RABEPRAZOL SUN 20 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the Patient

Rabeprazol SUN 20 mg Gastro-Resistant Tablets EFG

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

1. What is Rabeprazol SUN and what is it used for

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

Rabeprazol SUN tablets are used for the treatment of:

• “Gastroesophageal Reflux Disease” (GERD), which may include the occurrence of acidity. The cause of GERD is the passage of acid and food 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 Rabeprazol SUN and antibiotics together will eliminate the infection and the ulcer will heal. It will also stop 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.

2. What you need to know before you take Rabeprazol SUN

Do not take Rabeprazol SUN

• If you are allergic (hypersensitive) to rabeprazole sodium or any of the other ingredients of this medicine (listed in section 6).
• If you are pregnant or think you may be pregnant.
• If you are breastfeeding.

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

See also the section on Pregnancy and breastfeeding.

Children

Rabeprazol SUN should not be given to children.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Rabeprazol SUN:

• If you are allergic to proton pump inhibitors or “substituted benzimidazoles”.
• If liver and blood problems have been seen in some patients but often improve when treatment with Rabeprazol SUN is stopped.
• If you have a stomach tumor.
• If you have ever had liver problems.
• If you are taking atazanavir, a medicine for AIDS.
• If you have reduced body stores or have risk factors associated with reduced vitamin B12 and are receiving long-term treatment with rabeprazole sodium. Like all acid-reducing agents, rabeprazole sodium may lead to a reduction in vitamin B12 absorption.
• If you are scheduled to have a specific blood test (Chromogranin A)
• If you have ever had a skin reaction after treatment with a medicine similar to Rabeprazol SUN to reduce stomach acid

If you get a rash, especially in areas of the skin exposed to the sun, consult your doctor as soon as possible, as it may be necessary to stop treatment with Rabeprazol SUN. Remember to mention any other symptoms you may notice, such as joint pain. If you are unsure about the above, consult your doctor or pharmacist before taking this medicine.

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

If you are taking proton pump inhibitors like Rabeprazol SUN, especially for more than a year, you may have a slightly increased risk of hip, wrist, and spine fractures. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

During treatment with rabeprazole, kidney inflammation can occur. The signs and symptoms include: decreased urine volume or blood in the urine and/or hypersensitivity reactions such as fever, rash, and joint stiffness. You should report these signs to your doctor.

Using Rabeprazol SUN with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take 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. Rabeprazol SUN may decrease the amount of these medicines in your blood. Your doctor may need to adjust your dose.
• Atazanavir - a medicine used to treat AIDS. Rabeprazol SUN 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 a high dose of methotrexate, your doctor may temporarily stop your treatment with Rabeprazol SUN. If you are unsure about the above, consult your doctor or pharmacist before taking Rabeprazol SUN.

Pregnancy and breastfeeding

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

Consult your doctor or pharmacist before using any medicine during pregnancy or breastfeeding.

Driving and using machines

You may feel drowsy while taking Rabeprazol SUN. If this happens, do not drive or use tools or machines.

Rabeprazol SUN contains Allura Red (E 129)

This medicine may cause allergic reactions because it contains the colorant Allura Red (E 129).

It can cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Rabeprazol SUN

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. In case of doubt, 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 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 medicine for a long time, your doctor will want to monitor you.

Adults and elderly patients

For “Gastroesophageal Reflux Disease” (GERD)

Treatment of moderate to severe symptoms (Symptomatic GERD)

• The usual dose is one 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 10 mg tablet as needed (“on demand”).

Treatment of more severe symptoms (Erosive or Ulcerative GERD)

• The usual dose is one Rabeprazol SUN 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 GERD)

• The usual dose is one Rabeprazol 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 dose.

For stomach ulcers (peptic ulcers)

• The usual dose is one Rabeprazol SUN 20 mg tablet once a day for 6 weeks.
• Take the tablet in the morning before eating.
• Your doctor may tell you to take Rabeprazol SUN for another 6 weeks if your symptoms do not improve.

For intestinal ulcers (duodenal ulcers)

• The usual dose is one Rabeprazol SUN 20 mg tablet once a day for 4 weeks.
• Take the tablet in the morning before eating.
• Your doctor may tell you to take Rabeprazol SUN 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 Rabeprazol 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 the other medicines used to treat H. pylori, read the package leaflet for each of them.

Zollinger-Ellison Syndrome where there is an excess of acid in the stomach

• The usual dose is three Rabeprazol SUN 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 dose and symptom review.

Children.This medicine should not be given to children.

Patients with liver problems.Your doctor will take special care when starting and during treatment with Rabeprazol SUN.

