Peptirex: detailed information

Peptirex 15 mg hard capsules
Peptirex 30 mg hard capsules
EQUIVALENT MEDICINE
Please read this leaflet carefully before taking this medicine, as 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 they have the same symptoms as you, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Peptirex is and what it is used for
What you need to know before taking Peptirex
How to take Peptirex
Possible side effects
How to store Peptirex
Package contents and other information

1. WHAT PEPTIREX IS AND WHAT IT IS USED FOR

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

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 continuous treatment with non-steroidal anti-inflammatory drugs (NSAIDs, used for pain or inflammation)
Treatment of Zollinger-Ellison syndrome

Your doctor may have prescribed Peptirex for another indication or at a different dosage than that stated in this patient information leaflet. Follow your doctor's instructions for taking the medicine.

2. WHAT YOU SHOULD KNOW BEFORE TAKING PEPTIREX

Do not take Peptirex:

if you are allergic to lansoprazole or to any of the excipients in Peptirex (listed in section 6).
if you are taking a medicine containing the active substance atazanavir (used in the treatment of HIV).

Warnings and precautions
Tell your doctor if you have severe liver disease. Your doctor may need to adjust your dose.
Your doctor may perform or may have already performed an additional test called endoscopy to diagnose
your condition and/or rule out malignant disease.
If you develop diarrhoea during treatment with Peptirex, contact your doctor immediately, as Peptirex has
been associated with a small increased risk of infectious diarrhoea.
If your doctor has prescribed Peptirex in combination with other medicines for the treatment of
Helicobacter pylori infection (antibiotics) or together with anti-inflammatory medicines to treat pain or
rheumatic diseases: please read carefully the package leaflet of these medicines as well.
If you take Peptirex 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.
During treatment with lansoprazole, inflammation of the kidneys may occur. Signs and symptoms may
include reduced urine volume or blood in the urine and/or hypersensitivity reactions such as fever, rash,
and joint stiffness. These signs should be reported to your doctor.
Talk to your doctor before taking Peptirex:

if you have ever had a skin reaction after treatment with a medicine similar to Peptirex that reduces stomach acid.
if you need to undergo a specific blood test (chromogranin A).

If you notice the appearance of a skin rash, especially in sun-exposed areas, consult your doctor as soon
as possible, as it may be necessary to discontinue treatment with Peptirex. Remember to also report any
other adverse effects such as joint pain.
Other medicines and Peptirex
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicine, including those without a prescription.
In particular, tell your doctor if you are taking medicines containing any of the following active substances,
as Peptirex 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 organ 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)

Peptirex with food and drinks
For best results, take Peptirex at least 30 minutes before eating food.
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
Adverse effects such as dizziness, vertigo, fatigue, and visual disturbances may occasionally occur in
patients taking Peptirex.
If you experience such adverse effects, you should be cautious, as your ability to concentrate may be
impaired.
You are solely 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 reduce your ability
to perform these activities safely, due to their effects or side effects.
Descriptions of these effects can be found in other sections.
Read all the information contained in this leaflet as a guide.
If you are unsure about anything, discuss it with your doctor, nurse, or pharmacist.
Peptirex contains sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this
medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially ‘sodium-free’.

3. HOW TO TAKE PEPTIREX

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. If you have difficulty swallowing the capsules, your doctor may suggest an alternative way of taking the medicine. Do not crush or chew these capsules or the contents of emptied capsules, as the medicine will not work properly.
If you take Peptirex once daily, try to take it at the same time each day. You may achieve better results if you take Peptirex first thing in the morning.
If you take Peptirex twice daily, you should take the first dose in the morning and the second dose in the evening.
The dose of Peptirex depends on your condition. The recommended doses of Peptirex for adults are listed below. Your doctor may sometimes prescribe a different dose and will inform you of the duration of treatment.

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 combination with two different antibiotics in the morning and one 30 mg capsule in combination with two different antibiotics in the evening. Treatment lasts for 7 days.
The recommended antibiotic combinations are:
30 mg of Peptirex together with 250–500 mg of clarithromycin and 1,000 mg of amoxicillin
30 mg of Peptirex together with 250 mg of clarithromycin and 400–500 mg of 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 treatment: one 30 mg capsule daily for 4 weeks.
Prevention of duodenal or gastric ulcer in patients requiring continuous 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, based on your response to Peptirex, your doctor will determine the most appropriate dose for you.

Use in children
Peptirex must not be given to children.
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 Peptirex than you should
If you take more Peptirex than prescribed, seek immediate advice from your doctor.
In case of accidental ingestion or overdose of Peptirex*, contact your doctor immediately or go to the nearest hospital.*

If you forget to take Peptirex
If you forget to take a dose, take it as soon as you remember, unless it is almost time for the next dose. In that case, skip the missed dose and take the next capsules at the usual time. Do not take a double dose to make up for a forgotten capsule.

If you stop taking Peptirex
Do not stop treatment prematurely, even if your symptoms have improved. Your condition may not be fully 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 ADVERSE REACTIONS

Like all medicines, Peptirex can cause adverse reactions, although not everyone experiences them.

The following adverse reactions are common (occur in more than 1 out of 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 adverse reactions are uncommon (occur in less than 1 out of 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 take a proton pump inhibitor such as Peptirex, 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 have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis), consult your doctor.

The following adverse reactions are rare (occur in less than 1 out of 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 prickling sensation under the skin, bruising, redness, and excessive sweating
light sensitivity
hair loss
tingling sensation on the skin (paraesthesia), tremor
anaemia (pallor)
kidney problems
pancreatitis
liver inflammation (may present with yellowing of the skin or eyes)
breast swelling in men, impotence
candidiasis (fungal infection, may affect skin or mucous membranes)
angioedema; you must immediately see a doctor if you experience symptoms of angioedema such as swelling of the face, tongue or pharynx, difficulty swallowing, urticaria, or breathing difficulties

The following adverse reactions are very rare (occur in less than 1 out of 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
very severe skin reactions with redness, blistering, severe inflammation, and skin loss
very rarely, Peptirex 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).

The following adverse reactions have unknown frequency:

hypomagnesaemia
If you take Peptirex for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present with fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and 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 pain
visual hallucinations

Following the instructions contained in this leaflet reduces the risk of adverse reactions.
Reporting of adverse reactions
If any adverse reaction occurs, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report adverse reactions directly through the national reporting system: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE PEPTIREX

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

6. PACKAGING CONTENTS AND OTHER INFORMATION

What Peptirex contains
The active substance is lansoprazole.
The excipients 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) 30% dispersion (Eudragit L30 D-55), sodium hydroxide; capsule components: gelatin, titanium dioxide (E171), erythrosine (E127), iron oxide red (E172).

Description of the appearance of Peptirex and packaging contents
Hard capsules containing gastro-resistant granules.
Peptirex 15 mg hard capsules: Cartons containing 14 or 28 capsules.
Peptirex 30 mg hard capsules: Cartons containing 14 or 28 capsules.

Marketing Authorization Holder
I.B.N. Savio Srl
Via del Mare, 36 – POMEZIA (RM)

Manufacturer:
Laboratorios Salvat, S.A. – C/Gall 30-36 – Esplugues del Llobregat - Barcelona (Spain)
Special Product’s Line Spa – Via Fratta Rotonda Vado Largo, 1 – 03012 Anagni (FR) – Italy