Somac Control

Package leaflet: Information for the patient

SOMAC Control 20 mg gastro-resistant tablets

pantoprazole
Please 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 has told you to.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
• Talk to your doctor if you do not notice improvement 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 taking 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 acid in the stomach. Therefore, 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 return of acid from the stomach into the oesophagus ("food pipe"), which can become inflamed and cause pain. This may cause symptoms such as a painful burning sensation in the chest rising towards the throat (heartburn) and a sour taste in the mouth (acid regurgitation).
You may experience relief from acid reflux and heartburn symptoms as soon as one day after starting treatment with SOMAC Control, but this medicine is not designed to provide immediate relief. It may be necessary to take the tablets for 2-3 consecutive days to improve symptoms.
Consult your 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 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".

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 old and are taking daily over-the-counter treatments for indigestion
• if you are over 55 years old and have 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 the skin or eyes)
• if you regularly visit your doctor for serious health conditions or disorders
• if you are scheduled for an endoscopy or a breath test called 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 scheduled for a specific blood test (Chromogranin A)
• if you are taking HIV protease inhibitors such as atazanavir; nelfinavir (for the treatment of HIV infection) together with pantoprazole, consult your doctor for specific recommendations.

Do not take this medicine for more than 4 weeks without consulting your doctor. If reflux symptoms (heartburn or acid regurgitation) persist for more than 2 weeks, consult your doctor, who will decide whether long-term treatment with this medicine is necessary.
Long-term use of SOMAC Control may cause additional risks such as:

• reduced absorption of vitamin B_, and vitamin B_ deficiency if your body's vitamin B_ stores are already low. Consult your doctor if you notice any of the following symptoms, which may indicate low vitamin B_ levels:
• extreme tiredness or lack of energy
• tingling or prickling sensations
• red and sore tongue, mouth ulcers
• muscle weakness
• vision disturbances
• memory problems, confusion, depression
• fractures 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)
• reduced magnesium levels in the blood (possible symptoms: fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, rapid heartbeat). Low magnesium levels may also lead to reduced potassium or calcium levels in the blood. Consult 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.

Contact your doctor immediately, before or after taking this medicine, if you notice any of the following symptoms, which could be signs of another, more serious condition:

• unintentional weight loss (not related to diet or exercise program)
• vomiting, particularly if recurrent
• blood in vomit; this may appear dark, like ground coffee
• blood in stools; stools may appear black or tarry
• difficulty swallowing or pain when swallowing
• you look pale and feel weak (anaemia)
• chest pain
• stomach pain
• severe and/or persistent diarrhoea, as this medicine has been associated with a slight increase in infectious diarrhoea
• if you notice the appearance of a skin rash, especially in sun-exposed areas, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with SOMAC Control. Remember to also report any other adverse 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 erythema multiforme have been reported in association with pantoprazole treatment. Stop using pantoprazole and contact your doctor immediately if you notice any symptoms related to these serious skin reactions, described in section 4.

Your doctor may decide that you need certain tests.
If you are scheduled for a blood test, tell your doctor that you are taking this medicine.
You may experience relief from acid reflux and heartburn symptoms as early as one day after starting treatment with SOMAC Control, but this medicine is not designed to provide immediate relief. Do not take it as a preventive measure.
If you have suffered from recurrent heartburn or indigestion for some time, remember to see your doctor regularly.
Children and adolescents
SOMAC Control must not be used in children and adolescents under 18 years of age due to lack of safety information in this younger age group.
Other medicines and SOMAC Control
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
SOMAC Control may prevent other medicines from working properly, especially medicines containing any 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 the blood and prevent clots). You may need additional blood tests
• methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer) – if you are taking methotrexate, your doctor may temporarily discontinue treatment with SOMAC Control, as pantoprazole may increase methotrexate levels in the blood.

Do not take SOMAC Control with other medicines that reduce stomach acid production, such as another proton pump inhibitor (omeprazole, lansoprazole, or rabeprazole) or an H_ antagonist (e.g., ranitidine, famotidine).
However, if necessary, you may 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 scheduled for a specific urine test (for THC, tetrahydrocannabinol).
Pregnancy, breastfeeding, and fertility
Do not take this medicine if you are pregnant or breastfeeding.
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
If you experience adverse effects such as dizziness or vision disturbances, do not drive or operate 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 exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one tablet per day. Do not exceed the 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 from acid reflux and heartburn symptoms as soon as one day after starting treatment with SOMAC Control, but this medicine is not designed to provide immediate relief.
If you do not experience any symptom relief 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. Swallow the tablet whole with some water. Do not chew or break the tablet.
If you take more SOMAC Control than you should
Contact your doctor or pharmacist immediately if you have taken more than the recommended dose. If possible, bring the medicine and this patient information leaflet with you.
If you forget to take SOMAC Control
Do not take a double dose to make up for the missed dose. Take your next normal dose at the usual time the following day.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Consult your doctor immediately or contact the nearest hospital emergency department if you
experience any of the following serious side effects. Stop taking this
medicine immediately, but bring this leaflet and/or the tablets with you.

