Controloc Control

Основна информация

  • Търговско наименование:
  • Controloc Control
  • Използвай за:
  • Хората
  • Вид на лекарството:
  • алопатични наркотици

Документи

Локализация

  • Предлага се в:
  • Controloc Control
    Европейски съюз
  • Език:
  • английски

Терапевтична информация

  • Терапевтична група:
  • Proton pump inhibitors
  • Терапевтична област:
  • Gastroesophageal Reflux
  • Терапевтични показания:
  • Short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults.
  • Каталог на резюме:
  • Revision: 12

Състояние

  • Източник:
  • EMA - European Medicines Agency
  • Статус Оторизация:
  • Authorised
  • Номер на разрешението:
  • EMEA/H/C/001097
  • Дата Оторизация:
  • 11-06-2009
  • EMEA код:
  • EMEA/H/C/001097
  • Последна актуализация:
  • 07-05-2020

Доклад обществена оценка

7 Westferry Circus

Canary Wharf

London E14 4HB

United Kingdom

An agency of the European Union

Telephone

+44 (0)20 7418 8400

Facsimile

+44 (0)20 7418 8416

E-mail

info@ema.europa.eu

Website

www.ema.europa.eu

© European Medicines Agency, 2013. Reproduction is authorised provided the source is acknowledged.

EMA/185977/2013

EMEA/H/C/001097

EPAR summary for the public

Controloc Control

pantoprazole

This is a summary of the European public assessment report (EPAR) for Controloc Control. It explains

how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its

opinion in favour of granting a marketing authorisation and its recommendations on the conditions of

use for Controloc Control.

What is Controloc Control?

Controloc Control is a medicine that contains the active substance pantoprazole. It is available as

gastroresistant tablets (20 mg). ‘Gastroresistant’ means that the tablet’s contents pass through the

stomach without being broken down until they reach the intestine. This prevents the active substance

from being destroyed by the acid in the stomach.

Controloc Control is similar to a ‘reference medicine’ already authorised in the European Union (EU)

called Controloc.

What is Controloc Control used for?

Controloc Control is used for the short-term treatment of the symptoms of acid reflux in adults. Acid

reflux is when acid produced in the stomach escapes into the gullet, causing heartburn and acid

regurgitation (acid flowing up into the mouth).

The medicine can be obtained without a prescription.

How is Controloc Control used?

The recommended dose of Controloc Control is one tablet once a day until symptoms have stopped.

The patient may need to take the medicine for two to three days in a row for symptoms to improve. If

there is no improvement in symptoms within two weeks of continuous treatment, patients should

Controloc Control

EMA/185977/2013

Page 2/3

consult their doctor. Patients should not take the medicine for longer than four weeks without

consulting their doctor.

The tablets should be swallowed whole with liquid before a meal and should not be chewed or crushed.

How does Controloc Control work?

The active substance in Controloc Control, pantoprazole, is a proton pump inhibitor. It works by

blocking ‘proton pumps’, proteins found in specialised cells in the stomach lining that pump acid into

the stomach. By blocking the pumps, pantoprazole reduces acid production, relieving the symptoms of

acid reflux.

Pantoprazole-containing medicines have been available in the European Union (EU) since 1994. The

reference medicine, Controloc, is only available with a prescription. It is used for long-term treatments

and is also used to treat a wider range of gastrointestinal diseases (conditions affecting the gut) than

Controloc Control.

How has Controloc Control been studied?

Because pantoprazole has been in use for many years, the applicant presented data from the scientific

literature. The applicant also presented information from two main studies looking at the effects of

pantoprazole 20 mg in a total of 563 adults who had symptoms of acid reflux, including at least one

episode of heartburn in the three days before the studies began. The first study compared

pantoprazole with placebo (a dummy treatment) in 219 adults, and the second compared it with

ranitidine (another medicine used to treat acid reflux symptoms) in 344 adults. The main measure of

effectiveness was the number of patients with symptoms of heartburn over the first two weeks of

treatment.

What benefit has Controloc Control shown during the studies?

Pantoprazole was more effective than placebo and ranitidine at improving the symptoms of acid reflux.

In the first study, 74% of the patients taking pantoprazole (80 out of 108) and 43% of those taking

placebo (48 out of 111) had no heartburn after two weeks. Pantoprazole was also more effective than

placebo at reducing symptoms of acid regurgitation. In the second study, 70% of the patients taking

pantoprazole (121 out of 172) and 59% of those talking ranitidine (102 out of 172) had no heartburn

after two weeks of treatment.

What is the risk associated with Controloc Control?

The most common side effects with Controloc Control (seen in around 1 patient in 100) are diarrhoea

and headache. For the full list of all side effects reported with pantoprazole, see the package leaflet.

Controloc Control must not be used in people who are hypersensitive (allergic) to pantoprazole, soya

or any of the other ingredients. It must not be used with atazanavir (a medicine used to treat human

immunodeficiency virus [HIV] infection).

Why has Controloc Control been approved?

The CHMP noted that pantoprazole 20 mg was effective in the short-term treatment of reflux

symptoms and that there is a long safety experience with the medicine as a prescription medicine. It

was also of the opinion that, based on the experience of the use of pantoprazole, the availability of

Controloc Control without medical supervision is appropriate. The CHMP therefore decided that

Controloc Control

EMA/185977/2013

Page 3/3

Controloc Control’s benefits are greater than its risks and recommended that it be given marketing

authorisation.

Other information about Controloc Control

The European Commission granted a marketing authorisation valid throughout the EU for Controloc

Control on 12 June 2009.

