Pantecta Control

1 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX I 

 

SUMMARY OF PRODUCT CHARACTERISTICS 

 

 

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2 

1. NAME OF THE MEDICINAL PRODUCT 

 

PANTECTA Control 20 mg gastro-resistant tablets 

 

 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

 

Each gastro-resistant tablet contains 20 mg pantoprazole (as sodium sesquihydrate). 

 

For the full list of excipients, see section 6.1. 

 

 

3. PHARMACEUTICAL FORM 

 

Gastro-resistant tablet.  

 

Yellow, oval biconvex film-coated tablets imprinted with “P20” in brown ink on one side. 

 

 

4. CLINICAL PARTICULARS 

 

4.1 Therapeutic indications 

 

PANTECTA Control is indicated for short-term treatment of reflux symptoms (e.g. heartburn, acid 

regurgitation) in adults. 

 

4.2 Posology and method of administration 

 

Posology 

The recommended dose is 20 mg pantoprazole (one tablet) per day.  

 

It might be necessary to take the tablets for 2-3 consecutive days to achieve improvement of 

symptoms. Once complete relief of symptoms has occurred, treatment should be discontinued. 

The treatment should not exceed 4 weeks without consulting a doctor. 

 

If no symptom relief is obtained within 2 weeks of continuous treatment, the patient should be 

instructed to consult a doctor. 

 

Special populations 

No dose adjustment is necessary in elderly patients or in those with impaired renal or liver function. 

 

Paediatric population 

PANTECTA Control is not recommended for use in children and adolescents below 18 years of age 

due to insufficient data on safety and efficacy. 

 

Method of administration 

PANTECTA Control 20 mg gastro-resistant tablets should not be chewed or crushed, and should be 

swallowed whole with liquid before a meal. 

 

4.3 Contraindications 

 

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

 

Co-administration with atazanavir (see section 4.5). 

 

4.4 Special warnings and precautions for use 

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3 

 

Patients should be instructed to consult a doctor if: 

 

 They have unintentional weight loss, anaemia, gastrointestinal bleeding, dysphagia, persistent 
vomiting or vomiting with blood, since it may alleviate symptoms and delay diagnosis of a 

severe condition. In these cases, malignancy should be excluded. 

 

 They have had previous gastric ulcer or gastrointestinal surgery. 
 

 They are on continuous symptomatic treatment of indigestion or heartburn for 4 or more weeks.  
 

 They have jaundice, hepatic impairment, or liver disease. 
 

 They have any other serious disease affecting general well-being. 
 

 They are aged over 55 years with new or recently changed symptoms. 
 

Patients with long-term recurrent symptoms of indigestion or heartburn should see their doctor at 

regular intervals. Especially, patients over 55 years taking any non-prescription indigestion or 

heartburn remedy on a daily basis should inform their pharmacist or doctor. 

 

Patients should not take another proton pump inhibitor or H2 antagonist concomitantly. 

 

Patients should consult their doctor before taking this medicinal product if they are due to have an 

endoscopy or urea breath test. 

 

Patients should be advised that the tablets are not intended to provide immediate relief. 

Patients may start to experience symptomatic relief after approximately one day of treatment with 

pantoprazole, but it might be necessary to take it for 7 days to achieve complete heartburn control. 

Patients should not take pantoprazole as a preventive medicinal product. 

 

Gastrointestinal infections caused by bacteria 

Decreased gastric acidity, due to any means - including proton pump inhibitors - increases gastric 

counts of bacteria normally present in the gastrointestinal tract. Treatment with acid-reducing 

medicinal products leads to a slightly increased risk of gastrointestinal infections such as Salmonella, 

Campylobacter, or Clostridium difficile. 

 

4.5 Interaction with other medicinal products and other forms of interaction 

 

PANTECTA Control may reduce the absorption of active substances whose bioavailability is 

dependent on the gastric pH (e.g. ketoconazole). 

 

It has been shown that co-administration of atazanavir 300 mg/ritonavir 100 mg with omeprazole 

(40 mg once daily) or atazanavir 400 mg with lansoprazole (60 mg single dose) to healthy volunteers 

resulted in a substantial reduction in the bioavailability of atazanavir. The absorption of atazanavir is 

pH-dependent. Therefore, pantoprazole must not be co-administered with atazanavir (see section 4.3). 

 

Although no interaction during concomitant administration of phenprocoumon or warfarin has been 

observed in clinical pharmacokinetic studies, a few isolated cases of changes in International 

Normalised Ratio (INR) have been reported during concomitant treatment in the post-marketing 

period. Therefore, in patients treated with coumarin anticoagulants (e.g. phenprocoumon or warfarin), 

monitoring of prothrombin time/INR is recommended after initiation, termination or during irregular 

use of pantoprazole. 

