ANADIR 20 mg Enteric-Coated Hard Capsule

Зміст інструкції

1. Anadir 20 mg hard gastro-resistant capsules
   1. What Anadir is and what it is used for
   2. What you need to know before you take Anadir
   3. How to take Anadir
   4. Possible side effects
   5. How to store Anadir
   6. Contents of the pack and other information

Anadir 20 mg hard gastro-resistant capsules

Omeprazole
Generic medicine

Read this leaflet carefully before you start to take 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 ingredient 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 for the treatment of the following conditions:
In adults:

• “Gastro-oesophageal reflux disease” (GERD). This disease occurs when acid leaks from the stomach and passes into the oesophagus (the tube that connects the throat to the stomach) causing pain, inflammation and heartburn.
• Ulcers in the upper part of the intestine (duodenal ulcer) or of the stomach (gastric ulcer).
• Ulcers infected by a bacterium called ‘ Helicobacter pylori’. If you suffer from this disease, 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 can also be used to prevent the formation of ulcers if you are taking NSAIDs.
• Excessive acid in the stomach caused by an increase in tissue in the pancreas (Zollinger-Ellison syndrome).

In children:

Children over 1 year of age and with a body weight of 10 kg or more

• ‘Gastro-oesophageal reflux disease’ (GERD). This disease occurs when acid leaks from the stomach and passes into the oesophagus (the tube that connects the throat to the stomach) causing pain, inflammation and heartburn. In children, the symptoms of this disease also include the return of stomach contents into the mouth (regurgitation), discomfort (vomiting) and poor weight gain.

Children over 4 years of age and adolescents

• Ulcers infected by a bacterium called ‘ Helicobacter pylori’. If the child suffers from this

disease, the doctor may also prescribe antibiotics to treat the infection and allow the
ulcer to heal.

2. What you need to know before you take 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 you fall into any of the above-mentioned cases. If you have any doubts, ask 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 consult your doctor immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.
Anadir may mask the symptoms of other diseases. Therefore, if you should experience the symptoms described below before taking Anadir or while taking it, contact your doctor immediately:

• Unexplained weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting of food or blood.
• Darkening of the stools (melena: presence of digested blood in the stools).
• Severe or persistent diarrhea, because omeprazole has been associated with a slight increase in infectious diarrhea.
• Serious liver problems.
• If you have ever had a skin reaction after treatment with a medicine similar to Anadir that reduces stomach acid.

Tell 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. Tell your doctor if you notice the appearance of new and particular symptoms.
If you take a proton pump inhibitor such as Anadir, especially for a period 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 (thinning of the bones due to calcium loss) or are taking corticosteroids (cortisone), which can increase the risk of osteoporosis, consult your doctor.
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 stop therapy with Anadir.
Remember to also report any other undesirable effects such as joint pain.
During treatment with omeprazole, inflammation of your kidneys may occur. Signs and symptoms may include reduced urine volume or the presence of blood in the urine and/or hypersensitivity reactions such as fever, skin rash and joint stiffness. Report these signs to your doctor.

Children and adolescents
Some children with chronic illnesses may need long-term treatment although it 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
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is important because Anadir can affect the way some medicines work and in turn some medicines can have effects on the action of Anadir.
Do not take Anadir if you are taking a medicine containing nelfinavir(used for the treatment of HIV infections).
Tell 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 for the treatment of heart problems).
• Diazepam (used for the treatment of 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 (antibiotic also used for the treatment of tuberculosis).
• Atazanavir (used for the treatment of HIV infection).
• Tacrolimus (immunosuppressant drug, used in organ transplantation).
• St. John's Wort (Hypericum perforatum) (used for the treatment of mild depression).
• Cilostazol, used for the treatment of intermittent claudication.
• Saquinavir (used for the treatment of HIV infection).
• Clopidogrel (used to prevent blood clots: thrombi).
• Erlotinib (used for the treatment of cancer).
• Methotrexate (a chemotherapeutic medicine used in high doses for the treatment of cancer). If you are taking methotrexate in high doses, your doctor may temporarily interrupt treatment with Anadir. If your doctor has prescribed amoxicillin and clarithromycin antibiotics together with Anadir for the treatment of ulcers caused by Helicobacter pyloriinfections, it is very important that you tell your doctor if you are taking any other medicines.

