Rabeprazole Sodium 20 mg gastro-resistant tablets – patient leaflet, side effects, dosage

1. WHAT RABEPRAZOLE IS AND WHAT IT IS USED FOR

The name of your medicine is Rabeprazole Sodium 10 mg Gastro-resistant tablets or Rabeprazole Sodium 20 mg Gastro-resistant tablets (called Rabeprazole throughout this leaflet). This belongs to a group of medicines called ‘proton pump inhibitors’ (PPIs). They work by lowering the amount of acid that your stomach produces.

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 these 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 where your stomach produces too much acid.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RABEPRAZOLE

Do not take Rabeprazole

• if you are allergic to rabeprazole or any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant or think you are pregnant.
• if you are breast-feeding.

Warnings and precautions

Talk to your doctor or pharmacist before taking Rabeprazole

• if you are allergic to other proton pump inhibitors or ‘substituted benzimidazoles’
• blood and liver problems have been seen in some patients but often get better when rabeprazole 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 have ever had a skin reaction after treatment with a medicine similar to rabeprazole sodium that reduces stomach acid.
• if you are due to have a specific blood test (Chromogranin A).

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 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 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 sodium. Remember to also mention any other ill-effects like pain in your joints.

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 given to children as there is no experience with Rabeprazole in children.

Other medicines and Rabeprazole

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, tell your doctor or pharmacist if you are taking one of the following medicines:

• Medicines to treat fungal infections (e.g. ketoconazole or itraconazole).

  Rabeprazole may lower the amount of this type of medicine in your blood. Your doctor may need to adjust your dose.

• Atazanavir for the treatment of 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 and breast-feeding

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. There are no adequate data from the use of rabeprazole in pregnant women. Therefore you must not take Rabeprazole if you are pregnant or think you might be pregnant. It is not known whether the active substance passes into breast milk. Therefore you must not take Rabeprazole if you are breastfeeding. Driving and using machines

It is unlikely that Rabeprazole would affect your ability to drive and use machines. However, occasionally Rabeprazole can cause drowsiness. Therefore, you should not drive or use machines if you feel drowsy. Important information about Sodium content in your medicine

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

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 glass 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 older people

For ‘gastro-oesophageal reflux disease’ (GORD)

Treatment of moderate to severe symptoms (symptomatic GORD)

• The usual dose is one 10 mg 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 tablet as and when you require it.

Treatment of more severe symptoms (erosive or ulcerative GORD)

• The usual dose is one 20 mg 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 10 mg or 20 mg 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 20 mg 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 20 mg 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 20 mg tablet twice a day for 7 days.
• Your doctor will also tell you to take antibiotics called amoxicillin and clarithromycin. The following combination is recommended: Morning Evening

20 mg rabeprazole

sodium 20 mg rabeprazole sodium

500 mg clarithromycin 500 mg clarithromycin 1000 mg amoxicillin 1000 mg amoxicillin

For further information on the other medicines used to treat H. pylori, see the individual product information leaflets.

Zollinger-Ellison Syndrome where excess acid is produced in the stomach

• The usual recommended starting dose is 60 mg (three 20 mg) tablets once a day.
• The dose may then be adjusted by your doctor depending on how you respond to the treatment.

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 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.

Use in children

The product should not be used in children. If you take more Rabeprazole than you should

If you have taken more Rabeprazole than you should contact a doctor or go to a hospital straight away. 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 product, 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 straight away if you notice any of the following side effects – you may need urgent medical treatment:

• Serious allergic reactions (frequency rare: may affect up to 1 in 1,000 people): the signs may include: sudden swelling of your face, difficulty breathing or low blood pressure which may cause fainting or collapse.
• Other serious conditions (frequency rare: may affect up to 1 in 1,000 people): frequent infections, such as sore throat or high temperature (fever), ulcers in your mouth and throat, bruising or bleeding easily.

Serious skin conditions (frequency very rare: may affect up to 1 in 10,000 people): severe skin blistering, or soreness or ulcers in your mouth and throat (erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome).

• Other serious skin conditions (frequency cannot be estimated from the available data); rash, possibly with pain in the joints (sub-acute cutaneous lupus erythematosus) 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)
• Effect on your stomach or gut such as stomach pain, diarrhoea, feeling sick (nausea), being sick (vomiting), constipation or wind (flatulence), benign polyps in the stomach
• 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
• 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 (may affect up to 1 in 1,000 people)

• Loss of appetite (anorexia)
• Depression
• Hypersensitivity (includes allergic reactions)
• Visual disturbances
• 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)

• Inflammation of the gut (leading to diarrhoea) 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.

  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 or search for MHRA Yellow Card in the 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 this medicine out of the sight and reach of children.

Do not use Rabeprazole after the expiry date which is stated on the blister and outer carton after “EXP”. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

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 Rabeprazole Sodium 10 mg gastro-resistant tablet contains 10 mg of rabeprazole sodium, equivalent to 9.42 mg rabeprazole.

Each Rabeprazole Sodium 20 mg gastro-resistant tablet contains 20 mg of rabeprazole sodium, equivalent to 18.85 mg rabeprazole.

The other ingredients are:

Tablet core:

mannitol, magnesium oxide, sodium calcium edetate, crospovidone type A, calcium stearate, povidone

Tablet coating:

triethyl citrate, methacrylic acid-ethyl acrylate copolymer (1:1), ethylcellulose, hypromellose, sodium carbonate, anhydrous, titanium dioxide (E171), macrogol 400, yellow iron oxide (E172). Rabeprazole Sodium 10 mg gastro-resistant tablets also contain red iron oxide (E172). What Rabeprazole looks like and contents of the pack:

Rabeprazole 10 mg are pink, round, gastro-resistant tablets.

Rabeprazole 20 mg are yellow, round, gastro-resistant tablets.

They are supplied in blister packs of 5, 7, 14, 15, 25, 28, 30, 50, 56, 75, 98, 120 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder

Zentiva Pharma UK Limited, 12 New Fetter Lane, London, EC4A 1JP, United Kingdom Manufacturer(s)

Sofarimex – Ind. Quimica e Farmaceutica, S.A., Av. Das Indústrias – Alto do Colaride, 2735-213 Cacém

Portugal

or

S.C. Zentiva S.A., B-dul. Theodor Pallady nr. 50, Sector 3, Bucuresti, Cod 032266

Romania

This leaflet was last revised in November 2024.

947385

947385