OMEPRAZOLO 20 mg Enteric-Coated Hard Capsules

Зміст інструкції

1. OMEPRAZOLO FG 20 mg hard gastro-resistant capsules
   1. What is OMEPRAZOLO FG and what is it used for
   2. What you need to know before taking OMEPRAZOLO FG
   3. How to take OMEPRAZOLO FG
   4. Possible side effects
   5. How to store OMEPRAZOLO FG
   6. Contents of the pack and other information

OMEPRAZOLO FG 20 mg hard gastro-resistant capsules

Generic medicine

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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is OMEPRAZOLO FG and what is it used for

OMEPRAZOLO FG contains the active ingredient omeprazole. It belongs to a group
of drugs called “proton pump inhibitors”, which work by reducing the
amount of acid produced by the stomach.
OMEPRAZOLO FG is used for the treatment of the following conditions:
In adults:

• “Gastro-oesophageal reflux disease” (GERD). This disease occurs when acid leaks from the stomach and passes into the oesophagus (the tube that connects the throat to the stomach) causing pain, inflammation and heartburn.
• Ulcers in the upper part of the intestine (duodenal ulcer) or the stomach (gastric ulcer).
• Ulcers infected by a bacterium called “Helicobacter pylori”. If you suffer from this disease, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.
• Ulcers caused by medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). OMEPRAZOLO FG can also be used to prevent the formation of ulcers if you are taking NSAIDs.
• Excessive acid in the stomach caused by an overgrowth of tissue in the pancreas (Zollinger-Ellison syndrome).

In children:

Children over 1 year of age and with a body weight of 10 kg or more

• “Gastro-oesophageal reflux disease” (GERD). This disease occurs when acid leaks from the stomach and passes into the oesophagus (the tube that connects the throat to the stomach) causing pain, inflammation and heartburn. In children, the symptoms of this disease also include the return of stomach contents into the mouth (regurgitation), discomfort (vomiting) and poor weight gain.

Children over 4 years of age and adolescents
Ulcers infected by a bacterium called “Helicobacter pylori”.If the child suffers
from this disease, the doctor may also prescribe antibiotics to treat
the infection and allow the ulcer to heal.

2. What you need to know before taking OMEPRAZOLO FG

Do not take OMEPRAZOLO FG

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

Do not take OMEPRAZOLO FG if you fall into any of the above cases. If you have any
doubts, ask your doctor or pharmacist before taking OMEPRAZOLO FG.

Warnings and precautions
Talk to your doctor or pharmacist before taking OMEPRAZOLO FG.
Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis,
drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (PEAG) have been reported in association with treatment with OMEPRAZOLO FG. Stop using OMEPRAZOLO FG and
consult your doctor immediately if you notice any of the symptoms related to
these severe skin reactions described in section 4.
OMEPRAZOLO FG may mask the symptoms of other diseases. Therefore, if you should
experience the symptoms described below before taking OMEPRAZOLO FG or while
taking it, contact your doctor immediately:

• Unexplained weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting of food or blood.
• Darkening of the stools (presence of blood in the stools).
• Severe or persistent diarrhea, because omeprazole has been associated with a slight increase in infectious diarrhea.
• Severe liver problems.
• If you have ever had a skin reaction after treatment with a medicine similar to OMEPRAZOLO FG that reduces stomach acid.
• You are 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
interrupt therapy with OMEPRAZOLO FG. Remember to also report any
other side effects such as joint pain.
Taking proton pump inhibitors may cause changes in the results
of the urea breath test for the detection of Helycobacterpylori. Therefore, the
administration of omeprazole should be stopped 2 weeks before the test.
If you are taking a proton pump inhibitor such as OMEPRAZOLO FG, especially
for a period 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 can increase the risk of
osteoporosis) consult your doctor.
If you take OMEPRAZOLO FG for more than three months, it is possible that blood levels of
magnesium may decrease. Low levels of magnesium can manifest with
fatigue, involuntary muscle contractions, disorientation, convulsions,
dizziness, increased heart rate. If you have any of these symptoms, consult
your doctor immediately. Low levels of magnesium can also lead to
a reduction in blood levels of potassium or calcium. The doctor should decide whether
to periodically check magnesium levels in the blood.
If you take OMEPRAZOLO FG for a long time (more than 1 year) your doctor will
prescribe regular check-ups. Inform your doctor if you notice the appearance of new and particular symptoms.
During treatment with omeprazole, inflammation of the kidneys may occur.
Signs and symptoms may include reduced urine volume or the presence of
blood in the urine and/or hypersensitivity reactions such as fever, skin rashes and
joint stiffness. Report these signs to your doctor.
This medicine can affect the way your body absorbs vitamin B ,
especially if you need to take it for a long period. Contact your doctor
if you notice any of the following symptoms, which may indicate low levels of vitamin
B:

