Pantoprazole TowA

Package leaflet: Information for the patient

PANTOPRAZOLE TOWA 20 mg gastro-resistant tablets

Pantoprazole
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 others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What PANTOPRAZOLE TOWA is and what it is used for

This medicinal product contains the active substance pantoprazole, which belongs to a group of medicines called
selective proton pump inhibitors. PANTOPRAZOLE TOWA works by reducing the amount of acid
produced by the stomach, and is indicated for the treatment of:

• Inflammation of the oesophagus (reflux oesophagitis), caused by the backflow of acidic contents from the stomach into the oesophagus, in both adults and adolescents from the age of 12 years
• Stomach and intestinal damage (gastric and duodenal ulcers) caused by anti-inflammatory medicines (non-steroidal anti-inflammatory drugs, NSAIDs), for preventive use in individuals at risk who require ongoing treatment with these medicines.

2. What you need to know before taking PANTOPRAZOLO TOWA

Do not take PANTOPRAZOLO TOWA

• 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 other similar medicines (proton pump inhibitors);
• if you are taking other medicines in combination with PANTOPRAZOLO TOWA.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking pantoprazole:

• If you have ever had a skin reaction after treatment with a medicine similar to PANTOPRAZOLO TOWA that reduces gastric acidity.

• If you notice the appearance of a skin rash, especially in areas exposed to sunlight, contact your doctor as soon as possible, as it may be necessary to discontinue treatment with PANTOPRAZOLO TOWA. Remember to also report any other adverse effects such as joint pain.

• If you take pantoprazole for more than three months, it may lead to reduced magnesium levels in the blood. Low magnesium levels may manifest as fatigue, involuntary muscle contractions, confusion, seizures, dizziness, or rapid heartbeat. Inform your doctor immediately if you experience any of these symptoms. Low magnesium levels can also lead to reduced levels of potassium or calcium in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.
  Long-term treatment for more than one year may increase the risk of fractures (hip, wrist, and spine), especially if you are elderly, have osteoporosis, or are taking corticosteroids (which may increase the risk of osteoporosis).
  Pay particular attention and inform your doctor:

• if you have liver problems (hepatic insufficiency). In this case, your doctor must periodically check liver enzyme levels (liver enzymes), especially during prolonged treatment. If liver enzymes increase, treatment must be discontinued;

• if you are taking certain anti-inflammatory medicines (non-selective NSAIDs) and are predisposed to stomach and intestinal problems, for example if you are over 65 years old, or if you have previously had a stomach ulcer or gastrointestinal bleeding;

• if you are taking the medicine atazanavir (a medicine used to treat HIV infection). The combination of these two medicines is not recommended, except under strict medical necessity. In such a case, close medical monitoring is required, and your doctor may need to adjust the dose of atazanavir;

• if you have vitamin B12 (cyanocobalamin) deficiency or risk factors for low vitamin B12 levels, and are undergoing long-term treatment with this medicine, as it may reduce the absorption of vitamin B12;

• if you need to undergo a specific blood test (chromogranin A).

Inform your doctor immediately if you notice any of the following symptoms, as this medicine may relieve symptoms of cancer and could delay diagnosis:

• significant and unintentional weight loss;
• recurrent vomiting;
• difficulty swallowing (dysphagia);
• presence of blood in vomit (haematemesis);
• reduced red blood cells (anaemia);
• presence of blood in stools (melena);
• presence or suspicion of gastric ulcer. Your doctor may decide to perform tests to rule out a malignant disease (cancer). If your symptoms persist despite appropriate treatment, further investigations should be considered.

