Protonix/Controloc 40 mg. 28 tablets

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Protonix/Controloc 40 mg. 28 tablets
€ 27.00
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What is Controllock 40 mg and what is it used for
Controllock 40 mg contains the active substance pantoprazole (such as sodium sesquihydrate). Controllock 40 mg is a selective proton pump inhibitor, a drug that reduces the formation of acid in the stomach. It is used to treat diseases of the stomach and intestines caused by increased production of acid in the stomach.

Controllock 40 mg is used in adults and adolescents over 12 years of age for:
Gastroesophageal reflux disease - an inflammation of your esophagus that connects your throat to your stomach, accompanied by the return of stomach acid to your esophagus.

Controllock 40 mg is used in adults for:
- Infection with a bacterium called Helicobacter pylori in patients with duodenal or gastric ulcer, in combination with two antibiotics (treatment to eliminate the infection). The purpose of this treatment is to completely eliminate the bacteria and prevent the recurrence of the ulcers;
- Gastric and duodenal ulcers;
Zollinger-EUison syndrome and other conditions producing more than the required amount of stomach acid.

2 .. What you need to know before taking Controllok 40 mg

Do not take 40mg Control:
If you are allergic (hypersensitive) to pantoprazole or any of the other ingredients of this medicine (listed in section 6);
- If you are allergic to medicinal products containing other proton pump inhibitors. Talk to your doctor, pharmacist, or nurse before taking Controllock 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 often, especially if you are taking Kontrolok 40 mg for a long time. In the event of an increase in liver enzymes, treatment should be discontinued.
If you have reduced body supplies or risk factors for vitamin B12 reduction and receive long-term treatment with pantoprazole. Like all other acid-reducing drugs, pantoprazole can lead to decreased absorption of vitamin B12;

If you are taking a medicine containing atazanavir (to treat AIDS) with pantoprazole, ask your doctor for advice.
- People taking multiple daily doses of proton pump inhibitors for an extended period of time (one year or more) may have an increased risk of hip, wrist or spine fractures. Talk to your doctor about the risk of bone fractures if you are taking Kontrolok 40 mg.
- If you take pantoprazole for a period exceeding 3 months, the level of magnesium in your blood may decrease. Low levels of magnesium can manifest as fatigue, involuntary muscle movements, disorientation, muscle tremors, dizziness, and accelerated cardiac activity. Please tell your doctor immediately if you experience any of these symptoms. Low levels of magnesium can lead to decreased levels of potassium and calcium in the blood. Your doctor may decide that your blood magnesium levels be monitored regularly during treatment (see section 2).

Tell your doctor immediately if you notice any of the following symptoms, which may be a sign of another, more serious illness, before or after taking this medicine:

- Unwanted weight loss (not related to diet or exercise);
- Vomiting, especially recurrent;
- Vomiting of blood; it may manifest as vomiting of materials similar to coffee sludge;
- Notice blood in your stool; may be black or resinous;
- difficulty or swallowing pain;
- You look pale and feel weak (anemia);
- Chest pain;
- Stomach ache;
- Severe and / or prolonged diarrhea because Kontrolok 40 mg is associated with a slightly increased incidence of infectious diarrhea.

Your doctor may decide that you need some research to rule out malignancy because pantoprazole relieves the symptoms of the cancer and may delay its diagnosis. If your symptoms persist regardless of treatment, additional studies should be considered.
If you take Kontrolok 40 mg as a long-term treatment (more than 1 year), your doctor will probably keep you under review. You should inform your doctor of any new or unusual symptoms and conditions.

Children and adolescents
Controllock 40 mg is not recommended for children under 12 years of age, as it has not been shown to work in children under 12 years of age.

Other medicines and Kontrolok 40 mg
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Medicines such as ketoconazole, itraconazole and posaconazole (used to treat fungal 'infections) or erlotinib (used to treat some types of cancer) because Kontralok 40 mg tablets may prevent these drugs from acting properly.
Talk to your doctor, pharmacist, or nurse before taking Control
Children and adolescents
Controllock 40 mg is not recommended for children under 12 years of age, as it has not been shown to work in children under 12 years of age.

Other medicines and Kontrolok 40 mg
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Medicines such as ketoconazole, itraconazole and posaconazole (used to treat fungal infections) or erlotinib (used to treat some types of cancer) because Kontralok 40 mg,
tablets may prevent these medicines from acting properly;
- Warfarin and fenproormone, which thicken or dilute the blood. Additional studies may be required;
- Atazanavir (used to treat HIV infection) and other medicines used to treat HIV infection;
- Methotrexate (used to treat rheumatoid arthritis, psoriasis and cancer) - if you are taking methotrexate, your doctor may suspend your treatment because pantoprazole may increase blood levels of methotrexate;
- Tacrolimus (used to suppress the immune system in transplant patients) - Plasma concentration of tacrolimus may be increased when co-administered with pantoprazole. Regular monitoring of the plasma concentration of tacrolimus is recommended;
- Fluvoxamine (used in the treatment of depression) - leads to an increase in the plasma concentration of pantoprazole. Dosage of pantoprazole may be required.
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 breastfeeding
There are no adequate data from the use of pantoprazole in pregnant women. There have been reports of excretion in breast milk. If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
If you are pregnant or think you are pregnant or are currently breast-feeding, you should only take Controllock 40 mg if your doctor has determined that your benefits outweigh the potential risks to your child.
Driving and using machines
If you experience side effects such as lightheadedness and impaired vision, you should not drive or use machines.

