Esomeprazole Doc Generics: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE USER

ESOMEPRAZOLE DOC Generics 20 mg gastro-resistant hard capsules, 40 mg gastro-resistant hard capsules

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, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could 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:

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

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

ESOMEPRAZOLE DOC Generics 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.

ESOMEPRAZOLE DOC Generics is used to treat the following conditions:

Adults

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 ulcers or ulcers in the upper part of the digestive tract (intestine) caused by 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 non-steroidal anti-inflammatory drugs (NSAIDs). ESOMEPRAZOLE DOC Generics can also be used to help prevent 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 ulcer bleeding with intravenous esomeprazole.

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 ulcers or ulcers in the upper part of the digestive tract (intestine) caused by 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 DOC Generics

Do not take ESOMEPRAZOLE DOC Generics

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 Generics if you are in any of these conditions.
If you have any doubts, consult your doctor or pharmacist before taking ESOMEPRAZOLE DOC
Generics.
Warnings and precautions
Talk to your doctor or pharmacist before taking ESOMEPRAZOLE DOC Generics:

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 Generics that reduces stomach acidity
if you need to undergo a specific blood test (chromogranin A)

ESOMEPRAZOLE DOC Generics may mask symptoms of other diseases. Therefore, inform your
doctor immediately if, before starting or while taking ESOMEPRAZOLE DOC Generics, you
experience any of the following conditions:

if you lose weight significantly without reason and have difficulty swallowing
if you have stomach pain or indigestion
if you start vomiting food or blood
if your stools are dark-colored (blood in stools)

If ESOMEPRAZOLE DOC Generics has been prescribed for you to take "as needed", contact your
doctor if symptoms persist or if the nature of symptoms changes.
If you take a proton pump inhibitor such as ESOMEPRAZOLE DOC Generics, especially for
longer 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 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
ESOMEPRAZOLE DOC Generics.
Remember to also report any other adverse effects such as joint pain.
Other medicines and ESOMEPRAZOLE DOC Generics
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicine. This includes medicines you can buy without a prescription. This is because
ESOMEPRAZOLE DOC Generics may alter the effect of some medicines and some medicines
may affect ESOMEPRAZOLE DOC Generics.
Do not take ESOMEPRAZOLE DOC Generics capsules if you are taking a medicine containing
nelfinavir (used to treat HIV).
Tell your doctor or pharmacist if you are taking any of the following medicines:

atazanavir (used to treat HIV)
clopidogrel (used to treat or 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, 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 Generics
medicines used to make the blood less likely to clot, such as warfarin. Your doctor may need to monitor you when starting or stopping treatment with ESOMEPRAZOLE DOC Generics
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)
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 Generics)
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 Generics to treat ulcers caused by Helicobacter pylori infection, it is
very important that you inform your doctor about any other medicines you are taking.
ESOMEPRAZOLE DOC Generics with food and drink
You may take the capsules with food or on an empty stomach.
Pregnancy, breast-feeding and fertility
If you are pregnant, think you might be pregnant, plan to become pregnant, or are breast-feeding,
ask your doctor or pharmacist for advice before taking this medicine. Your doctor will decide
whether you can take ESOMEPRAZOLE DOC Generics during this time.
It is not known whether ESOMEPRAZOLE DOC Generics passes into breast milk. Therefore, do
not take ESOMEPRAZOLE DOC Generics if you are breast-feeding.
Driving and using machines
It is unlikely that ESOMEPRAZOLE DOC Generics will affect your ability to drive or use tools or
machinery. However, side effects such as dizziness and blurred vision may occur uncommonly or
rarely (see section 4). If you are affected, do not drive or use machinery.
ESOMEPRAZOLE DOC Generics contains sucrose
ESOMEPRAZOLE DOC Generics contains sugar spheres based on sucrose, a type of sugar. If
your doctor has told you that you have an intolerance to certain sugars, contact him before taking
this medicine.

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.

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 your doctor if your symptoms change.

How much 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.

Adults from 18 years of age and older:
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 ESOMEPRAZOLE DOC Generics 40 mg once daily for 4 weeks. Your doctor may instruct you to continue taking 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 ESOMEPRAZOLE DOC Generics 20 mg once daily.
If your oesophagus has not been damaged, the recommended dose is one capsule of ESOMEPRAZOLE DOC Generics 20 mg per day. Once your condition is under control, your doctor may advise you to take the medicine as and when needed, up to a maximum dose of one capsule of ESOMEPRAZOLE DOC Generics 20 mg per day.
If you have severe liver problems, your doctor may prescribe you a lower dose.

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

The recommended dose is one capsule of ESOMEPRAZOLE DOC Generics 20 mg twice daily for one week.
Your doctor will also instruct you to take antibiotics, such as amoxicillin and clarithromycin.

For the treatment of ulcers caused by NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):
The recommended dose is one capsule of ESOMEPRAZOLE DOC Generics 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 ESOMEPRAZOLE DOC Generics 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 gastro-resistant capsule of ESOMEPRAZOLE DOC Generics 40 mg twice daily.
Your doctor will adjust the 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 ESOMEPRAZOLE DOC Generics 40 mg once daily for 4 weeks.
Adolescents from 12 years of age and older
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 ESOMEPRAZOLE DOC Generics 40 mg once daily for 4 weeks. Your doctor may instruct you to continue taking 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 ESOMEPRAZOLE DOC Generics 20 mg once daily.
If your oesophagus has not been damaged, the recommended dose is one capsule of ESOMEPRAZOLE DOC Generics 20 mg per day.
If you have severe liver problems, your doctor may prescribe you a lower dose.

