Esomeprazole medical valley: detailed information

Package leaflet: Information for the patient

Esomeprazole Medical Valley, 20 mg, enteric hard capsules
Esomeprazole Medical Valley, 40 mg, enteric hard capsules
Esomeprazolum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are similar.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

What Esomeprazole Medical Valley is and what it is used for
Important information before taking Esomeprazole Medical Valley
How to take Esomeprazole Medical Valley
Possible side effects
How to store Esomeprazole Medical Valley
Contents of the pack and other information

1. What Esomeprazole Medical Valley is and what it is used for

Esomeprazole Medical Valley contains a medicine called esomeprazole. It belongs to a group of medicines known as "proton pump inhibitors". These medicines work by reducing the amount of acid produced by the stomach.

Esomeprazole Medical Valley is used to treat the following conditions:

Adults

Gastroesophageal reflux disease (GERD). This condition occurs when acid from the stomach flows back into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
Stomach ulcers or ulcers in the upper part of the intestine infected with bacteria called Helicobacter pylori. In this case, your doctor may also prescribe antibiotics to eliminate the infection and allow the ulcer to heal.
Stomach ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs). Esomeprazole Medical Valley may also be used to prevent stomach ulcers while taking NSAIDs.
Excess stomach acid caused by a tumour in the pancreas (Zollinger-Ellison syndrome).
Long-term treatment following prevention of recurrent bleeding from ulcers with intravenously administered esomeprazole.

Adolescents aged 12 years and older

Gastroesophageal reflux disease (GERD). This condition occurs when acid from the stomach flows back into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
Stomach ulcers or ulcers in the upper part of the intestine infected with bacteria called Helicobacter pylori. In this case, your doctor may also prescribe antibiotics to eliminate the infection and allow the ulcer to heal.

2. Important information before using Esomeprazole Medical Valley

When not to use Esomeprazole Medical Valley

If the patient is allergic to esomeprazole or any of the other ingredients of this medicine (listed in section 6)
If the patient is allergic to other medicines in the group of proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole)
If the patient is taking a medicine containing nelfinavir (used in the treatment of HIV infections)
If the patient has ever experienced severe skin rash, skin peeling, blisters and/or oral ulcers after taking esomeprazole or other similar medicines

Do not use Esomeprazole Medical Valley if any of the above situations apply to the patient. In case of doubt, consult a doctor or pharmacist before using Esomeprazole Medical Valley.

Warnings and precautions

Before starting treatment with Esomeprazole Medical Valley, discuss the following with your doctor or pharmacist:

If the patient has severe liver disease
If the patient has severe kidney disease
If the patient has ever had a skin reaction after taking a medicine similar to Esomeprazole Medical Valley that reduces stomach acid secretion
If the patient is due to undergo a specific blood test (chromogranin A levels)

Esomeprazole Medical Valley may mask symptoms of other diseases. Therefore, if any of the following symptoms occur before starting or during treatment with Esomeprazole Medical Valley, contact a doctor immediately:

Unexplained significant weight loss and difficulty swallowing
Abdominal pain or indigestion
Vomiting food or blood
Black stools (stool containing blood)

If Esomeprazole Medical Valley has been prescribed for occasional, as-needed use, consult a doctor if symptoms do not improve or change in character.

Taking a proton pump inhibitor such as Esomeprazole Medical Valley, especially for longer than one year, may slightly increase the risk of fractures of the hip, wrist, or spine. Inform your doctor if the patient has osteoporosis or is taking corticosteroids (which may increase the risk of osteoporosis).

Skin rash and skin-related symptoms

If the patient develops a skin rash, especially in areas exposed to sunlight, inform the doctor as soon as possible, as treatment with Esomeprazole Medical Valley may need to be discontinued. Also inform the doctor about any other adverse effects, such as joint pain.

Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with treatment with Esomeprazole Medical Valley. Immediately discontinue use of Esomeprazole Medical Valley and seek medical help if the patient experiences any symptoms related to these severe skin reactions, as described in section 4.

Esomeprazole Medical Valley and other medicines

Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take. This includes medicines obtained without a prescription. This is because Esomeprazole Medical Valley may affect the way certain medicines work, and some medicines may affect the action of Esomeprazole Medical Valley.

Do not take Esomeprazole Medical Valley if the patient is also taking a medicine containing nelfinavir (used in the treatment of HIV infections).

Inform your doctor or pharmacist if the patient is 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 in the treatment of malignant tumours)
Citalopram, imipramine, or clomipramine (used in the treatment of depression)
Diazepam (used to treat anxiety, reduce muscle tension, or treat epilepsy)
Phenytoin (used in the treatment of epilepsy). If the patient is taking phenytoin, medical monitoring will be necessary at the start or end of treatment with Esomeprazole Medical Valley
Medicines used to thin the blood, such as warfarin. Medical monitoring may be necessary at the start or end of treatment with Esomeprazole Medical Valley
Cilostazol (used in the treatment of intermittent claudication – leg pain during walking due to poor blood flow)
Cisapride (used in the treatment of indigestion and heartburn)
Digoxin (used in the treatment of heart disorders)
Methotrexate (a chemotherapeutic agent used in high doses to treat malignant tumours) – if the patient is taking a high dose of methotrexate, the doctor may temporarily discontinue treatment with Esomeprazole Medical Valley
Tacrolimus (used in organ transplantation)
Rifampicin (used in the treatment of tuberculosis)
St. John’s wort (Hypericum perforatum) (used in the treatment of depression)

If the doctor has prescribed antibiotics – amoxicillin and clarithromycin – together with Esomeprazole Medical Valley to treat ulcers caused by Helicobacter pylori infection, it is very important to inform the doctor about all other medicines being taken.

Esomeprazole Medical Valley with food and drink

Capsules may be taken with food or on an empty stomach.

Pregnancy and breastfeeding

If the patient is pregnant, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine. The doctor will decide whether the patient may take Esomeprazole Medical Valley during this time. It is not known whether Esomeprazole Medical Valley passes into human milk. Therefore, do not take Esomeprazole Medical Valley while breastfeeding.

Driving and operating machinery

It is unlikely that Esomeprazole Medical Valley affects the ability to drive or operate tools or machinery. However, uncommon or rare side effects such as dizziness and blurred vision may occur (see section 4). If these occur, do not drive or operate machinery.

Esomeprazole Medical Valley contains sucrose

Esomeprazole Medical Valley contains sugar-coated pellets which contain sucrose, a type of sugar. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

Esomeprazole Medical Valley contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning the medicine is considered "sodium-free".

3. How to use Esomeprazole Medical Valley

This medicine should always be used exactly as directed by the doctor or pharmacist. In case of doubt, consult the doctor or pharmacist.

If long-term use of the medicine is required (especially longer than one year), medical monitoring may be necessary.
If the doctor has prescribed the medicine for occasional, as-needed use, inform the doctor of any changes in symptoms.

Dosage

The doctor will determine the dose and duration of treatment. The dose depends on the patient's health condition, age, and liver function.
Recommended dosages are given below:

Use in adults aged 18 years and older

Treatment of heartburn caused by gastroesophageal reflux disease (GERD):

If the doctor determines that the tube connecting the throat to the stomach (oesophagus) has been slightly damaged, the recommended dose is 40 mg of Esomeprazole Medical Valley once daily for 4 weeks. The doctor may recommend continuing the same dose for another 4 weeks if the oesophagus has not yet healed.
The recommended dose after healing of the oesophagus is 20 mg of Esomeprazole Medical Valley once daily.
If the oesophagus has not been damaged, the recommended dose of Esomeprazole Medical Valley is 20 mg once daily. After relief of symptoms, the doctor may recommend taking the medicine occasionally, as needed, at a dose of up to 20 mg per day.
If the patient has severe liver impairment, the doctor may recommend a lower dose.

Treatment of ulcers caused by Helicobacter pylori infection and prevention of disease recurrence:

The recommended dose is 20 mg of Esomeprazole Medical Valley twice daily for one week.
The doctor will also prescribe antibiotics, such as amoxicillin and clarithromycin.

Treatment of gastric ulcers caused by NSAIDs (non-steroidal anti-inflammatory drugs):

The recommended dose is 20 mg of Esomeprazole Medical Valley once daily for 4 to 8 weeks.

Prevention of gastric ulcers during NSAID use:

The recommended dose is 20 mg of Esomeprazole Medical Valley once daily.

Treatment of excessive stomach acid caused by a pancreatic tumour (Zollinger-Ellison syndrome):

The recommended dose is 40 mg of Esomeprazole Medical Valley twice daily.
The doctor will adjust the dose according to the patient's needs and decide on the duration of treatment. The maximum dose is 80 mg twice daily.

Long-term treatment following prevention of recurrent bleeding from ulcers with intravenous esomeprazole:

The recommended dose is 40 mg of Esomeprazole Medical Valley once daily for 4 weeks.

Use in adolescents aged 12 years and older

Treatment of heartburn caused by gastroesophageal reflux disease (GERD):

If the doctor determines that the tube connecting the throat to the stomach (oesophagus) has been slightly damaged, the recommended dose is 40 mg of Esomeprazole Medical Valley once daily for 4 weeks. The doctor may recommend continuing the same dose for another 4 weeks if the oesophagus has not yet healed.
The recommended dose after healing of the oesophagus is 20 mg of Esomeprazole Medical Valley once daily.
If the oesophagus has not been damaged, the recommended dose of Esomeprazole Medical Valley is 20 mg once daily.
If the patient has severe liver impairment, the doctor may recommend a lower dose.

Treatment of ulcers caused by Helicobacter pylori infection and prevention of disease recurrence:

The recommended dose is 20 mg of Esomeprazole Medical Valley twice daily for one week.
The doctor will also prescribe antibiotics, such as amoxicillin and clarithromycin.

Taking Esomeprazole Medical Valley

Capsules may be taken at any time of day.
Capsules may be taken with food or on an empty stomach.
Capsules should be swallowed whole with water. Do not chew or crush the capsules, as they contain pellets coated with an acid-resistant layer. It is very important not to damage the pellets.

What to do if you have difficulty swallowing capsules

If the patient has difficulty swallowing capsules:
- Carefully open the capsule and pour the pellets into a glass half-filled with non-carbonated water. Do not use any other liquids.
- Drink the mixture immediately or within 30 minutes. Always stir the mixture before drinking.
- To ensure the entire dose is taken, refill the glass with half a glass of water and drink it. The undissolved solid residue contains the medicine – do not chew or crush it.
- If the patient cannot swallow independently, the capsule contents should be mixed with water, drawn into a syringe, and administered through a gastric tube directly into the stomach.

Use in children and adolescents under 12 years of age

Esomeprazole Medical Valley is not recommended for use in children under 12 years of age.

Elderly patients

There is no need to adjust the dose in elderly patients.

Taking more Esomeprazole Medical Valley than recommended

If more Esomeprazole Medical Valley is taken than prescribed, contact a doctor or pharmacist immediately.

Missing a dose of Esomeprazole Medical Valley

If a dose is missed, take it as soon as possible. However, if it is almost time for the 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 about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following serious adverse reactions occur, stop taking
Esomeprazole Medical Valley immediately and contact your doctor at once:

Yellowing of the skin, dark urine, and fatigue, which may be symptoms of liver function disorders. These adverse reactions are rare and may affect no more than 1 in 1,000 people.
Sudden wheezing, swelling of the lips, tongue, throat, or entire body, rash, fainting, or difficulty swallowing (severe allergic reaction). These adverse reactions are rare and may affect no more than 1 in 1,000 people.
Sudden onset of severe rash and redness of the skin with blister formation or peeling, which may occur even after several weeks of treatment. Large blisters and bleeding from the lips, eyes, mouth, nose, or genital organs may also occur. These rashes may progress to severe, widespread skin damage (peeling of the epidermis and superficial mucous membranes), which may be life-threatening. These may be symptoms of erythema multiforme, Stevens-Johnson syndrome, or toxic epidermal necrolysis. These adverse reactions are very rare and may affect no more than 1 in 10,000 people.
Widespread rash, high fever, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). These adverse reactions are rare and may affect

no more than 1 in 1,000 people.
Other adverse reactions include:
Common (may affect up to 1 in 10 people)

Headache
Effects on stomach or intestines: diarrhoea, abdominal pain, constipation, bloating (with gas)
Nausea or vomiting
Benign polyps in the stomach

Uncommon (may affect up to 1 in 100 people)

Swelling of feet and ankles
Sleep disturbances (insomnia)
Dizziness, tingling sensations such as "pins and needles", drowsiness
Sensation of spinning (dizziness)
Dry mouth
Changes in blood test results assessing liver function
Skin rash, nodular rash (urticaria), itching of the skin
Fractures of the hip, wrist, or spine (if the medicine is used in high doses and for a long time)

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

Blood disorders, such as reduced number of white blood cells or platelets. This may cause weakness, easy bruising, or increase the likelihood of infection.
Low sodium levels in the blood. This may cause weakness, vomiting, and muscle cramps.
Feeling of restlessness, disorientation, or depression
Taste disturbances
Vision disorders, such as blurred vision
Sudden wheezing or shortness of breath (bronchospasm)
Inflammation inside the mouth
Fungal infection called "thrush", which may affect the intestines
Liver function disorders, including jaundice, which may cause yellowing of the skin, dark urine, and fatigue
Hair loss (alopecia)
Skin rash after exposure to sunlight
Joint pain (arthralgia) or muscle pain (myalgia)
Malaise and lack of energy
Excessive sweating

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

Disorders in blood cell counts, including agranulocytosis (lack of white blood cells)
Aggression
Seeing, hearing, or sensing things that are not there (hallucinations)
Severe liver function disorders leading to liver failure and encephalopathy
Sudden onset of severe rash, blisters, or peeling of the skin. These symptoms may be accompanied by high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms)
Muscle weakness
Severe kidney function disorders
Enlargement of the breasts in men

Frequency unknown (frequency cannot be estimated from available data):

If the patient takes Esomeprazole Medical Valley for longer than three months, a decrease in blood magnesium levels may occur. Low magnesium levels may present as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, or rapid heartbeat. If any of these symptoms occur, the doctor should be informed immediately. Low magnesium levels may also lead to decreased levels of potassium or calcium in the blood. The doctor may decide to perform regular blood tests to monitor magnesium levels.
Inflammation of the intestines (leading to diarrhoea)
Rash with possible joint pain.

Esomeprazole Medical Valley may, in very rare cases, affect the number of white blood cells, leading to immunodeficiency. If an infection occurs with symptoms such as fever accompanied by marked deterioration in the patient's general condition, or fever with signs of local infection such as neck, throat, or mouth pain, or difficulty urinating, medical advice should be sought immediately so that blood tests can rule out lack of white blood cells (agranulocytosis). It is important to inform the doctor about taking this medicine in such a situation.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C,
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Esomeprazole Medical Valley

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack, carton or bottle
after: EXP. The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Keep in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. This will help protect
the environment.

6. Contents of the pack and other information

What Esomeprazole Medical Valley contains

The active substance is esomeprazole. Each hard enteric capsule contains esomeprazole magnesium trihydrate equivalent to 20 mg or 40 mg of esomeprazole.
Other ingredients are:
Capsule contents: sucrose, granules (containing sucrose and corn starch), hypromellose, talc, polysorbate 80, hydroxypropylcellulose, methacrylic acid-ethyl acrylate copolymer (1:1), 30% dispersion (containing sodium dodecyl sulfate and polysorbate 80), triethyl citrate.

Capsule shell:
20 mg – gelatin, titanium dioxide (E 171), iron oxide red (E 172)
40 mg – gelatin, titanium dioxide (E 171)

What Esomeprazole Medical Valley looks like and contents of the pack
Esomeprazole Medical Valley, enteric hard capsules, is available in two strengths, containing 20 mg or 40 mg of esomeprazole.

20 mg capsules are capsules with a pink cap and pink body (length: approximately 15 mm), containing enteric pellets of white to dark cream colour.
40 mg capsules are capsules with a white cap and white body (length: approximately 17 mm), containing enteric pellets of white to dark cream colour.

Esomeprazole Medical Valley 20 mg, enteric hard capsules, is available in the following pack sizes:

Blister packs made of OPA/Aluminium PVC/Aluminium foil, in cardboard boxes containing 7, 14, 28, 30, 35, 50, 56 or 60 capsules.
HDPE (high-density polyethylene) bottle with PP cap incorporating a desiccant containing silica gel, containing 62 capsules, in a cardboard box. HDPE bottle of 100 mL capacity – 62 capsules.

Esomeprazole Medical Valley 40 mg, enteric hard capsules, is available in the following pack sizes:

Blister packs made of OPA/Aluminium PVC/Aluminium foil, in cardboard boxes containing 7, 14, 28, 30, 35, 50, 56 or 60 capsules.
HDPE (high-density polyethylene) bottle with PP cap incorporating a desiccant containing silica gel, containing 62 capsules, in a cardboard box. HDPE bottle of 100 mL capacity – 62 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Medical Valley Invest AB
Brädgårdsvägen 28
236 32 Höllviken
Sweden
email: [email protected]

Manufacturer
Laboratorios Liconsa S.A.
Avenida De Miralcampo 7
Poligono Industrial Miralcampo
19200 Azuqueca De Henares, Guadalajara
Spain

This medicinal product is authorised in the European Economic Area countries under the following names:
Denmark: Esomeprazol “Medical Valley”
Netherlands: Esomeprazole Liconsa 20 mg Maagsapresistente capsule, hard
Esomeprazole Liconsa 40 mg Maagsapresistente capsule, hard
Iceland: Esomeprazole Pinewood 20 mg Gastro-resistant Hard Capsules
Esomeprazole Pinewood 20 mg Gastro-resistant Hard Capsules
Germany: Esomeprazol AXiromed 20 mg magensaftresistente Hartkapsel
Esomeprazol AXiromed 40 mg magensaftresistente Hartkapsel
Norway: Esomeprazol Medical Valley
Poland: Esomeprazole Medical Valley
Sweden: Esomeprazol Medical Valley

Further information
Detailed information about this medicinal product is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, www.urpl.gov.pl

Information intended exclusively for professional medical personnel:

Administration via an 8 French nasogastric tube (PUR or silicone)

Open the capsule and pour the pellets into an appropriate syringe, then fill the syringe with approximately 50 mL of water.
Use of PUR or silicone nasogastric tubes is recommended. PVC tubes should not be used, as adherence of pellets to the surface of PVC tubes has been observed, resulting in reduced drug recovery at the tube's distal end. Immediately after adding water, shake the syringe vigorously to ensure uniform dispersion of pellets throughout the suspension.
Immediately after adding water, shake the syringe vigorously to ensure uniform dispersion of pellets throughout the suspension.
Turn the syringe with the delivery tip upward and check whether it is blocked.
Connect the tube and syringe, holding the syringe upright (with the delivery tip pointing upward).
Shake the syringe, then turn it with the delivery tip downward. Immediately administer 5 to 10 mL into the tube. After administration, turn the syringe with the delivery tip upward and shake (keep the syringe upright with the delivery tip upward to prevent blockage).
Turn the syringe with the delivery tip downward and immediately administer the next 5 to 10 mL into the tube. Repeat these steps until the syringe is completely emptied.
If necessary, refill the syringe with 10 mL of water and repeat the procedure described in step 5 to remove any residue remaining in the syringe. When using certain types of nasogastric tubes, it may be necessary to add up to 50 mL of water.