Anadir

PACKAGE LEAFLET: INFORMATION FOR THE USER

Anadir 20 mg gastro-resistant hard capsules

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

Contents of this leaflet:

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

1. What Anadir is and what it is used for

Anadir 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.
Anadir 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 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 caused by 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).
• Anadir may also be used to prevent the formation of ulcers if you are taking NSAIDs.
• Excess 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 and 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 caused by 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 Anadir

Do not take Anadir

• 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 ANADIR if any of the above apply to you. If you are unsure, consult your doctor or
pharmacist before taking ANADIR.
Warnings and precautions
Talk to your doctor or pharmacist before taking Anadir.
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 treatment with Anadir. Stop using Anadir and contact a doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
Anadir may mask symptoms of other diseases. Therefore, if you experience any of the following symptoms before or while taking Anadir, contact your doctor immediately:

• Unexplained weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting food or blood.
• Dark-coloured stools (melena: presence of digested 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 Anadir that reduces gastric acidity.

Inform your doctor before taking this medicine if:

• You need to undergo a specific blood test (chromogranin A).

If you take Anadir 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 Anadir, 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 have osteoporosis (bone thinning due to calcium loss) or are taking corticosteroids (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 Anadir may need to be discontinued. Remember to also report any other adverse effects such as joint pain.
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 rashes, and joint stiffness. Report such signs to your doctor.
Children and adolescents
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 Anadir
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is important because Anadir may affect how some medicines work, and some medicines may affect how Anadir works.
Do not take Anadir 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 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 at the beginning and end of treatment with Anadir.
• 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 Anadir.
• Rifampicin (an antibiotic also used to treat tuberculosis).
• Atazanavir (used to treat HIV infection).
• Tacrolimus (an immunosuppressant 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).
• 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 Anadir. If your doctor has prescribed amoxicillin and clarithromycin antibiotics together with Anadir to treat ulcers caused by Helicobacter pylori infection, it is very important that you inform your doctor if you are taking any other medicines.

Anadir with food and drink
The capsules can be taken with food or on an empty stomach.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will decide whether you can take Anadir 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 Anadir while breastfeeding.
Driving and using machines
It is unlikely that Anadir will affect your ability to drive or use tools or machinery.
However, side effects such as dizziness and visual disturbances may occur (see section 4).
If you experience these, do not drive or operate machinery.
Anadir capsules contain less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially "sodium-free".
This medicine contains mannitol. It may have a mild laxative effect.

3. How to take Anadir

Take this medicine exactly as your doctor or pharmacist has told you. 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 dose is given below:

Adults:

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

• If your doctor has told you that your oesophagus 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 a further 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 recommended 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 Anadir twice daily for one week.
• Your doctor will also instruct you to take two antibiotics, chosen from amoxicillin, clarithromycin, and metronidazole.

For the treatment of excessive stomach acid caused by an overgrowth of tissue in the pancreas (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:
Anadir can 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:
Anadir can be taken by 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. 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 mix the contents into a glass of water (non-carbonated), acidic fruit juice (for example, 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 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 Anadir than you should
If you take more Anadir than prescribed by your doctor, contact your doctor or pharmacist immediately.

If you forget to take Anadir
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 Anadir
Do not stop taking Anadir without first talking to your doctor or pharmacist.
If you have any doubts about using 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 Anadir and contact your doctor immediately:

• Sudden wheezing, swelling of the lips, tongue, throat or body, skin rash (appearance of red spots on the skin), fainting or difficulty swallowing (severe allergic reaction) (rare).
• 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” (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 could be symptoms of liver problems (rare).

Other side effects include:
Common (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 (may affect up to 1 in 100 people)
Swelling of the feet and ankles.
Sleep disturbance (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 Anadir, 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 have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis), consult your doctor.

Rare (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 make infections more likely.
Allergic reactions, sometimes very severe, including swelling of the lips, tongue and throat, fever, wheezing.
Low levels of sodium in the blood. This may cause weakness, feeling unwell (vomiting) and cramps.
Feeling agitated, confused or depressed.
Changes in taste.
Vision problems, such as blurred vision.
Sudden wheezing or breathlessness (bronchospasm).
Dry mouth.
Inflammation inside the mouth.

• Fungal infection called “candidiasis” which may affect the intestine. 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 (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.

• Enlargement of the breasts in men.

Not known (frequency cannot be estimated from the available data)
Inflammation of the intestine (resulting in diarrhoea).
If you take Anadir for more than three months, your blood magnesium levels may decrease.
Low magnesium levels may present as tiredness, 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.
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, Anadir may affect white blood cells, leading to immunodeficiency. If you develop an infection with symptoms such as fever with a severe deterioration in 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 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 Anadir

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after Exp. The expiry date refers to the last day of that month.
Do not store above 30°C.
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 Anadir Contains

• The active substance is omeprazole. Each capsule contains 20 mg of omeprazole.
• The other components are: Core: microcrystalline cellulose, low-substituted hydroxypropylcellulose, mannitol, croscarmellose sodium, polysorbate 80, povidone K-30, arginine, sodium lauryl sulfate, glycine, light magnesium carbonate. Coating: hypromellose, methacrylic acid-ethyl acrylate copolymer, triethyl citrate, sodium hydroxide, titanium dioxide, talc. Capsule shell: gelatin, indigo carmine (E-132), titanium dioxide, water.

Description of the Appearance of Anadir and Package Contents
Blister pack containing 14 gastro-resistant hard capsules of 20 mg.
Blister pack containing 28 gastro-resistant hard capsules of 20 mg.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
S.F. Group S.r.l. – Via Tiburtina, 1143 – 00156 Rome
Manufacturer
Special Product’s Line S.p.A. – Via Campobello, 15 – 00040 Pomezia (RM)
Special Product’s Line S.p.A. – Via Fratta Rotonda Vado Largo, 1 – 03012 Anagni (FR)