Rabeprazole Sodium 20 Mg Gastro-Resistant Tablets
TEVA UK Ref: 231-30-88383-F LEA RABEPRAZOLE SODIUM A/S G/R TAB TUK Version: 2 23 September 2016
PAGE 1: FRONT FACE (INSIDE OF REEL)
Pharma code 212
Rabeprazole Sodium 10 & 20 mg Gastro-resistant Tablets
Rabeprazole sodium
Package leaflet: Information for the user
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.
What is in this leaflet
1. What Rabeprazole is and what it is used for
2. What you need to know before you take Rabeprazole
3. How to take Rabeprazole
4. Possible side effects
5. How to store Rabeprazole
6. Contents of the pack and other information
What Rabeprazole is and what it is used for
This medicine 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.
This medicine will be referred to Rabeprazole throughout the remainder of this PIL.
Rabeprazole gastro-resistant 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 escape 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.
©What you need to know before you take Rabeprazole
Do not take Rabeprazole:
• if you are allergic to rabeprazole sodium or any of the
other ingredients of this medicine (listed in section 6).
• if you are pregnant or think that you are pregnant.
• if you are breast-feeding.
Do not use Rabeprazole if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before using Rabeprazole.
Also see Pregnancy and breast-feeding section.
Warnings and precautions
Talk to your doctor or pharmacist before taking Rabeprazole:
• if you are allergic to other proton pump inhibitor medicines or 'substituted benzimidazoles'.
• Blood and liver problems have been seen in some patients but often get better when Rabeprazole sodium is stopped.
• if you have a stomach tumour.
• if you have ever had liver problems.
• if you are taking atazanavir for HIV infection.
• if you are due to have a specific blood test (Chromogranin A). • if you have ever had a skin reaction after treatment with a medicine similar to Rabeprazole that reduces stomach acid. 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 Rabeprazole. Remember to also mention any other ill-effects like pain in your joints.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Rabeprazole.
If you experience severe (watery or bloody) diarrhoea with symptoms such as fever, abdominal pain or tenderness, stop taking Rabeprazole and see a doctor straight away.
Taking a proton pump inhibitor like Rabeprazole, 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).
Children
Rabeprazole should not be used in children.
Other medicines and Rabeprazole
Tell your doctor or pharmacist if you are taking, have recently taken or might take 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 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 may lower the amount of this type of medicine in your blood and they should not be used together.
• Methotrexate (a chemotherapy medicine used in high doses to treat cancer) - if you are taking a high dose of methotrexate, your doctor may temporarily stop your Rabeprazole treatment
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using Rabeprazole.
Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
• Do not use Rabeprazole if you are pregnant or think you may be pregnant.
• Do not use Rabeprazole if you are breast-feeding or planning to breast-feed.
Driving and using machines
You may feel sleepy while taking Rabeprazole. If this happens, do not drive or use any tools or machines.
Rabeprazole contains lactose
This medicinal product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
^3 How to take Rabeprazole
Always take this medicine exactly as your doctor has told you. 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.Your doctor may carry out blood tests from time to time to check your blood and liver function.
The recommended dose is:
Adults and the elderly
For gastro-oesophageal reflux disease (GORD)
Treatment of moderate to severe symptoms (symptomatic GORD)
• The usual dose is 1 Rabeprazole 10 mg gastro-resistant tablet once a day for up to 4 weeks.
• Take the tablet in the morning before eating.
• If your condition returns after 4 weeks' treatment, your doctor may tell you to take one Rabeprazole 10 mg gastro-resistant tablet as and when you require it.
Treatment of more severe symptoms (erosive or ulcerative GORD)
• The usual dose is one Rabeprazole (20 mg gastro-resistant 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 10 mg or 20 mg gastro-resistant 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 20 mg gastro-resistant tablet once a day for 6 weeks.
• Take the tablet in the morning before eating.
• Your doctor may tell you to take Rabeprazole for another 6 weeks if your condition does not improve.
For ulcers of the intestine (duodenal ulcers)
• The usual dose is one Rabeprazole 20 mg gastro-resistant tablet once a day for 4 weeks.
• Take the tablet in the morning before eating.
• Your doctor may tell you to take Rabeprazole for another 4 weeks if your condition does not improve.
Zollinger-Ellison syndrome where excess acid is produced in the stomach
• The usual dose is three Rabeprazole 20 mg gastro-resistant tablets once a day to start with.
• The dose may then be adjusted by your doctor depending on how you respond to the treatment.
Top of page cut-off to middle of registration mark: 44 mm.
REG
0078193 Version 4.5 Approved
Page 1 of 3
tTTrW71
UK
Eastbourne
Artwork
Origination
Dim's Changed?: Length:
Width:
Depth:
Foil Width:
No 323 mm 200 mm N/A N/A
Colours Used:
PANTONE® GREEN C BLACK
CUTTER
PAGE 2: REAR FACE (OUTSIDE OF REEL)
If you are on long-term treatment you will need to see your doctor at regular intervals for review of your tablets and symptoms.
Use in children
The product should not be used in children.
If you have 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.
If you take more Rabeprazole than you should
If you take more Rabeprazole than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you.
If you forget to take Rabeprazole
• 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.
• for more than 5 days, talk to your doctor before taking any more medicine.
• Do not take a double dose to make up for a forgotten dose.
If you stop taking Rabeprazole
Relief of symptoms will normally occur before the ulcer has completely healed. It is important that you do not stop taking the gastro-resistant tablets until told to do so by your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine 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.
Stop taking Rabeprazole and see a doctor straight away if you notice any of the following side effects - you may need urgent medical treatment:
• 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.
These side effects are rare (may affect up to 1 in 1,000 people).
• Blistering of the skin, mouth, eyes and genitals, shedding of your skin
These side effects are very rare (may affect up to 1 in 10, 000 people).
Other possible side effects:
Common: may affect up to 1 in 10 people
• Infections
• Difficulty sleeping
• Headache or feeling dizzy
• Cough, runny nose 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
• Aches or back pain
• Weakness or flu-like symptoms Uncommon: may affect up to 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
• Muscle, leg or joint pain
• Bladder infection (urinary tract infection)
• Chest pain
• Chills or fever
• Changes in how your liver is working (shown in blood tests)
• Fracture of the hip, wrist or spine Rare: may affect up to 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
• Liver problems including 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.
Not known: frequency cannot be estimated from the available data
• Breast swelling in men
• Fluid retention
• Low blood levels of sodium which can cause tiredness and confusion, muscle twitching, fits and coma
• Patients who have previously had liver problems may very rarely get encephalopathy (a brain disease).
• Rash, possibly with pain in the joints.
If you are on Rabeprazole 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, 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.
Do not be concerned by this list of side effects. You may not get any of them.
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.
How to store Rabeprazole
Keep this medicine out of the sight and reach of children. Store below 25°C.
Store in original package in order to protect from moisture. Do not use this medicine after the expiry date which is stated on the pack.The expiry date refers to the last day of that month.
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 contains
The active substance is rabeprazole sodium.
Each 10 mg gastro-resistant tablet contains 10 mg rabeprazole sodium.
Each 20 mg gastro-resistant tablet contains 20 mg rabeprazole sodium.
The other ingredients are:
Core:
Mannitol, low substituted hydroxypropylcellulose, magnesium oxide, heavy, hydroxypropylcellulose, magnesium stearate.
Coating - 10 mg tablets:
Hypromellose (E464), cellulose microcrystalline, stearic acid, titanium dioxide (E171), hypromellose phthalate, triethyl citrate, lactose monohydrate, macrogol 4000, red iron oxide (E172), yellow iron oxide (E172).
Coating - 20 mg tablets:
Hypromellose (E464), cellulose microcrystalline, stearic acid, titanium dioxide (E171), hypromellose phthalate, triethyl citrate, lactose monohydrate, macrogol 4000, red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172). Printing ink:
Shellac, black iron oxide (E172), ammonium hydroxide, propylene glycol.
What Rabeprazole looks like and contents of the pack
• Rabeprazole Sodium 10 mg Gastro-resistant Tablets are pink, round tablets, imprinted on one side of the tablet with black ink "N" and "10".
• Rabeprazole Sodium 20 mg Gastro-resistantTablets are yellow, round tablets, imprinted on one side of the tablet with black ink "93" "64". Plain on the other side.
• Rabeprazole sodium gastro-resistant tablets are available in pack sizes of 1, 7, 14, 15, 20, 25, 28, 30, 50, 56, 57, 60, 75, 98, 100 and 120 gastro-resistant tablets. Hospital packs of 50 and 98 gastro-resistant tablets.
• Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer TEVA UK Limited, Eastbourne BN22 9AG
This leaflet was last revised in September 2016
PL 00289/1143-1144
TEUZD
teva uk limited 323 x 200mm
REG007
8193
Version 4.5
Approved
Page 2 of 3
This is a representation of an electronic record that was signed electronically and this
PAGE IS THE MANIFESTATION OF THE ELECTRONIC SIGNATURE
Teva Pharmaceuticals Europe B.V 1.3.2
mockup-pil-uk-pl-00289-1143-4-rabeprazole-10mg-20mg-gastroresistant-tabl
ets-EBN
Approvals
|
Signed by |
Meaning of Signature |
Server Date |
|
Yifan Li |
Regulatory Affairs Approval |
30-Sep-2016 10:55:31 AM |
REG0078193 Version 4.5 Approved Page 3 of 3