Esomeprazole Ratiopharm 40 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Esomeprazol ratiopharm 20 mg gastro-resistant tablets EFG

Esomeprazol ratiopharm 40 mg gastro-resistant tablets EFG

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.

• If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you. It could harm them.

• If you get any side effects, talk to your doctor or pharmacist, even if the side effects are not listed in this leaflet. See section 4.

Leaflet contents:

1. What Esomeprazol ratiopharm is and what it is used for
2. What you need to know before taking Esomeprazol ratiopharm
3. How to take Esomeprazol ratiopharm
4. Possible side effects
5. How to store Esomeprazol ratiopharm
6. Contents of the pack and other information

1. What is Esomeprazol ratiopharm and what is it used for?

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

Esomeprazole is used to treat the following conditions:

Adults

• Gastro-oesophageal reflux disease (GORD). This occurs when stomach acid flows back up into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
• Stomach or upper intestinal ulcers caused by a bacterium called "Helicobacter pylori". If you have this condition, your doctor will also prescribe antibiotics to treat the infection and help heal the ulcer.
• Stomach ulcers caused by medicines known as NSAIDs (non-steroidal anti-inflammatory drugs). Esomeprazol ratiopharm may also be used to help prevent ulcers in patients taking NSAIDs.
• Excessive stomach acid caused by a tumour in the pancreas (Zollinger-Ellison syndrome).
• Continuation treatment to prevent rebleeding from peptic ulcer following initial intravenous esomeprazole therapy.

Adolescents aged 12 years and older

• Gastro-oesophageal reflux disease (GORD). This occurs when stomach acid flows back up into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
• Stomach or upper intestinal ulcers caused by a bacterium called "Helicobacter pylori". If you have this condition, your doctor will also prescribe antibiotics to treat the infection and help heal the ulcer.

2. What you need to know before taking Esomeprazol ratiopharm

Do not take Esomeprazol ratiopharm

• 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 medicines in the proton pump inhibitor group (for example pantoprazole, lansoprazole, rabeprazole, omeprazole).
• If you are taking a medicine containing nelfinavir (used in the treatment of HIV infection).

Do not take Esomeprazol ratiopharm if any of these situations apply to you. If you are unsure, consult your doctor or pharmacist before taking Esomeprazol ratiopharm.

Warnings and precautions

Talk to your doctor or pharmacist before taking Esomeprazol ratiopharm:

• 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 Esomeprazol ratiopharm used to reduce stomach acidity.
• If you are scheduled to have a specific blood test (Chromogranin A).

Esomeprazol ratiopharm may mask symptoms of other diseases. Therefore, if you experience any of the following events before or while taking Esomeprazol ratiopharm, contact your doctor immediately:

• You lose a lot of weight without reason and have difficulty swallowing.
• You have stomach pain or indigestion.
• You start vomiting food or blood.
• Your stools appear black (blood-stained).

If Esomeprazol ratiopharm has been prescribed for you only when you have symptoms, you should contact your doctor if your symptoms persist or change.

Taking proton pump inhibitors such as Esomeprazol ratiopharm, especially for periods longer than one year, may slightly increase the risk of hip, wrist, and spine fractures. Consult your doctor if you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).

Skin rashes and skin symptoms

If you develop a skin rash, especially in areas exposed to sunlight, see your doctor as soon as possible, as treatment with Esomeprazol ratiopharm may need to be stopped. Remember to mention any other symptoms you may notice, such as joint pain.

Severe skin reactions have occurred in patients taking esomeprazole (see also section 4). The rash may include ulcers in the mouth, throat, nose, genitals, and conjunctivitis (red, swollen eyes). These severe skin reactions usually occur after flu-like symptoms such as fever, headache, and body aches. The rash may cover large areas of the body with blisters and skin peeling.

If at any time during treatment (even after several weeks) you develop a rash or any of these skin symptoms, stop taking this medicine and contact your doctor immediately.

Children under 12 years

Esomeprazol ratiopharm must not be used in children under 12 years of age. There are other pharmaceutical forms of this medicine more suitable for this age group.

Taking Esomeprazol ratiopharm with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription. This is because Esomeprazol ratiopharm may affect how some medicines work, and some medicines may influence the effect of Esomeprazol ratiopharm.

Do not take Esomeprazol ratiopharm if you are taking a medicine containing nelfinavir (used to treat HIV infection).

• Atazanavir or saquinavir (used to treat HIV infection)
• Clopidogrel (used to prevent blood clots)
• Ketoconazole, itraconazole or voriconazole (for fungal infections)
• Erlotinib (used to treat cancer)
• Digoxin (used to treat heart problems)
• Citalopram, imipramine, clomipramine (for treatment of depression)
• Diazepam (used to treat anxiety, as a muscle relaxant, or for epilepsy)
• Phenytoin (for epilepsy). If you are taking phenytoin, your doctor will need to monitor when you start or stop taking Esomeprazol ratiopharm
• Medicines used to thin the blood such as warfarin. Your doctor may need to monitor when you start or stop taking Esomeprazol ratiopharm
• Cilostazol (used to treat intermittent claudication – leg pain when walking caused by insufficient blood flow)
• Cisapride (used for indigestion and heartburn)
• Digoxin (used for heart problems)
• Methotrexate (a chemotherapy medicine used at high doses to treat cancer) – if you are taking high doses of methotrexate, your doctor may temporarily stop your treatment with Esomeprazol ratiopharm
• Tacrolimus (organ transplant)
• Rifampicin (used to treat tuberculosis)
• St. John’s wort (Hypericum perforatum) (used to treat mild depression)

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin in addition to Esomeprazol ratiopharm to treat ulcers caused by Helicobacter pylori, it is very important that you inform your doctor if you are taking any other medicines.

Taking Esomeprazol ratiopharm with food and drinks

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

Pregnancy, breast-feeding and fertility

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Your doctor will decide whether you can take Esomeprazol ratiopharm during this time.

It is not known whether Esomeprazol ratiopharm passes into breast milk. Therefore, Esomeprazol ratiopharm should not be taken during breast-feeding.

Driving and using machines

Esomeprazol ratiopharm is unlikely to affect your ability to drive or use tools or machines. However, adverse reactions such as dizziness and blurred vision are uncommon or rare (see section 4). If you are affected, you should not drive or use machinery.

Esomeprazol ratiopharm contains sucrose

This medicine contains sugar spheres which contain sucrose, a type of sugar. If your doctor has told you that you have an intolerance to certain sugars, consult him before taking this medicine.

Esomeprazol ratiopharm contains sodium

This medicine contains less than 1 mmol (23 mg of sodium) per dose; hence, it is essentially “sodium-free”.

3. How to take Esomeprazole ratiopharm

• Take Esomeprazole ratiopharm exactly as prescribed by your doctor.
• Swallow the tablet whole with water. Do not chew or crush the tablet.
• It is recommended to take the tablet at least one hour before a meal.
• If you have difficulty swallowing the tablet, you may dissolve it in a glass of still water. Use only non-carbonated water. Stir until the tablet disintegrates, then drink the mixture immediately or within 30 minutes. Do not use any other liquid to dissolve the tablet.
• Do not split the tablet unless it has a score line and your doctor has instructed you to do so.
• Continue taking Esomeprazole ratiopharm for as long as your doctor recommends, even if symptoms improve.

Follow exactly the administration instructions for this medicine as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

• If you take this medicine for a long period of time, your doctor will need to monitor you (especially if you take it for more than one year).
• If your doctor has instructed you to take this medicine only when you notice symptoms, inform your doctor if the symptoms change.

How much to take

• Your doctor will have told you how many tablets to take and when to take them. This will depend on your condition, age, and liver function.
• The recommended doses are indicated below.

Use in adults and adolescents from 12 years of age

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

• If your doctor has determined that your esophagus is slightly affected, the recommended dose is one 40 mg esomeprazole tablet daily for 4 weeks. Your doctor may instruct you to take the same dose for another 4 weeks if your esophagus has not yet healed.
• The recommended dose once the esophagus has healed is one 20 mg esomeprazole tablet once daily.
• If your esophagus has not been affected, the recommended dose is one 20 mg esomeprazole tablet daily. Once the condition is under control, your doctor will instruct you to take the medicine as needed, up to a maximum of one 20 mg esomeprazole tablet daily.
• If you have severe liver problems, your doctor may prescribe a lower dose.

For the treatment of ulcers caused by Helicobacter pylori infection and to prevent recurrences:

• The recommended dose is one 20 mg esomeprazole tablet twice daily for one week.
• Your doctor will also instruct you to take antibiotics, for example amoxicillin and clarithromycin.

Use in adults from 18 years of age

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

• The recommended dose is one 20 mg esomeprazole tablet once daily for 4 to 8 weeks.

For the prevention of stomach ulcers if you are taking NSAIDs (non-steroidal anti-inflammatory drugs):

• The recommended dose is one 20 mg esomeprazole tablet once daily.

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

• The recommended dose is one 40 mg esomeprazole tablet twice daily.
• Your doctor will adjust the dose according to your needs and will also decide for how long you should take this medicine. The maximum dose is 80 mg twice daily.

Continuation treatment for prevention of re-bleeding from peptic ulcer induced with intravenous esomeprazole:

• The recommended dose is one 40 mg esomeprazole tablet once daily for 4 weeks.

How to take this medicine

• You may take the tablets at any time of day.
• You may take the tablets with food or on an empty stomach.
• Swallow the tablets whole with a glass of water. Do not chew or crush the tablets. This is because the tablets contain coated granules that prevent the medicine from being destroyed by stomach acid. It is important not to damage the granules.

What to do if you have difficulty swallowing the tablets

• If you have difficulty swallowing the tablets:

• Place the tablets in half a glass of still water. Other liquids must not be used.

• Shake until the tablets break up (the mixture will not be clear). Then drink the mixture immediately or within 30 minutes. Always stir well just before drinking.

• To ensure you have taken all the medicine, rinse the glass thoroughly with half a glass of water and drink it. The solid particles contain the medicine – do not chew or crush the granules.

• If you cannot swallow at all, the tablets may be dispersed in water and administered via a syringe. This allows direct administration into the stomach through a tube (gastric tube).

Use in children under 12 years of age

Esomeprazol ratiopharm is not recommended for children under 12 years of age. There are other pharmaceutical forms of this medicine that are more suitable.

Elderly patients

No dose adjustment is required in elderly patients.

If you take more Esomeprazol ratiopharm than you should

If you take more esomeprazole than prescribed by your doctor, consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone 91 5620420, indicating the medicine and the amount ingested.

If you forget to take Esomeprazol ratiopharm

• If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, do not take the missed dose.
• Do not take a double dose (two doses at the same time) to make up for a forgotten dose.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

If you notice any of the following serious adverse effects, stop taking Esomeprazole ratiopharm and contact a doctor immediately:

• Yellowing of the skin, dark urine, and fatigue, which may be symptoms of liver problems. These effects are rare and may affect up to 1 in 1,000 people.
• Sudden difficulty breathing, swelling of the lips, tongue, throat, or entire body, skin rash, fainting, or difficulty swallowing (severe allergic reaction). These effects are rare and may affect up to 1 in 1,000 people.
• Sudden appearance of a severe skin rash or redness of the skin with blistering or peeling, even after several weeks of treatment. Severe blisters and bleeding of the lips, eyes, mouth, nose, and genitals may also occur. Skin rashes may progress to severe and widespread skin damage (peeling of the epidermis and superficial mucous membranes), potentially leading to life-threatening consequences. This could be a case of “erythema multiforme”, “Stevens-Johnson syndrome”, “toxic epidermal necrolysis”, or “drug reaction with eosinophilia and systemic symptoms (DRESS)”. These effects are very rare and may affect up to 1 in 10,000 people.

Other adverse effects include:

Common (affects up to 1 in 10 people)

• Headache
• Stomach or intestinal effects: stomach pain, constipation, diarrhea, gas (flatulence)
• Nausea or vomiting
• Benign polyps in the stomach

Uncommon (affects up to 1 in 100 people)

• Swelling of feet and ankles
• Sleep disturbances (insomnia)
• Dizziness, tingling and numbness, drowsiness
• Sensation of vertigo
• Dry mouth
• Abnormal blood test results indicating liver function
• Skin rash, hives, itching of the skin
• Fractures of the hip, wrist, or spine (if Esomeprazole ratiopharm is used at high doses or for prolonged periods)

Rare (affects up to 1 in 1,000 people)

• Blood disorders such as decreased number of white blood cells or platelets. This may cause weakness, bruising, or increased risk of infections
• Low sodium levels in blood. This may cause weakness, vomiting, and cramps
• Restlessness, confusion, or depression
• Taste disturbances
• Eye disorders such as blurred vision
• Sudden sensation of breathlessness or difficulty breathing (bronchospasm)
• Inflammation inside the mouth
• A fungal infection known as “candidiasis” that may affect the intestine
• Liver problems including jaundice, which may cause yellowing of the skin, dark urine, and fatigue
• Hair loss (alopecia)
• Dermatitis due to exposure to sunlight
• Joint pain (arthralgia) or muscle pain (myalgia)
• General feeling of malaise and lack of energy
• Increased sweating

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

• Changes in blood cell counts, including agranulocytosis (decreased number of white blood cells)
• Aggression
• Seeing, feeling, or hearing things that are not real (hallucinations)
• Liver disorders that may lead to liver failure or brain inflammation
• Sudden onset of severe skin rash, blistering, 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 disorders
• Breast enlargement in men

Frequency not known (cannot be estimated from available data)

• If you are taking esomeprazole for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or increased heart rate. If you experience any of these symptoms, contact your doctor as soon as possible. Low magnesium levels may also trigger a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.
• Inflammation of the intestine (causing diarrhea).
• Skin rash, possibly with joint pain

In very rare cases, Esomeprazole ratiopharm may affect white blood cells, causing immune deficiency. If you develop an infection with symptoms such as fever accompanied by a severe deterioration in general condition, or fever with signs of a local infection such as neck, throat, or mouth pain, or difficulty urinating, you should consult your doctor as soon as possible to rule out a reduced white blood cell count (agranulocytosis) via a blood test. It is important that, in such cases, you inform your doctor about your medication.

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products Website: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Esomeprazole ratiopharm

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

Do not store above 30°C.

Do not use this medicine after the expiry date stated on the packaging after “EXP” or “CAD”. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Esomeprazole ratiopharm

• The active substance is esomeprazole magnesium dihydrate.

Each Esomeprazole ratiopharm 20 mg tablet contains 20 mg of esomeprazole (equivalent to 21.75 mg of esomeprazole magnesium dihydrate).

Each Esomeprazole ratiopharm 40 mg tablet contains 40 mg of esomeprazole (equivalent to 43.5 mg of esomeprazole magnesium dihydrate).

• The other components are:

Tablet core: methacrylic acid and ethyl acrylate copolymer (1:1), talc, triethyl citrate, hypromellose, sugar spheres, magnesium stearate, hydroxypropyl cellulose, glycerol, mono-stearate 40-55, polysorbate 80, microcrystalline cellulose, povidone, macrogol 6000, crospovidone, sodium stearyl fumarate.

Tablet coating: hypromellose, titanium dioxide (E171), macrogol/PEG 400, iron oxide red (E172), iron oxide yellow (E172).

Appearance of the product and contents of the pack

Esomeprazole ratiopharm 20 mg are film-coated, biconvex, elliptical tablets, light pink in colour, 6.55 x 13.6 mm.

Esomeprazole ratiopharm 40 mg are film-coated, biconvex, elliptical tablets, pink in colour, 8.2 x 17 mm.

The tablets are supplied in:

Pack sizes:

Bottle: 28, 30, 60, 100 or 250 tablets.

Blister pack: 7, 10, 14, 28, 30, 56, 60, 90 or 100 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor

28108 Alcobendas, Madrid (Spain)

Manufacturer

Balkanpharma Dupnitsa AD.

3 Samakovsko Shose Str.

Dupnitsa 2600

Bulgaria

This patient information leaflet was approved in: May 2023.

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/"

The following information is intended for healthcare professionals only:

Administration via gastric tube

1. Place the tablets into an appropriate syringe and fill the syringe with approximately 25 ml of water and approximately 5 ml of air. For some tubes, dispersion in 50 ml of water may be required to prevent the pellets from blocking the tube.
2. Immediately shake the syringe to disperse the tablet.
3. Hold the syringe with the tip pointing upwards and check that the tip is not blocked.
4. Connect the syringe to the tube while maintaining the previous position.
5. Shake the syringe and position it with the tip pointing downwards. Immediately inject 5–10 ml into the tube. After injection, invert the syringe, shake it (the syringe must be kept with the tip pointing upwards to prevent blockage of the tip).
6. Reposition the syringe with the tip pointing downwards and immediately inject another 5–10 ml into the tube. Repeat this procedure until the syringe is empty.
7. Fill the syringe with 25 ml of water and 5 ml of air and repeat step 5 if necessary to flush any remaining residue from the syringe. For some tubes, 50 ml of water may be required.