Inizol

Package leaflet: Information for the patient

INIZOL 20 mg gastro-resistant tablets

Pantoprazole
Equivalent medicinal product
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, pharmacist, or nurse.
• This medicine has been prescribed for you only. Never give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact 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 taking 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 substance 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 from the age of 12 years onwards, for:

• 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 oesophagus accompanied by acid regurgitation from the stomach) and prevention of its recurrence. INIZOL is used in adults for:
• Prevention of duodenal and gastric 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 should 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 precautions Talk to your doctor, pharmacist, or nurse before taking INIZOL
• If you have severe liver problems. Inform your doctor if you have previously had liver problems. Your doctor may arrange for more frequent monitoring of your liver enzymes, especially if you are taking INIZOL for long-term treatment. If your liver enzymes increase, treatment should be stopped.
• If you need to take painkillers called NSAIDs continuously and are taking INIZOL because you are at increased risk of developing stomach and intestinal complications. Any increased risk will be assessed based on your personal 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 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 taking a medicine containing atazanavir (for the treatment of HIV infection) at the same time as pantoprazole, please consult your doctor for specific advice.
• Taking a proton pump inhibitor such as pantoprazole, particularly for more than one year, may slightly increase your risk of fractures of the hip, wrist, or spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).
• If you take INIZOL for more than three months, your blood magnesium levels may decrease. Symptoms of low magnesium levels in the blood may include fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, inform your doctor immediately. Low magnesium levels can also lead to reduced levels of potassium or calcium 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 acidity.
• If you develop a skin rash, especially in sun-exposed areas, inform your doctor as soon as possible, as it may be necessary to stop treatment with INIZOL. Remember also to mention any other adverse effects such as joint pain.
• you need to undergo a specific blood test (Chromogranin A) 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 condition:
• unintentional weight loss
• vomiting, particularly if recurrent
• presence of blood in vomit; this may appear like coffee grounds in the vomit
• if you notice blood in your stools; stools may appear black or tarry
• difficulty swallowing or pain when swallowing
• if you appear pale and feel weak (anemia)
• chest pain
• stomach ache
• severe and/or persistent diarrhea, as this medicine has been associated with a slight increase in infectious diarrhea episodes. Your doctor may decide that you need certain tests to rule out malignant disease, since pantoprazole also relieves symptoms of cancer and may delay diagnosis. If your symptoms persist despite treatment, further investigations should be considered. If you take INIZOL for long-term treatment (over 1 year), your doctor will likely schedule regular check-ups. You must report any new or unusual symptoms or circumstances whenever you see your doctor. Children and adolescents INIZOL is not recommended in children, as its efficacy has not been established in patients under 12 years of age. Other medicines and INIZOL Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription. INIZOL may affect the effectiveness of other medicines. 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 INIZOL may prevent these and other medicines from working properly.
• Warfarin and fenprocoumon, which affect blood clotting. You may need additional monitoring.
• Medicines used to treat HIV such as atazanavir.
• Methotrexate (used to treat rheumatoid arthritis, cancer, and psoriasis) – if you are taking methotrexate, your doctor may temporarily discontinue INIZOL treatment, as pantoprazole may increase methotrexate levels in the blood.
• Fluvoxamine (used to treat depression and other psychiatric disorders) – if you are taking fluvoxamine, your doctor may reduce the dose.
• Rifampicin (used to treat infections)
• St. John’s wort (Hypericum perforatum) (used to treat mild depression) Pregnancy and breastfeeding There are insufficient data on the use of pantoprazole in pregnant women. Excretion into human milk has been reported. If you are pregnant, breastfeeding, suspect you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine. You should use this medicine only if your doctor considers the benefit to you greater than the potential risk to the fetus or infant. Driving and using machines INIZOL has no effect or a negligible effect on the ability to drive or use machinery. However, 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 exactly as directed by 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, swallowing them whole with a little water.
The recommended dose is:
Adults and adolescents aged 12 years and over
For the treatment of symptoms associated with gastro-oesophageal reflux disorders (e.g. heartburn, acid regurgitation, pain on swallowing).
The usual dose is 1 tablet daily. This dose usually provides relief within 2–4 weeks – at most after 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 daily as needed.
For long-term treatment and prevention of recurrence of reflux oesophagitis
The usual dose is 1 tablet daily. If the disease recurs, your doctor may double the dose, in which case you may take INIZOL 40 mg, one tablet daily. After healing, the dose may be reduced back to one 20 mg tablet daily.
Adults:
Prevention of duodenal and gastric ulcers in patients requiring continuous treatment with NSAIDs
The usual dose is 1 tablet daily.
Patients with liver problems
If you have severe liver problems, you must not take more than one 20 mg tablet daily.
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. Symptoms of overdose are not known.
If you forget to take INIZOL
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 INIZOL
Do not stop treatment with these tablets without first consulting your doctor or pharmacist.
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 everybody gets them.
If you experience any of the following side effects, stop treatment with these tablets
immediately and contact your doctor or go to the nearest hospital emergency department:

