Omeprazole FG

Italy
Brand name Omeprazole FG
Form capsules, hard gelatin, gastro-resistant
Active substance / Dosage
OMEPRAZOLE
Prescription type Prescription only
ATC code
A02BC01
Registration number 038258
Manufacturer FG S.R.L.
Omeprazole FG capsules, hard gelatin, gastro-resistant

Table of Contents

Package leaflet: Information for the patient

OMEPRAZOLE FG 20 mg gastro-resistant hard capsules

Equivalent medicine
Please read all of 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, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

OMEPRAZOLO FG contains the active substance omeprazole. It belongs to a group of medicines called "proton pump inhibitors", which work by reducing the amount of acid produced by the stomach.
OMEPRAZOLO FG is used to treat the following conditions:

In adults:

  • Gastro-oesophageal reflux disease (GERD). This condition occurs when acid leaks from the stomach into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
  • Ulcers in the upper part of the intestine (duodenal ulcer) or in the stomach (gastric ulcer).
  • Ulcers infected with a bacterium called Helicobacter pylori. If you have this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.
  • Ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs). OMEPRAZOLO FG can also be used to prevent the formation of ulcers if you are taking NSAIDs.
  • Excessive production of stomach acid caused by abnormal tissue growth in the pancreas (Zollinger-Ellison syndrome).

In children:
Children over 1 year of age and weighing more than or equal to 10 kg

  • Gastro-oesophageal reflux disease (GERD). This condition occurs when acid leaks from the stomach into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn. In children, symptoms of this condition may also include regurgitation of stomach contents back into the mouth, vomiting, and poor weight gain.

Children over 4 years of age and adolescents
Ulcers infected with a bacterium called Helicobacter pylori. If your child has this condition, the doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

2. What you should know before taking OMEPRAZOLE FG

Do not take OMEPRAZOLE 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 OMEPRAZOLE FG if any of the above apply to you. If you are unsure, consult your doctor or pharmacist before taking OMEPRAZOLE FG.

Warnings and precautions

Talk to your doctor or pharmacist before taking OMEPRAZOLE FG.

Severe skin reactions have been reported in association with treatment with OMEPRAZOLE FG, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). Stop using OMEPRAZOLE FG and contact a doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

OMEPRAZOLE FG may mask symptoms of other diseases. Therefore, if you experience any of the following symptoms before or while taking OMEPRAZOLE FG, contact your doctor immediately:

  • Unintentional weight loss and difficulty swallowing.
  • Stomach pain or indigestion.
  • Vomiting of food or blood.
  • Dark-colored stools (indicating presence of blood in the stool).
  • Severe or persistent diarrhoea, as omeprazole has been associated with a slight increase in infectious diarrhoea.
  • Severe liver problems.
  • If you have ever had a skin reaction after treatment with a medicine similar to OMEPRAZOLE FG that reduces gastric acidity.
  • If you are scheduled to undergo a specific blood test (chromogranin A).

If you develop 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 OMEPRAZOLE FG. Remember to also report any other adverse effects such as joint pain.

Taking proton pump inhibitors may interfere with the results of the urea breath test for detecting Helicobacter pylori. Therefore, omeprazole treatment should be stopped at least 2 weeks before the test.

If you take a proton pump inhibitor such as OMEPRAZOLE FG, especially for over a 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 may increase the risk of osteoporosis), consult your doctor.

If you take OMEPRAZOLE FG for more than three months, your blood magnesium levels may decrease. Low magnesium levels may cause 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 may decide to monitor your blood magnesium levels periodically.

If you take OMEPRAZOLE FG for a long time (more than 1 year), your doctor will prescribe regular check-ups. Inform your doctor if you notice any new or unusual symptoms.

During treatment with omeprazole, kidney inflammation may occur. Signs and symptoms may include reduced urine volume or blood in the urine and/or hypersensitivity reactions such as fever, skin rash, and joint stiffness. Report such signs to your doctor.

