Patient Information Leaflet: Information for the User

Sedipanto 20 mg gastro-resistant tablets

Pantoprazole
Generic medicine
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice any improvement or if your symptoms worsen after 2 weeks.

Contents of this leaflet:

What Sedipanto is and what it is used for
What you need to know before taking Sedipanto
How to take Sedipanto
Possible side effects
How to store Sedipanto
Contents of the pack and other information

1. What Sedipanto is and what it is used for

Sedipanto contains the active substance pantoprazole, which blocks the acid-producing "pump" in the stomach. As a result, 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 backflow of acid from the stomach into the oesophagus, which may become inflamed and cause pain. This can lead to symptoms such as a painful burning sensation in the chest rising up to 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. You may need to take the tablets for 2-3 consecutive days to alleviate symptoms.
Consult your 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 to 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.
Speak to your doctor first:

if you have been treated for heartburn or indigestion continuously for 4 weeks or more,
if you are over 55 years old and are taking daily medicines for indigestion without a prescription,
if you are over 55 years old and have new symptoms or your symptoms have recently changed,
if you have previously had a gastric ulcer or stomach surgery,
if you have liver problems or jaundice (yellowing of the skin or eyes),
if you regularly visit your doctor for serious disorders or conditions,
if you are scheduled for an endoscopy or a breath test called C-urea test,
if you have ever had an allergic reaction after treatment with a medicine similar to Sedipanto that reduces stomach acidity,
if you are scheduled for 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, consult your doctor for specific advice.

Do not take this medicine for longer than 4 weeks without consulting your doctor.
If symptoms of gastroesophageal reflux (heartburn or gastric regurgitation) persist for more than 2 weeks, inform your doctor, who will decide whether prolonged treatment with this medicine is necessary.
If you take Sedipanto for a prolonged period, this may lead to additional risks, such as:

reduced absorption of Vitamin B12, and Vitamin B12 deficiency if you already have low levels of Vitamin B12,
fractures of the hip, wrist, and spine, especially if you already suffer from osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis),
decreased magnesium levels in the blood (possible symptoms: fatigue, involuntary muscle contractions, confusion, seizures, dizziness, increased heart rate). Low magnesium levels may also lead to reduced levels of potassium and calcium in the blood. You must inform your doctor if you have been taking this medicine for more than 4 weeks. Your doctor may decide to perform regular blood tests to monitor magnesium levels.

Inform your doctor immediately, before or after taking this medicine, if you notice any of the following symptoms, which could be signs of a more serious underlying condition:

unintentional weight loss (not related to diet or exercise program),
vomiting, especially if recurrent,
blood in the vomit; this may appear dark, like ground coffee,
blood in the stools, which may be black or tar-colored,
difficulty swallowing or pain when swallowing,
if you look pale and feel weak (anaemia),
chest pain,
stomach pain,
severe and/or persistent diarrhoea, as Sedipanto has been associated with a small increased risk of infectious diarrhoea,
if you develop a skin rash, especially on sun-exposed areas, inform your doctor as soon as possible, as you may need to stop treatment with Sedipanto. Remember to also mention any other side effects, such as joint pain. Your doctor may decide that further tests are needed.

If you need to have blood tests, inform 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 preventive measure.
If you suffer from recurrent heartburn or indigestion over a long period, remember to visit your doctor regularly.

Children and adolescents
Sedipanto must 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
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription. This includes herbal or homeopathic remedies.
Sedipanto may interfere with the proper functioning of certain medicines.
Inform your doctor or pharmacist if you are taking any medicine containing one of the following active substances:

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

Do not take Sedipanto with other medicines that reduce stomach acid production, such as another proton pump inhibitor (e.g. omeprazole, lansoprazole, or rabeprazole) or an H2 antagonist (e.g. ranitidine, famotidine).
However, if necessary, you may take Sedipanto with antacids (e.g. magaldrate, alginic acid, sodium bicarbonate, aluminium hydroxide, magnesium carbonate, or their combinations).

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.
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, do not drive or operate machinery.

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

3. How to take Sedipanto

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Take one tablet daily. 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 once you are completely free of symptoms. You may experience relief from acid reflux and burning symptoms after just one day of treatment with Sedipanto, but this medicine is not intended 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, every day at the same time. 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. There are no known symptoms of overdose.

If you forget to take Sedipanto
Do not take a double dose to make up for the missed dose. Take your next normal dose at the usual time the following day.

If you have any questions 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 everyone gets them.
Contact your doctor immediately or go to the nearest hospital emergency department if you
experience any of the following serious side effects. Stop taking this medicine immediately,
but bring this leaflet and/or the tablets with you.

Severe allergic reactions (rare: may affect up to 1 in 1,000 people): hypersensitivity reactions, so-called anaphylactic reactions, anaphylactic shock and angioedema. Typical symptoms are: swelling of the face, lips, mouth, tongue and/or throat, which may cause difficulty swallowing or breathing, urticaria, severe dizziness with rapid heartbeat and excessive sweating.
Severe skin reactions (frequency not known: frequency cannot be estimated from the available data): rash with swelling, blisters or peeling of the skin, loss of skin and bleeding around the eyes, nose, mouth or genitals, rapid deterioration in general health, or rash following exposure 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 gastric polyps.
Uncommon side effects (may affect up to 1 in 100 people): headache; dizziness; diarrhoea; feeling unwell; vomiting; bloating and flatulence (gas); constipation; dry mouth; stomach ache and discomfort; skin rash or urticaria; itching; feeling weak, tired or generally unwell; sleep disturbances; increased liver enzymes in blood tests; wrist, hip or spinal fracture.
Rare side effects (may affect up to 1 in 1,000 people): altered or complete loss of taste; visual disturbances such as blurred vision; joint pain; muscle pain; weight changes; elevated body temperature; swelling of the extremities; allergic reactions; depression; increased bilirubin and blood fat levels (observed in blood tests); breast enlargement in men; high fever and sudden drop in circulating granular white blood cells (observed in blood tests).
Very rare side effects (may affect up to 1 in 10,000 people): disorientation; reduced number of platelets in the blood, which may cause bleeding or bruising more than normal; reduced number of white blood cells, which may lead to more frequent infections; abnormal concurrent reduction in the number of red blood cells, white blood cells and platelets (observed in blood tests).
Frequency not known: hallucinations, confusion (particularly in patients who have previously experienced these symptoms); low sodium levels in the blood; low magnesium levels in the blood; skin rash, possible joint pain.

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via 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 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 you no longer use. This will help protect the environment.

6. Package contents and other information

What Sedipanto contains

The active substance is pantoprazole. Each gastro-resistant tablet contains 20 mg of pantoprazole as pantoprazole sodium sesquihydrate.
The other components 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, methacrylic acid - ethyl acrylate copolymer (1:1) dispersion 30%, sodium lauryl sulfate, polysorbate 80, macrogol 6000, and talc in the film coating.

Description of the appearance of Sedipanto and contents of the pack
The 20 mg gastro-resistant tablets are light yellow-brown,
oval (3 mm x 9 mm), slightly convex, film-coated tablets.
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 Authorization Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Responsible manufacturers 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

The following lifestyle and dietary recommendations may
help relieve symptoms related to heartburn and acid reflux.

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