Rabeprazole Sodium 10 Mg Gastro-Resistant Tablets
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Rabeprazole sodium 10 mg gastro-resistant tablets
Rabeprazole sodium
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Rabeprazole sodium is and what it is used for
2. Before you take Rabeprazole sodium
3. How to take Rabeprazole sodium
4. Possible side effects
5. How to store Rabeprazole sodium
6. Further information
1. WHAT RABEPRAZOLE SODIUM IS AND WHAT IT IS USED FOR
Rabeprazole sodium tablet contains the active ingredient rabeprazole sodium. This belongs to a group of medicines called ‘Proton Pump Inhibitors' (PPIs). They work by lowering the amount of acid that your stomach produces.
Rabeprazole sodium tablets are used to treat the following conditions:
• ‘Gastro-oesophageal reflux disease' (GORD), which can include heartburn. GORD is caused when acid and food from your stomach escapes into your food pipe (oesophagus).
• Ulcers in your stomach or the upper part of your gut (intestine).
• Zollinger-Ellison Syndrome where your stomach produces too much acid.
Rabeprazole sodium which is contained in Rabeprazole sodium 10 mg gastro-resistant tablets is also authorised to treat other conditions which are not mentioned in this leaflet.
Ask your doctor or pharmacist if you have further questions.
2. BEFORE YOU TAKE RABEPRAZOLE SODIUM
Do not take Rabeprazole sodium if:
• You are allergic (hypersensitive) to rabeprazole sodium, or any of the other ingredients of Rabeprazole sodium (listed in Section 6 below).
• You are pregnant or think that you are pregnant.
• You are breast-feeding.
Do not use Rabeprazole sodium if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before using Rabeprazole sodium.
Also see Pregnancy and breast-feeding section.
Children
Rabeprazole sodium should not be used in children.
Take special care with Rabeprazole sodium
Check with your doctor or pharmacist before taking Rabeprazole sodium if:
• You are allergic to other proton pump inhibitor medicines or ‘substituted benzimidazoles'.
• You have a stomach tumour.
• You have ever had liver problems.
• You are taking atazanavir-for HIV infection.
Blood and liver problems have been seen in some patients but often get better when Rabeprazole sodium is stopped.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Rabeprazole sodium.
If you experience severe (watery or bloody) diarrhoea with symptoms such as fever, abdominal pain or tenderness, stop taking Rabeprazole sodium and see a doctor straight away.
Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, including herbal medicines.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
• Ketoconazole or itraconazole-used to treat infections caused by a fungus. Rabeprazole sodium may lower the amount of this type of medicine in your blood. Your doctor may need to adjust your dose.
• Atazanavir-used to treat HIV-infection. Rabeprazole sodium may lower the amount of this type of medicine in your blood and they should not be used together.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using Rabeprazole sodium.
Taking Rabeprazole sodium with food and drink Having Rabeprazole sodium with or after food or drink does not have any effect on how the tablets work.
Pregnancy and breast-feeding
• Do not use Rabeprazole sodium if you are pregnant or think you may be pregnant.
• Do not use Rabeprazole sodium if you are breast-feeding or planning to breast-feed.
Ask your doctor or pharmacist for advice before taking any medicine during pregnancy or while breast-feeding.
Driving and using machines
You may feel sleepy while taking Rabeprazole sodium. If this happens, do not drive or use any tools or machines.
3. HOW TO TAKE RABEPRAZOLE SODIUM
Always take Rabeprazole sodium exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Taking this medicine
• Only remove a tablet from the blister strip when it is time to take your medicine.
• Swallow your tablets whole with a drink of water.
Do not chew or crush the tablets.
• Your doctor will tell you how many tablets to take and how long to take them for. This will depend on your condition.
• If you are taking this medicine for a long time, your doctor will want to monitor you.
Adults and the Elderly
For ‘gastro-oesophageal reflux disease’ (GORD)
Treatment of moderate to severe symptoms (symptomatic GORD)
• The usual dose is one Rabeprazole sodium 10 mg tablet once a day for up to 4 weeks.
• Take the tablet in the morning before eating.
• If your symptoms do not resolve within four weeks, consult your doctor.
• If your condition returns after 4 weeks treatment, your doctor may tell you to take one Rabeprazole sodium 10 mg tablet as and when you require it.
Treatment of more severe symptoms (erosive or ulcerative GORD)
• The usual dose is one Rabeprazole sodium 20 mg tablet once a day for 4 to 8 weeks.
• Take the tablet in the morning before eating.
Long-term treatment of symptoms (GORD maintenance)
• The usual dose is one Rabeprazole sodium 10 mg or 20 mg tablet once a day for as long as your doctor has told you.
• Take the tablet in the morning before eating.
• Your doctor will want to see you at regular intervals to check your symptoms and dosage.
For ulcers of the stomach (peptic ulcers)
• The usual dose is one Rabeprazole sodium 20 mg tablet once a day for 6 weeks.
• Take the tablet in the morning before eating.
• Your doctor may tell you to take Rabeprazole sodium for another 6 weeks if your condition does not improve.
For ulcers of the intestine (duodenal ulcers)
• The usual dose is one Rabeprazole sodium 20 mg tablet once a day for 4 weeks.
• Take the tablet in the morning before eating.
• Your doctor may tell you to take Rabeprazole sodium for another 4 weeks if your condition does not improve.
Relief of symptoms will normally occur before the ulcer has completely healed. It is important that you do not stop taking the tablets until told to do so by your doctor.
Zollinger-Ellison Syndrome where excess acid is produced in the stomach
• The usual dose is three Rabeprazole sodium 20 mg tablets once a day to start with.
• The dose may then be adjusted by your doctor depending on how you respond to the treatment.
If you are on long-term treatment you will need to see your doctor at regular intervals for review of your tablets and symptoms.
Children. The product should not to be used in children.
Patients with liver problems. You should consult your doctor who will take special care when beginning treatment with Rabeprazole sodium and while you continue to be treated with Rabeprazole sodium.
If you take more Rabeprazole sodium than you should
Do not take more tablets each day than you are prescribed. If you accidentally take more tablets than the prescribed dose, please consult your doctor or go to the hospital straight away. Always take the tablets and the carton with you to the hospital so that the doctor knows what has been taken.
If you forget to take Rabeprazole sodium
• 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 and continue as usual.
• If you forget to take your medicine for more than 5 days, talk to your doctor before taking any more medicine.
• Do not take a double dose (two doses at the same time) to make up for a forgotten dose.
If you stop taking Rabeprazole sodium
Do not stop treatment early because your symptoms have got better. Your condition may not have been fully healed and may reoccur if you do not finish your course of treatment. Do not change the dosage or stop the medication without discussing it with your doctor first.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Rabeprazole sodium can cause side effects, although not everybody gets them. The side effects are usually mild and improve without you having to stop taking this medicine.
Very common: Affects more than 1 user in 10
Common: Affects 1 to 10 users in 100
Uncommon: Affects 1 to 10 users in 1,000
Rare: Affects 1 to 10 users in 10,000
Very rare: Affects less than 1 ser in 10,000
Not known: Frequency cannot be estimated from available
data
Stop taking Rabeprazole sodium and see a doctor straight away if you notice any of the following side effects - you may need urgent medical treatment:
Rare side effect (affects 1 to 10 users in 10,000).
• Allergic reactions - the signs may include: sudden swelling of your face, difficulty breathing or low blood pressure which may cause fainting or collapse.
• Frequent infections, such as a sore throat or high temperature (fever), or ulcers in your mouth or throat.
• Bruising or bleeding easily.
Very rare side effects (affects less than 1 user in 10,000).
• Severe skin blistering, or soreness or ulcers in your mouth and throat.
Other possible side effects:
Common (affect less than 1 in 10 people)
• Infections.
• Difficulty sleeping (insomnia)
• Headache or feeling dizzy.
• Cough, runny nose (rhinitis) or sore throat (pharyngitis).
• Effects on your stomach or gut such as stomach pain, diarrhoea, wind (flatulence), feeling sick (nausea), being sick (vomiting) or constipation.
• Pain without any known cause, back pain.
