ESOMEPRAZOL TEVA 40 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the User

Esomeprazol Teva 40 mg Gastro-Resistant Tablets EFG

Esomeprazol

Read all of 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.

• Keep this leaflet, as 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 pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

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

1. What is Esomeprazol Teva and what is it used for

Esomeprazol Teva contains a medicine called esomeprazol. It belongs to a group of medicines called ‘proton pump inhibitors’. These work by reducing the amount of acid that the stomach produces.

Esomeprazol Teva is used for the treatment of the following conditions:

• Gastro-oesophageal reflux disease (GORD). This is where acid from the stomach escapes into the gullet (the tube which carries food from the mouth to the stomach) causing pain and inflammation.
• Excessive acid production in the stomach caused by a tumour in the pancreas (Zollinger-Ellison syndrome).
• Prevention of re-bleeding following treatment of bleeding ulcers with esomeprazol intravenous.

2. What you need to know before you take Esomeprazol Teva

Do not take Esomeprazol Teva

• If you are allergic (hypersensitive) to esomeprazol 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 a medicine that contains nelfinavir (used to treat HIV infection).
• If you have ever had a skin reaction after treatment with a medicine that reduces stomach acid.

If any of the above apply to you, do not take Esomeprazol Teva. If you are not sure, consult your doctor or pharmacist before taking Esomeprazol Teva.

Warnings and precautions

Before taking this medicine, tell your doctor if:

• You have ever had a skin reaction after treatment with a medicine that reduces stomach acid.
• You have severe liver problems.
• You have severe kidney problems.
• You are due to have a specific blood test (Chromogranin A)

Esomeprazol Teva may hide the symptoms of other diseases. Therefore, if you notice any of the following before or while you are taking Esomeprazol Teva, contact your doctor immediately:

• You lose a lot of weight for no reason and have problems swallowing.
• You have stomach pain or indigestion.
• You start vomiting food or blood.
• Your stools are black (blood-stained).

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

Taking a proton pump inhibitor like Esomeprazol Teva, especially over a period of more than one year, may slightly increase your risk of fracture in the hip, wrist or spine.

Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis)

Severe skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS) and erythema multiforme have been reported with esomeprazol. Stop taking esomeprazol and contact your doctor immediately if you notice any of the following symptoms: blisters, sores or ulcers in the mouth, red or purple skin patches, severe skin rash or skin peeling, fever, swelling of the face, lips, tongue or throat, difficulty breathing or swallowing, headache, high temperature (fever), rash, swollen lymph nodes.

Children

Esomeprazol Teva gastro-resistant tablets are not recommended for children under 12 years.

Other medicines and Esomeprazol Teva

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that you can buy without a prescription.

Do not take Esomeprazol Teva if you are taking:

• A medicine that contains nelfinavir (used to treat HIV infection).

Tell your doctor if you are taking:

• Atazanavir (used to treat 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, relax muscles or treat epilepsy).
• Phenytoin (used to treat epilepsy). If you are taking phenytoin, your doctor will need to monitor you when you start or stop taking Esomeprazol Teva.

• Medicines that are used to thin the blood, such as warfarin. Your doctor may need to monitor you when you start or stop taking Esomeprazol Teva.
• Cilostazol (used to treat intermittent claudication – a condition where the legs do not get enough blood).
• Cisapride (used for indigestion and heartburn).
• Digoxin (used for heart problems).
• Methotrexate (a chemotherapy medicine used to treat cancer) – if you are taking high doses of methotrexate, your doctor may temporarily stop your Esomeprazol Teva treatment.
• Tacrolimus (used after organ transplantation).
• Rifampicin (used to treat tuberculosis).
• St John’s Wort (Hypericum perforatum) (used to treat depression).

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin with Esomeprazol Teva to treat ulcers caused by Helicobacter pylori bacteria, it is very important that you tell your doctor about any other medicines you are taking.

Esomeprazol Teva with food and drink

You can take the tablets with or without food.

Pregnancy and breast-feeding

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.

Esomeprazol Teva is not likely to affect your ability to drive or use any tools or machines.

Esomeprazol Teva contains sunset yellow FCF (E110)

This medicine contains sunset yellow FCF (E110), which may cause allergic reactions.

Esomeprazol Teva contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e., essentially ‘sodium-free’.

3. How to take Esomeprazol Teva

Always take this medicine exactly as your doctor has told you to. Check with your doctor or pharmacist if you are not sure.

In case of doubt, consult your doctor or pharmacist.

• If you are taking this medicine for a long time, your doctor will want to monitor you (especially if you are taking it for more than a year).
• If your doctor has told you to take this medicine as and when you need it, you should contact your doctor if your symptoms change.

Taking this medicine

• You can take the tablets at any time of the day.
• You can take the tablets with or without food.
• Swallow the tablets whole with a glass of water. Do not chew or crush the tablets. This is because the tablets contain coated pellets which stop the medicine from being broken down by the acid in the stomach. It is important not to damage the pellets.

What to do if you have difficulty swallowing

If you have difficulty swallowing the tablets:

• Put the tablets in a glass of water. Do not use other liquids.
• Stir until the tablets break up (the mixture will not be clear). You can take the mixture immediately or within 30 minutes. Always stir well before taking.
• To make sure you get the full dose, rinse the glass with half a glass of water and drink it. The solid pieces contain the medicine – do not chew or crush them.

If you cannot swallow at all, the tablets can be dispersed in water and given through a syringe (oral syringe).

How much to take

• Your doctor will tell you how many tablets to take and when to take them. This will depend on your condition, age and liver function.
• The recommended dose is given below.

For the treatment of heartburn caused by gastro-oesophageal reflux disease (GORD):

Adults and children over 12 years:

• If your doctor has found that your gullet (oesophagus) is slightly damaged, the recommended dose is one Esomeprazol Teva 40 mg gastro-resistant tablet per day for 4 weeks.
• Your doctor may tell you to take the same dose for another 4 weeks if your oesophagus has not yet healed.
• If you have severe liver problems, your doctor may give you a lower dose.

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

Adults over 18 years:

• The recommended dose is Esomeprazol Teva 40 mg twice a day.
• Your doctor will adjust the dose according to your needs and also decide how long you will need to take the medicine. The maximum dose is 80 mg twice a day.

Prevention of re-bleeding following treatment of bleeding ulcers with esomeprazol intravenous:

The recommended dose is one Esomeprazol Teva 40 mg tablet per day for 4 weeks.

If you take more Esomeprazol Teva than you should

If you have taken more Esomeprazol Teva than you should, contact your doctor or pharmacist immediately or go to the nearest hospital.

If you forget to take Esomeprazol Teva

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

4. Possible side effects

Like all medicines, Esomeprazol Teva can cause side effects, although not everybody gets them.

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

• Sudden onset of severe rash, blistering or peeling of the skin, severe itching, swelling of the face, lips, tongue or throat, difficulty breathing or swallowing, fever, enlarged lymph nodes (anaphylactic reaction).
• Reddening of the skin with blisters or peeling. There may also be severe blisters in the mouth, eyes, or genital areas. This could be Stevens-Johnson syndrome or toxic epidermal necrolysis.
• Yellow skin, dark urine and tiredness which can be symptoms of liver problems. Rash, fever and swollen lymph nodes (DRESS syndrome or drug hypersensitivity), which is a rare condition.

These effects are rare and may affect up to 1 in 10,000 people.

Other side effects include:

Common (may affect up to 1 in 10 people)

• Headache.
• Effects on the stomach or intestines: stomach pain, constipation, diarrhoea, wind (flatulence).
• Feeling or being sick (nausea or vomiting).
• Benign polyps in the stomach.

Uncommon (may affect up to 1 in 100 people)

• Swelling of feet and ankles.
• Disturbed sleep (insomnia).
• Dizziness, tingling, numbness or sensation of pins and needles, drowsiness.
• Vertigo.
• Dry mouth.
• Abnormal liver function tests.
• Rash, itching, hives.
• Fracture of the hip, wrist or spine (if Esomeprazol Teva is used in high doses and over long periods).

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

• Blood disorders such as a reduced number of white cells or platelets. This can cause weakness, bruising or make infections more likely.
• Low levels of sodium in the blood. This can cause weakness, vomiting and cramps.
• Agitation, confusion, or depression.
• Disturbances in taste.
• Eye problems such as blurred vision.
• Sudden onset of a severe rash or blistering or peeling of the skin, possibly with fever, flu-like symptoms, or a feeling of being generally unwell. This could be a condition called Stevens-Johnson syndrome or toxic epidermal necrolysis.
• Severe liver problems, including liver failure and inflammation of the liver.
• Loss of hair (alopecia).
• Photosensitivity reaction (a skin reaction caused by sunlight).
• Pain in the joints (arthralgia) or muscles (myalgia).
• General feeling of being unwell, lack of energy.
• Increased sweating.

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

• Changes in blood count, including agranulocytosis (severe reduction in white blood cells).
• Aggression.
• Seeing, hearing or feeling things that are not there (hallucinations).
• Severe liver problems leading to liver failure and inflammation of the brain.
• Sudden onset of a severe rash or blistering or peeling of the skin. This could be a condition called erythema multiforme, Stevens-Johnson syndrome or toxic epidermal necrolysis.
• Muscle weakness.
• Severe kidney problems.
• Enlargement of the breasts in men.
• Low levels of magnesium in the blood. This can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate.

Frequency not known (cannot be estimated from the available data)

• If you are taking esomeprazol for more than three months, it is possible that the levels of magnesium in your blood may fall. Low levels of magnesium can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, fast heart rate. If you get any of these symptoms, please tell your doctor promptly. Low levels of magnesium can also lead to a reduction in the levels of potassium and calcium in the blood. Your doctor may decide to perform regular blood tests to monitor your levels of magnesium.
• Inflammation in the gut (leading to diarrhoea).
• Rash, possibly with a fever, joint pains, and/or swollen lymph nodes.

In very rare cases, Esomeprazol Teva may affect the white blood cells, leading to immune deficiency. If you have an infection with symptoms such as fever with a severely deteriorated general condition or fever with symptoms of a local infection such as pain in the neck, throat or mouth, or difficulty in urinating, you must consult your doctor as soon as possible so that a lack of white blood cells (agranulocytosis) can be ruled out by a blood test. It is important that you inform your doctor about your medicine.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Medicinal Products for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Esomeprazol Teva

• 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 label, carton or blister after CAD. The expiry date is the last day of the month indicated.

Blister packs

• Do not store above 30°C.
• Store in the original package to protect from moisture.

Bottles:

• Do not store above 30°C.
• Shelf life after first opening of the bottle: 100 days
• Keep the bottle tightly closed to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition of Esomeprazol Teva

• The active ingredient is esomeprazole. There are two concentrations of Esomeprazol Teva gastro-resistant tablets containing 20 mg or 40 mg of esomeprazole (as sodium salt).

• The other ingredients are:

Core:Microcrystalline cellulose spheres (microcrystalline cellulose and water), hypromellose (E464), talc (E553b), titanium dioxide (E171), glycerol monostearate, polysorbate 80, methacrylic acid-ethyl acrylate copolymer (1:1) dispersion at 30% (sodium lauryl sulfate, polysorbate 80, and methacrylic acid-ethyl acrylate copolymer), triethyl citrate (E1505), macrogol, microcrystalline cellulose (E460i), crospovidone (type A), and sodium stearyl fumarate.

Coating:Opadry II Dark Blue 85F30662 (partially hydrolyzed polyvinyl alcohol, titanium dioxide, macrogol, talc, aluminum lake carmine indigo/blue FD&C #2 (E132), black iron oxide (E172), and aluminum lake yellow FD&C #6/orange yellow S (E110).

Appearance of the product and package contents

• Esomeprazol Teva 40 mg gastro-resistant tablets are oval, blue-colored tablets.
• Esomeprazol Teva 40 mg is available in packs of 14, 28, or 56 tablets in blister packs, and in 28 tablets in bottles.
• Clinical pack of 100 tablets in blister packs and bottles.
• Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

The holder is:

Teva Pharma S.L.U.

C/ Anabel Segura nº 11 Edificio Albatros B, 1ª planta

28108 Alcobendas – Madrid

Spain

The manufacturer is:

Towa Pharmaceutical Europe S.L.

c/ San Martí, 75-97,

Martorelles, 08107 Barcelona

Spain

Date of last revision of this leaflet: February 2025

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