Pariet 10 mg gastro-resistant tablets

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

PARIET 10 mg gastro-resistant tablets

Sodium rabeprazole

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

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

Contents of the leaflet

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

1. What Pariet is and what it is 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:

• Gastroesophageal reflux disease (GERD), which may include heartburn. GERD is caused by stomach acid and food passing back from the stomach into the esophagus.
• Stomach ulcers or ulcers in the upper part of the intestine (duodenal ulcers). If these ulcers are infected with a bacterium called Helicobacter pylori (H. pylori), you will need to take antibiotics. Taking Pariet together with antibiotics will eliminate the infection and allow the ulcer to heal. This also helps prevent the infection and recurrence of the ulcer.
• Zollinger-Ellison syndrome, a condition characterized by excessive production of stomach acid.

2. What you need to know before taking Pariet

Do not take Pariet

• If you are allergic (hypersensitive) to sodium rabeprazole or to any of the excipients in this medicine (see list in section 6).
• If you are breastfeeding.

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

Warnings and precautions

Talk to your doctor or pharmacist before or during treatment with Pariet:

• If you are allergic to proton pump inhibitors or to "substituted benzimidazoles".

• If liver or blood problems have occurred in some patients, but these often improve when treatment with Pariet 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 associated with low levels of Vitamin B12 and are receiving long-term treatment with sodium rabeprazole. Like all agents that reduce acidity, sodium rabeprazole may reduce the absorption of Vitamin B12. Consult your doctor if you notice any of the following symptoms, which could indicate low levels of Vitamin B12:

• Extreme tiredness or lack of energy

• Tingling sensations

• Pain or redness of the tongue, mouth ulcers

• Muscle weakness

• Vision disturbances

• Memory problems, confusion, depression.

  • If you have ever had a skin reaction after treatment with a medicine similar to Pariet for reducing stomach acid.
  • If you develop a skin rash, especially in areas of skin exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to stop 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 (Chromogranin A).
  • During treatment with rabeprazole, kidney inflammation may occur. Signs and symptoms include: decreased urine volume or blood in the urine and/or hypersensitivity reactions such as fever, skin rash, and joint stiffness. You should report these signs to your doctor.

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

Children Pariet must not be given to children.

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

Taking a proton pump inhibitor such as Pariet, especially for more than one year, may slightly increase the risk of fractures of 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 medicines and Pariet Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription, such as herbal remedies.

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

• Ketoconazole or itraconazole, medicines used to treat fungal infections. Pariet may reduce the blood levels of these medicines. Your doctor may need to adjust your dose.
• Atazanavir, a medicine used to treat HIV infection. Pariet may reduce blood levels of this medicine; therefore, they should not be used together.
• Methotrexate (a chemotherapy medicine 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 are unsure whether any of the above applies to you, consult your doctor or pharmacist before taking Pariet.

Pregnancy, breastfeeding, and fertility

• Do not take Pariet while breastfeeding or if you plan to start breastfeeding.

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine. Your doctor will help you decide whether you should take Pariet during pregnancy.

Driving and use of machines You may feel drowsy while taking Pariet. If this occurs, do not drive or operate tools or machinery.

Pariet contains sodium

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

3. How to take Pariet

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

How to take this medicine

• Remove one tablet from the blister pack only when it is time to take your dose.
• Swallow the tablet whole with some water. Do not crush or chew the tablet.
• Your doctor will tell you how many tablets to take and for how long, depending on your condition.
• If you are taking this medicine for a long time, your doctor will want to monitor you regularly.

Adults and elderly patients

For gastroesophageal reflux disease (GERD)

Treatment of moderate to severe symptoms (symptomatic GERD)

• The usual dose is one Pariet 10 mg tablet once daily for up to 4 weeks.
• Take the tablet in the morning before eating.
• If your symptoms return after 4 weeks of treatment, your doctor will instruct you to take one Pariet 10 mg tablet as needed (“on-demand”).

Treatment of more severe symptoms (erosive or ulcerative GERD)

• The usual dose is one Pariet 20 mg tablet once daily for 4 to 8 weeks.
• Take the tablet in the morning before eating.

Long-term treatment of symptoms (maintenance of GERD)

• The usual dose is one Pariet 10 mg or 20 mg tablet once daily for as long as your doctor has instructed.
• 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 daily for 6 weeks.
• Take the tablet in the morning before eating.
• Your doctor may instruct you to continue Pariet for another 6 weeks if your symptoms do not improve.