• Extreme fatigue or lack of energy
• Tingling (paresthesia)
• Sore or red tongue, mouth ulcers
• Muscle weakness
• Blurred vision
• Memory problems, confusion, depression

Children
Some children with chronic illnesses may require long-term
treatment, although this is not recommended.
Do not give this medicine to children under 1 year of age or weighing
less than 10 kg.

Other medicines and OMEPRAZOLO FG
Tell your doctor or pharmacist if you are taking, have recently taken or
may take any other medicines.
This is important because OMEPRAZOLO FG can affect the way
some medicines work and, in turn, some medicines can affect the action of OMEPRAZOLO FG.
Do not take OMEPRAZOLO FG if you are taking a medicine containing

nelfinavir(used for the treatment of HIV infections).
Tell your doctor or pharmacist if you are taking any of the following
medicines:

• Ketoconazole, itraconazole, posaconazole or voriconazole (used to treat fungal infections).
• Digoxin (used for the treatment of heart problems).
• Diazepam (used for the treatment of anxiety, to relax muscles or for epilepsy).
• Phenytoin (used for epilepsy). If you are taking phenytoin, your doctor will monitor you at the beginning and end of treatment with OMEPRAZOLO FG.
• Medicines used to thin the blood, such as warfarin or other vitamin K antagonists. Your doctor will monitor you at the beginning and end of treatment with OMEPRAZOLO FG.
• Rifampicin (used for the treatment of tuberculosis).
• Atazanavir (used for the treatment of HIV infection).
• Tacrolimus (used in organ transplantation).
• St. John's Wort (Hypericum perforatum) (used for the treatment of mild depression).
• Cilostazol (used for the treatment of intermittent claudication).
• Saquinavir (used for the treatment of HIV infection).
• Clopidogrel (used to prevent blood clots (thrombi).
• Erlotinib (used for the treatment of cancer).
• Methotrexate (a chemotherapeutic medicine used in high doses for the treatment of cancer).
• If your doctor has prescribed you the antibiotics amoxicillin and clarithromycin together with
  OMEPRAZOLO FG for the treatment of ulcers caused by infections from

Helicobacter pylori, it is very important that you tell your doctor if you are taking
any other medicines.

OMEPRAZOLO FG with food and drink
See section 3.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are
breastfeeding, ask your doctor or pharmacist for advice before
taking this medicine. The doctor will decide whether you can take OMEPRAZOLO
FG during this period.
Omeprazole is excreted in breast milk but it is unlikely that when used at therapeutic doses it will have an effect on the baby. The doctor will decide whether you can take
OMEPRAZOLO FG during breastfeeding.

Driving and operating machinery
It is unlikely that OMEPRAZOLO FG can affect your ability to drive
vehicles or use tools or machinery. Adverse reactions to
the drug such as dizziness and visual disturbances may occur (see section 4). If you suffer from these, you should not
drive vehicles or use machinery.

OMEPRAZOLO FG contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, which is
essentially ‘sodium-free’.

3. How to take OMEPRAZOLO FG

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Your doctor will tell you how many capsules to take and for how long. This will depend on
your conditions and age.
The recommended dose is reported below.
Use in adults:
For the treatment of GERD symptoms, such as heartburn and acid reflux:

• If your doctor has told you that your esophagus is slightly damaged, the recommended dose is 20 mg once a day for 4-8 weeks. The doctor may increase the dose to 40 mg for another 8 weeks if the esophagus is not yet completely healed.
• The recommended dose once the esophagus has healed is 10 mg once a day.
• If the esophagus is not damaged, the usual dose is 10 mg once a day.

For the treatment of ulcers in the upper part of the intestine(duodenal ulcer):

• The recommended dose is 20 mg once a day for 2 weeks. The doctor may extend the intake of this dose for another 2 weeks if the ulcer has not yet healed.
• If the ulcer is not completely healed, the dose may be increased to 40 mg once a day for 4 weeks.

