Esomeprazole Doc Generici

PACKAGE LEAFLET: INFORMATION FOR THE USER

ESOMEPRAZOLE DOC Generics 20 mg gastro-resistant hard capsules, 40 mg gastro-resistant 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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. WHAT ESOMEPRAZOLE DOC Generici IS AND WHAT IT IS USED FOR

ESOMEPRAZOLE DOC Generici contains a medicine 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.
Adults and adolescents aged 12 years and older
ESOMEPRAZOLE DOC Generici is used to treat the following conditions:

• Gastro-oesophageal reflux disease (GORD). In this condition, acid from the stomach flows back into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
• Stomach or upper part of the digestive tract (intestine) 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 DOC Generici may also be used to help prevent stomach ulcers if you are taking NSAIDs.
• Excess acid production in the stomach due to a growth in the pancreas (Zollinger-Ellison syndrome).
• Long-term treatment following prevention of ulcer bleeding with intravenous esomeprazole.

2. WHAT YOU SHOULD KNOW BEFORE TAKING ESOMEPRAZOLE DOC Generici

Do not take ESOMEPRAZOLE DOC Generici

• if you are allergic to esomeprazole or to any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to other proton pump inhibitors (for example pantoprazole, lansoprazole, rabeprazole, omeprazole).
• if you are taking a medicine containing nelfinavir (used to treat HIV).

Do not take ESOMEPRAZOLE DOC Generici if you are in any of the above conditions.
If you have any doubts, consult your doctor or pharmacist before taking ESOMEPRAZOLE DOC Generici.

Warnings and precautions
Talk to your doctor or pharmacist before taking ESOMEPRAZOLE DOC Generici:

• if you have severe liver problems
• if you have severe kidney problems
• if you have ever had a skin reaction after treatment with a medicine similar to ESOMEPRAZOLE DOC Generici that reduces stomach acid
• if you are due to undergo a specific blood test (Chromogranin A)

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 discontinue treatment with ESOMEPRAZOLE DOC Generici. Remember to also report any other adverse effects such as joint pain.
ESOMEPRAZOLE DOC Generici may mask symptoms of other diseases. Therefore, inform your doctor immediately if, before starting or while taking ESOMEPRAZOLE DOC Generici, you experience any of the following conditions:

• unexplained weight loss and difficulty swallowing
• stomach pain or indigestion
• vomiting food or blood
• dark-coloured stools (blood in stools).

If you take a proton pump inhibitor such as ESOMEPRAZOLE DOC Generici, 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 can increase the risk of osteoporosis), consult your doctor.
If you have been prescribed ESOMEPRAZOLE DOC Generici to take “as needed”, contact your doctor if symptoms persist or if there is a change in the nature of symptoms.
Talk to your doctor, pharmacist, or nurse before taking ESOMEPRAZOLE DOC Generici.

Other medicines and ESOMEPRAZOLE DOC Generici
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those available without a prescription. This is because ESOMEPRAZOLE DOC Generici may alter the effect of some medicines, and some medicines may affect ESOMEPRAZOLE DOC Generici.
Do not take ESOMEPRAZOLE DOC Generici capsules if you are taking a medicine containing nelfinavir (used to treat HIV).
Inform your doctor or pharmacist if you are taking any of the following medicines:

• atazanavir or saquinavir (used to treat HIV)
• ketoconazole, itraconazole, or voriconazole (used to treat fungal infections)
• erlotinib (used to treat cancer)
• 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 DOC Generici
• medicines used to thin the blood, such as warfarin. Your doctor may need to monitor you when starting or stopping treatment with ESOMEPRAZOLE DOC Generici
• 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)
• clopidogrel (used to treat or prevent blood clots)
• tacrolimus (used in organ transplantation)
• methotrexate (a chemotherapy medicine used in high doses to treat cancer; if you are taking a high dose of methotrexate, your doctor may temporarily stop treatment with ESOMEPRAZOLE DOC Generici)
• 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 in addition to ESOMEPRAZOLE DOC Generici 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 DOC Generici with food and drink
You may take the capsules with food or on an empty stomach.

Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine. Your doctor will decide whether you may take ESOMEPRAZOLE DOC Generici during this time.
It is not known whether ESOMEPRAZOLE DOC Generici passes into breast milk. Therefore, do not take ESOMEPRAZOLE DOC Generici if you are breastfeeding.

