Esomeprazole Doc Generici: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE USER

ESOMEPRAZOLE DOC 20 mg gastro-resistant tablets, 40 mg gastro-resistant tablets

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, inform your doctor or pharmacist. See section 4.

What is in this leaflet:

What ESOMEPRAZOLE DOC is and what it is used for
What you need to know before taking ESOMEPRAZOLE DOC
How to take ESOMEPRAZOLE DOC
Possible side effects
How to store ESOMEPRAZOLE DOC
Contents of the pack and other information

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

ESOMEPRAZOLE DOC contains a medicine called esomeprazole. It belongs to a group of
medicines called "proton pump inhibitors". These work by reducing the amount of acid produced by
the stomach.
ESOMEPRAZOLE DOC is used to treat the following conditions:
Adults:

"gastroesophageal reflux disease" (GERD). This is a condition in which acid produced by the stomach flows back into the esophagus (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;
stomach ulcers caused by medicines called NSAIDs (non-steroidal anti-inflammatory drugs). ESOMEPRAZOLE DOC may also be used to prevent the formation of stomach ulcers if you are taking NSAIDs;
excess stomach acid caused by a growth in the pancreas (Zollinger-Ellison syndrome);
long-term treatment following prevention of re-bleeding from ulcers with intravenous esomeprazole.

Adolescents over 12 years of age:

"gastroesophageal reflux disease" (GERD). This is a condition in which acid produced by the stomach flows back into the esophagus (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 NEED TO KNOW BEFORE TAKING ESOMEPRAZOLE DOC

Do not take ESOMEPRAZOLE DOC:

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 infection).

Do not take ESOMEPRAZOLE DOC if any of the above conditions apply to you.
If you are unsure, consult your doctor or pharmacist before taking ESOMEPRAZOLE DOC.
Warnings and precautions
Talk to your doctor or pharmacist before taking ESOMEPRAZOLE DOC:

if you have severe liver problems
if you have severe kidney problems
if you have low levels of vitamin B12 in your body or are at risk of developing it
if you have ever had a skin reaction after treatment with a medicine similar to ESOMEPRAZOLE DOC that reduces stomach acid

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 ESOMEPRAZOLE DOC. Remember to also report any other adverse effects such as joint pain.
ESOMEPRAZOLE DOC may mask symptoms of other diseases. Therefore, inform your doctor immediately if, before starting or while taking ESOMEPRAZOLE DOC, 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 ESOMEPRAZOLE DOC has been prescribed for you to take “as needed”, contact your doctor if symptoms persist or if there is a change in the nature of symptoms.
Inform your doctor if you are scheduled for a laboratory test for cancer (chromogranin A measurement, CgA). Your doctor will instruct you to stop taking this medicine at least 5 days before the test.
If you take a proton pump inhibitor such as ESOMEPRAZOLE DOC, 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.
Other medicines and ESOMEPRAZOLE DOC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because ESOMEPRAZOLE DOC may alter the effect of some medicines and some medicines may affect ESOMEPRAZOLE DOC.
Do not take ESOMEPRAZOLE DOC tablets if you are taking a medicine containing nelfinavir (used to treat HIV infection).
Inform your doctor or pharmacist if you are taking any of the following medicines:

atazanavir (used to treat HIV infection)
clopidogrel (used to prevent blood clots)
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, muscle relaxation, or epilepsy)
phenytoin (used in epilepsy). If you are taking phenytoin, your doctor should monitor you when starting or stopping ESOMEPRAZOLE DOC
cilostazol (used to treat intermittent claudication – leg pain when walking caused by insufficient blood supply)
medicines used to thin the blood, such as warfarin. Your doctor may need to monitor you when starting or stopping ESOMEPRAZOLE DOC
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 a high dose of methotrexate, your doctor may temporarily stop treatment with ESOMEPRAZOLE DOC
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 in addition to ESOMEPRAZOLE DOC to treat ulcers caused by Helicobacter pylori infection, it is very important that you inform your doctor if you are taking other medicines.
ESOMEPRAZOLE DOC with food and drink
You may take the tablets with food or on an empty stomach.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Your doctor will decide whether you can take ESOMEPRAZOLE DOC during this period.
It is not known whether ESOMEPRAZOLE DOC passes into breast milk. Therefore, do not take ESOMEPRAZOLE DOC if you are breastfeeding.
Driving and using machines
It is unlikely that ESOMEPRAZOLE DOC affects the ability to drive or use tools or machines. However, undesirable effects such as dizziness and blurred vision may occur uncommonly or rarely (see section 4). If affected, do not drive or operate machinery.
ESOMEPRAZOLE DOC contains sucrose.
ESOMEPRAZOLE DOC contains sugar spheres which contain sucrose, a type of sugar. If your doctor has informed you that you have an intolerance to certain sugars, talk to your doctor before taking this medicine.

3. HOW TO TAKE ESOMEPRAZOLE DOC

Take this medicine exactly as prescribed 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 needed, inform them if your symptoms change.

