20 mg and 40 mg hard enteric 
capsules esomeprazole

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

This leaflet contains information about: 
1. What Esomeprazole Pensa is and what it is used for 
2. What you need to know before you use Esomeprazole Pensa 
3. How to use Esomeprazole Pensa 
4. Possible side effects 
5. Storage of Esomeprazole Pensa
6. Contents of the packaging and other information 

What Esomeprazole Pensa is and what it is used for

Esomeprazole Pensa contains a medicine called esomeprazole. It belongs to a group of medicines called proton pump inhibitors. These work by reducing the amount of acid produced in the stomach.

Esomeprazole Pensa is used to treat the following conditions:

Adults

  • Gastroesophageal reflux disease ( GERD ). This is when acid from the stomach leaks into the esophagus (the connection between the mouth and the stomach) and causes pain, inflammation, and heartburn.
  • Ulcers in the stomach or upper intestine are infected by a bacterium called ” Helicobacter pylori “. If you have such wounds, your doctor may also prescribe antibiotics to treat the infection and to allow wound healing.
  • A gastric ulcer is caused by so-called NSAIDs (Non-steroidal anti-inflammatory drugs). Esomeprazole Pensa can also be used to prevent stomach ulcers when taking NSAIDs 
  • Too much acid in the stomach is caused by a tumor in the pancreas (Zollinger-Ellison syndrome).
  • Continued treatment to prevent new bleeding from wounds after treatment with intravenous esomeprazole.

Young people from 12 years

  • Gastroesophageal reflux disease ( GERD ). This is when acid from the stomach leaks into the esophagus (the connection between the mouth and the stomach) and causes pain, inflammation, and heartburn.
  • Ulcers in the stomach or upper intestine are infected by a bacterium called ” Helicobacter pylori “. If you have such wounds, your doctor may also prescribe antibiotics to treat the infection and to allow wound healing.

Esomeprazole contained in Esomeprazole Pensa may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before using Esomeprazole Pensa

Do not take Esomeprazole Pensa

  • 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 (eg pantoprazole, lansoprazole, rabeprazole, omeprazole).
  • if you are taking a medicine containing nelfinavir (used to treat HIV – infection ).

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

Warnings and cautions

Talk to your doctor before taking Esomeprazole Pensa:

  • if you have severe liver problems.
  • if you have severe kidney problems.
  • if you have ever had a skin reaction after treatment with a medicine similar to Esomeprazole Pensa that reduces stomach acid.
  • if you are going to have a special blood test (chromogranin A).

Esomeprazole Pensa can mask the symptoms of other diseases. Therefore, you should contact your doctor immediately if any of the following occur before you start taking Esomeprazole Pensa, or while you are taking it:

  • You lose a lot of weight for no reason and have trouble swallowing.
  • You get stomach pains or indigestion.
  • You start vomiting food or blood.
  • You get black (blood-mixed) stools.

If you have been prescribed Esomeprazole Pensa to take “as needed”, consult your doctor if your symptoms persist or change in nature.

Using proton pump inhibitors such as Esomeprazole Pensa and especially if you use Esomeprazole Pensa for more than a year may increase the risk of hip, wrist, or vertebral fractures. Tell your doctor if you have osteoporosis ( osteoporosis ) or if you use medicines called corticosteroids because they may increase the risk of osteoporosis.

If you get a rash, especially in areas exposed to the sun, tell your doctor as soon as possible as you may need to stop taking Esomeprazole Pensa.

Also remember to mention any other side effects, such as joint pain.

Other medicines and Esomeprazole Pensa

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription, as Esomeprazole Pensa may affect the way other medicines work, and other medicines may affect the effect of Esomeprazole Pensa.

Do not take Esomeprazole Pensa if you are taking a medicine containing nelfinavir (used to treat HIV – infection ).

