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KONTROLOK table. 40 mg. 14 tablets

Product Code: KONTROLOK table. 40 mg. 14 tablets
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KONTROLOK table. 40 mg. 14 tablets

 KONTROLOK table. 40 mg, Kontrolok 40 mg is a selective inhibitor of the proton pump


Kontrolok 40 mg is a selective proton pump inhibitor - a drug that reduces the amount of acid produced in the stomach. It is used to treat diseases of the stomach and intestines caused by increased production of stomach acid.


Kontrolok40 mg used for:

Adults and children over 12 years:

 Gastroesophageal reflux disease - inflammation of your esophagus connects your throat to your stomach, accompanied by reflux of acid from the stomach into the esophagus.



 Infection with a bacterium called Helicobacter pylory in patients with duodenal or gastric ulcers in combination with two antibiotics (therapy to eliminate infection). The purpose of this is to get rid of the bacteria and prevent the possibility of recurrence of ulcers;

 Gastric and duodenal ulcers;

 Syndrome Zollinger-Ellison and other conditions producing greater than the acid in the stomach.




Do not take Kontrolok 40 mg

 If you are allergic (hypersensitive) to pantoprazole or any other ingredient Kontrolok 40 mg (see section 6);

 If you are allergic to medicines containing other proton pump inhibitors.


Take special care when taking these 40 mg

 If you have severe liver problems. Please tell your doctor if you have ever had liver problems. He will check your liver enzymes more frequently, especially if you take 40 mg Kontrolok long time. In case of elevated liver enzymes, treatment should be stopped;

 If you have reduced body stores or risk factors for reduced vitamin B12 and receive long-term treatment with pantoprazole. Like all other acid reducing drugs, pantoprazole may lead to decreased absorption of vitamin B12;

 If you are taking a medicine containing atazanavir (for the treatment of AIDS) with pantoprazole, ask your doctor.


Tell your doctor immediately if you notice any of the following symptoms:

 Unwanted weight loss;

Repeated vomiting;

 Difficulty in swallowing;

Vomiting of blood;

 Look pale and feel weak (anemia);

Notice blood in your stools;

 Heavy and / or prolonged diarrhea because Kontrolok 40 mg was associated with a slightly increased incidence of infectious diarrhea.


Your doctor may decide that you need some tests to rule out malignant disease because pantoprazole relieves the symptoms of cancer and may delay the diagnosis. If your symptoms persist despite treatment, you should discuss further research.

If you take 40 mg Kontrolok a long-term (over one year), your doctor will probably keep you under observation. You should tell your doctor about any new or unusual symptoms and conditions.


If you are taking other medicines

Kontrolok 40 mg can affect the effectiveness of other medications, so tell your doctor if you take:

 Drugs such as ketoconazole, itraconazole and posaconazole (used to treat fungal infections) or erlotinib (used to treat some types of cancer) because Kontrolok 40 mg gastro-resistant tablets can prevent these medicines from working properly;

 Warfarin and phenprocoumon to thicken or thin the blood. You may need to perform additional studies;

 Atazanavir (used to treat HIV).


Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.


Pregnancy and lactation

There are no adequate data from the use of pantonrazol in pregnant women. There have been released into the milk. If you are pregnant or think you are pregnant or breastfeeding. You should take 40 mg Kontrolok if your doctor has determined that the benefits to you outweigh the potential risks to your baby.

Ask your doctor or pharmacist for advice before taking any medicine.


Driving and operating machinery

If you experience side effects such as dizziness and blurred vision, do not drive or operate machinery.


Important information about some of the ingredients of the 40 mg Kontrolok

Kontrolok contains 40 mg of soybean oil. If you are allergic to peanut or soya, do not take this medicine.




Always take Kontrolok 40 mg exactly as your doctor tells you e. Consult your doctor or pharmacist if you are not sure.


When and how should you take Kontrolok 40 mg?

Kontrolok 40 mg taken one hour before meals, with water without chewing or breaking the tablet.


If your doctor advises otherwise, the usual dose is:

Adults and children over the age of 12

Treatment of gastroesophageal reflux disease:

The usual dose of one gastro-resistant tablet Kontrolok 40 mg daily. Your doctor may tell you to increase to 2 gastro-resistant tablets daily. Term treatment of gastroesophageal reflux disease is usually between 4 and 8 weeks. Your doctor will tell you how long to continue treatment.



For the treatment of infections with bacteria called Helicobacter pylori in patients with duodenal or gastric ulcers in combination with two antibiotics (treatment to remove bacteria).


Each gastro-resistant tablet twice daily plus two antibiotics - amoxicillin, clarithromycin and metronidazole (or tinidazole), each taken twice daily with gastro-resistant tablets Pantoprazole. Take the first gastro-resistant pantoprazole tablet one hour before breakfast and the second gastro-resistant pantoprazole tablet one hour before dinner. Follow your doctor's instructions, and read the information leaflets antibiotics. The usual treatment period is 1 to 2 weeks.


