20 mg enteric capsule, hard 
esomeprazole

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

Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist.

– Save this information, you may need to read it again.

– If you need more information and advice, contact the pharmacy staff.

– 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.

– You must talk to a doctor if you do not feel better or if you feel worse after 14 days.

In this leaflet: 
1. What Esomeprazole Apofri is and what it is used for 
2. What you need to know before you use Esomeprazole Apofri 
3. How to use Esomeprazole Apofri 
4. Possible side effects 
5. How to store Esomeprazole Apofri 
6. Contents of the pack and other information 

What Esomeprazole Apofri is and what it is used for

Esomeprazole Apofri contains the active substance 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 Apofri is indicated for the short-term treatment of reflux symptoms (eg heartburn and acid reflux).

Reflux is the reflux of acid from the stomach to the esophagus (the connection between the mouth and stomach) that can become inflamed and hurt. This can cause symptoms such as a painful feeling in the chest that rises in the throat (heartburn) and a sour taste in the mouth (acid regurgitation).

You may experience relief from the symptoms of acid reflux and heartburn after the first day you have taken this medicine, but Esomeprazole Apofri is not intended to provide immediate relief. You may need to take the capsules 2-3 days in a row before you feel better. You must talk to a doctor if you do not feel better or if you feel worse after 14 days.

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

What you need to know before you use Esomeprazole Apofri

Do not use Esomeprazole Apofri

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

Warnings and cautions

Talk to your doctor before using Esomeprazole Apofri if:

  • you have severe liver problems
  • you have severe kidney problems
  • you have ever had a skin reaction after treatment with medicine like Esomeprazole Apofri that reduces stomach acid
  • you should undergo a specific blood test (chromogranin A).

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

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

• 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 your symptoms are persistent or change in nature, consult a doctor.

Using proton pump inhibitors such as Esomeprazole Apofri and especially if you use Esomeprazole Apofri for more than one 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.

Children and young people

This medicine should not be used by children and adolescents under 18 years of age.

Other medicines and Esomeprazole Apofri

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

Do not use Esomeprazole Apofri if you are taking any medicine containing nelfinavir(used to treat HIV – infection ).

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

  • atazanavir (used in 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, for 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 Esomeprazole Apofri.
  • cilostazol (used to treat window disease – pain in the legs when walking due to insufficient blood supply to the legs)
  • drugs used for blood thinning, such as warfarin. Your doctor may need to monitor you when you start or stop using Esomeprazole Apofri.
  • cisapride (used for digestive problems or heartburn).
  • digoxin (used for heart problems)
  • methotrexate (a chemotherapeutic drug used in high doses to treat cancer) – if you are taking high doses of methotrexate, your doctor may pause your treatment with Esomeprazole Apfori
  • rifampicin (used to treat tuberculosis ).
  • St. John’s wort ( Hypericum perforatum) (used to treat depression).
  • tacrolimus (used in organ transplantation)

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

Esomeprazole Apofri with food, drink, and alcohol

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, 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 Apofri during that time.

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

Driving and using machines

Esomeprazole Apofri is unlikely to affect your ability to drive or use tools or machines. However, side effects such as dizziness and visual disturbances may occur in less common cases. (see section 4).

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.

How to use Esomeprazole Apofri

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

How much should you take?

• The recommended dose is one capsule per day.

• Do not take more than this recommended dose of one capsule (20 mg) per day, even if you do not feel any immediate improvement.

• You may need to take the capsules 2 or 3 days in a row before your reflux symptoms (for example

heartburn and acid reflux) gets better.

• The treatment time is up to 14 days.

• Stop taking this medicine when your reflux symptoms have completely disappeared.

If your reflux symptoms worsen or do not improve after taking this medicine

For 14 days in a row, consult a doctor.

If you have persistent or prolonged, recurrent symptoms even after treatment with this medicine, consult your doctor.

Taking the medicine

• The capsules can be taken at any time of the day or night.

• The capsules can be taken with food or on an “empty stomach”.

• Swallow the capsules are whole with water. Do not chew or crush the capsules as they contain granules that are coated with a substance that protects the medicine from falling apart in the acidic environment of your stomach. It is therefore important that the granules are not damaged.

