Nexopral 40 mg. 14 tablets

1. What Nexopral is and what it is used for

Nexopral contains a medicine called esomeprazole. It belongs to a group of medicines called 'proton pump inhibitors'. They work by reducing the amount of acid your stomach produces.

Nexopral is used to treat:

Adults and adolescents over 12 years of age

Gastroesophageal reflux disease (GERD). It occurs when stomach acid backs up into the esophagus (the tube that connects your throat to your stomach)* causing pain, inflammation and heartburn.

Nexopral can also be used to treat ulcers in the stomach or upper part of the gastrointestinal tract (intestine) that are infected with a bacteria called Helicobacter pylori. If you have this condition, your doctor may prescribe this medicine in combination with some antibiotics to treat the infection, which will allow the ulcer to heal.

Adults

Nexopral can also be used to treat stomach ulcers caused by medicines called NSAIDs (non-steroidal anti-inflammatory drugs). Nexopral is given to stop stomach and duodenal ulcers from forming if you are taking NSAIDs.

Nexopral can be used to treat excessive stomach acid caused by a mass in the pancreas (Zollinger-Elliso syndrome?).

Long-term treatment after intravenous esomeprazole for the prevention of gastric ulcer bleeding.

2. What you need to know before you take Nexopral

Do not take Nexopral

If you are allergic to esomeprazole or any of the other ingredients of this medicine (listed in section 6).

If you are allergic to other proton pump inhibitors.

If you are taking atazanavir (a medicine used to treat AIDS.

Do not take Nexopral if any of the above apply to you. If you are not sure, ask your doctor or pharmacist before taking Nexopral.

Warnings and precautions

Talk to your doctor or pharmacist before taking Nexopral:

If you have severe liver problems.

If you have severe kidney problems.

Nexopral can mask the symptoms of other diseases. Therefore, if any of the following happen before you start taking Nexopral or while you are taking it, talk to your doctor straight away:

If you lose a lot of weight for no reason and have trouble swallowing.

If you get stomach pain or indigestion.

If you start vomiting food or blood.

If you have black stools (stools with blood).

When you are prescribed Nexopral "as needed", you should contact your doctor if your symptoms persist or change in nature.

Taking proton pump inhibitors (such as Nexopral), especially for more than a year, may slightly increase the risk of fractures of the hip, wrist or spine. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).

Other medicines and Nexopral

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is necessary because Nexopral can affect the way some medicines work and some medicines can have an effect on Nexopral.

Do not take Nexopral if you are taking medicine containing nelfinavir (used to treat AIDS).

Tell your doctor or pharmacist if you are taking any of the following medicines:

Atazanavir (used to treat AIDS).

Ketoconazole, itraconazole or voriconazole (used to treat infections caused by fungi).

Citalopram, imipramine or clomipramine (used to treat depression).

Diazepam (used to treat anxiety, muscle relaxation or epilepsy).

Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when you start or stop taking Nexopral.

Medicines used to thin the blood, e.g. warfarin. Your doctor may need to monitor you when you start or stop taking Nexopral.

Cisalride (used for indigestion and heartburn).

Digoxin (to treat heart failure)

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin at the same time as Nexopral to treat ulcers caused by Helicobacter pylori infection, it is very important that you inform your doctor about all other medicines you are taking.

Nexopral c food and drink

Nexopral can be taken with or without food.

Pregnancy, lactation and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor before using this medicine.

Before taking Nexopral, tell your doctor if you are pregnant or trying to become pregnant.

Ask a doctor or pharmacist before taking any medicine. Your doctor will decide if you can take Nexopral during this time. It is unknown

does Nexopral pass into breast milk. Therefore, you should not take Nexopral if you are breast-feeding.

Driving and using machines

Nexopral is unlikely to affect your ability to drive or operate tools or machines.

3. How to take Nexopral

Always take Nexopral exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Nexopral gastro-resistant tablets are not recommended for children under 12 years of age.

If you take this medicine for a long time, your doctor will want to monitor you more often (especially if you take it for longer than 1 year).

If your doctor has recommended that you take this medicine as needed, let him know if your symptoms change.

