Pergastid

Package leaflet: Information for the user

Pergastid 15 mg hard capsules, 30 mg hard capsules

Lansoprazole
“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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Pergastid is and what it is used for

Pergastid contains the active substance lansoprazole, which is a proton pump inhibitor.
Proton pump inhibitors reduce the amount of acid produced in your stomach.
Your doctor may prescribe Pergastid for the following conditions:

• Treatment of duodenal and gastric ulcers
• Treatment of inflammation of the oesophagus (reflux esophagitis)
• Prevention of reflux esophagitis
• Treatment of heartburn and acid regurgitation (gastro-oesophageal reflux disease)
• Treatment of infections caused by the bacterium Helicobacter pylori, when given in combination with antibiotic therapy
• Treatment or prevention of duodenal or gastric ulcers in patients requiring continuous treatment with non-steroidal anti-inflammatory drugs (NSAIDs, used for pain or inflammation)
• Treatment of Zollinger-Ellison syndrome

Talk to your doctor if you do not feel better or if you feel worse.

2. What you should know before taking Pergastid

Do not take Pergastid

• if you are allergic 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 or pharmacist before taking Pergastid.

• Inform your doctor if you have liver disease. Your doctor may need to adjust your dose. 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 Pergastid, contact your doctor immediately, as Pergastid has been associated with a small increased risk of infectious diarrhoea.
• If your doctor has prescribed Pergastid 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: read carefully the package leaflet of these medicines as well.
• If you take Pergastid long-term (for more than 1 year), your doctor will likely monitor you regularly. You must report any new or unusual symptoms and circumstances each time you see your doctor.
• If you have ever had a skin reaction after treatment with a medicine similar to Pergastid that reduces gastric acidity.
• If you notice the appearance of a skin rash, especially in areas exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to stop treatment with Pergastid. Remember to also report any other adverse effects such as joint pain.
• If you are due to undergo a specific blood test (Chromogranin A).

If you take Pergastid for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. Low magnesium levels may also lead to reduced blood levels of potassium or calcium. Your doctor should decide whether to monitor your blood magnesium levels regularly.

Children and adolescents
Pergastid must not be taken by children.

Other medicines and Pergastid
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, tell your doctor if you are taking medicines containing any of the following active substances, as Pergastid 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 reflux)
• sucralfate (used to heal ulcers)
• St. John’s wort (Hypericum perforatum) (used to treat mild depression)

Pergastid with food and drinks
You must take Pergastid at least 30 minutes before eating.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
If you experience adverse effects such as dizziness, vertigo, drowsiness, or visual disturbances after taking Pergastid, you should exercise caution, as your ability to concentrate may be reduced.
You should assess whether you are fit to drive or operate machinery, since taking medicines is one of the factors that may impair your ability to perform these tasks safely due to their effects or side effects (see section 4 “Possible side effects”).

If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

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

3. How to take Pergastid

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Swallow the capsule whole with a glass of water, at least 30 minutes before eating.
If you have difficulty swallowing the capsules, your doctor may suggest an alternative way to take the medicine.
Do not crush or chew the capsules or the contents of emptied capsules, as the medicine will not work properly. If you take Pergastid once daily, try to take it at the same time each day.
You may achieve better results if you take Pergastid first thing in the morning.
If you take Pergastid twice a day, take the first dose in the morning and the second dose in the evening.
The dose of Pergastid depends on your condition.
The recommended doses of Pergastid for adults are listed below.
Your doctor may prescribe a different dose and will inform you how long the treatment should last.

Treatment of heartburn and acid regurgitation (gastroesophageal reflux disease):
The recommended dose is one 15 mg or 30 mg capsule daily for 4 weeks. If symptoms persist, inform your doctor. If symptoms do not improve within 4 weeks, contact your doctor.

Treatment of duodenal ulcer:
The recommended dose is one 30 mg capsule daily for 2 weeks.

Treatment of gastric ulcer:
The recommended dose is one 30 mg capsule daily for 4 weeks.

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

Prevention of reflux oesophagitis:
The recommended dose is one 15 mg capsule daily; your doctor may adjust the dose up to one 30 mg capsule daily.

Treatment of Helicobacter pylori infection:
The recommended 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 lasts for 7 days.
The recommended antibiotic combinations are:

• 30 mg Pergastid together with 250–500 mg clarithromycin and 1,000 mg amoxicillin
• 30 mg Pergastid together with 250 mg clarithromycin and 400–500 mg metronidazole

If you are being treated for this 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 do not miss any dose.

