Pantoprazole Git

Patient Information Leaflet: Information for the User

Pantoprazole GIT 20 mg gastro-resistant tablets

Generic 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 may be harmful.
• If you notice any adverse reaction, contact your doctor or pharmacist. This includes any possible adverse reaction not listed in this leaflet.

Contents of this leaflet:

1. What PANTOPRAZOLE GIT is and what it is used for
2. What you need to know before taking PANTOPRAZOLE GIT
3. How to take PANTOPRAZOLE GIT
4. Possible side effects
5. How to store PANTOPRAZOLE GIT
6. Package contents and other information

1. What PANTOPRAZOLO GIT is and what it is used for

Pantoprazolo GIT is a selective "proton pump inhibitor," a medicine that reduces the amount of acid produced in the stomach. It is used to treat acid-related diseases of the stomach and intestine.
Pantoprazolo GIT is used for:
Adults and adolescents aged 12 years and older:

• Treatment of symptoms (e.g. heartburn, acid regurgitation, pain on swallowing) associated with gastroesophageal reflux disease caused by acid reflux from the stomach.
• Long-term treatment of reflux esophagitis (inflammation of the esophagus accompanied by acid regurgitation from the stomach) and prevention of its recurrence.
  Adults:
• Prevention of duodenal and gastric ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs, e.g. ibuprofen) in at-risk patients who require ongoing NSAID therapy.

2. What you need to know before taking PANTOPRAZOLO GIT

Do not take Pantoprazolo GIT

• if you are allergic to pantoprazole or to any of the excipients of this medicine (listed in section 6).
• if you are allergic to medicines containing other proton pump inhibitors.

Warnings and precautions

• if you have severe liver problems. Inform your doctor if you have previously had liver issues. Your doctor will arrange for more frequent monitoring of your liver enzymes, especially if you are
  taking Pantoprazolo GIT for long-term therapy. If liver enzymes increase,
  treatment must be discontinued.

• if you require ongoing treatment with NSAIDs and are taking Pantoprazolo GIT due to an increased risk of developing gastric and intestinal complications. Any increased risk will be assessed based on your individual risk factors such as age (65 years and older), history of gastric or duodenal ulcers, or gastrointestinal bleeding.

• if you have low body reserves or risk factors for low vitamin B12 levels and are undergoing long-term treatment with pantoprazole. As with all agents that reduce acidity, pantoprazole may lead to reduced absorption of vitamin B12.

• if you are simultaneously taking a medicine containing atazanavir (for the treatment of HIV infection), please consult your doctor for specific advice.

Inform your doctor immediately if you experience any of the following symptoms:

• unintentional weight loss
• recurrent vomiting
• difficulty swallowing
• presence of blood in vomit
• you appear pale and feel weak (anemia)
• presence of blood in stools
• severe and/or persistent diarrhoea, as Pantoprazolo GIT has been associated with a slight increase in infectious diarrhoea.

Your doctor may decide that you need certain tests to rule out malignancy, as pantoprazole relieves symptoms of cancer and could delay diagnosis. If your symptoms persist despite treatment, further investigations should be considered.
If you take Pantoprazolo GIT for long-term treatment (over 1 year), your doctor will likely monitor you regularly. You must report any new or unusual symptoms or circumstances at every medical visit.
Children
The use of this medicine is not recommended in children under 12 years of age.
Other medicines and Pantoprazolo GIT
Pantoprazolo GIT may affect the effectiveness of other medicines, so inform your doctor if you are taking:

• medicines such as ketoconazole, itraconazole and posaconazole (used to treat fungal infections) or erlotinib (used for certain types of cancer), as Pantoprazolo GIT may prevent these and other medicines from working properly;
• warfarin and fenprocoumon, which affect blood clotting. You may need additional monitoring;
• atazanavir (used to treat HIV infection).

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, are breastfeeding, or planning to become pregnant, consult your doctor or pharmacist before taking this medicine.
Pregnancy
There are insufficient data on the use of pantoprazole in pregnant women. You should use this medicine only if your doctor considers the benefit to you greater than the potential risk to the fetus.
Breastfeeding
Excretion in human milk has been reported. You should use this medicine only if your doctor considers the benefit to you greater than the potential risk to the infant.
Driving and using machines
If you experience adverse effects such as dizziness or visual disturbances, you must not drive or operate machinery.