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

  • Atazanavir or saquinavir (used for the treatment of HIV – infection ).
  • Clopidogrel (used to prevent blood clots).
  • Ketoconazole , itraconazole or voriconazole (used to treat fungal infections).
  • Erlotinib (used to treat cancer).
  • 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 when you start or stop taking Esomeprazole Pensa.
  • Drugs used for blood thinning, such as warfarin. Your doctor may need to monitor you when you start or stop taking Esomeprazole Pensa.
  • Cilostazol (used to treat window disease – pain in the legs when walking due to insufficient blood supply to the legs).
  • Cisapride (used for indigestion or heartburn).
  • Digoxin (used for heart problems).
  • Tacrolimus (organ transplantation).
  • Methotrexate (a chemotherapeutic drug used in high doses to treat cancer) – if you are taking high doses of methotrexate, your doctor may temporarily stop your treatment with Esomeprazole Pensa.
  • Rifampicin (used to treat tuberculosis ).
  • St. John’s wort – Hypericum perforatum (used to treat depression).

If the doctor has prescribed the antibiotics amoxicillin and clarithromycin, in combination with esomeprazole Pensa to treat ulcers caused by Helicobacter pylori – infection, you must tell your doctor if you are also taking other medicines.

Esomeprazole Pensa with food and drink

You can take your capsules with a meal or on an empty stomach.

Pregnancy, breastfeeding, and fertility

If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will decide if you can take Esomeprazole Pensa during that time.

It is not known if Esomeprazole Pensa passes into breast milk. Therefore, you should not take Esomeprazole Pensa if you are breast-feeding.

Driving and using machines

Esomeprazole Pensa is unlikely to affect your ability to drive or handle tools or machines. However, side effects such as dizziness and visual disturbances may occur in uncommon cases or rare cases (see section 4). If you are affected, do not drive or use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Esomeprazole Pensa contains sucrose

Esomeprazole Pensa contains granules (round grains) of sucrose, which is a type of sugarIf you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to use Esomeprazole Pensa

Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

  • If you use this medicine for a long time, your doctor will want to follow up on your treatment (especially if you are taking the medicine for more than a year).
  • If you have been told by your doctor that you must take this medicine, tell your doctor if your symptoms change.

Recommended dose

  • Your doctor will tell you how many capsules to take and how long to take them. Dosage one depends on your condition, how old you are, and how well your liver is working.
  • The recommended doses are given below.

Adults from 18 years

For the treatment of heartburn caused by gastroesophageal reflux disease ( GERD ):

  • If your doctor has found that your esophagus is slightly damaged, the recommended dose is one capsule of Esomeprazole Pensa 40 mg once daily for 4 weeks. 
    Your doctor may recommend that you take the same dose for another 4 weeks if the damage to your esophagus is not healed.
  • The recommended dose when the esophagus is healed is 1 capsule of Esomeprazole Pensa 20 mg once daily.
  • If your esophagus is not damaged, the recommended dose is 1 capsule of Esomeprazole Pensa 20 mg once daily. When your condition is under control, your doctor may recommend that you take the medicine up to a maximum of 1 capsule of Esomeprazole Pensa 20 mg once daily if necessary.
  • If you have a severe hepatic impairment, your doctor may recommend a lower dose.

To treat ulcers caused by Helicobacter pylori – infection and to prevent the ulcer from occurring again :

  • The recommended dose is 1 capsule of Esomeprazole Pensa 20 mg twice daily for one week.
  • Your doctor will also recommend that you take antibiotics, such as amoxicillin and clarithromycin.

For the treatment of stomach ulcers caused by NSAIDs (Non-steroidal anti-inflammatory drugs):

  •  The recommended dose is 1 capsule of Esomeprazole Pensa 20 mg once daily for 4 to 8 weeks.

To prevent stomach ulcers if you are taking NSAIDs (Non-steroidal anti-inflammatory drugs):

  • The recommended dose is 1 capsule of Esomeprazole Pensa 20 mg once daily.

For the treatment of excess acid in the stomach caused by a tumor of the pancreas (Zollinger-Ellison syndrome):

  • The recommended dose is 1 capsule of Esomeprazole Pensa 40 mg twice daily.
  • Your doctor will adjust the dose according to your needs and will also decide how long you should take the medicine. The maximum dose is 80 mg twice daily.

Continued treatment to prevent new bleeding from wounds after treatment with intravenous Esomeprazole :

  • The recommended dose is 1 capsule of Esomeprazole Pensa 40 mg once daily for 4 weeks.

