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Rabeprazole 10 Mg Gastro-Resistant Tablets

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Rabeprazole 10 mg gastro-resistant tablets Rabeprazole 20 mg gastro-resistant tablets

rabeprazole sodium

Read all of this leaflet carefully before you start taking this medicine.

-    Keep this leaflet. Y ou may need to read it again.

-    If you have any further questions, ask your doctor or pharmacist.

-    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

-    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Rabeprazole is and what it is used for

2.    Before you take Rabeprazole

3.    How to take Rabeprazole

4.    Possible side effects

5.    How to store Rabeprazole

6.    Further information

1. WHAT RABEPRAZOLE IS AND WHAT IT IS USED FOR

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:

•    ulcer in the upper part of the intestine (duodenal ulcer) and benign stomach ulcer

•    gastro-oesophageal reflux disease (GORD) with or without ulcer. GORD is commonly referred to as inflammation of the gullet caused by acid and associated with heartburn. Heartburn is a burning feeling rising from the stomach or lower chest up towards the neck. Rabeprazole may also be used as a long term treatment of GORD (GORD maintenance). Rabeprazole may also be used for the symptomatic treatment of moderate to very severe gastro-oesophageal reflux disease (symptomatic GORD).

•    Zollinger-Ellison Syndrome, which is a condition when the stomach makes extremely high amounts of acid.

2. 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 breast feeding

Take special care with Rabeprazole

•    if you are allergic to other proton pump inhibitors

•    if you have or have had any liver problems

•    if you are taking a medicine called atazanavir (used to treat HIV)

If the above applies to you, consult your doctor before using Rabeprazole.

Your doctor may perform or have performed an additional investigation called an endoscopy in order to diagnose your condition and/or exclude malignant disease. The possibility of stomach and oesophageal tumours should be excluded before treatment is started.

If you take Rabeprazole on a long-term basis (longer than 1 year) your doctor will probably monitor you regularly. You should report any new or different symptoms whenever you see your doctor.

Some abnormal blood values have been reported during treatment with Rabeprazole. Usually, the values become normal when the treatment is discontinued.

Rabeprazole is not recommended for use in children.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other 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); it is not recommended to take Rabeprazole if you are taking atazanavir

•    ketaconazole or itraconazole (used to treat infections caused by a fungus)

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

Rabeprazole must not be used during pregnancy and breast-feeding.

Driving and using machines

It is unlikely that Rabeprazole would affect your ability to drive or operate machinery.

However, occasionally rabeprazole can cause sleepiness. Therefore, driving and operating complex machinery should be avoided if your are affected.

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. The usual dose is as follows:

Adults and elderly

Duodenal ulcer and benign gastric ulcer: 20 mg of Rabeprazole to be taken once daily in the morning. Most patients with duodenal ulcer are treated for four weeks and most patients with benign gastric ulcer are treated for six weeks. However a few patients may require additional treatment to achieve healing.

Gastro-Oesophageal Reflux Disease (GORD) with ulcer: 20 mg of Rabeprazole to be taken once daily for four to eight weeks.

Long term treatment of GORD: 10 mg or 20 mg of Rabeprazole once daily depending upon response.

Symptomatic treatment of GORD: 10 mg of Rabeprazole once daily for 4 weeks. Once symptoms have cleared your doctor may tell you to take 10 mg of Rabeprazole once daily when needed for subsequent symptom control.

Zollinger-Ellison Syndrome: 60 mg of Rabeprazole 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.

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 prescribed by your doctor, seek medical advice.

If you forget to take Rabeprazole

Do not take a double dose to make up for a forgotten dose. If you forget to take a dose, take it as soon as you remember. If it is almost time to take the next dose, wait until then. Do not take a double dose to make up for a forgotten dose.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Rabeprazole can cause side effects, although not everybody gets them.

If you notice any of the following serious side effects, stop taking Rabeprazole and contact a doctor immediately:

-    Sudden wheezing, swelling of your lips, face or body, rash, fainting or difficulties swallowing (severe allergic reaction).

-    Yellow skin, dark urine and tiredness which can be symptoms of liver problems.

-    Reddening of the skin with blisters or peeling and may be associated with a high fever and joint pains. There may also be severe blisters and bleeding in the lips, eyes, mouth, nose and genitals. This could be erythema multiforme, Stevens-Johnson syndrome or toxic epidermal necrolysis.

The frequency of possible side effects listed below is defined using the following convention: Very common:    affects more than 1 user in 10

Common:    affects    1 to 10 users    in 100

Uncommon:    affects    1 to 10 users    in 1,000

Rare:    affects    1 to 10 users    in 10,000

Very rare:    affects    less    than 1 user in 10,000

Not known:    frequency cannot be estimated from the available data

Common:

-    cough, sore throat (inflammation of the pharynx), running nose

-    nausea, vomiting, abdominal    pain,    diarrhoea, constipation, wind (flatulence)

-    back pain, non-specific pain

-    weakness or loss of strength,    flu like symptoms

-    sleeplessness

-    headache, dizziness

-    infection

Uncommon:

-    nervousness

-    sleepiness

-    inflammation of the bronchial tubes (bronchitis), inflammation of the sinuses (sinusitis)

-    indigestion, dry mouth, belching

-    rash, skin redness (erythema)

-    muscle pains, j oint pains, leg cramps

-    urinary tract infection

-    chest pain, chills, fever

-    increased liver enzymes, which is measured by blood tests

Rare:

-    blood problems such as reduced number of white cells or platelets. This can cause weakness, bruising

or make infections more likely.

-    increased number of white blood cells

-    allergic reactions including facial swelling, low blood pressure and breathing difficulties

-    loss of appetite

-    depression

-    visual disturbance

-    inflammation of the stomach, inflammation of the mouth, taste disturbance

-    inflammation of the liver, jaundice (yellowing of the skin or eyes), brain disturbance associated with liver failure (hepatic encephalopathy)

-    itching, sweating, skin blisters

-    kidney inflammation (interstitial nephritis)

-    increased weight

Very rare:

-    sudden onset of severe rash or blistering or peeling skin. This may be associated with a high fever and joint pains (erythema multiforme, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN))

Not known

-    low levels of sodium in the blood

-    confusion

-    swelling of the feet and ankles

-    enlarged breasts in men

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE RABEPRAZOLE

Keep out of the reach and sight 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. FURTHER 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: Aptil Pharma Limited 9th Floor, CP House

97-107 Uxbridge Road, Ealing London W5 5TL

Manufacturer:

Actavis hf Reykjavikurvegi 78 P.O.Box 420 IS-220 Hafnarfjordur Iceland

This leaflet was last updated in 10/2016.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Rabeprazole 10 mg gastro-resistant tablets Rabeprazole 20 mg gastro-resistant tablets

rabeprazole sodium

Read all of this leaflet carefully before you start taking this medicine.

-    Keep this leaflet. Y ou may need to read it again.

-    If you have any further questions, ask your doctor or pharmacist.

-    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

-    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

7.    What Rabeprazole is and what it is used for

8.    Before you take Rabeprazole

9.    How to take Rabeprazole

10.    Possible side effects

11.    How to store Rabeprazole

12.    Further information

7. WHAT RABEPRAZOLE IS AND WHAT IT IS USED FOR

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:

•    ulcer in the upper part of the intestine (duodenal ulcer) and benign stomach ulcer

•    gastro-oesophageal reflux disease (GORD) with or without ulcer. GORD is commonly referred to as inflammation of the gullet caused by acid and associated with heartburn. Heartburn is a burning feeling rising from the stomach or lower chest up towards the neck. Rabeprazole may also be used as a long term treatment of GORD (GORD maintenance). Rabeprazole may also be used for the symptomatic treatment of moderate to very severe gastro-oesophageal reflux disease (symptomatic GORD).

•    Zollinger-Ellison Syndrome, which is a condition when the stomach makes extremely high amounts of acid.

8. 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 breast feeding

Take special care with Rabeprazole

•    if you are allergic to other proton pump inhibitors

•    if you have or have had any liver problems

•    if you are taking a medicine called atazanavir (used to treat HIV)

If the above applies to you, consult your doctor before using Rabeprazole.

Your doctor may perform or have performed an additional investigation called an endoscopy in order to diagnose your condition and/or exclude malignant disease. The possibility of stomach and oesophageal tumours should be excluded before treatment is started.

If you take Rabeprazole on a long-term basis (longer than 1 year) your doctor will probably monitor you regularly. You should report any new or different symptoms whenever you see your doctor.

Some abnormal blood values have been reported during treatment with Rabeprazole. Usually, the values become normal when the treatment is discontinued.

Rabeprazole is not recommended for use in children.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other 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); it is not recommended to take Rabeprazole if you are taking atazanavir

•    ketaconazole or itraconazole (used to treat infections caused by a fungus)

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

Rabeprazole must not be used during pregnancy and breast-feeding.

Driving and using machines

It is unlikely that Rabeprazole would affect your ability to drive or operate machinery.

