Antra

Package leaflet: Information for the patient

Antra 10 mg gastro-resistant hard capsules, 20 mg gastro-resistant hard capsules

Omeprazole
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 other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. (See section 4).

Contents of this leaflet:

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

1. What Antra is and what it is used for

Antra 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.
Antra 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 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 medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Antra may also be used to prevent ulcers if you are taking NSAIDs.
• Excessive acid production due to 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

• '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 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 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 Antra

Do not take Antra

• 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 Antra if any of the above apply to you. If you are unsure, consult your doctor or pharmacist before taking Antra.

Warnings and precautions

Talk to your doctor or pharmacist before taking Antra.

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 Antra treatment. Stop using Antra and contact a doctor immediately if you notice any symptoms related to these serious skin reactions described in section 4.

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

• Unintentional weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting food or blood.
• Dark-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 Antra that reduces stomach acid.
• If you are scheduled for a specific blood test (chromogranin A).

If you have been taking Antra for a long time (more than 1 year), your doctor will arrange regular check-ups. Inform your doctor if you develop any new or unusual symptoms.

If you take a proton pump inhibitor such as Antra, 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, especially in areas exposed to sunlight, consult your doctor as soon as possible, as treatment with Antra may need to be stopped. Remember to also report any other side effects such as joint pain.

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

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

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

Children

Some children with chronic conditions may require long-term treatment, even though it is not generally recommended.

Do not give this medicine to children under 1 year of age or weighing less than 10 kg.

Other medicines and Antra

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 Antra may affect how some medicines work, and some medicines may affect how Antra works.

Do not take Antra 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 when starting and stopping treatment with Antra.
• Medicines used to thin the blood, such as warfarin or other vitamin K antagonists. Your doctor will monitor you closely when starting and stopping treatment with Antra.
• 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 stop your Antra treatment.

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin together with Antra 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.

Antra 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, ask your doctor or pharmacist for advice before taking 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 Antra while breastfeeding.

Driving and using machines

It is unlikely that Antra will affect your ability to drive or use machines. 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.

Antra capsules contain lactose and sodium

Antra capsules contain lactose. If you have been diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.

Antra capsules contain less than 1 mmol (23 mg) of sodium per capsule, i.e., essentially “sodium-free”.

3. How to take Antra

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 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.
• The recommended dose once the oesophagus has healed 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 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 Antra 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 of tissue in the pancreas (Zollinger-Ellison syndrome):

• The recommended dose is 60 mg per day.
• 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:

• Antra 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:

• Antra 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 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-carbonated), into an 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 that all the medicine is taken, 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 Antra than you should
If you take more Antra than prescribed by your doctor, contact your doctor or pharmacist immediately.

If you forget to take Antra
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 Antra
Do not stop taking Antra 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 Antra 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)
• Redness of the skin 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 appear at the beginning of treatment (acute generalized exanthematous pustulosis). (rare)
• Yellowing of the skin, dark urine and fatigue may 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 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 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.
• 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.
• Erythema multiforme.
• Muscle weakness.
• Breast enlargement in men.

Frequency not known (cannot be estimated from the available data)

• Inflammation of the intestine (resulting in diarrhoea).
• If you take Antra for more than three months, magnesium levels in your blood 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 blood levels of potassium or calcium. Your doctor should decide whether to periodically monitor your blood magnesium levels.
• Erythema, possible joint pain.

In very rare cases, Antra 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 symptoms of a local infection such as neck, throat or mouth pain, or difficulty urinating, you must 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.

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 Antra

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton 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 its original packaging (blister) 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 in use. This will help protect the environment.

6. Package contents and other information

What Antra contains

• The active substance is omeprazole. Each capsule (gastro-resistant capsule) contains 10 mg or 20 mg of omeprazole.
• The other components are disodium phosphate dihydrate, 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, liquid paraffin. (See section 2, “Antra capsules contain lactose”).

Description of the appearance of Antra and contents of the pack

• Antra 10 mg capsules have a pink body printed with “10” and a pink cap printed with “A/OS”.
• Antra 20 mg capsules have a pink body printed with “20” and a brownish-red cap printed with “A/OM”.

Pack sizes:

• 10 mg: blister packs containing 14 capsules.
• 20 mg: blister packs containing 14 capsules.

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany
Manufacturers:
Saneca Pharmaceuticals a.s.
Nitrianska 100
Hlohovec, 920 27
Slovakia
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 23 – 24
17489 Greifswald
Germany
This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Other sources of information
More detailed information on this medicinal product is available on the website of the Italian Medicines Agency (AIFA) https://www.aifa.gov.it/ .