SOMAC Control 20 mg gastro-resistant tablets

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.

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 insection 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 are over 55 years old with new or recently changed symptoms
• you have previously had a gastric ulcer or stomach surgery
• you have liver problems or jaundice (yellowing of skin or eyes)
• you regularly see your doctor for serious complaints or conditions
• 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 yourdoctor or pharmacist if you are using anymedicines 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 alsoincludes herbal or homeopathic remedies.

UsingSOMAC 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.

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.

Always take SOMAC Control exactly as described in this leaflet. You should check with your doctor orpharmacist 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.

Childrenand 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.

Like all medicines, SOMAC Control can cause side effects, although not everybody gets them.

Tellyour 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.

• Seriousallergic 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
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.
• Rareside 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.

Keep out of the reach and sight of children.

Do not use SOMAC Control after the expiry date, which isstated 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.

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: hyprome llose, 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

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:

BelgiëBelgiqueBelgien Nycomed Belgium TélTel 32 2 464 06 11 LuxembourgLuxemburg Nycomed Belgium Belgique Belgien TélTel 32 2 464 06 11

Te. 359 2 958 27 36 Magyarorszg Nycomed Pharma Kft. Tel. 36 1 47 199 30

eská 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

Nycomed Hellas S.A. 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

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

Slovenská republika Nycomed s.r.o. Tel 421202060 2600 Ísland Nycomed GmbH skalandi Sími 49 7531 84-0

SuomiFinland Oy Leiras Finland Ab PuhTel 358 20 746 5000 Italia Recordati Industria Chimica e Farmaceutica S.p.A. Tel 3902487871

Sverige Nycomed AB Tel 46 8 731 28 00 Nycomed Hellas S.A. 30 210 6729570

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

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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.