 

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Concomitant use of high dose methotrexate (e.g. 300 mg) and proton-pump inhibitors has been 

reported to increase methotrexate levels in some patients. Therefore in settings where high-dose 

methotrexate is used, for example cancer and psoriasis, a temporary withdrawal of pantoprazole may 

need to be considered. 

 

Pantoprazole is metabolized in the liver via the cytochrome P450 enzyme system. Interaction studies 

with carbamazepine, caffeine, diazepam, diclofenac, digoxin, ethanol, glibenclamide, metoprolol, 

naproxen, nifedipine, phenytoin, piroxicam, theophylline and an oral contraceptive containing 

levonorgestrel and ethinyl oestradiol did not reveal clinically significant interactions. However, an 

interaction of pantoprazole with other substances which are metabolised by the same enzyme system 

cannot be excluded.  

 

There were no interactions with concomitantly administered antacids. 

 

4.6 Fertility, pregnancy and lactation 

 

Pregnancy 

There are no adequate data from the use of pantoprazole in pregnant women. Studies in animals have 

shown reproductive toxicity. Preclinical studies revealed no evidence of impaired fertility or 

teratogenic effects (see section 5.3). The potential risk for humans is unknown. Pantoprazole should 

not be used during pregnancy. 

 

Breast-feeding 

It is unknown whether pantoprazole is excreted in human breast milk. Animal studies have shown 

excretion of pantoprazole in breast milk. Pantoprazole should not be used during breast-feeding. 

 

Fertility 

There was no evidence of impaired fertility following the administration of pantoprazole in animal 

studies (see section 5.3). 

 

4.7 Effects on ability to drive and use machines 

 

PANTECTA Control has no or negligible influence on the ability to drive and use machines. However 

adverse  reactions such as dizziness and visual disturbances may occur (see section 4.8). If affected, 

patients should not drive or use machines. 

 

4.8 Undesirable effects 

 

Summary of the safety profile 

Approximately 5% of patients can be expected to experience adverse  reactions . The most commonly 

reported adverse reactions are diarrhoea and headache, both occuring in approximately 1% of 

patients.  

 

Tabulated list of adverse reactions 

The following adverse reactions have been reported with pantoprazole. 

 

Within the following table, adverse reactions are ranked under the MedDRA  frequency classification: 

 

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), not known (cannot be estimated from the available 

data). 

 

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

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Table 1. Adverse reactions with pantoprazole in clinical trials and post-marketing experience 

 

 Frequency 

System 

Organ Class 

Uncommon Rare Very rare Not known 

Blood and 

lymphatic system 

disorders 

 Agranulocytosis Thrombocytopenia; 

Leukopenia, 

Pancytopenia 

 

Immune system 

disorders 

 Hypersensitivity 

(incl. anaphylactic 

reactions and 

anaphylactic 

shock) 

  

Metabolism and 

nutrition 

disorders 

 Hyperlipidaemias 

and lipid increases 

(triglycerides, 

cholesterol); 

Weight changes 

 Hyponatraemia, 

Hypomagnesae-

mia 

Psychiatric 

disorders 

Sleep disorders Depression (and 

all aggravations) 

Disorientation (and 

all aggravations) 

Hallucination; 

Confusion 

(especially in 

pre-disposed 

patients, as well 

as the 

aggravation of 

these symptoms 

in case of 

pre-existence) 

Nervous system 

disorders 

Headache; 

Dizziness 

Taste disorders   

Eye disorders  Disturbances in  

vision / blurred 

vision 

  

Gastrointestinal 

disorders 

Diarrhoea; 

Nausea / 

vomiting; 

Abdominal 

distension and 

bloating; 

Constipation; 

Dry mouth; 

Abdominal pain 

and discomfort 

   

Hepatobiliary 

disorders 

Liver enzymes 

increased 

(transaminases, 

γ-GT) 

Bilirubin 

increased 

 Hepatocellular 

injury; Jaundice; 

Hepatocellular 

failure 

Skin and 

subcutaneous 

tissue disorders 

Rash / 

exanthema / 

eruption; 

Pruritus 

Urticaria; 

Angioedema 

 Stevens-Johnson 

syndrome; Lyell 

syndrome; 

Erythema 

multiforme; 

Photosensitivity 

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Musculoskeletal 

and connective 

tissue disorders 

 Arthralgia; 

Myalgia 

  

Renal and urinary 

disorders 

   Interstitial 

nephritis 

Reproductive 

system and breast 

disorders 

 Gynaecomastia   

General disorders 

and 

administration 

site conditions 

Asthenia, fatigue 

and malaise 

Body temperature 

increased; 

Oedema 

peripheral 

  

 

 

Reporting of suspected adverse reactions 

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 

allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 

professionals are asked to report any suspected adverse reactions via the national reporting system 

listed in Appendix V. 