How much ESOMEPRAZOLE DOC to take

Your doctor will tell you how many tablets to take and for how long. This will depend on your condition, your age, and liver function.
The recommended doses are indicated below.

Adults aged over 18 years
To treat heartburn caused by gastro-oesophageal reflux disease (GORD)

If your doctor has diagnosed that your digestive tract (oesophagus) has been slightly damaged, the recommended dose is one gastro-resistant tablet of ESOMEPRAZOLE DOC 40 mg once daily for 4 weeks. Your doctor may prescribe the same dose for another 4 weeks if the oesophagus has not yet healed.
The recommended dose once the oesophagus has healed is one gastro-resistant tablet of ESOMEPRAZOLE DOC 20 mg once daily.
If the oesophagus has not been damaged, the recommended dose is one gastro-resistant tablet of ESOMEPRAZOLE DOC 20 mg daily. Once the condition is under control, your doctor may prescribe taking the medicine as needed, up to a maximum of one gastro-resistant tablet of ESOMEPRAZOLE DOC 20 mg daily.
If you have severe liver problems, your doctor may prescribe a lower dose.

To treat ulcers caused by Helicobacter pylori infection and to prevent their recurrence

The recommended dose is one gastro-resistant tablet of ESOMEPRAZOLE DOC 20 mg twice daily for one week.
Your doctor may also prescribe antibiotics, such as amoxicillin and clarithromycin.

To treat stomach ulcers caused by NSAIDs (Non-Steroidal Anti-Inflammatory Drugs)

The recommended dose is one gastro-resistant tablet of ESOMEPRAZOLE DOC 20 mg once daily for 4–8 weeks.

To prevent stomach ulcers if you are taking NSAIDs (Non-Steroidal Anti-Inflammatory
Drugs)

The recommended dose is one gastro-resistant tablet of ESOMEPRAZOLE DOC 20 mg once daily.

To treat excess stomach acid caused by a growth in the pancreas (Zollinger-Ellison syndrome)

The recommended dose is one gastro-resistant tablet of ESOMEPRAZOLE DOC 40 mg twice daily.
Your doctor will adjust the dose according to your needs and will also decide how long you should take the medicine. The maximum dose is 80 mg twice daily.

Long-term treatment following prevention of re-bleeding from ulcers with intravenous esomeprazole
The recommended dose is one tablet of ESOMEPRAZOLE DOC 40 mg once daily for 4 weeks.
Adolescents aged over 12 years
To treat heartburn caused by gastro-oesophageal reflux disease (GORD)

If your doctor has diagnosed that your digestive tract (oesophagus) has been slightly damaged, the recommended dose is one gastro-resistant tablet of ESOMEPRAZOLE DOC 40 mg once daily for 4 weeks. Your doctor may prescribe the same dose for another 4 weeks if the oesophagus has not yet healed.
The recommended dose once the oesophagus has healed is one gastro-resistant tablet of ESOMEPRAZOLE DOC 20 mg once daily.
If the oesophagus has not been damaged, the usual dose is one gastro-resistant tablet of ESOMEPRAZOLE DOC 20 mg daily.
If you have severe liver problems, your doctor may prescribe a lower dose.

To treat ulcers caused by Helicobacter pylori infection and to prevent their recurrence

The recommended dose is one gastro-resistant tablet of ESOMEPRAZOLE DOC 20 mg twice daily for one week.
Your doctor may also prescribe antibiotics, such as amoxicillin and clarithromycin.

Method and route of administration

You may take the tablets at any time of day.
You may take the tablets with food or on an empty stomach.
Swallow the tablets whole with water. Do not chew or crush the tablets. This is because the tablets contain coated granules that prevent the medicine from being inactivated by stomach acid. It is important not to damage the granules.

What to do if you have difficulty swallowing the tablets

If you have difficulty swallowing the tablets:
Place the tablets in a glass of plain water (not sparkling). Do not use any other liquid.
Stir until the tablets break up (the mixture will appear cloudy). Drink the mixture immediately or within 30 minutes. Always stir the mixture again just before drinking.
To ensure 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 completely unable to swallow, the tablets may be mixed with some water and placed in a syringe. They can then be administered via a tube directly into the stomach ('gastric tube').

Use in children under 12 years of age
The use of ESOMEPRAZOLE DOC is not recommended in children under 12 years of age. Other
formulations, such as sachets, may be more suitable for this patient group.
Ask your doctor or pharmacist if you need further information.
Elderly
Dose adjustment is not required in the elderly.
If you take more ESOMEPRAZOLE DOC than you should
If you take more ESOMEPRAZOLE DOC than prescribed by your doctor, contact your doctor or pharmacist immediately.
If you forget to take ESOMEPRAZOLE DOC

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 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 ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Serious adverse reactions
If you notice any of the following serious adverse reactions, stop taking ESOMEPRAZOLE DOC and contact a doctor immediately

Sudden shortness of breath, swelling of lips, tongue and throat or body, fever, rash, fainting or difficulty swallowing (severe allergic reaction).
Yellowing of the skin, dark-coloured urine and fatigue, which may be symptoms of liver problems. These effects are rare and may affect up to 1 in 1,000 people.
Skin redness with blistering or peeling. Large blisters and severe bleeding of the lips, eyes, mouth, nose and genitals may also occur. This could be "Stevens-Johnson syndrome" or "toxic epidermal necrolysis"; these effects are very rare and may affect up to 1 in 10,000 people.

