Controloc 20

SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE MEDICINAL PRODUCT

Controloc 20, 20 mg, enteric-coated tablets

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each enteric-coated tablet contains 20 mg of pantoprazole (as sodium pantoprazole
sesquihydrate).
For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Enteric-coated tablet (tablet).
Yellow, oval, biconvex coated tablet with brown imprint "P20" on one side.

4. CLINICAL PARTICULARS
4.1 Therapeutic Indications
Controloc 20 is indicated for use in adults and adolescents aged 12 years and above for:

• Symptomatic gastroesophageal reflux disease (GERD).
• Long-term treatment and prevention of relapse of reflux esophagitis.

Controloc 20 is indicated for use in adults for:

• Prevention of gastric and duodenal ulcers induced by non-selective non-steroidal anti-inflammatory drugs (NSAIDs) in patients at increased risk, who require long-term NSAID therapy (see section 4.4).

4.2 Dosage and Administration

Dosage
Adults and adolescents aged 12 years and above
Symptomatic gastroesophageal reflux disease
The recommended oral dose of Controloc 20 is 20 mg once daily. Symptoms usually resolve within 2–4 weeks of treatment. If the response is inadequate, the medication may be continued for another 4 weeks. After symptom resolution, recurrent symptoms may be managed on-demand with 1 tablet of Controloc 20 once daily as needed. If symptoms cannot be controlled with on-demand (as-needed) dosing, continuous treatment may be considered.

Long-term treatment and prevention of relapse of reflux esophagitis
For long-term management, a maintenance dose of 1 tablet of Controloc 20 once daily is recommended. If disease relapse occurs, the dose may be increased to 40 mg pantoprazole per day. In such cases, use of Controloc 40 is recommended. After healing of the relapse, the dose may be reduced again to 1 tablet of Controloc 20 daily.

Adults
Prevention of gastric and duodenal ulcers induced by long-term use of non-selective non-steroidal anti-inflammatory drugs (NSAIDs) in patients at increased risk who require prolonged NSAID therapy.
The recommended dose is 1 tablet of Controloc 20 once daily.

Special patient groups
Patients with hepatic impairment
In patients with severe liver impairment, the daily dose should not exceed 20 mg of pantoprazole (see section 4.4).

Patients with renal impairment
No dosage adjustment is required in patients with renal impairment (see section 5.2).

Elderly patients
No dosage adjustment is required in elderly patients (see section 5.2).

Children and adolescents
Controloc 20 is not recommended for use in children under 12 years of age due to limited data on safety and efficacy in this age group (see section 5.2).

Administration
Oral administration.
Tablets must not be chewed or crushed. They should be taken 1 hour before a meal, swallowed whole with water.

4.3 Contraindications

Hypersensitivity to the active substance, substituted benzimidazoles, or to any of the
excipients listed in section 6.1.

4.4 Special warnings and precautions for use

Hepatic impairment
In patients with severe liver impairment, during treatment with pantoprazole, especially when the product is used long-term, liver enzyme activity should be monitored regularly. If liver enzyme activity increases, treatment should be discontinued (see section 4.2).

Concomitant administration with NSAIDs
The use of Controloc 20 for prevention of gastric and duodenal ulcers in patients receiving non-selective non-steroidal anti-inflammatory drugs (NSAIDs) should be limited to patients who require continued NSAID therapy and who are at increased risk of gastrointestinal complications. Increased risk of gastrointestinal complications should be determined based on individual risk factors, including advanced age (over 65 years), history of gastric or duodenal ulcer, or gastrointestinal bleeding.

Gastric malignancy
Symptomatic response to pantoprazole may mask symptoms of gastric malignancy and may delay its diagnosis. In the presence of alarm symptoms (such as significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis, anaemia, or melaena), or when ulcers of the stomach are suspected or confirmed, malignancy must be excluded.

Further investigations should be considered in patients whose symptoms persist despite appropriate treatment.

Concomitant administration with HIV protease inhibitors
Concomitant administration of pantoprazole with HIV protease inhibitors whose absorption depends on acidic gastric pH, such as atazanavir, is not recommended, as this may significantly reduce their bioavailability (see section 4.5).

Effect on vitamin B₁₂ absorption
Pantoprazole, like other drugs that inhibit gastric acid secretion, may reduce absorption of vitamin B₁₂ (cyanocobalamin). This is due to deficiency of hydrochloric acid in gastric juice or achlorhydria. This should be taken into account during long-term treatment of patients with vitamin B₁₂ deficiency or those at risk factors for impaired absorption, or if clinical symptoms occur.

Long-term therapy
During long-term therapy, particularly when treatment lasts longer than one year, patients should be under regular medical supervision.

Gastrointestinal infections caused by bacteria
Treatment with Controloc 20 may cause a slight increase in the risk of gastrointestinal infections caused by bacteria of the Salmonella and Campylobacter families or Clostridium difficile.

Hypomagnesaemia
In patients treated with proton pump inhibitors (PPIs), such as pantoprazole, for at least three months, and in most cases for one year or longer, severe hypomagnesaemia has rarely been reported. Symptoms of severe hypomagnesaemia such as fatigue, tetany, confusion, seizures, dizziness, and ventricular arrhythmias may develop insidiously and therefore may not be recognized. Hypomagnesaemia may lead to hypocalcaemia and/or hypokalaemia (see section 4.8). In patients with the most severe hypomagnesaemia (and hypomagnesaemia associated with hypocalcaemia and/or hypokalaemia), discontinuation of proton pump inhibitors and initiation of magnesium supplementation led to improvement.

In patients expected to be on long-term PPI therapy, and in patients receiving PPIs together with drugs such as digoxin or other medicinal products that may cause hypomagnesaemia (e.g. diuretics), healthcare professionals should consider measuring magnesium levels before initiating PPI therapy and periodically during treatment.

Bone fractures
The use of proton pump inhibitors, especially at high doses and long-term therapy (over 1 year), may slightly increase the risk of hip, wrist, and spine fractures, particularly in elderly patients or those with other risk factors. Observational studies suggest that proton pump inhibitors may increase the overall risk of fractures by 10–40%. The increased risk may also be due to other factors. Patients at risk of osteoporosis should be managed according to current clinical guidelines to ensure adequate intake of vitamin D and calcium.

