PARIET 10 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the User

PARIET 10 mg 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.

Contents of the pack

1. What is Pariet and what is it used for
2. What you need to know before you take Pariet
3. How to take Pariet
4. Possible side effects
5. Storage of Pariet
6. Contents of the pack and other information

1. What is Pariet and what is it used for

Pariet contains the active ingredient rabeprazole sodium. Pariet belongs to a class of medicines known as “Proton Pump Inhibitors” (PPIs), which work by reducing the amount of acid produced by the stomach.

Pariet tablets are used for the treatment of:

• “Gastro-oesophageal reflux disease” (GORD), which may include symptoms such as acid reflux. The cause of GORD is acid and food flowing back into the oesophagus from the stomach.
• Stomach ulcers or ulcers of the upper part of the intestine (duodenal ulcers). If these ulcers are infected with a bacteria called “Helicobacter pylori” (H. pylori), you will also need to take antibiotics. Taking Pariet and antibiotics together will get rid of the infection and the ulcer will heal. It will also stop the infection and the ulcer from coming back.
• Zollinger-Ellison syndrome, a disease where very high amounts of acid are produced in the stomach.

2. What you need to know before you take Pariet

Do not take Pariet

• If you are allergic (hypersensitive) to rabeprazole sodium or any of the other ingredients of this medicine (see section 6).
• If you are pregnant or think you may be pregnant.
• If you are breast-feeding.

Do not take Pariet if you are in any of the above situations. If you are not sure, consult your doctor or pharmacist before taking Pariet.

Warnings and precautionsConsult your doctor or pharmacist before taking Pariet:

• If you are allergic to proton pump inhibitors or “substituted benzimidazoles”.
• If liver or blood problems have been seen in some patients but usually get better when Pariet treatment is stopped.
• If you have a stomach tumour.
• If you have ever had liver problems.
• If you are taking atazanavir, a medicine for HIV infection.
• If you have reduced body stores or risk factors for low vitamin B12 and are taking long-term acid-reducing treatment with rabeprazole sodium. Like all acid-reducing agents, rabeprazole sodium may lead to a reduced absorption of vitamin B12.
• If you have ever had a skin reaction with a medicine that reduces stomach acid.
• If you get a rash on your skin, especially in areas exposed to the sun, tell your doctor as soon as possible, as you may need to stop your treatment with Pariet. Also remember to mention any other symptoms you might notice, such as joint pain.
• If you are due to have a specific blood test (Chromogranin A).
• During treatment with rabeprazole, kidney inflammation may occur. Signs and symptoms include: decreased urine output or blood in the urine and/or hypersensitivity reactions such as fever, rash and joint stiffness. You should inform your doctor of these signs.

If you are unsure about any of the above, consult your doctor or pharmacist before taking Pariet.

ChildrenPariet should not be used in children.

If you experience severe diarrhoea with blood and mucous, fever, abdominal pain or tenderness, stop taking Pariet and see a doctor immediately.

Taking a proton pump inhibitor like Pariet, especially over a period of more than one year, may slightly increase the risk of fracture of 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).

Other medicines and ParietTell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those 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, medicines for fungal infections. Pariet may decrease the amount of these medicines in your blood. Your doctor may need to adjust your dose.
• Atazanavir, a medicine used to treat HIV infection. Pariet may decrease the amount of this type of medicine in your blood, so they should not be used together.
• Methotrexate (a chemotherapy medicine used at high doses to treat cancer) – if you are taking high doses of methotrexate, your doctor may temporarily stop your treatment with Pariet.

If you are unsure about any of the above, consult your doctor or pharmacist before taking Pariet.Pregnancy, breast-feeding and fertility

• Do not take Pariet if you are pregnant or think you may be pregnant.
• Do not take Pariet during breast-feeding or if you plan to breast-feed.

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.Driving and using machinesYou may feel drowsy while taking Pariet. If this happens, do not drive or use tools or machines.

Pariet contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per gastro-resistant tablet; this is essentially “sodium-free”.

3. How to take Pariet

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are unsure, consult your doctor or pharmacist again.

Taking this medicine

• Only remove a tablet from the blister when it is time to take your medicine.
• Swallow the tablet whole with a little water. Do not chew or crush the tablet.
• Your doctor will tell you how many tablets to take and for how long. This will depend on your condition.
• If you are taking this medicine for a long time, your doctor will want to check you regularly.

Adults and elderly patients

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 symptoms come back after 4 weeks of treatment, your doctor will tell you to take one Pariet 10 mg tablet when you need it (“on demand”)

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 (maintenance therapy for GORD)

• 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 your dose

For stomach ulcers (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 symptoms do not improve

For ulcers of the upper part 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 symptoms do not improve

For ulcers caused by H. Pylori infection and to prevent recurrence

• The usual dose is one Pariet 20 mg tablet twice a day for 7 days
• Your doctor will also tell you to take antibiotics called amoxicillin and clarithromycin

For more information about the other medicines used to treat H. pylori, read the package leaflets for each of them.Zollinger-Ellison syndrome where there is too much acid in the stomach

• The usual dose is three Pariet 20 mg tablets once a day to start with
• The dose may be adjusted by your doctor depending on how you respond to treatment

If you are on long-term treatment, you will need to see your doctor at regular intervals for your dose and symptoms to be checked

Patients with liver problems.Your doctor will be very careful when starting and during treatment with Pariet.

If you take more Pariet than you shouldIf you take more Pariet than you should, talk to your doctor or go to a hospital straight away. Take the medicine with you.