Anadir with food and drink
The capsules can be taken with or without food.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine. The doctor will decide whether you can take Anadir during this period.
Omeprazole is excreted in breast milk but it is unlikely to have an effect on the baby when used at therapeutic doses. The doctor will decide whether you can take Anadir during breastfeeding.

Driving and operating machinery
It is unlikely that Anadir will affect your ability to drive vehicles or operate tools or machinery.
Side effects of the medicine such as dizziness and visual disturbances (see section 4) may occur. If you suffer from these, you should not drive vehicles or operate machinery.
Anadir capsules contains less than 1 mmol (23 mg) of sodium per capsule, that is to say essentially “sodium-free”.
This medicine contains mannitol. It may have a mild laxative effect.

3. How to take Anadir

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts consult your doctor or pharmacist.
The 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 reported below:
Adults:
For the treatment of symptoms of GERD, such as heartburn and acid reflux:

• If your doctor has told you that your esophagus is slightly damaged, the recommended dose is 20 mg once a day for 4-8 weeks. The doctor may increase the dose to 40 mg for another 8 weeks if the esophagus is not yet completely healed.
• The recommended dose once the esophagus has healed is 10 mg once a day.
• If the esophagus is not damaged, the recommended dose is 10 mg once a day.

For the treatment of ulcers in the upper part of the intestine(duodenal ulcer):

• The recommended dose is 20 mg once a day for 2 weeks. The doctor may extend the intake of this dose for another 2 weeks if the ulcer has not yet healed.
• If the ulcer is not completely healed, the dose may be increased to 40 mg once a day for 4 weeks.

For the treatment of stomach ulcers(gastric ulcer):

• The recommended dose is 20 mg once a day for 4 weeks. The doctor may extend the intake of this dose for another 4 weeks if the ulcer has not yet healed.
• If the ulcer is not completely healed, the dose may be increased to 40 mg once a day for 8 weeks.

To preventthe recurrence of duodenal and gastric ulcers:

• The recommended dose is 10 mg or 20 mg once a day. The doctor may increase the dose to 40 mg once a day.

For the treatment of duodenal and gastric ulcers caused by taking NSAIDs(Non-Steroidal Anti-Inflammatory Drugs):

• The recommended dose is 20 mg once a day for 4-8 weeks.

To prevent the formation of duodenal and gastric ulcersif you are using NSAIDs:

• The recommended dose is 20 mg once a day.

For the treatment of ulcers caused by infection with Helicobacter pyloriand prevention of their
recurrence :

• The recommended dose is 20 mg of Anadir twice a day for one week.
• The doctor will tell you to also take two antibiotics among amoxicillin, clarithromycin and metronidazole.

For the treatment of excessive acid in the stomach caused by an increase in
tissue in the pancreas (Zollinger-Ellison syndrome):

• The recommended dose is 60 mg per day.
• The doctor will adjust the dose according to your needs and 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 reflux:
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 weight and the exact dose will be decided by
the doctor.
For the treatment and prevention of the recurrence of ulcers causedby infection with Helicobacter
pylori:
Anadir can be taken by children over 4 years of age. The dose for children is based on the
child's weight and the exact dose will be decided by the doctor.
The doctor will also prescribe two antibiotics called amoxicillin and clarithromycin to your child.

Taking this medicine
It is recommended to take the capsules in the morning.
The capsules can be taken with food or on an empty stomach.
The capsules should be swallowed 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 the acid present in the stomach. 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 capsules and swallow the contents directly with half a glass of water or pour the contents into a glass of water (non-carbonated), fruit juice (e.g. apple, orange or pineapple) or applesauce.
• Always shake the contents before drinking (the mixture will not be clear), then drink the preparation immediately or within 30 minutes.
• To be sure you have taken all the medicine, rinse the glass very well with half a glass of water and drink the contents. The solid particles contain the medicine - do not chew or crush them.

If you take more Anadir than you should
If you take a quantity of Anadir greater than that prescribed by the doctor, consult immediately
your doctor or pharmacist.

