Ermès

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ermes 15 mg hard capsules, 30 mg hard capsules

Lansoprazole
EQUIVALENT 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 adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Ermes is and what it is used for

The active substance of Ermes is lansoprazole, which is a proton pump inhibitor.
Proton pump inhibitors reduce the amount of acid produced by your stomach.
Your doctor may prescribe Ermes 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 Ermes for an indication or dosage different from that stated in this leaflet. Follow your doctor's instructions for taking the medicine.

2. What you need to know before taking Ermes

Do not take Ermes:

• 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 or pharmacist before taking Ermes:

• if you have ever had a skin reaction after treatment with a medicine similar to Ermes that reduces gastric acidity.
• if you need to undergo a specific blood test (Chromogranin A).

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 discontinue treatment with Ermes.
Remember to also report any other adverse effects such as joint pain.
Tell your doctor if you have severe liver disease. Your doctor may need to adjust the dose.
Your doctor may perform or may have already performed an additional examination called endoscopy to diagnose your condition and/or rule out malignancy.
If you develop diarrhoea during treatment with Ermes, contact your doctor immediately, as Ermes has been associated with a slight increase in the risk of infectious diarrhoea.
If your doctor has prescribed Ermes in combination with other medicines for the treatment of Helicobacter pylori infection (antibiotics) or together with anti-inflammatory medicines for pain or rheumatic diseases: please read carefully the package leaflet of these medicines as well.
If you take Ermes 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.
If you take a proton pump inhibitor such as ERMES, especially for longer than 1 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 may increase the risk of osteoporosis), consult your doctor.
During treatment with lansoprazole, inflammation of the kidneys may occur.
Signs and symptoms may include decreased urine volume or blood in the urine and/or hypersensitivity reactions such as fever, skin rash, and joint stiffness. These signs must be reported to your doctor.

Other medicines and Ermes
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
In particular, tell your doctor if you are taking medicines containing any of the following active substances, as Ermes 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)

Ermes with food and drinks
For best results, take Ermes at least 30 minutes before eating food.

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
If you are pregnant, think you may be pregnant, plan 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 Ermes.
If you experience such adverse effects, you should be cautious, as your ability to concentrate may be reduced.
You are solely responsible for deciding whether you are fit to drive a motor vehicle or perform other tasks requiring increased concentration. The use of medicines is one of the factors that may impair 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 in this leaflet as a guide.
If you are unsure about anything, discuss it with your doctor or pharmacist.

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

3. How to take Ermes

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Swallow the capsule whole with a glass of water. If you find it difficult to swallow the capsules, your doctor may advise you on an alternative way to take 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 Ermes once daily, try to take it at the same time every day. You may achieve better results if you take Ermes first thing in the morning.
If you take Ermes twice daily, you should take the first dose in the morning and the second dose in the evening.
The dose of Ermes depends on your condition. The usual doses of Ermes 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 combined with two different antibiotics, and one 30 mg capsule in the evening combined with two different antibiotics. The treatment lasts for 7 days.
The recommended antibiotic combinations are:
30 mg of Ermes together with 250–500 mg of clarithromycin and 1,000 mg of amoxicillin
30 mg of Ermes together with 250 mg of clarithromycin and 400–500 mg of metronidazole
If you are being treated for the 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, depending on your response to Ermes, your doctor will decide the most appropriate dose for you.

Use in children:
The use of Ermes is not recommended in children because clinical data are limited.
Treatment of children under one year of age should be avoided, as available data have not shown beneficial effects in the treatment of gastro-oesophageal reflux disease.

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

If you forget to take Ermes
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 Ermes
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 questions about the use of Ermes, consult your doctor or pharmacist.

4. Possible side effects

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

The following side effects are common (may 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 stomach polyps

The following side effects are uncommon (may affect 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 Ermes, 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 side effects are rare (may affect less than 1 in 1,000 patients):

• fever
• restlessness, drowsiness, confusion, hallucinations, insomnia, vision 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 as 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 see a doctor if you experience symptoms of angioedema such as swelling of the face, tongue or pharynx, difficulty swallowing, hives, or breathing difficulties.

The following side effects are very rare (may affect 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
• very severe skin reactions with redness, blistering, severe inflammation, and skin loss
• very rarely, Ermes 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).

Frequency not known:

• hypomagnesaemia
  If you take Ermes for more than three months, your blood magnesium levels may decrease. Low magnesium levels may cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, 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 to periodically monitor your blood magnesium levels.
• erythema, possible joint pain, visual hallucinations

Following the instructions provided in the package leaflet reduces the risk of side effects.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. Side effects can also be reported directly via the national reporting system at the following website:
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Ermes

Keep this medicine out of the sight and reach of children.
Do not use Ermes 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 medicines via 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 Ermes 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) 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 Ermes and contents of the pack
Gastro-resistant granule-filled hard capsules.
Ermes 15 mg hard capsules: Boxes of 14 and 28 capsules.
Ermes 30 mg hard capsules: Boxes of 14 and 28 capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder
LANOVA FARMACEUTICI S.r.l.
Via Conca D’oro, 212 – 00141 Rome, Italy

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

This patient information leaflet was last updated