What to do if you have difficulty swallowing the enteric capsule

• Open the capsule and pour the granules into half a glass (not carbonated) water. Do not use other liquids.

Stir and drink the mixture immediately or at the latest within 30 minutes. Always stir the mixture immediately before drinking it. The solution will not be ready.

• To be sure that you have ingested all the medicine, rinse thoroughly out of the glass with another half glass of water and drink it up. The solid granules contain the medicine – do not chew or crush them.

If you use more Esomeprazole Apofri than you should  

If you take more Esomeprazole Apofri than you should If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you forget to use Esomeprazole Apofri

If you forget to take a dose, take it as soon as you remember. If it is near the time of the next dose – skip the missed dose. Do not take a double dose (two doses at the same time) to compensate for a missed 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, Esomeprazole Apofri can cause side effects, although not everybody gets them.

Stop taking Esomeprazole Apofri 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 blisters or peeling. 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 may be symptoms of liver problems.

These side effects are rare and occur in less than 1 in 1,000 users.

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 in the stomach.

Uncommon (may affect up to 1 in 100 people):

• swelling of the feet and ankles

• sleep disorders (insomnia)

• dizziness, tingling, drowsiness

• vertigo ( vertigo )

• dry mouth

• changes in the blood picture that show the function of the liver

• skin rash, hives, and itching

• hip, wrist, or vertebral fractures (if Esomeprazole Apofri 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 reduced 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 upset, confused, or depressed

• 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” that can affect the gut

• 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 feeling of illness and lack of energy

• increased sweating.

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

• changes in blood count, 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 appearance 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 ( frequency can not be calculated from available data):

• if you use Esomeprazole Apofri for more than three months, your blood magnesium levels may drop. Low levels of magnesium in the blood 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 your blood magnesium levels using regular blood tests.

• inflammation of the intestine (causes diarrhea)

• skin rash, possibly with joint pain.

Esomeprazole Apofri can in very rare cases affect the white blood cells so that the immune system is weakened. If you get an infection with symptoms such as fever and severe general malaise, or fever with symptoms of local infection such as pain in the neck, throat, or mouth or difficulty urinating, you should contact a doctor as soon as possible so that any lack of white blood cells ( agranulocytosis ) can be ruled out by a blood test. It is important that you then information about your medication.

Reporting of side effects ar

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly via:

The Medical Products Agency

Box 26

SE-751 03 Uppsala

www.lakemedelsverket.se.

By reporting side effects, you can help increase drug safety information.

5. How to store Esomeprazole Apofri

Keep out of sight and reach of children.

Do not store above 25 ° C.

Close the jar tightly. Store the medicine in the original package (blister). Moisture sensitive.

Do not use this medicine after the expiry date which is stated on the carton after EXP. or “EXP”. The expiration date is the last day of the specified month.

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 Apofri hard enteric capsules contain 20 mg of esomeprazole (as magnesium dihydrate).

Other ingredients are:

Capsule contents

Pellet core: carrageenan, microcrystalline cellulose, mannitol, sodium hydroxide, sodium bicarbonate

Insulating casing: polyvinyl alcohol-PEG copolymer, sodium hydroxide, talc, titanium dioxide (E171), colloidal hydrogenated silicon

Acid-resistant coating: methacrylic acid-ethyl acrylate copolymer (1: 1), triethyl citrate, talc, titanium dioxide (E171).

Capsules:

Capsule cap: gelatin, titanium dioxide (E171), iron oxide, yellow (E172)

Capsule body: gelatin, titanium dioxide (E171)

What the medicine looks like and the contents of the pack

Enterocapsules, hard, with white opaque capsule body and light yellow opaque capsule lid, containing white to off-white acid-resistant granules.

The capsules are packed in an HDPE plastic jar with a desiccant capsule in the polypropylene lid or aluminum-aluminum blisters. The desiccant capsule must not be ingested.

Pack sizes: 14 and 28 capsules

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

Apofri AB

Box 120

182 12 Danderyd

Manufacturer

Medinsa SA

Solana, 26

28850 Torrejón de Ardoz Madrid

Spain

Muhammad Nadeem

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