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 to
take the 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 the use of 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) or very rare (may affect up to 1 in 10,000) but serious side effects, stop taking Anadir and contact your doctor immediately:

• Sudden wheezing, swelling of the lips, tongue and throat or body, skin rash (appearance of red spots on the skin), fainting or difficulty swallowing (severe allergic reaction) (rare).
• Redness of the skin with the appearance of blisters or peeling. A severe formation of blisters with bleeding of the lips, eyes, mouth, nose and genitals may also appear. This could be “Stevens-Johnson syndrome” or “toxic epidermal necrolysis” (very rare).
• Widespread skin rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome) (rare).
• A widespread red and scaly skin 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-colored urine and fatigue may be symptoms of liver problems (rare).

Other side effects include:

Common (may affect up to 1 in 10 people)
Headache.
Effects on the stomach or intestines: diarrhea, stomach pain, constipation, passing gas (flatulence).
Feeling unwell (nausea) or being sick (vomiting).
Benign polyps in the stomach.

Uncommon (may affect up to 1 in 100 people)
Swelling of the feet and ankles.
Disturbed sleep (insomnia).
Dizziness, tingling, feeling sleepy.
Feeling giddy (vertigo).
Changes in blood tests related to liver function.
Skin rash, skin rash with swelling of the skin (urticaria) and itching on the skin.
General feeling of being unwell and lack of energy.
If you are taking a proton pump inhibitor like Anadir, especially for a period 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 can increase the risk of osteoporosis) consult your doctor.

Rare (may affect up to 1 in 1000 people)
Changes in blood composition, such as a reduction in the number of white blood cells or platelets. This can cause weakness and easy bruising, or may make you more likely to get infections.
Allergic reactions, sometimes very serious, including swelling of the lips, tongue and throat, fever, wheezing.
Low levels of sodium in the blood. This can cause weakness, feeling sick (vomiting) and cramps.
Feeling agitated, confused or depressed.
Changes in taste.
Problems with vision, such as blurred vision.
Sudden wheezing or shortness of breath (bronchospasm).
Dry mouth.
Inflammation inside the mouth.

• Infection called “candidiasis” which can affect the intestines and is caused by a fungus. Hair loss (alopecia).

Skin rash during exposure to the sun.

• Joint pain (arthralgia) or muscle pain (myalgia). Serious kidney problems (interstitial nephritis). Increased sweating.

Very rare (may affect up to 1 in 10,000 people)
Changes in the count of blood cells, including agranulocytosis (lack of white blood cells)
Aggressiveness.
Seeing, feeling or hearing events that are not real (hallucinations).
Serious liver problems up to liver failure and brain inflammation.
Multiforme erythema.
Muscle weakness.

• Enlargement of the breast in men.

Not known (frequency cannot be estimated from the available data)
Inflammation of the intestine (resulting in diarrhea).
If you take Anadir for more than three months, it is possible that blood levels of magnesium may decrease.
Low levels of magnesium can manifest with fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you have any of these symptoms, consult your doctor immediately. Low levels of magnesium can also lead to a reduction in blood levels of potassium or calcium. The doctor should decide whether to check blood magnesium levels periodically.
Reduction of calcium levels in the blood (hypocalcemia). The reduction of calcium levels in the blood may result from very low levels of magnesium.
Reduction of potassium levels in the blood (hypokalaemia).
Erythema, possible joint pains.
In very rare cases Anadir can affect the white blood cells leading to immunodeficiency. If you should develop an infection with symptoms such as fever with a severedeterioration of the general condition or fever with symptoms of local infection such as sore throat or difficulty urinating, you should consult a doctor as soon as possible, in order to exclude a lack of white blood cells (agranulocytosis) by performing a blood test. It is important in this case to inform the doctor about the medicine you are taking.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through 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 which is stated on the pack after Exp. The expiry date refers to the last day of that month.
Do not store at a temperature above 30°C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Anadir contains

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

Description of the appearance of Anadir and contents of the pack
Blisters containing 14 hard gastro-resistant capsules of 20 mg.
Blisters containing 28 hard gastro-resistant capsules of 20 mg.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
S.F. Group S.r.l. – Via Tiburtina, 1143 – 00156 Roma

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)