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Pariet 10mg

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PARIET® 10mg (rabeprazole sodium)

Patient Information Leaflet

27mm

This product is known as the above name but will be referred to as Pariet throughout this leaflet.

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

• 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. 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 Pariet is and what it is used for

2. Before you take Pariet

3. How to take Pariet

4. Possible side effects

5. How to store Pariet

6. Further information

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1. What Pariet is and what it is used for

Pariet tablets contain 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.

Pariet 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 escapes into your food pipe (oesophagus)

• Ulcers in your stomach or the upper part of your gut (intestine). If these ulcers are infected with bacteria called ‘Helicobacter pylori' (H. Pylori), you will also be given antibiotics. Using Pariet 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. Before you take Pariet

Do not take Pariet if:

• You are allergic (hypersensitive) to rabeprazole sodium, or any of the other ingredients of Pariet (listed in Section 6 overleaf)

• You are pregnant or think that you are pregnant

• You are breast-feeding.

Do not use Pariet if any of the above apply to you. If you are not sure talk to your doctor or pharmacist before using Pariet.

Also see Pregnancy and breast-feeding section Children

Pariet should not be used in children.

Take special care with Pariet

Check with your doctor or pharmacist before taking Pariet 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 Pariet is stopped

• You have a stomach tumour

• You have ever had liver problems

• If you are taking atazanavir- for HIV infection.

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

If you experience severe (water or bloody) diarrhoea with symptoms such as fever, abdominal pain or tenderness, stop taking Pariet and see a doctor straight away.

Taking a proton pump inhibitor like Pariet 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).

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 of the following medicines:

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

• Atazanavir- used to treat HIV-infection. Pariet may lower the amount of this 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 Pariet. Pregnancy and breast-feeding

• Do not use Pariet if you are pregnant or think you may be pregnant

• Do not use Pariet if you are breast-feeding or planning to breastfeed.

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 Pariet. If this happens, do not drive or use any tools or machines.

3. How to take Pariet

Always take Pariet exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Taking this medicine

• Your doctor will tell you how many tablets to take and how long to take them for. This will depend on your condition

• Only remove a tablet from the blister strip when it is time to take your medicine

• Swallow your tablets whole with a drink of water. Do not chew or crush the tablets

• If you 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 Pariet 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 Pariet 10 mg tablet as and when you require it.

Treatment of more severe symptoms (erosive or ulcerative GORD)

• The usual dose is one Pariet 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 Pariet 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 Pariet 20 mg tablet once a day for 6 weeks

• Take the tablet in the morning before eating

• Your doctor may tell you to take Pariet for another 6 weeks if your condition does not improve.

For ulcers of the intestine (duodenal ulcers)

• The usual dose is one Pariet 20 mg tablet once a day for 4 weeks

• Take the tablet in the morning before eating

• Your doctor may tell you to take Pariet 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 Pariet 20 mg 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.

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

• The usual dose is three Pariet 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.

If you are on long-term treatment you will need to see your doctor at regular intervals for review of your tablets and symptoms.

Children. This product should not be used in children.

Patients with liver problems. You should consult your doctor who will take special care when beginning treatment with Pariet and while you continue to be treated with Pariet.

If you take more Pariet than you should

If you take more Pariet 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 Pariet

• 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 Pariet

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, Pariet 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 Pariet 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 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 (affects less than 1 in 10 people)

• Infections

• Difficulty sleeping

• Headache or feeling dizzy

• 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

• Weakness or flu-like symptoms.

Uncommon (affects less than 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

• Bladder infection (urinary tract infection)

• Chest pain

• Chills or fever

• Changes in how your liver is working (shown in blood tests)

• Musculoskeletal disorders

• Fracture of the hip, wrist or spine.

Rare (affects less than 1 in 1,000 people)

• 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 of your eyes (jaundice)

• Itchy rash or blistering skin

• Sweating

• Kidney problems

• Weight gain

• Change in white blood cells (shown in blood tests) which may result in frequent infection.

• Reduction in platelets resulting in bleeding or bruising more easily than normal.

Other possible side effects (unknown frequency)

• 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 Pariet 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.

Do not be concerned by this list of side effects. You may not get any of them. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. How to store Pariet

• Pariet 10mg should not be stored above 25°C.

• Store in the original container.

• Do not refrigerate.

• Do not use after the expiry date printed on the blister label or carton. The expiry date refers to the last day of that month.

• KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.

• If the tablets become discoloured or show any other signs of deterioration, you should seek the advice of your pharmacist who will advise you what to do.

• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.

6. Further information

Your medicine is called Pariet 10mg.

Each pink, round, tablet contains 10mg rabeprazole sodium as the active ingredient equivalent to 9.42mg rabeprazole in an enteric coated delayed release (gastro-resistant) formulation and is marked ‘e241'on one side and is plain on the reverse.

Pariet 10mg also contain the following inactive ingredients:

mannitol, magnesium oxide, low substituted hyprolose, hyprolose, magnesium stearate, ethylcellulose, hypromellose phthalate, diacetylated monoglycerides, carnauba wax, talc, titanium dioxide (E171), red iron oxide (E172), and black printing ink.

Pariet 10mg is available as calendar blister strips, each containing 14 tablets, in packs of 14 and 28 tablets.

POM PL No: 06464/2788

This product is manufactured by Eisai Ltd., Hammersmith International Centre, 3 Shortlands, London, W6 8EE, England and/or Eisai Manufacturing Limited, European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, United Kingdom and/or Eisai Co. ltd., (Misato Plant), 950 Oaza Hiroki, Misato-cho, kodama-gun, Saitama Prefecture 367-0198, Japan and procured from within the EU and repackaged by the Product Licence holder:

Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR

Leaflet revision and issue date (Ref.) 07.09.2012 Pariet is a registered trademark of Eisai Kabushiki Kaisha.

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