Severe cutaneous adverse reactions (SCAR)
Severe cutaneous adverse reactions have been reported with the use of pantoprazole with an incidence frequency of "not known", including erythema multiforme, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS), which may be life-threatening or result in death (see section 4.8).

When prescribing the medicinal product, patients should be informed about subjective and objective symptoms and closely monitored for skin reactions.

If subjective or objective symptoms indicating these reactions occur, pantoprazole should be discontinued immediately and alternative treatment considered.

Subacute cutaneous lupus erythematosus (SCLE)
The use of proton pump inhibitors has been associated with rare occurrence of subacute cutaneous lupus erythematosus (SCLE). If skin lesions appear, especially in sun-exposed areas, accompanied by joint pain, the patient should seek immediate medical attention, and the physician should consider discontinuing treatment with Controloc 20.

Occurrence of SCLE following previous treatment with a proton pump inhibitor may increase the risk of SCLE during treatment with other proton pump inhibitors.

Effect on laboratory test results
Increased chromogranin A (CgA) levels may interfere with tests detecting neuroendocrine tumours. To avoid this, treatment with Controloc 20 should be interrupted for at least 5 days before measuring CgA levels (see section 5.1). If, after the initial measurement, CgA and gastrin levels remain outside the reference range, measurements should be repeated 14 days after discontinuation of proton pump inhibitor therapy.

Controloc 20 contains sodium.
This medicinal product contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

4.5 Interactions with other medicinal products and other forms of interactions

Medicinal products whose absorption pharmacokinetics depend on pH
Due to the strong and long-lasting inhibition of gastric hydrochloric acid secretion, pantoprazole may impair the absorption of other medicinal products for which gastric pH is an important factor affecting oral bioavailability, e.g. certain antifungal azoles such as ketoconazole, itraconazole, posaconazole, and other drugs such as erlotinib.

HIV protease inhibitors
Concomitant administration of pantoprazole with HIV protease inhibitors whose absorption depends on acidic gastric pH, such as atazanavir, is not recommended, as this may significantly reduce their bioavailability (see section 4.4).
If concomitant administration of an HIV protease inhibitor with a proton pump inhibitor is necessary, close monitoring of the patient's clinical status (e.g. viral load) is advised. The dose of pantoprazole should not exceed 20 mg per day. Dose adjustment of the HIV protease inhibitor may be required.

Vitamin K antagonists (phenprocoumon or warfarin)
Concomitant administration of pantoprazole with warfarin or phenprocoumon had no effect on the pharmacokinetics of warfarin, phenprocoumon, or changes in INR (international normalized ratio) values. However, increased INR and prothrombin time have been reported in patients receiving proton pump inhibitors together with warfarin or phenprocoumon. Elevated INR and prothrombin time may lead to abnormal bleeding, and even death. In patients treated concomitantly with pantoprazole and warfarin or phenprocoumon, monitoring of INR and prothrombin time may be necessary.

Methotrexate
In some patients, concomitant use of high-dose methotrexate (e.g. 300 mg) with proton pump inhibitors has been observed to increase methotrexate concentrations. Therefore, in patients receiving high doses of methotrexate, e.g. for neoplastic disease or psoriasis, temporary discontinuation of pantoprazole should be considered.

Other interaction studies
Pantoprazole is extensively metabolized in the liver by the cytochrome P-450 enzyme system. The main metabolic pathway is demethylation via CYP2C19, while other metabolic pathways include oxidation via CYP3A4.
Interaction studies with other medicinal products metabolized by the same enzyme system, such as carbamazepine, diazepam, glibenclamide, nifedipine, and oral contraceptives containing levonorgestrel and ethinylestradiol, did not reveal clinically significant interactions.
Interactions between pantoprazole and other medicinal products or compounds metabolized by the same enzyme system cannot be excluded.
Results from interaction studies indicate that pantoprazole has no effect on the metabolism of active substances metabolized by CYP1A2 (e.g. caffeine, theophylline), CYP2C9 (e.g. piroxicam, diclofenac, naproxen), CYP2D6 (e.g. metoprolol), CYP2E1 (e.g. ethanol), and does not interfere with P-glycoprotein-dependent absorption of digoxin.
No interactions were observed with concomitantly administered antacids.

Interaction studies have also been conducted in which pantoprazole was administered concomitantly with appropriate antibiotics (clarithromycin, metronidazole, amoxicillin). No clinically significant interactions were observed.

Medicinal products that inhibit or induce CYP2C19
Cytochrome CYP2C19 inhibitors such as fluvoxamine may increase systemic exposure to pantoprazole. Dose reduction should be considered in patients receiving long-term high-dose pantoprazole therapy or in patients with impaired liver function.
Enzyme inducers of CYP2C19 and CYP3A4, such as rifampicin or St John's wort (Hypericum perforatum), may reduce plasma concentrations of proton pump inhibitors metabolized by these enzyme systems.

Effect on laboratory tests
In some screening tests for urinary tetrahydrocannabinol (THC), false-positive results have been observed in patients receiving pantoprazole. An alternative testing method should be considered to confirm positive results.

4.6 Fertility, pregnancy and lactation

Pregnancy
A moderate amount of data from pregnant women (between 300-1000 pregnant women) does not indicate that pantoprazole causes developmental abnormalities or has toxic effects on the foetus and newborn.
Animal studies have shown adverse effects on reproduction (see section 5.3). For safety reasons, it is recommended to avoid the use of Controloc 20 during pregnancy.

Breast-feeding
In animal studies, pantoprazole has been shown to pass into milk. There are insufficient data on the passage of pantoprazole into human milk; however, there are reports indicating such transfer. The risk of adverse reactions in the breastfed newborn/infant cannot be excluded. Therefore, a decision should be made whether to discontinue breast-feeding or to discontinue/abstain from the use of Controloc 20, taking into account the benefits of breast-feeding for the child and the benefits of treatment for the mother.

