INIZOL 20 mg Enteric-Coated Tablet

Зміст інструкції

1. What INIZOL is and what it is used for
2. What you need to know before taking INIZOL
3. How to take INIZOL
4. Possible side effects
5. How to store INIZOL
6. Package Contents and Other Information
7. What you need to know before taking INIZOL
8. How to take INIZOL
9. Possible side effects
10. How to store INIZOL
11. Contents of the pack and other information

INIZOL 20 mg gastro-resistant tablets
Pantoprazole
Generic medicine

Read this leaflet carefully before you start 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, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could 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 INIZOL is and what it is used for
• 2. What you need to know before you take INIZOL
• 3. How to take INIZOL
• 4. Possible side effects
• 5. How to store INIZOL
• 6. Contents of the pack and other information

1. What INIZOL is and what it is used for

INIZOL contains the active ingredient pantoprazole. INIZOL 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. INIZOL is used for the treatment of adults and adolescents 12 years and older of

• symptoms (e.g. heartburn, acid regurgitation, pain when 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 reflux from the stomach) and prevention of its recurrence. INIZOL is used in adults for the treatment of
• Prevention of duodenal and stomach ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs, for example, ibuprofen) in patients at risk who require continuous treatment with NSAIDs.

2. What you need to know before taking INIZOL

Do not take INIZOL

• if you are allergic to pantoprazole 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. Warnings and precautionsTalk to your doctor, pharmacist or nurse before taking INIZOL
• If you have severe liver problems. Tell your doctor if you have had liver problems in the past. Your doctor will arrange for more frequent monitoring of your liver enzymes, especially if you are taking INIZOL for long-term therapy. If liver enzymes increase, treatment should be discontinued.
• If you need to take nonsteroidal anti-inflammatory drugs (NSAIDs) continuously and are taking INIZOL because you have an increased risk of developing gastric and intestinal complications. Any increased risk will be assessed based on your personal risk factors such as age (65 years and over), a history of gastric or duodenal ulcers or gastrointestinal bleeding.
• If you have reduced body stores or risk factors for reduced vitamin B12 and are undergoing long-term treatment with pantoprazole. As with all agents that reduce acidity, pantoprazole can lead to reduced absorption of vitamin B12.
• If you are simultaneously taking a medicine containing atazanavir (for the treatment of HIV infection), ask your doctor for specific advice.
• Taking a proton pump inhibitor such as pantoprazole, especially for a period of more than one year, may slightly increase your risk of fracture of the hip, wrist or spine. Tell your doctor if you suffer from osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).
• If you take INIZOL for more than three months, your magnesium levels in the blood may decrease. Symptoms of low blood magnesium levels may include fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heartbeat. If you experience any of these symptoms, tell your doctor immediately. Low magnesium levels can also lead to a decrease in potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor your magnesium levels.
• If you have had skin reactions after treatment with a medicine similar to INIZOL that reduces stomach acid.
• 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 INIZOL. Also remember to mention any other adverse effects such as joint pain.
• you are to undergo a specific blood test (Chromogranin A) Tell your doctor immediately, 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
• vomiting, especially if recurrent
• presence of blood in the vomit; it may appear as coffee grounds in the vomit
• if you notice blood in your stools; which may appear black or tarry
• difficulty swallowing or pain when swallowing
• if you appear pale and feel weak (anemia)
• chest pain
• stomach pain
• severe and/or persistent diarrhea, as this medicine has been associated with a modest increase in episodes of infectious diarrhea. Your doctor may decide that you need to undergo some tests to rule out malignancy, as pantoprazole also relieves the symptoms of cancer and can cause a delay in diagnosis. If your symptoms persist, despite treatment, further investigations should be considered. If you take INIZOL for long-term treatment (more than 1 year), your doctor will probably subject you to a regular check-up. You must report any new or unusual symptom or circumstance whenever you see your doctor. Children and adolescentsINIZOL is not recommended in children as its functioning has not been proven below the age of 12. Other medicines and INIZOLTell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those available without a prescription. INIZOL can affect the effectiveness of other medicines, tell your doctor if you are taking:
• Medicines such as ketoconazole, itraconazole and posaconazole (used to treat fungal infections) or erlotinib (used for some types of cancer), as INIZOL may prevent these and other medicines from working properly.
• Warfarin and phenprocoumon, which affect the thickening or thinning of the blood. You may need further checks.
• Medicines used for the treatment of HIV such as atazanavir.
• Methotrexate (used for the treatment of rheumatoid arthritis, cancer and psoriasis) - if you are taking methotrexate, your doctor may temporarily suspend treatment with INIZOL as pantoprazole may increase methotrexate levels in the blood.
• Fluvoxamine (used for the treatment of depression and other psychiatric disorders - if you are taking fluvoxamine, your doctor may reduce the dose
• Rifampicin (used for the treatment of infections)
• St John's Wort (Hypericum perforatum) (used for the treatment of mild depression) Pregnancy and breastfeedingThere are no adequate data on the use of pantoprazole in pregnant women. Excretion in human breast milk has been reported. If you are pregnant or breastfeeding, if you suspect or are planning a pregnancy, ask your doctor or pharmacist for advice before taking this medicine. You should only use this medicine if your doctor considers the benefit for you greater than the potential risk to the fetus or infant. Driving and using machinesINIZOL has no influence or has a negligible influence on the ability to drive vehicles or operate machinery. If you experience adverse effects such as dizziness or visual disturbances, do not drive or operate machinery.