• Severe allergic reactions (rare frequency: may affect up to 1 in 1,000 patients): hypersensitivity reactions, so-called anaphylactic reactions, anaphylactic shock and angioedema. Typical symptoms include: swelling of the face, lips, mouth, tongue and/or throat, which may cause difficulty in swallowing or breathing, hives, severe dizziness with very rapid heartbeat and profuse sweating.
• Severe skin reactions (frequency not known: frequency cannot be determined from available data): you may notice one or more of the following:
  • skin rash with swelling, appearance of blisters or skin detachment, peeling and bleeding around the eyes, nose, mouth or genitals, and rapid worsening of general health, or skin rash particularly in sun-exposed areas of the skin. You may also experience joint pain or flu-like symptoms, fever, swollen glands (e.g. in the armpit), and blood tests may show changes in white blood cell count or liver enzymes.
  • Flat, non-elevated red spots, circular or target-shaped, on the trunk, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals and eyes. These serious skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
  • Widespread skin rash, high fever and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• Other serious side effects (frequency not known): yellowing of the skin or the white of the eye (due to severe liver damage), or fever, rash and kidney enlargement, sometimes with painful urination, and pain in the lower back (severe kidney inflammation), which may lead to kidney failure.

Other side effects include:

• Common side effects (may affect up to 1 in 10 patients): benign gastric polyps.
• Uncommon side effects (may affect up to 1 in 100 patients): headache; dizziness; diarrhoea; feeling unwell, vomiting; bloating and flatulence (meteorism); constipation; dry mouth; stomach ache and malaise; skin rash or hives; itching; weakness, fatigue or general malaise; sleep disturbances; increased liver enzymes in blood tests; fracture of the hip, wrist or spine.
• Rare side effects (may affect up to 1 in 1,000 patients): altered 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 blood fat levels (detected in blood tests); breast enlargement in men; high fever and severe reduction in circulating granulocytes (observed in blood tests).
• Very rare side effects (may affect up to 1 in 10,000 patients): disorientation; reduced platelet count in the blood, which may cause increased bleeding or bruising; reduced white blood cell count, which may lead to more frequent infections; concomitant abnormal reduction in red blood cells, white blood cells and platelets (observed in blood tests).
• Frequency not known (frequency cannot be determined from 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; tingling, pricking, stinging, burning or numbness sensations; inflammation of the large intestine, causing persistent watery diarrhoea.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via 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 carton and blister after
"EXP.". The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine via 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 substance 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 oxides (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 cardboard outer packaging.
Pack sizes containing 7 or 14 gastro-resistant tablets. Not all pack sizes may be marketed.

Marketing Authorization Holder
Takeda GmbH
Byk-Gulden-Straße 2, 78467 Konstanz
Germany

Manufacturer
Takeda GmbH
Oranienburg site
Lehnitzstraße 70-98, 16515 Oranienburg
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Takeda Belgium NV Takeda, UAB
Tél/Tel: + 32 2 464 06 11 Tel: +370 521 09 070
[email protected] [email protected]

България Luxembourg/Luxemburg
Такеда България ЕООД Takeda Belgium NV
Teл.: +359 2 958 27 36 Tél/Tel: + 32 2 464 06 11
[email protected] [email protected]

Česká republika Magyarország
Takeda Pharmaceuticals Czech Republic s.r.o. Takeda Pharma Kft.
Tel: +420 234 722 722 Tel.: +36 1 270 7030
[email protected] [email protected]

Danmark Malta
Takeda Pharma A/S Takeda HELLAS S.A.
Tlf: +45 46 77 10 10 Tel: +30 210 6387800
[email protected] [email protected]

Deutschland Nederland
Takeda GmbH Takeda Nederland B.V.
Tel: +49 (0) 800 825 3325 Tel: +31 20 203 5492
[email protected] [email protected]

Eesti Norge
Takeda Pharma AS Takeda AS
Tel: +372 6177 669 Tlf: +47 800 800 30
[email protected] [email protected]

Ελλάδα Österreich
Takeda ΕΛΛΑΣ Α.Ε. Takeda Pharma Ges.m.b.H.
Τηλ: +30 210 6387800 Tel: +43 (0) 800-20 80 50
[email protected] [email protected]

España Polska
Takeda Farmacéutica España, S.A. Takeda Pharma Sp. z o.o.
Tel: +34 917 90 42 22 Tel.: +48223062447
[email protected] [email protected]

France Portugal
Takeda France SAS Takeda Farmacêuticos Portugal, Lda.
Tél: + 33 1 40 67 33 00 Tel: + 351 21 120 1457
[email protected] [email protected]

Hrvatska România
Takeda Pharmaceuticals Croatia d.o.o. Takeda Pharmaceuticals SRL
Tel: +385 1 377 88 96 Tel: +40 21 335 03 91
[email protected] [email protected]

Ireland Slovenija
Takeda Products Ireland Ltd Takeda Pharmaceuticals farmacevtska družba d.o.o.
Tel: 1800 937 970 Tel: + 386 (0) 59 082 480
[email protected] [email protected]

Ísland Slovenská republika
Vistor hf. Takeda Pharmaceuticals Slovakia s.r.o.
Sími: +354 535 7000 Tel: +421 (2) 20 602 600
[email protected] [email protected]

Italia Suomi/Finland
Takeda Italia S.p.A. Takeda Oy
Tel: + 39 06 502601 Puh/Tel: 0800 774 051
[email protected] [email protected]

Κύπρος Sverige
Takeda ΕΛΛΑΣ Α.Ε. Takeda Pharma AB
Τηλ: +30 210 6387800 Tel: 020 795 079
[email protected] [email protected]

Latvija United Kingdom (Northern Ireland)
Takeda Latvia SIA Takeda UK Ltd
Tel: +371 67840082 Tel: +44 (0) 3333 000 181
[email protected] [email protected]

More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.

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The following lifestyle and dietary recommendations may also help relieve symptoms related to heartburn and acid reflux:

• 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 going to bed
• Raise the head of the bed (if symptoms occur at night)
• Reduce consumption of foods that may cause heartburn. These may include: chocolate, peppermint, mint, fatty and fried foods, acidic foods, spicy foods, citrus fruits and fruit juices, tomatoes.