Fertility
Animal studies have not shown impairment of fertility following administration of pantoprazole (see section 5.3).

4.7 Effects on ability to drive and use machines

Pantoprazole has no effect or has a negligible effect on the ability to drive motor vehicles
and operate mechanical devices.
Adverse reactions such as dizziness and visual disturbances may occur (see
section 4.8). In such cases, patients should not drive motor vehicles or
operate mechanical devices.

4.8 Undesirable effects

Undesirable effects (ADR - adverse drug reactions) may occur in approximately 5% of patients.
The undesirable effects listed in the table below are classified according to the following frequency categories:
Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (≤1/10,000), frequency not known (cannot be estimated based on available data).
For all undesirable effects reported after product marketing authorization, it is not possible to apply a frequency classification; therefore, their frequency is designated as "not known".
Within each frequency group, undesirable effects are listed in order from the most severe to the least severe.
Table 1. Undesirable effects associated with pantoprazole use reported in clinical trials and post-marketing experience

Hypokalaemia and (or) hypokalaemia may be associated with hypomagnesaemia
(see section 4.4).
Muscle cramps due to electrolyte disturbances.
Reporting suspected adverse reactions
After marketing authorization of the medicinal product, reporting suspected adverse reactions is important. This enables continuous monitoring of the benefit-risk ratio of the medicinal product. Healthcare professionals should report any suspected adverse reactions via the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Adverse reactions may also be reported to the marketing authorization holder.

4.9 Overdose

Symptoms of overdose in humans are not known.
Doses up to 240 mg administered intravenously over 2 minutes were well tolerated.
Since pantoprazole is highly bound to plasma proteins, it is difficult to remove by dialysis.
In cases of overdose with clinical signs of poisoning, apart from symptomatic and supportive treatment, there are no specific therapeutic recommendations.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Proton pump inhibitors, ATC code: A02BC02

Mechanism of action

Pantoprazole is a substituted benzimidazole that inhibits gastric acid secretion by specifically blocking the proton pump in parietal cells.
In the acidic environment of the parietal cells, pantoprazole is converted into its active form and inhibits the activity of H+, K+-ATPase, the final step in gastric acid production.
The degree of inhibition of gastric acid secretion is dose-dependent and affects both basal and stimulated acid secretion. In most patients, symptom relief is achieved within 2 weeks.
As with other proton pump inhibitors and histamine H₂-receptor antagonists, treatment with pantoprazole leads to reduced gastric acidity and a secondary, proportional increase in gastrin secretion. Gastrin secretion is reversible.
Since pantoprazole binds to the proton pump at the cellular receptor level, it can inhibit acid secretion independently of stimulation by other substances (acetylcholine, histamine, gastrin). The effect is the same regardless of whether the product is administered orally or intravenously.

Pharmacodynamic effects

Fasting serum gastrin concentrations increase under the influence of pantoprazole. During short-term treatment, these values usually do not exceed the upper limit of normal. During long-term treatment, gastrin concentrations typically double. However, marked increases in gastrin levels occur only sporadically.
As a result, during rare cases of prolonged treatment, mild to moderate increases in the number of specific enterochromaffin-like (ECL) cells in the stomach (simple to adenomatous hyperplasia) have been observed.
However, according to available studies, the development of pre-malignant changes (atypical hyperplasia) or gastric carcinoids, observed in animal studies (see section 5.3), has not been reported in humans.

In long-term therapy lasting more than one year, based on animal study results, a potential influence of pantoprazole on endocrine parameters of the thyroid gland cannot be completely ruled out.

During treatment with acid-suppressive medicinal products, serum gastrin concentration increases in response to reduced gastric acid secretion. Chromogranin A (CgA) levels also increase due to reduced intragastric acidity. Elevated CgA levels may interfere with tests detecting the presence of neuroendocrine tumors.

Available published evidence indicates that treatment with proton pump inhibitors should be discontinued 5 to 2 weeks before measuring CgA concentration. This is intended to allow CgA levels, falsely elevated due to proton pump inhibitor therapy, to return to the reference range.

5.2 Pharmacokinetic Properties

Absorption
Pantoprazole is rapidly absorbed from the gastrointestinal tract, achieving maximum plasma concentration even after a single oral dose of 20 mg. Peak serum concentration occurs on average 2.0–2.5 hours after administration and reaches approximately 1–1.5 µg/mL. These values remain unchanged after repeated administration.
There are no differences in pharmacokinetics between single and multiple dosing. Over the dose range of 10 to 80 mg, the plasma kinetics of pantoprazole are linear for both oral and intravenous administration.
The total bioavailability of pantoprazole in tablet form is approximately 77%. Concomitant food intake does not affect the area under the curve (AUC), maximum serum concentration, and thus does not influence bioavailability. However, simultaneous food intake may delay the onset of action of the drug.

Distribution
Pantoprazole is approximately 98% bound to plasma proteins. The volume of distribution is about 0.15 L/kg.

Metabolism
The substance is metabolized almost exclusively in the liver. The main metabolic pathway is demethylation via CYP2C19, followed by sulfation; other metabolic pathways include oxidation via CYP3A4.

Elimination
The terminal elimination half-life is approximately 1 hour, and clearance is about 0.1 L/h/kg.
Several cases of delayed elimination have been reported. Since pantoprazole specifically binds to the proton pump in parietal cells, the elimination half-life does not correlate with the prolonged duration of action (inhibition of acid secretion).
Pantoprazole metabolites are primarily excreted via the kidneys (approximately 80%), with the remainder eliminated in feces. The main metabolite in both plasma and urine is demethylpantoprazole sulfate. The half-life of the main metabolite (approximately 1.5 hours) does not differ significantly from that of pantoprazole.

Special Patient Groups

Poor Metabolizers
In approximately 3% of the European population, classified as poor metabolizers, functional CYP2C19 enzyme is absent. In these individuals, pantoprazole metabolism is likely catalyzed mainly by CYP3A4. After a single 40 mg dose of pantoprazole, the mean area under the plasma concentration-time curve (AUC) was 6 times higher in poor metabolizers compared to individuals with functional CYP2C19 (extensive metabolizers). Mean maximum plasma concentrations increased by approximately 60%. These data do not influence pantoprazole dosing.

