ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
SOMAC Control 20 mg gastro-resistant tablets
2.
Each gastro-resistant tablet contains 20 mg pantoprazole (as sodium sesquihydrate).
Excipient: contains 1.06 microgram soya lecithin per gastro-resistant tablet.
For a full list of excipients, see section 6.1.
3.
Gastro-resistant tablet
Yellow, oval biconvex film-coated tablets imprinted with “P20” in brown ink on one side.
4.
Short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults.
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 use
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.
Hypersensitivity to the active substance, to soya or to any of the other excipients (see section 6.1).
Co-administration with atazanavir (see section 4.5).
2
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 H
2
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.
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 C. difficile.
SOMAC 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).
Pantoprazole is metabolized in the liver via the cytochrome P450 enzyme system. An interaction of
pantoprazole with other substances which are metabolized by the same enzyme system cannot be
excluded. However, no clinically significant interactions were observed in specific tests with
carbamazepine, caffeine, diazepam, diclofenac, digoxin, ethanol, glibenclamide, metoprolol, naproxen,
nifedipine, phenytoin, piroxicam, theophylline and an oral contraceptive containing levonorgestrel and
ethinyl oestradiol.
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),
3
monitoring of prothrombin time/INR is recommended after initiation, termination or during irregular
use of pantoprazole.
There were no interactions with concomitantly administered antacids.
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. This medicinal product
should not be used during pregnancy.
Lactation
It is unknown whether pantoprazole is excreted in human breast milk. Animal studies have shown
excretion of pantoprazole in breast milk. This medicinal product should not be used during
breast-feeding.
Adverse drug reactions such as dizziness and visual disturbances may occur (see section 4.8). If
affected, patients should not drive or operate machines.
Approximately 5% of patients can be expected to experience adverse drug reactions (ADRs). The most
commonly reported ADRs are diarrhoea and headache, both occuring in approximately 1% of patients.
The following undesirable effects have been reported with pantoprazole.
Within the following table, undesirable effects are ranked under the following 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, undesirable effects are presented in order of decreasing seriousness.
4
Frequency
System
Organ Class
Uncommon
Rare
Very rare
Not known
Blood and
lymphatic system
disorders
Thrombocytopenia;
Leukopenia
Nervous system
disorders
Headache;
Dizziness
Eye disorders
Disturbances in
vision / blurred
vision
Gastrointestinal
disorders
Diarrhoea;
Nausea /
vomiting;
Abdominal
distension and
bloating;
Constipation;
Dry mouth;
Abdominal pain
and discomfort
Renal and urinary
disorders
Interstitial
nephritis
Skin and
subcutaneous
tissue disorders
Rash /
exanthema /
eruption; Pruritus
Urticaria;
Angioedema
Stevens-Johnson
syndrome; Lyell
syndrome;
Erythema
multiforme;
Photosensitivity
Musculoskeletal
and connective
tissue disorders
Arthralgia;
Myalgia
Metabolism and
nutrition
disorders
Hyperlipidaemias
and lipid increases
(triglycerides,
cholesterol);
Weight changes
Hyponatraemia
General disorders
and
administration
site conditions
Asthenia, fatigue
and malaise
Body temperature
increased;
Oedema
peripheral
Immune system
disorders
Hypersensitivity
(incl. anaphylactic
reactions and
anaphylactic
shock)
Hepatobiliary
disorders
Liver enzymes
increased
(transaminases,
γ-GT)
Bilirubin
increased
Hepatocellular
injury; Jaundice;
Hepatocellular
failure
5
Frequency
System
Organ Class
Uncommon
Rare
Very rare
Not known
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)
There are no known symptoms of overdose in man.
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.
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: 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.
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
6
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
(t
max
) of a single 20 mg oral dose, the maximum serum concentrations (C
max
) 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 C
max
), but increased the variability of the lag-time (t
lag
).
Distribution
Volume of distribution is about 0.15 l/kg and serum protein binding is about 98%.
Metabolism and excretion
Clearance is about 0.1 l/h/kg, and terminal half-life (t
1/2
) 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).
Pantoprazole is almost exclusively metabolized in the liver. 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 C
max
only increased slightly by a factor of 1.3 compared with healthy subjects.
Elderly
7
The slight increase in AUC and C
max
in elderly volunteers compared with younger subjects was not
clinically relevant.
5.3 Preclinical safety data
Preclinical data reveal no special hazard to 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.
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)
Soya lecithin
Titanium dioxide (E171)
8
Antifoam DC 1510
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 containing 7 or 14 gastro-resistant tablets or Alu/Alu blisters with cardboard
reinforcement containing 7 or 14 gastro-resistant tablets.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements.
7.
Nycomed GmbH
Byk-Gulden-Str. 2
D-78467 Konstanz
Germany
Telephone: +49-(0)7531-84-0
Telefax: +49-(0)7531-84-2474
8.