3. How to take INIZOL

Take this medicine following exactly the instructions of your doctor. If you have any doubts
consult your doctor or pharmacist

Method of administration
Take the tablets one hour before a meal, without chewing or crushing them, and swallow
them whole with a little water.
The recommended dose is:

Adults and adolescents 12 years and over

For the treatment of symptoms associated with gastro-esophageal reflux disease (e.g. heartburn,

acid regurgitation, pain when swallowing).
The usual dose is 1 tablet a day. This dose usually provides relief in 2-4
weeks – at most after another 4 weeks. Your doctor will tell you how long to continue
taking the medicine. After that, each recurrence of symptoms can be controlled
by taking one tablet a day, as needed.

For the long-term treatment and prevention of recurrent reflux esophagitis
The usual dose is one tablet a day. If the disease returns, your doctor may double
the dose, in which case you can take INIZOL 40 mg, one tablet a day. After healing
you can reduce the dose back to one 20 mg tablet a day.

Adults:

Prevention of duodenal and gastric ulcers in patients who require continuous treatment

with NSAIDs
The usual dose is 1 tablet a day.

Patients with liver problems
If you have severe liver problems, you should not take more than one 20 mg tablet a
day.

Use in children and adolescents
These tablets are not recommended for use in children under 12 years of age.

If you take more INIZOL than you should
Inform your doctor or pharmacist. No symptoms of overdose are known.

If you forget to take INIZOL
Do not take a double dose to make up for a missed dose. Take the normal
dose at the next scheduled time

If you stop taking INIZOL
Do not stop treatment with these tablets without first consulting your doctor or
pharmacist.
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.

If you experience any of the following side effects, stop treatment with these
tablets and consult your doctor immediately, or contact the nearest hospital emergency room:

• Severe allergic reactions (rare; affects 1 user in 10,000): swelling of the tongue and/or throat, difficulty swallowing, skin rash (urticaria), difficulty breathing, allergic swelling of the face (angioedema/Quincke's edema), severe dizziness with a very fast heartbeat and profuse sweating.
• Serious skin conditions( frequency not known: the frequency cannot be estimated based on the available data) :appearance of skin blisters and rapid deterioration of general conditions, erosion (including slight bleeding) of eyes, nose, mouth/lips or genitals (Stevens-Johnson syndrome, Lyell's syndrome, Multiforme erythema) and light sensitivity.
• Other serious conditions (frequency not known: the frequency cannot be estimated based on the available data): yellowing of the skin or whites of the eyes (serious damage to liver cells, jaundice) or fever, rash and enlargement of the kidneys sometimes painful with pain when urinating and lower back pain (serious kidney inflammation), which can lead to kidney failure. Other possible side effects are:
• Common: Benign polyps in the stomach
• Uncommon(affects 1 to 10 users out of 1,000) headache; dizziness; diarrhea; nausea, vomiting; abdominal distension and flatulence (gas); constipation; dry mouth; abdominal pain and feeling unwell; skin rashes, exanthema, eruption, itching; feeling of weakness, fatigue or general malaise; sleep disorders; hip, wrist and spine fracture.
• Rare(affects 1 to 10 users out of 10,000) distortion or complete loss of taste; visual disturbances such as blurred vision; urticaria; joint pain; muscle pain; weight changes; increased body temperature; swelling of the extremities (peripheral edema); allergic reactions; depression; increased breast volume in men.
• Very rare (affects less than 1 user in 10,000) disorientation.
• Not known (the frequency cannot be estimated based on the available data) Hallucinations, confusion (especially in patients with a history of these symptoms); decreased levels of sodium in the blood, decreased levels of magnesium in the blood, (see section 2), sensation of tingling, prickling, pins and needles, burning or numbness, skin rash, possible joint pain. Inflammation of the large intestine, causing persistent watery diarrhea Side effects identified through blood tests:
• Uncommon(affects 1 to 10 users out of 1,000) Increased liver enzymes
• Rare(affects 1 to 10 users out of 10,000) an increase in bilirubin; increased fats in the blood; a sudden drop in circulating granular white blood cells associated with high fever.
• Very rare(affects less than 1 user in 10,000) a reduction in the number of platelets which may cause more bleeding or bruising than normal; a reduction in white blood cells which may lead to more frequent infections;

concomitant abnormal reduction in the number of red blood cells and white blood cells, as well as
platelets.

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.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 INIZOL

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 label, on the carton and
on the blister after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 INIZOL contains

• The active ingredient is pantoprazole. Each gastro-resistant tablet contains 20 mg of pantoprazole (as pantoprazole sodium sesquihydrate). The other ingredients are: Tablet core: mannitol, anhydrous sodium carbonate, sodium starch glycolate (type A), basic butylated methacrylate copolymer (Eudragit E PO), calcium stearate. Coating: Opadry white OY-D-7233 (hypromellose, titanium dioxide E171, talc, macrogol 400, sodium lauryl sulfate). Enteric coating: Kollicoat MAE 30 DP, yellow (methacrylic acid - ethyl acrylate copolymer dispersion, propylene glycol, yellow iron oxide (E172), titanium dioxide E171, talc). Description of the appearance of INIZOL and content of the packGastro-resistant tablet, light yellow in colour, elliptical in shape, biconvex. Pack: Blisters: 14 tablets. Blisters: 28 tablets. Marketing Authorisation HolderS.F. Group S.r.l. Via Tiburtina 1143
• 00156- Rome Italy ManufacturerActavis Ltd. BLB016 Bulebel Industrial Estate Zejtun ZTN 3000 Malta Actavis ehf, Reykjavíkurvegur 78 220 Hafnarfjörður Iceland Balkanpharma – Dupnitsa AD 3 Samokovsko Schosse Str. Dupnitsa 2600 Bulgaria

14 May 2019

INIZOL 40 mg gastro-resistant tablets
Pantoprazole
Generic medicine

Read this leaflet carefully before you start 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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, 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 INIZOL is and what it is used for
• 2. What you need to know before you take INIZOL
• 3. How to take INIZOL
• 4. Possible side effects
• 5. How to store INIZOL
• 6. Contents of the pack and other information
• 1. What INIZOL is and what it is used forINIZOL contains the active ingredient pantoprazole. INIZOL is a “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. INIZOL is used for the treatment of adults and adolescents aged 12 years and over for
• Reflux oesophagitis. Inflammation of the oesophagus (the tube connecting the throat to the stomach), accompanied by acid regurgitation. INIZOL is used in adults for the treatment of :
• An infection caused by a bacterium called Helicobacter pyloriin patients with duodenal ulcer and gastric ulcer in combination with two antibiotics (Eradication therapy). The aim is to eliminate the bacteria so as to reduce the possibility of these ulcers returning.
• Stomach and duodenal ulcers.
• Zollinger-Ellison syndrome and other conditions in which too much acid is produced in the stomach.

2. What you need to know before taking INIZOL

Do not take INIZOL

• if you are allergic to pantoprazole or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to medicines containing other proton pump inhibitors. Warnings and precautionsTalk to your doctor, pharmacist or nurse before taking INIZOL
• If you have severe liver problems. Tell your doctor if you have had liver problems in the past. Your doctor will arrange for more frequent monitoring of your liver enzymes, especially if you are taking INIZOL for long-term therapy. If liver enzymes increase, treatment should be discontinued.
• If you have reduced body stores or risk factors for reduced vitamin B12 and are undergoing long-term treatment with pantoprazole. As with all agents that reduce acidity, pantoprazole can lead to reduced absorption of vitamin B12.
• If you are simultaneously taking a medicine containing atazanavir (for the treatment of HIV infection) with pantoprazole, ask your doctor for specific advice.
• Taking a proton pump inhibitor such as pantoprazole, particularly for a period of more than one year, may slightly increase your risk of fracture of the hip, wrist or spine. Tell your doctor if you suffer from osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).
• If you take INIZOL for more than three months, your magnesium levels in the blood may decrease. Symptoms of low blood magnesium levels may include fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heartbeat. If you experience any of these symptoms, inform your doctor immediately. Low levels of magnesium can also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor your magnesium levels.
• If you have had skin reactions after treatment with a medicine similar to INIZOL that reduces stomach acid
• 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 INIZOL. Also remember to mention any other negative effects such as joint pain.
• you are to undergo a specific blood test (Chromogranin A) Tell your doctor immediately,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
• vomiting, especially if recurrent
• presence of blood in the vomit; it may appear as coffee grounds in the vomit
• if you notice blood in the stool; which may appear black or tarry
• difficulty swallowing or pain when swallowing
• if you appear pale and feel weak (anemia)
• chest pain
• stomach pain
• severe and/or persistent diarrhea, as this medicine has been associated with a modest increase in episodes of infectious diarrhea. Your doctor may decide that you need to undergo some tests to rule out a malignancy, as pantoprazole also relieves the symptoms of cancer and can cause a delay in diagnosis. If your symptoms persist despite treatment, further investigations should be considered. If you take INIZOL for long-term treatment (more than 1 year), your doctor will probably subject you to a regular check-up. You should report any new or exceptional symptom or circumstance whenever you meet your doctor. Children and adolescentsINIZOL is not recommended in children as its functioning has not been proven below the age of 12. Other medicines and INIZOLTell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those available without a prescription. INIZOL can affect the effectiveness of other medicines, tell your doctor if you are taking: Medicines such as ketoconazole, itraconazole and posaconazole (used to treat fungal infections) or erlotinib (used for some types of cancer), as INIZOL may prevent these and other medicines from working properly.
• Warfarin and phenprocoumon, which affect blood clotting or thinning. You may need further checks.
• Medicines used for the treatment of HIV such as atazanavir.
• Methotrexate (used for the treatment of rheumatoid arthritis, cancer and psoriasis) - if you are taking methotrexate, your doctor may temporarily suspend treatment with INIZOL as pantoprazole can increase methotrexate levels in the blood.
• Fluvoxamine (used for the treatment of depression and other psychiatric disorders - if you are taking fluvoxamine, your doctor may reduce the dose
• Rifampicin (used for the treatment of infections)
• St John's Wort (Hypericum perforatum) (used for the treatment of mild depression) Pregnancy and breastfeedingThere are no adequate data on the use of pantoprazole in pregnant women. Excretion in human breast milk has been reported. If you are pregnant or breastfeeding, if you suspect or are planning a pregnancy, ask your doctor or pharmacist for advice before taking this medicine. You should only use this medicine if your doctor considers the benefit to you greater than the potential risk to the fetus or infant. Driving and using machinesINIZOL has no influence or has a negligible influence on the ability to drive vehicles or use machines. If you experience side effects such as dizziness or visual disturbances, do not drive or use machines.

3. How to take INIZOL

Take this medicine following the instructions of your doctor exactly. If you have any doubts
consult your doctor or pharmacist.

Method of administration
Take the tablets one hour before a meal, without chewing or crushing them, and swallow them
whole with a little water.
The recommended dose is:

Adults and adolescents 12 years of age and over

For the treatment of reflux esophagitis
The usual dose is one tablet a day. Your doctor may tell you to increase the dose to 2
tablets a day. The treatment period for reflux esophagitis is usually between 4 and
8 weeks. Your doctor will tell you how long to take the medicine.

Adults
For the treatment of an infection caused by a bacterium called Helicobacter pylori in
patients with duodenal ulcer and gastric ulcer in combination with two antibiotics (Eradication
Therapy).
One tablet twice a day, plus two antibiotic tablets, i.e. amoxicillin or
clarithromycin and metronidazole (or tinidazole), each to be taken twice a day with the
pantoprazole tablet. Take the first pantoprazole tablet in the morning, 1 hour
before breakfast and the second one hour before the evening meal. Follow the instructions of your
usual treatment is one or two weeks.

For the treatment of gastric and duodenal ulcers.
The usual dose is one tablet a day. 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 between 4 and 8 weeks. The period for the treatment of duodenal
ulcers is typically between 2 and 4 weeks.

For the long-term treatment of Zollinger-Ellison syndrome and other conditions
in which too much acid is produced in the stomach.
The recommended starting dose is usually two tablets a day.
Take the two tablets 1 hour before a meal. Subsequently, your doctor may adjust
the dosage, depending on the amount of gastric acid produced. If more than two
tablets are prescribed per day, the tablets must be taken twice a day.
If your doctor prescribes a daily dose of more than four tablets a day, they will tell you
exactly when to stop taking the medicine.

Patients with kidney problems
If you have kidney problems, do not take INIZOL for the treatment of Helicobacter pylori.

Patients with liver problems
If you have severe liver problems, you should not take more than one 20 mg tablet a day
(20 mg pantoprazole tablets are available for this purpose).
If you have moderate to severe liver problems, do not take INIZOL for the treatment of

Helicobacter pylori.

Use in children and adolescents
These tablets are not recommended for use in children under 12 years of age.

If you take more INIZOL than you should
Inform your doctor or pharmacist. No symptoms of overdose are known.

If you forget to take INIZOL
Do not take a double dose to make up for a missed dose. Take the normal
next dose at the scheduled time

If you stop taking INIZOL
Do not stop treatment with these tablets without first consulting your doctor or
pharmacist.
If you have any doubts about 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 .
If you experience any of the following side effects, stop treatment with these
tablets and consult your doctor immediately, or contact the nearest hospital emergency
room:

• Severe allergic reactions (rare; affects 1 in 10,000 users): swelling of the tongue and/or throat, difficulty swallowing, skin rash (urticaria), difficulty breathing, allergic swelling of the face (angioedema/Quincke's edema), severe dizziness with a very fast heartbeat and heavy sweating.
• Serious skin conditions (frequency not known: frequency cannot be defined based on available data): appearance of skin blisters and rapid deterioration of your general condition, erosion (including mild bleeding) of eyes, nose, mouth/lips or genitals (Stevens-Johnson syndrome, Lyell's syndrome, Multiforme erythema) and light sensitivity.
• Other serious conditions (frequency not known: frequency cannot be defined based on available data): yellowing of the skin or whites of the eyes (serious damage to liver cells, jaundice) or fever, rash and enlargement of the kidneys sometimes painful with pain when urinating and lower back pain (serious inflammation of the kidneys), which can lead to kidney failure. Other possible side effects are:
• Common: Benign polyps in the stomach
• Uncommon(affects 1 to 10 users out of 1,000) headache; dizziness; diarrhea; feeling of nausea, vomiting; abdominal bloating and flatulence (gas); constipation; dry mouth; abdominal pain and feeling unwell; skin rashes, exanthema, eruption, itching; feeling of weakness, fatigue or general malaise; sleep disorders; hip, wrist and spine fracture.
• Rare (affects 1 to 10 users out of 10,000) distortion or complete loss of taste; visual disturbances such as blurred vision; urticaria; joint pain; muscle pain; weight changes; increased body temperature; swelling of the extremities (peripheral edema); allergic reactions; depression; increased breast volume in men.
• Very rare (affects less than 1 in 10,000 users) disorientation .
• Not known (frequency cannot be defined based on available data)

Hallucinations, confusion (especially in patients with a history of these symptoms);
decreased levels of sodium in the blood, decreased levels of magnesium in the blood,
(see section 2), sensation of tingling, prickling, pins and needles, sensation of
burning or numbness, skin rash, possible joint pain.
Inflammation of the large intestine, causing persistent watery diarrhea

Side effects identified through blood tests:

• Uncommon(affects 1 to 10 users out of 1,000) Increased liver enzymes
• Rare(affects 1 to 10 users out of 10,000) an increase in bilirubin; increased fats in the blood; a sudden drop in circulating granular white blood cells associated with high fever.
• Very rare(affects less than 1 in 10,000 users) a reduction in the number of platelets which can cause more bleeding or bruising than normal; a reduction in white blood cells which can lead to more frequent infections; concurrent abnormal reduction in the number of red blood cells and white blood cells, as well as platelets. Reporting of side effectsIf you get any side effect, even if not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at 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 INIZOL

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 label, on the carton and
on the blister after EXP. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions
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 INIZOL contains

• The active ingredient is pantoprazole. Each gastro-resistant tablet contains 20mg of pantoprazole (as pantoprazole sodium sesquihydrate).
• The other ingredients are: Tablet core: mannitol, anhydrous sodium carbonate, sodium starch glycolate (type A), basic butyl methacrylate copolymer (Eudragit E PO), calcium stearate. Coating: Opadry white OY-D-7233 (hypromellose, titanium dioxide E171, talc, macrogol 400, sodium lauryl sulfate). Enteric coating: Kollicoat MAE 30 DP, yellow (methacrylic acid - ethyl acrylate copolymer dispersion, propylene glycol, yellow iron oxide (E172), titanium dioxide E171, talc). Description of the appearance of INIZOL and contents of the packGastro-resistant tablet, light yellow in color, elliptical in shape, biconvex. Pack: Blisters: 14 tablets. Blisters: 28 tablets. Marketing Authorisation HolderS.F. Group S.r.l. Via Tiburtina 1143
• 00156- Rome Italy Manufacturer

Actavis Ltd.
BLB016 Bulebel Industrial Estate
Zejtun ZTN 3000
Malta
Actavis ehf,
Reykjavíkurvegur 78
220 Hafnarfjörður
Iceland
Balkanpharma – Dupnitsa AD
3 Samokovsko Schosse Str.Dupnitsa 2600
Bulgaria
14 May 2019