Protonix/Controloc 20 mg. 14 tablets

€12

Protonix 20 mg contains the active substance pantoprazole (such as sodium sesquihydrate). Protonix 20 mg is a selective proton pump inhibitor - a medicine that reduces the formation of acid in the stomach.

Quantity

What is Protonix 20 mg and what is it used for

Protonix  20 mg contains the active substance pantoprazole (such as sodium sesquihydrate). Kontrolok 20 mg is a selective proton pump inhibitor - a medicine 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.

Protonix  20 mg is used for:

Protonix  20 mg is used in adults and adolescents over 12 years of age to treat symptoms (such as heartburn, acid tingling, swallowing pain) associated with gastroesophageal reflux disease caused by the return of gastric acid to the esophagus.

• Long-term treatment of esophagitis reflux (inflammation of the esophagus accompanied by the return of stomach acid to the esophagus) and prevent recurrence of this condition.

Protonix  20 mg is used in adults to prevent duodenal and gastric ulcers caused by the use of so-called non-steroidal anti-inflammatory drugs (NSAIDs, eg ibuprofen) in patients at increased risk who are required to take NSAIDs for a long time.

2. What you need to know before taking Protonix  20 mg

Do not take  Protonix  20 mg

- If you are allergic (hypersensitive) to pantoprazole or any of the other ingredients of this medicine (see section 6).

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

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Kontrolok 20 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 20 mg for a long time. In the event of an increase in liver enzymes, treatment should be discontinued.

If you need to take NSAIDs for a long time and get Protonix   20 mg because you are at increased risk of developing stomach or intestinal complications. Increased risk is associated with your personal risk factors, such as your age (over 65 years), past gastric or duodenal ulcers, or gastric or intestinal bleeding.

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 extended periods of time (one year or more) may be at increased risk of hip, wrist or spine fractures. Talk to your doctor about the risk of bone fractures if you are taking Kontrolok 20 mg.

If you take pantoprazole for a period exceeding 3 months, your blood magnesium level 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 20 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 20 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

Protonix  20 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 Protonix  20 mg

Tell your doctor or pharmacist if you are taking, have recently taken or might take any

Use in children and adolescents

These tablets are not recommended for use in children below 12 years of age. Application method

Protonix 20 mg is taken 1 hour before eating with little water without chewing or crushing the tablet.

If you take more Protonix  20 mg than you should

Talk to your doctor or pharmacist. There are no known symptoms of overdose. If you forget to take  Protonix 20 mg

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

If you stop taking Protonix  20 mg

Do not stop taking Protonix  20 mg without telling your doctor or pharmacist.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

- Serious allergic reactions (rare - may affect up to 1 in 1,000 patients): swelling of the tongue and / or throat, difficulty swallowing, hives (hives), difficulty breathing, allergic swelling of the face, (Quinke swelling / angioedema), severe dizziness with severely accelerated cardiac activity and profuse sweating.

- Serious skin reactions (with unknown frequency): blisters and rapid deterioration of the general condition, ulcers (including minor bleeding) of the eyes, nose, mouth / lips or external genitals (Stevens-Johnson syndrome, Lyell syndrome, multiple erythema) and sensitivity to light.

- Other serious conditions (not known): yellowing of the skin or eyes (severe hepatic impairment, jaundice) or fever, rash, enlargement of the kidneys, sometimes with painful urination and low back pain (severe inflammation of the kidneys)

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 gas;

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 levels of calcium.

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.

5. How to store Kontrolok 20 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  Protonix 20 mg contains

The active substance is pantoprazole. Each gastro-resistant tablet contains 22.6 mg pantoprazole sodium sesquihydrate equivalent to 20 mg pantoprazole.

The other ingredients are:

Core: Sodium carbonate (anhydrous), mannitol, crospovidone, povidone K90, calcium stearate. Sheath: Chstromellose, povidone K25, titanium dioxide (E171),

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