Omeprazole ABC

PACKAGE LEAFLET: INSTRUCTIONS FOR THE USER

OMEPRAZOLE ABC 10 mg gastro-resistant hard capsules, 20 mg gastro-resistant hard capsules

Omeprazole
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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Omeprazolo ABC is and what it is used for

Omeprazolo ABC 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 ABC is used to treat the following conditions:

In adults

• "Gastro-oesophageal reflux disease" (GERD). This condition occurs when acid leaks out of 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 associated with a bacterial infection 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 ABC may also be used to prevent ulcers if you are taking NSAIDs.
• Excessive acid production due to a growth in the pancreas (Zollinger-Ellison syndrome).

In children
Children aged over 1 year and weighing more than or equal to 10 kg

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

Children aged over 4 years and adolescents

• Ulcers associated with a bacterial infection 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 need to know before taking Omeprazole ABC

Do not take Omeprazole ABC

• 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 to treat HIV infections).

Do not take Omeprazole ABC if any of the above apply to you. If you have any doubts, consult your doctor or
pharmacist before taking Omeprazole ABC.
Warnings and precautions
Talk to your doctor or pharmacist before taking Omeprazole ABC.
Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), have been reported in association with omeprazole treatment. Stop using Omeprazole ABC and seek immediate medical advice if you notice any of the symptoms related to these serious skin reactions described in section 4.
Omeprazole ABC may mask symptoms of other conditions. Therefore, if you experience any of the following symptoms before or while taking Omeprazole ABC, contact your doctor immediately:

• Unintentional weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting food or blood.
• Black-coloured stools (indicating presence of blood in stools).
• 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 ABC that reduces stomach acid.
• If you are scheduled for a specific blood test (chromogranin A).

If you have been taking Omeprazole ABC for a long time (more than one year), your doctor will prescribe regular check-ups.
Inform your doctor if you notice the appearance of new or unusual symptoms.
If you take a proton pump inhibitor such as Omeprazole ABC, 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 may increase the risk of osteoporosis), consult your doctor.
If you develop a skin rash, particularly in areas exposed to sunlight, consult your doctor as soon as possible, as treatment with Omeprazole ABC may need to be discontinued. Remember to also report any other adverse effects such as joint pain.
This medicine may affect how your body absorbs vitamin B_{12}, especially if you need to take it for a long time. Contact your doctor if you notice any of the following symptoms, which may indicate low vitamin B_{12} levels:

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

During treatment with omeprazole, inflammation of the kidneys 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.
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 ABC
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription. This is important because Omeprazole ABC may affect how some medicines work, and some medicines may affect the action of Omeprazole ABC.
Do not take Omeprazole ABC if you are taking a medicine containing nelfinavir (used to treat HIV infections).
Inform your doctor or pharmacist if you are taking one or more 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 beginning and end of treatment with Omeprazole ABC;
• medicines used to thin the blood, such as warfarin or other vitamin K antagonists. Your doctor will monitor you closely at the beginning and end of treatment with Omeprazole ABC;
• rifampicin (used to treat tuberculosis);
• atazanavir (used to treat HIV infection);
• tacrolimus (used in organ transplants);
• 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 to treat cancer) – if you are taking high-dose methotrexate, your doctor may temporarily discontinue your treatment with Omeprazole ABC.

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin together with Omeprazole ABC for the treatment of ulcers caused by Helicobacter pylori infection, it is very important that you inform them if you are taking any other medicines.
Omeprazole ABC with food and drinks
See section 3.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Omeprazole is excreted in breast milk, but it is unlikely to affect the infant when used at therapeutic doses.
Your doctor will decide whether you can take Omeprazole ABC while breastfeeding.
Driving and using machines
It is unlikely that Omeprazole ABC will affect your ability to drive or use tools or machinery. However, adverse drug reactions such as dizziness and visual disturbances may occur (see section 4). If you experience these, do not drive or operate machinery.
Omeprazole ABC contains sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.
Omeprazole ABC 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 ABC

Take this medicine exactly as directed by your doctor or pharmacist. If you are unsure, 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 doses are as follows:

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

• If your doctor has informed you that your oesophagus (the tube through which food passes) 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 oesophagus has not yet fully healed.
• Once the oesophagus has healed, the recommended dose is 10 mg once daily.
• If the oesophagus 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 the prevention of 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 taking 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 ABC twice daily for one week.
• Your doctor will also instruct you to take two antibiotics from the following: amoxicillin, clarithromycin, and metronidazole.

For the treatment of excessive stomach acid caused by pancreatic tissue overgrowth (Zollinger-Ellison syndrome) :

• The recommended dose is 60 mg daily.
• Your doctor will adjust the dose according to your needs and will also determine 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 ABC 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 ABC 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. Do not chew or crush the capsules, as they contain coated granules designed 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-fizzy), into an acidic fruit juice (such as 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 the full dose is taken, rinse the glass thoroughly with half a glass of water and drink the rinse water as well. The solid particles contain the medicine—do not chew or crush them.

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

If you forget to take Omeprazole ABC
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 ABC
Do not stop taking Omeprazole ABC without first discussing it with 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 gets them.

If you experience 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 ABC 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)
• Reddening of the skin with blistering or peeling. There may also be severe blistering with bleeding of the lips, eyes, mouth, nose and genitals. This may 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)
• A widespread 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 tiredness may be symptoms of liver problems.

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) and 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 (dizziness)
• Changes in blood tests related to liver function
• Skin rash, skin rash with swelling of the skin (urticaria) and itching of the skin
• General feeling of being unwell and lack of energy

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

• Changes in blood composition, such as reduced numbers of white blood cells or platelets. This may cause weakness and easy bruising, or may make infections more likely.
• 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
• A fungal infection called “candidiasis” which may affect the intestine
• Hair loss (alopecia)
• Skin rash during 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 counts 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 inflammation of the brain
• Erythema multiforme
• Muscle weakness
• Breast enlargement in men

Not known (frequency cannot be estimated from the available data)

• Inflammation of the intestine (resulting in diarrhoea)
• If you take Omeprazole ABC for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, 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 periodically monitor your blood magnesium levels.
• Erythema, possible joint pain

In very rare cases, Omeprazole ABC may affect white blood cells, leading to immunodeficiency. If you develop an infection with symptoms such as fever accompanied by a severe deterioration in your general health, or fever with signs of local infection such as neck, throat or mouth pain, or difficulty urinating, you should consult your doctor as soon as possible to rule out a lack of white blood cells (agranulocytosis) by means of a blood test. It is important that in such cases you inform your doctor about the medicine you are taking.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Reporting of suspected adverse reactions

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 the following website: 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 ABC

Keep this medicine out of the reach and sight of children.
For the bottle:
Do not use this medicine after the expiry date stated on the packaging after "Exp" and after 28
days from the first opening of the bottle. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
The shelf life after first opening of the bottle is 28 days (record the date of first opening
in the designated space on the carton).
For the PVC-PVDC/Al blister:
do not store above 25 °C.
Close the bottle tightly after use.
Do not dispose of medicines 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 Omeprazolo ABC contains
The active substance is omeprazole. Each capsule (gastro-resistant capsule) contains 10 mg or 20 mg of
omeprazole.
Omeprazolo ABC 10 mg gastro-resistant hard capsules contain 10 mg of omeprazole
The other components are:
capsule contents: hypromellose, talc, titanium dioxide (E171), methacrylic acid copolymer ethyl acrylate,
triethyl citrate, sucrose spheres, disodium phosphate dihydrate.
Capsule shell: titanium dioxide (E171), purified water, gelatin, black ink.
Omeprazolo ABC 20 mg gastro-resistant hard capsules contain 20 mg of omeprazole
The other components are:
capsule contents: hypromellose, talc, titanium dioxide (E171), methacrylic acid copolymer ethyl acrylate,
triethyl citrate, sucrose spheres, disodium phosphate dihydrate.
Capsule shell: titanium dioxide (E171), purified water, gelatin, black ink.
Description of the appearance of Omeprazolo ABC and package contents
Gastro-resistant hard capsules.
Omeprazolo ABC 10 mg: a bottle contains 14 gastro-resistant hard capsules of 10 mg
Omeprazolo ABC 20 mg: a bottle contains 14 gastro-resistant hard capsules of 20 mg
Omeprazolo ABC 10 mg: PVC-PVDC/Al blisters pack sizes of 14 and 28 gastro-resistant hard capsules of 10 mg
Omeprazolo ABC 20 mg: PVC-PVDC/Al blisters pack sizes of 14 and 28 gastro-resistant hard capsules of 20 mg
Marketing Authorization Holder
ABC Farmaceutici S.p.A. – Corso Vittorio Emanuele II, 72 – 10121 Turin, Italy
Manufacturer
Towa Pharmaceutical Europe S.l. – C. de Sant Martì 75-97, 08107 Martorelles – Barcelona (Spain)