Package Insert: Information for the Patient

Rabeprazol Stada 10 mg Gastrorresistant Tablets EFG

Rabeprazol Sodium

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

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms of illness 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 package insert. See section 4.

Rabeprazol Stada contains the active substance rabeprazol sodium. It belongs to a group of medicines known as “Proton Pump Inhibitors” (PPIs), which act 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 heartburn. 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 small intestine (duodenal ulcers). If these ulcers are infected with a bacteria called “Helicobacter pylori” (H. pylori), you will need to take antibiotics. Taking rabeprazol sodium 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 Rabeprazol Stada:

• if you are allergic 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 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 more than a year, may slightly increase your risk of breaking a hip, wrist, or spine. 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 inhibitors or to "substituted benzimidazoles"
• if you have seen liver and blood problems in some patients, but often improve when the treatment with rabeprazole sodium is stopped
• 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 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 may lead to reduced B12 absorption.

Thismedicine may affect the way your body absorbs vitamin B12, particularly if you need to take it for a long period. 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
• Tickling
• Painful or red tongue, mouth ulcers
• Muscle weakness
• Distorted vision
• Memory problems, confusion, depression

• if you have ever had a skin reaction after treatment with a similar medicine to rabeprazole sodium for reducing stomach acid
• if you suffer from a skin rash, especially in sun-exposed areas, consult your doctor as soon as possible, as it may be necessary to stop treatment with rabeprazole sodium. Remember to mention any other symptoms you may notice, such as joint pain.
• if you are due to have a specific blood test (Cromogranin A)

If you are unsure about the above, consult your doctor or pharmacist before taking rabeprazole sodium.

Children

Rabeprazole 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, especially for more than a year, may slightly increase the risk of breaking a 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 Rabeprazol Stada

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

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

• Ketoconazole or itraconazole, antifungal medicines. Rabeprazole sodium may decrease the amount of these medicines in the 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 type of medicine 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 rabeprazole sodium.

If you are unsure about the above, 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 become pregnant.

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

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and operating machinery

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

Rabeprazol Stada contains sodium

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

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

Medication intake

• Only take one tablet out of the blister pack when it's 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 guidelines or treatment duration yourself.

For gastroesophageal reflux disease (GERD)

Symptomatic treatment of moderate to severe symptoms (GERD symptomatic)

• 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 reappear after 4 weeks of treatment, your doctor will tell you to take one Rabeprazol Stada 10 mg tablet as needed.

Treatment of more severe symptoms (GERD erosive or ulcerative)

• 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.

Maintenance treatment of symptoms (GERD maintenance)

• 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 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 recurrences

• 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 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 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 review and symptom check.

Patients with liver problems

Consult your doctor, who will have special care in the initiation 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. Always take the tablets and the carton 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 compensate for the missed dose.

If you interrupt treatment with Rabeprazol Stada

Relief of symptoms usually occurs before the ulcer has completely healed.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.

Stop taking Rabeprazol Stada and consult 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
• Cardenales or ease of bleeding

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

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

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

Other possible side effects:

Frequent (they may affect up to 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 (nauseas), vomiting or constipation
• Pain or back pain
• Weakness or flu-like symptoms (pseudogripal)
• Benign polyps in the stomach

Less frequent (they may affect up to 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 (they may affect up to 1 in 1,000 people):

• Loss of appetite (anorexia)
• Depression
• Hypersensitivity (including allergic reactions)
• Visual disturbances
• Inflamed mouth (stomatitis) or taste disturbances
• Stomach upset or stomach pain
• Liver problems that include yellowing of the skin and white of the eyes (jaundice)
• Rash 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

Unknown frequency (the frequency cannot be estimated from the available data):

• Swelling of the breasts in men
• Fluid retention
• Inflammation of the intestine (which leads 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 pantoprazole sodium 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 of 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 prospectus. You can also report them through the Spanish System for Pharmacovigilance of Medicines for Human Use.https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

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

Do not use this medication if you observe the packaging damaged or with signs of manipulation.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment..

Composition of Rabeprazol Stada

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

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, iron oxide red (E172), titanium dioxide (E171), talc.

Appearance of the product and contents of the packaging

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

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

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

STADA Laboratorios, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern

(Barcelona)

Spain

[email protected]

Responsible for manufacturing:

Laboratorios Liconsa, S.A.

Avda. Miralcampo, Nº7

Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara)

Spain

Last review date of this leaflet: April 2023

The 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/