Prospect: Information for the User

PARIET 10 mg gastro-resistant tablets

Rabeprazol sodium

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect.See section 4.

1.What is Pariet and for what it is used
2.What you need to know before starting to take Pariet

3.How to take Pariet

4.Possible adverse effects
5.Storage of Pariet

6.Contents of the package and additional information

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

Pariet tablets are used for the treatment of:

• “Gastroesophageal reflux disease” (GERD), which may include the appearance of acid reflux. The cause of GERD is the passage of acid and food from the stomach into the esophagus.
• Stomach ulcers or ulcers of the upper part of the small intestine (duodenal ulcers). If these ulcers are infected with a bacteria called “Helicobacter pylori” (H. pylori), you will need to take antibiotics. Taking Pariet and antibiotics together will eliminate the infection and the ulcer will heal. It will also prevent the infection and the recurrence of the ulcer.
• Zollinger-Ellison syndrome, a disease characterized by the production of very high amounts of acid in the stomach.

Do not take Pariet

• If you are allergic (hypersensitive) to rabeprazole sodium, or to any of the excipients of this medication (see list in section 6).
• If you are pregnant or think you may be pregnant.
• If you are breastfeeding.

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

Warnings and precautionsConsult your doctor or pharmacist before starting to take Pariet:

• If you are allergic to proton pump inhibitors or to "substituted benzimidazole compounds".
• If you have seen liver and blood problems in some patients but often improve when the treatment with Pariet is interrupted.
• If you have a stomach tumor.
• If you have had any liver problems.
• If you are taking atazanavir, a medication for HIV infection.
• If you have reduced body reserves or have risk factors associated with a reduced amount of B12 and are receiving long-term treatment with rabeprazole sodium. Like all acid-reducing agents, rabeprazole sodium can lead to reduced B12 absorption.
• If you have ever had a skin reaction after treatment with a similar medication to Pariet for reducing stomach acid.
• If you suffer from a skin eruption, especially in areas of skin exposed to the sun, consult your doctor as soon as possible, as it may be necessary to interrupt treatment with Pariet. Remember to mention any other symptoms you may notice, such as joint pain.
• If you are scheduled to have a specific blood test (Cromogranin A).
• During treatment with rabeprazole, inflammation in your kidney may occur. Among the signs and symptoms are: decreased urine volume or blood in the urine and/or hypersensitivity reactions such as fever, skin rash, and joint stiffness. You must notify these signs to your doctor.

If you have doubts about whether the above affects you, consult your doctor or pharmacist before taking Pariet.

Children
Pariet should not be administered to children.

If you experience severe diarrhea (watery or bloody) with symptoms such as fever, abdominal pain, or sensitivity, stop taking Pariet and see your doctor immediately.

Taking a proton pump inhibitor like Pariet, especially for a period of more than one year, may slightly increase the risk of fracture in the hip, wrist, or spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).

Other medications and Pariet

Inform your doctor or pharmacist if you are taking or have recently taken other medications, including over-the-counter medications and herbal supplements.

In particular, inform your doctor or pharmacist if you are taking any of the following medications:

• Ketoconazole or itraconazole, medications for fungal infections. Pariet may decrease the amount of these medications in the blood. Your doctor may need to adjust your dose.
• Atazanavir, a medication used to treat HIV infection. Pariet may decrease the amount of this type of medication in the blood, so they should not be used together.
• Methotrexate (a chemotherapy medication used at high doses to treat cancer) – if you are taking a high dose of methotrexate, your doctor may temporarily stop your treatment with Pariet.

If you have doubts about whether the above affects you, consult your doctor or pharmacist before taking Pariet.

Pregnancy, breastfeeding, and fertility

• Do not take Pariet if you are pregnant or think you may be pregnant.
• Do not take Pariet during breastfeeding or if you plan to start breastfeeding.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.
Driving and operating machinery
You may feel drowsiness while taking Pariet. If this occurs, do not drive or operate tools or machinery.

Pariet contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per rabeprazole sodium gastro-resistant tablet; it is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Administration of this medication

• Only remove one tablet from the blister pack when it is time to take your medication.
• Swallow the tablet whole with a little water. Do not crush or chew the tablet.
• Your doctor will tell you how many tablets to take and the duration of your treatment, which will depend on your indication.
• If you are taking this medication for a long time, your doctor will want to monitor you.