Patients with Impaired Renal Function
Dose reduction of pantoprazole is not necessary in patients with impaired renal function (including patients undergoing dialysis). As in healthy individuals, the half-life of pantoprazole is short. Only small amounts of pantoprazole are removed during dialysis. Although the half-life of the main metabolite is moderately prolonged (2–3 hours), excretion remains rapid and no accumulation occurs.

Patients with Impaired Hepatic Function
In patients with liver cirrhosis (Child class A and B), the half-life is prolonged to 3–6 hours and AUC values increase 3–5-fold. Nevertheless, maximum serum concentration increases only slightly, by a factor of 1.3 compared to healthy individuals.

Elderly Patients
The slight increase in AUC and maximum concentration (C_max) observed in elderly volunteers compared to younger volunteers is not clinically significant.

Children and Adolescents
After administration of a single oral dose of 20 or 40 mg pantoprazole to children aged 5–16 years, AUC and C_max values corresponded to the range observed in adults.
After single intravenous administration of pantoprazole at doses of 0.8 or 1.6 mg/kg body weight to children aged 2–16 years, no significant relationship was observed between pantoprazole clearance and age or body weight. AUC and volume of distribution were consistent with data obtained in adults.

5.3 Preclinical safety data

Non-clinical data derived from conventional pharmacological safety studies, repeated-dose toxicity studies, and genotoxicity studies revealed no special hazard for humans.

In two-year carcinogenicity studies conducted in rats, neuroendocrine tumors were observed. Additionally, in one study, squamous cell papillomas in the forestomach of rats were observed. The mechanism leading to gastric tumors induced by substituted benzimidazoles has been thoroughly investigated and indicates that this is a secondary reaction to markedly increased serum gastrin concentrations occurring in rats during long-term administration of high doses of pantoprazole.

In two-year rodent studies, an increased incidence of liver tumors was observed in rats and female mice, which was attributed to a phenomenon related to the high rate of hepatic metabolism of pantoprazole.

In rats receiving the highest doses of pantoprazole (200 mg/kg body weight), a slight increase in the frequency of neoplastic changes in the thyroid gland was observed. The occurrence of these tumors is associated with altered thyroxine disposition in the liver of rats induced by pantoprazole. However, since therapeutic doses in humans are low, no adverse effects on the thyroid gland are expected.

In a rat pre- and postnatal development study assessing bone development, signs of toxicity in offspring (mortality, lower mean body weight, reduced average weight gain, and decreased bone growth) were observed at exposure (C_max) corresponding to approximately twice the clinical exposure in humans. At the end of the recovery phase, bone parameters were similar across all groups, and body weights also showed a tendency toward recovery after the recovery period without drug administration. Increased mortality was observed only in young rats before weaning (up to 21 days of age), which approximately correspond to infants up to 2 years of age. The significance of this observation for pediatric populations is unknown. An earlier rat pre- and postnatal study using slightly lower doses did not show any adverse effects after administration of a dose of 3 mg/kg body weight, compared to the low dose of 5 mg/kg body weight used in this study.

Studies showed no effect on fertility impairment or teratogenic activity.

Studies in rats investigating placental transfer of the drug demonstrated increased passage of the drug across the placental barrier in late pregnancy. As a result, pantoprazole concentrations in the fetal circulation are elevated shortly before delivery.

6. PHARMACEUTICAL DATA

6.1 List of excipients

Core
Sodium carbonate anhydrous
Mannitol (E421)
Crospovidone
Povidone K90
Calcium stearate

Coating
Hypromellose
Povidone K25
Titanium dioxide (E171)
Yellow iron oxide (E172)
Propylene glycol (E1520)
Methacrylic acid and ethyl acrylate copolymer (1:1)
Polysorbate 80
Sodium lauryl sulfate
Triethyl citrate

Printing ink
Shellac
Red iron oxide (E172)
Black iron oxide (E172)
Yellow iron oxide (E172)
Concentrated ammonium hydroxide

6.2 Pharmaceutical incompatibilities

Not applicable.

6.3 Shelf life

Packages containing blisters
3 years
Bottles
Unopened: 3 years
Shelf life of the product after first opening: 120 days.

6.4 Special precautions during storage

No special requirements for storage of the medicinal product.

6.5 Type and content of container

HDPE bottle with LDPE cap.
7 enteric-coated tablets
10 enteric-coated tablets
14 enteric-coated tablets
15 enteric-coated tablets
24 enteric-coated tablets
28 enteric-coated tablets
30 enteric-coated tablets
48 enteric-coated tablets
49 enteric-coated tablets
56 enteric-coated tablets
60 enteric-coated tablets
84 enteric-coated tablets
90 enteric-coated tablets
98 enteric-coated tablets
98 (2x49) enteric-coated tablets
100 enteric-coated tablets
112 enteric-coated tablets
Hospital packs
50 enteric-coated tablets
56 enteric-coated tablets
84 enteric-coated tablets
90 enteric-coated tablets
112 enteric-coated tablets
140 enteric-coated tablets
140 (10x14), (5x28) enteric-coated tablets
150 (10x15) enteric-coated tablets
280 (20x14), (10x28) enteric-coated tablets
500 enteric-coated tablets
700 (5x140) enteric-coated tablets

Aluminium/Aluminium blisters.
Aluminium/Aluminium blisters with paper overwrap (blisters wallet).
7 enteric-coated tablets
10 enteric-coated tablets
14 enteric-coated tablets
15 enteric-coated tablets
24 enteric-coated tablets
28 enteric-coated tablets
30 enteric-coated tablets
48 enteric-coated tablets
49 enteric-coated tablets
56 enteric-coated tablets
60 enteric-coated tablets
84 enteric-coated tablets
90 enteric-coated tablets
98 enteric-coated tablets
98 (2x49) enteric-coated tablets
100 enteric-coated tablets
112 enteric-coated tablets
168 enteric-coated tablets
Hospital packs
50 enteric-coated tablets
56 enteric-coated tablets
84 enteric-coated tablets
90 enteric-coated tablets
112 enteric-coated tablets
140 enteric-coated tablets
50 (50x1) enteric-coated tablets
140 (10x14), (5x28) enteric-coated tablets
150 (10x15) enteric-coated tablets
280 (20x14), (10x28) enteric-coated tablets
500 enteric-coated tablets
700 (5x140) enteric-coated tablets

In Poland, packaging containing 14, 28 and 60 tablets in Aluminium/Aluminium blisters;
14 and 28 tablets in Aluminium/Aluminium blisters with paper overwrap; and 14, 28 and 100
tablets in HDPE bottle with LDPE cap are registered.
Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No special requirements.
Any unused residues of the product or waste materials must be disposed of in accordance with
local regulations.

