PULSET 40 mg. 14 tablets
The active substance in PULSET is pantoprazole, which belongs to the group of proton pump inhibitors. Proton pump inhibitors reduce the amount of acid that is released in the stomach.
PULSET used for treatment of:
Gastric ulcer and duodenal ulcer
Gastroesophageal reflux disease, gastro-oesophageal reflux disease and related symptoms (heartburn, acid reflux disease, pain on swallowing, etc.).
In combination with an appropriate antibiotic for the eradication of Helicobacter pylori in patients with duodenal ulcer
2. BEFORE YOU TAKE PULSET
Do not take PULSET
if you are allergic (hypersensitive) to pantoprazole or any of the other ingredients of PULSET. An allergic reaction may be recognized as a: rash, itching, redness of the skin or difficulty breathing.
if you have severe liver damage.
Take special care with PULSET
Before starting treatment with PULSET please tell your doctor:
- If you have severe liver damage. It will control your liver indicators regularly during treatment with PULSET, especially during prolonged therapy. In establishing increased levels of liver enzymes adoption of PULSET should be discontinued.
- If you have impaired renal function or are on hemodialysis.
- If you have a malignancy of the esophagus or stomach. PULSET can alleviate symptoms associated with malignant disease and thus to delay its diagnosis.
Use in children and adolescents
Not studied the safety and effectiveness of pantoprazole in children and adolescents.
Use in elderly patients
In elderly patients do not need dose adjustment.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
PULSET can be used simultaneously with other antacids.
Studies have shown that pantoprazole does not enter into clinically significant interaction with drugs such as warfarin, phenytoin, theophylline and diazepam in healthy subjects.
PULSET provides a strong and long-lasting inhibition of gastric acid secretion; therefore theoretically possible to influence the absorption of drugs such as ketoconazole, ampicillin esters, iron salts, in which the acidity of gastric juice is a determinant of the extent to which penetrate tissues or organs after dosing.
Taking PULSET with food and drink
PULSET should be taken before meals.
The tablets are taken with a full glass of water, not chewed or crushed.
Pregnancy and lactation
Ask your doctor or pharmacist before taking any medicine.
Before taking PULSET is important to tell your doctor if you are pregnant, planning to become pregnant, breastfeeding or planning to breastfeed.
Clinical experience with pantoprazole in pregnant women is limited.
It is unknown whether pantoprazole is excreted in human milk.
If you are pregnant, you think you are pregnant or breast-feeding can take PULSET only if your doctor considers that the benefit to the mother is greater than the potential risk to the fetus or infant.
Driving and using machines
No data PULSET influence on the ability to drive and use machines.
3. HOW TO TAKE PULSET
Always take PULSET, just as you have been told by your doctor. If you are not sure ask your doctor or pharmacist.
The usual dose is:
If you take more dose PULSET
If you take more dose PULSET immediately contact your doctor.
If you forget to take PULSET
If you forget to take PULSET, take the tablet as soon as you remember unless it is very close to the next dose. If this happens, skip the intake and take the next tablet as you follow the prescribed treatment.
Do not take a double dose to make up for a forgotten tablet.
If you stop taking PULSET
Do not stop treatment before you have completed the full course of treatment even though you feel better. You may not have cured completely and some of the symptoms to recur.
If you have any further questions on the use of this product, ask
Your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, PULSET can cause side effects, although not everybody gets them. PULSET generally well tolerated.
In this leaflet, when side effects are described as "common" this means that they have been reported in more than 1 in every 100 patients, but less than 1 in every 10 patients.
When side effects are described as "uncommon", this means that they were reported in more than 1 in 1000 patients but less than 1 out of 100 patients.
When side effects are described as "rare", this means that they were reported in more than 1 in 10 000 patients, but less than 1 in 1000 patients.
When side effects are described as "very rare", this means that they have been reported in less than 1 in every 10,000 patients.
Gastrointestinal disorders - abdominal pain, diarrhea, constipation, flatulence and bloating.
Nervous system - headache.
Gastrointestinal disorders - nausea.
Nervous system - dizziness, blurred vision.
Skin and subcutaneous tissue disorders - Allergic reactions such as itching and skin rashes.
General disorders and administration site conditions - peripheral edema (swelling subsided after completion of treatment).
Hepato - biliary disorders - severe liver cell damage leading to jaundice (yellowing of the skin and whites of the eyes caused by liver problems or blood) with or without liver failure.
Immune system - a severe allergic reaction which causes difficulty in breathing or dizziness.
Clinical laboratory tests and other studies - increased levels of liver enzymes, increased triglycerides, increased body temperature (resolve after completion of treatment).
Psychiatric disorders - depression (resolved after treatment).
Disorders of the musculoskeletal system and connective tissue - muscle aches (resolving after treatment).
Renal and urinary disorders - inflammation of the kidneys (interstitial nephritis).
Skin and subcutaneous tissue - urticaria (an allergic skin reaction that is characterized by redness, rise above the surrounding skin and itching), angioedema (severe allergic reaction that causes swelling of the face and throat), severe skin reactions such as Stevens- syndrome Johnson (serious illness accompanied by blistering of the skin, mouth, eyes and genitals), erythema multiforme, syndrome Lyell (serious skin allergic reactions), photosensitivity.
If any of the side effects gets serious, or you notice other effects not listed in
this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE PULSET
Keep out of reach of children.
Store in the original container.
Do not store above 30 ° C.
Protect from light and moisture.
Do not use PULSET after the expiry date stated on the carton. The expiry date refers to the last day of that month.
6. ADDITIONAL INFORMATION
- Active substance is pantoprazole. Each gastro-resistant tablet contains: pantoprazole sodium sesquihydrate, equivalent to 40 mg of pantoprazole.
- The other ingredients are:
tablet core: tri sodium phosphate anhydrous, isomalt, carmellose sodium, crospovidone, sodium stearyl fumarate
in the gastro-resistant coating: hypromellose, povidone, propylene glycol, titanium dioxide (E 171), yellow iron oxide (E 172)
Gastro-resistant coating: methacrylic acid copolymer - ethyl acrylate (1: 1) 30% dispersion, triethyl citrate, simethicone
PULSET looks like and contents of the pack
Light yellow, oval gastro-resistant tablets.
Al / Al blisters. One blister contains 4 or 14 pieces gastro-resistant tablets.
Pack sizes: 4, 14 or 28 gastro-resistant tablets.