This medicine may affect how your body absorbs vitamin B12, particularly if you need to take it for a long time. Contact your doctor if you notice any of the following symptoms, which could indicate low vitamin B12 levels:

  • Extreme tiredness or lack of energy
  • Tingling sensations (paraesthesia)
  • Sore or red tongue, mouth ulcers
  • Muscle weakness
  • Disturbed vision
  • Memory problems, confusion, depression

Children

Some children with chronic conditions 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 OMEPRAZOLE FG

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

This is important because OMEPRAZOLE FG may affect how some medicines work, and some medicines may affect the action of OMEPRAZOLE FG.

Do not take OMEPRAZOLE FG 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:

  • Ketoconazole, itraconazole, posaconazole, or voriconazole (used to treat fungal infections).
  • Digoxin (used to treat heart problems).
  • Diazepam (used to treat anxiety, to relax muscles, or for epilepsy).
  • Phenytoin (used for epilepsy). If you are taking phenytoin, your doctor will monitor you closely at the start and end of treatment with OMEPRAZOLE FG.
  • Medicines used to thin the blood, such as warfarin or other vitamin K antagonists. Your doctor will monitor you closely at the start and end of treatment with OMEPRAZOLE FG.
  • Rifampicin (used to treat tuberculosis).
  • Atazanavir (used to treat HIV infection).
  • Tacrolimus (used in organ transplantation).
  • St John’s wort (Hypericum perforatum) (used to treat mild depression).
  • Cilostazol (used to treat intermittent claudication).
  • Saquinavir (used to treat HIV infection).
  • Clopidogrel (used to prevent blood clots (thrombi)).
  • Erlotinib (used to treat cancer).
  • Methotrexate (a chemotherapeutic agent used in high doses for cancer treatment).
  • If you are taking high-dose methotrexate, your doctor may temporarily discontinue your treatment with OMEPRAZOLE FG.

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

OMEPRASOLE FG with food and drink

See section 3.

Pregnancy, breastfeeding and fertility

If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine. Your doctor will decide whether you can take OMEPRAZOLE FG during this time.

Omeprazole is excreted in breast milk, but it is unlikely to affect the breastfed infant when used at therapeutic doses. Your doctor will decide whether you can take OMEPRAZOLE FG while breastfeeding.

Driving and using machines

It is unlikely that OMEPRAZOLE FG will affect your ability to drive or use machines. However, adverse reactions such as dizziness and visual disturbances may occur (see section 4). If you experience these, do not drive or operate machinery.

OMEPRASOLE FG contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially ‘sodium-free’.

3. How to take OMEPRAZOLE FG

Take this medicine exactly as directed by 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 condition and age.
The recommended dose is given below.

Use in adults:
For the treatment of symptoms of GERD, such as heartburn and acid regurgitation:

  • If your doctor has informed you that your esophagus is slightly damaged, the recommended dose is 20 mg once daily for 4–8 weeks. Your doctor may increase the dose to 40 mg for an additional 8 weeks if the esophagus has not yet fully healed.
  • The recommended dose once the esophagus has healed is 10 mg once daily.
  • If the esophagus is not damaged, the usual dose is 10 mg once daily.

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

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

For the treatment of stomach ulcers (gastric ulcer):

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

For preventing the recurrence of duodenal and gastric ulcers:

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

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

  • The recommended dose is 20 mg once daily for 4–8 weeks.

For preventing the formation of duodenal and gastric ulcers if you are using NSAIDs:

  • The recommended dose is 20 mg once daily.

For the treatment of ulcers caused by Helicobacter pylori infection and prevention of their recurrence:

  • The recommended dose is 20 mg of OMEPRAZOLE FG twice daily for one week.
  • Your doctor will also instruct you to take two antibiotics among amoxicillin, clarithromycin, and metronidazole.

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

  • The recommended dose is 60 mg daily.
  • Your doctor will adjust the dose according to your needs and will also decide how long you should continue taking the medicine.

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

  • OMEPRAZOLE FG may be taken by children over 1 year of age and weighing more than 10 kg. The dose for children is based on body weight, and the exact dose will be determined by the doctor.

