SOMAC 20 mg Enteric-Coated Tablet

Содержание инструкции

1. SOMAC Control 20 mg gastro-resistant tablets
   1. What is SOMAC Control and what is it used for
   2. What you need to know before taking SOMAC Control
   3. How to take SOMAC Control
   4. Possible side effects
   5. How to store SOMAC Control
   6. Package Contents and Other Information

SOMAC Control 20 mg gastro-resistant tablets

pantoprazole

Read this leaflet carefully before 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 has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effect occurs, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after 2 weeks.
• Do not take SOMAC Control tablets for more than 4 weeks without consulting a doctor.

Contents of 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 is SOMAC Control and what is it used for

SOMAC Control contains the active ingredient pantoprazole, which blocks the ‘pump’ that produces acid
in the stomach. Therefore, it reduces the amount of acid in your stomach.
SOMAC Control is used for the short-term treatment of symptoms of reflux (such as
heartburn, acid regurgitation) in adults.
Reflux is the return of acid from the stomach into the esophagus (“food pipe”), which can
become inflamed and cause pain. This can cause symptoms such as a painful burning
sensation in the chest that rises towards the throat (heartburn) and a sour taste in the mouth (acid regurgitation).
You may experience relief of symptoms related to acid reflux and heartburn after just
one day of treatment with SOMAC Control, but this medicine is not intended to provide immediate
relief. You may need to take the tablets for 2-3 consecutive days to improve your symptoms.
See a doctor if you do not feel better or if you feel worse after 2 weeks.

2. What you need to know before taking SOMAC Control

Do not take SOMAC Control

• if you are allergic to pantoprazole or 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”.

Warnings and precautions
Talk to your doctor or pharmacist 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 of age and take daily treatments for indigestion without a prescription
• if you are over 55 years of age and experience any new or recently changed reflux symptoms
• if you have previously had a stomach ulcer or operations on the stomach
• if you have problems with the liver or jaundice (yellowing of the skin or eyes)
• if you regularly visit your doctor for serious health problems or conditions
• if you are going 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 going 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, consult your doctor for specific recommendations.

Do not take this medicine for more than 4 weeks without consulting your doctor. If your reflux symptoms (heartburn or acid regurgitation) persist for more than 2 weeks, see your doctor who will decide if you need to take this medicine long-term.
Taking SOMAC Control for prolonged periods may cause additional risks such as:

• reduced absorption of vitamin B12, and vitamin B12 deficiency if your body's stores of vitamin B12 are already low. See your doctor if you notice any of the following symptoms, which may indicate low levels of vitamin B12:
• extreme fatigue or lack of energy
• tingling or numbness
• red and sore tongue, mouth ulcers
• muscle weakness
• vision problems
• memory problems, confusion, depression
• fracture of the hip, wrist or spine, especially if you already have osteoporosis (reduced bone density) or if your doctor has told you that you are at risk of developing osteoporosis (e.g. if you are taking steroids).
• reduction of magnesium levels in the blood (possible 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. See your doctor if you have been using this medicine for more than 4 weeks. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.

Immediately inform your doctor,before or after taking this medicine, if you notice
any of the following symptoms, which could be a sign of another, more serious, disorder:

• unintentional weight loss (not related to a diet or exercise program)
• vomiting, especially if recurrent
• blood in the vomit; this may appear dark like coffee grounds
• blood in the stool; which may appear black or tarry
• difficulty swallowing or pain when swallowing
• appearing pale and feeling weak (anemia)
• chest pain
• stomach pain
• severe and/or persistent diarrhea, as this medicine has been associated with a slight increase in infectious diarrhea
• if you notice the appearance of a skin rash, especially in areas exposed to sunlight, see your doctor as soon as possible, as you may need to stop treatment with SOMAC Control. Remember to report any other unwanted effects such as joint pain.
• Serious skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) and multiforme erythema have been reported in association with treatment with pantoprazole. Stop using pantoprazole and see your doctor immediately if you notice any of the symptoms related to these serious skin reactions, described in section 4.

The doctor may decide that you need some tests.
If you are going to have a blood test, tell your doctor that you are taking this medicine.
You may experience relief of symptoms related to acid reflux and heartburn as early as
one day of treatment with SOMAC Control, but this medicine is not designed to provide
immediate relief. You should not take it as a preventative measure.
If you have suffered from recurrent heartburn or indigestion for some time, remember to go
to your doctor regularly.

Children and adolescents
SOMAC Control should not be used by children and adolescents under 18 years of age due to
lack of safety information in this younger age group.