Other adverse reactions include:
Common (may affect up to 1 in 10 people)

Headache
Stomach or bowel problems: diarrhoea, stomach pain, constipation, bloating (flatulence)
Nausea or vomiting

Uncommon (may affect up to 1 in 100 people)

Swelling of feet and ankles
Sleep disorders (insomnia)
Dizziness, tingling sensations like "pins and needles", drowsiness
Feeling of dizziness
Dry mouth
Changes in blood test results related to liver function
Rash, urticaria and itching
Fracture of hip, wrist or spine (if the product is used at high doses and for a long time)

Rare (may affect up to 1 in 1,000 people)

Blood problems 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
Agitation, confusion or depression
Taste disturbances
Vision problems such as blurred vision
Sudden feeling 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-coloured urine and fatigue
Hair loss (alopecia)
Rash after exposure to sunlight
Joint pain (arthralgia) or muscle pain (myalgia)
General feeling of being unwell and lack of 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, sensing or hearing things that are not real (hallucinations)
Severe liver problems leading to liver failure and inflammation of the brain
Sudden onset of a severe skin rash or 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 (cannot be estimated from the available data)

If you take ESOMEPRAZOLE DOC 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, 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 to monitor your blood magnesium levels periodically.
Inflammation of the intestine (leading to diarrhoea)
Erythema, possible joint pain

In very rare cases, ESOMEPRAZOLE DOC may affect white blood cells, causing immune deficiency. If you develop an infection with symptoms such as fever accompanied by a severely compromised general condition, or fever with signs of local infection such as neck, throat or mouth pain or difficulty urinating, contact your doctor as soon as possible so that a deficiency in white blood cells (agranulocytosis) can be ruled out by blood tests. At this stage, it is important that you inform the doctor about your treatment.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report adverse reactions directly via the national reporting system at 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

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after “Exp.”. The expiry date refers to the last day of that month.
Do not store above 30°C.
Keep the blister in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What ESOMEPRAZOLO DOC contains
The active substance is esomeprazole.
ESOMEPRAZOLO DOC 20 mg gastro-resistant tablets
Each tablet contains 20 mg of esomeprazole (as amorphous esomeprazole magnesium).
ESOMEPRAZOLO DOC 40 mg gastro-resistant tablets
Each tablet contains 40 mg of esomeprazole (as amorphous esomeprazole magnesium).

The other components are:
Tablet core:
hydroxypropyl cellulose (E463), crospovidone (Type A)
Coating:
povidone K30, macrogol-400, macrogol-4000, macrogol 6000, hypromellose phthalate (HP-55S),
hypromellose phthalate (HP-50), diethyl phthalate, hydroxypropyl cellulose, microcrystalline cellulose (PH
101), microcrystalline cellulose (PH 112), crospovidone (Type B), sodium stearyl fumarate, Opadry
brown 03B86651 (HMPC 2910/Hypromellose 6cP, titanium dioxide (E171), Macrogol/PEG 400,
iron oxide red (E 172)), sugar spheres (sucrose and maize starch), talc (E553b).

Description of the appearance of ESOMEPRAZOLO DOC and contents of the pack
ESOMEPRAZOLO DOC 20 mg gastro-resistant tablets:
Film-coated, oval, biconvex tablets, light brick-red to brown in colour, with "E5" printed on one side and smooth on the other side.
ESOMEPRAZOLO DOC 40 mg gastro-resistant tablets:
Film-coated, oval, biconvex tablets, light brick-red to brown in colour, with "E6" printed on one side and smooth on the other side.

The tablets are available in the following pack sizes:
20 mg and 40 mg:
OPA-Al-PVC/Al blisters containing 14, 28, 56, 98 and 100 tablets.
OPA-Al-PE-desiccant-HDPE/Al blisters containing 14, 28, 56, 98 and 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
DOC Generici S.r.l
Via Turati 40
20121 Milan
Italy

Responsible manufacturers for batch release
Ranbaxy Ireland Ltd.
Spafield, Cork Road, Cashel, Co. Tipperary, Ireland
Basics GmbH
Hemmelrather Weg 201, D-51377 Leverkusen, Germany
Terapia SA
124 Fabricii Street, 400 632 Cluj Napoca, Romania
Sanico NV
Veedijk 59, B-2300, Turnhout, Belgium

This patient information leaflet was last approved in the month of