Adults and elderly patients

Gastroesophageal reflux disease (GERD)

Symptomatic treatment of moderate to severe symptoms (GERD symptomatic)

• 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 recur after 4 weeks of treatment, your doctor will tell you to take a Pariet 10 mg tablet as needed ("on demand")

Treatment of more severe symptoms (GERD erosive or ulcerative)

• 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

Maintenance treatment of symptoms (GERD maintenance)

• The usual dose is one Pariet 10 mg or 20 mg tablet once a day for as long as your doctor has indicated
• 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 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 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 on other medications used to treat H. pylori, read the prospectus for each one

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

• The usual dose is three Pariet 20 mg tablets once a day initially
• 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 review of the dose and symptoms

Patients with liver problems.Consult your doctor, who will have special care in the initiation and during treatment with Pariet.

If you take more Pariet than you should
If you take more Pariet than you should, talk to your doctor or go to the hospital immediately. Bring the medication with you.

In case of overdose or accidental ingestion, consult the Toxicological Information Service (Telephone: 91 5620420).

If you forget to take Pariet

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

If you interrupt treatment withPariet
The relief of symptoms will usually occur before the ulcer has healed completely.It is essential not to interrupt treatment until your doctor tells you to.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Side effects are usually mild and improve without you stopping treatment.

Stop taking Pariet and see your doctor immediately if you notice any of the following side effects - you may need urgent medical treatment:

• Allergic reactions - symptoms may include: sudden swelling of your face, difficulty breathing or low blood pressure that can cause dizziness or collapse
• Frequent infections, such as sore throat or high temperature (fever), or ulcers in your mouth or throat
• Thrombocytopenia or easy bleeding.

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

• Severe skin blisters, or sores or ulcers in your mouth and throat.

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

Other possible side effects:

Frequent (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, diarrhea, gas (flatulence), feeling sick (nausea), being sick (vomiting) or constipation
• Pain or back pain
• Weakness or flu-like symptoms (pseudogripal)
• Benign polyps in the stomach

Occasional (affect less than 1 in 100 people)

• Feeling nervous or drowsy
• Chest infection (bronchitis)
• Blocked and painful sinuses (sinusitis)
• Dry mouth
• Indigestion or belching
• Rash on the skin or redness
• Muscle pain, leg pain or joint pain
• Fractures in the hip, wrist and spine
• Urinary tract infection
• Chest pain
• Chills or fever
• Changes in liver function (shown in blood tests)

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

• Loss of appetite (anorexia)
• Depression
• Hypersensitivity (including allergic reactions)
• Visual disturbances
• Inflamed mouth (stomatitis) or taste disorders
• Stomach upset or stomach pain
• Liver problems that include yellowing of the skin and white of the eyes (jaundice)
• Eruption with itching or blisters
• Sweating
• Renal problems
• Weight gain
• Changes in white blood cells in the blood (shown in blood tests) that may cause frequent infections
• Decreased platelets in the blood that may cause bleeding or the appearance of bruises with increased ease

Other possible side effects (frequency unknown)

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

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

If you take Pariet for more than three months, it is possible that your magnesium levels in the blood will decrease. Low magnesium levels may manifest as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you experience any of these symptoms, please inform your doctor immediately. Low magnesium levels may also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.

Do not worry about the list of side effects. You may not experience any of them.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:http://www.notificaram.es/. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of sight and reach of children.

Do not store at a temperature above 25 °C.

Do not refrigerate.

Do not use Pariet after the expiration date that appears on the packaging and in the blister pack. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition ofPariet

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

Appearance of the product and contents of the pack

Pariet 10 mg gastro-resistant tablet is a pink, biconvex tablet with a legend "E 241" engraved on one of the faces.

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

All pack sizes are not marketed.

Marketing Authorization Holder

Janssen-Cilag, S.A.

Paseo de Las Doce Estrellas, 5-7

28042 Madrid

Responsible for manufacturing

JANSSEN PHARMACEUTICA, N.V (CHEMICAL MANUFACTURING PLANT)

Turnhoutseweg, 30 (Beerse) - 2340 – Belgium

EISAI GMBH

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

LUSOMEDICAMENTA – SOCIEDADE TÉCNICA FARMACÊUTICA S.A.

Estrada Consiglieri Pedroso 66, 69 B

Queluz de Baixo

2730-055 Barcarena

Portugal

This medicine is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Name ofMedicine Name

Member State

AustriaPariet

BelgiumPariet

DenmarkPariet

FinlandPariet

FrancePariet

GermanyPariet

GreecePariet

IrelandPariet

ItalyPariet

LuxembourgPariet

NetherlandsPariet

PortugalPariet

SpainPariet

SwedenPariet

United Kingdom (Northern Ireland) Pariet

Last review date of this leaflet:September 2022.

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/