How to take the medicine

You can take the tablets at any time of the day.

You can take the tablets with food or on an empty stomach.

Swallow the tablets whole with a glass of water. Do not chew or crush them. This is important because the tablets contain coated pellets that protect the medicine from being broken down by stomach acids. Therefore, you should not destroy the pellets.

What to do if you have difficulty swallowing tablets

If you have difficulty swallowing the tablets:

Place them in a glass of plain (still) water. Do not use any other liquids.

Stir until the tablet disintegrates (the mixture should not be clear). Then drink it immediately or within 30 minutes. Always stir the mixture immediately before drinking it.

To make sure you drink all the medicine, rinse the glass very well with half water and drink it. The solid particles contain the medicine - do not chew or crush them.

If you cannot swallow at all:

The tablet can be mixed with a little water and put into a syringe. So it can be administered through a tube directly into your stomach (gastric tube).

How many tablets to take

Your doctor will tell you how many tablets and how long to take them. This is your condition, age and liver function.

Usual doses are given below:

For the treatment of heartburn due to gastro-oesophageal reflux disease Adults and children over 12 years of age:

If your doctor has diagnosed mild damage to the esophagus, the usual dose is 1 tablet of Nexopral 40 mg once a day for 4 weeks. Your doctor may recommend that you continue to take the same dose for another 4 weeks if your esophagus has not healed.

After recovery, the usual dose is 1 gastro-resistant tablet of Nexopral 20 mg once a day.

If there are no disorders of the esophagus, the usual dose is 1 gastro-resistant tablet of Nexopral 20 mg every day. Once your condition is under control, your doctor may recommend that you take the medicine only as needed, up to a maximum dose of 1 gastro-resistant tablet of Nexopral 20 mg each day.

If you have severe liver problems, your doctor may recommend a lower dose.

To treat ulcers caused by Helicobacter pylori infection and to prevent their recurrence:

Adults and children over 12 years of age or older: the usual dose is 1 tablet Nexopral 20 mg 2 times a day for 1 week.

Your doctor will also prescribe antibiotics called amoxicillin and clarithromycin.

To treat stomach ulcers caused by NSAIDs (non-steroidal anti-inflammatory drugs):

Adults 18 years and older: the usual dose is 1 Nexopral 20 mg gastro-resistant tablet once daily for 4 to 8 weeks.

To prevent stomach ulcers if you take NSAIDs (non-steroidal anti-inflammatory drugs):

Adults 18 years and over: the usual dose is 1 Nexopral 20 mg gastro-resistant tablet once a day.

In long-term treatment after prevention of rebleeding of ulcers with intravenous administration of esomeprazole:

The usual dose is 1 gastro-resistant tablet of Nexopral 40 mg once a day for 4 weeks.

To treat excessive stomach acid caused by a mass in the pancreas (Zollinger-EUisott syndrome):

Adults aged 18 and over: the usual dose is 1 gastro-resistant tablet Nexopral 40 mg 2 times a day.

Your doctor will adjust the dose according to your needs and will also decide how long you will need to take the medicine. The maximum dose is 80 mg 2 times a day.

If you have taken more Nexopral than you should

If you take more Nexopral than the dose prescribed by your doctor, consult your doctor or pharmacist immediately.

If you forget to take Nexopral

If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose.

Do not take a double dose (two doses at the same time) to make up for a missed dose.

If you have any further questions related to the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

If you notice any of the following serious side effects, stop taking Nexopral and contact a doctor immediately:

Sudden wheezing, swelling of the lips, tongue and throat or body, rash, fainting or difficulty swallowing (severe allergic reaction).

Redness of the skin with blistering or peeling of the skin. There may also be severe blistering and bleeding from the lips, eyes, mouth, nose and genitals. This could be Stevens-Johnson syndrome or toxic epidermal necrolysis.

Yellowing of the skin, darkening of the urine and fatigue, which may be symptoms of a liver problem

and.

These reactions are rare - affecting less than 1 in 1,000 patients.