For the treatment and prevention of recurrence of ulcers caused by Helicobacter pylori infection:

  • OMEPRAZOLE FG may be taken by children over 4 years of age. The dose for children is based on body weight, and the exact dose will be determined by the doctor.
  • Your doctor will also prescribe two antibiotics called amoxicillin and clarithromycin for your child.

How to take this medicine

  • It is recommended to take the capsules in the morning.
  • The capsules may be taken with food or on an empty stomach.
  • Swallow the capsules whole with half a glass of water. The capsules must not be chewed or crushed, as they contain granules coated to prevent the medicine from being broken down by stomach acid. 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 capsule and take the contents directly with half a glass of water, or pour the contents into a glass of water (non-carbonated), into a glass of acidic fruit juice (e.g., apple, orange, or pineapple juice), or into apple puree.
    • Always shake the mixture before drinking (the mixture will not be clear), and drink it immediately or within 30 minutes.
    • To ensure you have taken the full dose, rinse the glass thoroughly with half a glass of water and drink the rinse water. The solid particles contain the medicine—do not chew or crush them.

If you take more OMEPRAZOLE FG than you should
If you take more OMEPRAZOLE FG than prescribed by your doctor, contact your doctor or pharmacist immediately.

If you forget to take OMEPRAZOLE FG
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 the forgotten dose.

If you stop taking OMEPRAZOLE FG
Do not stop taking OMEPRAZOLE FG without first talking to your doctor or pharmacist.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although
not everyone will experience 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 people) but serious side effects, stop taking OMEPRAZOLE FG and contact your doctor immediately:

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

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

  • Headache.
  • Stomach or intestinal problems: diarrhoea, stomach pain, constipation, passing wind (flatulence).
  • Feeling unwell (nausea) or being unwell (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, drowsiness.
  • Sensation of spinning (vertigo).
  • Changes in blood tests related to liver function.
  • Skin rash, skin rash with skin swelling (urticaria) and itching of 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 composition, such as reduced number of white blood cells or platelets. This may cause weakness and easy bruising, or may increase the likelihood of infections.
  • Low levels of sodium in the blood. This may cause weakness, feeling unwell (vomiting) and cramps.
  • Feeling restless, confusion or depression.
  • Changes in taste.
  • Vision problems, such as blurred vision.
  • Sudden wheezing or breathlessness (bronchospasm).
  • Dry mouth.
  • Inflammation inside the mouth.
  • An infection called “candidiasis” affecting the intestine, caused by a fungus.
  • Hair loss (alopecia).
  • Skin rash upon exposure to sunlight.
  • Joint pain (arthralgia) or muscle pain (myalgia).
  • Severe kidney problems (interstitial nephritis).
  • Increased sweating.

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

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

In very rare cases, OMEPRAZOLE FG may affect white blood cells, leading to
immunodeficiency. If you develop an infection with symptoms such as fever with
a severe deterioration in general health, or fever with symptoms of 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
by a blood test. It is important that in this case you inform your doctor about the medicine
you are taking.

  • Side effects with unknown frequency (frequency cannot be determined from the available data)
  • Altered urea breath test (see section 2).
  • Hypomagnesaemia (low magnesium levels in the blood) (see section 2).
  • Reduced calcium levels in the blood (hypocalcaemia). Low calcium levels may result from very low magnesium levels.
  • Reduced potassium levels in the blood (hypokalaemia).
  • Inflammation of the intestine (resulting in diarrhoea).
  • Erythema, possible joint pain.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your
doctor or pharmacist. You can also report side effects directly via 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 OMEPRAZOLE FG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging
after Exp. The expiry date refers to the last day of that month.
Store below 30°C.
Keep this medicine in the original packaging to protect it
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. Package contents and other information

What OMEPRAZOLE FG 20 mg gastro-resistant hard capsules contain
The active substance is omeprazole.
Each gastro-resistant hard capsule contains 20 mg of omeprazole.
The other components 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 shell: gelatin, indigo carmine (E-132), titanium dioxide, water.

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

Marketing Authorization 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)