RABEPRAZOL STADA 10 mg GASTRO-RESISTANT TABLETS

Introduction

Patient Information Leaflet

Rabeprazol Stada 10 mg gastro-resistant EFG tablets

Rabeprazole sodium

Read the entire leaflet carefully before starting to take this medication, as it contains important information for you.

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

Contents of the leaflet

1. What is Rabeprazol Stada and what is it used for
2. What you need to know before taking Rabeprazol Stada
3. How to take Rabeprazol Stada
4. Possible side effects
5. Storage of Rabeprazol Stada
6. Package contents and additional information

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

Rabeprazol Stada contains the active substance rabeprazole sodium. It belongs to a group of medications known as "Proton Pump Inhibitors" (PPIs), which work by reducing the amount of acid produced by the stomach.

Rabeprazol is used to treat the following diseases:

• "Gastroesophageal reflux disease" (GERD), which may include the appearance of acidity. The cause of GERD is the passage of acid and food from the stomach to the esophagus.
• Stomach ulcers or ulcers in the upper part of the intestine (duodenal). If these ulcers are infected with a bacterium called "Helicobacter pylori" (H. pylori), you will need to take antibiotics. Taking rabeprazole sodium 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 taking Rabeprazol Stada

Do not take Rabeprazol Stada:

• if you are allergic to rabeprazole sodium or any of the other components of this medication (listed in section 6)
• if you are pregnant, or think you may be pregnant
• if you are breastfeeding

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

Warnings and precautions

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

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

• If you are allergic to proton pump inhibitor medications or "substituted benzimidazoles".
• If liver and blood problems have been seen in some patients, but often improve when treatment with rabeprazole sodium is discontinued.
• If you have a stomach tumor.
• If you have ever had liver problems.
• If you are taking atazanavir, a medication for HIV infection.
• If you have reduced body stores or have risk factors associated with reduced vitamin B12 levels and receive long-term treatment with rabeprazole sodium. Like all acid-reducing agents, rabeprazole sodium may lead to reduced absorption of vitamin B12.

This medication may affect how your body absorbs vitamin B12, especially if you need to take it for a long time. Please contact your doctor if you notice any of the following symptoms, which indicate low levels of vitamin B12:

• Extreme fatigue or lack of energy
• Numbness
• Painful or red tongue, mouth ulcers
• Muscle weakness
• Altered vision
• Memory problems, confusion, depression

• If you have ever had a skin reaction after treatment with a similar medication to rabeprazole sodium to reduce stomach acid.
• If you experience a skin rash, especially in areas of the skin exposed to the sun, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with rabeprazole sodium. 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).

If you have doubts about whether the above applies to you, consult your doctor or pharmacist before taking rabeprazole sodium.

Children

Rabeprazol 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 rabeprazole sodium and see your doctor immediately.

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

Other medications and Rabeprazol Stada

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication, including over-the-counter medications and herbal remedies.

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

• Ketoconazole or itraconazole, medications for fungal infections. Rabeprazole sodium may decrease the amount of these medications in your blood. Your doctor may need to adjust your dose.
• Atazanavir, a medication used to treat HIV infection. Rabeprazole sodium may decrease the amount of this medication in your 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 rabeprazole sodium.

If you have doubts about whether the above applies to you, consult your doctor or pharmacist before taking rabeprazole sodium.

Pregnancy, breastfeeding, and fertility

Do not take rabeprazole if you are pregnant or think you may be pregnant.

Do not take rabeprazole if you are breastfeeding or plan to start breastfeeding.

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Driving and using machines

You may feel drowsy while taking Rabeprazol Stada. If this occurs, do not drive or operate tools or machines.

Rabeprazol Stada contains sodium

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

3. How to take Rabeprazol Stada

Follow the administration instructions for this medication indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist again.

Taking this medication

• Only remove a 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

The guidelines indicated below are recommended for adults and elderly patients. Do not modify the guidelines or duration of treatment yourself.