Use of this medicine may increase the risk of stomach and intestinal infections caused by bacteria such as Salmonella, Campylobacter, and C. difficile.
Children under 12 years of age
The use of this medicine is not recommended in children under 12 years of age.
Other medicines and PANTOPRAZOLO TOWA
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pay particular attention and inform your doctor if you are taking:

• medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections), and other medicines such as erlotinib (used for certain types of cancer), as dose adjustment may be necessary;
• medicines used to treat HIV infections, such as atazanavir, because PANTOPRAZOLO TOWA reduces their effectiveness. Therefore, this combination is not recommended;
• medicines used to improve blood fluidity (coumarin anticoagulants), such as warfarin and phenprocoumon: in this case, your doctor will prescribe specific blood tests (prothrombin time/INR), to be performed at the start of treatment with PANTOPRAZOLO TOWA, when stopping treatment, or when this medicine is administered intermittently;
• methotrexate (a medicine used to treat certain types of cancer and psoriasis); if you are taking methotrexate, your doctor may temporarily discontinue treatment with PANTOPRAZOLO TOWA, as this medicine may increase methotrexate levels in the blood.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before taking PANTOPRAZOLO TOWA.
If you are pregnant or breastfeeding, take this medicine only if absolutely necessary and under direct medical supervision. Your doctor will evaluate the benefits for the mother against the risks for the fetus or infant.

Driving and using machines
This medicine may cause dizziness or visual disturbances. If you experience these symptoms, avoid driving or operating machinery.
PANTOPRAZOLO TOWA contains monohydrate lactose
This medicine contains monohydrate lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take PANTOPRAZOLE TOWA

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Swallow the tablets whole with some water, without chewing or crushing them, one hour before a meal.

Use in adults and adolescents from 12 years of age
Treatment of reflux esophagitis: unless otherwise prescribed by your doctor, the recommended dose is 1
tablet per day. Your doctor may decide to increase the dose to 2 tablets per day (40 mg). The treatment period for
reflux esophagitis is usually four weeks, which may be extended by a further four weeks if necessary. Your doctor
will advise you on how long you should take the medicine based on your condition.

Long-term treatment and prevention of relapse of reflux esophagitis.
For long-term treatment, the recommended maintenance dose is 1 tablet per day. Your doctor may decide to
increase the dose to 2 tablets per day (40 mg) in case of relapse. After healing of the relapse, the dose may be
reduced again to 1 tablet per day.

Treatment of gastric ulcer and duodenal ulcer
The recommended dose is 1 tablet per day.
Your doctor will tell you how long to take the medicine.

Use in patients with kidney problems (renal impairment)
If you have kidney disorders (impaired renal function), dose adjustment is not required.

Use in patients with liver problems (hepatic impairment)
If you have severe liver disorders, you must not take more than 20 mg of PANTOPRAZOLE TOWA per day.

Use in children
This medicine is not recommended for children under 12 years of age.

If you take more PANTOPRAZOLE TOWA than you should
In case of accidental overdose, contact your doctor immediately or go to the nearest hospital. Symptoms of
overdose are not known.

If you forget to take PANTOPRAZOLE TOWA
Do not take a double dose to make up for the forgotten tablet. Take the next dose at the usual time.

If you stop taking PANTOPRAZOLE TOWA
Do not stop treatment with this medicine 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 get them.
The following side effects may occur:
Common (may affect up to 1 in 10 people)

• benign gastric polyps

Uncommon (may affect up to 1 in 100 people)

• headache and dizziness;
• sleep disturbances;
• vomiting, nausea, and diarrhoea;
• abdominal pain and swelling, flatulence, and constipation;
• dry mouth;
• increased levels of liver enzymes (transaminases, *γ-*GT);
• skin irritations (rash), formation of blisters and vesicles on the skin (exanthema), and itching;
• fatigue and general malaise;
• fractures of the hip, wrist, or spine (see section 2).

Rare (may affect up to 1 in 1,000 people)

• decrease in the number of granulocytes (a type of white blood cells) in the blood (agranulocytosis);
• serious allergic reactions (anaphylactic reactions and shock);
• increased levels of triglycerides and cholesterol in the blood;
• weight changes;
• depression;
• altered taste;
• visual disturbances, blurred vision;
• liver disorders (increased bilirubin);
• skin irritation (urticaria);
• joint pain (arthralgia) and muscle pain (myalgia);
• swelling of the extremities (peripheral oedema) or around the eyes and mouth (angioedema);
• increased body temperature;
• breast enlargement in men (gynaecomastia).