7. MARKETING AUTHORISATION HOLDER

Takeda Pharma Sp. z o.o.
ul. Prosta 68
00-838 Warszawa
[email protected]

8. MARKETING AUTHORISATION NUMBER

9. DATE OF FIRST AUTHORISATION OR RENEWAL OF THE AUTHORISATION

DATE OF REVISION OF THE TEXT
Date of first authorisation: 29 February 2000
Date of latest renewal: 16 March 2010

10. DATE OF APROVAL OR PARTIAL CHANGE OF THE TEXT

SUMMARY OF PRODUCT CHARACTERISTICS
26 April 2023
PACKAGING LABELS
INFORMATION ON OUTER PACKAGING
Box for blisters (1 x 14 tab)
Box for blisters (2 x 14 tab)
Box for blisters (4 x 15 tab)

1. NAME OF THE MEDICINAL PRODUCT

Controloc 20, 20 mg, enteric-coated tablets
pantoprazole

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each enteric-coated tablet contains 20 mg of pantoprazole (as sodium pantoprazole
sesquihydrate).
3. LIST OF EXCIPIENTS
4. PHARMACEUTICAL FORM AND PACKAGE CONTENTS
14 enteric-coated tablets, code 5909990478767
28 enteric-coated tablets, code 5909990478774
60 enteric-coated tablets, code 5909990820351

5. METHOD AND ROUTE OF ADMINISTRATION

Oral administration.
Read the instructions in the leaflet before using the medicine.
Swallow whole, do not chew or crush.

6. WARNING ON STORAGE OF THE MEDICINAL PRODUCT

KEEP OUT OF SIGHT AND REACH OF CHILDREN
Keep the medicine out of the sight and reach of children.
7. OTHER SPECIAL WARNINGS, IF NECESSARY
8. EXPIRY DATE
Expiry date (EXP):
9. STORAGE CONDITIONS
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR
WASTE DERIVED FROM SUCH PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Takeda Pharma Sp. z o.o.
ul. Prosta 68
00-838 Warszawa
((logo of the company))

12. MARKETING AUTHORISATION NUMBER

Authorisation number 4787

13. LOT NUMBER

Lot number (Lot):

14. GENERAL AVAILABILITY CATEGORY

Rp - Medicinal product subject to medical prescription.
15. INSTRUCTIONS FOR USE
16. INFORMATION IN BRAILLE
Controloc 20

17. UNIQUE IDENTIFIER – 2D CODE

Includes a 2D code serving as the carrier of the unique identifier.

18. UNIQUE IDENTIFIER – HUMAN-READABLE INFORMATION

PC:
SN:
NN:
INFORMATION ON OUTER PACKAGING
Blister pack in paper sleeve (2 x 7 tab)
Blister pack in paper sleeve (4 x 7 tab)

1. NAME OF THE MEDICINAL PRODUCT

Controloc 20, 20 mg, enteric-coated tablets
pantoprazole

2. ACTIVE SUBSTANCE CONTENT

Each enteric-coated tablet contains 20 mg of pantoprazole (as sodium pantoprazole
sesquihydrate).
3. LIST OF EXCIPIENTS
4. PHARMACEUTICAL FORM AND PACKAGING CONTENTS
14 enteric-coated tablets code 5909990614967
28 enteric-coated tablets code 5909990614974

5. METHOD AND ROUTE OF ADMINISTRATION

Oral administration.
Read the instruction leaflet before using the medicine.
Swallow whole, do not chew or crush.

6. WARNING ON STORAGE OF THE MEDICINAL PRODUCT

KEEP OUT OF SIGHT AND REACH OF CHILDREN
Keep the medicine out of sight and reach of children.
7. OTHER SPECIAL WARNINGS, IF NECESSARY
8. EXPIRY DATE
Expiry date (EXP):
9. STORAGE CONDITIONS
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCT OR
WASTE DERIVED FROM SUCH MEDICINAL PRODUCT, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Takeda Pharma Sp. z o.o.
Prosta 68 Street
00-838 Warsaw
((logo of the marketing authorisation holder))

12. MARKETING AUTHORISATION NUMBER

Authorisation number 4787

13. BATCH NUMBER

Batch number (Lot):

14. GENERAL AVAILABILITY CATEGORY

Rp - Medicinal product subject to medical prescription.
15. INSTRUCTIONS FOR USE
16. INFORMATION IN BRAILLE
controloc 20

17. UNIQUE IDENTIFIER – 2D CODE

Not applicable

18. UNIQUE IDENTIFIER – HUMAN-READABLE INFORMATION

Not applicable
INFORMATION ON OUTER PACKAGING
Box for bottle (14 tab)
Box for bottle (28 tab)
Box for bottle (100 tab)

1. NAME OF THE MEDICINAL PRODUCT

Controloc 20, 20 mg, enteric-coated tablets
pantoprazole

2. ACTIVE SUBSTANCE CONTENT

Each enteric-coated tablet contains 20 mg of pantoprazole (as sodium pantoprazole sesquihydrate).
3. LIST OF EXCIPIENTS
4. PHARMACEUTICAL FORM AND PACKAGING CONTENT
14 enteric-coated tablets code 5909990478729
28 enteric-coated tablets code 5909990478736
100 enteric-coated tablets code 5909990478743

5. METHOD AND ROUTE OF ADMINISTRATION

Oral administration.
Read the instructions in the leaflet before using the medicine.
Swallow whole, do not chew or crush.

