Package Insert: Information for the Patient

Rabeprazol Kern Pharma 20 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 for you only, and you should 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 package insert. See section 4.

1. What is Rabeprazol Kern Pharma and what it is used for

2. What you need to know before starting to take Rabeprazol Kern Pharma

3. How to take Rabeprazol Kern Pharma

4. Possible adverse effects

5. Storage of Rabeprazol Kern Pharma

6. Contents of the package and additional information

Rabeprazol Kern Pharma contains the active ingredient rabeprazol sodium. It belongs to a group of medications known as “Proton Pump Inhibitors” (PPIs).

These act by reducing the amount of acid produced by the stomach.

Rabeprazol Kern Pharma tablets are used to treat the following diseases:

• "Gastroesophageal reflux disease" (GERD), which may include pyrosis. GERD occurs when acid and stomach contents flow up into the esophagus.
• Ulcers in the stomach or the upper part of the small intestine. If these ulcers are infected with a bacteria called "Helicobacter pylori" (H. Pylori), antibiotics will also be administered. The use of Rabeprazol Kern Pharma tablets and antibiotics together eliminates the infection and allows the ulcer to heal. It also prevents the recurrence of the infection and the ulcer.
• Zollinger-Ellison syndrome, where the stomach produces too much acid.

You should consult your doctor if you do not feel well or get worse.

Do not take Rabeprazol Kern Pharma:

• if you are allergic (hypersensitive) to rabeprazol sodium or to 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 use rabeprazol if you are in any of the above situations. If you are unsure, speak with your doctor or pharmacist before using rabeprazol.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Rabeprazol Kern Pharma.

• if you are allergic to proton pump inhibitors or to "substituted benzimidazoles" Problems in the blood and liver have been observed in some patients, but often improve when rabeprazol is stopped.
• if you have a stomach tumor.
• if you have a severe liver disease.
• if you are taking a medication called atazanavir (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 rabeprazol sodium. Like all acid-reducing agents, rabeprazol sodium may lead to reduced B12 absorption.
• if you have ever had a skin reaction after treatment with a similar medication to rabeprazol for reducing stomach acid.
• if you have a skin eruption, especially in sun-exposed areas, inform your doctor as soon as possible, as you may need to interrupt treatment with Rabeprazol Kern Pharma. Also, mention any other harmful effects such as joint pain.
• if a specific blood test (Cromogranin A) is planned.
• During treatment with rabeprazol, inflammation in your kidneys 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 must notify your doctor of these signs.

If you are unsure whether any of the above applies to you, speak with your doctor or pharmacist before using rabeprazol.

Children

Rabeprazol Kern Pharma is not recommended for children.

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• If you experience intense diarrhea (watery or bloody) with symptoms such as fever, abdominal pain, or sensitivity, stop taking rabeprazol and consult a doctor immediately.

The use of a proton pump inhibitor like Rabeprazol, especially for more than a year, may significantly increase the risk of suffering fractures of the hip, wrist, or spine. Consult your doctor if you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).

Use of Rabeprazol Kern Pharma with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This includes medications purchased without a prescription, including herbal medications.

-Ketoconazole or itraconazole (used to treat fungal infections). Rabeprazol may increase the amount of this type of medication in your blood. Your doctor may need to adjust your dose.

-Atazanavir (used to treat HIV infection). Rabeprazol may decrease the amount of this type of medication in your blood and should not be used together.

-Metotrexate (a chemotherapy medication used at high doses to treat cancer and inflammatory conditions) – if you are taking a high dose of metotrexate, your doctor may temporarily suspend your treatment with rabeprazol.

If you are unsure whether any of the above applies to you, speak with your doctor or pharmacist before using rabeprazol.

Pregnancy, breastfeeding, and fertility

- Do not use rabeprazol if you are pregnant or think you may be pregnant.

- Do not use rabeprazol if you are breastfeeding or plan to breastfeed.

If you are pregnant or breastfeeding, or 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 drowsy while taking rabeprazol. If this happens, do not drive or use tools or machinery.

Rabeprazol Kern Pharma 20 mg gastro-resistant tablets contain sodium:

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

Follow exactly the administration instructions of this medication as 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 tablets whole with a glass of water. Do not chew or crush the tablets.

- Your doctor will tell you how many tablets to take and for how long. This will depend on your condition.

- If you are taking this medication for a prolonged period, your doctor will want to monitor you.

Adults and elderly:

The following doses are generally recommended for adults and the elderly. Do not change the dose or duration of treatment yourself.

For gastroesophageal reflux disease (GERD)

Symptomatic treatment of moderate to severe symptoms (GERD symptomatic)

- The usual dose is one rabeprazole 10 mg tablet once a day for a maximum of 4 weeks.

- Take the tablet in the morning before eating.

- If your condition reappears after 4 weeks of treatment, your doctor may instruct you to take a rabeprazole 10 mg tablet as needed.

Treatment of more severe symptoms (GERD erosive or ulcerative)

- The usual dose is one rabeprazole 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 rabeprazole 10 mg or 20 mg tablet once a day for the time indicated by your doctor.

- Take the tablet in the morning before eating.

- Your doctor will want to see you at regular intervals to monitor your symptoms and dose.

For stomach ulcers (peptic ulcers)

- The usual dose is one rabeprazole 20 mg tablet once a day for 6 weeks.

- Take the tablet in the morning before eating.

- Your doctor may instruct you to take rabeprazole for another 6 weeks if your condition does not improve.

For duodenal ulcers

- The usual dose is one rabeprazole 20 mg tablet once a day for 4 weeks.

- Take the tablet in the morning before eating.

- Your doctor may instruct you to take rabeprazole for another 4 weeks if your condition does not improve.

For ulcers caused by H. Pylori infection and to prevent them from returning

- The usual dose is two rabeprazole 20 mg tablets once a day for 7 days.

- Your doctor will also instruct you to take antibiotics called amoxicillin and clarithromycin.

For more information on other medications used to treat H. Pylori, see the individual product information leaflet.

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

- The usual dose is three rabeprazole 20 mg tablets once a day initially.

- Your doctor may adjust the dose depending on how you respond to treatment.

If you are on long-term treatment, you should see your doctor at regular intervals to review your tablets and symptoms.

Patients with liver problems. You should consult your doctor, who will take special care when starting treatment with rabeprazole and while continuing to be treated with rabeprazole.

If you take more Rabeprazol Kern Pharma than you should

Do not take more tablets than prescribed. 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).

If you forget to take Rabeprazol Kern Pharma

If you forget to take a tablet, take one as soon as you remember and then continue as usual. However, if it is almost time to take the next dose, skip the missed tablet and continue as usual.

If you forget to take your medication for more than 5 days, call your doctor before taking more medication.

Do not take a double dose (two tablets at the same time) to compensate for the missed doses.

If you interrupt treatment with Rabeprazol Kern Pharma

Relief of symptoms will usually occur before the ulcer has fully healed. It is essential not to stop taking the tablets until your doctor tells you to.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The side effects are usually mild and improve without having to stop taking this medicine.

Stop taking rabeprazol and consult a doctor immediately if you notice any of the following side effects; you may need urgent medical treatment:

-Allergic reactions: – the signs may include: swelling of the face, difficulty breathing or low blood pressure that may cause dizziness or collapse

-Frequent infections, such as sore throat or high temperature (fever), or ulcers in the mouth or throat.

-Bruising or bleeding easily.

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

-Severe blisters on the skin, pain or ulcers in the mouth and throat.

Other possible side effects:

Frequent side effects(they may affect up to 1 in 10 people):

• Weakness or flu-like syndromeBenign polyps in the stomach

Rare side effects(they may affect up to 1 in 100 people):

Changes in liver function (shown in blood tests).

Rare side effects(they may affect up to 1 in 1,000 people):

-Loss of appetite (anorexia)

Reduction of platelets in the blood that cause bleeding or bruising with greater ease than normal.

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

-If you are takingrabeprazolfor more than three months it is possible that the levels of magnesium in the blood may decrease. Low levels of magnesium may cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you have any of these symptoms, see a doctor immediately. Low levels of magnesium may also produce a decrease in potassium and calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.

Do not worry about this list of side effects. It is possible that you will not get any of them.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for human use: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 after “CAD”. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25 °C. Store in the original packaging.

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 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 packaging and medications you no longer need.By doing so, you will help protect the environment.

Rabeprazol Kern Pharma Composition

The active ingredient is rabeprazol sodium.

Each Rabeprazol Kern Pharma 20 mg gastro-resistant tablet contains 20 mg of rabeprazol sodium, equivalent to 18.85 mg of rabeprazol.

The other components are:

Tablet core:mannitol (E421), heavy magnesium oxide (E530), hydroxypropylcellulose (E463), magnesium stearate (E572).

Subcoat:ethylcellulose (E462), heavy magnesium oxide (E530).

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

Product appearance and packaging contents

Yellow, biconvex gastro-resistant tablets.

The packaging contains aluminum blister strips of 1, 5, 7, 14, 15, 25, 28, 30, 50, 56, 75, 98, and 120 tablets.

Not all presentations may be marketed.

Marketing authorization holder:

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Responsible manufacturer:

Laboratorios LICONSA, S.A.

Avda. Miralcampo, Nº7, Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara)

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: June 2021

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/