Omeprazole Aristo Pharma

Italy
Brand name Omeprazole Aristo Pharma
Form capsules, hard gelatin, gastro-resistant
Active substance / Dosage
OMEPRAZOLE
Prescription type Prescription only
ATC code
A02BC01
Registration number 047056
Manufacturer ARISTO PHARMA GMBH

Table of Contents

Package leaflet: Information for the user

OMEPRAZOLE ARISTO PHARMA 10 mg gastro-resistant hard capsules, 20 mg gastro-resistant hard capsules

Omeprazole
Equivalent medicine
Please read all of this leaflet carefully before you start using 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 they have the same symptoms as you, because 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 ARISTO PHARMA is and what it is used for
  2. What you need to know before taking OMEPRAZOLE ARISTO PHARMA
  3. How to take OMEPRAZOLE ARISTO PHARMA
  4. Possible side effects
  5. How to store OMEPRAZOLE ARISTO PHARMA
  6. Contents of the pack and other information

1. What OMEPRAZOLO ARISTO PHARMA is and what it is used for

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

In adults:

  • 'Gastro-oesophageal reflux disease' (GERD). This condition occurs when acid leaks out of the stomach and enters 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 suffer from this condition, 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 ARISTO PHARMA may also be used to prevent the formation of ulcers if you are taking NSAIDs.
  • Excessive production of stomach acid caused by a growth of tissue in the pancreas (Zollinger-Ellison syndrome).

Children older than 1 year and with body weight greater than or equal to 10 kg:

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

Children older than 4 years and adolescents:

  • Ulcers infected with a bacterium called 'Helicobacter pylori'. If the child suffers from 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 OMEPRAZOLO ARISTO PHARMA

Do not take OMEPRAZOLO ARISTO PHARMA

  • If you are allergic to omeprazole or to any of the excipients 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).

If you have any doubts, consult your doctor or pharmacist before taking OMEPRAZOLO ARISTO PHARMA.

Warnings and precautions

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

  • Unintentional weight loss and difficulty swallowing;
  • Stomach pain or indigestion;
  • Vomiting of food or blood;
  • Dark-coloured stools (indicating presence of blood in stools);
  • Severe or persistent diarrhoea, because 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 OMEPRAZOLO ARISTO PHARMA that reduces gastric acidity;
  • If you are scheduled to undergo a specific blood test (chromogranin A).

If you notice the appearance of a skin rash, especially in areas exposed to sunlight, contact your doctor as soon as possible, as it may be necessary to discontinue treatment with OMEPRAZOLO ARISTO PHARMA. Remember to report any other adverse effects such as joint pain.

If you have been taking OMEPRAZOLO ARISTO PHARMA for a long time (more than 1 year), your doctor will prescribe regular check-ups. Inform your doctor if you notice new or unusual symptoms.

Taking a proton pump inhibitor such as OMEPRAZOLO ARISTO PHARMA, particularly for more than one year, may slightly increase the risk of fracture of the hip, wrist, or spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

Other medicines and OMEPRAZOLO ARISTO PHARMA

Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those not requiring a prescription. This is important because OMEPRAZOLO ARISTO PHARMA may affect how some medicines work, and conversely, some medicines may affect the action of OMEPRAZOLO ARISTO PHARMA.

Do not take OMEPRAZOLO ARISTO PHARMA if you are using a medicine containing nelfinavir (used for the treatment of HIV infections).

Inform your doctor or pharmacist if you are taking one or more of the following medicines:

  • Ketoconazole, posaconazole, itraconazole 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 OMEPRAZOLO ARISTO PHARMA;
  • 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 OMEPRAZOLO ARISTO PHARMA;
  • 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 at high doses for cancer treatment) – if you are taking a high dose of methotrexate, your doctor may temporarily suspend your treatment with OMEPRAZOLO ARISTO PHARMA.

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin together with OMEPRAZOLO ARISTO PHARMA 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.

OMEPRAZOLO ARISTO PHARMA with food and drinks

Take the capsules preferably on an empty stomach. The capsules must NOT be chewed or crushed. They should be swallowed whole with a glass of water.

Pregnancy and breastfeeding

Before taking OMEPRAZOLO ARISTO PHARMA, inform your doctor if you are pregnant or planning to become pregnant. Your doctor will decide whether you can take OMEPRAZOLO ARISTO PHARMA during this period.

Your doctor will decide whether you can take OMEPRAZOLO ARISTO PHARMA during breastfeeding.

Driving and using machines

It is unlikely that OMEPRAZOLO ARISTO PHARMA will affect your ability to drive or use tools or 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.

OMEPRAZOLO ARISTO PHARMA contains sucrose and sodium

If you have been diagnosed with an intolerance to certain sugars, contact your doctor before taking this medicine.

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

3. How to take OMEPRAZOLO ARISTO PHARMA

Always take this medicine exactly as instructed by your doctor. 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:
For the treatment of symptoms of GERD, such as heartburn and acid regurgitation:

  • If your doctor has informed you that your oesophagus is slightly damaged, the usual 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 usual 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 usual 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 usual 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 usual 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 usual dose is 20 mg once daily for 4–8 weeks.

For the prevention of duodenal and gastric ulcers if you are taking NSAIDs:

  • The usual dose is 20 mg once daily.

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

  • The usual dose is 20 mg of OMEPRAZOLO ARISTO PHARMA twice daily for one week.
  • Your doctor will also instruct you to take two antibiotics, selected from amoxicillin, clarithromycin, and metronidazole.