6. WARNINGS ON STORAGE OF THE MEDICINAL PRODUCT

KEEP OUT OF SIGHT AND REACH OF CHILDREN
Keep the medicine in a place out of sight and reach of children.
7. OTHER SPECIAL WARNINGS, IF NECESSARY
8. EXPIRY DATE
Expiry date (EXP):
Do not use the medicine after 120 days from the first opening of the bottle.
9. STORAGE CONDITIONS
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR
WASTE DERIVED FROM SUCH PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Takeda Pharma Sp. z o.o.
Prosta 68
00-838 Warsaw
((logo of the company))

12. MARKETING AUTHORISATION NUMBER

Authorisation number 4787

13. BATCH NUMBER

Batch number (Lot):

14. GENERAL AVAILABILITY CATEGORY

Rp - Prescription-only medicine.
15. INSTRUCTIONS FOR USE
16. INFORMATION PROVIDED IN BRAILLE
controloc 20

17. UNIQUE IDENTIFIER – 2D CODE

Includes a 2D code serving as the carrier of the unique identifier.

18. UNIQUE IDENTIFIER – HUMAN-READABLE DATA

PC:
SN:
NN:
INFORMATION ON IMMEDIATE PACKAGING
Blister wallet

1. NAME OF THE MEDICINAL PRODUCT

Controloc 20, 20 mg, enteric-coated tablets
pantoprazole

2. CONTENT OF ACTIVE SUBSTANCE

Each enteric-coated tablet contains 20 mg of pantoprazole (as sodium pantoprazole
sesquihydrate).
3. LIST OF OTHER INGREDIENTS
4. PHARMACEUTICAL FORM AND PACKAGE CONTENTS
7 enteric-coated tablets

5. METHOD AND ROUTE OF ADMINISTRATION

Oral administration.
Read the instructions in the leaflet before using the medicine.
Swallow whole, do not chew or crush.

6. WARNING ON STORAGE OF THE MEDICINAL PRODUCT

KEEP OUT OF SIGHT AND REACH OF CHILDREN
Keep the medicine out of sight and reach of children.
7. OTHER SPECIAL WARNINGS, IF NECESSARY
8. EXPIRY DATE
EXP:
9. STORAGE CONDITIONS
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR
WASTE DERIVED FROM SUCH PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Takeda Pharma Sp. z o.o.
Prosta 68
00-838 Warsaw
((logo of the company))

12. AUTHORISATION NUMBER

Authorisation number 4787

13. BATCH NUMBER

Lot:

14. GENERAL AVAILABILITY CATEGORY

Rp - Prescription-only medicine.
15. INSTRUCTIONS FOR USE
16. INFORMATION IN BRAILLE
MINIMUM INFORMATION TO BE INCLUDED ON BLISTER PACKS OR FOIL PACKAGING
Blister

1. NAME OF THE MEDICINAL PRODUCT

Controloc 20, 20 mg, tablets
pantoprazole

2. NAME OF THE MARKETING AUTHORISATION HOLDER

((logo of the marketing authorisation holder))

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. OTHERS

INFORMATION ON IMMEDIATE PACKAGING
Label on the bottle

1. NAME OF THE MEDICINAL PRODUCT

Controloc 20, 20 mg, enteric-coated tablets
pantoprazole

2. ACTIVE SUBSTANCE CONTENT

Each enteric-coated tablet contains 20 mg of pantoprazole (as sodium pantoprazole
sesquihydrate).
3. LIST OF EXCIPIENTS
4. PHARMACEUTICAL FORM AND PACKAGING CONTENTS
14 enteric-coated tablets
28 enteric-coated tablets
100 enteric-coated tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral administration.
Read the instructions in the leaflet before using the medicine.
Swallow whole, do not chew or crush.

6. WARNINGS ON STORAGE OF THE MEDICINAL PRODUCT

KEEP OUT OF SIGHT AND REACH OF CHILDREN
Keep the medicine in a place out of sight and reach of children.
7. OTHER SPECIAL WARNINGS, IF NECESSARY
8. EXPIRY DATE
EXP:
Do not use this medicine after 120 days from the first opening of the bottle.
9. STORAGE CONDITIONS
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCT OR
WASTE MATERIAL DERIVING FROM SUCH MEDICINAL PRODUCT, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Takeda Pharma Sp. z o.o.
Prosta 68 Street
00-838 Warsaw
((logo of the company))

12. MARKETING AUTHORISATION NUMBER

Authorisation number: 4787

13. BATCH NUMBER

Lot:

14. GENERAL CATEGORY OF AVAILABILITY

Rp - Prescription-only medicine.
15. INSTRUCTIONS FOR USE
16. INFORMATION IN BRAILLE
17. UNIQUE IDENTIFIER – 2D CODE
18. UNIQUE IDENTIFIER – HUMAN-READABLE DATA

Package leaflet: information for the patient

Controloc 20, 20 mg, enteric-coated tablets
pantoprazole
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 further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

1. What Controloc 20 is and what it is used for
2. What you need to know before taking Controloc 20
3. How to take Controloc 20
4. Possible side effects
5. How to store Controloc 20
6. Contents of the pack and other information

1. What Controloc 20 is and what it is used for

Controloc 20 contains the active substance pantoprazole. Controloc 20 is a selective "proton pump inhibitor", a medicine that reduces acid secretion in the stomach. It is used in the treatment of stomach and intestinal disorders related to hydrochloric acid secretion.
Controloc 20 is indicated in adults and adolescents aged 12 years and above for:

• Treatment of symptoms (e.g. heartburn, acid regurgitation, pain on swallowing) associated with gastroesophageal reflux disease (GERD) caused by backflow of hydrochloric acid from the stomach.
• Long-term treatment of reflux esophagitis (inflammation of the oesophagus accompanied by backflow of hydrochloric acid from the stomach) and prevention of its recurrence.