• Severe allergic reactions (uncommon frequency; affects 1 in 10,000 users): swelling of the tongue and/or throat, difficulty swallowing, skin rash (urticaria), breathing difficulties, allergic swelling of the face (Quincke's oedema/angioedema), severe dizziness with very rapid heartbeat and profuse sweating.
• Serious skin disorders (frequency not known: frequency cannot be estimated from the available data): appearance of skin blisters and rapid deterioration in general condition, erosion (including mild bleeding) of eyes, nose, mouth/lips or genitals (Stevens-Johnson syndrome, Lyell's syndrome, erythema multiforme), and sensitivity to light.
• Other serious disorders (frequency not known: frequency cannot be estimated from the available data): yellowing of the skin or whites of the eyes (severe liver cell damage, jaundice) or fever, skin rash and swollen kidneys sometimes painful, with painful urination and lower back pain (severe kidney inflammation), which may lead to kidney failure. Other possible side effects include:
• Common: benign gastric polyps
• Uncommon (affects 1 to 10 users in 1,000): headache; dizziness; diarrhoea; 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 disturbances; hip, wrist or spine fractures.
• Rare (affects 1 to 10 users in 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 oedema); allergic reactions; depression; breast enlargement in men.
• Very rare (affects less than 1 in 10,000 users): disorientation.
• Not known (frequency cannot be estimated from the available data): hallucinations, confusion (especially in patients with a history of these symptoms); decreased sodium levels in the blood, decreased magnesium levels in the blood (see section 2), tingling sensation, prickling, tingling, burning sensation or numbness, skin rash, possible joint pain. Inflammation of the large intestine, causing persistent watery diarrhoea.
  Side effects identified through blood tests:
• Uncommon (affects 1 to 10 users in 1,000): increased liver enzymes
• Rare (affects 1 to 10 users in 10,000): increased bilirubin; increased blood lipids; sudden drop in circulating granulocytes associated with high fever.
• Very rare (affects less than 1 in 10,000 users): reduced platelet count, which may cause bleeding or bruising more than normal; reduced white blood cell count, which may lead to more frequent infections;
  abnormally low concurrent reduction in red blood cells, white blood cells, and platelets.

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.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 stated on the label, carton and
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 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 INIZOL contains

• The active substance is pantoprazole. Each gastro-resistant tablet contains 20 mg of pantoprazole (as sodium pantoprazole sesquihydrate). The other components 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, iron oxide yellow (E172), titanium dioxide E171, talc).

Description of the appearance of INIZOL and contents of the pack

Gastro-resistant tablet, light yellow in colour, elliptical, biconvex.
Pack: Blister: 14 tablets. Blister: 28 tablets.

