Esomeprazole Zentiva

Package leaflet: Information for the user

Esomeprazole Zentiva 20 mg gastro-resistant hard capsules, 40 mg gastro-resistant hard capsules

Please read all of this leaflet carefully before you start 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, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Esomeprazole Zentiva is and what it is used for

Esomeprazole Zentiva contains an active substance called esomeprazole, which belongs to a group of
medicines known as "proton pump inhibitors". These medicines work by reducing the amount of
acid produced by your stomach.
Esomeprazole Zentiva is used to treat the following conditions:
Adults and adolescents from 12 years of age

• Gastro-oesophageal reflux disease (GORD). In this condition, acid moves from the stomach into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation and heartburn.
• Stomach or upper intestinal ulcers infected with bacteria called "Helicobacter pylori". If you have this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

Adults

• Stomach ulcers caused by medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Esomeprazole Zentiva may also be used to prevent the formation of stomach ulcers if you are taking NSAIDs.
• Excess acid production due to enlargement of the pancreas (Zollinger-Ellison syndrome).
• Long-term treatment following prevention of ulcer bleeding with intravenous esomeprazole.

Adolescents from 12 years of age

• Gastro-oesophageal reflux disease (GORD). This occurs when acid passes from the stomach into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation and heartburn.
• Stomach or upper intestinal ulcers infected with bacteria called "Helicobacter pylori". If you have this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

2. WHAT YOU SHOULD KNOW BEFORE TAKING ESOMEPRAZOLE ZENTIVA

Do not take Esomeprazole Zentiva

• If you are allergic to esomeprazole or to any of the excipients of this medicine (listed in section 6).
• If you are allergic to other proton pump inhibitor medicines (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole).
• If you are taking a medicine containing nelfinavir (used to treat HIV infection).

Do not take Esomeprazole Zentiva if any of these apply to you. If you have any doubts, consult your doctor or pharmacist before taking Esomeprazole Zentiva.

Warnings and precautions

Consult your doctor or pharmacist before taking Esomeprazole Zentiva:

• If you have severe liver problems.
• If you have severe kidney problems.
• If you have previously experienced a serious skin reaction after treatment with medicines similar to Esomeprazole Zentiva that reduce stomach acidity. * if you are due to undergo a specific blood test (chromogranin A). *

Esomeprazole Zentiva may mask the symptoms of other diseases. Therefore, if any of the following conditions occur before you start taking Esomeprazole Zentiva or while you are taking it, contact your doctor immediately:

• If you lose a lot of weight without reason and have difficulty swallowing.
• If you have stomach pain or indigestion.
• If you vomit food or blood.
• If you have dark stools (blood in the stool).

If you have been prescribed Esomeprazole Zentiva “as needed”, you must contact your doctor if symptoms persist or change in nature.

If you take a proton pump inhibitor such as Esomeprazole Zentiva, 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 suffer from osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis), consult your doctor.

If you develop a skin rash, particularly in areas exposed to sunlight, contact your doctor as soon as possible, as it may be necessary to discontinue treatment with Esomeprazole Zentiva. Remember to report any other symptoms such as joint pain.

Children under 12 years of age

Dosage information for children aged 1 to 11 years is available in the product information for esomeprazole granules (ask your doctor or pharmacist for further information).

Other medicines and Esomeprazole Zentiva

Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines purchased without a prescription. Esomeprazole Zentiva may affect how some medicines work, and some medicines may affect Esomeprazole Zentiva.

Do not take Esomeprazole Zentiva capsules if you are taking a medicine containing nelfinavir (used to treat HIV infections).

Inform your doctor or pharmacist if you are taking any of the following medicines:

* atazanavir (used to treat HIV infections);
* clopidogrel (used to prevent blood clots);
* ketoconazole, itraconazole or voriconazole (used to treat fungal infections);
* citalopram, imipramine or clomipramine (used to treat depression);
* diazepam (used to treat anxiety, to relax muscles or in epilepsy);
* phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when starting or stopping treatment with Esomeprazole Zentiva;
* medicines used to thin the blood, such as warfarin. Your doctor may need to monitor you when starting or stopping treatment with Esomeprazole Zentiva;
* cilostazol (used to treat intermittent claudication, leg pain when walking caused by inadequate blood supply);
* cisapride (used for indigestion and heartburn);
* digoxin (used for heart problems);
* methotrexate (a chemotherapy medicine used at high doses to treat cancer) – If you are taking high doses of methotrexate, your doctor may temporarily stop treatment with Esomeprazole Zentiva;
* tacrolimus (used in organ transplantation);
* rifampicin (used to treat tuberculosis);
* St John’s wort (Hypericum perforatum) (used to treat depression).