3. How to take PANTOPRAZOLE GIT

Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
When and how should you take Pantoprazole GIT?
Take the tablets 1 hour before a meal, without chewing or crushing them, swallowing them whole with
some water.
For the treatment of symptoms associated with gastro-oesophageal reflux disease (e.g. heartburn, acid
regurgitation, painful swallowing)
The recommended dose is one tablet per day. This dose usually provides relief within 2–4 weeks,
and at the latest within a further 4 weeks. Your doctor will advise you on how long to continue taking the medicine. After that, any recurrence of symptoms can be managed by taking one tablet per day as needed.

For long-term treatment and prevention of recurrence of reflux oesophagitis
The recommended dose is one tablet per day. If symptoms recur, your doctor may double the dose; in this case, you may alternatively use Pantoprazole GIT 40 mg tablets, one tablet per day. After healing, the dose may be reduced back to one 20 mg tablet per day.
For prevention of duodenal and gastric ulcers in patients requiring continuous treatment with NSAIDs
The recommended dose is one tablet per day.
Use in adolescents
For the treatment of symptoms associated with gastro-oesophageal reflux disease (e.g. heartburn,
acid regurgitation, painful swallowing)
The recommended dose is one tablet per day. This dose provides symptom relief within 2–4 weeks – at the latest within a further 4 weeks. Your doctor will advise you on how to continue taking this medicine. After this, recurrent symptoms can be managed by taking one tablet per day as needed.
For long-term treatment and prevention of recurrence of reflux oesophagitis
The recommended dose is one tablet per day. If symptoms recur, your doctor may double the dose; in this case, you may alternatively use Pantoprazole GIT 40 mg tablets, one tablet per day. After healing, the dose may be reduced back to one 20 mg tablet per day.
Special patient groups
If you have severe liver problems, you must not take more than one 20 mg tablet per day.
If you take more Pantoprazole GIT than you should
Consult your doctor or pharmacist if you take more Pantoprazole GIT than you should. Symptoms of overdose are not known.
If you forget to take Pantoprazole GIT
Do not take a double dose to make up for the missed dose. Take your next dose at the scheduled time.
If you stop taking Pantoprazole GIT
Do not stop treatment with these tablets without first consulting 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 will experience them.
If you experience any of the following side effects, stop taking this medicine immediately
and contact your doctor or go to the nearest hospital emergency department:

• Severe allergic reactions (uncommon): swelling of the tongue and/or throat, difficulty swallowing, hives, breathing difficulties, allergic swelling of the face (Quincke's oedema / angioedema), severe dizziness with very rapid heartbeat and profuse sweating.
• Severe skin disorders (frequency not known): appearance of skin blisters and rapid deterioration in general condition, erosion (including mild bleeding) of the eyes, nose, mouth/lips or genitals (Stevens-Johnson syndrome, Lyell syndrome, erythema multiforme), and photosensitivity.
• Other severe disorders (frequency not known): yellowing of the skin or whites of the eyes (severe liver cell damage, jaundice), or fever, skin rash and kidney enlargement sometimes with painful urination or lower back pain (severe kidney inflammation).

Other side effects include:

• Uncommon (may affect up to 1 in 100 people): headache; dizziness; diarrhoea; nausea, vomiting; abdominal distension and flatulence (gas); constipation; dry mouth; abdominal pain and feeling unwell; skin rash, exanthema, eruption; itching; feeling of weakness, fatigue or general malaise; sleep disturbances.
• Rare (may affect up to 1 in 1,000 people): visual disturbances such as blurred vision; urticaria; joint pain; muscle pain; weight changes; increased body temperature; swelling of the extremities (peripheral oedema); allergic reactions; depression; breast enlargement in men.
• Very rare (may affect up to 1 in 10,000 people): disorientation.
• Not known (frequency cannot be estimated from the available data): hallucinations, confusion (especially in patients with prior experience of these symptoms); decreased levels of sodium in the blood.

Side effects identified through blood tests:

• Uncommon (may affect up to 1 in 100 people): increased liver enzymes.
• Rare (may affect up to 1 in 1,000 people): increased bilirubin; increased blood lipids.
• Very rare (may affect up to 1 in 10,000 people): reduced platelet count, which may cause increased bleeding or bruising; reduced white blood cell count, which may lead to more frequent infections.

If you notice any side effect, talk to your doctor or pharmacist. This includes any possible side effect not listed in this leaflet.

5. How to store PANTOPRAZOLE GIT

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
Do not dispose of medicines 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 PANTOPRAZOLO GIT contains

• The active substance is pantoprazole. Each gastro-resistant tablet contains 20 mg of pantoprazole (as sodium sesquihydrate).
• The other components are:
  Tablet core: mannitol, anhydrous sodium carbonate, sodium carboxymethyl starch, methacrylic acid - ethyl acrylate copolymer (Eudragit E PO), calcium stearate.
  Inner coating: Opadry white OY-D-7233 (hypromellose, titanium dioxide E171, talc, macrogol 400, sodium lauryl sulfate).
  Gastro-resistant coating: Kollicoat MAE 30 DP, light yellow (methacrylic acid - ethyl acrylate copolymer dispersion, propylene glycol, yellow iron oxide (E172), titanium dioxide (E171), talc).

Description of the appearance of PANTOPRAZOLO GIT and contents of the pack
Light yellow, elliptical, biconvex gastro-resistant tablet.
Packs:
HDPE bottle: 7, 10, 14, 15, 20, 28, 30, 60, 100, 140, 500 tablets
Blister packs: 7, 10, 14, 15, 20, 28, 30, 60, 100, 140, (10x14), 500 tablets
Not all pack sizes may be marketed.

Marketing Authorization Holder
S.F. GROUP S.R.L.
VIA TIBURTINA, 1143
00156 ROMA
Italy

Manufacturers
Actavis Ltd.
BLB016 Bulebel Industrial Estate
Zejtun ZTN 3000
Malta
Actavis hf.
Reykjavíkurvegur 76-78, 220 Hafnafjördur
Iceland
Balkanpharma – Dupnitsa AD
3 Samokovsko Schosse Str.
Dupnitsa 2600
Bulgaria

This medicinal product is authorized in the EEA Member States under the following names:
Italy: Pantoprazolo GIT 20 mg gastro-resistant tablets
Portugal: Pantoprazol Germed
Spain: Pantoprazol Edigen 20 mg gastro-resistant tablets EFG

This Patient Information Leaflet was last reviewed on:

Package leaflet: Information for the user

PANTOPRAZOLE GIT 40 mg gastro-resistant tablets

Generic medicine
Please read this leaflet carefully before taking this medicine as 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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reaction, contact your doctor or pharmacist. This includes any possible adverse reaction not listed in this leaflet.

Contents of this leaflet:

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

1. What PANTOPRAZOLO GIT is and what it is used for

Pantoprazolo GIT is a selective "proton pump inhibitor", a medicine that reduces the amount of acid produced in the stomach. It is used for the treatment of acid-related diseases of the stomach and intestine.
Pantoprazolo GIT is used for the treatment of:
Adults and adolescents aged 12 years and older:

• Gastroesophageal reflux disease (GERD). Inflammation of the esophagus (the tube connecting the throat to the stomach) associated with regurgitation of gastric acid.

Adults:

• Infection with a bacterium called Helicobacter pylori in patients with duodenal ulcer and gastric ulcer, in combination with two antibiotics (Eradication therapy). The aim is to eliminate the bacteria in order to reduce the risk of recurrence of these ulcers.
• Gastric and duodenal ulcers.
• Zollinger-Ellison syndrome and other conditions characterized by excessive production of stomach acid.

2. What you need to know before taking PANTOPRAZOLO GIT

Do not take Pantoprazolo GIT

• if you are allergic to pantoprazole or to any of the excipients of this medicine (listed in section 6).
• if you are allergic to medicines containing other proton pump inhibitors.

Warnings and precautions

• If you have severe liver problems. Inform your doctor if you have previously had liver problems. Your doctor will arrange for more frequent monitoring of your liver enzymes, especially if you are taking PANTOPRAZOLO GIT for long-term treatment. If liver enzymes increase, treatment should be discontinued.
• If you have low body reserves or risk factors for vitamin B12 deficiency and are undergoing long-term treatment with pantoprazole. As with all agents that reduce acidity, pantoprazole may lead to reduced absorption of vitamin B12.
• If you are simultaneously taking a medicine containing atazanavir (for the treatment of HIV infection), please consult your doctor for specific advice.

Inform your doctor immediately if you experience any of the following symptoms:

• unintentional weight loss
• recurrent vomiting
• difficulty swallowing
• blood in vomit
• paleness and weakness (anemia)
• blood in the stool
• severe and/or persistent diarrhoea, as PANTOPRAZOLO GIT has been associated with a slight increase in infectious diarrhoea.

Your doctor may decide that you need certain tests to rule out a malignant disease, since pantoprazole relieves symptoms of cancer as well and could therefore delay diagnosis. If your symptoms persist despite treatment, further investigations should be considered.
If you take PANTOPRAZOLO GIT for long-term treatment (over 1 year), your doctor will likely monitor you regularly. You must report any new or unusual symptoms or circumstances at every visit with your doctor.
Children
The use of this medicine is not recommended in children under 12 years of age.
Other medicines and Pantoprazolo GIT
PANTOPRAZOLO GIT may affect the effectiveness of other medicines, so inform your doctor if you are taking:

• medicines such as ketoconazole, itraconazole and posaconazole (used to treat fungal infections) or erlotinib (used for certain types of cancer), since PANTOPRAZOLO GIT may prevent these and other medicines from working properly.
• warfarin and fenprocoumon, which affect blood clotting. You may need additional monitoring.
• atazanavir (used to treat HIV infection).

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are breastfeeding, or planning to become pregnant, consult your doctor or pharmacist before taking this medicine.
Pregnancy
There are insufficient data on the use of pantoprazole in pregnant women. This medicine should be used only if your doctor considers the benefit to you to outweigh the risk to the fetus.
Breastfeeding
Excretion into human breast milk has been reported. This medicine should be used only if your doctor considers the benefit to you to outweigh the risk to the infant.
Driving and using machines
If you experience adverse effects such as dizziness or visual disturbances, you must not drive or operate machinery.

3. How to take PANTOPRAZOLE GIT

Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
When and how should you take PANTOPRAZOLE GIT?
Take the tablets 1 hour before a meal, without chewing or crushing them, swallowing them whole with
a little water.
For the treatment of reflux esophagitis.
The recommended dose is one tablet daily. Your doctor may instruct you to increase the dose to 2
tablets daily. The treatment period for reflux esophagitis is usually between 4 and 8 weeks. Your doctor
will tell you how long to take the medicine.
For the treatment of infection with a bacterium called Helicobacter pylori in patients with
duodenal ulcer and gastric ulcer, in combination with two antibiotics (Eradication therapy).
One tablet twice daily, plus two tablets of an antibiotic—either amoxicillin, clarithromycin, or
metronidazole (or tinidazole)—each taken twice daily together with the pantoprazole tablet. Take the first
pantoprazole tablet 1 hour before breakfast and the second pantoprazole tablet 1 hour before the evening
meal. Follow your doctor's instructions and make sure to read the package leaflet for these antibiotics. The
usual treatment duration is one or two weeks.
For the treatment of gastric and duodenal ulcers.
The recommended dose is one tablet daily. After consulting your doctor, the dose may be doubled.
Your doctor will tell you how long to take the medicine. The treatment period for gastric ulcers is
generally between 4 and 8 weeks. The treatment period for duodenal ulcers is generally between 2 and
4 weeks.
For long-term treatment of Zollinger-Ellison syndrome and other conditions in which too much
stomach acid is produced.
The usual recommended initial dose is two tablets daily.
Take both tablets 1 hour before a meal. Your doctor may subsequently adjust the dosage depending on
the amount of gastric acid produced. If more than two tablets daily are prescribed, the tablets should be
taken twice daily.
If your doctor prescribes a daily dosage of more than four tablets daily, you will be given specific
instructions on when to stop taking the medicine.
Use in adolescents
For the treatment of reflux esophagitis
The recommended dose is one tablet daily. Your doctor will tell you whether to increase the daily dose to 2
tablets daily. Treatment of reflux esophagitis normally lasts from 4 to 8 weeks. Your doctor will tell you
how long to take this medicine.
Particular patient groups :

• if you have moderate or severe renal problems, you must not take PANTOPRAZOLE GIT for Helicobacter pylori eradication.
• if you have severe hepatic impairment, you must not take more than one 20 mg pantoprazole tablet daily (tablets containing 20 mg of pantoprazole are available for this purpose).

If you take more PANTOPRAZOLE GIT than you should
If you take more PANTOPRAZOLE GIT than you should, consult your doctor or pharmacist. Symptoms of
overdose are not known.
If you forget to take PANTOPRAZOLE GIT
Do not take a double dose to make up for the missed dose. Take your next dose at the usual scheduled
time.
If you stop taking PANTOPRAZOLE GIT
Do not stop treatment with these tablets without first consulting 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 experience any of the following side effects, stop taking this medicine immediately
and contact your doctor or go to the nearest hospital emergency department:

• Severe allergic reactions (rare frequency): swelling of the tongue and/or throat, difficulty swallowing, hives, breathing difficulties, allergic swelling of the face (Quincke's edema / angioedema), severe dizziness with very rapid heartbeat and profuse sweating.
• Severe skin disorders (frequency not known): appearance of skin blisters and rapid deterioration of your general condition, erosion (including mild bleeding) of the eyes, nose, mouth/lips or genitals (Stevens-Johnson Syndrome, Lyell's Syndrome, Erythema multiforme), and light sensitivity.
• Other severe disorders (frequency not known): yellowing of the skin or whites of the eyes (severe liver cell damage, jaundice), or fever, skin rash and kidney enlargement sometimes with pain during urination and lower back pain (severe kidney inflammation).

Other side effects include:

• Uncommon (may affect up to 1 in 100 people): headache; dizziness; diarrhoea; nausea, vomiting; abdominal distension and flatulence (gas); constipation; dry mouth; abdominal pain and feeling unwell; skin rash, exanthema, eruption; itching; feeling of weakness, exhaustion or general malaise; sleep disturbances.
• Rare (may affect up to 1 in 1,000 people): vision disorders such as blurred vision; urticaria; joint pain; muscle pain; weight changes; increased body temperature; swelling of the extremities (peripheral oedema); allergic reactions; depression; breast enlargement in men.
• Very rare (may affect up to 1 in 10,000 people): disorientation.
• Not known (frequency cannot be estimated from the available data): hallucinations, confusion (especially in patients with prior experience of these symptoms); decreased sodium levels in the blood.

Side effects identified through blood tests:

• Uncommon (may affect up to 1 in 100 people): increased liver enzymes.
• Rare (may affect up to 1 in 1,000 people): increased bilirubin; increased blood lipids.
• Very rare (may affect up to 1 in 10,000 people): reduction in platelet count, which may cause bleeding or bruising more than normal; reduction in white blood cell count, which may lead to more frequent infections.

If you notice any side effect, talk to your doctor or pharmacist. This includes any possible side effect not listed in this leaflet.

5. How to store PANTOPRAZOLE GIT

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
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 PANTOPRAZOLO GIT contains

• The active substance is pantoprazole. Each gastro-resistant tablet contains 40 mg of pantoprazole (as sodium sesquihydrate).
• The other components are: Tablet core: mannitol, anhydrous sodium carbonate, sodium carboxymethyl starch (type A), methacrylic acid - ethyl acrylate copolymer (Eudragit E PO), calcium stearate. Inner coating: Opadry white OY-D-7233 (hypromellose, titanium dioxide (E171), talc, macrogol 400, sodium lauryl sulfate). Enteric coating: Kollicoat MAE 30 DP, light yellow (methacrylic acid - ethyl acrylate copolymer dispersion, propylene glycol, yellow iron oxide (E172), titanium dioxide (E171), talc).

Description of the appearance of PANTOPRAZOLO GIT and contents of the pack
Yellowish-brown, elliptical, biconvex gastro-resistant tablet.
Pack sizes:
Blister packs: 7, 10, 14, 15, 20, 28, 30, 60, 100, 140, (10x14), 500 tablets
Bottles: 7, 10, 14, 15, 20, 28, 30, 60, 100, 140, 500 tablets
Not all pack sizes may be marketed.

Marketing Authorization Holder
S.F. GROUP S.R.L.
VIA TIBURTINA, 1143
00156 ROMA
Italy

Manufacturers
Actavis Ltd.
BLB016 Bulebel Industrial Estate
Zejtun ZTN 3000
Malta
Actavis hf.
Reykjavíkurvegur 76-78, 220 Hafnafjördur
Iceland
Balkanpharma – Dupnitsa AD
3 Samokovsko Schosse Str.
Dupnitsa 2600
Bulgaria

This medicinal product is authorized in EEA Member States under the following names:
Italy: Pantoprazolo GIT 40 mg gastro-resistant tablets
Portugal: Pantoprazol Germed
Spain: Pantoprazol Edigen 40 mg gastro-resistant tablets EFG

This leaflet was last reviewed on: