Informations for option: Rabeprazole Sodium 20 Mg Gastro-Resistant Tablets, show other option

Select option:

1. Rabeprazole Sodium 20 Mg Gastro-Resistant Tablets
2. Rabeprazole Sodium 20 Mg Gastro-Resistant Tablets

Document: leaflet TEVA UK_PL 15773-0915 change

• leaflet CONSILIENT HEALTH_PL 01656-0081
• leaflet MAH GENERIC_PL 00289-1144
• leaflet MAH GENERIC_PL 01656-0081
• leaflet MAH GENERIC_PL 15773-0915
• leaflet MAH GENERIC_PL 16363-0299
• leaflet MAH GENERIC_PL 17907-0458
• leaflet MAH GENERIC_PL 21690-0014
• leaflet MAH GENERIC_PL 36687-0061
• leaflet MYLAN_PL 21690-0014
• leaflet TEVA UK_PL 15773-0915

---

Ref: 231-30-18752-B LEA RABEPRAZOLE SODIUM A/S G/R TAB TUK <RAT	Version: 1	23 November 2012
PL Number(s), PL 15773/0914-5. Ratiopharm GmbH Licence, MA Holder & Packer: packed at TEVA UK Eastbourne. Packing U1030.

TFWTl

TEVA UK LIMITED

PAGE 1: FRONT FACE (INSIDE OF REEL)

RABEPRAZOLE SODIUM 10 mg AND 20 mg GASTRO-RESISTANT TABLETS

PACKAGE LEAFLET: INFORMATION FORTHE USER

Read all of this leaflet carefully before you start taking

this medicine.

♦    Keep this leaflet. You may need to read it again.

♦    Ifyou have any further questions, ask your doctor or pharmacist.

♦    This medicine has been prescribed foryou. 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.

INTHIS LEAFLET:

1. What Rabeprazole Sodium is and what it is used for

2. Before you take Rabeprazole Sodium

3. How to take Rabeprazole Sodium

4. Possible side effects

5. How to store Rabeprazole Sodium

6. Further information

OWHAT RABEPRAZOLE SODIUM IS AND WHAT IT IS USED FOR

This medicine contains the active ingredient rabeprazole __ sodium.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 sodium gastro-resistant tablets are 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 escape into your food pipe (oesophagus).

♦ Ulcers in your stomach orthe upper part ofyour gut (intestine). Ifthese ulcers are infected with bacteria called ‘Helicobacterpylori {H. pylori), you will also be given antibiotics. Using Rabeprazole sodium 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.

BEFORE YOU TAKE RABEPRAZOLE SODIUM

Do not take Rabeprazole Sodium

• ifyou are allergic (hypersensitive) to rabeprazole sodium

or any ofthe other ingredients of Rabeprazole sodium (listed in section 6 below)

♦ ifyou are pregnant orthinkthat you are pregnant • ifyouare breast-feeding.

Do not use Rabeprazole sodium if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before using Rabeprazole sodium.

Also see Pregnancy and breast-feeding section.

Children

Rabeprazole sodium should not be used in children.

Take special care with Rabeprazole Sodium

Check with your doctor or pharmacist before taking Rabeprazole sodium 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 sodium is stopped ♦ You have a stomach tumour ♦ You have ever had liver problems ♦ You are taking atazanavir for HIV infection.

Ifyou are not sure if any ofthe above applies to you, talk to your doctor or pharmacist before using Rabeprazole sodium.

Taking a proton pump inhibitor like Rabeprazole sodium, especially over a period of morethan one year, may slightly increase your risk of fracture in the hip, wrist or spine.Tell your doctor ifyou have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis). Ifyou experience severe (watery or bloody) diarrhoea with symptoms such as fever, abdominal pain or tenderness, stop taking Rabeprazole sodium and see a doctor straight away.

Using other medicines

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 ofthe following medicines:

♦    Ketoconazole or itraconazole - used to treat infections caused by a fungus. Rabeprazole sodium may lower the amount ofthis type of medicine in your blood. Your doctor may need to adjust your dose.

♦    Atazanavir - used to treat HIV infection. Rabeprazole sodium may lower the amount ofthis type of medicine in your blood and they should not be used together.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using Rabeprazole sodium.

Pregnancy and breast-feeding

♦    Do not use Rabeprazole sodium if you are pregnant or think you may be pregnant.

♦    Do not use Rabeprazole sodium ifyou are breastfeeding or planning to breast-feed.

Ask your doctor or pharmacist for advice before taking any medicine during pregnancy or while breast-feeding.

Driving and using machines

You may feel sleepy while taking Rabeprazole sodium. If this happens, do not drive or use any tools or machines. Important information about some of the ingredients of Rabeprazole Sodium

This medicinal product contains lactose. Ifyou have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

^ 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.

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 ofwater. 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.

♦    Ifyou are taking this medicine for a long time, your doctor will want to monitor you.

Adults and the elderly

For gastro-oesophageal reflux disease (GORD).

Treatment of moderate to severe symptoms (symptomatic GORD)

♦    The usual dose is one Rabeprazole sodium 10 mg gastro-resistant tablet once a day for up to 4 weeks.

♦    Take the tablet in the morning before eating.

♦    Ifyourcondition returnsafter4weeks'treatment,your doctor may tell you to take one Rabeprazole sodium

10 mg gastro-resistant tablet as and when you require it. Treatment of more severe symptoms (erosive or ulcerative GORD)

♦    The usual dose is one Rabeprazole sodium (20 mg gastro-resistant tablet once a day for 4to8 weeks).

♦    Take the tablet in the morning before eating.

Long-term treatment of symptoms (GORD maintenance)

♦    The usual dose is one Rabeprazole sodium 10 mg or 20 mg gastro-resistant tablet once a day for as long as yourdoctor 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 sodium 20 mg gastro-resistant tablet once a day for 6 weeks.

♦    Take the tablet in the morning before eating.

♦    Your doctor may tell you to take Rabeprazole sodium for another 6 weeks ifyour condition does not improve.

For ulcers of the intestine (duodenal ulcers)

♦    The usual dose is one Rabeprazole sodium 20 mg gastro-resistant tablet once a day for 4 weeks.

♦    Take the tablet in the morning before eating.

♦    Your doctor may tell you to take Rabeprazole sodium for another4weeks ifyourcondition does not improve.

For ulcers caused by H. pylori infection and to stop them coming back

♦    The usual dose is one Rabeprazole sodium 20 mg gastro-resistant 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 the 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 sodium 20 mg gastro-resistant tablets once a day to start with.

Ref: 231-30-18752-B LEA RABEPRAZOLE SODIUM A/S G/R TAB TUK <RAT	Version: 1	23 November 2012
PL Number(s), PL 15773/0914-5. Ratiopharm GmbH Licence, MA Holder & Packer: packed at TEVA UK Eastbourne. Packing U1030.

TTWTl

TEVA UK LIMITED

PAGE 2: REAR FACE (OUTSIDE OF REEL)

♦    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 yourtablets and symptoms.

Children

The product should not be used in children.

Patients with liver problems

You should consult your doctorwho will take special care when beginning treatment with Rabeprazole sodium and while you continue to be treated with Rabeprazole sodium.

If you take more Rabeprazole sodium than you should If you take more Rabeprazole sodium than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you.

If you forget to take Rabeprazole sodium

♦    If you forget to take a dose, take it as soon as you remember it. However, if it is almost time foryour 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 sodium Relief of symptoms will normally occur before the ulcer has completely healed. It is important that you do not stop taking the gastro-resistant 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.

POSSIBLE SIDE EFFECTS

Like all medicines, Rabeprazole sodium 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 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 appear include sudden swelling ofyour 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.

♦    Bruisingorbleedingeasily.

These side effects are rare (affect less than 1 in 1,000 people).

♦    Severe skin blistering, or soreness or ulcers in your mouth and throat.

These side effects are very rare (affect fewer than 1 in 10,000 people).

Other possible side effects:

Common side effects (affect 1 to 10 users in 100):

♦    Infections

♦    Difficulty sleeping

♦    Headacheorfeelingdizzy

♦    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

♦    Weaknessorflulikesymptoms.

Uncommon side effects (affect 1 to 10 users in 1,000):

♦    Feeling nervous or drowsy

♦    Chest infection (bronchitis)

♦    Painful and blocked sinuses (sinusitis)

♦    Dry mouth

♦    Indigestion or belching

♦    Skinrashorredness

♦    Muscle, leg orjoint pain

♦    Bladder infection (urinarytract infection)

♦    Chest pain

♦    Chills or fever

♦    Changes in howyour liver is working (shown in blood tests)

♦    Slight increase in the risk of hip, wrist or spine fractures if you take Rabeprazole sodium over a period of more than one year.

Rare side effects (affect 1 to 10 users in 10,000):

♦    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 ofyour eyes (jaundice)

♦    Itchy rash or blistering

♦    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):

♦    Breastswellinginmen

♦    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).

Ifyou 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 muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you get any ofthese 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. If any of the side effects gets serious, or ifyou notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

how to store rabeprazole sodium

Keep out of the reach and sight of children.

Store below 25⁰C.

Store in original package in order to protect from moisture.

Do not use Rabeprazole Sodium afterthe expiry date which is stated on the pack. The expiry date refers to the last day of that month.

Medicines should not be disposed ofvia wastewater or household waste. Askyour pharmacist how to dispose of medicines no longer required.These measures will help to protect the environment.

^ FURTHER INFORMATION

what Rabeprazole Sodium contains

The active substance is rabeprazole sodium.

Each 10 mg gastro-resistant tablet contains 10 mg rabeprazole sodium.

Each 20 mg gastro-resistant tablet contains 20 mg rabeprazole sodium.

The other ingredients are:

Core:

Mannitol, lowsubstituted hydroxypropylcellulose, magnesium oxide, heavy, hydroxypropylcellulose, magnesium stearate.

Coating - 10 mg tablets:

Hypromellose (E464), cellulose, microcrystalline, stearic acid,titanium dioxide (E171), hypromellose phthalate, triethyl citrate, lactose monohydrate, macrogol 4000, red iron oxide (E172), yellow iron oxide (E172).

Coating - 20 mg tablets:

Hypromellose (E464), cellulose, microcrystalline, stearic acid,titanium dioxide (E171), hypromellose phthalate, triethyl citrate, lactose monohydrate, macrogol 4000, red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172).

Printing ink:

Shellac, black iron oxide (E172), ammonium hydroxide, propylene glycol.

what Rabeprazole Sodium looks like and contents of the pack

♦    Rabeprazole Sodium 10 mg Gastro-resistant Tablets are pink, round tablets, imprinted on one side of the tablet with black ink"N" and "107

♦    Rabeprazole sodium 20 mg Gastro Resistant Tablets are yellow, round coated tablets, imprinted on one side of the tablet with black ink "93" "64". Plain on the other side.

♦    Rabeprazole sodium gastro-resistant tablets are available in pack sizes of 7, 14, 28, 30, 50, 56 and 98 gastro-resistant tablets.

♦    Not all pack sizes may be marketed.

Marketing Authorisation Holder

Ratiopharm GmbH, Graf-Arco-Str. 3, 89079 Ulm,

Germany.

Manufacturer

TEVA UK Limited, Eastbourne, East Sussex, BN22 9AG. This leaflet was last revised in November 2012.

PL 15773/0914-5

18752-B