Very rare (may affect up to 1 in 10,000 people)

• disorientation;
• decreased levels of platelets (thrombocytopenia) and white blood cells (leucopenia);
• simultaneous decrease in blood components (red blood cells, white blood cells, and platelets).

Not known (frequency cannot be estimated from the available data)

• hallucinations and confusion (especially in patients who have previously experienced these disorders);
• decreased sodium levels in the blood (hyponatraemia);
• decreased magnesium levels in the blood (hypomagnesaemia - see section 2), with or without decreased calcium levels in the blood (hypocalcaemia);
• decreased potassium levels (hypokalaemia);
• yellowing of the skin or whites of the eyes due to liver cell damage, jaundice, and other liver problems (hepatocellular failure);
• skin irritations and inflammations (Stevens-Johnson Syndrome, Lyell's Syndrome, Erythema multiforme);
• sensitivity to light (photosensitivity);
• kidney inflammation causing difficulty and pain during urination (interstitial nephritis);
• tingling sensation, pricking, pins and needles, burning, or numbness;
• muscle spasms or cramps;
• erythema, possible joint pain;
• inflammation of the large intestine causing persistent watery diarrhoea.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://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 PANTOPRAZOLE TOWA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp".
The expiry date refers to the last day of that month.
Packaging in Bottle
Do not use this medicine more than twenty-eight days after the first opening of the bottle.
Packaging in Blister
Store this medicine at a temperature not exceeding 30°C.
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. Package contents and other information

What PANTOPRAZOLO TOWA contains

• The active substance is pantoprazole. Each tablet contains 20 mg of pantoprazole (as sodium sesquihydrate 22.55 mg).
• The other components of the tablet core are: microcrystalline cellulose (E460i), lactose monohydrate, croscarmellose sodium, anhydrous colloidal silica, magnesium stearate (vegetable origin).
• The other components of the tablet coating are: methacrylic acid-ethyl acrylate copolymer 1:1, sodium lauryl sulfate, polysorbate 80, triethyl citrate (E1505), talc (E553b), polyvinyl alcohol, macrogol 3350, titanium dioxide (E171), iron oxide yellow (E172), quinoline yellow (E104).

Description of the appearance of PANTOPRAZOLO TOWA and pack contents
PANTOPRAZOLO TOWA tablets are gastro-resistant film-coated, yellow, oval-shaped and biconvex.
Bottle containing 14 gastro-resistant tablets.
Box containing 14 gastro-resistant tablets in blister packs.
Box containing 28 gastro-resistant tablets in blister packs.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
TOWA Pharmaceutical Europe, S.L.
C/ de Sant Martí, 75-97
08107 Martorelles (Barcelona)
Spain

Manufacturer
Esteve Pharmaceuticals, S.A.
C/ Sant Martí, 75-97,
Martorelles, 08107 Barcelona
Spain

Patient Information Leaflet

PANTOPRAZOLE TOWA 40 mg gastro-resistant tablets

Pantoprazole
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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

2. What PANTOPRAZOLO TOWA is and what it is used for

This medicinal product contains the active substance pantoprazole, which belongs to a group of medicines called
proton pump inhibitors. PANTOPRAZOLO TOWA works by reducing the amount of acid produced by the stomach, and is indicated for the treatment of:

• inflammation of the oesophagus (reflux oesophagitis), caused by the backflow of acidic contents from the stomach into the oesophagus, in both adults and adolescents from the age of 12;
• stomach ulcers associated with infection by the bacterium Helicobacter pylori, in combination with appropriate antibiotic therapy (eradication therapy). The aim is to treat the infection in order to reduce the likelihood of these ulcers recurring;
• stomach and intestinal lesions (gastric and duodenal ulcers);
• a condition known as Zollinger-Ellison syndrome, in which the stomach produces excessive amounts of acid, causing damage to the stomach and intestine;
• other disorders caused by increased acid secretion in the stomach (hypersecretory conditions).

2. What you need to know before taking PANTOPRAZOLE TOWA

Do not take PANTOPRAZOLE TOWA

• 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 other similar medicines (proton pump inhibitors);
• if you are taking other medicines in combination with PANTOPRAZOLE TOWA.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking pantoprazole:

• If you have ever had a skin reaction after treatment with a medicine similar to PANTOPRAZOLE TOWA that reduces gastric acidity.

• If you notice the appearance of a skin rash, especially in areas exposed to sunlight, contact your doctor as soon as possible, as it may be necessary to discontinue treatment with PANTOPRAZOLE TOWA. Remember to also report any other adverse effects such as joint pain.

• If you take pantoprazole for more than three months, it may lead to reduced magnesium levels in the blood. Low magnesium levels may cause symptoms such as fatigue, involuntary muscle contractions, confusion, seizures, dizziness, or rapid heartbeat. Inform your doctor immediately if you experience any of these symptoms. Low magnesium levels may also lead to reduced potassium or calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.

Long-term treatment for more than one year may increase the risk of fractures, especially if you are elderly, have osteoporosis, or are taking corticosteroids (which may increase the risk of osteoporosis). Your doctor should regularly monitor your blood magnesium levels during treatment.
Pay special attention and inform your doctor:

• if you have liver problems (hepatic insufficiency). In this case, your doctor should periodically monitor liver enzyme levels (liver enzymes), especially during prolonged treatment. If liver enzymes increase, treatment must be discontinued;
• if you are taking the medicine atazanavir (a medicine used to treat HIV infection). The combination of these two medicines is not recommended, except under strict medical necessity. In such cases, close medical monitoring is required, and your doctor may need to adjust the atazanavir dosage;
• if you have vitamin B12 (cyanocobalamin) deficiency or risk factors for low vitamin B12 levels, and are undergoing long-term treatment with this medicine, as it may reduce vitamin B12 absorption;
• if you need to undergo a specific blood test (chromogranin A).

Inform your doctor immediately if you notice any of the following symptoms, as this medicine may relieve symptoms of a tumor (cancer) and could delay diagnosis:

• significant and unintentional weight loss;
• recurrent vomiting;
• difficulty swallowing (dysphagia);
• presence of blood in vomit (hematemesis);
• reduced red blood cells (anemia);
• presence of blood in stools (melena);
• presence or suspicion of gastric ulcer. Your doctor may decide to perform tests to rule out a malignant condition (tumor). If your symptoms persist despite appropriate treatment, further investigations should be considered.

Use of this medicine may increase the risk of stomach and intestinal infections caused by bacteria such as Salmonella, Campylobacter, and C. difficile.
Children under 12 years of age
The use of this medicine is not recommended in children under 12 years of age.
Other medicines and PANTOPRAZOLE TOWA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Pay particular attention and inform your doctor if you are taking:

• medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections), and other medicines like erlotinib (used for certain types of cancer), as dosage adjustments may be necessary;
• medicines used to treat HIV infections, such as atazanavir, since PANTOPRAZOLE TOWA reduces their effectiveness. Therefore, this combination is not recommended;
• medicines used to improve blood fluidity (coumarin anticoagulants), such as warfarin and phenprocoumon: in this case, your doctor will prescribe specific blood tests (prothrombin time/INR), to be performed at the beginning of treatment with PANTOPRAZOLE TOWA, when stopping treatment, or when this medicine is administered intermittently;
• methotrexate (a medicine used to treat certain types of cancer and psoriasis); if you are taking methotrexate, your doctor may temporarily discontinue treatment with PANTOPRAZOLE TOWA, as this medicine may increase methotrexate levels in the blood.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking PANTOPRAZOLE TOWA.
If you are pregnant or breastfeeding, take this medicine only if absolutely necessary and under direct medical supervision. Your doctor will evaluate the benefits for the mother against the potential risks for the fetus or infant.

Driving and using machines
This medicine may cause dizziness or visual disturbances. If you experience these symptoms, avoid driving or operating machinery.
PANTOPRAZOLE TOWA contains lactose monohydrate
This medicine contains lactose monohydrate, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take PANTOPRAZOLE TOWA

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Swallow the tablets whole with a little water, without chewing or crushing them, one hour before a meal.

Use in adults and adolescents aged 12 years and older
Treatment of reflux esophagitis: unless otherwise prescribed by your doctor, the recommended dose is 1
tablet per day. Your doctor may decide to increase the dose to 2 tablets per day, especially if the treatment is not effective. The treatment period for reflux esophagitis is usually four
weeks, which may be extended by a further four weeks if necessary. Your doctor will advise you how long you should take the medicine, depending on your condition.

Use in adults
Treatment of duodenal ulcer and gastric ulcer associated with Helicobacter pylori infection (Eradication therapy): this treatment involves taking antibiotics in combination with this medicine, which will be prescribed by your doctor.
The recommended dose is 1 tablet of PANTOPRAZOLE TOWA plus 2 tablets of an antibiotic such as amoxicillin, clarithromycin, and metronidazole (or tinidazole), twice daily.
Take the first tablet of pantoprazole one hour before breakfast and the second tablet of pantoprazole one hour before the evening meal. Follow your doctor's instructions and make sure to read the package leaflet for the correct use of these antibiotics. The usual treatment duration is one or two weeks.
If further treatment with this medicine is required to ensure ulcer healing, you should follow the recommended dose for the treatment of gastric and duodenal ulcers.

Treatment of gastric ulcer and duodenal ulcer: the recommended dose is 1 tablet per day. After consulting your doctor, the dose may be doubled if necessary.
Your doctor will advise you on how long to take the medicine.
The treatment period for gastric ulcers is generally between four and eight weeks.
The treatment period for duodenal ulcers is generally between two and four weeks.

Treatment of Zollinger-Ellison syndrome and other pathological conditions characterized by
acid hypersecretion: the recommended initial dose is 2 tablets per day.
Take the 2 tablets one hour before a meal. Your doctor may adjust the dose later depending on your condition. If more than 2 tablets per day are required, they should be divided into two daily doses.
If necessary, your doctor may temporarily prescribe a daily dose exceeding 4 tablets per day. The duration of treatment will be determined by your clinical condition.

Use in patients with kidney problems (renal impairment)
If you have kidney disorders (impaired renal function), no dose adjustment is necessary.
If you have renal insufficiency, you must not take this medicine as part of combination therapy for Helicobacter pylori infection (eradication therapy).

Use in patients with liver problems (hepatic impairment)
If you have severe liver disorders, you must not take more than 20 mg of PANTOPRAZOLE TOWA per day
(tablets containing 20 mg of PANTOPRAZOLE TOWA are available).
If you have liver disorders (moderate to severe hepatic dysfunction), do not take this medicine as part of combination therapy for Helicobacter pylori infection (eradication therapy).

Use in children
The use of this medicine is not recommended in children under 12 years of age.

If you take more PANTOPRAZOLE TOWA than you should
In case of accidental overdose, contact your doctor immediately or go to the nearest hospital.
Symptoms of overdose are not known.

If you forget to take PANTOPRAZOLE TOWA
Do not take a double dose to make up for the missed tablet. Take the next dose at the usual scheduled time.

If you stop taking PANTOPRAZOLE TOWA
Do not stop treatment with this medicine without first consulting your doctor or pharmacist.
If you have any doubts about using 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.

The following side effects may occur:

Common (may affect up to 1 in 10 people)

• benign polyps in the stomach

Uncommon (may affect up to 1 in 100 people)

• headache (cephalalgia) and dizziness;
• sleep disorders;
• vomiting, nausea, and diarrhoea;
• abdominal pain and swelling, flatulence, and constipation;
• dry mouth;
• increased levels of liver enzymes (transaminases, *γ-*GT);
• skin irritations (rashes), formation of blisters and skin eruptions (exanthema), and itching;
• fatigue and general feeling of malaise;
• fractures of the hip, wrist, or spine (See section 2).

Rare (may affect up to 1 in 1,000 people)

• decrease in the number of granulocytes (a type of white blood cells) in the blood (agranulocytosis);
• serious allergic reactions (anaphylactic reactions and shock);
• increased levels of triglycerides and cholesterol in the blood;
• weight changes;
• depression;
• altered taste;
• visual disturbances, blurred vision;
• liver disorders (increased bilirubin);
• skin irritation (urticaria);
• joint pain (arthralgia) and muscle pain (myalgia);
• swelling of the extremities (peripheral oedema) or around the eyes and mouth (angioedema);
• increased body temperature;
• breast enlargement in men (gynaecomastia).

Very rare (may affect up to 1 in 10,000 people)

• disorientation;
• decreased levels of platelets (thrombocytopenia) and white blood cells (leucopenia);
• simultaneous decrease in blood components (red blood cells, white blood cells, and platelets).

Not known (frequency cannot be estimated from the available data)

• hallucinations and confusion (especially in patients who have previously experienced these conditions);
• decreased sodium levels in the blood (hyponatraemia);
• decreased magnesium levels in the blood (hypomagnesaemia – see section 2), with or without decreased calcium levels in the blood (hypocalcaemia);
• decreased potassium levels (hypokalaemia);
• yellowing of the skin or whites of the eyes due to liver cell damage (jaundice), and other liver problems (liver failure and hepatocellular injury);
• skin irritations and inflammations (Stevens-Johnson Syndrome, Lyell’s Syndrome, Erythema multiforme);
• sensitivity to light (photosensitivity);
• inflammation of the kidneys causing difficulty and pain when urinating (interstitial nephritis);
• tingling sensation, pricking, stinging, burning, or numbness;
• muscle spasms or cramps;
• erythema, possible muscle pain;
• inflammation of the large intestine, causing persistent watery diarrhoea.

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://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 PANTOPRAZOLO TOWA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after “Exp”.
The expiry date refers to the last day of that month.
Bottle packaging
Do not use this medicine more than twenty-eight days after first opening the bottle.
Blister packaging
Store this medicine at a temperature not exceeding 30°C.
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 TOWA contains

• The active substance is pantoprazole. Each tablet contains 40 mg of pantoprazole (as sodium sesquihydrate 45.10 mg).
• The other components of the tablet core are: microcrystalline cellulose (E460i), lactose monohydrate, croscarmellose sodium, anhydrous colloidal silica, magnesium stearate (vegetable origin).
• The other components of the tablet coating are: methacrylic acid-ethyl acrylate copolymer 1:1, sodium lauryl sulfate, polysorbate 80, triethyl citrate (E1505), talc (E553b), polyvinyl alcohol, macrogol 3350, titanium dioxide (E171), iron oxide yellow (E172).

Description of the appearance of PANTOPRAZOLO TOWA and package contents
PANTOPRAZOLO TOWA tablets are gastro-resistant film-coated, yellow, oval-shaped and biconvex.
Bottle containing 14 gastro-resistant tablets.
Box containing 14 gastro-resistant tablets in blister packs.
Box containing 28 gastro-resistant tablets in blister packs.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
TOWA Pharmaceutical Europe, S.L.
C/ de Sant Martí, 75-97
08107 Martorelles (Barcelona)
Spain

Manufacturer
Esteve Pharmaceuticals, S.A.
C/ Sant Martí, 75-97,
Martorelles, 08107 Barcelona
Spain