iMeds.se

Refexxin

Information för alternativet: Refexxin 40 Mg Enterotablett, Refexxin 20 Mg Enterotablett, visar 2 alternativ

Package leaflet: Information for the patient

Refexxin 20 mg gastro-resistant tablets

Refexxin 40 mg gastro-resistant tablets

esomeprazole


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


What is in this leaflet:

1. What Refexxin is and what it is used for

2. What you need to know before you take Refexxin

3. How to take Refexxin

4. Possible side effects

5. How to store Refexxin

6. Contents of the pack and other information


1. What Refexxin is and what it is used for

Refexxin contains a medicine called esomeprazole. This belongs to a group of medicines called ‘proton pump inhibitors’. They work by reducing the amount of acid that your stomach produces.

Refexxin is used to treat the following conditions:

Adults


Adolescents aged 12 years and above


2. What you need to know before you take Refexxin

Do not take Refexxin :


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


Warnings and precautions

Talk to your doctor or pharmacist before taking Refexxin:


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


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


Taking a proton pump inhibitor like Refexxin, 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).


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 Refexxin. Remember to also mention any other ill effects like pain in your joints.


Children under the age of 12 years

Information on dosing for children aged 1 to 11 years is provided in Refexxin sachet product information (ask your doctor or pharmacist if you require further information).


Other medicines and Refexxin

Tellyour 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 Refexxin can affect the way some medicines work and some medicines can have an effect on Refexxin.

Do not take Refexxin Tablets 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:

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


Refexxin with food and drink

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


Pregnancy, breastfeeding and fertility

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will decide whether you can take Refexxin during this time. It is not known if Refexxin passes into breast milk. Therefore, you should not take Refexxin if you are breastfeeding.


Driving andusing machines

Refexxin 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 (see section 4). If affected, you should not drive or use machines.


Refexxin contain sucrose

Refexxin ets contains sugar spheres which contain sucrose, a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.


3. How to take Refexxin

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



How much to take


Adults aged 18 and above


To treat heartburn caused by gastroesophageal reflux disease (GERD):

If your doctor has found that your food pipe (gullet) has been slightly damaged, the recommended dose is one Refexxin 40 mg gastro-resistant tablet once a day for 4 weeks. Your doctor may tell you to take the same dose for a further 4 weeks if your gullet has not yet healed.

The recommended dose once the gullet has healed is one Refexxin 20 mg gastro-resistant tablet once a day



To treat ulcers caused by Helicobacter pylori infection and to stop them coming back:

The recommended dose is one Refexxin 20 mg gastro-resistant tablet twice a day for one week.

Your doctor will also tell you to take antibiotics for example amoxicillin and clarithromycin.


To treat stomach ulcers caused by NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):

The recommended dose is one Refexxin 20 mg gastro-resistant tablet once a day for 4 to 8 weeks.


To prevent stomach ulcers if you are taking NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):

The recommended dose is one Refexxin 20 mg gastro-resistant tablet once a day.


To treat too much acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison syndrome):


Prolonged treatment after prevention of re-bleeding of ulcers with intravenous Refexxin:

The recommended dose is one Refexxin 40 mg tablet once a day for 4 weeks.


Adolescents aged 12 or above


To treat heartburn caused by gastroesophageal reflux disease (GERD):

If your doctor has found that your food pipe (gullet) has been slightly damaged, the recommended dose is one Refexxin 40 mg gastro-resistant tablet once a day for 4 weeks. Your doctor may tell you to take the same dose for a further 4 weeks if your gullet has not yet healed.


To treat ulcers caused by Helicobacter pylori infection and to stop them coming back:

The recommended dose is one Refexxin 20 mg gastro-resistant tablet twice a day for one week.

Your doctor will also tell you to take antibiotics for example amoxicillin and clarithromycin.


Taking this medicine


What to do if you have trouble swallowing the tablets


Children under the age of 12 years

Refexxin gastro-resistant tablets are not recommended for children less than 12 years old.

Information on dosing for children aged 1 to 11 years is provided in Refexxin sachet product information (ask your doctor or pharmacist if you require further information).


Elderly

Dose adjustment is not required in the elderly.


If you take more Refexxin than you should

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


If you forget to take Refexxin


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


4. Possible side effects


Like all medicines, this medicine can cause side effects, although not everybody gets them.

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


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

Other side effects include:

Common (may affect up to 1 in 10 people)

Uncommon (may affect up to 1 in 100 people)


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

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


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

If you are on Refexxin 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.


Refexxin 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 severelyreduced 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.


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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Refexxin


6. Contents of the pack and other information

What Refexxin contains


What Refexxin looks like and contents of the pack


Marketing Authorisation Holder and Manufacturer

[To be completed nationally]


This medicine is authorised in the Member states of the EEA under the following names:


Member State

Name of medicinal product

Sweden

Refexxin

Italy

Lucen


This leaflet was last revised in 2016-04-01


Other sources of information


Detailed information on this medicine is available on the web site of {MS/Agency}


<----------------------------------------------------------------------------------------------------------------------------->

The following information is intended for healthcare professionals only:


Administration through gastric tube


1. Put the tablet into an appropriate syringe and fill the syringe with approximately 25 ml water and approximately 5 ml air. For some tubes, dispersion in 50 ml water is needed to prevent the pellets from clogging the tube.

2. Immediately shake the syringe for approximately 2 minutes to disperse the tablet.

3. Hold the syringe with the tip up and check that the tip has not clogged.

4. Attach the syringe to the tube whilst maintaining the above position.

5. Shake the syringe and position it with the tip pointing down. Immediately inject 5 – 10 ml into the tube. Invert the syringe after injection and shake (the syringe must be held with the tip pointing up to avoid clogging of the tip)

6. Turn the syringe with the tip down 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 wash down any sediment left in the syringe. For some tubes, 50 ml water is needed.


Page 9 of 9