For "gastroesophageal reflux disease" (GERD)

Treatment of moderate to severe symptoms (symptomatic GERD)

• The recommended dose is one Rabeprazol Stada 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 one Rabeprazol Stada 10 mg tablet as needed ("on demand").

Treatment of more severe symptoms (erosive or ulcerative GERD)

• The recommended dose is one Rabeprazol Stada 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 recommended dose is one Rabeprazol Stada 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 recommended dose is one Rabeprazol Stada 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 Stada for another 6 weeks if your symptoms do not improve.

For intestinal ulcers (duodenal ulcers)

• The recommended dose is one Rabeprazol Stada 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 Stada for another 4 weeks if your symptoms do not improve.

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

• The recommended dose is one Rabeprazol Stada 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 medications used to treat H. pylori, read the leaflets for each of them.

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

• The recommended dose is three Rabeprazol Stada 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.

Patients with liver problems

Consult your doctor, who will take special care when starting and during treatment with Rabeprazol Stada.

If you take more Rabeprazol Stada than you should

Do not take more tablets than prescribed per day. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. Always take the tablets and the cardboard box with you to the hospital so that the doctor knows what has been taken.

If you forget to take Rabeprazol Stada

• If you forget to take a tablet, take it as soon as you remember 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 restarting treatment.
• Do not take a double dose (two doses at the same time) to make up for the missed dose.

If you stop treatment with Rabeprazol Stada

Relief from 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 other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

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

• Allergic reactions - 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 mouth or throat ulcers
• Bruises or easy bleeding

These side effects are rare (may affect up to 1 in 1,000 people).

• Severe skin blisters or ulcers or mouth and throat ulcers

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

Other possible side effects:

Common (may affect up to 1 in 10 people):

• Infections
• Difficulty sleeping

• Headache or dizziness
• Cough, runny nose, or sore throat (pharyngitis)

• Stomach or intestine effects 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 stomach polyps

Uncommon (may affect up to 1 in 100 people):

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

Rare (may affect up to 1 in 1,000 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
• Decreased platelet count that can cause bleeding or bruising more easily than normal

Frequency not known (frequency cannot be estimated from available data):

• Breast swelling in men
• Fluid retention
• Inflammation of the intestine (leading to diarrhea)

• 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)

• Skin rash, possibly with joint pain

If you take pantoprazole sodium for more than three months, it is possible that your magnesium levels in the blood may decrease. Low magnesium levels can 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 can also lead to reduced 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them through the Spanish Pharmacovigilance System for Human Use Medications. https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Rabeprazol Stada

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

Do not use this medication after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.

Do not store above 30°C. Store in the original packaging to protect from light and moisture.

Do not use this medication if you notice the packaging is damaged or shows signs of tampering.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Packaging Content and Additional Information

Composition of Rabeprazol Stada

The active ingredient is sodium rabeprazole. Each Rabeprazol Stada 10 mg tablet contains 10 mg of sodium rabeprazole, equivalent to 9.42 mg of rabeprazole.

The other components are:

Core of the tablet:mannitol (E421), magnesium oxide (E530), hydroxypropylcellulose (E463), magnesium stearate (E572).

Intermediate layer:ethylcellulose (E462), heavy magnesium oxide (E530).

Tablet coating:hypromellose phthalate, dibutyl sebacate, red iron oxide (E172), titanium dioxide (E171), talc.

Appearance of the Product and Packaging Content

Rabeprazol Stada 10 mg gastro-resistant tablets: pink, film-coated, and round tablets.

The packages contain blisters of 1, 5, 7, 14, 15, 25, 28, 30, 50, 56, 75, 98, or 120 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratory STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern

(Barcelona)

Spain

[email protected]

Manufacturer:

Laboratorios Liconsa, S.A.

Avda. Miralcampo, Nº7

Miralcampo Industrial Estate

19200 Azuqueca de Henares (Guadalajara)

Spain

Date of the Last Revision of this Leaflet:April 2023

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