Rabeprazole Sodium 10 Mg Gastro-Resistant Tablets
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Rabeprazole sodium 10 mg
gastro-resistant tablets
Rabeprazole sodium 20 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 tablets contain rabeprazole. It belongs to a
class of medicines called proton pump inhibitors. They act by
reducing the amount of acid made by the stomach.
Rabeprazole sodium tablets are used for:
• Active duodenal ulcer or active benign gastric/stomach ulcer (peptic ulcers).
• Symptomatic erosive or ulcerative gastro-oesophageal reflux disease (GORD) commonly referred to as inflammation of the gullet caused by acid and associated with heartburn, or for long-term treatment of GORD (GORD maintenance).
• The symptomatic treatment of moderate to very severe gastrooesophageal reflux disease (symptomatic GORD) also associated with heartburn.
• Zollinger-Ellison syndrome, a rare condition in patients whose stomachs make extremely high amounts of acid.
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
• if you are pregnant, you think you might be pregnant or if you are breast feeding (please see Pregnancy and breast-feeding)
Take special care with Rabeprazole sodium
• Tell your doctor or pharmacist:
• if you are allergic to other proton pump inhibitors
• if you have been told you have a stomach tumour
• if you have a history of liver disease
• if you are taking atazanavir (a drug used to treat HIV)
If you are taking this medicine for] a long time, your doctor will want to monitor you.
Blood and liver problems have b^en seen in some patients but often get better when rabeprazolq treatment is stopped. Rabeprazole sodium should not tje used in children.
Taking a proton pump inhibitor like Rabeprazole sodium tablets, 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 osjteoporosis).
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicinds, including medicines obtained without a prescription.
Tell your doctor or pharmacist:
• if you are taking ketoconazole cjr itraconazole (drugs used to treat fungal infections)
• if you are taking atazanavir (a d'rug used to treat HIV)
Pregnancy and breast-feeding
Ask your doctor or pharmacist forj advice before taking any medicine.
Do not take Rabeprazole sodium'tablets if you are pregnant or think you may be pregnant.
Do not take Rabeprazole sodium tablets if you are breast-feeding or planning to breast-feed.
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.
YOU MUST SWALLOW THE RABEPRAZOLE SODIUM TABLET WHOLE.
DO NOT CRUSH OR CHEW IT.
The dosages below are those usually recommended for adults and the elderly. Do not change the dose or length of the treatment yourself. Rabeprazole sodium should not be used in children. Active duodenal ulcer and active benign gastric ulcer The usual dose is one Rabeprazole sodium 20 mg tablet once a day.
If you have an active duodenal ulcer, your treatment is expected to continue for four weeks; but after that time your doctor may decide to continue your treatment for a further four weeks.
If you have an active benign gastric ulcer, your treatment is expected to continue for six weeks; but after that time your doctor may decide to continue your treatment for a further six weeks.
Erosive or ulcerative gastro-oesophageal reflux disease The usual dose is one Rabeprazole sodium 20 mg once a day. Your treatment is expected to continue for four weeks; but after that time your doctor may decide to continue your treatment for a further four weeks.
GORD maintenance
The usual dose is one Rabeprazole sodium 10 mg or 20 mg once a day. Your doctor will advise you on how long to take your tablets. You need to see your doctor at regular intervals for review of your tablets and symptoms.
Symptomatic GORD
The usual dose is one Rabeprazole sodium 10 mg once a day. Your once daily treatment is expected to continue for up to four weeks. If your symptoms do not resolve within four weeks consult your doctor. Following this initial four week treatment, if your symptoms return, your doctor may then tell you to take one Rabeprazole sodium 10 mg tablet as and when you require it in order to control your symptoms.
Zollinger-Ellison syndrome
The usual recommended 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. Your doctor will tell you how many tablets to take and when to take them. You need to see your doctor at regular intervals for review of your tablets and symptoms.
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, just take it immediately when you remember, and then continue as usual. If you forget to take your medicine for more than 5 days, call your doctor before taking any more medicine.
Do not take a double dose to make up for a forgotten gastro-resistant tablet.
If you stop taking Rabeprazole sodium
Do not change the dosage or stop the medication without discussing it with your doctor first.
PMS-433U-KRKA
4. Possible side effects
Like all medicines, Rabeprazole sodium can cause side effects, although not everybody gets them.
|
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 |
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Stop taking Rabeprazole sodium and see a doctor straight away if you notice reddening of the skin with blisters or peeling. There may also be severe blisters and bleeding in the lips, eyes, mouth, nose and genitals. This could be ‘Stevens-Johnson syndrome' or ‘toxic epidermal necrolysis'.
Other possible side effects:
Common:
• Infection
• Insomnia (difficult sleeping)
• Headaches, dizziness
• Cough, pharyngitis (sore throat), rhinitis (runny nose)
• Diarrhoea, vomiting, nausea, abdominal pain, constipation (costiveness), flatulence (wind)
• Pain without any known cause, back pain
• Asthenia (weakness), flu like syndrome.
Uncommon:
• Nervousness or drowsiness
• Bronchitis, sinusitis
• Dyspepsia (indigestion), dry mouth, eructation (belching)
• Skin rash, redness of the skin
• Muscle or joint pain, leg cramps, fracture of the hip, wrist or spine
• Urinary tract infection
• Chest pain
• Chills, fever
• Changes in liver function test values
Rare:
• Anorexia (loss of appetite)
• Depression
• Hypersensitivity - a severe immediate allergic reaction for example facial swelling, low blood pressure and shortness of breath which resolve after stopping the treatment.
• Vision disturbances
• Gastritis (upset stomach or stomach pain), stomatitis (sore mouth), taste disturbances
• Liver problems such as hepatitis (inflammation of the liver) and jaundice (yellowing of your skin and whites of your eyes), hepatic encephalopathy (brain damage due to liver disease)
• Itching, sweating, skin blisters (these reactions have usually resolved after discontinuation of therapy)
• Kidney problems such as interstitial nephritis (disorders of the connective tissue within the kidney)
• Weight gain
• Changes in white blood cells:
- Neutropenia (decrease of neutrophils, a type of white blood cell) or leucopenia (decrease of white blood cells) - reductions in white blood cells resulting in frequent infections, such as sore throath or high temperature (fever), or ulcers in your mouth or throat.
- Leucocytosis (increase in white blood cells)
- Thrombocytopenia (decreasq of blood platelets) - reduction in blood platelets resulting in bleeding or bruising more easily than normal.
Very rare:
• Severe skin reactions such are:]
- Erythema multiforme (reddeping of the skin with blisters)
- Toxic epidermal necrolysis (severe skin damage with the detachment of the top layer df skin from the lower layers of the skin over the body)
- Stevens-Johnson syndrome (severe blisters, peeling and bleeding in the skin and also'in the lips, eyes, mouth and nose)
Frequency not known:
• Confusion
• Swelling of the feet or ankles
• Breast swelling in men
• Hyponatremia (low levels of socjium in the blood) - the symptoms are feeling sick and unwell with iweak muscles or confused.
If you are on rabeprazole for mdre 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, increased heart rate. If you get pny of these symptoms, please tell your doctor promptly. Low levels of magnesium can also lead to a reduction in potassium or dalcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor your levels of magnesium.
If any of the side effects gets seripus, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. How to store Rabeprazole sodium
For both strengths, boxes of 7,10,14,15,28, 30, 56,60,90,98 and 100 gastro-resistant tablets in blisters are available. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
KRKA, d.d., Novo mesto, Smarjeska cesta 6,8501 Novo mesto,
Slovenia
This leaflet was last approved in8/2012
Keep out of the reach and sight of children.
Do not use Rabeprazole sodium after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.
Store in the original package in order to protect from moisture and light. Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines 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 gastro-resistant tablet contains 10 mg rabeprazole sodium, equivalent to 9.42 mg rabeprazole. Each gastro-resistant tablet contains 20 mg rabeprazole sodium, equivalent to 18.85 mg rabeprazole.
• The other ingredients are mannitol (E421), light magnesium oxide (E530), hydroxypropylcellulose (E463), low-substituted hydroxypropylcellulose (E463) and magnesium stearate (E572) in the tablet core, and ethylcellulose (E462), light magnesium oxide (E530), hypromellose phthalate, diacetylated monoglycerides (E472a), talc (E553b), titanium dioxide (E171), red iron oxide (E172) (10 mg only) and yellow iron oxide (E172) (20 mg only) in the coating.
What Rabeprazole sodium looks like and contents of the pack
10 mg gastro-resistant tablets are orange-pink, biconvex, round tablets with bevelled edges.
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20 mg gastro-resistant tablets are slightly brownish yellow, biconvex and round.