Rabeprazole Sodium 10 Mg Gastro-Resistant Tablets
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
Package leaflet: Information for the user
Rabeprazole sodium 10mg Gastro-resistant Tablets
What is in this leaflet
1. What Rabeprazole sodium is and what it is used for
2. What you need to know before you take Rabeprazole sodium
3. How to take Rabeprazole sodium
4. Possible side effects
5. How to store Rabeprazole sodium
6. Contents of the pack and other 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.
• In combination with two antibiotics (clarithromycin and amoxycillin) Rabeprazole sodium tablets are used for the eradication of H pylori infection in patients with peptic ulcer disease.
2. What you need to know before you take Rabeprazole sodium
Do not take Rabeprazole sodium
• if you are allergic to rabeprazole sodium or any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant, you think you might be pregnant or if you are breast feeding (please see Pregnancy and breast-feeding)
Warnings and precautions
Talk to your doctor or pharmacist before taking Rabeprazole sodium:
• 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)
Taking a proton pump inhibitor like Rabeprazole sodium, 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 are taking this medicine for a long time, your doctor will want to monitor you.
Blood and liver problems have been seen in some patients but often get better when rabeprazole treatment is stopped.
Patient with liver problems.
You should consult your doctor who will take special care when beginning treatment with rabeprazole and while you continue to be treated with rabeprazole.
Use in children
Rabeprazole sodium should not be used in children.
If you experience severe (watery or bloody) diarrhoea with symptoms such as fever, abdominal pain or tenderness, stop taking this medicine and see a doctor straight away.
Other medicines and Rabeprazole sodium
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Tell your doctor or pharmacist:
• if you are taking ketoconazole or itraconazole (drugs used to treat fungal infections)
• if you are taking atazanavir (a drug used to treat HIV)
Pregnancy, breast-feeding and fertility
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.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
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 this medicine exactly as your doctor has told you. 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 gastrooesophageal 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.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects:
Stop taking Rabeprazole sodium and go to the nearest hospital straight away if:
• you notice yellowing of skin and whites of eyes (symptoms of liver problem), brain damage due to liver disease
• you notice hypersensitivity - a severe immediate allergic reaction for example facial swelling, low blood pressure and shortness of breath which resolve after stopping the treatment.
These side effects are rare (may affect up to 1 in 1,000 people).
• 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
Other possible side effects
Common (may affect up to 1 in 10 people)
• infection
• difficulty sleeping
• headaches, dizziness
• cough, sore throat, runny nose
• diarrhoea, being sick, feeling sick, stomach pain, constipation, wind
• pain without any known cause, back pain
• weakness, flu like syndrome.
Uncommon(may affect up to 1 in 100 people)
• nervousness or drowsiness
• chest infection, painful and blocked sinuses
• indigestion, dry mouth, belching
• skin rash, redness of the skin
• muscle or joint pain, leg cramps
• bladder infection (urinary tract infection)
• chest pain
• chills, fever
• changes in liver function test values (shown in blood tests)
• fracture of the hip, wrist or spine.
Rare (may affect up to 1 in 1,000 people)
• loss of appetite
• depression
• visual disturbances
• upset stomach or stomach pain, sore mouth, taste disturbances
• itching, sweating, skin blisters (these reactions have usually resolved after discontinuation of therapy)
• kidney problems
• weight gain
• changes in white blood cells (shown in blood tests):
* decrease in white blood cells resulting in frequent infections, such as sore throat or fever, or ulcers in your mouth or throat
* increase in white blood cells
• decrease in blood platelets resulting in bleeding or bruising more easily than normal.
Not known(frequency cannot be estimated from the available data)
• confusion
• swelling of the feet or ankles
• breast swelling in men
• low levels of sodium in the blood - the symptoms are feeling sick and unwell with weak muscles or confusion
• if you are on Rabeprazole sodium 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 tiredness, involuntary muscle contractions, disorientation, fits, dizziness, 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.
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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Rabeprazole sodium
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. The expiry date refers to the last day of that month. Do not store above 30°C. Store in the original package in order to protect from moisture and light.
Do not use any Rabeprazole sodium pack that is damaged or shows signs of tampering.
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.
6. Contents of the pack and other information
What Rabeprazole sodium contains
The active substance is rabeprazole sodium.
Each Rabeprazole sodium 10 mg gastro-resistant tablet contains 10 mg rabeprazole sodium, equivalent to 9.42 mg rabeprazole.
The other ingredients are:
Tablet core: mannitol, magnesium oxide, heavy, hydroxypropyl cellulose, magnesium stearate. Intermediate layer: ethylcellulose, magnesium oxide, heavy.
Tablet coating: hypromellose phthalate, dibutyl sebacate, yellow iron oxide (only Rabeprazole sodium 20 mg gastro-resistant tablets), red iron oxide (only Rabeprazole sodium 10 mg gastro-resistant tablets), titanium dioxide, talc.
What Rabeprazole sodium looks like and contents of the pack
Rabeprazole sodium 10 mg gastro-resistant tablets: pink, film-coated, biconvex, round tablets.
The tablets are supplied in blister packs of 1, 5, 7, 14, 15, 25, 28, 30, 50, 56, 75, 98 or 120 tablets.
Not all pack sizes or tablet strengths may be marketed.
Marketing Authorisation Holder:
CHEMO IBERICA, S.A.
Gran Via Carlos III, 98 7th floor
08028 Barcelona
SPAIN
Manufacturer:
LABORATORIOS LICONSA, S.A.
Avda. Miralcampo, N° 7,
Poligono Industrial Miralcampo 19200 Azuqueca de Henares (Guadalajara), SPAIN
543852
This leaflet was last revised in April 2014.