The full EPAR for Controloc Control can be found on the Agency’s website:

ema.europa.eu/Find

medicine/Human medicines/European public assessment reports. For more information about

treatment with Controloc Control, read the package leaflet (also part of the EPAR) or contact your

doctor or pharmacist.

This summary was last updated in 03-2013.

Листовка за пациента: състав, показания, Нежелани лекарствени реакции, дозиране, взаимодействия, бременност, кърмене

B. PACKAGE LEAFLET

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

What CONTROLOC Control is and what it is used for

What you need to know before you take CONTROLOC Control

How to take CONTROLOC Control

Possible side effects

How to store CONTROLOC Control

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.

2.

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 HIV protease inhibitors such as atazanavir; nelfinavir (for the treatment of

HIV-infection) See ‘Other medicines and CONTROLOC 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)

if you are taking HIV protease inhibitors such as atazanavir; nelfinavir (for the treatment of

HIV-infection) at the same time as pantoprazole, ask your doctor for specific advice.

Do not take this product for longer than 4 weeks without consulting your doctor. If your reflux

symptoms (heartburn or acid regurgitation) persist for longer than 2 weeks, consult your doctor who

will decide about the need for long-term intake of this medicinal product.

If you take CONTROLOC Control for longer periods, this may cause additional risks, such as:

reduced absorption of Vitamin B12, and Vitamin B12 deficiency if you already have low body

stores of Vitamin B12.

fracture of your hip, wrist or spine, especially if you already suffer from osteoporosis or if you

are taking corticosteroids (which can increase the risk of osteoporosis).

falling magnesium levels in your blood (potential symptoms: fatigue, involuntary muscle

contractions, disorientation, convulsions, dizziness, increased heart rate). Low levels of

magnesium can also lead to a reduction in potassium or calcium levels in the blood. You should

talk to your doctor if you have been using this product for more than 4 weeks. Your doctor may

decide to perform regular blood tests to monitor your levels of magnesium.

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:

HIV protease inhibitors such as atazanavir, nelfinavir (for the treatment of HIV-infection). You

must not use CONTROLOC Control if you are taking HIV protease inhibitors. 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:

Common (may affect up to 1 in 10 people): Benign polyps in the stomach.

-

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; fracture

in the hip, wrist or spine.

-

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;

feeling of tingling, prickling, pins and needles, burning sensation or numbness, inflammation in

the large bowel, that causes persistent watery diarrhoea.

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 the national reporting system listed in

Appendix V. 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:

België/Belgique/Belgien

Takeda Belgium

Tél/Tel: + 32 2 464 06 11

takeda-belgium@takeda.com

България

Такеда България

Teл.: + 359 (2) 958 27 36

Česká republika

Takeda Pharmaceuticals Czech Republic s.r.o.

Tel: + 420 234 722 722

Danmark

Takeda Pharma A/S

Tlf: + 45 46 77 11 11

Deutschland

Takeda GmbH

Tel:

0800

3324

medinfo@takeda.de

Eesti

Takeda Pharma AS

Tel: +372 617 7669

info@takeda.ee

Ελλάδα

TAKEDA ΕΛΛΑΣ Α.Ε

Τηλ: +30 210 6729570

gr.info@takeda.com

España

Takeda Farmacéutica España S.A.

Tel: + 349 1 714 9900

spain@takeda.com

France

Takeda France S.A.S.

Tél: + 33 1 46 25 16 16

Hrvatska

Takeda Pharmaceuticals

Croatia d.o.o.

Tel: +385 1 377 88 96

Ireland

Takeda Products Ireland Limited

Tel: + 353 16 42 00 21

Lietuva

Takeda, UAB

Tel: +370 521 09070

lt-info@takeda.com

Luxembourg/Luxemburg

Takeda Belgium

Tél/Tel: + 32 2 464 06 11

takeda-belgium@takeda.com

Magyarország

Takeda Pharma Kft.

Tel: +361 2707030

Malta

Takeda Italia S.p.A.

Tel: +39 06 502601

Nederland

Takeda Nederland bv

Tel: +31 23 56 68 777

nl.medical.info@takeda.com

Norge

Takeda Nycomed AS

Tlf: + 47 6676 3030

infonorge@takeda.com

Österreich

Takeda Pharma Ges.m.b.H.

Tel: +43 (0)800-20 80 50

Polska

Takeda Pharma sp. z o.o.

Tel.: + 48 22 608 13 00

Portugal

Takeda - Farmacêuticos Portugal, Lda.

Tel: + 351 21 120 1457

România

Takeda Pharmaceuticals SRL

Tel: + 40 21 335 03 91

Slovenija

Takeda GmbH, Podružnica Slovenija

Tel: + 386 (0) 59082480

Slovenská republika

Takeda Pharmaceuticals Slovakia s.r.o.

Tel: +421 (2) 20602600

Suomi/Finland

Takeda Oy

Puh/Tel: + 358 20 746 5000

Sverige

Takeda Pharma AB

Tel: + 46 8 731 28 00

infosweden@takeda.com

United Kingdom

Takeda UK Limited

Tel: +44 (0)1628 537 900

Ísland

Vistor hf.

tel: +354 535 7000

vistor@vistor.is

Italia

Takeda Italia S.p.A.

Tel: +39 06 502601

Κύπρος

TAKEDA ΕΛΛΑΣ Α.Ε

Τηλ: +30 210 6729570

gr.info@takeda.com

Latvija

Takeda Latvia SIA

Tel: + 371 67840082

This leaflet was last revised in {mm/yyyy}

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.