Patient leaflet - Rabeprazole 10 mg gastro-resistant tablets
1. WHAT RABEPRAZOLE IS AND WHAT IT IS USED FOR
Rabeprazole tablets contain the active ingredient rabeprazole sodium. Rabeprazole belongs to a group of medicines called Proton Pump Inhibitors (PPIs). Rabeprazole acts by reducing the amount of acid made by the stomach. Rabeprazole is 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). If the ulcers are infected with bacteria called ‘Helicobacter pylori’ (H. pylori), you will also be given antibiotics. Using rabeprazole tablets and antibiotics together gets rid of the infection and makes the ulcer heal. It also stops the infection and ulcer from coming back
- Zollinger-Ellison Syndrome, which is a condition when the stomach produces too much acid.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RABEPRAZOLE
Do not take Rabeprazole
- if you are allergic (hypersensitive) to rabeprazole sodium or any of the other ingredients of Rabeprazole gastro-resistant tablets (listed in Section 6).
- if you are pregnant or think that you are pregnant
- if you are breast feeding.
Do not use rabeprazole tablets if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before using rabeprazole.
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 is stopped.
- You have a stomach tumour.
- You have ever had liver problems.
- If you are taking atazanavir- for HIV infection.
- If you have reduced body stores or risk factors for reduced vitamin B12 and receive long term treatment with rabeprazole sodium. As with all acid reducing agents, rabeprazole sodium may lead to a reduced absorption of vitamin B12.
- 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.
- You are due to have a specific blood test (chromogranin A).
When taking rabeprazole, inflammation in your kidney may occur. Signs and symptoms may include decreased
volume of urine or blood in your urine and/or hypersensitivity reactions such as fever, rash and joint stiffness. You should report such signs to the treating physician.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking rabeprazole.
This medicine may affect the way that your body absorbs vitamin B12, particularly if you need to take it for a long time. Please contact your doctor if you notice any of the following symptoms, which could indicate low levels of Vitamin B12:
- Extreme tiredness or lack of energy
- Pins and needles
- Sore or red tongue, mouth ulcers
- Muscle weakness
- Disturbed vision
- Problems with memory, confusion, depression
Children
Rabeprazole 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 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).
Other medicines and rabeprazole
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: including medicines obtained without a prescription. This is especially important in case you are taking any of the following medicines:
- atazanavir (used to treat HIV infection); rabeprazole may lower the amount of this type of medicine in your blood. Your doctor may need to adjust your dose.
- ketaconazole 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.
- 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 before taking rabeprazole.
Pregnancy, breast-feeding and fertility
- 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.
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 any medicine.
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 sodium
This medicine contains less than 1 mmol sodium (23 mg) per gastro-resistant tablet, that is to say essentially ‘sodium-free’.
This medicine contains mannitol and may have a mild laxative effect.
3. HOW TO TAKE RABEPRAZOLE
Always take Rabeprazole 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 elderly
For ‘gastro-oesophageal reflux disease’ (GORD)
Treatment of moderate to severe symptoms (symptomatic GORD)
- The usual dose is one rabeprazole 10mg tablets once a day for up to 4 weeks.
- Take the tablet in the morning before eating
- If you condition returns after 4 weeks treatment, your doctor may tell you to take one rabeprazole 10mg tablet as and when you require it.
Treatment of more severe symptoms (erosive or ulcerative GORD)
- The usual dose is one rabeprazole 20mg 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 10mg or 20mg 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 20mg 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 20mg 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.
For ulcers caused by H. Pylori infection and to stop them coming back
- The usual dose is one rabeprazole 20mg tablet twice a day for seven days.
- Your doctor will also tell you to take antibiotics called amoxicillin and clarithromycin.
For further information on the other medicines used for H. Pylori treatment, see the individual product information leaflets.
Zollinger-Ellison Syndrome where excess acid is produced in the stomach
- The usual dose is three rabeprazole 20mg tablets once a day to start with.
The dose may then be adjusted by your doctor depending on how you respond to the treatment. 8092466-7803
If you are on long term treatment you will need to see your doctor at regular intervals for review of your tablets and symptoms.
Patients 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.
Children
Rabeprazole is not recommended for use in children.
Instructions for use
The tablets must be swallowed whole with half a glass of water and may not be chewed or crushed. When Rabeprazole is taken once daily, the tablets should be taken in the morning before breakfast.
If you take more Rabeprazole than you should
If you have taken more Rabeprazole than you should, talk to a doctor or go to a hospital straightaway. Take the medicine pack with you.
If you forget to take Rabeprazole
- 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
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.
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. The side effects are usually mild and improve without you having to stop taking this medicine.
Stop taking rabeprazole and see a doctor straightaway 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 sore throat or high temperature (fever), or ulcers in your mouth or throat.
- Bruising or bleeding easily.
These side effects are rare (affect less than 1 in 1000 people).
- Severe skin blistering, or soreness or ulcers in your mouth and throat.
These side effects are very rare (affect less than 1 in 10,000 people).
Other possible side effects:
Common (affect less than 1 in 10 people)
- 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
- Benign polyps in the stomach.
- Infections
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
- Muscle, leg or joint pain
- Fractures of the hip, wrist and spine
- 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 1000 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
Other possible side effects (unknown frequency)
- Breast swelling in men
- Fluid retention
- Inflammation of the gut (leading to diarrhoea)
- 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 MHRA Yellow Card Scheme (www.mhra.gov.uk/yellowcard) or search for MHRA Yellow Card on Google Play or Apple App store. By reporting side effects, you can help provide more information on the safety of this medicine.
5. HOW TO STORE RABEPRAZOLE
Keep out of the sight and reach of children.
Blister packs: Store below 25°C. Store in the original package in order to protect from moisture. Tablet containers: Store below 25°C. Keep the container tightly closed in order to protect from moisture.
Do not use Rabeprazole after the expiry date which is stated on the carton and label/blister after Expiry Date/Exp. 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 no longer required. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Rabeprazole gastro-resistant tablets contain
- The active substance is rabeprazole sodium. Each tablet contains 10 mg or 20 mg rabeprazole
- sodium.
The other ingredients are:
core: povidone, mannitol (E421), light magnesium oxide, low substituted hydroxypropyl cellulose, magnesium stearate;
sealing: ethyl cellulose, light magnesium oxide;
gastro-resistant coating: methacrylic acid-ethyl acrylate copolymer, polysorbate 80, sodium lauryl sulphate, propylene glycol, talc, iron oxide red (E172) iron oxide yellow (E172) titanium dioxide (E171)
What Rabeprazole gastro-resistant tablets look like and contents of the pack
Rabeprazole 10 mg gastro-resistant tablet: Pink, coated, elliptical, biconvex tablet. Rabeprazole 20 mg gastro-resistant tablet: Yellow, coated, elliptical, biconvex tablet.
Pack sizes:
Blister packs (aluminium/aluminium): 1, 5, 7, 14, 15, 20, 25, 28, 30, 50, 56, 60, 75, 98, 100 and 120 tablets Plastic tablet containers with a desiccant: 30, 100 and 250 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Torrent Pharma (UK) Ltd.
3rd Floor, Nexus Building
4 Gatwick Road
Crawley
West Sussex
RH10 9BG
United Kingdom
Manufacturer:
Coripharma ehf.
Reykjavikurvegur 78
IS-220 Hafnarfjordur
Iceland