 

4.9 Overdose 

 

 

Doses up to 240 mg administered intravenously over 2 minutes were well tolerated. 

As pantoprazole is extensively protein bound, it is not readily dialysable. 

 

In the case of overdose with clinical signs of intoxication, apart from symptomatic and supportive 

treatment, no specific therapeutic recommendations can be made. 

 

 

5. PHARMACOLOGICAL PROPERTIES 

 

5.1  Pharmacodynamic properties 

 

Pharmacotherapeutic group: : Drugs for acid related disorders,Proton pump inhibitors, ATC code: 

A02BC02 

 

Mechanism of action 

Pantoprazole is a substituted benzimidazole which inhibits the secretion of hydrochloric acid in the 

stomach by specific blockade of the proton pumps of the parietal cells. 

 

Pantoprazole is converted to its active form, a cyclic sulphenamide, in the acidic environment in the 

parietal cells where it inhibits the H+, K+-ATPase enzyme, i. e. the final stage in the production of 

hydrochloric acid in the stomach.  

The inhibition is dose-dependent and affects both basal and stimulated acid secretion. In most 

patients, freedom from heartburn and acid reflux symptoms is achieved in 1 week. Pantoprazole 

reduces acidity in the stomach and thereby increases gastrin in proportion to the reduction in acidity. 

The increase in gastrin is reversible. Since pantoprazole binds to the enzyme distal to the receptor 

level, it can inhibit hydrochloric acid secretion independently of stimulation by other substances 

(acetylcholine, histamine, gastrin). The effect is the same whether the active substance is given orally 

or intravenously. 

 

The fasting gastrin values increase under pantoprazole. On short-term use, in most cases they do not 

exceed the upper limit of normal. During long-term treatment, gastrin levels double in most cases. An 

excessive increase, however, occurs only in isolated cases. As a result, a mild to moderate increase in 

the number of specific endocrine (ECL) cells in the stomach is observed in a minority of cases during 

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http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


7 

long-term treatment (simple to adenomatoid hyperplasia). However, according to the studies 

conducted so far, the formation of carcinoid precursors (atypical hyperplasia) or gastric carcinoids as 

were found in animal experiments (see section 5.3) have not been observed in humans. 

 

Clinical efficacy  

In a retrospective analysis of 17 studies in 5960 patients with gastro-oesophageal reflux disease 

(GORD) who were treated with 20 mg pantoprazole monotherapy, the symptoms associated with acid 

reflux e.g. heartburn and acid regurgitation were evaluated according to a standardised methodology. 

Studies selected had to have at least one acid reflux symptom recording point at 2 weeks. GORD 

diagnosis in these studies was based on endoscopic assessment, with the exception of one study in 

which the inclusion of the patients was based on symptomatology alone.  

 

In these studies, the percentage of patients experiencing complete relief from heartburn after 7 days 

was between 54.0% and 80.6% in the pantoprazole group. After 14 and 28 days, complete heartburn 

relief was experienced in 62.9% to 88.6% and 68.1% to 92.3% of the patients, respectively.  

 

For the complete relief from acid regurgitation, similar results were obtained as for heartburn. After 

7 days the percentage of patients experiencing complete relief from acid regurgitation was between 

61.5% and 84.4%, after 14 days between 67.7% and 90.4%, and after 28 days between 75.2% and 

94.5%, respectively. 

 

Pantoprazole was consistently shown to be superior to placebo and H2RA and non-inferior to other 

PPIs. Acid-reflux symptom relief rates were largely independent of the initial GORD stage. 

 

5.2 Pharmacokinetic properties 

 

Pharmacokinetics do not vary after single or repeated administration. In the dose range of 10 to 

80 mg, the plasma kinetics of pantoprazole are linear after both oral and intravenous administration. 

 

Absorption 

Pantoprazole is completely and rapidly absorbed after oral administration. The absolute 

bioavailability from the tablet was found to be about 77 %. On average, at about 2.0 h - 2.5 h post 

administration (tmax) of a single 20 mg oral dose, the maximum serum concentrations (Cmax) of about 

1-1.5 µg/ml are achieved, and these values remain constant after multiple administration. Concomitant 

intake of food had no influence on bioavailability (AUC or Cmax), but increased the variability of the 

lag-time (tlag). 

 

Distribution 

Volume of distribution is about 0.15 l/kg and serum protein binding is about 98%. 

 

Biotransformation 

Pantoprazole is almost exclusively metabolized in the liver. 

 

Elimination 

Clearance is about 0.1 l/h/kg, and terminal half-life (t1/2) about 1 h. There were a few cases of subjects 

with delayed elimination. Due to the specific binding of pantoprazole to the proton pumps within the 

parietal cell, the elimination half-life does not correlate with the much longer duration of action 

(inhibition of acid secretion). 

 

Renal elimination represents the major route of excretion (about 80%) for the metabolites of 

pantoprazole; the rest is excreted with the faeces. The main metabolite in both serum and urine is 

desmethylpantoprazole, which is conjugated with sulphate. The half-life of the main metabolite (about 

1.5 h) is not much longer than that of pantoprazole. 

 

Special populations 

Renal impairment 

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No dose reduction is recommended when pantoprazole is administered to patients with impaired renal 

function (including patients on dialysis, which removes only negligible amounts of pantoprazole). As 

with healthy subjects, the half-life of pantoprazole is short. Although the main metabolite has a longer 

half-life (2-3h), excretion is still rapid and thus accumulation does not occur. 

 

Hepatic impairment 

After administration of pantoprazole to patients with liver impairment (Child-Pugh classes A, B and 

C) the half-life values increased to between 3 and 7 h and the AUC values increased by a factor of 

3-6, whereas the Cmax only increased slightly by a factor of 1.3 compared with healthy subjects.  

 

Elderly 

The slight increase in AUC and Cmax in elderly volunteers compared with younger subjects was not 

clinically relevant. 

 

5.3 Preclinical safety data 

 

Non-clinical data reveal no special hazard for humans based on conventional studies of safety 

pharmacology, repeated dose toxicity and genotoxicity. 

 

In the 2-year carcinogenicity studies in rats, neuroendocrine neoplasms were found. In addition, 

squamous cell papillomas were found in the forestomach of rats in one study. The mechanism leading 

to the formation of gastric carcinoids by substituted benzimidazoles has been carefully investigated 

and allows the conclusion that it is a secondary reaction to the massively elevated serum gastrin levels 

occurring in the rat during chronic high-dose treatment. 

 

In the 2-year rodent studies an increased number of liver tumors was observed in rats (in one rat study 

only) and in female mice and was interpreted as being due to pantoprazole's high metabolic rate in the 

liver. 

A slight increase of neoplastic changes of the thyroid was observed in the group of rats receiving the 

highest dose (200 mg/kg) in one 2-year study. The occurrence of these neoplasms is associated with 

the pantoprazole-induced changes in the breakdown of thyroxine in the rat liver. As the therapeutic 

dose in man is low, no side effects on the thyroid glands are expected. 

 

In animal studies (rats) 5 mg/kg was the observed NOAEL (No Observed Adverse Effect Level) for 

embryotoxicity. Investigations revealed no evidence of impaired fertility or teratogenic effects.  

Penetration of the placenta was investigated in the rat and was found to increase with advanced 

gestation. As a result, concentration of pantoprazole in the foetus is increased shortly before birth. 

 

 

6. PHARMACEUTICAL PARTICULARS 

 

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 

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Methacrylic acid-ethyl acrylate copolymer (1:1) 

Sodium laurilsulfate 

Polysorbate 80 

Triethyl citrate 

 

Printing ink 

Shellac  

Red iron oxide (E172) 

Black iron oxide (E172) 

Yellow iron oxide (E172) 

Ammonia solution, concentrated 

 

6.2 Incompatibilities 

 

Not applicable.  

 

6.3 Shelf life 

 

3 years 

 

6.4 Special precautions for storage 

 

Store in the original package in order to protect from moisture. 

 

6.5 Nature and contents of container 

 

Alu/Alu blisters with or without cardboard reinforcement containing 7 or 14 gastro-resistant  tablets. 

   

Not all pack sizes may be marketed.  

 

6.6 Special precautions for disposal 

 

 

Any unused medicinal product or waste material should be disposed of in accordance with local 

requirements. 

 

7. MARKETING AUTHORISATION HOLDER 

 

Takeda GmbH 

Byk-Gulden-Str. 2 

D-78467 Konstanz 

Germany 

Telephone:  0800 825332 4 

Telefax:   0800 825332 9 

 

 

8. MARKETING AUTHORISATION NUMBER(S)  

 

EU/1/09/518/001-004 

 

 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 

 

Date of first authorisation:12 June 2009 

 

 

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10. DATE OF REVISION OF THE TEXT 

 

{MM/YYYY} 

 

 

Detailed information on this medicinal product is available on the website of the European Medicines 

Agency  http://www.ema.europa.eu/. 

 

 

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http://www.ema.europa.eu/


11 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX II 

 

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH 

RELEASE 

 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY 

AND USE  

 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE 

MARKETING AUTHORISATION 

 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO 

THE SAFE AND EFFECTIVE USE OF THE MEDICINAL 

PRODUCT 

 

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A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 

 

Name and address of the manufacturer responsible for batch release 

 

Takeda GmbH 

Production site Oranienburg 

Lehnitzstraße 70-98 

D-16515 Oranienburg 

Germany 

 

 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE OF THE 

MARKETING AUTHORISATION 

 

 

Medicinal product not subject to medical prescription. 