Other medicines and SOMAC Control
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
SOMAC Control can prevent other medicines from working properly. Especially
medicines containing one of the following active ingredients:

• HIV protease inhibitors such as atazanavir, nelfinavir (for the treatment of HIV infection). You should 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 the blood and prevent clots). You may need further blood tests
• methotrexate (used for the treatment of rheumatoid arthritis, psoriasis and cancer) - if you are taking methotrexate, your doctor may temporarily suspend treatment with SOMAC Control as pantoprazole may increase methotrexate levels in the blood.

Do not take SOMAC Control with other medicines that limit the amount of acid produced in
the stomach, such as another proton pump inhibitor (omeprazole, lansoprazole or rabeprazole) or an
H2 antagonist (e.g. ranitidine, famotidine).
However, if necessary, you can take SOMAC Control with antacids (e.g. magaldrate, alginic acid, sodium
bicarbonate, aluminium hydroxide, magnesium carbonate, or their combinations).
Talk to your doctor before taking SOMAC Control if you are going to have a particular urine test (for THC, tetrahydrocannabinol).

Pregnancy and breastfeeding and fertility
Do not take this medicine if you are pregnant or breastfeeding.
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
If you experience side effects such as dizziness or vision problems, you should not drive or use
machinery.

SOMAC Control contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
‘sodium-free’.

3. How to take SOMAC Control

Take this medicine following exactly the instructions in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
The recommended dose is one tablet a day. Do not exceed this recommended dose of 20 mg of
pantoprazole per day.
You should take this medicine for at least 2-3 consecutive days. Stop taking SOMAC
Control when you no longer have any symptoms. You may experience relief of symptoms related to acid reflux
and heartburn as early as one day of treatment with SOMAC Control, but this
medicine is not designed to provide immediate relief.
If you do not experience any relief of symptoms after taking this medicine continuously for 2 weeks,
consult your doctor.
Do not take SOMAC Control for more than 4 weeks without consulting your doctor.
Take the tablet before a meal, at the same time each day. You must swallow the tablet
whole with a little water. Do not chew or break the tablet.

If you take more SOMAC Control than you should
Consult your doctor or pharmacist immediately if you have taken more than the recommended dose. If possible, bring

If you forget to take SOMAC Control
Do not take a double dose to make up for a missed dose. Take the normal dose
next day, at the scheduled 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.

Consult your doctor immediatelyor contact the nearest hospital emergency room if you
experience any of the following serious side effects. Stop taking this medicine immediately

• 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 can cause difficulty swallowing or breathing, hives, severe dizziness with a very fast and strong heartbeat and profuse sweating.
• Severe skin reactions (frequency not known: the frequency cannot be estimated based on available data): you may notice one or more of the following effects:
• skin rash with swelling, blistering or peeling of the skin, scaling and bleeding around the eyes, nose, mouth or genitals and rapid deterioration of general health condition, or rash particularly in areas of skin exposed to the sun. You may also experience joint pain or flu-like symptoms, fever, enlarged glands (e.g. in the armpit) and blood tests may show changes in white blood cell count or liver enzymes.
• Reddish, flat or target-shaped spots on the trunk, often with blisters in the center, peeling of the skin, ulcers on the mouth, throat, nose, genitals and eyes. These severe skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Widespread rash, high fever and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• Other serious side effects (frequency not known): yellowing of the skin or whites of the eyes (due to severe liver damage), or fever, rash and enlargement of the kidneys, sometimes with painful urination, and lower back pain (severe kidney inflammation), which can lead to kidney failure.

Other side effects include:

• Common side effects(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; diarrhea; feeling unwell, vomiting; bloating and flatulence; constipation; dry mouth; stomach pain and discomfort; skin rash or hives; itching; weakness, fatigue or general malaise; sleep disturbances; increased liver enzymes in blood tests; hip, wrist or spine fracture.
• Rare side effects(may affect up to 1 in 1,000 people) alteration or complete loss of taste; visual disturbances such as blurred vision; joint pain; muscle pain; weight changes; increased body temperature; swelling of the extremities; depression; increased bilirubin and fat levels in the blood (detected in blood tests); breast enlargement in men; high fever and severe decrease in circulating granulocytes (observed in blood tests).
• Very rare side effects(may affect up to 1 in 10,000 people) disorientation; reduced number of platelets in the blood, which can cause bleeding or bruising more than usual; reduced number of white blood cells, which can lead to more frequent infections; concurrent abnormal reduction in the number of red blood cells, white blood cells and platelets (observed in blood tests).
• Frequency not known(the frequency cannot be estimated based on available data) hallucinations, confusion (especially in patients with a history of these symptoms); decreased levels of sodium, magnesium, calcium or potassium in the blood (see section 2); erythema, possible joint pain; sensation of tingling, prickling, pinpricks, burning or numbness; inflammation of the large intestine, causing persistent watery diarrhea.