Controloc 20 is indicated in adults for:

• Prevention of duodenal and/or gastric ulcers induced by non-steroidal anti-inflammatory drugs (NSAIDs, e.g. ibuprofen) in patients at risk who require continuous NSAID therapy.

2. What you need to know before taking Controloc 20

When not to take Controloc 20

• If you are allergic to pantoprazole or any of the other ingredients of this medicine (listed in section 6).
• If you have previously experienced an allergic reaction to medicines containing other proton pump inhibitors.

Warnings and precautions
Before starting treatment with Controloc 20, inform your doctor, pharmacist, or nurse:

• If you have severe liver function impairment. Inform your doctor if you have ever had liver problems in the past. Your doctor may recommend more frequent monitoring of liver enzyme activity, especially during long-term treatment with Controloc 20. If liver enzyme activity increases, treatment should be discontinued.

• If you are required to take NSAIDs continuously while also taking Controloc 20, due to an increased risk of gastrointestinal complications. This increased risk will be assessed based on patient-specific risk factors such as age (65 years or older), history of gastric or duodenal ulcers, or gastrointestinal bleeding.

• If you have vitamin B deficiency or risk factors indicating possible reduced vitamin B levels, and you are receiving long-term pantoprazole therapy. Like all medicines that reduce (inhibit) gastric acid secretion, pantoprazole may lead to reduced absorption of vitamin B. Contact your doctor if you notice any of the following symptoms, which may indicate low vitamin B levels:

• extreme fatigue or lack of energy,

• numbness and tingling sensations,

• pain or redness of the tongue, mouth ulcers,

• muscle weakness,

• visual disturbances,

• memory problems, disorientation, depression.

• If you are taking HIV protease inhibitors such as atazanavir (used in the treatment of HIV infection) concomitantly with pantoprazole, consult your doctor for detailed advice.

• The use of a proton pump inhibitor such as pantoprazole, especially for more than 1 year, may slightly increase the risk of fractures of the hip, wrist, or spine. Inform your doctor if you have osteoporosis (reduced bone density) or if you have been informed by your doctor that you are at risk of developing osteoporosis (e.g. if you are taking steroid medicines). If you take Controloc 20 for longer than three months, you may experience reduced magnesium levels in the blood, which may subsequently lead to fatigue, tetany, disorientation, seizures, dizziness, and ventricular arrhythmias. If you experience any of these symptoms, inform your doctor. Low magnesium levels in the blood may also lead to reduced potassium and calcium levels in the blood. Your doctor may decide to perform periodic blood magnesium level tests.

• If you have previously experienced a skin reaction to a medicine similar to Controloc 20 that reduces gastric acid secretion.

• If you develop a skin rash, especially in areas exposed to sunlight, inform your doctor immediately, as discontinuation of Controloc 20 may be necessary. Also report any other adverse reactions, such as joint pain.

• Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and erythema multiforme, have been reported with pantoprazole use. Discontinue pantoprazole and seek immediate medical advice if you notice any symptoms related to these serious skin reactions described in section 4.

• Regarding a planned specific blood test (chromogranin A levels).

Contact your doctor immediately before starting or during treatment if you experience any of the
following symptoms, which may indicate another, more serious condition:

• unintentional weight loss;
• vomiting, especially recurrent;
• vomiting blood, which may appear dark like coffee grounds;
• blood in stool, black or tarry stools;
• difficulty swallowing or pain during swallowing;
• pallor and weakness (anaemia);
• chest pain;
• abdominal pain;
• severe and/or persistent diarrhoea, as use of this medicine is associated with a slightly increased risk of infectious diarrhoea.

Your doctor may decide to perform tests to rule out an underlying tumour, as pantoprazole treatment may alleviate symptoms of tumour disease and delay diagnosis. If symptoms persist despite treatment, further investigations should be considered.
If you are taking Controloc 20 for a prolonged period (over 1 year), you are likely to be under regular medical supervision. In such cases, report any new or unexpected symptoms and their circumstances during each visit to your doctor.
Children and adolescents
Controloc 20 is not recommended for use in children, as its efficacy has not been established in children under 12 years of age.
Controloc 20 and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those obtained without a prescription.
Since Controloc 20 may affect the efficacy 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 in certain types of cancer), as Controloc 20 may inhibit the proper action of these and other medicines.
• Warfarin and phenprocoumon, which affect blood clotting and prevent thrombosis. Further testing may be required.
• Medicines used in the treatment of HIV infection, such as atazanavir.
• Methotrexate (used in the treatment of rheumatoid arthritis, psoriasis, and cancerous diseases); when methotrexate is used, your doctor may temporarily discontinue Controloc 20, as pantoprazole may increase methotrexate blood levels.
• Fluvoxamine (used in the treatment of depression and other psychiatric disorders); if you are taking fluvoxamine, your doctor may recommend a dose reduction.
• Rifampicin (used to treat infections).
• St. John's wort (Hypericum perforatum) (used in the treatment of mild depression).

Discuss with your doctor before starting pantoprazole if you are scheduled for a specific urine test [for tetrahydrocannabinol (THC)].
Pregnancy, breastfeeding, and fertility
Experience with use in pregnant women is limited. The active substance has been shown to pass into human milk.
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
This medicine may be used in pregnant women, women in whom pregnancy cannot be excluded, or breastfeeding women only if your doctor considers that the benefit outweighs the potential risk to the unborn child or infant.
Driving and operating machinery
Controloc 20 has no effect or negligible effect on the ability to drive and operate mechanical devices.
Do not drive or operate machinery if you experience adverse effects such as dizziness or visual disturbances.

Controloc 20 contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

3. How to take Controloc 20

Always take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
Method of administration
Take the medicine one hour before a meal, without chewing or dividing the tablet. Swallow whole with water.
Recommended dose
Adults and adolescents aged 12 years and above:

• For treatment of symptoms (e.g. heartburn, acid regurgitation, pain on swallowing) associated with gastroesophageal reflux disease The usual dose is one tablet per day. Relief is usually achieved within 2-4 weeks of treatment - at the latest within the following 4 weeks. Your doctor will decide how long you should continue treatment. Recurrent symptoms can be managed by taking one tablet per day as needed.
• For long-term treatment and prevention of recurrence of reflux esophagitis The usual dose is one tablet per day. If symptoms recur, your doctor may recommend doubling the dose. In this case, one tablet per day of Controloc 40 may be used. After symptoms resolve, the dose may be reduced again to one tablet (20 mg) per day.

Adults:

• For prevention of duodenal and/or gastric ulcers in patients who must continuously take NSAIDs The usual dose is one tablet per day.

Patients with impaired liver function
In cases of severe liver disease, do not take more than one 20 mg tablet per day.
Use in children and adolescents
Tablets are not recommended for use in children under 12 years of age.
Taking more than the recommended dose of Controloc 20
Consult your doctor or pharmacist. Symptoms of overdose are not known.
Missing a dose of Controloc 20
Do not take a double dose to make up for a missed dose. Take the next scheduled dose at the usual time.
Stopping treatment with Controloc 20
Do not stop taking the tablets without first consulting your doctor or pharmacist.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine may cause side effects, although not everyone experiences them.
If any of the following adverse reactions occur, stop taking the tablets and immediately contact your doctor or the nearest hospital emergency department:

• Severe allergic reactions (rare: not more than 1 in 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, urticaria (rash like nettle stings), breathing difficulties, facial angioedema (Quincke's oedema/angioedema), severe dizziness with rapid heartbeat and profuse sweating.
• Severe skin reactions (frequency unknown: frequency cannot be estimated from available data): you may notice one or more of the following symptoms
• blistering of the skin and sudden worsening of general condition, erosion (with slight bleeding) of the eyes, nose, mouth/oral cavity or genital organs, or rash, especially in areas of skin exposed to sunlight. Joint pain or flu-like symptoms, fever, swollen glands (e.g. under the arms), and blood test results showing changes in certain white blood cells or liver enzymes may also occur.
• red, non-elevated spots or round patches on the trunk, often with blisters in the centre, skin peeling, ulceration of the mouth, throat, nose, genital organs, and eyes. The onset of such severe skin rash may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• widespread rash, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• Other severe reactions (frequency unknown: frequency cannot be estimated from available data): yellowing of the skin and eyes (severe liver cell damage, jaundice) or fever, rash, and kidney problems manifested by kidney enlargement, sometimes with pain during urination and lower back pain (severe kidney inflammation), which may lead to kidney failure.

Other adverse reactions occurring:

• Common (not more than 1 in 10 people) Benign gastric polyps.
• Uncommon (not more than 1 in 100 people) Headache; dizziness; diarrhoea; nausea, vomiting; feeling of fullness in the abdomen and bloating with flatulence (wind); constipation; dry mouth; abdominal pain and discomfort

in the abdominal area; skin rash, erythema, skin eruptions; itching of the skin; weakness,
exhaustion or general malaise; sleep disturbances, fractures of the hip, wrist, or spine.

• Rare (not more than 1 in 1,000 people) Disturbances or complete loss of taste sensation; visual disturbances, such as blurred vision; urticaria; joint pain; muscle pain; changes in body weight; elevated body temperature; high fever; limb swelling (peripheral oedema); allergic reactions; depression; gynaecomastia in men.
• Very rare (not more than 1 in 10,000 people) Disorientation.
• Frequency not known (frequency cannot be estimated from available data) Hallucinations, confusion (especially in patients who have previously experienced such symptoms); sensations of tingling, pricking, numbness, burning, or pins and needles, painful rash, inflammation of the large intestine causing persistent watery diarrhoea.

Adverse reactions identified by blood tests occurring:

• Uncommon (not more than 1 in 100 people) Increased liver enzyme activity.
• Rare (not more than 1 in 1,000 people) Increased bilirubin levels; increased blood lipid levels; sudden decrease in circulating granulocytes - white blood cells, associated with high fever.
• Very rare (not more than 1 in 10,000 people) Decreased platelet count, which may lead to more frequent bleeding and bruising; decreased white blood cell count, which may predispose to more frequent infections; concurrent, abnormal decrease in red blood cells, white blood cells, and platelets.
• Frequency not known (frequency cannot be estimated from available data) Decreased sodium, magnesium, calcium, or potassium levels in the blood (see section 2).

Reporting of adverse reactions
If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Adverse reactions can also be reported to the marketing authorisation holder. Reporting adverse reactions helps to gather more information on the safety of the medicine.

5. How to store Controloc 20

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister, or bottle following the EXP. The expiry date refers to the last day of the specified month.
Bottle: do not use the medicine after 120 days from the first opening of the bottle.
No special storage conditions are required.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Controloc 20 contains

• The active substance is pantoprazole. Each enteric-coated tablet contains 20 mg of pantoprazole (as pantoprazole sodium sesquihydrate).
• Other ingredients are: Core: anhydrous sodium carbonate, mannitol (E421), crospovidone, povidone K90, calcium stearate. Coating: hypromellose, povidone K25, titanium dioxide (E171), yellow iron oxide (E172), propylene glycol (E1520), methacrylic acid and ethyl acrylate copolymer (1:1), polysorbate 80, sodium lauryl sulphate, triethyl citrate. Ink: shellac, red, black and yellow iron oxides (E172), concentrated ammonium hydroxide.

What Controloc 20 looks like and contents of the pack
Controloc 20 is a yellow, oval, biconvex enteric-coated tablet with the imprint "P20" on one side.
Packaging: HDPE bottles with LDPE cap or aluminium/aluminium foil blisters or aluminium/aluminium foil blisters in a paper overwrap (blister wallet).
Controloc 20 is available in the following pack sizes containing:
14, 28, 60 and 100 enteric-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Takeda Pharma Sp. z o.o.
ul. Prosta 68
00-838 Warsaw
[email protected]
Manufacturer
Takeda GmbH
Manufacturing site Oranienburg
Lehnitzstrasse 70-98
16515 Oranienburg
Germany
This medicinal product is authorised for marketing in the European Economic Area countries under the following names: