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Rabeprazole Sodium 20mg Gastro-Resistant Tablets

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Document: leaflet MAH GENERIC_PL 17780-0577 change

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Rabeprazole Sodium 10mg Gastro-resistant tablets

and

Rabeprazole Sodium 20mg 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 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

1. WHAT RABEPRAZOLE IS AND WHAT IT IS USED FOR


The name of your medicine is Rabeprazole Sodium 10mg Gastro-resistant tablets or Rabeprazole Sodium 20mg 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 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 sodium that reduces stomach acid.

•    if you are due to have a specific blood test (Chromogranin A).

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.

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.

_2_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 not known: 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)

•    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 1000 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)

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.

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.

What Rabeprazole contains:

The active substance is: rabeprazole sodium

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

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

The other ingredients are:

Tablet core:

Mannitol, magnesium oxide, sodium 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 10mg gastro-resistant tablets additionally 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, One Onslow Street, Guildford, Surrey, GU1 4YS, UK MANUFACTURER

Sofarimex - Ind. Quimica e Farmaceutica, S.A.

Av. Das Industrias - Alto do Colaride 2735-213 Cacem 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 September 2016.