 

 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 

 

 Periodic Safety Update Reports 
 

The marketing authorisation holder shall submit periodic safety update reports for this product in 

accordance with the requirements set out in the list of Union reference dates (EURD list) provided for 

under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal. 

 

 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT   

 

 Risk Management Plan (RMP) 
 

Not applicable 

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13 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX III 

 

LABELLING AND PACKAGE LEAFLET 

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14 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

A. LABELLING 

 

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15 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

OUTER CARTON FOR BLISTER 

OUTER CARTON FOR BLISTER WITH CARDBOARD REINFORCEMENT 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

PANTECTA Control 20 mg gastro-resistant tablets 

Pantoprazole  

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each gastro-resistant tablet contains 20 mg pantoprazole (as sodium sesquihydrate). 

 

 

3. LIST OF EXCIPIENTS 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

7 gastro-resistant tablets 

14 gastro-resistant tablets 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Tablets should be swallowed whole.  

Read the package leaflet before use. 

Oral use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP 

 

 

9. SPECIAL STORAGE CONDITIONS 

 

Store in the original package in order to protect from moisture. 

 

 

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10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Takeda GmbH 

Byk-Gulden-Str. 2 

D-78467 Konstanz 

Germany 

 

 

12. MARKETING AUTHORISATION NUMBER(S)  

 

EU/1/09/518/001-004 

 

 

13. BATCH NUMBER 

 

Batch 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

Medicinal product not subject to medical prescription. 

 

 

15. INSTRUCTIONS ON USE 

 

For short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults. 

Take one tablet (20 mg) per day. Do not exceed this dose. This medicine may not bring immediate 

relief.  

Relieves heartburn 

 

 

16. INFORMATION IN BRAILLE 

 

PANTECTA Control 20 mg 

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17 

 

PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING 

 

CARDBOARD REINFORCEMENT  

 

1. NAME OF THE MEDICINAL PRODUCT 

 

PANTECTA Control 20 mg gastro-resistant tablets 

Pantoprazole  

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each gastro-resistant tablet contains 20 mg pantoprazole (as sodium sesquihydrate). 

 

 

3. LIST OF EXCIPIENTS 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

7 gastro-resistant tablets 

14 gastro-resistant tablets 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Oral use. 

Tablets should be swallowed whole. 

Read the package leaflet before use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP 

 

 

9. SPECIAL STORAGE CONDITIONS 

 

Store in the original package in order to protect from moisture. 

 

 

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18 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Takeda GmbH 

Byk-Gulden-Str. 2 

D-78467 Konstanz 

Germany 

 

 

12. MARKETING AUTHORISATION NUMBER(S)  

 

EU/1/09/518/001-004 

 

 

13. BATCH NUMBER 

 

Batch 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

Medicinal product not subject to medical prescription. 

 

 

15. INSTRUCTIONS ON USE 

 

For short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults. 

Take one tablet (20 mg) per day. Do not exceed this dose. This medicine may not bring immediate 

relief.  

Relieves heartburn. 

 

 

16. INFORMATION IN BRAILLE 

 

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19 

 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

BLISTERS  

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

PANTECTA Control 20 mg gastro-resistant tablets 

Pantoprazole 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Takeda GmbH 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Batch 

 

 

5. OTHER 

 

 

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20 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

B. PACKAGE LEAFLET 

 

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21 

 

Package leaflet: Information for the patient 

PANTECTA Control 20 mg gastro-resistant tablets 

Pantoprazole  

 

Read all of this leaflet carefully before you start taking this medicine because it contains 

important information for you. 

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have 

told you. 

 

- Keep this leaflet. You may need to read it again. 

- Ask your pharmacist if you need more information or advice. 

- If you get any side effects , talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 

- You must talk to a doctor if you do not feel better or if you feel worse after 2 weeks. 

- You should not take PANTECTA Control tablets for more than 4 weeks without consulting a 

doctor. 

 

 

What is in  this leaflet  

1. What PANTECTA Control is and what it is used for 

2. What you need to know before you take PANTECTA Control  

3. How to take PANTECTA Control  

4. Possible side effects 

5. How to store PANTECTA Control 

6. Contents of the pack and other information 

 

 

1. What PANTECTA Control is and what it is used for 

 

PANTECTA Control contains the active substance pantoprazole, which blocks the ‘pump’ that 

produces stomach acid. Hence it reduces the amount of acid in your stomach.  

 

PANTECTA Control is used for the short-term treatment of reflux symptoms (for example heartburn, 

acid regurgitation) in adults.  

Reflux is the backflow of acid from the stomach into the gullet (“foodpipe”), which may become 

inflamed and painful. This may cause you symptoms such as a painful burning sensation in the chest 

rising up to the throat (heartburn) and a sour taste in the mouth (acid regurgitation). 

