Can you overdose on Nexium?

Nexium Control 20mg

Patient information for Nexium Control 20mg

1.What Nexium Control 20mg is and what it is used for

1.1 What are the properties of the medicinal product?

Nexium Control 20mg contains the active substance esomeprazole, a medicine in a group of medicines called 'proton pump inhibitors', which work by reducing the amount of acid your stomach produces.

Esomeprazole is usually given in salt form as esomeprazole hemimagnesium.

Nexium Control 20mg is only available in pharmacies and without a prescription.

1.2 Active strength and dosage form of Nexium Control 20mg

- Tablets containing 20 mg esomeprazole (as hemimagnesium 1.5 H2O).

Your doctor or your pharmacist will advise you whether this strength and dosage form are suitable for your treatment.

1.3 Nexium Control 20mg is used for

Short-term treatment of symptoms of reflux (e.g. heartburn and acid regurgitation) in adults.

Reflux is the reflux of acid from the stomach into the esophagus (the connection between the throat and the stomach), which can cause inflammation and pain. This can cause symptoms such as a painful sensation in the chest rising up into the throat (heartburn) and a sour taste in the mouth (acid regurgitation).

Nexium Control 20mg is not intended for immediate relief. You may need to take the tablets for 2 to 3 consecutive days before you feel better. If you don't feel better or even worse after 14 days, contact your doctor.

2. What do you need to know before you take Nexium Control 20mg?

2.1 Nexium Control 20mg must not be taken

- if you are allergic to esomeprazole or any of the other ingredients of this medicine.

- if you are allergic to medicines containing other proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole or omeprazole).

- if you are taking a medicine containing nelfinavir (used to treat HIV infection).

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

2.2 Special care is required when taking Nexium Control 20mg

Talk to your doctor or pharmacist before taking Nexium Control 20mg if:

- you have had a stomach ulcer or surgery in the past.

- you have been on ongoing treatment for reflux or heartburn for 4 weeks or more.

- you have jaundice (yellowing of the skin or eyes) or severe liver problems.

- If you have severe kidney problems.

- you are over 55 years old and have had new or recently changed symptoms of reflux, or you are taking nonprescription medicines every day to treat indigestion or heartburn.

Tell your doctor immediately, before or after taking this medicine, if you notice any of the following symptoms, which could be signs of other more serious conditions:

- You lose a lot of weight for no apparent reason.

- You have problems or pain when swallowing.

- You get stomach pain or signs of indigestion such as nausea, bloating, gas, especially after eating.

- You begin to vomit food or blood, which may look like dark coffee grounds in the vomit.

- You pass black stools (bloody faeces).

- you have severe or persistent diarrhea; Esomeprazole has been associated with a slightly increased risk of infectious diarrhea.

See a doctor straight away if you experience chest pain with lightheadedness, sweating, dizziness, or shoulder pain with shortness of breath. This could be a sign of serious heart disease.

Before taking this medicine, tell your doctor if:

- you are planning to have an endoscopy or a urea breath test.

- you are scheduled to have a specific blood test (chromogranin A).

If any of the above apply to you (or if you are not sure), contact your doctor immediately.

Note on other ingredients: Nexium Control 20mg contains sugar-starch pellets, which contain sucrose, a certain type of sugar. Please take Nexium Control 20mg only after consulting your doctor if you know that you suffer from an intolerance to certain sugars.

2.2.a) Children

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

2.2.b) Elderly patients

There are no special precautions.

2.2.c) Pregnancy

As a precautionary measure, you should avoid taking Nexium Control 20mg if possible during pregnancy. You should not take this medicine if you are breast-feeding.

If you are pregnant, think you may be pregnant, or are planning to become pregnant, ask your doctor for advice before taking this medicine. Ask your doctor or pharmacist for advice before taking any medicine.

2.2.d) Breastfeeding

If you are breast-feeding, ask your doctor for advice before taking this medicine. Ask your doctor or pharmacist for advice before taking any medicine.

2.2.e) Ability to drive and use machines

The chance that Nexium Control 20mg will affect your ability to drive and use machines is small. However, side effects such as dizziness and blurred vision may occasionally occur. If you are affected, you should not drive or use machines.