However, occasionally rabeprazole can cause sleepiness. Therefore, driving and operating complex machinery should be avoided if your are affected.

9. 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. The usual dose is as follows:

Adults and elderly

Duodenal ulcer and benign gastric ulcer: 20 mg of Rabeprazole to be taken once daily in the morning. Most patients with duodenal ulcer are treated for four weeks and most patients with benign gastric ulcer are treated for six weeks. However a few patients may require additional treatment to achieve healing.

Gastro-Oesophageal Reflux Disease (GORD) with ulcer: 20 mg of Rabeprazole to be taken once daily for four to eight weeks.

Long term treatment of GORD: 10 mg or 20 mg of Rabeprazole once daily depending upon response.

Symptomatic treatment of GORD: 10 mg of Rabeprazole once daily for 4 weeks. Once symptoms have cleared your doctor may tell you to take 10 mg of Rabeprazole once daily when needed for subsequent symptom control.

Zollinger-Ellison Syndrome: 60 mg of Rabeprazole 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.

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 prescribed by your doctor, seek medical advice.

If you forget to take Rabeprazole

Do not take a double dose to make up for a forgotten dose. If you forget to take a dose, take it as soon as you remember. If it is almost time to take the next dose, wait until then. Do not take a double dose to make up for a forgotten dose.

10. POSSIBLE SIDE EFFECTS

Like all medicines, Rabeprazole can cause side effects, although not everybody gets them.

If you notice any of the following serious side effects, stop taking Rabeprazole and contact a doctor immediately:

-    Sudden wheezing, swelling of your lips, face or body, rash, fainting or difficulties swallowing (severe allergic reaction).

-    Yellow skin, dark urine and tiredness which can be symptoms of liver problems.

-    Reddening of the skin with blisters or peeling and may be associated with a high fever and joint pains. There may also be severe blisters and bleeding in the lips, eyes, mouth, nose and genitals. This could be erythema multiforme, Stevens-Johnson syndrome or toxic epidermal necrolysis.

The frequency of possible side effects listed below is defined using the following convention: Very common:    affects more than 1 user in 10

Common:    affects    1 to 10 users    in 100

Uncommon:    affects    1 to 10 users    in 1,000

Rare:    affects    1 to 10 users    in 10,000

Very rare:    affects    less    than 1 user in 10,000

Not known:    frequency cannot be estimated from the available data

Common:

-    cough, sore throat (inflammation of the pharynx), running nose

-    nausea, vomiting, abdominal    pain,    diarrhoea, constipation, wind (flatulence)

-    back pain, non-specific pain

-    weakness or loss of strength,    flu like symptoms

-    sleeplessness

-    headache, dizziness

-    infection

Uncommon:

-    nervousness

-    sleepiness

-    inflammation of the bronchial tubes (bronchitis), inflammation of the sinuses (sinusitis)

-    indigestion, dry mouth, belching

-    rash, skin redness (erythema)

-    muscle pains, j oint pains, leg cramps

-    urinary tract infection

-    chest pain, chills, fever

-    increased liver enzymes, which is measured by blood tests

Rare:

-    blood problems such as reduced number of white cells or platelets. This can cause weakness, bruising

or make infections more likely.

-    increased number of white blood cells

-    allergic reactions including facial swelling, low blood pressure and breathing difficulties

-    loss of appetite

-    depression

-    visual disturbance

-    inflammation of the stomach, inflammation of the mouth, taste disturbance

-    inflammation of the liver, jaundice (yellowing of the skin or eyes), brain disturbance associated with liver failure (hepatic encephalopathy)

-    itching, sweating, skin blisters

-    kidney inflammation (interstitial nephritis)

-    increased weight

Very rare:

-    sudden onset of severe rash or blistering or peeling skin. This may be associated with a high fever and joint pains (erythema multiforme, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN))

Not known

-    low levels of sodium in the blood

-    confusion

-    swelling of the feet and ankles

-    enlarged breasts in men

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

11. HOW TO STORE RABEPRAZOLE

Keep out of the reach and sight 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.

12. FURTHER 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:

Aptil Pharma Limited

9th Floor, CP House

97-107 Uxbridge Road, Ealing

London

W5 5TL

Manufacturers:

Actavis hf Reykjavikurvegi 78 P.O.Box 420 IS-220 Hafnarfjordur Iceland

Balkanpharma Dupnitsa AD 3 Samokovsko Shosse Str.

Dupnitsa 2600 Bulgaria

This leaflet was last updated in 10/2016.

6