 

You may experience relief from your acid reflux and heartburn symptoms after just one day of 

treatment with PANTECTA Control, but this medicine is not meant to bring immediate relief. It may 

be necessary to take the tablets for 2-3 consecutive days to relieve the symptoms.  

 

You must talk to a doctor if you do not feel better or if you feel worse after 2 weeks. 

 

 

2. What you need to know before you take PANTECTA Control 
 

Do not take PANTECTA Control:  

- if you are allergic  to pantoprazole or to any of the other ingredients of this medicine (listed in 

section 6). 

- if you are taking a medicine containing atazanavir (for the treatment of HIV-infection) See 

‘Other medicines and PANTECTA Control’. 

 

Warnings and precautions 

Talk to your doctor before taking PANTECTA Control  

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- if you have been treated for heartburn or indigestion continuously for 4 or more weeks 

- if you are over 55 years old and taking non-prescription indigestion treatment on a daily basis 

- if you are over 55 years old with any new or recently changed reflux symptoms 

- if you have previously had a gastric ulcer or stomach surgery 

- if you have liver problems or jaundice (yellowing of skin or eyes) 

- if you regularly see your doctor for serious complaints or conditions   

- if you are due to have an endoscopy or a breath test called a C-urea test. 

 

Tell your doctor immediately, before or after taking this medicine, if you notice any of the following 

symptoms, which could be a sign of another, more serious, disease: 

- an unintentional loss of weight (not related to a diet or an exercise programme) 
- vomiting, particularly if repeated 
- vomiting blood; this may appear as dark coffee grounds in your vomit 
- you notice blood in your stools; which may be black or tarry in appearance 
- difficulty in swallowing or pain when swallowing 
- you look pale and feel weak (anaemia) 
- chest pain 
- stomach pain 
- severe and/or persistent diarrhoea, because this medicine has been associated with a small 

increase in infectious diarrhoea. 

Your doctor may decide that you need some tests.  

 

If you are due to have a blood test, tell your doctor that you are taking this medicine. 

 

You may experience relief from your acid reflux and heartburn symptoms after just one day of 

treatment with PANTECTA Control, but this medicine is not meant to bring immediate relief. 

You should not take it as a preventive measure. 

 

If you have been suffering from repetitive heartburn or indigestion symptoms for some time, 

remember to see your doctor regularly. 

 

Children and adolescents 

PANTECTA Control should not be used by children and adolescents under 18 years of age due to a 

lack of safety information in this younger age group.. 

 

Other medicines and PANTECTA Control 

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines 

PANTECTA Control may stop certain other medicines from working properly. Especially medicines 

containing one of the following active substances:  

- atazanavir (used to treat HIV-infection). You must not use PANTECTA Control if you are taking 
atazanavir. See ‘Do not take PANTECTA Control’. 

- ketoconazole (used for fungal infections). 
- warfarin and phenprocoumon (used to thin blood and prevent clots). You may need further 

blood tests 

- methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer) – if you are taking 
methotrexate your doctor may temporarily stop your PANTECTA Control treatment because 

pantoprazole can increase levels of methotrexate in the blood. 

 

Do not take PANTECTA Control with other medicines which limit the amount of acid produced in 

your stomach, such as another proton pump inhibitor (omeprazole, lansoprazole or rabeprazole) or an 

H2 antagonist (e.g. ranitidine, famotidine). 

However, you may take PANTECTA Control with antacids (e.g. magaldrate, alginic acid, sodium 

bicarbonate, aluminium hydroxide, magnesium carbonate, or combinations thereof), if needed. 

 

 

Pregnancy and breast-feeding  

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You should not take this medicine if you are pregnant or while-breastfeeding. 

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 

your doctor or pharmacist for advice before taking this medicine. 

 

 

Driving and using machines 

If you experience side effects like dizziness or disturbed vision, you should not drive or use machines. 

 

 

3. How to take PANTECTA Control 

 

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have 

told you. Check with your doctor or pharmacist if you are not sure.  

 

The recommended dose is one tablet a day. Do not exceed this recommended dose of 20 mg 

pantoprazole daily.  

 

You should take this medicine for at least 2-3 consecutive days. Stop taking PANTECTA Control 

when you are completely symptom-free. You may experience relief from your acid reflux and 

heartburn symptoms after just one day of treatment with PANTECTA Control, but this medicine is 

not meant to bring immediate relief. 

 

If you have no symptom-relief after taking this medicine for 2 weeks continuously, consult your 

doctor.  

Do not take PANTECTA Control tablets for more than 4 weeks without consulting your doctor. 

 

Take the tablet before a meal, at the same time every day. You should swallow the tablet whole with 

some water. Do not chew or break the tablet. 