2.3 Which interactions with other medicinal products have to be considered?

Please inform your doctor or pharmacist if you are taking / using or have recently taken / used any other medicines, including medicines obtained without a prescription.

This is because this medicine can affect the way some medicines work and some medicines can affect the way this medicine works.

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

In particular, tell your doctor or pharmacist if you are taking clopidogrel (used to prevent blood clots).

Do not take this medicine with other medicines that reduce the production of acid in your stomach, such as proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole or omeprazole) or H2 antagonists (e.g. ranitidine or famotidine).

You can take this medicine with antacids (e.g. magaldrate, alginic acid, sodium bicarbonate, aluminum hydroxide, magnesium carbonate, or combinations of these) if you need them.

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

- ketoconazole and itraconazole (used to treat infections caused by a fungus)

- voriconazole (used to treat infections caused by a fungus) and clarithromycin (used to treat infections). If you have severe liver problems or if you are being treated for a long time, your doctor may adjust your dose.

Erlotinib (used to treat cancer)

- methotrexate (used to treat cancer and rheumatoid diseases).

Digoxin (used for heart problems)

- atazanavir, saquinavir (used to treat HIV infection)

- citalopram, imipramine or clomipramine (used to treat depression)

- diazepam (used to treat anxiety, relax muscles or in epilepsy)

Phenytoin (used to treat epilepsy)

- Medicines used to thin the blood, such as warfarin. Your doctor may need to do check-ups when you start and stop taking your medicine.

- cilostazol (used to treat intermittent limping, a condition called intermittent claudication, where poor blood supply to the leg muscles causes pain and difficulty walking)

- Cisapride (used for indigestion and heartburn)

- rifampicin (used to treat tuberculosis)

- tacrolimus (in organ transplant cases)

- St. John's wort (Hypericum perforatum) (used to treat depression)

2.4 What should be thought of when taking Nexium Control 20mg together with food, beverages and tobacco?

There are no special precautions.

3. How to take Nexium Control 20mg

Always take Nexium Control 20mg exactly as your doctor has told you. Please ask your doctor or pharmacist if you are not sure.

3.1 Type and duration of application

You can take your tablet at any time of the day, either with food or on an empty stomach.

Swallow your tablet whole with a glass of water. The tablet must not be chewed or crushed. This is because the tablet contains coated pellets which prevent the acid from breaking down the medicine in the stomach. It is important not to damage the pellets.

Alternative method of administration: Put the tablet in a glass of still (non-carbonated) water. Do not use any other liquids. Stir until the tablet disintegrates (the liquid is not clear). Then drink the liquid immediately or within 30 minutes. Always stir the mixture just before drinking it. To make sure that you have drunk all of the mixture, rinse the glass by filling it halfway with water and drink it out. The solid parts contain the medicine - do not chew or crush them.

The duration of treatment is up to 14 days.

Stop taking this medicine when you are completely symptom-free. If your reflux symptoms get worse or do not improve after taking this medicine for 14 consecutive days, contact your doctor.

If you have persistent or long-lasting, recurring symptoms even after treatment with this medicine, you should contact your doctor.

3.2 Unless otherwise prescribed by the doctor, the usual dose is

The recommended dose is 1 tablet (20 mg) per day.

Do not take more than the recommended dose of one tablet (20 mg) per day, even if you do not get immediate improvement. You may need to take the tablets for 2 to 3 consecutive days before your reflux symptoms (such as heartburn and acid regurgitation) get better.

3.3 If you take more Nexium Control 20mg than you should

If you take more Nexium Control 20mg than recommended, contact your doctor or pharmacist immediately. You may experience symptoms such as diarrhea, abdominal pain, constipation, nausea, vomiting, and weakness.

3.4 If you forget to take Nexium Control 20mg

If you forget to take a dose, take it as soon as you remember on the same day. Do not take a double dose to make up for a forgotten dose.

3.5 Effects if treatment with Nexium Control 20mg is stopped

Please discuss this with your doctor or pharmacist beforehand.

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

4. What are the possible side effects?

Like all medicines, Nexium Control 20mg can cause side effects, although not everybody gets them.