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

The recommended dose is one capsule of ESOMEPRAZOLE DOC Generics 20 mg twice daily for one week. Your doctor will also instruct you to take antibiotics, such as 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. This is because the capsules contain granules that protect 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) Carefully open the capsule over a glass of plain water (not sparkling) and empty the contents of the capsule (granules) into the glass. Do not use any other liquid. 2) Stir. Then drink the mixture immediately or within 30 minutes. Always stir the mixture just before drinking. 3) 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 unable to swallow anything, the granules may be mixed with a small amount of water and administered via a syringe. They can then be delivered directly into the stomach via a tube (‘gastric tube’).

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, contact 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 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 everybody gets 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 the lips, tongue or throat or body, rash, fainting or difficulty swallowing (severe allergic reaction).
Skin redness with blistering and peeling. There may be blistering and severe bleeding also on the lips, eyes, mouth, nose and genitals. This may 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 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 the feet and hands.
Sleep disorders (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 problems, such as a reduction in the number of white blood cells or platelets. This may cause weakness, bruising or make infections more likely.
Low levels of sodium in the blood. This may cause weakness, vomiting and cramps.
Feeling agitated, confusion or depression.
Altered taste.
Vision problems such as blurred vision.
Sudden feeling of breathlessness or shortness of breath (bronchospasm).
Inflammation inside the mouth.
A fungal infection called “thrush” that 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 the number of blood cells including agranulocytosis (lack of white blood cells).
Aggression.
Seeing, feeling or hearing things that are not real (hallucinations).
Severe liver problems leading to liver failure and brain inflammation.
Sudden onset of severe 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, dizziness, or increased heart rate. If you experience any of these symptoms, contact 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).
Rash, possible joint pain.

ESOMEPRAZOLE DOC Generics may very rarely affect white blood cells, causing immunodeficiency. If you develop an infection with symptoms such as fever accompanied by 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 deficiency in white blood cells (agranulocytosis) can be ruled out with a blood test. It is important that you provide your doctor with any information about medicines you are taking.
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 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 ESOMEPRAZOLE DOC Generics

Keep this medicine out of the sight and reach of children.
Do not use ESOMEPRAZOLE DOC Generics after the expiry date stated on the carton or blister pack following "Exp". The expiry date refers to the last day of that month.
Do not store above 30°C. Store in the original packaging to protect 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. PACKAGING CONTENTS AND OTHER INFORMATION

What ESOMEPRAZOLO DOC Generics contains

The active substance is esomeprazole. ESOMEPRAZOLO DOC Generics is available in two strengths containing 20 mg or 40 mg of esomeprazole (as sodium salt).
The other components are: Capsule contents: Sugar spheres (containing maize starch and sucrose), methylcellulose, talc, titanium dioxide (E 171), glyceryl monostearate, polysorbate 80, sodium lauryl sulfate, methacrylic acid-ethyl acrylate copolymer, triethyl citrate. Capsule coating: Carrageenan, potassium chloride, red iron oxide (E172), titanium dioxide (E 171), hypromellose, printing ink (containing shellac, potassium hydroxide and black iron oxide (E172)).

Description of the appearance of ESOMEPRAZOLO DOC Generics and pack contents
ESOMEPRAZOLO DOC Generics 20 mg capsules have a light opaque pink cap and body, size 4 (approximately 14 mm), printed (cap ES/body 20), containing spherical granules.
ESOMEPRAZOLO DOC Generics 40 mg capsules have a opaque pink cap and body, size 2 (approximately 18 mm), printed (cap ES/body 40), containing spherical granules.
ESOMEPRAZOLO DOC Generics is available in:
Aluminum/Aluminum blisters: 14 capsules
Not all pack sizes may be marketed.

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

Manufacturer responsible for batch release
Laboratorios Dr. Esteve, S.A.
C/San Martí, s/n, Polígon Industrial, Martorelles
08107 Barcelona
Spain

This medicinal product is authorized in the European Economic Area countries under the following names:
Italy: ESOMEPRAZOLO DOC Generics
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The following information is intended for healthcare professionals only
Administration via gastric tube

Mix the contents of the capsule with approximately 25 ml or 50 ml of water. (For certain tubes, dispersion in 50 ml of water is required to prevent granules from blocking the tube). Shake.
Pour the suspension into a syringe and add approximately 5 ml of air.
Immediately shake the syringe for about 2 minutes to disperse the granules.
Hold the syringe with the tip pointing upwards and check that the tip is not blocked.
Attach the syringe to the gastric tube, maintaining the above position.
Shake the syringe and reposition it with the tip pointing downwards. Immediately inject 5–10 ml into the tube. After injection, invert the syringe and shake (the syringe must be held with the tip pointing upwards to prevent blockage of the tip).
Turn the syringe with the tip pointing downwards and immediately inject another 5–10 ml into the tube. Repeat this procedure until the syringe is empty.
Fill the syringe with 25 ml of water and 5 ml of air, and repeat step 6 if necessary to flush out any remaining residue in the syringe. For certain tubes, 50 ml of water may be required.

Any unused medicine and waste material derived from this medicine must be disposed of in accordance with local regulations.