TAKEDA

CONTROLOC CONTROL 20MG X 14 GASTRO-RESISTANT TABLETS

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Composition

The active substance is pantoprazole. Each tablet contains 20 mg pantoprazole (as sodium sesquihydrate). The other components are: - Core: anhydrous sodium hydrogen carbonate, mannitol, crospovidone, povidone K90, calcium stearate - Film: hypromellose, povidone, titanium dioxide (E171), yellow iron oxide (E172), propylene glycol, 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

Therapeutic indications

CONTROLOC Control contains pantoprazole as an active substance, which blocks the "pump" that produces acid in the stomach. Thus, it reduces the amount of acid in the stomach.

CONTROLOC Control is used for the short-term treatment of reflux symptoms (e.g., heartburn-pyrosis, acid regurgitation) in adults.

Reflux is the backward flow of acid from the stomach into the esophagus ("throat"), which can become inflamed and painful. This can cause symptoms such as a painful burning sensation in the chest with an upward tendency towards the throat (heartburn) and a sour taste in the mouth (acid regurgitation).

You may experience an improvement in acid reflux and heartburn symptoms after just one day of treatment with CONTROLOC Control, but this medicine is not designed to provide immediate relief. It may be necessary to take tablets for 2-3 consecutive days to achieve symptom relief.

If after 14 days you do not feel better or feel worse, you should consult a doctor

Contraindications/Warnings

Before taking CONTROLOC Control, consult your doctor:

• if you have been treated for heartburn or indigestion continuously for 4 or more weeks
• if you are over 55 years old and take daily over-the-counter treatment for indigestion
• if you are over 55 years old and experience any new or recently changed reflux symptoms
• if you have had a gastric ulcer or undergone stomach surgery
• if you have liver problems or jaundice (yellowing of the skin or eyes)
• if you regularly see a doctor for serious symptoms or conditions
• if you are scheduled for an endoscopy or a breath test called a C-urea test.
• if you have had a skin reaction after treatment with a medicine similar to CONTROLOC Control that reduces stomach acid.
• if you are scheduled for a specific blood test (Chromogranin A)

Dosage and method of administration

Always use this medicine exactly as your doctor or pharmacist has told you. Talk to your doctor or pharmacist if you are not sure.

The recommended dose is one tablet per day. Do not exceed the recommended daily dose of 20 mg pantoprazole.

You should take this medicine for at least 2-3 consecutive days. Stop taking CONTROLOC Control after symptoms have completely disappeared. You may experience an improvement in acid reflux and heartburn symptoms after just one day of treatment with CONTROLOC Control, but this medicine is not designed to provide immediate relief. If symptoms do not improve after continuous administration of this medicine for 2 weeks, consult your doctor.

Do not use CONTROLOC Control tablets 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 quantity of water. Do not chew or break the tablet.

Special warnings

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, 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 such as dizziness or visual disturbances, you should not drive or operate machinery.

Packaging: CONTROLOC Control is available in Al/Al blisters with or without a cardboard backing. Packs containing 14 gastro-resistant tablets

Page updated on: 09.06.2021