When evaluating side effects, the following frequencies are used as a basis:

- very common: more than 1 in 10 people

- common: less than 1 in 10, but more than 1 in 100 patients

- uncommon: less than 1 in 100, but more than 1 in 1,000 patients

- rarely: less than 1 in 1,000 but more than 1 in 10,000 people treated

- very rare: less than 1 in 10,000 patients, including isolated cases

- Frequency not known: frequency cannot be calculated from the available data

4.1 Which side effects can occur in detail?

If you notice any of the following serious side effects, stop taking Nexium Control 20mg and see a doctor straight away:

- Sudden wheezing, swelling of the lips, tongue and throat, rash, fainting or difficulty swallowing (severe allergic reaction, these have rarely been seen).

- Reddening of the skin with blistering or peeling of the skin. There may also be severe blistering and bleeding of the lips, eyes, mouth, nose, and genitals. This could indicate "Stevens-Johnson syndrome" or "toxic epidermal necrolysis". These have been observed very rarely.

- Yellow skin, dark urine and tiredness may be signs that you have liver problems. This has rarely been observed.

Talk to your doctor as soon as possible if you notice any of the following signs of infection: This medicine can very rarely affect the white blood cells and lead to a weakened immune system. If you have an infection with symptoms such as fever with a severely reduced general health condition or fever with symptoms of a local infection such as pain in the neck, throat or mouth or difficulty urinating, you must see your doctor as soon as possible so that an absence white blood cells (agranulocytosis) can be excluded by a blood test.

It is important that you tell your doctor about the medicines you are currently taking.

Other side effects are:

4.1.a) Often

A headache. Effects on the stomach or intestines: diarrhea, abdominal pain, constipation, wind (flatulence). Nausea or vomiting.

4.1.b) Occasionally

Swelling of the feet and ankles. Difficulty sleeping (insomnia), tiredness. Dizziness, pins and needles like pins and needles. Spinning sensation (vertigo). Dry mouth. Changes in the results of blood tests that check how well your liver is working. Skin rash, lumpy rash (hives) and itching.

4.1.c) Rarely

Blood disorders such as a decrease in the total number of white blood cells or platelets. This can lead to weakness and bruising, or make infections more likely. Low levels of sodium in the blood. This can lead to weakness, nausea (vomiting) and muscle cramps. Agitation, confusion, depression. Changes in taste. Visual disturbances such as blurred vision. Sudden wheezing or shortness of breath (bronchial spasm). Inflammation inside the mouth. An infection called "thrush" that can affect the gastrointestinal tract and is caused by a fungus. Hair loss (alopecia). Rash from exposure to sunlight. Joint pain (arthralgia) or muscle pain (myalgia). General feeling unwell and decreased drive Sweat.

4.1.d) Very rare

Low numbers of red and white blood cells and platelets (a disease called pancytopenia). Aggressiveness. Seeing, feeling and hearing things that are not there (hallucinations). Severe liver problems causing liver failure and brain damage. Muscle weakness. Severe kidney problems. Male breast enlargement.

4.1.e) Not known (frequency cannot be estimated from the available data)

Low levels of magnesium in the blood. This can manifest itself as exhaustion, nausea (vomiting), convulsions, tremors and irregular heartbeat (arrhythmias). If you have very low levels of magnesium in your blood, your blood calcium and / or potassium levels may also be low.

Inflammation of the intestines (causing diarrhea).

4.2 What countermeasures should be taken if side effects occur?

Let your doctor know if you experience any side effects. He will decide on possible measures.

If you experience a sudden or severe side effect, inform a doctor immediately, as certain drug side effects (e.g. excessive drop in blood pressure, hypersensitivity reactions) can under certain circumstances have serious consequences. In such cases, do not continue to take the medicine without doctor's advice.

Reporting of side effects: If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not listed in the package insert. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Nexium Control 20mg

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 after "EXP" and on the blister after "EXP". The expiry date refers to the last day of the month indicated.

Do not store above 30 ° C.

Store in the original package in order to protect from moisture. Do not dispose drugs in the wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. You help to protect our environment.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer need. This measure helps to protect the environment.

6. Source and processing status

Information from the SCHOLZ database based on the data approved by the Federal Office for Drugs and Medical Devices

Copyright by ePrax GmbH, Munich; August 2014