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin together with Esomeprazole Zentiva to treat ulcers caused by Helicobacter pylori infection, it is very important that you inform your doctor if you are taking any other medicines.

Esomeprazole Zentiva with food and drinks

You may take the capsules with food or on an empty stomach.

Pregnancy, breast-feeding and fertility

If you are pregnant, think you may be pregnant or are planning to become pregnant, or if you are breast-feeding, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will decide whether you can take Esomeprazole Zentiva during this time.

It is not known whether Esomeprazole Zentiva passes into breast milk. Therefore, you should not take Esomeprazole Zentiva if you are breast-feeding.

Driving and using machines

It is unlikely that Esomeprazole Zentiva will affect your ability to drive or use tools or machines. However, side effects such as dizziness and blurred vision may rarely or uncommonly occur (see section 4). If these occur, do not drive or use machines.

Esomeprazole Zentiva contains sucrose, a type of sugar, propyl-p-hydroxybenzoate (E216) and methyl-p-hydroxybenzoate (E218)

• If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.
• Parahydroxybenzoates may cause allergic reactions (possibly delayed).

3. How to take Esomeprazolo Zentiva

Take this medicine exactly as instructed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.

• If you have been taking this medicine for a long time, your doctor will want to monitor you (especially if you have been taking it for more than one year).
• If your doctor has told you to take this medicine as and when needed, inform your doctor if your symptoms change.

How much Esomeprazolo Zentiva to take
* Your doctor will tell you how many capsules to take and for how long. This will depend on your condition,
your age, and how well your liver is working.
* The recommended doses are listed below.
Adults
For the treatment of heartburn caused by gastro-oesophageal reflux disease (GORD):
* If your doctor has found that your oesophagus has been slightly damaged, the recommended dose is
one capsule of Esomeprazolo Zentiva 40 mg once daily for 4 weeks. Your doctor may tell you to take the
same dose for another 4 weeks if your oesophagus has not yet healed.
* The recommended dose once your oesophagus has healed is one capsule of Esomeprazolo Zentiva 20 mg
once daily.
* If your oesophagus has not been damaged, the recommended dose is one capsule of Esomeprazolo
Zentiva 20 mg daily. Once your condition is under control, your doctor may tell you to take the medicine
as and when needed, up to a maximum dose of one capsule of Esomeprazolo Zentiva 20 mg daily.
* If you have severe liver problems, your doctor may prescribe a lower dose.
For the treatment of ulcers caused by Helicobacter pylori infection and to prevent them from returning:
* The recommended dose is one capsule of Esomeprazolo Zentiva 20 mg twice daily for one
week.
* Your doctor will also tell you to take antibiotics, for example amoxicillin and clarithromycin.
For the treatment of ulcers caused by NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):
* The recommended dose is one capsule of Esomeprazolo Zentiva 20 mg once daily for 4-8
weeks.
For the prevention of stomach ulcers if you are taking NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):

• The recommended dose is one capsule of Esomeprazolo Zentiva 20 mg once daily.

For the treatment of excess stomach acid caused by a growth in the pancreas (Zollinger-Ellison syndrome):
* The recommended dose is one capsule of Esomeprazolo Zentiva 40 mg twice daily.
* Your doctor will adjust your dose according to your needs and will also decide how long you should
take this medicine. The maximum dose is 80 mg twice daily.
Long-term treatment following prevention of ulcer bleeding with intravenous esomeprazole:
The recommended dose is one capsule of Esomeprazolo Zentiva 40 mg once daily for 4 weeks.
Adolescents aged 12 years and above
For the treatment of heartburn caused by gastro-oesophageal reflux disease (GORD):

• If your doctor has found that the food pipe (oesophagus) has been slightly damaged, the recommended dose is one capsule of Esomeprazolo Zentiva 40 mg once daily for 4 weeks. Your doctor may tell you to take the same dose for another 4 weeks if the oesophagus has not yet healed.
• The recommended dose once the oesophagus has healed is one capsule of Esomeprazolo Zentiva 20 mg once daily.
• If the oesophagus has not been damaged, the recommended dose is one capsule of Esomeprazolo Zentiva 20 mg daily. Once control has been achieved, your doctor may tell you to take the medicine as and when needed, up to a maximum of one capsule of Esomeprazolo Zentiva 20 mg daily.
• If you have severe liver problems, your doctor may give you a lower dose.

