Omeprazole Almus Pharma

Package leaflet: Information for the user

OMEPRAZOLE ALMUS PHARMA 10 mg gastro-resistant hard capsules, 20 mg gastro-resistant hard capsules, 40 mg gastro-resistant hard capsules

Equivalent 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as yours, because it may be harmful.
• If any adverse reaction occurs, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

OMEPRAZOLO ALMUS PHARMA 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 in the stomach.
OMEPRAZOLO ALMUS 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 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 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 ALMUS PHARMA may also be used to prevent ulcers from forming if you are taking NSAIDs.
• Excess acid in the stomach caused by overgrowth of tissue in the pancreas (Zollinger-Ellison syndrome).

In children:
Children aged over 1 year and with body weight greater than or equal to 10 kg
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• '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 of stomach contents back into the mouth, vomiting, and poor weight gain.

Children aged over 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 should know before taking OMEPRAZOLO ALMUS PHARMA

Do not take OMEPRAZOLO ALMUS PHARMA

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

• Unintentional weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting of food or blood.
• Dark-coloured stools (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 OMEPRAZOLO ALMUS PHARMA that reduces gastric acidity.
• If you are due to have 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 treatment with
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OMEPRAZOLO ALMUS PHARMA may need to be discontinued. Remember to also report any other adverse effects such as joint pain.
If you have been taking OMEPRAZOLO ALMUS PHARMA 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 are taking a proton pump inhibitor such as OMEPRAZOLO ALMUS PHARMA, 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.
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 OMEPRAZOLO ALMUS PHARMA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is important because OMEPRAZOLO ALMUS PHARMA can affect how some medicines work, and conversely, some medicines may affect the action of OMEPRAZOLO ALMUS PHARMA.
Do not take OMEPRAZOLO ALMUS PHARMA 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:

• Posaconazole, ketoconazole, 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 ALMUS 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 ALMUS 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). 3/10
• 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 OMEPRAZOLO ALMUS PHARMA.

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin together with OMEPRAZOLO
ALMUS PHARMA for the treatment of ulcers caused by Helicobacter pylori infection, it is
very important that you inform your doctor if you are taking any other medicines.
OMEPRAZOLO ALMUS PHARMA with food and drink
The capsules can be taken with food or on an empty stomach.
Pregnancy and breastfeeding
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 OMEPRAZOLO ALMUS PHARMA 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 OMEPRAZOLO ALMUS
PHARMA while breastfeeding.
Driving and using machines
It is unlikely that OMEPRAZOLO ALMUS PHARMA will affect your ability to drive
or use tools or machinery. 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.
OMEPRAZOLO ALMUS PHARMA contains sucrose.
If you have been diagnosed with an intolerance to certain sugars, contact your doctor before taking this medicine.
OMEPRAZOLO ALMUS PHARMA contains sodium.
This medicine contains less than 1 mmol (23 mg) of sodium per gastro-resistant hard capsule, i.e. essentially ‘sodium-free’.

3. How to take OMEPRAZOLE ALMUS PHARMA

Take this medicine exactly as directed 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 doses are:
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 preventing the formation of duodenal and gastric ulcers if you are taking NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):

• The recommended dose is 20 mg once daily.

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

• The recommended dose is 20 mg of OMEPRAZOLE ALMUS PHARMA 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 take the medicine.

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

• OMEPRAZOLE ALMUS PHARMA may be taken by children over one 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 ALMUS PHARMA may be taken by children over four 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 granules with a special coating 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), acidic fruit juice (such as apple, orange, or pineapple juice), 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 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 ALMUS PHARMA than you should
If you take more OMEPRAZOLE ALMUS PHARMA than prescribed by your doctor, contact your doctor or pharmacist immediately.

If you forget to take OMEPRAZOLE ALMUS 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.

If you stop taking OMEPRAZOLE ALMUS PHARMA
Do not stop taking OMEPRAZOLE ALMUS PHARMA 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 OMEPRAZOLE ALMUS 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). (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)
• A widespread red, scaly rash with bumps under the skin and blisters accompanied by fever. Symptoms usually occur at the beginning of treatment (acute generalised exanthematous pustulosis). (Rare)
• Yellowing of the skin, dark urine and fatigue could be symptoms of liver problems. (Rare)

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Other side effects are listed below by frequency:
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
• Feeling of spinning (vertigo)
• Abnormal liver function blood tests
• 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 OMEPRAZOLE ALMUS PHARMA, 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 can 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 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.
• Restlessness, confusion or depression.
• Taste disturbances.
• 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 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. 7/10
• 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 ALMUS PHARMA for more than three months, your blood magnesium levels may decrease. Low magnesium levels may cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness and 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 check your blood 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, OMEPRAZOLE ALMUS PHARMA 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 a 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 in this case 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 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 ALMUS PHARMA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after Exp. The expiry date refers to the last day of that month.
Store below 30°C.
Keep in the original packaging 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 no longer used. This will help protect the environment.

6. Package contents and other information

What OMEPRAZOLO ALMUS PHARMA contains
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• The active substance is omeprazole. Each capsule contains gastro-resistant granules of 10 mg, 20 mg or 40 mg of omeprazole.
• The other components are: Capsule core: sugar spheres (sucrose and maize starch), sodium carboxymethylamidum (Type A), sodium lauryl sulfate, povidone, trisodium phosphate dodecahydrate, hypromellose, methacrylic acid-ethyl acrylate copolymer (1:1), triethyl citrate, titanium dioxide (E171), talc, sodium hydroxide. Capsule cap: iron oxide red (E172) (only 10 mg), erythrosine (E127), indigo carmine (E132) (only 20 mg and 40 mg), titanium dioxide (E171), water, gelatin. Capsule body: quinoline yellow (E104), erythrosine (E127), titanium dioxide (E171), water, gelatin. Printing ink: shellac, povidone, propylene glycol, sodium hydroxide, titanium dioxide (E171).

Description of the appearance of OMEPRAZOLO ALMUS PHARMA and pack sizes
OMEPRAZOLO ALMUS PHARMA 10 mg:
Hard gelatin capsules, size 3, with an opaque red cap and an opaque orange body.
The letter “O” is printed in white ink on the cap and the number “10” on the body.
The capsules are filled with pelleted microgranules of white to beige colour.
Blister packs containing 14 and 28 capsules.
OMEPRAZOLO ALMUS PHARMA 20 mg:
Hard gelatin capsules, size 2, with an opaque blue cap and an opaque orange body.
The letter “O” is printed in white ink on the cap and the number “20” on the body.
The capsules are filled with pelleted microgranules of white to beige colour.
Blister packs containing 14 and 28 capsules.
OMEPRAZOLO ALMUS PHARMA 40 mg:
Hard gelatin capsules, size 0, with an opaque blue cap and an opaque orange body.
The letter “O” is printed in white ink on the cap and the number “40” on the body.
The capsules are filled with pelleted microgranules of white to beige colour.
Blister packs containing 14 capsules.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pharmacare S.r.l.
Via Marghera, 29
20149 Milan
Italy
(logo of Marketing Authorisation Holder)
Manufacturer
TEVA Pharma S.L.U.
Poligono Industrial Malpica, calle C., number 4
50016 Zaragoza
Spain
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