Esomeprazole 20mg – 28 Tablets

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

The recommended dose for adults:

One capsule to be taken daily, with a whole glass of water.

Esomeprazole capsules/tablets should not be crushed, chewed or opened.

Depending on symptom control, your prescriber will advise further regarding treatment and dosage frequency.

If you take more Esomeprazole than you should

If you take more Esomeprazole than prescribed, talk to your doctor or pharmacist straight away.

If you forget to take Esomeprazole

If you forget to take a dose, take it as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose.

Do not take a double dose (two doses at the same time) to make up for a forgotten dose.

Like all medicines, this medicine can cause side effects, although not everybody gets them. Some of the side effects are temporary with continued treatment or disappeared when treatment is stopped.

Side Effects

Common

• Headache
• Diarrhoea, stomach pain, constipation, wind (flatulence)
• Nausea or vomiting
• Benign polyps in the stomach

Uncommon

• Swelling of the feet and ankles
• Insomnia
• Dizziness, tingling feelings such as “pins and needles”, feeling sleepy
• Vertigo
• Dry mouth
• Changes in blood tests that check how the liver is working
• Dkin rash, lumpy rash (hives) and itchy skin
• Fracture of the hip, wrist or spine (if Esomeprazole is used in high doses and over long duration)

Rare

• Blood problems 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 may cause weakness, being sick (vomiting) and cramps
• Feeling agitated, confused or depressed
• Taste changes
• Eyesight problems such as blurred vision
• Suddenly feeling wheezy or short of breath (bronchospasm)
• Inflammation of the inside of the mouth
• Thrush, which can affect the gut
• Liver problems, including jaundice which can cause yellow skin, dark urine, and tiredness
• Hair loss
• Skin rash on exposure to sunshine
• Joint pains (arthralgia) or muscle pains (myalgia)
• Feeling unwell and lacking energy
• Increased sweating

Very Rare

• Changes in blood count including agranulocytosis (lack of white blood cells).
• Aggression
• Hallucinations
• Severe liver problems leading to liver failure and inflammation of the brain
• Sudden onset of a severe rash or blistering or peeling skin. This may be associated with a high fever and joint pains (Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms)
• Muscle weakness
• Severe kidney problems
• Enlarged breasts in men

Frequency Not Known

• Inflammation in the gut (leading to diarrhoea)
• Rash, possibly with pain in the joints
• Low magnesium levels in the blood (hypomagnesaemia)

Esomeprazole may in very rare cases affect the white blood cells leading to immune deficiency. If you have an infection with symptoms such as fever with a severely reduced general condition or fever with symptoms of a local infection such as pain in the neck, throat or mouth or difficulties 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 for you to give information about your medication at this time.

Serious Side Effects

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

• Yellow skin, dark urine and tiredness which can be symptoms of liver problems. These effects are rare.
• Sudden wheezing, swelling of your lips, tongue and throat or body, rash, fainting or difficulties in swallowing (severe allergic reaction), These effects are rare.
• Sudden onset of a severe rash or reddening of the skin with blisters or peeling may occur even after several weeks of treatment. There may also be severe blisters and bleeding in the lips, eyes, mouth, nose and genitals. The skin rashes may develop into serious widespread skin damage (peeling of the epidermis and superficial mucous membranes) with life threatening consequences. This could be ‘erythema multiforme’, ‘Stevens-Johnson syndrome’, ‘toxic epidermal necrolysis’ or ‘drug reaction with eosinophilia and systemic symptoms’. These effects are very rare.
• Widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome), seen very rarely.

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 Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

Warning & Precautions

Do not take Esomeprazole

• if you are allergic to esomeprazole or any of the other ingredients of this medicine
• if you are allergic to other proton pump inhibitor medicines (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole)
• if you are taking a medicine containing nelfinavir (used to treat HIV infection)
• if you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking esomeprazole or other related medicines.

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

Talk to your doctor or pharmacist before taking this medicine if:

• you have severe liver problems
• you have severe kidney problems
• you have ever had a skin reaction after treatment with a medicine similar to Esomeprazole that reduces stomach acid. Serious skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with esomeprazole treatment. Stop using esomeprazole and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions
• you are due to have a specific blood test (Chromogranin A).

Esomeprazole may hide the symptoms of other diseases. Therefore, if any of the following happen to you before you start taking Esomeprazole or while you are taking it, talk to your doctor straight away:

• you lose a lot of weight for no reason and have problems swallowing
• you get stomach pain or indigestion
• you begin to vomit food or blood
• you pass black stools (blood-stained faeces)

If you have been prescribed Esomeprazole “on demand” you should contact your doctor if your symptoms continue or change in character.

If you are on Esomeprazole for more than three months it is possible that the levels of magnesium in your blood may fall. Low levels of magnesium can be seen as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness or increased 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 potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor your levels of magnesium.

Taking a proton pump inhibitor like Esomeprazole, 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).

Rash and skin symptoms

If you get a rash on your skin, especially in areas exposed to the sun tell your doctor as soon as you can, as you may need to stop your treatment with Esomeprazole. Remember to also mention any other ill effects like pain in your joints.

Serious skin rashes have occurred in patients taking esomeprazole. The rash can involve ulcers of the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes). These serious skin rashes often come after flu-like symptoms such as fever, headache, body ache. The rash may cover large parts of the body with blistering and peeling of the skin.If at any time during the treatment (even after several weeks) you develop a rash or any of these skin symptoms, stop taking this medicine and contact your doctor immediately.

Age Restrictions

Adults age 18 years and over.

Other Medicines and Conditions

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that you buy without a prescription. This is because Esomeprazole can affect the way some medicines work and some medicines can have an effect on Esomeprazole.

Do not take Esomeprazole capsules 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 (used to treat HIV infection)
• Clopidogrel (used to prevent blood clots)
• Ketoconazole, itraconazole or voriconazole (used to treat infections caused by a fungus)
• Erlotinib (used to treat cancer)
• Citalopram, imipramine or clomipramine (used to treat depression)
• Diazepam (used to treat anxiety, relax muscles or in epilepsy)
• Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when you start or stop taking Esomeprazole.
• Medicines that are used to thin your blood, such as warfarin. Your doctor may need to monitor you when you start or stop taking Esomeprazole.
• Cilostazol (used to treat intermittent claudication – a pain in your legs when you walk which is caused by an insufficient blood supply)
• Cisapride (used for indigestion and heartburn)
• Digoxin (used for heart problems)
• Methotrexate (a chemotherapy medicine used in high doses to treat cancer) – if you are taking a high dose of methotrexate, your doctor may temporarily stop your esomeprazole treatment.
• Tacrolimus (organ transplantation)
• Rifampicin (used for treatment of tuberculosis)
• St. John’s wort (Hypericum perforatum) (used to treat depression)

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

Esomeprazole with food and drink

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

Driving and using machines

Esomeprazole is not likely to affect you being able to drive or use any tools or machines. However, side effects such as dizziness and blurred vision may uncommonly or rarely occur. If affected, you should not drive or use machines.

Pregnancy and Breastfeeding

This medicine is not suitable for use in pregnancy and breastfeeding.

Patient Information Leaflet

https://www.medicines.org.uk/emc/files/pil.2328.pdf

Ingredients

• Active Ingredients: Esomeprazole
• Other Ingredients: Tablet Core: Hydroxypropyl cellulose (E463), Crospovidone (Type A). Tablet Coating: Povidone (K30), Macrogol-400, Macrogol-4000, Macrogol 6000, Hypromellose phthalate (HP-55S), Hypromellose phthalate (HP-50), Diethylphthalate, Hydroxypropyl cellulose, Microcrystaline cellulose (PH 101), Microcrystaline cellulose (PH 112), Crosspovidone (TypeB), Sodium stearyl fumarate, Opadry 03B86651 Brown (HMPC 2910/Hypromellose 6cP, Titanium Dioxide(E171), Macrogol/PEG 400, Iron Oxide red (E172)), Sugar spheres (sucrose and maize starch), Talc (E553b)

Product Information

• Brand Name: Esomeprazole (Generic)
• Route of Administration: Oral
• Legal Classification: Prescription Only Medication (POM)
• Strength: 20mg
• Dosage From: Tablet

Storage

• 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 and blister after ‘EXP’. The expiry date refers to the last day of that month.
• This medicinal product does not require any special storage conditions.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

Advice & Helpful Links

https://www.nhs.uk/conditions/heartburn-and-acid-reflux/