If you take more Rabeprazol SUN than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Rabeprazol SUN

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

If you stop taking Rabeprazol SUN

Relief of symptoms usually 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 further questions about the use of this product, 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 improve without you stopping treatment.

Stop taking Rabeprazol SUN and see your doctor immediately 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 that can cause fainting or collapse.
• Frequent infections, such as sore throat or high temperature (fever), or ulcers in your mouth or throat.
• Bruising 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 (erythema multiforme, toxic epidermal necrolysis (TEN), Stevens-Johnson Syndrome (SJS)).

These side effects are very rare (may affect between 1 and 10 in 10,000 people).

Other possible side effects:

Common (may affect between 1 and 10 in 100 people)

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

Uncommon (may affect between 1 and 10 in 1,000 people)

• Feeling nervous or drowsy.
• Chest infection (bronchitis).
• Painful sinuses and blockage (sinusitis).
• Dry mouth.
• Indigestion or belching.
• Redness of the skin or rash.
• Fractures in the hip, wrist, and spine.
• Muscle pain, leg pain, or joint pain.
• Urinary tract infection (urinary tract infection).
• Chest pain.
• Chills or fever.
• Changes in liver function (shown in blood tests).

Rare (may affect between 1 and 10 in 10,000 people)

• Lack of appetite (anorexia).
• Depression.
• Hypersensitivity (including allergic reactions).
• Visual disturbances.
• Inflamed mouth (stomatitis) or taste disorders.
• Stomach disorder or stomach pain.
• Liver problems including yellowing of the skin and whites of the eyes (jaundice).
• Itchy rash or blisters.
• Sweating.
• Kidney problems.
• Weight gain.
• Changes in white blood cells (shown in blood tests) that can cause frequent infections.

Other possible side effects (frequency not known)

• Swelling of the breasts in men.
• Fluid retention.
• Low sodium levels in the blood that can cause fatigue and confusion, muscle spasms, convulsions, and coma.
• Patients who have previously had liver problems may very rarely develop encephalopathy (brain disease).
• If you are taking Rabeprazol for more than three months, it is possible that your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you have any of these symptoms, see your doctor immediately. Low magnesium levels can also lead to a decrease in potassium and calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.
• Skin rash, possibly with joint pain.
• Inflammation of the intestine (leading to diarrhea)

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

Reporting side effects

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

5. Storing Rabeprazol SUN

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date stated on the packaging and blister. The expiration date is the last day of the month indicated.

Do not store above 25°C. Do not refrigerate or freeze. Store in the original packaging to protect from moisture.

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

6. PACKAGING CONTENT AND ADDITIONAL INFORMATION

Rabeprazol SUN Composition

• The active ingredient is rabeprazol sodium. Each tablet contains 20 mg of rabeprazol sodium equivalent to 18.85 mg of rabeprazol.
• The other components are:

Core: mannitol, heavy magnesium oxide, low-substituted hydroxypropyl cellulose, hydroxypropyl cellulose (L), magnesium stearate.

Subcoating: ethylcellulose (7cps), light magnesium oxide, hydroxypropyl cellulose (L).

Enteric coating: hypromellose phthalate, diacetylated monoglycerides, talc, titanium dioxide (E 171), yellow iron oxide (E 172).

Printing ink: shellac, Allura Red Aluminum Lacquer (E 129), titanium dioxide (E 171),

Propylene glycol

Product Appearance and Packaging Content

Rabeprazol SUN 20 mg: yellow, round, biconvex, gastro-resistant tablet marked with "RA" on one face and smooth on the other face.

The tablets are presented in packages containing: 7, 14, or 28 gastro-resistant tablets.

Not all packages are marketed.

Marketing Authorization Holder and Manufacturer:

Sun Pharmaceutical Industries Europe B.V.,

Polarisavenue 87,

2132JH Hoofddorp,

Netherlands

Manufacturer:

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

Netherlands

TERAPIA S.A.

124 Fabricii Street

400 632 Cluj Napoca,

Romania

Alkaloida Chemical Company Zrt.

Kabay Janós u. 29.,

Tiszavasvári - 4440

Hungary

Local Representative

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 Barcelona. Spain

Tel.:+34 93 342 78 90

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

France: Rabeprazole SUN 20 mg, gastro-resistant tablet

Italy: Rabeprazolo SUN 20 mg gastro-resistant tablets

Netherlands: Rabeprazolnatrium Ranbaxy 20 mg, gastro-resistant tablet

Romania: Rabeprazol Terapia 20 mg gastro-resistant tablets

Spain: Rabeprazol SUN 20 mg gastro-resistant tablets EFG

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/