 

 

If you take more PANTECTA Control than you should 

Tell your doctor or pharmacist if you have taken more than  the recommended dose. If possible take 

your medicine and this leaflet with you 

 

If you forget to take PANTECTA Control  

Do not take a double dose to make up for the forgotten dose. Take your next, normal dose, the next 

day, at your usual time. 

 

If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 

 

 

4. Possible side effects 

 

Like all medicines, this medicine  can cause side effects, although not everybody gets them. 

 

Tell your doctor immediately or contact the casualty department at your nearest hospital, if you get 

any of the following serious side effects. Stop taking this medicine straight away, but take this leaflet 

and/or the tablets with you. 

- Serious allergic reactions (rare: may affect up to 1 in 1,000 people): Hypersensitivity 

reactions, so-called anaphylactic reactions, anaphylactic shock and angioedema. Typical 

symptoms are: swelling of the face, lips, mouth, tongue and/or throat, which may cause difficulty in 

swallowing or breathing, hives (nettle rash), severe dizziness with very fast heartbeat and heavy 

sweating. 

- Serious skin reactions (frequency not known: frequency cannot be estimated from the 

available data): rash with swelling, blistering or peeling of the skin, losing skin and bleeding 

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24 

around eyes, nose, mouth or genitals and rapid deterioration of your general health, or rash when 

exposed to the sun. 

- Other serious reactions (frequency not known): yellowing of the skin and eyes (due to 

severe liver damage), or kidney problems such as painful urination and lower back pain with 

fever. 

 

Other side effects include: 

 

- Uncommon side effects(may affect up to 1 in 100 people):  

headache; dizziness; diarrhoea; feeling sick, vomiting; bloating and flatulence (wind); 

constipation; dry mouth; bellyache and discomfort; skin rash or hives; itching; feeling weak, 

exhausted or generally unwell; sleep disorders; increase in liver enzymes in a blood test. 

 

- Rare side effects:  

distortion or complete lack of the sense of taste; disturbances in vision such as blurred vision; 

pain in the joints; muscle pains; weight changes; raised body temperature; swelling of the 

extremities; depression; increased bilirubin and fat levels in blood (seen in blood tests), breast 

enlargement in males; high fever and a sharp drop in circulating granular white blood cells 

(seen in blood tests). 

 

- Very rare side effects (may affect up to 1 in 10,000 people): 

disorientation; reduction in the number of blood platelets, which may cause you to bleed or 

bruise more than normal; reduction in the number of white blood cells, which may lead to more 

frequent infections; coexisting abnormal reduction in the number of red and white blood cells, 

as well as platelets (seen in blood tests). 

 

- Frequency not known: 

hallucination, confusion (especially in patients with a history of these symptoms); decreased 

level of sodium in blood; decreased level of magnesium in blood. 

 

Reporting of side effects 

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 

not listed in this leaflet. You can also report side effects directly via the national reporting system 

listed in Appendix V. By reporting side effects you can help provide more information on the safety 

of this medicine. 

 

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http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


25 

 

5. How to store PANTECTA Control 

 

Keep this medicine out of the sight and reach of children. 

 

Do not use this medicine after the expiry date, which is stated on the carton and the blister after 

‘EXP’. The expiry date refers to the last day of that month. 

 

Store in the original package in order to protect from moisture. 

 

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 

throw away medicines you no longer use. These measures will help protect the environment. 

 

 

6. Contents of the pack and other information 

 

What PANTECTA Control contains 

- The active substance is pantoprazole. Each tablet contains 20 mg pantoprazole (as sodium 

sesquihydrate). 

- The other ingredients are:  

 - Core: sodium carbonate (anhydrous), mannitol, crospovidone, povidone K90, calcium 

stearate. 

 - Coating: hypromellose, povidone, titanium dioxide (E171), yellow iron oxide (E172), 

propylene glycol, methacrylic acid-ethyl acrylate copolymer, sodium lauril sulfate, 

polysorbate 80, triethyl citrate. 

 - Printing ink: shellac, red, black and yellow iron oxide (E172) and ammonia solution, 

concentrated.  

 

What PANTECTA Control looks like and contents of the pack 

The gastro-resistant tablets are yellow, oval, biconvex film-coated tablets imprinted with “P20” on 

one side. 

PANTECTA Control is available in Alu/Alu blisters with or without cardboard reinforcement. 

Packs containing 7 or 14 gastro-resistant tablets. Not all pack sizes may be marketed. 