In case of overdose or accidental ingestion, contact the Toxicology Information Service (Telephone: 91 5620420).If you forget to take Pariet

• If you forget to take a tablet, take one as soon as you remember and then continue as normal. However, if it is almost time for your next tablet, just skip the missed tablet and continue as normal
• If you forget to take your medicine for more than 5 days, consult your doctor before taking any more medicine
• Do not take a double dose (two doses at the same time) to make up for a missed dose.

If you stop taking ParietRelief of symptoms normally occurs before the ulcer is completely healed. It is important that you do not stop treatment until your doctor tells you to.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Side effects are usually mild and get better without you having to stop taking the medicine.Stop taking Pariet and see a doctor straight away if you notice any of the following serious 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 dizziness or fainting
• Frequent infections, such as sore throat or high temperature (fever), or mouth or throat ulcers
• Bruising or easy bleeding.

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

• Severe skin blistering or bleeding in the lips, eyes, mouth, nose and genitals.

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

Other possible side effects:Common (affect less than 1 in 10 people)

• Infections
• Difficulty sleeping
• Headache or dizziness
• Cough, runny nose or sore throat (pharyngitis)
• Effects on your stomach or intestines such as stomach pain, diarrhoea, wind (flatulence), feeling sick (nausea), being sick (vomiting) or constipation
• Pains or back pain
• Weakness or flu-like symptoms
• Benign polyps in the stomach

Uncommon (affect less than 1 in 100 people)

• Feeling nervous or sleepy
• Chest infection (bronchitis)
• Painful sinuses (sinusitis)
• Dry mouth
• Indigestion or belching
• Rash or redness of the skin
• Muscle or leg or joint pain
• Fractures of the hip, wrist or spine
• Urinary tract infection (infection of the urine system)
• Chest pain
• Chills or fever
• Changes in the way your liver is working (shown in blood tests)

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

• Lack of appetite (anorexia)
• Depression
• Hypersensitivity (including allergic reactions)
• Vision problems
• Inflamed mouth (stomatitis) or taste problems
• Stomach problems or stomach pain
• Liver problems including yellowing of the skin and the whites of the eyes (jaundice)
• Itchy rash or blistering
• Sweating
• Kidney problems
• Weight increase
• Changes in the number of white blood cells (shown in blood tests) which may lead to frequent infections
• Decrease in the number of blood platelets which may lead to bleeding or bruising more easily than normal

Other possible side effects (frequency not known)

• Swelling of the breasts in men
• Fluid retention
• Inflammation of the intestine (leading to diarrhoea)

• Low levels of sodium in the blood which can cause tiredness and confusion, muscle cramps, convulsions and coma
• Patients who have previously had liver problems may very rarely develop a brain disease (encephalopathy)
• Skin rash, possibly with joint pain

If you take Pariet for more than three months, it is possible that the levels of magnesium in your blood will fall. Low levels of magnesium can make you feel tired, get muscle cramps, feel confused, have convulsions, feel dizzy and have a fast heart rate. If you get any of these symptoms, please tell your doctor immediately. Low levels of magnesium can also lead to a reduction in the levels of potassium or calcium in your blood. Your doctor may decide to perform regular blood tests to monitor your levels of magnesium.

Do not worry about this list of side effects. You may not get any of them.

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 Spanish Pharmacovigilance System for Medicines for Human Use: http://www.notificaram.es/. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pariet

Keep out of the sight and reach of children.

Do not store above 25°C.

Do not refrigerate.

Do not use Pariet after the expiry date which is stated on the carton and on the blister. The expiry date is the last day of the month stated.

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 protect the environment.

6. Packaging Content and Additional Information

Composition ofPariet

• The active ingredient is sodium rabeprazole. Each Pariet 10 mg gastro-resistant tablet contains 10 milligrams of sodium rabeprazole as the active ingredient.
• The other components are mannitol, magnesium oxide, slightly substituted hydroxypropyl cellulose, hydroxypropyl cellulose, magnesium stearate, ethyl cellulose, hypromellose phthalate, diacetylated monoglycerides, talc, titanium dioxide (E171), red iron oxide (E172), carnauba wax, and ink (white lacquer, black iron oxide (E172)), anhydrous ethanol, 1-butanol.

Appearance of the Product and Packaging Content

Pariet 10 mg gastro-resistant tablet is a pink, biconvex, film-coated tablet with the inscription "E 241" engraved on one side.

The tablets are packaged in blisters, and the package sizes contain: 1, 5, 7, 14, 15, 25, 28, 30, 50, 56, 75, 98, 112, or 120 tablets.

Not all packages are marketed.

Marketing Authorization Holder

Janssen-Cilag, S.A.

Paseo del Club Deportivo 1, Edificio 16

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

JANSSEN PHARMACEUTICA, N.V (CHEMICAL MANUFACTURING PLANT)

Turnhoutseweg, 30 (Beerse) - 2340 – Belgium

EISAI GMBH

Edmund-Rumpler-Straße 3, 60549 Frankfurt am Main, Germany

LUSOMEDICAMENTA – SOCIEDADE TÉCNICA FARMACÊUTICA S.A.

Estrada Consiglieri Pedroso 66, 69 B

Queluz de Baixo

2730-055 Barcarena

Portugal

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Medicinal Product Name

Member State

Austria Pariet

Belgium Pariet

Denmark Pariet

Finland Pariet

France Pariet

Germany Pariet

Greece Pariet

Ireland Pariet

Italy Pariet

Luxembourg Pariet

Netherlands Pariet

Portugal Pariet

Spain Pariet

Sweden Pariet

United Kingdom (Northern Ireland) Pariet

Date of the Last Revision of this Leaflet:September 2022.

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/