Other side effects are:

Very common: Affects more than 1 in 10 patients

Common: Affects less than 1 in 10 patients

Uncommon: Affects less than 1 in 100 patients

Rare: Affects less than 1 in 1,000 patients

Very rare: Affects less than 1 in 10,000 patients

Frequency not known: No estimate can be made from the available data

Frequent

Headache.

Effects on the stomach or intestines: diarrhea, stomach pain, constipation, gas (flatulence).

Nausea or vomiting.

Infrequent

Swelling of the feet and ankles.

Disturbed sleep (insomnia).

Dizziness, numbness, e.g. "pins and needles", drowsiness.

Dizziness (vertigo).

Dry mouth.

Changes in blood tests that check liver function.

Skin rash, raised rash (hives) and itchy skin.

Rare

Blood disorders, such as a reduced number of white blood cells or platelets. This can cause weakness, bruising and frequent infections.

Low blood sodium levels. This can lead to weakness, vomiting and cramps.

Feeling anxious, confused or depressed.

Changes in taste.

Visual disturbances such as blurred vision.

Sudden wheezing or shortness of breath (bronchospasm).

Inflammation of the oral cavity.

An infection called "thrush" that can affect the intestines and is caused by a fungus.

Liver problems, including jaundice, which can cause yellowing of the skin, dark urine and tiredness.

Hair loss (alopecia).

Skin rash when exposed to the sun.

Joint pain (arthralgia) or muscle pain (myalgia).

A feeling of general malaise and lack of energy.

Increased sweating.

Very rare

Changes in the blood count, including a lack of white blood cells (agranulocytosis) and a decrease in the number of red and white blood cells and platelets (pancytopenia).

Aggressiveness.

Seeing, feeling or hearing things that are not there (hallucinations).

Severe liver problems leading to liver failure and inflammation of the brain.

A severe rash with sudden onset or blistering or peeling of the skin. This may be associated with high fever and joint pain (Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).

Muscle weakness.

Severe kidney problems.

Male breast enlargement.

In very rare cases, Nexopral can affect white blood cells, leading to immune deficiency. If you have an infection with symptoms, e.g. fever with a severely impaired general condition or fever with symptoms of local infection, e.g. pain in the neck, throat or mouth, or you have difficulty urinating, you should consult your doctor as soon as possible so that a lack of white blood cells (agranulocytosis) can be ruled out by carrying out blood tests. It is important then to provide information about your treatment.

With an unknown frequency

If you take omeprazole for more than three months, it is possible that the levels of magnesium in your blood may fall. Low magnesium levels are seen (manifested) as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, increased heart rate. If you experience any of these symptoms, please tell your doctor immediately. A low level of magnesium can cause low levels of potassium or calcium in the blood. Your doctor may perform regular blood tests to track your magnesium level.

Don't be alarmed by this list of possible side effects. You may not get any of them. If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. How to store Nexopral

Keep out of the reach of children.

Do not use Nexopral after the expiration date stated on the package.

The expiration date corresponds to the last day of the specified month.

Do not store above 25°C.

Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the package and additional information

What Nexopral contains

The active substance is esomeprazole.

Each gastro-resistant tablet contains 40 mg of esomeprazole (as magnesium dihydrate).

The other ingredients are:

Tablet core: mannitol (E421); microcrystalline cellulose; sodium lauryl sulfate; hydroxypropyl cellulose; talc (E553b); methacrylic acid-ethyl acrylate copolymer 1:1; propylene glycol; triethyl citrate; polysorbate 80; glycerol monostearate 40-55; colloidal anhydrous silica; hypromellose; magnesium stearate; calcium hydrogen phosphate dihydrate; crospovidone.

Tablet coating: hypromellose 15cP (E464); titanium dioxide (E171); polydextrose (E1200); talc (E553b); maltodextrin; medium chain triglycerides; yellow iron oxide (E 172); red iron oxide (E 172).

What Nexopral looks like and what it contains

the packaging

Pink, oblong, biconvex, film-coated tablets, engraved with "40" on one side and measuring approximately 17.2 x 8.7 mm.

The tablets are available in cardboard boxes of 7, 14, 15, 28, 30, 50, 56, 60, 90, 98 and 100 tablets in blisters of ORA/aluminum/BUR/aluminum.

Not all types of packaging can be put on sale.