CONTROLOC 20MG TBL.OBD. N14

ATC code: A02BC02 

Active substances: Pantoprazolum

Vendor, principal: Altana Pharma Ag. 

 Prescription drug (℞) 

CONTROLOC CONTROL 20MG N7

Package leaflet: Information for the patient CONTROLOC 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.
-   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.
-   You should not take CONTROLOC Control tablets for more than 4 weeks without consulting a doctor.

What is in this leaflet

1.   What CONTROLOC Control is and what it is used for
2.   What you need to know before you take CONTROLOC Control
3.   How to take CONTROLOC Control
4.   Possible side effects
5.   How to store CONTROLOC Control
6.   Contents of the pack and other information

1. What CONTROLOC Control is and what it is used for

CONTROLOC Control contains the active substance pantoprazole, which blocks the ‘pump’ that produces stomach acid. Hence it reduces the amount of acid in your stomach.
CONTROLOC 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 CONTROLOC 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.

What you need to know before you take CONTROLOC Control Do not take CONTROLOC 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 a medicine containing atazanavir (for the treatment of HIV-infection) See ‘Other medicines and PANTOLOC Control’.

Warnings and precautions

Talk to your doctor before taking CONTROLOC 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 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 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.
if you have ever had a skin reaction after treatment with a medicine similar to CONTROLOC
Control that reduces stomach acid.
if you are due to have a specific blood test (Chromogranin A)
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 this medicine has been associated with a small increase in infectious diarrhoea.
-   If you get a rash on your skin, especially in areas exposed to the sun tell your doctor as soon as
you can, as you may need to stop your treatment with CONTROLOC Control. Remember to also mention any other ill-effects like pain in your joints.
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 CONTROLOC 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

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

Other medicines and CONTROLOC Control

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. CONTROLOC Control may stop certain other medicines from working properly. Especially medicines containing one of the following active substances:
-   atazanavir (used to treat HIV-infection). You must not use CONTROLOC Control if you are taking atazanavir. See ‘Do not take CONTROLOC Control’.
-   ketoconazole (used for fungal infections).
-   warfarin and phenprocoumon (used to thin blood and prevent clots). You may need further blood tests.
-   methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer) - if you are taking methotrexate your doctor may temporarily stop your CONTROLOC Control treatment because pantoprazole can increase levels of methotrexate in the blood.
Do not take CONTROLOC 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 CONTROLOC Control with antacids (e.g. magaldrate, alginic acid, sodium bicarbonate, aluminium hydroxide, magnesium carbonate, or combinations thereof), if needed.

Pregnancy and, breast-feeding

You should not take this medicine if you are pregnant or while-breastfeeding.
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 use machines.

3. How to take CONTROLOC 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 CONTROLOC 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 CONTROLOC 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 CONTROLOC 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.

If you take more CONTROLOC Control than you should

Tell your doctor or pharmacist if you have taken more than the recommended dose. If possible take your medicine and this leaflet with you

If you forget to take CONTROLOC 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 medicine, ask your doctor or pharmacist.

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: 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 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: frequency cannot be estimated from the
available data): 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.
Other side effects include:

-   Uncommon side effects (may affect up to 1 in 100 people):

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; 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 (may affect up to 1 in 10,000 people):

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, rash, possibly with pain in the joints.

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

5. How to store CONTROLOC 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 after ‘EXP’. 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.

6. Contents of the pack and other information

What CONTROLOC 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: 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 CONTROLOC 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.
CONTROLOC 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:

Belgie/Belgique/Belgien

Takeda Belgium Tel/Tel: + 32 2 464 06 11 [email protected]

Btnrapnn

TaKega Etnrapna Ten.: + 359 (2) 958 27 36

Lietuva

Takeda, UAB Tel: +370 521 09070 lt-info @ takeda. com

Luxembourg/Luxemburg

Takeda Belgium Tel/Tel: + 32 2 464 06 11 [email protected]

Česka republika   Magyarorszag

Takeda Pharmaceuticals Czech Republic s.r.o. Takeda Pharma Kft. Tel: + 420 234 722 722    Tel: +361 2707030

Malta
Takeda Italia S.p.A. Tel: +39 06 502601

Danmark

Takeda Pharma A/S Tlf: + 45 46 77 11 11

Deutschland Takeda GmbH Tel: 0800 825 3324 medinfo @ takeda. de	Nederland Takeda Nederland bv Tel: +31 23 56 68 777 [email protected]
Eesti Takeda Pharma AS Tel: +372 617 7669 [email protected]	Norge Takeda Nycomed AS Tlf: + 47 6676 3030 infonorge @ takeda. com
EkldSa TAKEDA EAAAI A.E Tnk: +30 210 6729570 gr.info @ takeda. com	Österreich Takeda Pharma Ges.m.b.H. Tel: +43 (0)800-20 80 50
Espana Takeda Farmaceutica Espana S.A. Tel: + 349 1 714 9900 spain@ takeda. com	Polska Takeda Polska Sp. z o.o. Tel.: + 48 22 608 13 00
France Takeda France S.A.S. Tel: + 33 1 46 25 16 16	Portugal Takeda - Farmaceuticos Portugal, Lda. Tel: + 351 21 120 1457
Hrvatska Takeda Pharmaceuticals Croatia d.o.o. Tel: +385 1 377 88 96	Romania Takeda Pharmaceuticals SRL Tel: + 40 21 335 03 91
Ireland Takeda Products Ireland Limited Tel: + 353 16 42 00 21	Slovenija Takeda GmbH, Podružnica Slovenija Tel: + 386 (0) 59082480
Island Vistor hf. tel: +354 535 7000 [email protected]	Slovenska republika Takeda Pharmaceuticals Slovakia s.r.o. Tel: +421 (2) 20602600
Italia Takeda Italia S.p.A. Tel: +39 06 502601	Suomi/Finland Takeda Oy Puh/Tel: + 358 20 746 5000
Knnpoq TAKEDA EAAAI A.E Tnk: +30 210 6729570 gr.info @ takeda. com	Sverige Takeda Pharma AB Tel: + 46 8 731 28 00 infosweden @ takeda. com
Latvija Takeda Latvia SIA Tel: + 371 67840082	United Kingdom Takeda UK Limited Tel: +44 (0)1628 537 900
This leaflet was last revised in October 2016

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