For intestinal ulcers (duodenal ulcers)

• The usual dose is one Pariet 20 mg tablet once daily for 4 weeks.
• Take the tablet in the morning before eating.
• Your doctor may instruct you to continue Pariet for another 4 weeks if your symptoms do not improve.

For ulcers caused by H. pylori infection and to prevent relapses

• The usual dose is one Pariet 20 mg tablet twice daily for seven days.
• Your doctor will also instruct you to take antibiotics called amoxicillin and clarithromycin.

For more information about the other medicines used to treat H. pylori, please read the package leaflets for each of them.

Zollinger-Ellison syndrome, a condition where the stomach produces excess acid

• The usual starting dose is three Pariet 20 mg tablets once daily.
• Your doctor may adjust the dose depending on your response to treatment.

If you are on long-term treatment, you will need to see your doctor regularly to review your dose and symptoms.

Patients with liver problems. Consult your doctor, who will exercise special caution when starting and during treatment with Pariet.

If you take more Pariet than you should
If you take more Pariet than prescribed, speak to your doctor or go to a hospital immediately. 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, then continue as usual. However, if it is almost time for your next dose, simply skip the missed dose and continue with your regular schedule.
• If you have forgotten 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 Pariet
Relief of symptoms usually occurs before the ulcer is completely healed. It is important not to stop treatment until your doctor tells you to do so.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone gets them. Adverse effects are usually mild and improve without you needing to stop treatment. Stop taking Pariet and see your doctor immediately if you notice any of the following adverse effects – you may need urgent medical treatment:

• Allergic reactions – signs may include: sudden swelling of your face, difficulty breathing, or low blood pressure which may cause fainting or collapse
• Frequent infections, such as sore throat or high temperature (fever), or ulcers in your mouth or throat
• Bruising or bleeding easily

These adverse effects are rare (affect fewer than 1 in 1,000 people).

• Severe blistering of the skin, or sores or ulcers in your mouth and throat

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

Other possible adverse effects:

Frequent (affect fewer than 1 in 10 people)

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

Uncommon (affect fewer than 1 in 100 people)

• Feeling nervous or drowsy
• Chest infection (bronchitis)
• Painful and blocked sinuses (sinusitis)
• Dry mouth
• Indigestion or burping
• Skin rash or redness
• Muscle, leg or joint pain
• Fractures in the hip, wrist or spine
• Bladder infection (urinary tract infection)
• Chest pain
• Chills or fever
• Changes in liver function (shown in blood tests)

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

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

Other possible adverse effects (frequency not known)

• Breast swelling in men
• Fluid retention
• Inflammation of the intestine (leading to diarrhoea)
• Low levels of sodium in the blood which may cause tiredness and confusion, muscle spasms, seizures and coma
• Patients who have previously had liver problems may very rarely develop encephalopathy (brain disease)
• Skin rash, possibly with joint pain

If you take Pariet for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as tiredness, involuntary muscle contractions, disorientation, seizures, dizziness, or increased heart rate. If you experience any of these symptoms, please inform your doctor immediately. Low magnesium levels may also lead to reduced levels of potassium or calcium in the blood. Your doctor may decide to carry out periodic blood tests to monitor your magnesium levels.

Do not be alarmed by this list of adverse effects. You may not experience any of them.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaram.es/. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage instructions for Pariet

Keep out of sight and reach of children.

Do not store above 25 °C.

Do not refrigerate.

Do not use Pariet after the expiry date stated on the packaging and on the blister. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pariet

• The active substance is sodium rabeprazole. Each Pariet 10 mg gastro-resistant tablet contains 10 milligrams of sodium rabeprazole as the active substance.
• The other components are: mannitol (E421), magnesium oxide, low-substituted hydroxypropyl cellulose, hydroxypropyl cellulose, magnesium stearate, ethylcellulose, hypromellose phthalate, diacetylated monoglycerides, talc, titanium dioxide (E171), red iron oxide (E172), carnauba wax, and printing ink (white shellac, black iron oxide (E172)), dehydrated ethanol, 1-butanol.

Appearance of the product and contents of the pack

Pariet 10 mg gastro-resistant tablet is a pink, biconvex, film-coated tablet with the imprint “E 241” on one side.

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

Not all pack sizes 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 European Economic Area member states 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

Date of the most recent review of this leaflet: March 2026.

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