For the treatment of ulcers caused by Helicobacter pylori infection and to prevent them from returning:

• The recommended dose is one capsule of Esomeprazolo Zentiva 20 mg twice daily for one week.
• Your doctor will also tell you to take antibiotics, for example amoxicillin and clarithromycin.

How to take this medicine
* You may take the capsules at any time of day.
* You may take the capsules with food or on an empty stomach.
* Swallow the capsules whole with a glass of water. Do not chew or crush the capsules or their
contents. This is because the capsules contain coated granules that prevent the medicine from being
destroyed by stomach acid. It is important not to damage the granules.
What to do if you have difficulty swallowing the capsules

• If you have difficulty swallowing the capsules: 1) Open the capsule and empty the contents (the granules) into a glass of plain water (not sparkling). Do not use other liquids. 2) Stir. Then drink the mixture immediately or within 30 minutes. Always stir the mixture just before drinking. 3) To make sure you have taken all the medicine, rinse the glass with half a glass of water and drink it. The solid particles contain the medicine – do not chew or crush them.
• If you are unable to swallow anything, the granules can be mixed with a small amount of water and placed in a syringe. They can then be administered through a tube directly into the stomach (“gastric feeding tube”).

Children under 12 years of age
Esomeprazolo Zentiva capsules are not recommended for children under 12 years of age.
Elderly
Dose adjustment is not required in the elderly.
If you take more Esomeprazolo Zentiva than you should
If you take more Esomeprazolo Zentiva than prescribed by your doctor, inform your doctor or pharmacist immediately.
If you forget to take Esomeprazolo Zentiva
* If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose.
* Do not take a double dose (two doses at the same time) to make up for a forgotten dose.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
If you notice any of the following serious side effects, stop treatment with Esomeprazole Zentiva and contact your doctor immediately:
* Sudden breathlessness, swelling of the lips, tongue or throat or body, rash, fainting or difficulty swallowing (severe allergic reaction).
* Skin redness with blistering or peeling. There may be severe blistering and bleeding also on the lips, eyes, mouth, nose and genitals. This could be "Stevens-Johnson syndrome" or "toxic epidermal necrolysis".
* Yellowing of the skin, dark urine and fatigue, which may be symptoms of liver problems.
These effects are rare and may affect between 1 and 10 people in 10,000.

Other side effects include:
Common (may affect up to 1 in 10 people)
* Headache.
* Stomach or intestinal problems: diarrhoea, stomach pain, constipation, flatulence, benign polyps in the stomach.
* Nausea or vomiting.

Uncommon (may affect up to 1 in 100 people)
* Swelling of the feet and ankles.
* Sleep disorders (insomnia).
* Dizziness, tingling sensations such as "pins and needles", drowsiness.
* Vertigo.
* Dry mouth.
* Changes in blood test values used to monitor liver function.
* Skin rash, urticaria and itching.
* Fractures of the hip, wrist or spine (if Esomeprazole Zentiva is used at high doses and for a prolonged period).

Rare (may affect up to 1 in 1,000 people)
* Blood disorders, such as reduced number of white blood cells or platelets. This may cause weakness, bruising or make infections more likely.
* Low sodium levels in the blood. This may cause weakness, vomiting and cramps.
* Feeling agitated, confused or depressed.
* Altered taste.
* Vision problems such as blurred vision.
* Sudden sensation of breathlessness or shortness of breath (bronchospasm).
* Inflammation inside the mouth.
* A fungal infection called "thrush" which may affect the intestine.
* Liver problems, including jaundice which may cause yellowing of the skin, dark urine and fatigue.
* Hair loss (alopecia).
* Skin redness after exposure to sunlight.
* Joint pain (arthralgia) or muscle pain (myalgia).
* Feeling generally unwell and lacking energy.
* Increased sweating.

Very rare (may affect up to 1 in 10,000 people)
* Changes in blood cell counts including agranulocytosis (lack of white blood cells).
* Aggressiveness.
* Seeing, feeling or hearing things that are not real (hallucinations).
* Severe liver problems leading to liver failure and brain inflammation.
* Sudden onset of severe rash, blisters or skin peeling. This may be associated with high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
* Muscle weakness.
* Severe kidney problems.
* Breast enlargement in men.

Not known (frequency cannot be estimated from the available data)

• If you take Esomeprazole Zentiva 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, inform your doctor immediately. Low magnesium levels may also lead to reduced levels of potassium or calcium in the blood. Your doctor may decide to perform regular blood tests to monitor your magnesium levels.
• Inflammation in the intestine (leading to diarrhoea).
• Skin rash, possibly with joint pain.

Esomeprazole Zentiva may, in very rare cases, affect white blood cells causing immunodeficiency. If you develop an infection with symptoms such as fever associated with a severely deteriorated general condition, or fever with signs of a local infection such as neck, throat or mouth pain or difficulty urinating, you must consult your doctor as soon as possible so that a blood test can exclude a deficiency of white blood cells (agranulocytosis). It is important that you provide information about the medicines you are taking.

Reporting of side effects
If you experience any side effects, 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 the website: 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 Esomeprazole Zentiva

• Keep this medicine out of the sight and reach of children.
• Do not use Esomeprazole Zentiva after the expiry date stated on the carton, bottle, or blister pack. The expiry date refers to the last day of the month.
• Do not store above 25°C.
• Store the medicine in its original packaging (blister) or keep the container tightly closed (bottle) to protect the medicine from moisture.
• After opening the bottle, the capsules must be used within 3 months.
• Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Esomeprazolo Zentiva contains
* The active substance is esomeprazole. Esomeprazolo Zentiva is available in two strengths containing 20 mg or 40 mg of esomeprazole (as magnesium dihydrate).
* The other components are:
Contents of the capsule:
sugar spheres (sucrose and maize starch), hypromellose, 35% dimethicone emulsion [containing dimethicone, propyl-p-hydroxybenzoate (E216), methyl-p-hydroxybenzoate (E218), sorbic acid, sodium benzoate, polyethylene glycol sorbitan monolaurate, octylphenoxy polyethoxyethanol and propylene glycol], polysorbate 80, mannitol, diacetylated monoglycerides, talc, methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30% [containing methacrylic acid-methyl acrylate copolymer, sodium lauryl sulfate and polysorbate 80], triethyl citrate and stearoyl macrogol glycerides.
Capsule shell:
black iron oxide (E 172), lacquer, gelatin, yellow iron oxide (E172) and titanium dioxide (E171).

Description of the appearance of Esomeprazolo Zentiva and package contents

• Esomeprazolo Zentiva 20 mg capsules have an opaque yellow cap and an opaque white body. "20 mg" is printed in black on both the cap and the body.
• Esomeprazolo Zentiva 40 mg capsules have an opaque yellow cap and an opaque yellow body. "40 mg" is printed in black on both the cap and the body.
• Capsules are available in packs of: Bottles of 28, 30, 90 or 98 capsules; Blister packs of 3, 7, 14, 15, 25, 28, 30, 50, 56, 60, 90, 98, 100 or 140 capsules. Not all pack sizes may be marketed.

Marketing Authorization Holder
Zentiva Italia S.r.l.
Viale Bodio 37/b – 20158 Milano
Italy

Manufacturers
ETHYPHARM
Z.I de Saint-Arnoult, 28170 Châteauneuf-en-Thymerais
France
ETHYPHARM
Chemin de la Poudrière - 76120 Grand-Quevilly
France
FAMAR L'AIGLE
Zone industrielle N°1, Route de Crulai, 61300 L'Aigle
France
LAPHAL INDUSTRIES
248 avenue de la Victoire, 13106 Rousset
France
ROTTENDORF PHARMA
Zone industrielle N°2, Batterie 1000, 59309 Valenciennes Cedex
France
S.C. Zentiva S.A.
B-dul Theodor Pallady n. 50, Sector 3
032266 Bucharest
Romania

This medicinal product is authorized in the European Economic Area countries under the following names:
France:
Esoméprazole Zentiva 20 mg, gélule gastro-résistante
Esoméprazole Zentiva 40 mg, gélule gastro-résistante
Greece:
Helides 20 mg σκληρές γαστρο-ανθεκτικές κάψουλες
Helides 40 mg σκληρές γαστρο-ανθεκτικές κάψουλες
Italy:
Esomeprazolo Zentiva 20 mg capsule rigide gastroresistenti
Esomeprazolo Zentiva 40 mg capsule rigide gastroresistenti
Portugal:
Esomeprazole Zentiva 20 mg cápsulas gastrorresistentes
Esomeprazole Zentiva 40 mg cápsulas gastrorresistentes