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 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 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 gastroesophageal 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 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 (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)
Warnings and Precautions
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).
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 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.
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
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
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 and breast-feeding
Ask your doctor or pharmacist for 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.
Eradication of H. pylori The usual recommended dose is Rabeprazole sodium 20 mg to be taken (in combination with two antibiotics - clarithromycin 500 mg and amoxycillin 1 g) twice each day and normally for 7 days. Relief of symptoms will normally occur before the ulcer has completely healed. Therefore it is important that you do not stop taking the tablets until told to do so by your doctor. For further information on the other components of the H. pylori eradication therapy see the individual product information leaflets.
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.
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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, Rabeprazole sodium can cause side effects, although not everybody gets them.
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:
• 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 (affect up to 1 in
1.000 people).
• 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). These side effects are rare (affect up to 1 in 1,000 people).
• Kidney problems such as interstitial nephritis (disorders of the connective tissue within the kidney). These side effects are rare (affect up to 1 in
1.000 people).
• Erythema multiforme (reddening of the skin with blisters) or soreness or ulcers in your mouth and throat. These side effects are very rare (affect up to 1 in 10,000 people).
• Toxic epidermal necrolysis (severe skin damage with the detachment of the top layer of skin from the lower layers of the skin over the body). These side effects are very rare (affect up to 1 in 10,000 people)
• Steven-Johnson syndrome (severe blisters, peeling and bleeding in the skin and also in the lips, eyes, mouth and nose). These side effects are very rare (affect up to 1 in 10,000 people)
• 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 fatigue, involuntary 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. These side effects are very rare (affect up to 1 in 10,000 people)
Other possible side effects:
Common (may affect up to 1 in 10 people)
- 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 (may affect up to 1 in 100 people)
- Nervousness or drowsiness
- Bronchitis, sinusitis
- Dyspepsia (indigestion), dry mouth, eructation (belching)
- Skin rash, redness of the skin
- Muscle or joint pain, leg cramps
- Urinary tract infection
- Chest pain
- Chills, fever
- Changes in liver function test values
- Fracture of the hip, wrist or spine.
Rare (may affect up to 1 in 1,000 people)
- 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
- Itching, sweating, skin blisters (these reactions have usually resolved after discontinuation of therapy)
- 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 throat or high temperature (fever), or ulcers in your mouth or throat.
- Leucocytosis (increase in white blood cells)
- Thrombocytopenia (decrease of blood platelets) - reduction 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
- Hyponatremia (low levels of sodium in the blood) - the symptoms are feeling sick and unwell with weak muscles or confused.
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 Yellow Card Scheme website: 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 out of the reach and sight of children.
• Do not use Rabeprazole sodium after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.
• Do not store above 300C. 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.
• 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 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.
Each Rabeprazole sodium 20 mg gastro-resistant tablet contains 20 mg rabeprazole sodium, equivalent to 18.85 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.
Rabeprazole sodium 20 mg gastro-resistant tablets: yellow, 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:
Name and Address Bristol Laboratories Ltd,
Unit 3, Canalside, Northbridge road, Berkhamsted, Hertfordshire, HP4 1EG, United Kingdom
Telephone: 0044(0)1442 200922
Fax: 0044(0)1442 873717
Email: info@brisol-labs.co.uk
Manufacturer:
Laboratorios LICONSA, S.A.
Avda. Miralcampo, N°7, Polfgono Industrial Miralcampo 19200 Azuqueca de Henares (Guadalajara), SPAIN
Rabeprazole sodium 10 mg gastro-resistant tablets; PL 17907/0457 Rabeprazole sodium 20 mg gastro-resistant tablets; PL 17907/0458
This leaflet was last revised in January 2015
To request a copy of this leaflet in Braille, large print or audio format, contact the licence holder at the address (or telephone, fax, email) above.
V7 22-01-15 D0
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