3. How to take Kontrolok 40 mg
Always take Kontrolok 40 mg exactly as your doctor or pharmacist has told you. Talk to your doctor or pharmacist if you are not sure.

The recommended dose is:
Adults and adolescents over 12 years of age:

Treatment of gastroesophageal reflux disease
The usual dose is 1 gastro-resistant tablet Kontrolok 40 mg daily. Your doctor may tell you to increase the dose of 2 gastro-resistant tablets a day. The treatment period for gastroesophageal reflux disease is usually between 4 and 8 weeks. Your doctor will tell you how long to continue treatment.

Adults:

For the treatment of a bacterial infection called Helicobacter pylori in patients with duodenal or gastric ulcer, in combination with three antibiotics (treatment for bacterial elimination) One gastro-resistant tablet twice daily plus two of the following antibiotic-amoxicillin, clarithromycin and metronidazole (or tinidazole), each taken twice daily with the gastro-resistant pantoprazole tablet. Take your first gastro-resistant pantoprazole tablet one hour before breakfast and your second gastro-resistant pantoprazole tablet 1 hour before dinner. Follow your doctor's instructions and read the antibiotic information leaflets. The treatment period is usually 1 to 2 weeks.

For the treatment of gastric and duodenal ulcers
The usual dose is 1 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. The period for the treatment of gastric ulcers is usually 4 to 8 weeks. Treatment for duodenal ulcer usually lasts 2 to 4 weeks.
For the long-term treatment of Zollinger-Ellison syndrome and other conditions with the production of more than the required amount of stomach acid
The recommended starting dose is 2 gastro-resistant tablets Kontrolok 40 mg daily. Take both gastro-resistant tablets 1 hour before eating. Subsequently, your doctor may adjust the dose depending on the amount of acid that your stomach forms. If you are prescribed to take more than two gastro-resistant tablets daily, take the gastro-resistant tablets in two equal doses.
If your doctor has prescribed you more than four gastro-resistant tablets a day, you should be told exactly when to stop taking the medicine.

Patients with kidney problems
If you have kidney problems, moderate or severe liver problems, you should not take Helicobacter pylori medicines.

Patients with liver problems
If you suffer from severe liver disorders, you should take no more
Other side effects are:

Common (may affect up to 1 in 10 patients)

Benign gastric polyps.
Uncommon (may affect up to 1 in 100 patients)

Headache; fatigue; diarrhea; discomfort; vomiting; bloating and venting; constipation; dry mouth; colic and discomfort; skin rash; redness of the skin; raised rash; itching; feeling weak, feeling tired or feeling unwell; sleep disturbance.
Rare (may affect up to 1 in 1,000 patients)

Distortion or complete loss of taste; visual disturbances, such as double vision; hives (hives); joint pain; muscle pain; changes in body weight; fever; severe fever; swelling of the limbs (peripheral edema); allergic reactions; depression, breast enlargement in men.
Very rare (may affect up to 1 in 10,000 patients)

Disorientation.
Unknown frequency (frequency cannot be determined by available data)

Hallucinations, confusion (especially in patients with a history of these symptoms); decreased blood sodium levels; feeling tired; daggers; limb numbness; burning sensation and tingling sensation; low levels of potassium, which can lead to muscle weakness, heart failure, or heart failure; muscle cramps or cramps; low calcium levels ..
Adverse reactions identified by blood tests:

Uncommon (may affect up to 1 in 100 patients)

Enhancement of liver enzymes.
Rare (may affect up to 1 in 1,000 patients)

Increased bilirubin; increase in the level of fat in the blood; sharp decline in circulating granular white blood cells associated with severe fever.
Very rare (may affect up to 1 in 10,000 patients)

Reduction of platelet count, which can lead to bleeding or more easily saturation than usual; reduction in white blood cell count, which can lead to more frequent infections; simultaneous reduction of red and white blood cells and platelets.
Reporting side effects
If you get any side effects, talk to your doctor or pharmacist or nurse. This includes all possible side effects not listed in this leaflet; You can also report side effects directly through the national drug reporting system at 8 Damian Gruev Str., 1303 Sofia, Website: www.bda.bg. By reporting side effects, you can contribute to the more information on the safety of this medicine.

5. How to store Controllock 40 mg
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is 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.
Do not dispose of medicines in sewage or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Controlock 40 mg contains

The active substance is pantoprazole. Each gastro-resistant tablet contains 45.1 mg pantoprazole sodium sesquihydrate equivalent to 40 mg pantoprazole.
The other ingredients are:
Core: Sodium carbonate (anhydrous), mannitol, crospovidone, povidone K90, calcium stearate.

Sheath: 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.

Print ink: Shellac, red, black and yellow iron oxide (E 172) and concentrated ammonia solution.

What Kontrolok 40 mg looks like and contents of the pack
Yellow, oval, biconvex tablets with one side written on it

Package: blister (Alu / Alu blister) containing 14 gastro-resistant tablets.
Controllock 40 mg is available in packs containing 14 or 28 gastro-resistant tablets. Not all pack sizes may be marketed.
€ 27.00
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