Driving and using machines
It is unlikely that ESOMEPRAZOLE DOC Generici will affect your ability to drive or use tools or machines. However, side effects such as dizziness and blurred vision may occur uncommonly or rarely (see section 4). If affected, do not drive or use machinery.

ESOMEPRAZOLE DOC Generici contains sucrose and parahydroxybenzoates
ESOMEPRAZOLE DOC Generici gastro-resistant capsules contain sucrose, a type of sugar, propyl-p-hydroxybenzoate (E216), and methyl-p-hydroxybenzoate (E218):

• If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
• Parahydroxybenzoates may cause allergic reactions (including delayed reactions).

3. HOW TO TAKE ESOMEPRAZOLE DOC Generics

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

• ESOMEPRAZOLE DOC Generics gastro-resistant capsules are not recommended for children under 12 years of age.
• 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 instructed you to take this medicine as and when needed, inform your doctor if your symptoms change.

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. This is because the capsules contain granules that prevent your 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 granules into half a glass of still (non-carbonated) water. Do not use any other liquid.
2. Stir the mixture and drink it immediately or within 30 minutes. Always stir the mixture again just before drinking.
3. To ensure you have taken all the medicine, rinse the glass thoroughly 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 administered through a syringe. They can then be delivered directly into the stomach via a tube (‘gastric tube’).

How much ESOMEPRAZOLE DOC Generics 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 functioning.
• The recommended doses are listed below.

For treatment of heartburn caused by gastro-oesophageal reflux disease (GORD):
Adults and children from 12 years of age and older:

• If your doctor has found that your oesophagus has been slightly damaged, the recommended dose is one gastro-resistant capsule of ESOMEPRAZOLE DOC Generics 40 mg once daily for 4 weeks. Your doctor may instruct you to continue the same dose for another 4 weeks if your oesophagus has not yet healed.
• The recommended dose once your oesophagus has healed is one gastro-resistant capsule of ESOMEPRAZOLE DOC Generics 20 mg once daily.
• If your oesophagus has not been damaged, the recommended dose is one gastro-resistant capsule of ESOMEPRAZOLE DOC Generics 20 mg daily. Once your condition is under control, your doctor may instruct you to take the medicine as and when needed, up to a maximum dose of one gastro-resistant capsule of ESOMEPRAZOLE DOC Generics 20 mg daily.
• If you have severe liver problems, your doctor may prescribe a lower dose.

For treatment of ulcers caused by Helicobacter pylori infection and to prevent their recurrence:

• Adults and children from 12 years of age and older:
• The recommended dose is one gastro-resistant capsule of ESOMEPRAZOLE DOC Generics 20 mg twice daily for one week.
• Your doctor will also instruct you to take antibiotics called amoxicillin and clarithromycin.

For treatment of ulcers caused by NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):

• Adults from 18 years of age and older: the recommended dose is one gastro-resistant capsule of ESOMEPRAZOLE DOC Generics 20 mg once daily for 4–8 weeks.

For prevention of stomach ulcers if you are taking NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):

• Adults from 18 years of age and older: the recommended dose is one gastro-resistant capsule of ESOMEPRAZOLE DOC Generics 20 mg once daily.

For treatment of excess stomach acid caused by a growth in the pancreas (Zollinger-Ellison syndrome):

• Adults from 18 years of age and older: the recommended dose is one gastro-resistant capsule of ESOMEPRAZOLE DOC Generics 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:

• Adults from 18 years of age and older: the recommended dose is one capsule of ESOMEPRAZOLE DOC Generics 40 mg once daily for 4 weeks.

Use in children under 12 years of age
The use of ESOMEPRAZOLE DOC Generics is not recommended in children under 12 years of age.
Elderly
Dose adjustment is not required in the elderly.
If you take more ESOMEPRAZOLE DOC Generics than you should
If you take more ESOMEPRAZOLE DOC Generics than prescribed by your doctor, speak to your doctor or pharmacist immediately.
If you forget to take ESOMEPRAZOLE DOC Generics

• 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 doubts about how to use this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If you notice any of the following serious adverse reactions, stop treatment with
ESOMEPRAZOLE DOC Generics and contact your doctor immediately:

• Sudden breathlessness, swelling of lips, tongue and throat or body, erythema, fainting or difficulty swallowing (severe allergic reaction)
• Skin redness with blistering and peeling. There may be blisters and severe 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 reactions are rare and affect fewer than 1 in 1000 people.
Other adverse reactions include:
Common (may affect up to 1 in 10 people)

• Headache
• Stomach or intestinal problems: diarrhoea, stomach pain, constipation, gas (flatulence)
• Nausea or vomiting
• Benign polyps in the stomach

Uncommon (may affect up to 1 in 100 people)

• Swelling of hands and feet
• Sleep disturbances (insomnia)
• Dizziness, tingling sensations such as “pins and needles”, drowsiness
• Vertigo
• Dry mouth
• Changes in blood test values used to assess liver function
• Skin rash, urticaria and itching
• Fracture of the hip, wrist or spine (if ESOMEPRAZOLE DOC Generics is used at high doses and for a long time)

Rare (may affect up to 1 in 1000 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 restless, confusion or depression
• 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 oesophagus
• 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)
• Aggression
• Seeing, feeling or hearing things that are not there (hallucinations)
• Severe liver problems leading to liver failure and brain inflammation
• Sudden onset of severe skin redness, blistering or peeling of the skin. 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 DOC Generics for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as fatigue, involuntary muscle contractions, disorientation, seizures, vertigo, or increased heart rate. If you experience any of these symptoms, consult your doctor immediately. Low magnesium levels may also lead to reduced levels of potassium or calcium in the blood. Your doctor should decide whether periodic monitoring of blood magnesium levels is necessary.
• Inflammation of the intestine (leading to diarrhoea)
• Erythema, possible joint pain

ESOMEPRAZOLE DOC Generics may, in very rare cases, affect white blood cells causing
immunodeficiency. If you develop an infection with symptoms such as fever with a
severely reduced general condition or fever with signs of a local infection such as neck,
throat or mouth pain, or difficulty urinating, you must contact your doctor as soon as possible
so that a lack of white blood cells (agranulocytosis) can be ruled out with a blood test. It is
important that you provide your doctor with all information about the medicines you are taking.
The list of adverse reactions should not alarm you. You may not experience any of them.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist.
You can also report adverse reactions directly via the national reporting system at the website http://www.agenziafarmaco.gov.it/responsabili.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE ESOMEPRAZOLE DOC Generici

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

6. PACK CONTENTS AND OTHER INFORMATION

What ESOMEPRAZOLO DOC Generici contains
The active substance is esomeprazole. ESOMEPRAZOLO DOC Generici is available in two
strengths containing 20 mg or 40 mg of esomeprazole (as magnesium dihydrate).
The other components are:
Capsule contents:
sugar spheres (sucrose and maize starch), hypromellose, dimethicone emulsion 35%
(containing dimethicone, propyl-p-hydroxybenzoate (E216), methyl-p-hydroxybenzoate (E218),
sorbic acid, sodium benzoate, polyoxyethylene sorbitan monolaurate, octiphenyl
polyoxyethanol and propylene glycol), polysorbate 80, mannitol, diacetylated monoglycerides,
talc, methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30% (containing
methacrylic acid copolymer and ethyl acrylate, sodium lauryl sulfate and polysorbate 80),
triethyl citrate and stearoyl macrogol glycerides.
Capsule shell:
black iron oxide (E172), shellac, gelatin, yellow iron oxide (E172) and titanium dioxide
(E171).
Description of the appearance of ESOMEPRAZOLO DOC Generici and pack contents
ESOMEPRAZOLO DOC Generici 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 DOC Generici 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 the following pack sizes:
20 mg and 40 mg: bottles of 28 capsules
20 mg: blisters of 7, 14, 28 or 50 capsules
40 mg: blisters of 14, 28 or 50 capsules
Not all pack sizes may be marketed.
Marketing Authorization Holder
DOC Generici S.r.l
Via Turati 40
20121 Milano
Manufacturer responsible for batch release
ETHYPHARM
Z.I de Saint-Arnoult, 28170 Châteauneuf-en-Thymerais
France
ETHYPHARM
Chemin de la Poudrière - 76120 Grand-Quevilly
France
Lamp San Prospero S.p.A.
Via della Pace, 25/A
San Prospero (MO)
Italy
Special Product’s Line S.p.A.
Strada Paduni 240
03012 Anagni (FR)
Italy
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
France: ETIZOL
Iceland: ETIZOL
Italy: ESOMEPRAZOLO DOC Generici