PULSET table. 40 mg. 28 tablets

PULSET WHAT IS AND WHAT IT IS USED

The active substance is pantoprazole PULSET which belongs to the class of proton pump inhibitors. Proton pump inhibitors reduce the amount of acid that is secreted in the stomach.

PULSET is used to treat:

Gastric ulcer and duodenal ulcer

Gastroesophageal reflux disease, gastro-oesophageal reflux disease and associated symptoms (heartburn, acid reflux, pain on swallowing, etc.).

In combination with appropriate antibiotic eradication of Helicobacter pylori in patients with duodenal ulcer

 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 by the presence of: rash, itching, redness of skin and 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 monitor your liver performance regularly during treatment with PULSET, especially during prolonged therapy. In establishing increased levels of liver enzymes adopting PULSET should be discontinued.

 If you have impaired kidney function or are on hemodialysis.

 If you have cancer of the esophagus or stomach. PULSET can alleviate symptoms associated with cancer and thus delay its diagnosis.

Use in children and adolescents

The safety and effectiveness of pantoprazole in children and adolescents.

Use in elderly patients

In elderly patients do not require a change in dose.

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 relevant interaction with drugs such as warfarin, phenytoin, diazepam and theophylline in healthy subjects.

PULSET provides strong and lasting inhibition of gastric acid secretion and therefore, it is theoretically possible to influence the absorption of drugs such as ketoconazole, ampicillin esters, iron salts, in which the acidity of the gastric juice is a determinant of the extent to which penetrate the tissues or bodies after dosing.

Taking PULSET with food and drink

PULSET should be taken before meals.

Tablets should be taken with a full glass of water, not be 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 not known whether pantoprazole is excreted in breast milk.

If you are pregnant, think you are pregnant or breast-feeding can take PULSET only if your doctor has determined that the benefits of treatment to the mother outweighs the potential risk to the fetus or infant.

Driving and operating machinery

No data PULSET your ability to drive or operate machinery.

 HOW TO TAKE PULSET

Always PULSET, just as you have been told by your doctor. If you are unsure ask your doctor or pharmacist.

The usual dose is:

If you take more than the dose PULSET

If you take more than the dose PULSET immediately contact your doctor.

If you forget to take PULSET

If you forget to take PULSET, take it 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 they have completed the full course of treatment even though you feel better. You may not have healed 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.

POSIBLE  SIDE EFFECTS

Like all medicines, PULSET can cause side effects, although not everybody gets them. PULSET generally well tolerated.

In this leaflet, when a side effect is described as "common", this means that they have been reported in more than 1 in every 100 patients but less than 1 in 10 patients.

When side effects were described as "uncommon", this means that they have been reported in more than 1 in 1,000 patients but less than 1 in 100 patients.

When side effects were described as "rare", this means that they have been reported in more than 1 in 10,000 patients, but less than 1 in 1000 patients.

When side effects were described as "very rare", this means that they have been reported in less than 1 in 10,000 patients.

Common:

Gastrointestinal disorders - abdominal pain, diarrhea, constipation, flatulence and bloating.

Nervous system - headaches.

Uncommon:

Gastrointestinal disorders - nausea.

Nervous system - dizziness, blurred vision.

Skin and subcutaneous tissue disorders - allergic reactions such as itching and rashes.

Very rare:

General disorders and administration site conditions - peripheral edema (resolving after 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 tests - increased liver enzymes, increased triglycerides, increased body temperature (resolved after treatment).

Psychiatric disorders - depression (resolved after treatment).

Musculo-skeletal and connective tissue - muscle pain (resolving after treatment).

Renal and urinary disorders - inflammation of the kidneys (nephritis).

Skin and subcutaneous tissue disorders - Urticaria (allergic skin reaction characterized by redness, raised 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 (severe allergic skin reaction), 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.

 HOW TO STORE PULSET

Keep out of reach of children.

Store in original container.

Do not store above 30 º C.

Protect from light and moisture.

PULSET Do not use after the expiry date stated on the carton. The expiry date refers to the last day of that month.

 ADDITIONAL INFORMATION

What PULSET

 The active substance is pantoprazole. Each gastro-resistant tablet contains pantoprazole sodium sesquihydrate equivalent to 40 mg pantoprazole.

 The other ingredients are:

Core: Tri-substituted sodium phosphate anhydrous, isomalt, croscarmellose sodium, crospovidone, sodium stearyl

under the enteric coating: hypromellose, povidone, propylene glycol, titanium dioxide (E 171), yellow iron oxide (E 172)

gastro-resistant coating: methacrylic acid - ethyl acrylate copolymer (1:1) dispersion 30%, triethyl citrate, simethicone