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 through the national reporting system listed in Annex 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 package and blister after
“EXP.”. The expiry date refers to the last day of that month.
Store in the original package to protect the medicine from moisture.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What SOMAC Control contains

• The active ingredient is pantoprazole. Each tablet contains 20 mg of pantoprazole (as sodium sesquihydrate).
• The other ingredients are: Core: sodium carbonate (anhydrous), mannitol (E421), crospovidone, povidone K90, calcium stearate. Coating: hypromellose, povidone, titanium dioxide (E171), yellow iron oxide (E172), propylene glycol (E1520), methacrylic acid-ethyl acrylate copolymer, sodium lauryl sulfate, polysorbate 80, triethyl citrate. Printing ink: shellac, red, black and yellow iron oxide (E172) and concentrated ammonia solution.

Description of the appearance of SOMAC Control and package contents
The gastro-resistant tablets are yellow, oval, biconvex film-coated tablets marked
“P20” on one side.
SOMAC Control is available in Alu/Alu blisters with or without a 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
Oranienburg Production Site
Lehnitzstraße 70-98, 16515 Oranienburg
Germany
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

Lietuva
Takeda, UAB
Tel: +370 521 09 070
[email protected]

България
Такеда България ЕООД
Тел.: +359 2 958 27 36
[email protected]

België/Belgique/Belgien
Takeda Belgium NV
Tél/Tel: + 32 2 464 06 11
[email protected]

Luxembourg/Luxemburg
Takeda Belgium NV
Tél/Tel: + 32 2 464 06 11
[email protected]

Česká republika
Takeda Pharmaceuticals Czech Republic s.r.o.
Tel: +420 234 722 722
[email protected]

Magyarország
Takeda Pharma Kft.
Tel.: +36 1 270 7030
[email protected]

Danmark
Takeda Pharma A/S
Tlf: +45 46 77 10 10
[email protected]

Malta
Takeda HELLAS S.A.
Tel: +30 210 6387800
[email protected]

Deutschland
Takeda GmbH
Tel: +49 (0) 800 825 3325
[email protected]

Nederland
Takeda Nederland B.V.
Tel: +31 20 203 5492
[email protected]

Eesti
Takeda Pharma AS
Tel: +372 6177 669
[email protected]

Norge
Takeda AS
Tlf: +47 800 800 30
[email protected]

Ελλάδα
Takeda ΕΛΛΑΣ Α.Ε.
Τηλ: +30 210 6387800
[email protected]

Österreich
Takeda Pharma Ges.m.b.H.
Tel: +43 (0) 800-20 80 50
[email protected]

España
Takeda Farmacéutica España, S.A.
Tel: +34 917 90 42 22
[email protected]

Polska
Takeda Pharma Sp. z o.o.
Tel.: +48223062447
[email protected]

France
Takeda France SAS
Tél: + 33 1 40 67 33 00
[email protected]

Portugal
Takeda Farmacêuticos Portugal, Lda.
Tel: + 351 21 120 1457
[email protected]

România
Takeda Pharmaceuticals SRL
Tel: +40 21 335 03 91
[email protected]

Ireland
Takeda Products Ireland Ltd
Tel: 1800 937 970
[email protected]

Hrvatska
Takeda Pharmaceuticals Croatia d.o.o.
Tel: +385 1 377 88 96
[email protected]

Slovenija
Takeda Pharmaceuticals farmacevtska družba d.o.o.
Tel: + 386 (0) 59 082 480
[email protected]

Ísland
Vistor hf.
Sími: +354 535 7000
[email protected]

Slovenská republika
Takeda Pharmaceuticals Slovakia s.r.o.
Tel: +421 (2) 20 602 600
[email protected]

Italia
Takeda Italia S.p.A.
Tel: + 39 06 502601
[email protected]

Suomi/Finland
Takeda Oy
Puh/Tel: 0800 774 051
[email protected]

Κύπρος
Takeda ΕΛΛΑΣ Α.Ε.
Τηλ: +30 210 6387800
[email protected]

Sverige
Takeda Pharma AB
Tel: 020 795 079
[email protected]

Latvija
Takeda Latvia SIA
Tel: +371 67840082
[email protected]

United Kingdom (Northern Ireland)
Takeda UK Ltd
Tel: +44 (0) 3333 000 181
[email protected]
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu.
__________________________________________________________________________________
The following recommendations regarding lifestyle and dietary changes may also
help to relieve symptoms related to heartburn and acidity.

• Avoid large meals
• Eat slowly
• Stop smoking
• Reduce alcohol and caffeine intake
• Lose weight (if overweight)
• Avoid tight clothing or belts
• Avoid eating at least three hours before bedtime
• Raise the head of the bed (if symptoms occur at night)
• Reduce the intake of food that can cause heartburn. This may include: chocolate, peppermint, spearmint, fatty and fried foods, acidic foods, spicy foods, citrus fruits and juices, tomatoes.