Somac Control

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ANNEX I

SUMMARY OF PRODUCT CHARACTERISTICS



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1. NAME OF THE MEDICINAL PRODUCT

SOMAC 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

SOMAC 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
SOMAC 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
SOMAC 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. 



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Co-administration of Pantoprazole is not recommended with HIV protease inhibitors for which 
absorption is dependent on acidic intragastric pH such as atazanavir, nelfinavir; due to significant 
reduction in their bioavailability (see section 4.5).

4.4 Special warnings and precautions for use

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.

Subacute cutaneous lupus erythematosus (SCLE) 
Proton pump inhibitors are associated with very infrequent cases of SCLE. If lesions occur, especially 
in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help 
promptly and the health care professional should consider stopping SOMAC Control. SCLE after 
previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump 
inhibitors.

Interference with Laboratory Tests
Increased Chromogranin A (CgA) level may interfere with investigations for neuroendocrine tumours. 
To avoid this interference, SOMAC Control treatment should be stopped for at least 5 days before CgA 
measurements (see section 5.1). If CgA and gastrin levels have not returned to reference range after 



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initial measurement, measurements should be repeated 14 days after cessation of proton pump inhibitor 
treatment.

This medicinal product is intended for short-term use (up to 4 weeks) only (Refer to section 4.2). 
Patients should be warned about additional risks with long-term use of the medicinal products and the 
need for prescription and regular surveillance should be emphasized.

The following additional risks are considered relevant for long-term use

Influence on Vitamin B12 Absorption
Pantoprazole, as all acid-blocking medicines, may reduce the absorption of vitamin B12 
(cyanocobalamin) due to hypo- or achlorhydria. This should be considered in patients with reduced 
body stores or risk factors for reduced vitamin B12 absorption on long-term therapy or if respective 
clinical symptoms are observed.

Bone Fracture
Proton pump inhibitors, especially if used in high doses and over long durations (> 1 year), may 
modestly increase the risk of hip, wrist and spine fracture, predominantly in older people or in presence 
of other recognised risk factors. Observational studies suggest that proton pump inhibitors may increase 
the overall risk of fracture by 10–40%. Some of this increase may be due to other risk factors. Patients 
at risk of osteoporosis should receive care according to current clinical guidelines and they should have 
an adequate intake of vitamin D and calcium.

Hypomagnesemia
Severe hypomagnesaemia has been reported in patients treated with PPIs like pantoprazole for at least 
three months, and in most cases for a year. Serious manifestations of hypomagnesaemia such as fatigue, 
tetany, delirium, convulsions, dizziness, and ventricular arrhythmia can occur but they may begin 
insidiously and be overlooked. In most affected patients, hypomagnesaemia improved after magnesium 
replacement and discontinuation of the PPI.

For patients expected to be on prolonged treatment or who take PPIs with digoxin or medicinal products 
that may cause hypomagnesaemia (e.g. diuretics), health care professionals should consider measuring 
magnesium levels before starting PPI treatment and periodically during treatment.

4.5 Interaction with other medicinal products and other forms of interaction

SOMAC Control may reduce the absorption of active substances whose bioavailability is dependent on 
the gastric pH (e.g. ketoconazole).

HIV Protease Inhibitors
Co-administration of pantoprazole is contraindicated with HIV protease inhibitors for which absorption 
is dependent on acidic intragastric pH such as atazanavir, nelfinavir; due to significant reduction in their 
bioavailability (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.

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.



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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

Pantoprazole/metabolites have been identified in human milk. The effect of pantoprazole on 
newborns/infants is unknown. SOMAC Control 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

SOMAC 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

Common 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
Hypocalcaemia 
(1)

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 Paraesthesia

Eye disorders Disturbances in 
vision / blurred 
vision

Gastrointestinal 
disorders

Fundic 
gland 
polyps 
(benign)

Diarrhoea;
Nausea / 
vomiting; 
Abdominal 
distension and 
bloating; 
Constipation; 
Dry mouth; 
Abdominal 
pain and 
discomfort

Microscopic 
colitis



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Frequency
System
Organ Class

Common Uncommon Rare Very rare Not known

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

Subacute 
cutaneous lupus 
erythematosus 
(see section 
4.4).

Musculoskeletal 
and connective 
tissue disorders

Fracture of 
wrist, hip and 
spine.

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

(1) Hypocalcemia in association with hypomagnesemia 

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



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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 
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.

During treatment with antisecretory medicinal products, serum gastrin increases in response to the 
decreased acid secretion. Also CgA increases due to decreased gastric acidity. The increased CgA level 
may interfere with investigations for neuroendocrine tumours.

Available published evidence suggests that proton pump inhibitors should be discontinued between 5 
days and 2 weeks prior to CgA measurements. This is to allow CgA levels that might be spuriously 
elevated following PPI treatment to return to reference range.

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.



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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
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 



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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 a peri-postnatal rat reproduction study designed to assess bone development, signs of offspring 
toxicity (mortality, lower mean body weight, lower mean body weight gain and reduced bone growth) 
were observed at exposures (Cmax) approximately 2x the human clinical exposure. By the end of the 
recovery phase, bone parameters were similar across groups and body weights were also trending 
toward reversibility after a drug-free recovery period. The increased mortality has only been reported in 
pre-weaning rat pups (up to 21 days age) which is estimated to correspond to infants up to the age of 2 
years old. The relevance of this finding to the paediatric population is unclear. A previous peri-postnatal 
study in rats at slightly lower doses found no adverse effects at 3 mg/kg compared with a low dose of 
5 mg/kg in this study. 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
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



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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/1/09/516/001-004

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 12 June 2009
Date of latest renewal: 21 February 2014

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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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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ANNEX III

LABELLING AND PACKAGE LEAFLET



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A. LABELLING



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PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON FOR BLISTER
OUTER CARTON FOR BLISTER WITH CARDBOARD REINFORCEMENT

1. NAME OF THE MEDICINAL PRODUCT

SOMAC 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/1/09/516/001-004

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

SOMAC Control 20 mg



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PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING

CARDBOARD REINFORCEMENT 

1. NAME OF THE MEDICINAL PRODUCT

SOMAC 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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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/1/09/516/001-004

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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MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTERS 

1. NAME OF THE MEDICINAL PRODUCT

SOMAC 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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B. PACKAGE LEAFLET



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Package leaflet: Information for the patient
SOMAC 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 SOMAC Control tablets for more than 4 weeks without consulting a doctor.

What is in this leaflet
1. What SOMAC Control is and what it is used for
2. What you need to know before you take SOMAC Control 
3. How to take SOMAC Control 
4. Possible side effects
5. How to store SOMAC Control
6. Contents of the pack and other information

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

SOMAC Control contains the active substance pantoprazole, which blocks the ‘pump’ that produces 
stomach acid. Hence it reduces the amount of acid in your stomach. 

SOMAC 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 SOMAC 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 SOMAC Control

Do not take SOMAC 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 HIV protease inhibitors such as atazanavir, nelfinavir (for the treatment of 

HIV-infection). See ‘Other medicines and SOMAC Control’.



23

Warnings and precautions
Talk to your doctor before taking SOMAC Control
- 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.
- if you have ever had a skin reaction after treatment with a medicine similar to SOMAC Control 

that reduces stomach acid.
- if you are due to have a specific blood test (Chromogranin A)
- if you are taking HIV protease inhibitors such as atazanavir, nelfinavir (for the treatment of 

HIV-infection) at the same time as pantoprazole, ask your doctor for specific advice.

Do not take this product for longer than 4 weeks without consulting your doctor. If your reflux 
symptoms (heartburn or acid regurgitation) persist for longer than 2 weeks, consult your doctor who 
will decide about the need for long-term intake of this medicinal product.

If you take SOMAC Control for longer periods, this may cause additional risks, such as:

- reduced absorption of Vitamin B12, and Vitamin B12 deficiency if you already have low body 
stores of Vitamin B12

- fracture of your hip, wrist or spine, especially if you already suffer from osteoporosis or if you 
are taking corticosteroids (which can increase the risk of osteoporosis).

- falling magnesium levels in your blood (potential symptoms: fatigue, involuntary muscle 
contractions, disorientation, convulsions, dizziness, increased heart rate). Low levels of 
magnesium can also lead to a reduction in potassium or calcium levels in the blood. You should 
talk to your doctor if you have been using this product for more than 4 weeks. Your doctor may 
decide to perform regular blood tests to monitor your levels of magnesium.

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.
- if you get a rash on your skin, especially in areas exposed to the sun tell your doctor as soon as 

you can, as you may need to stop your treatment with SOMAC Control. Remember to also 
mention any other ill-effects like pain in your joints.

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 SOMAC Control, but this medicine is not meant to bring immediate relief.
You should not take it as a preventive measure.



24

If you have been suffering from repetitive heartburn or indigestion symptoms for some time, remember 
to see your doctor regularly.

Children and adolescents
SOMAC 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 SOMAC Control
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. 
SOMAC Control may stop certain other medicines from working properly. Especially medicines
containing one of the following active substances: 
- HIV protease inhibitors such as atazanavir, nelfinavir (for the treatment of HIV-infection). You 

must not use SOMAC Control if you are taking HIV protease inhibitors. See ‘Do not take 
SOMAC 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 SOMAC Control treatment because 
pantoprazole can increase levels of methotrexate in the blood.

Do not take SOMAC 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 SOMAC Control with antacids (e.g. magaldrate, alginic acid, sodium 
bicarbonate, aluminium hydroxide, magnesium carbonate, or combinations thereof), if needed.

Pregnancy and, breast-feeding
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 SOMAC 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 SOMAC 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 SOMAC 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 SOMAC 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.



25

If you take more SOMAC 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 SOMAC 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 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:
- Common (may affect up to 1 in 10 people): Benign polyps in the stomach

- 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; fracture 
in the hip, wrist or spine.

- 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).



26

- 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, rash, possibly with pain in the joints; 
feeling of tingling, prickling, pins and needles, burning sensation or numbness, inflammation in 
the large bowel, that causes persistent watery diarrhoea.

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.

5. How to store SOMAC 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 SOMAC 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 SOMAC 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.
SOMAC 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



27

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

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 Pharma 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



28

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

Italia
Takeda Italia S.p.A.
Tel: +3906502601

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.


	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