Marketing Authorization Holder

S.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

Package leaflet: Information for the patient

INIZOL 40 mg gastro-resistant tablets

Pantoprazole
Equivalent 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, pharmacist, or nurse.
• This medicine has been prescribed for you only. Never give it to other people, even if their symptoms are the same as yours, because it could be dangerous.
• If you experience any side effect, including those not listed in this leaflet, contact 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 taking INIZOL

3. How to take INIZOL

4. Possible side effects

5. How to store INIZOL

6. Contents of the pack and other information

7. What INIZOL is and what it is used for
   INIZOL contains the active substance pantoprazole. INIZOL 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. INIZOL is used for the treatment of adults and adolescents aged 12 years and above with:

• Gastro-oesophageal reflux disease (GORD). An inflammation of the oesophagus (the tube connecting the throat to the stomach), accompanied by regurgitation of gastric acid. INIZOL is used in adults for the treatment of:
• Helicobacter pylori infection 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 in which excessive acid is produced in the stomach.

2. What you should 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 precautions

Talk to your doctor, pharmacist, or nurse before taking INIZOL:

• 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 INIZOL for long-term treatment. If your liver enzymes increase, treatment must be stopped.
• 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 taking a medicine containing atazanavir (for the treatment of HIV infection) at the same time as pantoprazole, consult your doctor for specific advice.
• Taking a proton pump inhibitor such as pantoprazole, particularly for more than one year, may slightly increase your risk of fracture of the hip, wrist, or spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).
• If you take INIZOL for more than three months, your blood magnesium levels may decrease. Symptoms of low magnesium levels in the blood may include fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, inform your doctor immediately. Low magnesium levels can also lead to reduced levels of potassium or calcium 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 acidity.
• If you develop a skin rash, especially in areas exposed to sunlight, inform your doctor as soon as possible, as it may be necessary to discontinue treatment with INIZOL. Also remember to mention any other adverse effects such as joint pain.
• You may need to undergo a specific blood test (Chromogranin A).

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 condition:

• unintentional weight loss
• vomiting, particularly if recurrent
• presence of blood in vomit; this may appear as coffee-ground material in the vomit
• blood in your stools; stools may appear black or tarry
• difficulty swallowing or pain when swallowing
• if you appear pale and feel weak (anemia)
• chest pain
• stomach ache
• severe and/or persistent diarrhoea, as this medicine has been associated with a slight increase in infectious diarrhoea episodes. Your doctor may decide that you need further tests to rule out malignant disease, since pantoprazole may also relieve symptoms of cancer and could delay diagnosis. If your symptoms persist despite treatment, further investigations should be considered. If you are taking INIZOL for long-term treatment (more than 1 year), your doctor will likely schedule regular check-ups. You must report any new or unusual symptoms or circumstances each time you see your doctor.

Children and adolescents

INIZOL is not recommended in children, as its efficacy has not been proven in individuals under 12 years of age.

Other medicines and INIZOL

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.

INIZOL may affect the effectiveness of other medicines. 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 INIZOL may prevent these and other medicines from working properly.
• Warfarin and fenprocoumon, which affect blood clotting. You may need additional monitoring.
• 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 to treat infections).
• St. John’s wort (Hypericum perforatum) (used for the treatment of mild depression).

Pregnancy and breastfeeding

There are insufficient data on the use of pantoprazole in pregnant women. Excretion in human breast milk has been reported. If you are pregnant, breastfeeding, suspect you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine. You should use this medicine only if your doctor considers the benefit to you greater than the potential risk to the fetus or infant.

Driving and using machines

INIZOL has no influence or a negligible influence on the ability to drive vehicles or use machinery. However, 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 exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Method of administration
Take the tablets one hour before a meal, without chewing or crushing them, swallowing them whole with some water.
The recommended dose is:
Adults and adolescents aged 12 years and older
For the treatment of reflux esophagitis
The usual dose is one tablet per day. Your doctor may instruct you to increase the dose to two tablets per 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 daily, plus two antibiotic tablets—either amoxicillin or clarithromycin and metronidazole (or tinidazole)—each to be taken twice daily together 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 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 usual dose is one tablet per 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 ranges from 4 to 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 acid is produced in the stomach.
The recommended initial dose is usually two tablets per day.
Take both tablets one hour before a meal. Afterwards, your doctor may adjust the dosage depending on the amount of gastric acid produced. If more than two tablets per day are prescribed, the tablets should be taken twice daily.
If your doctor prescribes a daily dosage of more than four tablets per day, you will be specifically instructed 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 per 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. Symptoms of overdose are not known.
If you forget to take INIZOL
Do not take a double dose to make up for the forgotten dose. Take your next dose at the usual scheduled time.
If you stop treatment with INIZOL
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 treatment with this medicine immediately and contact your doctor, or go to the nearest hospital emergency department:

• Severe allergic reactions (uncommon frequency; affects 1 in 10,000 users): swelling of the tongue and/or throat, difficulty swallowing, skin rash (urticaria), breathing difficulties, allergic swelling of the face (Quincke's edema/angioedema), severe dizziness with rapid heartbeat and profuse sweating.
• Serious skin disorders (frequency not known: frequency cannot be estimated based on available data): appearance of skin blisters and rapid deterioration of general condition, erosion (including mild bleeding) of eyes, nose, mouth/lips or genitals (Stevens-Johnson syndrome, Lyell syndrome, erythema multiforme), and photosensitivity.
• Other serious disorders (frequency not known: frequency cannot be estimated based on available data): yellowing of the skin or whites of the eyes (severe liver cell damage, jaundice), or fever, skin rash and kidney enlargement sometimes painful, with painful urination and back pain (severe kidney inflammation), which may lead to renal failure.

Other possible side effects include:

• Common: Benign gastric polyps
• Uncommon (affects 1 to 10 users in 1,000): headache; dizziness; diarrhoea; nausea, vomiting; abdominal distension and flatulence (gas); constipation; dry mouth; abdominal pain and malaise; skin rashes, exanthema, rash, pruritus; feeling of weakness, fatigue or general malaise; sleep disorders; hip, wrist or spine fractures.
• Rare (affects 1 to 10 users in 10,000): distortion or complete loss of taste sensation; visual disturbances such as blurred vision; urticaria; joint pain; muscle pain; weight changes; increased body temperature; swelling of extremities (peripheral oedema); allergic reactions; depression; breast enlargement in men.
• Very rare (affects less than 1 in 10,000 users): disorientation.
• Not known (frequency cannot be estimated based on available data): hallucinations, confusion (particularly in patients with a history of such symptoms); decreased sodium levels in blood, decreased magnesium levels in blood (see section 2), tingling sensation, pricking, formication, burning sensation or numbness, skin rash, possible joint pain. Inflammation of the large intestine, causing persistent watery diarrhoea.

Side effects identified through blood tests:

• Uncommon (affects 1 to 10 users in 1,000): increased liver enzymes
• Rare (affects 1 to 10 users in 10,000): increased bilirubin; increased blood lipid levels; sudden drop in circulating granulocytes associated with high fever.
• Very rare (affects less than 1 in 10,000 users): reduced platelet count, which may cause increased bleeding or bruising; reduced white blood cell count, which may lead to more frequent infections; concomitant abnormal reduction in red blood cells, white blood cells, and platelets.

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.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 stated on the label, the carton and
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 via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer in use. This will help protect the environment.

6. Pack contents and other information

What INIZOL contains

• The active substance is pantoprazole. Each gastro-resistant tablet contains 20 mg of pantoprazole (as pantoprazole sodium sesquihydrate).
• The other components 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, iron oxide yellow (E172), titanium dioxide E171, talc).

Description of the appearance of INIZOL and pack contents
Gastro-resistant tablet, light yellow in colour, elliptical, biconvex.
Pack: Blister pack: 14 tablets. Blister pack: 28 tablets.

Marketing Authorisation Holder
S.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