Young people from 12 years

For the treatment of heartburn caused by gastroesophageal reflux disease ( GERD ):

  • If your doctor has found that your esophagus is slightly damaged, the recommended dose is 1 capsule of Esomeprazole Pensa 40 mg once daily for 4 weeks. 
    Your doctor may recommend that you take the same dose for another 4 weeks if the damage to your esophagus is not healed.
  • The recommended dose one after the esophagus is healed is 1 capsule of Esomeprazole Pensa 20 mg once daily.
  • If your esophagus is not damaged, the recommended dose is 1 capsule of Esomeprazole Pensa 20 mg once daily.
  • If you have a severe hepatic impairment, your doctor may recommend a lower dose.

To treat ulcers caused by Helicobacter pylori – infection and to prevent the ulcer from occurring again:

  • The recommended dose is 1 capsule of Esomeprazole Pensa 20 mg twice daily for one week.
  • Your doctor will also recommend that you take antibiotics, such as amoxicillin and clarithromycin.

Taking the medicine

  • You can take the capsules at any time of the day.
  • You can take the capsules with a meal or on an empty stomach.
  • Swallow the capsules whole with a glass of water. Do not chew or crush the capsules or their contents. This is because the capsules contain granules covered with a casing that prevents the medicine from being broken down by the acid in the stomach. The granules mustn’t be damaged.

What you can do if you have difficulty swallowing the capsules

  • If you have problems swallowing the capsules:1) Carefully open the capsule above a glass of water (not carbonated) and empty the contents of the capsule ( granules one) into the glass. Do not use other liquids.2) Stir. Drink mixture one at a time or within 30 minutes. Always stir the mixture one before drinking it.3) To make sure you have taken all the medicine; rinse the glass thoroughly with another half glass of water and drink up. The solid particles contain the medicine – do not chew or crush them.
  • If you can not swallow at all, the contents of the capsule can be mixed with a little water and placed in a syringe. Mixture one can then be given directly into the stomach via a probe.

Children under 12 years

Esomeprazole Pensa should not be used by children under 12 years of age.

Older

Dose one does not need to be adapted to the elderly.

If you take more Esomeprazole Pensa then you should

If you have ingested too much medicine or if e.g. a child ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you forget to take Esomeprazole Pensa

  • If you forget to take a dose, take it as soon as you notice it. If it is near the time of the next dose – skip the missed dose.
  • Do not take a double dose to make up for a forgotten dose.

If you have any further questions on 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.

Stop taking Esomeprazole Pensa and contact your doctor immediately if you notice any of the following serious side effects:

  • 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 flaking. Severe blistering and bleeding on the lips, eyes, mouth, nose, and genitals may also occur. This can be “Stevens-Johnson syndrome” or “toxic epidermal necrolysis”.
  • Yellowed skin, dark urine, and fatigue, which can be symptoms of liver problems.

These side effects are rare and may affect up to 1 in 1,000 people.

Other side effects include:

Common (may affect up to 1 in 10 people)

  • Headache.
  • Effects on the stomach or intestines: diarrhea, abdominal pain, constipation, flatulence.
  • Nausea or vomiting.
  • Benign polyps are in the stomach.

Uncommon (may affect up to 1 in 100 people)

  • Swelling of the feet and ankles.
  • Sleep disorders (insomnia).
  • Dizziness, tingling, drowsiness.
  • Scams ( vertigo ).
  • Dry mouth.
  • Changes in the blood picture show the function of the liver.
  • Skin rash, hives, and itching.
  • Hip, wrist, or vertebral fractures (if Esomeprazole Pensa is used in high doses and for a long time).

Rare (may affect up to 1 in 1,000 people)

  • Altered blood count such as decreased number of white blood cells or platelets. This can cause weakness, bruising, or susceptibility to infection.
  • Low levels of sodium in the blood. This can cause weakness, vomiting, and cramps.
  • Feeling of agitation, confusion, or depression.
  • Taste changes.
  • Vision problems, such as blurred vision.
  • Sudden wheezing or shortness of breath ( bronchospasm ).
  • Inflammation of the oral cavity.
  • A fungal infection called “cod” can affect the intestines.
  • Liver problems including jaundice, which can cause yellowing of the skin, dark urine, and fatigue.
  • Hair loss ( alopecia ).
  • Skin rash when sunbathing.
  • Joint pain ( arthralgia ) or muscle pain ( myalgia ).
  • General malaise and lack of energy.
  • Increased sweating.