• Weakness (asthenia) or flu-like symptoms.
Uncommon (affect less than 1 in 100 people)
• Feeling nervous or drowsy.
• Chest infection (bronchitis).
• Painful and blocked sinuses (sinusitis).
• Dry mouth.
• Indigestion or belching.
• Skin rash or redness of the skin.
• Muscle or joint pain, leg cramps.
• Bladder infection (urinary tract infection).
• Chest pain.
• Chills or fever.
• Changes in how your liver is working (shown in blood tests).
Rare (affect less than 1 in 1,000 people)
• Loss of appetite (Anorexia).
• Depression.
• Hypersensitivity (includes allergic reactions).
• Visual disturbance.
• Sore mouth (stomatitis) or taste disturbance.
• Upset stomach or stomach pain (gastritis).
• Liver problems such as inflammation of the liver (hepatitis), brain damage due to liver disease (hepatic encephalopathy) and yellowing of your skin and whites of your eyes (jaundice).
• Itchy rash or blistering skin.
• Sweating.
• Kidney problems.
• Weight gain.
• Changes in white blood cells (shown in blood tests) which may result in frequent infection.
• Reduction in blood platelets resulting in bleeding or bruising more easily than normal.
Other possible side effects (unknown frequency)
• Breast swelling in men.
• Fluid retention.
• Low blood levels of sodium which can cause tiredness and confusion, muscle twitching, fits and coma (Hyponatremia).
• Confusion.
Do not be concerned by this list of side effects. You may not get any of them. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Tablet coating:
Ethylcellulose (E462)
Magnesium Oxide, Light (E530)
Hypromellose Phthalate Diacetylated Monoglycerides (E472a)
Talc (E553b)
Titanium Dioxide (E171)
Iron Oxide Yellow (E172)
Carnauba Wax
What Rabeprazole sodium looks like and contents of the pack
Rabeprazole sodium 10mg gastro-resistant tablets are yellow, round, biconvex gastro-resistant tablets with a diameter of 6 mm approximately.
Rabeprazole sodium 10mg gastro-resistant tablets are packed in OPA/Aluminium/PVC-Aluminium blisters of 7, 14, 28, 56 and 98 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Specifar S.A.
1,28 Octovriou str.,
123 51 Ag. Varvara Athens, Greece
This medicinal product is authorised in the Member States of the EEA under the following names:
The Netherlands: Rabeprazolnatrium Specifar
10 mg maagsapresistente tabletten Austria: Rabeprazol Specifar 10 mg
magensaftresistente Tabletten Belgium: Rabeprazolnatrium Specifar
10 mg maagsapresistente tabletten/ Rabeprazole-sodium Specifar 10 mg comprime gastro-resistant/ Rabeprazol-Natrium Specifar 10 mg magensaftresistente Tabletten Denmark: Rabeprazolnatrium Specifar 10 mg
enterotabletter
Germany: Rabeprazol-Natrium Specifar 10 mg
magensaftresistente Tabletten Spain: Rabeprazol sodico Specifar 10 mg
comprimidos gastrorresistentes EFG Hungary: Rabeprazol-natrium Specifar
20mg gastrorezisztens tabletta Ireland: Rabeprazole sodium Specifar 10 mg
gastro-resistant tablets Italy: Rabeprazolo Specifar
Portugal: Rabeprazol sodico Specifar
United Kingdom: Rabeprazole sodium 10 mg gastro-resistant tablets
This leaflet was last approved in 03/2012
5. HOW TO STORE RABEPRAZOLE SODIUM
Keep out of the reach and sight of children.
Do not store above 25°C.
Do not use Rabeprazole sodium after the expiry date which is stated on the carton and blister foil. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Rabeprazole sodium contains
The active substance is rabeprazole sodium.
Each tablet contains 10 mg rabeprazole sodium, equivalent to 9.42 mg of rabeprazole.
The other ingredients are:
Tablet core:
Mannitol (E421)
Magnesium Oxide, Light (E530)
Hydroxypropylcellulose (E463)
Povidone (E1201)
Magnesium Stearate (E572)
PL 20354/0169