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This is an X-PIL, which is a text only patient information leaflet, designed for people with sight problems.


Takeda Products Ireland Ltd

Unit 2051 Castle Drive, Citywest Business Campus, Dublin 24, Ireland
Telephone: +353 1 642 0021
Fax: +353 1 642 0020
WWW: http://www.takeda.ie
Medical Information Direct Line: 1800 937970
Medical Information e-mail: medinfo@takeda.co.uk
Medical Information Facsimile: +44 (0)1628 526 617


Patient Information Leaflet last updated on medicines.ie: 05/11/2013
XPIL SOMAC Control 20 mg gastro-resistant tablets

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.
  • You should not take SOMAC Control tablets for more than 4 weeks without consulting a doctor.
  • 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.

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

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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.

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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 '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.

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 new or recently changed 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.

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.

Children and adolescents

SOMAC Control should not be used by children and young people under 18 years of age.

Other medicines and SOMAC Control

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.
  • methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer) – if you are taking methotrexate your doctor may temporarily stop your SOMAC Control treatment.

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.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This also includes herbal or homeopathic remedies.

SOMAC Control with food and drink

The tablets should be swallowed whole with liquid before a meal.

Pregnancy, breast-feeding and fertility

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 operate machines.

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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.

Use in 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.

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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): 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.
  • 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; allergic reactions; 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:
    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).
  • 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.

Reporting of side effects

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to

Pharmacovigilance section
Irish Medicines Board
Kevin O'Malley House
Earlsfort Centre
Earlsfort Terrace
IRL – Dublin 2
Tel: +353 1 6764971
Fax:+353 1 6767836
Website:www.imb.ie
email:email:imbpharmacovigilance@imb.ie

By reporting side effects you can help provide more information on the safety of this medicine.

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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. 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.

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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 (excipients) 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
Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Ireland
Takeda Products Ireland Limited
Tel:+ 353 16 42 00 21
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This leaflet was last revised in 05/2013.

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.

This leaflet is available in all EU/EEA languages on the European Medicines Agency website.

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.


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Active Ingredients

 
   Pantoprazole sodium sesquihydrate