 

Marketing Authorisation Holder 

Takeda GmbH 

Byk-Gulden-Straße 2, 78467 Konstanz  

Germany 

 

Manufacturer 

Takeda GmbH 

Production site Oranienburg 

Lehnitzstraße 70-98, 16515 Oranienburg 

Germany 

 

For any information about this medicine, please contact the local representative of the Marketing 

Authorisation Holder: 

 

België/Belgique/Belgien 

Takeda Belgium 

Tél/Tel: + 32 2 464 06 11 

takeda-belgium@takeda.com  

 

Lietuva 

Takeda, UAB 

Tel: +370 521 09070 

lt-info@takeda.com 

 

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mailto:takeda-belgium@takeda.com
mailto:lt-info@takeda.com


26 

България 

Такеда България 

Teл.: + 359 (2) 958 27 36 

 

Luxembourg/Luxemburg 

Takeda Belgium 

Tél/Tel: + 32 2 464 06 11 

takeda-belgium@takeda.com  

 

Česká republika  

Takeda Pharmaceuticals Czech Republic s.r.o. 

Tel: + 420 234 722 722  

 

Magyarország 

Takeda Pharma Kft. 

Tel: +361 2707030 

 

Danmark 

Takeda Pharma A/S 

Tlf: + 45 46 77 11 11 

 

Malta 

Takeda Italia S.p.A. 

Tel: +39 06 502601 

 

Deutschland 

Takeda GmbH 

Tel: 0800 825 3324 

medinfo@takeda.de 

 

Nederland 

Takeda Nederland bv 

Tel: +31 23 56 68 777 

nl.medical.info@takeda.com 

 

Eesti 

Takeda Pharma AS 

Tel: +372 617 7669 

info@takeda.ee 

Norge 

Takeda Nycomed AS 

Tlf: + 47 6676 3030 

infonorge@takeda.com 

 

Ελλάδα  

TAKEDA ΕΛΛΑΣ Α.Ε 

Τηλ: +30 210 6729570  

gr.info@takeda.com 

 

Österreich 

Takeda Pharma Ges.m.b.H.  

Tel: +43 (0)800-20 80 50 

 

España 

Takeda Farmacéutica España S.A.  

Tel: + 349 1 714 9900 

spain@takeda.com 

 

Polska 

Takeda Polska Sp. z o.o. 

Tel.: + 48 22 608 13 00 

 

France 

Takeda France S.A.S. 

Tél: + 33 1 46 25 16 16 

 

Portugal 

Takeda - Farmacêuticos Portugal, Lda. 

Tel: + 351 21 120 1457 

 

Hrvatska 

Takeda Pharmaceuticals 

Croatia d.o.o. 

Tel: +385 1 377 88 96 

 

România 

Takeda Pharmaceuticals SRL 

Tel: + 40 21 335 03 91 

 

Ireland 

Takeda Products Ireland Limited 

Tel: + 353 16 42 00 21 

 

Slovenija 

Takeda GmbH, Podružnica  

Slovenija 

Tel: + 386 (0) 59082480 

 

Ísland 

Vistor hf. 

tel: +354 535 7000 

vistor@vistor.is  

 

Slovenská republika 

Takeda Pharmaceuticals Slovakia s.r.o. 

Tel: +421 (2) 20602600 

 

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mailto:takeda-belgium@takeda.com
mailto:medinfo@takeda.de
mailto:nl.medical.info@takeda.com
mailto:info@takeda.ee
mailto:infonorge@takeda.com
mailto:gr.info@takeda.com
mailto:spain@takeda.com
mailto:vistor@vistor.is


27 

Italia 

Takeda Italia S.p.A. 

Tel: +39 06 502601 

 

Suomi/Finland 

Takeda Oy 

Puh/Tel: + 358 20 746 5000 

 

Κύπρος  

TAKEDA ΕΛΛΑΣ Α.Ε 

Τηλ: +30 210 6729570 

gr.info@takeda.com  

 

 

Sverige 

Takeda Pharma AB 

Tel: + 46 8 731 28 00 

infosweden@takeda.com 

 

Latvija 

Takeda Latvia SIA 

Tel: + 371 67840082 

 

United Kingdom 

Takeda UK Limited 

Tel: +44 (0)1628 537 900 

 

 

This leaflet was last revised in  {MM/YYYY} 

 

Detailed information on this medicine is available on the European Medicines Agency web site: 

http://www.ema.europa.eu/. 

 

_________________________________________________________________________________ 

 

The following recommendations for lifestyle and dietary changes may also help to relieve heartburn 

or acid related symptoms. 

- Avoid large meals 

- Eat slowly 

- Stop smoking 

- Reduce alcohol and caffeine consumption 

- Reduce weight (if overweight) 

- Avoid tight-fitting clothing or belts 

- Avoid eating less than three hours before bedtime 

- Elevate bedhead (if you suffer from nocturnal symptoms) 

- Reduce intake of food that can cause heartburn. These might include: Chocolate, peppermint, 

spearmint, fatty and fried food, acidic food, spicy food, citrus fruits and fruit juices, tomatoes. 

 

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mailto:gr.info@takeda.com
mailto:infosweden@takeda.com
http://www.ema.europa.eu/

	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE OF THE MARKETING AUTHORISATION
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET