Omeprazol

Package leaflet: Information for the user

OMEPRAZEN 10 mg gastro-resistant hard capsules, 20 mg gastro-resistant hard capsules, 40 mg gastro-resistant hard capsules

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

1. What OMEPRAZEN is and what it is used for

OMEPRAZEN 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.
OMEPRAZEN 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 passes 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 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 medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). OMEPRAZEN may also be used to prevent ulcer formation if you are taking NSAIDs.
• Excess stomach acid caused by a growth of tissue 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 and passes 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 (bringing up stomach contents into the mouth), vomiting, and poor weight gain.

Children aged over 4 years and adolescents
Ulcers associated 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 need to know before taking OMEPRAZEN

Do not take OMEPRAZEN:

• 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).

Do not take OMEPRAZEN if any of the above apply to you. If you are in doubt, consult your doctor or
pharmacist before taking OMEPRAZEN.
Warnings and precautions
Inform your doctor before taking this medicine if you are scheduled for a specific blood test (Chromogranin A).
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 during treatment with OMEPRAZEN. Stop using
OMEPRAZEN and consult a doctor immediately if you experience any symptoms related to
these severe skin reactions described in section 4.
OMEPRAZEN may mask symptoms of other diseases. Therefore, if you experience any of the following symptoms before or while taking OMEPRAZEN, contact your doctor
immediately:

• Unintentional weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting 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.
• You have ever had a skin reaction after treatment with a medicine similar to OMEPRAZEN that reduces gastric acidity.

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
OMEPRAZEN. Remember to also report any other adverse effects such as joint pain.
If you have been taking OMEPRAZEN for a long time (more than 1 year), your doctor will prescribe regular check-ups.
Inform your doctor if you notice the onset of new or unusual symptoms.
If you take a proton pump inhibitor such as OMEPRAZEN, 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.
During treatment with omeprazole, inflammation of the kidneys may occur. Signs and symptoms may include reduced urine volume or presence of blood in the urine and/or hypersensitivity reactions such as fever, skin rashes and joint stiffness. Report such signs to your doctor.
This medicine may affect the way your body absorbs vitamin B_{12}, particularly 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_{12}:

• 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,
despite it not being recommended.
Do not give this medicine to children under 1 year of age or weighing less than 10 kg.
Other medicines and OMEPRAZEN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including over-the-counter medicines. This is important
because OMEPRAZEN may affect how some medicines work, and some medicines may affect the action of OMEPRAZEN.
Do not take OMEPRAZEN if you are taking a medicine containing nelfinavir (used for the
treatment of HIV infections).
Inform your doctor or pharmacist if you are taking one or 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 at the beginning and end of treatment with OMEPRAZEN.
• 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 OMEPRAZEN.
• 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 for cancer treatment) – if you are taking high-dose methotrexate, your doctor may temporarily discontinue treatment with OMEPRAZEN.

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin together with OMEPRAZEN for the
treatment of ulcers caused by Helicobacter pylori infections, it is very important that you inform your doctor if you are taking any other medicines.
OMEPRAZEN with food and drink
See section 3.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine. Your doctor will decide whether you can take OMEPRAZEN during this period.
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 OMEPRAZEN while breastfeeding.
Driving and using machines
OMEPRAZEN does not affect or has a negligible effect on the ability to drive and use tools or machines. However, adverse drug reactions such as dizziness and visual disturbances may occur (see section 4). If you experience these, you must not drive or use machinery.
OMEPRAZEN capsules contain lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact them 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 OMEPRAZEN

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:

Adults

For the treatment of GERD symptoms, 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 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 OMEPRAZEN 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 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 decide how long you should continue taking the medicine.

Use in children and adolescents

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

• OMEPRAZEN 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:

• OMEPRAZEN 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 protect 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 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 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 OMEPRAZEN than you should
If you take more OMEPRAZEN than prescribed by your doctor, contact your doctor or pharmacist immediately.

If you forget to take OMEPRAZEN
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 a forgotten dose.

If you stop taking OMEPRAZEN
Do not stop taking OMEPRAZEN 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 everybody 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 people) but serious side effects, stop taking OMEPRAZEN 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. 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)
• 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 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 ache, 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.
• If you take a proton pump inhibitor such as OMEPRAZEN, 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.

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 make infections more likely.
• Low levels of sodium in the blood. This may cause weakness, feeling unwell (vomiting) and cramps.
• Feeling restless, confused or depressed.
• Changes in taste.
• Vision problems, such as blurred vision.
• Sudden wheezing or breathlessness (bronchospasm).
• Dry mouth.
• Inflammation inside the mouth.
• An infection called “candidiasis” which may affect the intestine and is caused by a fungus.
• Hair loss (alopecia).
• Skin rash after 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.

Side effects not known (frequency cannot be estimated from the available data)

• Inflammation of the intestine (resulting in diarrhoea).
• If you take OMEPRAZEN for more than three months, your blood magnesium levels may decrease. Low magnesium levels may cause fatigue, involuntary muscle contractions, confusion, seizures, dizziness, 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 to monitor your magnesium levels periodically.
• Reduced calcium levels in the blood (hypocalcaemia). Reduced calcium levels in the blood may result from very low magnesium levels.
• Reduced potassium levels in the blood (hypokalaemia).
• Erythema, possible joint pain.

In very rare cases, OMEPRAZEN 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 local infection such as neck, throat or mouth pain or difficulty urinating, you should contact 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 you inform your doctor about the medicine you are taking.
Reporting of side effects
If you experience any side effects, 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 OMEPRAZEN

• Keep this medicine out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton, bottle, or blister after Exp. The expiry date refers to the last day of that month.
• Do not store above 30°C.
• Store this medicine in the original packaging (blister) or keep the bottle tightly closed to protect the medicine 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 OMEPRAZEN contains

• The active substance is omeprazole. Each gastro-resistant hard capsule contains 10 mg, 20 mg or 40 mg of omeprazole.
• The excipients are dibasic sodium phosphate dihydrate, low-substituted hydroxypropylcellulose, hypromellose, anhydrous lactose, magnesium stearate, mannitol, methacrylic acid - ethyl acrylate copolymer (1:1) dispersion 30%, microcrystalline cellulose, macrogol (polyethylene glycol 400), sodium lauryl sulfate, iron oxide E172, titanium dioxide E171, gelatin, printing ink (containing shellac, ammonia, potassium hydroxide and black iron oxide E172), colloidal anhydrous silica and liquid paraffin (see section 2, “OMEPRAZEN capsules contain lactose”).

Description of the appearance of OMEPRAZEN and package contents

• OMEPRAZEN 10 mg capsules have a pink body printed with “10” and a pink cap printed with “A/OS”.
• OMEPRAZEN 20 mg capsules have a pink body printed with “20” and a reddish-brown cap printed with “A/OM”.
• OMEPRAZEN 40 mg capsules have a reddish-brown body printed with “40” and a reddish-brown cap printed with “A/OL”.

Pack sizes:

• 10 mg:
• Blister packs containing 14, 28 and 35 capsules.
• 20 mg:
• Blister packs containing 14 and 28 capsules.
• 40 mg:
• HDPE bottle containing 14 capsules.

Not all pack sizes may be marketed.
Marketing Authorization Holder
MALESCI Istituto Farmacobiologico S.p.A. Via Lungo L’Ema 7, Bagno a Ripoli (FI).
Under licence from CHEPLAPHARM Arzneimittel GmbH
Manufacturer
A. Menarini Manufacturing Logistic and Services srl, Via Campo di Pile, L’Aquila, Italy
For the 10 mg and 20 mg strengths only:
Laboratorios Menarini SA, C/Alfonso XII, 587, Badalona (BA), Spain
For the 40 mg strength only:
AstraZeneca AB, Gärtunavägen, SE-152 57 Södertälje, Sweden
This medicinal product is authorised in the European Economic Area countries under the
following names:
Italy Omeprazen
Further sources of information
More detailed information on this medicinal product is available on the website of the Italian Medicines Agency (AIFA) http://www.agenziafarmaco.gov.it/.