Treatment of duodenal or gastric ulcer in patients requiring continuous NSAID therapy:
The recommended dose is one 30 mg capsule daily for 4 weeks.

Prevention of duodenal or gastric ulcer in patients requiring continuous NSAID therapy (age > 65 or history of gastric or duodenal ulcer):
The recommended dose is one 15 mg capsule daily; your doctor may adjust the dosage up to one 30 mg capsule daily.

Zollinger-Ellison syndrome:
The recommended initial dose is two 30 mg capsules daily; thereafter, based on your response to Pergastid, your doctor will determine the most appropriate dose for you.

Hepatic impairment
Patients with moderate or severe liver disease should be regularly monitored, and your doctor will recommend a reduction in the daily dose.

Elderly
In elderly patients, the dose will be adjusted by the doctor according to individual needs.

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

If you take more Pergastid than you should
If you take more Pergastid than prescribed, seek immediate advice from your doctor.
In case of accidental ingestion or overdose of Pergastid, contact your doctor immediately or go to the nearest hospital.

If you forget to take Pergastid
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 the missed capsule.

If you stop taking Pergastid
Do not stop treatment prematurely even if your 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 questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.

Common (occurs in more than 1 out of 100 patients)

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

Uncommon (occurs in less than 1 out of 100 patients)

• depression
• joint and muscle pain
• fluid retention or swelling
• reduced number of platelets and white blood cells in the blood
• hip, wrist or spinal fractures. If you are taking a proton pump inhibitor such as Pergastid, especially for longer than one year, there may be a slight increase in the risk of hip, wrist or spinal fractures.

If you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis), consult your doctor.

Rare (occurs in less than 1 out of 1,000 patients)

• fever
• restlessness, drowsiness, confusion, hallucinations, insomnia, vision disturbances, dizziness
• disturbances in taste sensation, loss of appetite, inflammation of the tongue (glossitis)
• skin reactions such as red spots (petechiae and purpura), erythema multiforme, and excessive sweating
• sensitivity to light
• hair loss
• tingling sensation on the skin (paraesthesia), tremor
• anaemia
• kidney problems
• pancreatitis
• inflammation of the liver and jaundice (yellowing of the skin or eyes)
• breast enlargement in men, impotence
• oesophageal candidiasis (fungal infection, may affect skin or mucosa)
• angioedema; you must immediately see a doctor if you experience symptoms of angioedema such as swelling of the face, tongue or throat, difficulty swallowing, hives, and breathing difficulties.

Very rare (occurs in less than 1 out of 10,000 patients)

• severe allergic reactions including shock. Symptoms of allergic 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
• very severe skin reactions with redness, blistering, severe inflammation and skin loss (Stevens-Johnson syndrome and toxic epidermal necrolysis)
• decrease in all blood cells (red blood cells, white blood cells and platelets)
• very rarely, Pergastid may cause a reduction in the number of white blood cells, and therefore resistance to infections may decrease. If you develop an infection with symptoms such as fever and severe worsening of your general condition, or fever with signs of local infection such as inflamed throat/pharynx/mouth or urinary problems, you must immediately see a doctor. A blood test will be performed to check for a possible reduction in white blood cells (agranulocytosis).

Not known (frequency cannot be estimated from available data)

• hypomagnesaemia

If you take Pergastid for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness and increased heart rate. Low magnesium levels may also lead to reduced levels of potassium or calcium in the blood. Your doctor should decide whether to regularly monitor your blood magnesium levels.

• cutaneous lupus erythematosus
• erythema, possible joint pain

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

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

5. How to store Pergastid

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label.
The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not dispose of any medicine via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer used.
This will help protect the environment.

6. Package contents and other information

What Pergastid contains

• The active substance is lansoprazole
• The other components are: sucrose and maize starch spheres, heavy magnesium carbonate, hypromellose, polysorbate 80, macrogol 6000, triethyl citrate, talc, titanium dioxide (E171), methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30% (Eudragit L30 D-55), sodium hydroxide; capsule components: gelatin, titanium dioxide (E171), erythrosine (E127), iron oxide red (E172)

Description of the appearance of Pergastid and contents of the pack
Hard capsules containing gastro-resistant granules
Pergastid 15 mg hard capsules: boxes of 14 capsules
Pergastid 30 mg hard capsules: boxes of 14 capsules
Marketing Authorization Holder
AGIPS FARMACEUTICI S.r.l. – Via Amendola, 4 – 16035 Rapallo (GE)
Manufacturer:
Laboratorios Salvat, S.A. – C/Gall 30-36 – Esplugues del Llobregat - Barcelona (Spain)