZOLE 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 treating gastro-oesophageal reflux disease.

If you take more LANSOPRAZOLE PENSA than you should
"In case of accidental ingestion/overdose of LANSOPRAZOLE PENSA, contact your doctor immediately or go to the nearest hospital."

If you forget to take LANSOPRAZOLE PENSA
If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose. In that case, do not take the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a forgotten capsule.

If you stop taking LANSOPRAZOLE PENSA
Do not stop treatment prematurely, even if your symptoms have improved. Your condition may not be fully healed and symptoms may return if you do not complete the full course of treatment.

"If you have any doubts about the use of LANSOPRAZOLE PENSA, consult your doctor or pharmacist."

4. POSSIBLE ADVERSE EFFECTS

Like all medicines, LANSOPRAZOLE PENSA may cause adverse effects, although not everyone experiences them.

The following adverse effects are common (occur in more than 1 in 100 patients):

• Headache, dizziness
• Diarrhea, constipation, stomach pain, feeling unwell, gas (flatulence), dry or inflamed mouth or throat
• Skin rash, itching
• Changes in liver function tests
• Fatigue
• Benign stomach polyps

The following adverse effects are uncommon (occur in less than 1 in 100 patients):

• Depression
• Joint and muscle pain
• Fluid retention or swelling
• Changes in red blood cell count
• Fractures of the hip, wrist, or spine
  If you are taking a proton pump inhibitor such as LANSOPRAZOLE PENSA, especially for more than one year, there may be a slight increase in the risk of fractures of the hip, wrist, or spine. If you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis), consult your doctor.

The following adverse effects are rare (occur in less than 1 in 1,000 patients):

• Fever
• Restlessness, drowsiness, confusion, hallucinations, insomnia, visual disturbances, dizziness
• Altered taste sensation, loss of appetite, inflammation of the tongue (glossitis)
• Skin reactions such as burning or tingling sensation under the skin, bruising, redness, and excessive sweating
• Light sensitivity
• Hair loss
• Skin tingling sensation (paresthesia), tremor
• Anemia (pallor)
• Kidney problems
• Pancreatitis
• Liver inflammation (may present with yellowing of the skin or eyes)
• Breast enlargement in men, impotence
• Candidiasis (fungal infection, may affect the skin or mucous membranes)
• Angioedema; you must immediately contact your doctor if you experience symptoms of angioedema such as swelling of the face, tongue, or pharynx, difficulty swallowing, hives, or breathing difficulties.

The following adverse effects are very rare (occur in less than 1 in 10,000 patients):

• Severe hypersensitivity reactions including shock. Symptoms of hypersensitivity reactions may include fever, rash, swelling, and sometimes low blood pressure
• Inflammation of the mouth (stomatitis)
• Colitis (inflammation of the colon)
• Changes in laboratory values such as sodium, cholesterol, and triglyceride levels
• Severe skin reactions with redness, blistering, severe inflammation, and skin loss
• Very rarely, LANSOPRAZOLE PENSA may cause a reduction in white blood cell count, thereby reducing resistance to infections. If you develop an infection with symptoms such as fever and severe worsening of your general condition, or fever with signs of localized infection such as inflamed throat/pharynx/mouth or urinary problems, seek immediate medical attention. A blood test will be performed to check for a possible reduction in white blood cells (agranulocytosis).

Frequency not known:

• Hypomagnesemia
  If you take LANSOPRAZOLE PENSA for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or increased heart rate. If you experience any of these symptoms, consult your doctor immediately. Low magnesium levels may also lead to reduced blood levels of potassium or calcium. Your doctor should decide whether regular monitoring of blood magnesium levels is necessary.
• Cutaneous lupus erythematosus
• Erythema, possible joint pains.
  “Following the instructions provided in this leaflet reduces the risk of adverse effects.”

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, talk to your doctor or pharmacist. Adverse effects can also be reported directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting adverse effects contributes to providing further information on the safety of this medicine.

5. HOW TO STORE LANSOPRAZOLE PENSA

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

6. PACK CONTENTS AND OTHER INFORMATION

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

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

Description of the appearance of LANSOPRAZOLO PENSA and pack contents
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 Authorization Holder and Manufacturer
Marketing Authorization Holder:
Pensa Pharma S.p.A.
Via Ippolito Rosellini, 12
20124 Milan
Italy

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

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