Very rare (may affect up to 1 in 10,000 people)

  • Changes in the blood picture including agranulocytosis (lack of white blood cells ).
  • Aggression.
  • Hallucinations (seeing, feeling, or hearing things that do not exist).
  • Severe liver problems leading to liver failure and encephalitis.
  • Sudden onset of severe rash, blistering or flaky skin. This may be associated with high fever and joint pain (Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis ).
  • Muscle weakness.
  • Severe kidney problems.
  • Enlargement of the mammary glands in men.

No known frequency (cannot be calculated from the available data)

  • If you use Esomeprazole Pensa for more than three months, your blood magnesium levels may drop. Low levels of magnesium can manifest as fatigue, involuntary muscle movements, confusion, cramps, dizziness, and rapid heartbeat. If you get any of these symptoms, contact your doctor immediately. Low levels of magnesium can also lead to decreased levels of potassium or calcium in the blood. Your doctor may measure the level of magnesium in your blood using regular blood tests.
  • Inflammation of the intestine (causes diarrhea).
  • Skin rash, possibly with joint pain.

In very rare cases, esomeprazole Pensa can affect the white blood cells so that the immune system is weakened. If you have an infection with symptoms such as fever with severe deterioration of the general condition or fever with symptoms of a local infection such as. pain in the throat, pharynx, or mouth or difficulty urinating, you must seek medical attention as soon as possible so that any lack of white blood cells ( agranulocytosis ) can be ruled out with a blood test. It is important that you then provide information about the medicines you are taking.

5. Storage of Esomeprazole Pensa

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton, jar, or blister. The expiration date is the last day of the specified month.

Blister: 
Do not store above 30 ° C. Store in the original package. Moisture sensitive.

Jar: 
Do not store above 30 ° C. Close the jar tightly. Moisture sensitive.

Shelf life for the opened jar: 6 months.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is esomeprazole. Esomeprazole Pensa enteric capsules are available in two strengths containing 20 mg or 40 mg of esomeprazole (as sodium salt).
  • Other ingredients are Capsule contents: Sugar spheres (sucrose and corn starch), methylcellulose, talc, titanium dioxide (E171), glycerol monostearate, polysorbate 80, sodium lauryl sulfate, methacrylic acid ethyl acrylate copolymer, and triethyl citrate.
    Capsule shell: Carrageenan, potassium chloride, red iron oxide (E172), titanium dioxide (E171), hypromellose, capsule labeling (shellac, potassium hydroxide, and black iron oxide (E172)).

What the medicine looks like and the contents of the pack

Esomeprazole Pensa 20 mg enteric capsules

Esomeprazole Pensa 20 mg enteric capsules have an opaque light pink upper and lower part, size 4 (approx. 14 mm), marked with “ES” on the upper part and “20” on the lower part. The capsule contains round granules.

Aluminum / aluminum blister:

7, 14, 28, 30 and 56 capsules

White opaque polyethylene (PE) jar with desiccant (silica gel) and PE lid with a safety closure:

14, 28, 90, 100, and 500 capsules

Esomeprazole Pensa 40 mg enteric capsules

Esomeprazole Pensa 40 mg capsules have an opaque pink top and bottom, size 2 (approximately 18 mm), marked with “ES” on the top and “40” on the bottom. The capsule contains round granules.

Aluminum / aluminum blister:

7, 14, 28, 30 and 56 capsules

A white opaque plastic jar of polyethylene (PE) with desiccant (silica gel) and PE lid with a safety closure:

14, 28, 90, 100, and 500 capsules

Not all pack sizes may be marketed.

Manufacturer

TOWA PHARMACEUTICAL EUROPE, SL

C / de Sant Marti, 75-97

08107 Martorelles (Barcelona)

Spain

This medicinal product is authorized under the European Economic Area under the following names:

Country Name
THE Esomeprazole Apomed
DK, NO, NL, SE Esomeprazole Pensa
IT Esomeprazolo Pensa Pharma

Muhammad Nadeem

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