For the treatment of stomach ulcers(gastric ulcer):

• The recommended dose is 20 mg once a day for 4 weeks. The doctor may extend the intake of this dose for another 4 weeks if the ulcer has not yet healed.
• If the ulcer is not completely healed, the dose may be increased to 40 mg once a day for 8 weeks.

To preventthe recurrence of duodenal and gastric ulcers:

• The recommended dose is 10 mg or 20 mg once a day. The doctor may increase the dose to 40 mg once a day.

For the treatment of duodenal and gastric ulcers caused by taking
NSAIDs(Non-Steroidal Anti-Inflammatory Drugs):

• The recommended dose is 20 mg once a day for 4-8 weeks.

To prevent the formation of duodenal and gastric ulcersif you are using

NSAIDs:

• The recommended dose is 20 mg once a day.

For the treatment of ulcers caused by infection byHelicobacter pyloriand
prevention of their recurrence:

• The recommended dose is 20 mg of OMEPRAZOLO FG twice a day for one week.
• The doctor will tell you to also take two antibiotics among amoxicillin, clarithromycin and metronidazole.

For the treatment of excessive acid in the stomach caused by an
increase of tissue in the pancreas (Zollinger-Ellison syndrome):

• The recommended dose is 60 mg per day.
• The doctor will adjust the dose according to your needs and also decide how long you will have to take the medicine.

Use in children and adolescents:
For the treatment of GERD symptoms, such as heartburn and acid reflux:

• OMEPRAZOLO FG can be taken by children over 1 year of age and weighing more than 10 kg. The dose for children is based on the child's weight and the exact dose will be decided by the doctor.

For the treatment and prevention of the recurrence of ulcers causedby infection

byHelicobacter pylori:

• OMEPRAZOLO FG can be taken by children over 4 years of age. The dose for children is based on the child's weight and the exact dose will be decided by the doctor.
• The doctor will also prescribe two antibiotics called amoxicillin and clarithromycin to your child.

Taking this medicine

• It is recommended to take the capsules in the morning.
• The capsules can be taken with food or on an empty stomach.
• The capsules should be swallowed whole with half a glass of water. The capsules must not be chewed or crushed, as they contain granules coated in such a way as to prevent the medicine from being broken down by the acid present in the stomach. It is important not to damage the granules.

What to do if you or the child has difficulty swallowing the capsules

• If you or the child has difficulty swallowing the capsules:
• Open the capsules and swallow the contents directly with half a glass of water or pour the contents into a glass of water (non-carbonated), acidic fruit juice (e.g. apple, orange or pineapple) or applesauce.
• Always shake the contents before drinking (the mixture will not be clear), then drink the preparation immediately or within 30 minutes.
• To be sure you have taken all the medicine, rinse the glass very well with half a glass of water and drink the contents. The solid particles contain the medicine - do not chew or crush them.

If you take more OMEPRAZOLO FG than you should
If you take an amount of OMEPRAZOLO FG greater than that prescribed by
your doctor, contact your doctor or pharmacist immediately.

If you forget to take OMEPRAZOLO FG
If you forget to take a dose, take it as soon as you remember. However, if it is
almost time to take the next dose, skip the missed dose. Do not take a
double dose to make up for the missed dose.

If you stop taking OMEPRAZOLO FG
Do not stop taking OMEPRAZOLO FG without first talking to your doctor or
pharmacist.
If you have any doubts about the use of this medicine, contact your doctor or
pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although
not everyone gets them.

If you notice any of the following rare (may affect up to 1
in 1,000 people) or very rare (may affect up to 1 in 10,000)
but serious side effects, stop taking OMEPRAZOLO FG and contact
your doctor immediately:

• Sudden wheezing, swelling of the lips, tongue and throat or body, skin rash, fainting or difficulty swallowing (severe allergic reaction). (Rare)
• Reddening of the skin with the appearance of blisters or peeling. Severe blistering with bleeding of the lips, eyes, mouth, nose and genitals may also occur. This could be “Stevens-Johnson syndrome” or “toxic epidermal necrolysis”. (Very rare)
• Widespread skin rash, high temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). (Rare)
• A widespread red and scaly skin rash with bumps under the skin and blisters accompanied by fever. Symptoms usually appear early in treatment (acute generalized exanthematous pustulosis). (Rare)
• Yellowing of the skin, dark urine and fatigue may be symptoms of liver problems. (Rare)

Other side effects include:

Common side effects (may affect up to 1 in 10 people)

• Headache.
• Effects on the stomach or intestines: diarrhea, stomach pain, constipation, passing gas (flatulence).
• Feeling unwell (nausea) or being sick (vomiting).
• Benign polyps in the stomach.