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

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

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

  • OMEPRAZOLO ARISTO PHARMA may 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 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:

  • OMEPRAZOLO ARISTO PHARMA may be used in children over 4 years of age. The dose for children is based on the child's 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 in such a way as 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 your 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), acidic fruit juice (e.g., apple, orange, or pineapple), or 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 entire dose, rinse the glass 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 OMEPRAZOLO ARISTO PHARMA than you should
If you take more OMEPRAZOLO ARISTO PHARMA than prescribed by your doctor, contact your doctor or pharmacist immediately.
If you forget to take OMEPRAZOLO ARISTO PHARMA
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.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
If you notice any of the following rare but serious side effects, stop taking
OMEPRAZOLE ARISTO PHARMA and contact your doctor immediately:

  • Sudden wheezing, swelling of the lips, tongue, throat or body, skin rash, fainting or difficulty swallowing (severe allergic reaction).
  • Skin redness with blistering 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”.
  • 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 bowel effects: 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 sensations such as “pins and needles”, drowsiness.
  • Feeling dizzy (vertigo).
  • Changes in blood tests relating 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 number of white blood cells or platelets. This may cause weakness and easy bruising, or make infections more likely.
  • Allergic reactions, sometimes very severe, including swelling of the lips, tongue and throat, fever and wheezing.
  • Low levels of sodium in the blood. This may cause weakness, feeling unwell (vomiting) and cramps.
  • Feeling restless, confused or depressed.
  • Taste disturbances.
  • Vision problems, such as blurred vision.
  • Sudden wheezing or breathlessness (bronchospasm).
  • Dry mouth.
  • Inflammation inside the mouth.
  • An infection called "candidiasis" which can affect the bowel and is caused by a fungus.
  • Liver problems including jaundice, which can cause yellowing of the skin, dark urine and tiredness.
  • Hair loss (alopecia).
  • Skin rash occurring 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.
  • Sudden onset of severe skin rash or blisters and skin peeling. These effects may be associated with high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
  • Muscle weakness.
  • Breast enlargement in men.

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

  • Inflammation of the intestine (leading to diarrhoea).
  • If you have been taking OMEPRAZOLE ARISTO PHARMA for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as tiredness, involuntary muscle contractions, disorientation, seizures, dizziness or increased heart rate. If you develop 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 perform regular blood tests to monitor your magnesium levels.
  • Skin rash, possible joint pain.

In very rare cases, OMEPRAZOLE ARISTO PHARMA may affect white blood cells, leading to
immunodeficiency. If you develop an infection with symptoms such as fever with a severe deterioration in your general health, or fever with signs of a 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 this case 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. If any of the side effects worsen, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.
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 ARISTO PHARMA

  • 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 the month.
  • For Al/Al blisters: Store below 30°C. Keep the blister in the original packaging to protect the medicine from moisture.
  • For PVC-PVDC/Al blisters: Store below 25°C. Keep the blister in the original packaging to protect the medicine from moisture.
  • For bottles: This medicine does not require any special storage temperature conditions. Store the bottle tightly closed to protect the medicine from moisture.
  • Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What OMEPRAZOLO ARISTO PHARMA contains

  • The active substance is omeprazole. OMEPRAZOLO ARISTO PHARMA 10 mg gastro-resistant hard capsules contain 10 mg of omeprazole. OMEPRAZOLO ARISTO PHARMA 20 mg gastro-resistant hard capsules contain 20 mg of omeprazole.
  • The other components are sugar spheres (sucrose and maize starch), hypromellose (E-464), talc (E-553b), titanium dioxide (E-171), disodium phosphate dihydrate (E-339 ii), sodium lauryl sulfate, polysorbate 80, methacrylic acid-ethyl acrylate copolymer, triethyl citrate (E-1505). Capsule: gelatin, titanium dioxide (E-171), printing ink (black iron oxide (E-172), potassium hydroxide and shellac). See section 2: OMEPRAZOLO ARISTO PHARMA contains sucrose.

Description of the appearance of OMEPRAZOLO ARISTO PHARMA and contents of the pack
OMEPRAZOLO ARISTO PHARMA 10 mg capsules are hard gelatin capsules with an opaque white body printed with “OM 10”, containing granules.
OMEPRAZOLO ARISTO PHARMA 20 mg capsules are hard gelatin capsules with an opaque white body printed with “OM 20”, containing granules.
White HDPE bottles with hermetically sealed screw caps and desiccant cap: 14, 28, 90 and 100 capsules.
Al/Al blisters: 14 and 28 capsules.
PVC-PVDC/Al blisters: 14, 28, 30 and 100 capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Esteve Pharmaceuticals, S.A.
Passeig de la Zona Franca, 109, 08038, Barcelona, Spain

Responsible manufacturer for batch release
TOWA Pharmaceutical Europe, S.L.
C/ de Sant Martí, 75-97, Martorelles, 08107 Barcelona, Spain

This medicinal product is authorized in the European Economic Area countries under the following names:
Belgium: Omeboix 10, 20, 40 mg gastro-resistant capsules
France: Omeprazole Alter 20 mg gastro-resistant capsule
Germany: Omeboix 10, 20, 40 mg magensaftresistente Hartkapseln
Italy: Omeboix
Netherlands: Omecat 10, 20, 40 mg maagsapresistente capsule, hard
Poland: Omeboix
Portugal: Omeboix 20 & 40 mg cápsula gastrorresistente
Czech Republic: Omeboix
Romania: Omez 10, 20, 40 mg capsule gastrorezistente
Spain: Omeprazol cinfa 40 mg cápsula dura gastrorresistente

This Patient Information Leaflet was last approved on