SEDIPANTO 20 mg Enteric-Coated Tablet

Зміст інструкції

1. Sedipanto 20 mg gastro-resistant tablets
   1. What Sedipanto is and what it is used for
   2. What you need to know before taking Sedipanto
   3. How to take Sedipanto
   4. Possible side effects
   5. How to store Sedipanto
   6. Package Contents and Other Information

Sedipanto 20 mg gastro-resistant tablets

Pantoprazole
Generic medicine

Read this leaflet carefully before taking this medicine as it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your
doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms get worse after 2 weeks.

Contents of this leaflet:

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

1. What Sedipanto is and what it is used for

Sedipanto contains the active ingredient pantoprazole which blocks the “pump” that produces acid
in the stomach. Therefore, it reduces the amount of acid in the stomach.
Sedipanto is used for the short-term treatment of symptoms of reflux (e.g.,
heartburn, acid regurgitation) in adults.
Reflux is the return of acid from the stomach into the esophagus, which can become inflamed and cause
pain. This can cause symptoms such as a painful burning sensation in the chest that rises
into the throat (heartburn) and a bitter taste in the mouth (acid regurgitation).
You may experience relief from acid reflux and heartburn symptoms after just one day of
treatment with Sedipanto, but this medicine is not intended to provide immediate relief.
It may be necessary to take the tablets for 2-3 consecutive days
to relieve symptoms.
See a doctor if you do not feel better or if you feel worse after 2 weeks.

2. What you need to know before taking Sedipanto

Do not take Sedipanto

• if you are allergic to pantoprazole or any of the other ingredients of this medicine (listed in section 6),
• if you are taking HIV protease inhibitors such as atazanavir, nelfinavir (for the treatment of HIV infection). See “Other medicines and Sedipanto”.

Warnings and precautions
Talk to your doctor or pharmacist before taking Sedipanto.
Talk to your doctor:

• if you have been treated for heartburn or indigestion continuously for 4 weeks or more,
• if you are over 55 years of age and are taking medicines for indigestion daily without medical prescription,
• if you are over 55 years of age and have new symptoms or the symptoms have changed recently,
• if you have previously had a stomach ulcer or surgery to the stomach,
• if you have liver problems or jaundice (yellowing of the skin or eyes),
• if you regularly see your doctor for serious illnesses or conditions,
• if you need to undergo an endoscopy or a breath test called a C-urea test
• if you have ever had an allergic reaction after treatment with a medicine similar to Sedipanto that reduces stomach acid.
• if you need to undergo a specific blood test (Chromogranin A).
• if you are taking HIV protease inhibitors such as atazanavir; nelfinavir (for the treatment of HIV infection) together with pantoprazole, ask your doctor for specific advice.

Do not take this medicine for a period longer than 4 weeks without having
consulted your doctor. If the symptoms of acid reflux (heartburn or acid regurgitation) persist for more than 2 weeks, tell your doctor who will decide on the need
for a long period of taking this medicine.
If you take Sedipanto for a prolonged period, this may determine additional risks,
such as:

• reduced absorption of Vitamin B12, and Vitamin B12 deficiency if you already have low concentrations of Vitamin B12
• fracture of the hip, wrist, and spine, especially if you already suffer from osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis)
• decreased levels of magnesium in the blood (potential symptoms: fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate). Low levels of magnesium can also lead to a reduction in levels of potassium and calcium in the blood. You should tell your doctor if you are taking this medicine for more than 4 weeks. Your doctor may decide to have regular blood tests to monitor magnesium levels.

Immediately inform your doctor, before or after taking this medicine, if you notice
any of the following symptoms, which may be a sign of a more serious condition:

• unintentional weight loss (not related to a diet or exercise program)
• vomiting, especially if recurrent
• presence of blood in the vomit; this may appear dark like coffee grounds
• presence of blood in the stool, which may be black or tar-colored
• difficulty swallowing or pain when swallowing
• if you are pale and feel weak (anemia)
• chest pain
• stomach pain
• severe and/or persistent diarrhea, as Sedipanto has been associated with a small increase in infectious diarrhea
• if you have a skin rash, especially in areas exposed to the sun, tell your doctor as soon as possible as you may need to stop treatment with Sedipanto. Remember to also mention all other undesirable effects, such as joint pain. The doctor may decide that you need to undergo some tests.

If you need to have blood tests, tell your doctor that you are taking this
medicine.
You may experience relief from acid reflux and heartburn symptoms after just one day of
treatment with Sedipanto, but this medicine is not designed to provide
immediate relief. Do not take it as a preventative measure.
If you suffer from recurrent heartburn or indigestion for some time, remember to see
your doctor regularly.

Children and adolescents
Sedipanto should not be used in children and adolescents under 18 years of age due to
lack of safety information in this age group.

Other medicines and Sedipanto
Tell your doctor or pharmacist if you are taking, have recently taken, or may
take any other medicines, including those obtained without a prescription. This
includes herbal remedies or homeopathic medicines.
Sedipanto can block the proper functioning of some medicines.
Tell your doctor or pharmacist if you are taking any medicine that contains one of the
following active ingredients:

• HIV protease inhibitors such as atazanavir, nelfinavir (for the treatment of HIV infections). You should not take Sedipanto if you are taking HIV protease inhibitors. See “Do not take Sedipanto”.
• ketoconazole (used for fungal infections)
• warfarin and phenprocoumon (used to thin the blood and prevent clots). You may need to have blood tests.
• methotrexate (used for the treatment of rheumatoid arthritis, psoriasis and cancer) - if you are taking methotrexate, your doctor may temporarily interrupt treatment with Sedipanto, as pantoprazole can increase methotrexate levels in the blood.

Do not take Sedipanto with other medicines that limit the amount of acid produced in the
stomach, such as another proton pump inhibitor (omeprazole, lansoprazole or
rabeprazole) or an H2 antagonist (e.g. ranitidine, famotidine).
However, if necessary, you can take Sedipanto with antacids (e.g. magaldrate, alginic acid, sodium bicarbonate, aluminum hydroxide, magnesium carbonate or their combinations).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are
breastfeeding, ask your doctor or pharmacist for advice before taking
this medicine.
Do not take this medicine if you are pregnant or breastfeeding.

Driving and using machines
If you experience side effects such as dizziness or visual disturbances, you should not drive or
use machines.

Sedipantocontains sorbitol (E420). If your doctor has told you that you have an intolerance to
certain sugars, contact your doctor before taking this medicine.

3. How to take Sedipanto

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Take one tablet a day. Do not exceed the recommended dose of 20 mg of pantoprazole
per day.
Take this medicine for at least 2-3 consecutive days. Stop taking Sedipanto
when you are completely free from symptoms. You may experience relief from acid reflux and
burning symptoms after just one day of treatment with Sedipanto, but this
medicine is not designed to provide immediate relief.
If you do not experience symptom relief after taking this medicine continuously
for 2 weeks, consult your doctor.
Do not take Sedipanto tablets for more than 4 weeks without consulting your doctor.
Take the tablets before a meal, at the same time each day. You must swallow the
tablet whole with a little water. Do not chew or crush the tablet.

If you take more Sedipanto than you should
Inform your doctor or pharmacist immediately. If possible, bring the medicine and this leaflet
with you. No symptoms of overdose are known.

If you forget to take Sedipanto
Do not take a double dose to make up for a missed dose. Take the normal
dose next day at the usual time.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Immediately inform your doctoror contact the nearest hospital emergency room if you experience any of the following serious side effects. Stop taking it immediately

• Serious allergic reactions (rare: may affect up to 1 in 1,000 ): hypersensitivity reactions, so-called anaphylactic reactions, anaphylactic shock and angioedema. Typical symptoms are: swelling of the face, lips, mouth, tongue and/or throat, which can cause difficulty swallowing or breathing, urticaria, severe dizziness with a very fast heartbeat and profuse sweating.
• Severe skin reactions (frequency not known: the frequency cannot be estimated based on available data ): rash with swelling, blisters or peeling of the skin, loss of skin and bleeding around the eyes, nose, mouth or genitals and rapid deterioration of general health, or rash when exposed to sunlight.
• Other serious reactions (frequency not known): yellowing of the skin and eyes (due to severe liver damage), or kidney problems such as painful urination and lower back pain with fever.

Other side effects include:

• Common side effects(may affect up to 1 in 10 people) :benign polyps in the stomach.
• Uncommon side effects(may affect up to 1 in 100 people) :headache; dizziness; diarrhea; feeling unwell; vomiting; bloating and flatulence (gas); constipation; dry mouth; stomach pain and discomfort; skin rash or urticaria; itching; feeling weak, tired and generally unwell; sleep disturbances; increased liver enzymes in blood tests, wrist, hip and spine fracture.
• Rare side effects(may affect up to 1 in 1,000 people) :alteration or complete loss of taste; vision disorders such as blurred vision; joint pain; muscle pain; weight changes; high body temperature; swelling of the extremities; allergic reactions; depression; increased bilirubin and fat levels in the blood (observed in blood tests); breast enlargement in men; high fever and sudden decrease in circulating granular white blood cells (observed in blood tests).
• Very rare side effects(may affect up to 1 in 10,000): disorientation; reduced number of platelets in the blood, which can cause bleeding or bruising more than normal; reduced number of white blood cells, which can lead to more frequent infections; abnormal coexisting reduction in the number of red blood cells and white blood cells, as well as platelets (observed in blood tests)
• Frequency not known:hallucinations, confusion (especially in patients who have had these

symptoms in the past); low level of sodium in the blood; low level of magnesium in the blood;
skin rash, possibility of joint pain.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa .
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Sedipanto

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 packaging after
EXP. The expiry date refers to the last day of that month.
Store in the original package to protect the medicine from moisture.
Do not dispose of any medicine in 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 Sedipanto contains

• The active ingredient is pantoprazole. Each gastro-resistant tablet contains 20 mg of pantoprazole as pantoprazole sodium sesquihydrate.
• The other ingredients are mannitol, crospovidone (type B), anhydrous sodium carbonate, sorbitol (E420) and calcium stearate in the tablet core, and hypromellose, povidone, titanium dioxide (E171), yellow iron oxide (E172), propylene glycol, acrylic acid - ethyl acrylate copolymer (1:1) dispersion 30%, sodium lauryl sulfate, polysorbate 80, macrogol 6000 and talc in the film coating.

Description of Sedipanto and package contents
The 20 mg gastro-resistant tablets are light yellow-brown,
oval (3 mm x 9 mm) tablets, slightly convex and film-coated.
Sedipanto is available in packs of 7 and 14 gastro-resistant tablets in blister packs
containing 7 or 14 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturers responsible for batch release
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, D-27472 Cuxhaven, Germany
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The following recommendations regarding lifestyle and dietary changes may
help to relieve symptoms related to heartburn and acidity.

• Avoid large meals
• Eat slowly
• Stop smoking
• Reduce alcohol and caffeine consumption
• Lose weight (if overweight)
• Avoid clothing or belts that are too tight
• Avoid eating at least three hours before going to bed
• Raise the head of the bed (if you suffer from nighttime symptoms)
• Reduce the intake of food that can cause heartburn. These may include: chocolate, peppermint, spearmint, fatty and fried foods, acidic foods, spicy foods, citrus fruits and juices, tomatoes.