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WHAT Nolpaza IS AND WHAT IT IS USED FOR
Nolpaza is a selective "proton pump inhibitor", a medicine that reduces the formation of acid in your stomach. It is used to treat stomach and intestinal diseases caused by increased acid production in the stomach.
Nolpaza is used to:
Adults and adolescents 12 years and older:
Treatment of symptoms (such as stomach acid, acid eruptions, swallowing pain) associated with gastroesophageal reflux disease caused by the return of acid from the stomach to the esophagus;
Prolonged treatment of reflux oesophagitis (inflammation of the esophagus accompanied by acid reflux from the stomach in the esophagus) and prevention of recurrence of this condition.
Prevention of duodenal and gastric ulcer induced by the use of so-called non-steroidal anti-inflammatory drugs (NSAIDs, eg ibuprofen) in patients at high risk who need to take prolonged NSAIDs.
2. BEFORE YOU TAKE Nolpaza
Do not take Nolpaza:
If you are allergic (hypersensitive) to pantoprazole, sorbitol or any of the other ingredients of Nolpaza (see section 6);
If you are allergic to medicinal products containing other proton pump inhibitors.
Take special precautions when taking Nolpaza
If you have severe liver problems. Please tell your doctor if you have ever had a liver problem. He will check your liver enzymes more often, especially if you take Nolpaza for a long time. If hepatic enzymes are elevated, treatment should be stopped;
If you need to take long-term medicines called NSAIDs and you are taking Nolpaza because you have an increased risk of developing stomach or intestinal complications. Increased risk is associated with your personal risk factors such as your age (over 65 years), gastric or duodenal ulcers or gastric or intestinal bleeding;
If you have reduced body stores or risk factors for vitamin B12 depletion and receive long-term treatment with pantoprazole. Like all other acid-lowering medicines, pantoprazole can lead to reduced absorption of vitamin B12. If you are taking a medicine containing atazanavir (for AIDS treatment), together with pantoprazole, ask your doctor for advice;
Taking proton pump inhibitors, such as Nalpaza, especially for more than one year, may slightly increase the risk of fracture of the thigh, wrist, or spine. Tell your doctor if you suffer from osteoporosis or are taking corticosteroids (they may increase the risk of osteoporosis).
Tell your doctor immediately if you notice any of the following symptoms:
unwanted weight loss;
difficulty in swallowing;
vomiting of blood;
you look pale and feel weak (anemia);
you notice blood in your stools;
severe and / or prolonged diarrhea because Nalapa is associated with a slightly increased incidence of infectious diarrhea.
Your doctor may decide that you need some studies to exclude malignancy because pantoprazole relieves the symptoms of cancer and may delay its diagnosis. If your symptoms continue regardless of treatment, further research should be considered.
If you take Nopalaza as a long-term treatment (more than 1 year), your doctor will probably keep you under surveillance. You should tell your doctor about any new or abnormal symptoms and conditions.
Taking other medicines
Nalpase can affect the efficacy of other medicines, so tell your doctor if you are taking:
Medicines such as ketoconazole, itraconazole and posaconazole (used to treat fungal infections) or erlotinib (used to treat some cancers) because Nalapa gastro-resistant tablets may prevent these medicines from working properly;
Warfarin and fenprocorhon that thicken or thin the blood. Further research may be required;
Atazanavir (used to treat AIDS).
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 insufficient data from the use of pantoprazole in pregnant women. Separation in breast milk has been reported. If you are pregnant or think you are pregnant or breast-feeding you should only take this medicine if your doctor has determined that the benefits to you are greater than the potential risks to your unborn baby or baby. Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
If you experience side effects such as dizziness and impaired vision, you should not drive or operate machinery.
Important information about some of the ingredients of Nolpaza
Nolpaza contains sorbitol. If your doctor has told you that you have an intolerance to some sugars, you should check with
HOW TO TAKE Nolpaza
Always take Nolpaza exactly as your doctor has told you. Consult your doctor or pharmacist if you are not sure.
When and how should you take Nolpaza?
Take the tablets 1 hour before eating without chewing or crushing them and swallow them whole with water.
If your doctor has not prescribed otherwise, the usual dose is:
Adults and adolescents 12 years and older:
Treatment of symptoms (eg stomach acid, acid eruptions, swallowing pain) associated with gastro-oesophageal reflux disease:
The usual dose is one tablet a day. This dose usually results in improvement for 2-4 weeks, at most after another 4 weeks. Your doctor will tell you how long to take your medicine. Prevention of recurrences can then be achieved by taking one tablet daily as needed.
Prolonged treatment of reflux oesophagitis (inflammation of the esophagus accompanied by the return of stomach acid to the esophagus) and prevention of a recurrence of this condition:
The usual dose is one tablet a day. If the disease resumes, your doctor may double the dose, in which case you can use Nolpaza 40 mg tablets, one tablet a day. After healing, you can reduce the dose to one 20 mg tablet per day.
Prophylaxis of duodenal ulcer and stomach in patients who have to take prolonged periods NSAIDs:
The usual dose is one tablet a day.
Special patient groups:
If you suffer from severe liver problems, you should take no more than one 20 mg tablet per day;
Children under 12 years of age. These tablets are not recommended for use in children under 12 years of age.
If you take more Nopalaza than you should
Consult your doctor or pharmacist. There are no known symptoms of overdose.
If you forget to take Nolpaza
Do not take a double dose to make up for the forgotten dose. Take the next prescribed dose at the usual time.
If you stop taking Nolpaza
Do not stop taking Nolpaza without telling your doctor or pharmacist.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. ADVERSE REACTIONS
Like all other medicines, Nolpaza can cause side effects, although not everybody gets them.
The frequency of possible side effects is listed below and 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 1,000);
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 the available data).
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 (frequency: rare): swelling of the tongue and / or throat, swallowing difficulty, urticaria (hives), breathing difficulty, allergic edema of the face (swelling of angioedema), severe dizziness with high- activity and abundant sweating;
Serious skin reactions (not known): blistering of the skin and rapid worsening of the general condition, ulcers (including mild haemorrhage) from the eyes, nose, mouth or lips or external genital organs (Stevens-Johnson syndrome, Lyell's syndrome, multiple erythema) and sensitivity to light;
Other serious conditions (not known): yellowing of the skin or white eyes (severe liver cell damage, jaundice) or fever, rash, enlargement of the kidneys, sometimes with painful urination and back pain (severe kidney inflammation);
If you take pantoprazole for more than three months, your blood magnesium levels may decrease. Low levels of magnesium may occur with nausea, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you get any of these symptoms, please tell your doctor immediately. Low levels of magnesium can also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor your levels of magnesium.
Other side effects are:
Uncommon (affects 1 to 10 users in 1,000):
Headache; fatigue; diarrhea; malaise, vomiting; bloating and gas discharge; constipation; dry mouth; abdominal pain and discomfort; skin rash; redness of the skin, raised rash; cracking of the skin, itching; fracture of the hip, wrist or spine, feeling weak, feeling tired or feeling unwell; sleep disturbance.
Rare (affects 1 to 10 users in 10,000):
Vision disorders, such as double vision; hives; joint pains; muscle pain;
Very rare (affects less than 1 user in 10,000):
Decreasing the number of platelets, which can lead to bleeding or bruising than usual; a reduction in the number of white blood cells, which may lead to more frequent infections.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
5. STORAGE OF Nolpaza
Keep out of the reach and sight of children.
Blister pack: Store in the original package in order to protect from moisture.
Container: Store the container tightly closed to prevent moisture.
Do not use Nolpaza after the expiry date which is stated on the pack. The expiration date expires on the last day of that month.
HDPE tablet container:
Shelf life after initial opening is 3 months.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the unnecessary medicine. These measures will help to protect the environment.
6. ADDITIONAL INFORMATION
What Nolpaza contains
Each gastro-resistant tablet contains 20 mg of pantoprazole (as pantoprazole sodium sesquihydrate).
The other ingredients are mannitol, crospovidone (type B), sodium carbonate, anhydrous, sorbitol (E420), calcium stearate in the tablet core and hypromellose, povidone (K25), titanium dioxide, E171, iron oxide, , propylene glycol, methacrylic acid-methacrylate copolymer, sodium lauryl sulfate, polysorbate 80, macrogol 6000 and talc in the film coating.
What Nolpaza looks like and what the package contains
20 mg gastro-resistant tablets are light brownish-yellow, oval, slightly biconvex tablets.
Boxes of 7, 14, 15, 28, 30, 56, 60, 84, 100, 100 x 1, 112 and 140 gastro-resistant tablets in a blister pack.
Plastic container with 250 gastro-resistant tablets.
Not all pack sizes may be marketed.
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