Uncommon side effects (may affect up to 1 in 100 people)

• Swelling of the feet and ankles.
• Disturbed sleep (insomnia).
• Dizziness, tingling, feeling sleepy.
• Feeling giddy (vertigo).
• Changes in blood tests related to liver function.
• Skin rash, skin rash with swelling of the skin (urticaria) and itching on the skin.
• General feeling of being unwell and lack of energy.
• Fracture of the hip, wrist or spine (see section 2).

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

• Changes in blood cell counts, such as a decrease in the number of white blood cells or platelets. This can cause weakness and easy bruising, or may make you more likely to get infections.
• Low levels of sodium in the blood. This can cause weakness, feeling sick (vomiting) and cramps.
• Feeling agitated, confused or depressed.
• Changes in taste.
• Problems with your eyesight, such as blurred vision.
• Sudden wheezing or shortness of breath (bronchospasm).
• Dry mouth.
• Inflammation inside the mouth.
• An infection called “candidiasis” which can affect the intestines and is caused by a fungus.
• Hair loss (alopecia).
• Skin rash during exposure to the sun.
• Joint pain (arthralgia) or muscle pain (myalgia).
• Serious kidney problems (interstitial nephritis).
• Increased sweating.

Very rare side effects (may affect up to 1 in 10,000 people)

• Changes in the count of blood cells, including agranulocytosis (lack of white blood cells).
• Aggression.
• Seeing, feeling or hearing things that are not real (hallucinations).
• Serious liver problems up to liver failure and brain inflammation.
• Erythema multiforme.
• Muscle weakness.
• Enlargement of the breasts in men.

In very rare cases OMEPRAZOLO FG can affect white blood cells leading to an
immuno-deficiency. If you develop an infection with symptoms such as fever with
a serious worsening of your general condition or fever with symptoms of
local infection such as sore throat, sore throat or mouth or difficulty urinating,
you should consult a doctor as soon as possible, so that a lack of
white blood cells (agranulocytosis) can be ruled out by performing a blood test. It is important that in
this case you inform the doctor about the medicine you are taking.

• Side effects with unknown frequency (frequency cannot be estimated based on available data)Alteration of the urea breath test (see section 2).
• Hypomagnesemia (low levels of magnesium in the blood) (see section 2).
• Reduction of calcium levels in the blood (hypocalcemia). The reduction of calcium levels in the blood may result from very low levels of magnesium.
• Reduction of potassium levels in the blood (hypokalaemia).
• Inflammation of the intestine (resulting in diarrhea).
• Erythema, possible joint pain.

Reporting of side effects
If you get any side effects, even those not listed in this
leaflet, tell your doctor or pharmacist. You can also report side
effects directly through the national reporting system at
https:// 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 OMEPRAZOLO FG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the packaging
after Exp. The expiry date refers to the last day of that month.
Store at a temperature below 30°C.
Keep this medicine in the original packaging, to protect the medicine
from humidity.
Do not dispose of any medicine in wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help to
protect the environment.

6. Contents of the pack and other information

What OMEPRAZOLO FG 20 mg gastro-resistant hard capsules contain
The active ingredient is omeprazole.
Each gastro-resistant hard capsule contains 20 mg of omeprazole
The other ingredients are:

Core:microcrystalline cellulose, low-substituted hydroxypropylcellulose, mannitol,
sodium croscarmellose, polysorbate 80, povidone K-30, arginine, sodium lauryl sulfate,
glycine, light magnesium carbonate.

Coating:hypromellose, methacrylic acid-ethyl acrylate copolymer, triethyl citrate,
sodium hydroxide, titanium dioxide, talc.

Capsule:gelatin, indigo carmine (E-132), titanium dioxide, water.

Description of the appearance of OMEPRAZOLO FG and contents of the pack
Gastro-resistant hard capsules.
Packs containing 14 and 28 gastro-resistant hard capsules in blisters

Marketing Authorisation Holder
FG S.r.l. – Via San Rocco, 6 – 85033 Episcopia (PZ)

Manufacturer
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo, 1 - 03012 - Anagni (FR)