CONTROLOC Control 20 mg gastro-resistant tablets

 

What is it and how is it used?

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.

What do you have to consider before using it?

Do not take CONTROLOC Control:

  • if you are allergic (hypersensitive) to pantoprazole, to soya or to any of the other ingredients of CONTROLOC Control (listed insection 6 ‘What CONTROLOC 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 CONTROLOC 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 CONTROLOC 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 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.

Using other medicines
CONTROLOC 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 CONTROLOC Control if you are taking atazanavir.

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.

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.

Using CONTROLOC Control with food and drink
The tablets should be swallowed whole with liquid before a meal.

Pregnancy and breast-feeding
Do not take CONTROLOC 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 CONTROLOC Control CONTROLOC Control contains soya lecithin. If you are allergic to peanut or soya, do not use this medicine.

How is it used?

Always take CONTROLOC 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 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.

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

If you take more CONTROLOC 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 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 product, ask your doctor or pharmacist.

What are possible side effects?

Like all medicines, CONTROLOC Control 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: 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.

How should it be stored?

Keep out of the reach and sight of children.

Do not use CONTROLOC 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 is it?

Controloc Control is a medicine that contains the active substance pantoprazole. It is available as yellow, oval gastro-resistant tablets (20 mg). ‘Gastro-resistant’ 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 it 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 it 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 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. Controloc Control is not recommended for use in patients below 18 years of age.

How does it 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 it 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 benefits has it 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?

The most common side effects with Pantoprazole 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 should not be used in people who may be 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 it been approved?

The Committee for Medicinal Products for Human Use (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 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’s benefits are greater than its risks for the short-term treatment of reflux symptoms in adults without prescription. The Committee recommended that Controloc Control be given marketing authorisation.

Further information

The European Commission granted a marketing authorisation valid throughout the EU for Controloc Control to Nycomed GmbH on 12 June 2009.