For the treatment of gastric and duodenal ulcers

The usual dosage is one gastro-resistant tablet Kontrolok 40 mg daily. After consulting your doctor, the dose may be doubled.

Your doctor will tell you how long to take the medicine. Term treatment of gastric ulcers is usually 4 to 8 weeks. Treatment of duodenal ulcers is usually 2 to 4 weeks.


For long-term treatment of syndrome Zollingcr-Ellison and other conditions producing greater than the acid in the stomach

The recommended starting dose is two tablets are Kontrolok 40 mg daily. Take two tablets are one hour before eating. Subsequently, your doctor may adjust your dose depending on the amount of acid you produce stomach. If you are prescribed to take more than two gastro-resistant tablets daily, take gastro-resistant tablets into two equal doses.

If your doctor has prescribed more than four gastro-resistant tablets a day, you will be told when to stop taking the drug.


Special populations:

 If you have kidney problems, moderate or severe liver problems, you should not take for removing Helicobacter pylori;

 If you have severe liver problems, you should not take more than one gastro-resistant tablet contains 20 mg pantoprazole daily (for this purpose are available gastro-resistant tablet contains 20 mg pantoprazole);

 Children under 12 years of age. These tablets are not recommended for use in children under 12 years of age.


If you take more than 40 mg dose Kontrolok

Consult your doctor or pharmacist. There are no known symptoms of overdose.


If you miss taking these 40 mg

Do not take a double dose to make up for lost. Take your next dose at the usual time.


If you stop taking these 40 mg

Do not stop taking these 40 mg, without you tell your doctor or pharmacist.


If you have further questions about the use of 40 mg, tell your doctor or pharmacist.




Like all medicines, Kontrolok 40 mg can cause side effects, although not everybody gets them.


The frequency of possible side effects can be 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 1000;

 rare: affects 1 to 10 users in 10,000;

 very rare: affects less than 1 user in 10,000;

 Not known (frequency can not be estimated from available data).


If you experience any of the following serious side effects, stop taking the medicine and tell your doctor immediately or contact your nearest hospital:


Serious allergic reactions (frequency rare): swelling of the tongue and / or throat, difficulty swallowing, urticaria (hives), difficulty breathing, allergic facial swelling (Quincke's edema / angioedema), severe dizziness with very fast heartbeat and heavy sweating.


Serious skin reactions (frequency not known): blistering and rapid deterioration of general condition, ulcers (including minor bleeding) from the eyes, nose, mouth / lips or vulva (syndrome Stevens-Johnson, syndrome Lyell, multiple erythema ) and sensitivity to light.


Other serious conditions (frequency not known): yellowing of the skin or eyes (severe liver cells, jaundice) or fever, rash, enlarged kidneys, sometimes painful urination and lower back pain (severe inflammation of the kidneys).


Other side effects are:

Uncommon (affects 1 to 10 users in 1,000):

 Headache, fatigue, diarrhea, malaise, vomiting, bloating and flatulence, constipation, dry mouth, cramps and discomfort, skin rash, skin redness, bumpy rash, itching, weakness, feeling tired or unwell , sleep disorder.


Rare (affects 1 to 10 users in 10,000):

 Distortion or complete loss of the sense of taste, visual disturbances such as double vision, hives (urticaria), joint pain, muscle pain, weight changes, fever, high fever, swelling of the extremities (peripheral edema); allergic reactions, depression, breast enlargement in men.


Very rare (affects less than 1 in 10,000 users):



Not known (frequency can not be estimated from available data):

Hallucinations, confusion (especially in a patient with a history of these symptoms) decreased sodium levels: low magnesium levels in the blood.


Adverse reactions identified through blood tests:

Uncommon (affects 1 to 10 users in 1,000):

 elevation of liver enzymes.


Rare (affects 1 to 10 users in 10,000):

 increase in bilirubin, increase the level of fat in the blood drop in circulating granular white blood cells associated with high fever.


Very rare (affects less than 1 in 10,000 users):

 reduction in the number of platelets, which can cause bleeding or bruising more easily than usual: a reduction in the number of white blood cells, which can lead to frequent infections, while reducing the number of red and white blood cells, and platelets.


If any of the side effects gets serious, or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.




Keep out of reach of children.

Do not use Kontrolok 40 mg after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

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 Kontrolok 40 mg

The active substance is pantoprazole. Each gastro-resistant tablet contains 40 mg pantoprazole (as pantoprazole sodium seskihidrat).


The other ingredients are:

Core: Sodium carbonate (anhydrous), mannitol, crospovidone, povidone K90, calcium stearate.

Coating: hypromellose, povidone K25, titanium dioxide (E171), yellow iron oxide (E172), propylene glycol, methacrylic acid-ethyl acrylate copolymer (1:1), polysorbate 80, sodium lauryl sulfate, triethyl citrate.

Printing ink: shellac, red, black and yellow iron oxide (E172) and concentrated ammonia solution.


How does Kontrolok 40 mg and what the contents are

Yellow, oval, biconvex gastro-resistant tablets as one side says "R40".


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