9.
Detailed information on this medicinal product is available on the website of the European Medicines
Agency (EMEA) http://www.emea.europa.eu/.
9
ANNEX II
A.
MANUFACTURING AUTHORISATION HOLDER
RESPONSIBLE FOR BATCH RELEASE
B.
CONDITIONS OF THE MARKETING AUTHORISATION
10
A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturer responsible for batch release
Nycomed GmbH
Production site Oranienburg
Lehnitzstraße 70-98
D-16515 Oranienburg
Germany
B. CONDITIONS OF THE MARKETING AUTHORISATION
Medicinal product not subject to medical prescription.
•
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND
EFFECTIVE USE OF THE MEDICINAL PRODUCT
Not applicable.
•
OTHER CONDITIONS
Pharmacovigilance system
The MAH must ensure that the system of pharmacovigilance, as described in version 3.0 dated
07.11.2008 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and
functioning before and whilst the product is on the market.
PSUR
The PSUR submission schedule for SOMAC Control 20 mg gastro-resistant tablets should follow the
PSUR submission schedule of the reference medicinal product.
11
ANNEX III
LABELLING AND PACKAGE LEAFLET
12
A. LABELLING
13
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
OUTER CARTON FOR BLISTER
OUTER CARTON FOR BLISTER WITH CARDBOARD REINFORCEMENT
1.
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
Contains soya lecithin. See leaflet for further information.
4.
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 REACH AND SIGHT OF CHILDREN
Keep out of the reach and sight 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.
14
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
APPROPRIATE
Nycomed GmbH
Byk-Gulden-Str. 2
D-78467 Konstanz
Germany
EU/0/00/000/000
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
15
PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING
CARDBOARD REINFORCEMENT
1.
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
Contains soya lecithin. See leaflet for further information.
4.
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 REACH AND SIGHT OF CHILDREN
Keep out of the reach and sight 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.
16
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
APPROPRIATE
Nycomed GmbH
Byk-Gulden-Str. 2
D-78467 Konstanz
Germany
EU/0/00/000/000
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
17
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
BLISTERS
1.
SOMAC Control 20 mg gastro-resistant tablets
Pantoprazole
2.
Nycomed GmbH
3.
EXPIRY DATE
EXP
4.
BATCH NUMBER
Batch
5.
OTHER
18
B. PACKAGE LEAFLET
19
PACKAGE LEAFLET: INFORMATION FOR THE USER
SOMAC Control 20 mg gastro-resistant tablets
Pantoprazole
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to use SOMAC Control
carefully to get the best results from it.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
You must contact a doctor if your symptoms worsen or do not improve after 2 weeks.
-
You should not take SOMAC Control tablets for more than 4 weeks without consulting a
doctor.
-
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet
:
1.
What SOMAC Control is and what it is used for
2.
Before you take SOMAC Control
4.
Possible side effects
5.
How to store SOMAC Control
6.
Further 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.
2.
BEFORE YOU TAKE SOMAC CONTROL
Do not take SOMAC Control:
-
if you are allergic (hypersensitive) to pantoprazole, to soya or to any of the other ingredients of
SOMAC Control (listed in
section 6 ‘What SOMAC Control contains’).
-
if you are taking a medicine containing atazanavir (for the treatment of HIV-infection)
-
if you are under 18 years of age
-
if you are pregnant or breast-feeding.
Take special care with SOMAC Control
Talk to your doctor first if:
-
you have been treated for heartburn or indigestion continuously for 4 or more weeks
-
you are over 55 years old and taking non-prescription indigestion treatment on a daily basis
-
you have previously had a gastric ulcer or stomach surgery
20
3.
How to take SOMAC Control
-
you are over 55 years old with new or recently changed symptoms
-
you have liver problems or jaundice (yellowing of skin or eyes)
-
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 SOMAC Control 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 SOMAC 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.
Using other medicines
SOMAC Control may stop certain other medicines from working properly. Tell your
doctor or
pharmacist if you are using any
medicines containing one of the following active substances:
-
ketoconazole (used for fungal infections).
-
warfarin and phenprocoumon
(used to thin blood and prevent clots). You may need further
blood tests
-
atazanavir (used to treat HIV-infection). You must not use SOMAC Control if you are taking
atazanavir.
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.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription. This also
includes herbal or homeopathic
remedies.
Using
SOMAC Control with food and drink
The tablets should be swallowed whole with liquid before a meal.
Pregnancy and breast-feeding
Do not take SOMAC Control if you are pregnant, think you may be pregnant, or are breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
If you experience side effects like dizziness or disturbed vision, you should not drive or operate
machines.
21
-
you regularly see your doctor for serious complaints or conditions
Important information about some of the ingredients of SOMAC Control
SOMAC Control contains soya lecithin. If you are allergic to peanut or soya, do not use this medicine.
3.
HOW TO TAKE SOMAC CONTROL
Always take SOMAC Control exactly as described in this leaflet. You should check with your doctor
or
pharmacist if you are not sure.
Take 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.
Children
and adolescents
SOMAC Control should not be used by children and young people under 18 years of age.
If you take more SOMAC Control than you should
Tell your doctor or pharmacist straight away. If possible take your medicine and this leaflet with you.
There are no known symptoms of overdose.
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 product, ask your doctor or pharmacist.
4.
POSSIBLE SIDE EFFECTS
Like all medicines, SOMAC Control 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)
: 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)
: 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.
Side effects may occur with certain frequencies, which are defined as follows:
very common: affects more than 1 user in 10
common: affects 1 to 10 users in 100
22
uncommon: affects 1 to 10 users in 1,000
rare: affects 1 to 10 users in 10,000
very rare: affects less than 1 user in 10,000
not known: frequency cannot be estimated from the available data.
-
Uncommon side effects
:
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
:
disturbances in vision such as blurred vision; pain in the joints; muscle pains; weight changes;
raised body temperature; swelling of the extremities; allergic reactions; depression; increased
bilirubin and fat levels in blood (seen in blood tests).
-
Very rare side effects
:
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.
-
Frequency not known
:
hallucination, confusion (especially in patients with a history of these symptoms); decreased
level of sodium in blood.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.
5.
HOW TO STORE SOMAC CONTROL
Keep out of the reach and sight of children.
Do not use SOMAC Control after the expiry date, which is
stated on the carton and the blister. The
expiry date refers to the last day of that month.
Store in the original package in order to protect from moisture
.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.
6.
FURTHER 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), soya lecithin, titanium
dioxide (E 171) and antifoam DC 1510.
What SOMAC Control looks like and contents of the pack
23
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
Nycomed GmbH
Byk-Gulden-Straße 2, 78467 Konstanz
Germany
Manufacturer
Nycomed 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
Nycomed Belgium
Tél/Tel: + 32 2 464 06 11
Luxembourg/Luxemburg
Nycomed Belgium
Belgique / Belgien
Tél/Tel: + 32 2 464 06 11
България
ТП Никомед ГМБХ
Teл.: + 359 (2) 958 27 36
Magyarorszбg
Nycomed Pharma Kft.
Tel.: + 36 1 47 199 30
Česká republika
Nycomed s.r.o.
Tel: +420 239 044 244
Malta
Nycomed GmbH
Il-Germanja
Tel: + 49 7531 84-0
Danmark
Nycomed Danmark ApS
Tlf: + 45 46 77 11 11
Nederland
Nycomed bv
Tel: + 31 23 56 69 750
Deutschland
Nycomed Deutschland GmbH
Tel: + 49 800 295 6666
Norge
Nycomed Pharma AS
Tlf: + 47 6676 3030
Eesti
Nycomed SEFA AS
Tel: +372 617 7669
Österreich
Nycomed Pharma GmbH
Tel: + 43 1 815 02 02
Ελλάδα
Nycomed Hellas S.A.
Τηλ: +30 210 6729570
Polska
Nycomed Pharma Sp. z o.o.
Tel.: + 48 22 608 13 00
España
Nycomed Pharma S.A.
Tel: + 349 1 714 9900
Portugal
Nycomed Portugal –
Produtos Farmacêuticos, Lda.
Tel: + 351 21 446 02 00
24
France
Nycomed France S.A.S.
Tél: + 33 1 56 61 48 48
România
Nycomed Pharma SRL
Tel: + 40 21 335 03 93
Ireland
Nycomed Products Limited
Tel: + 353 16 42 00 21
Slovenija
Nycomed GmbH
Tel: + 386 1 2396 110
Ísland
Nycomed GmbH
Þýskalandi
Sími: + 49 7531 84-0
Slovenská republika
Nycomed s.r.o.
Tel: + 421202060 2600
Italia
Recordati Industria Chimica e Farmaceutica
S.p.A.
Tel: + 3902487871
Suomi/Finland
Oy Leiras Finland Ab
Puh/Tel: + 358 20 746 5000
Κύπρος
Nycomed Hellas S.A.
Ελλάδα
Τηλ: +30 210 6729570
Sverige
Nycomed AB
Tel: + 46 8 731 28 00
Latvija
SIA Nycomed Latvia
Tel: + 371 67840082
United Kingdom
Nycomed UK Limited
Tel: + 44 16 28 64 64 00
Lietuva
Nycomed, UAB
Tel: +370 521 09070
This leaflet was last approved in
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web
_________________________________________________________________________________
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
-
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.
25
-
Reduce weight (if overweight)
Source: European Medicines Agency
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