Rabeprazole Kern Pharma 10 mg gastro-resistant tablets EFG

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

Rabeprazol Kern Pharma 10 mg gastro-resistant tablets EFG

Sodium rabeprazole

Read the entire 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.

Leaflet Contents:

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

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

Rabeprazol Kern Pharma contains the active substance rabeprazol. It belongs to a group of medicines called "Proton Pump Inhibitors" (PPIs).

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

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

• "Gastroesophageal reflux disease" (GERD), which may include heartburn. GERD occurs when acid and food from the stomach flow back into the esophagus (gullet).
• Ulcers in the stomach or in the upper part of the intestine. If these ulcers are infected with a bacterium called "Helicobacter pylori" (H. pylori), you will also be given antibiotics. Taking Rabeprazol Kern Pharma tablets together with antibiotics eradicates the infection and allows the ulcer to heal. It also prevents the infection and ulcer from recurring.
• Zollinger-Ellison syndrome, a condition in which your stomach produces too much acid.

You should consult your doctor if you do not feel well or if your condition worsens.

2. What you need to know before taking Rabeprazol Kern Pharma

Do not take Rabeprazol Kern Pharma:

• If you are allergic (hypersensitive) to sodium rabeprazole or to 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.

Warnings and precautions

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

• If you are allergic to proton pump inhibitors or to "substituted benzimidazoles".
• Blood and liver problems have been observed in some patients, but these often improve when rabeprazole is discontinued.
• If you have a stomach tumor.
• If you have severe liver disease.
• If you are taking a medicine called atazanavir (for HIV infection).
• If you have reduced body stores or risk factors associated with low vitamin B12 levels and are receiving long-term treatment with sodium rabeprazole. Like all agents that reduce acidity, sodium rabeprazole may lead to reduced absorption of vitamin B12.
• If you have ever had a skin reaction after treatment with a medicine similar to rabeprazole used to reduce stomach acid.
• If you develop a skin rash, especially in areas exposed to sunlight, inform your doctor as soon as possible, as you may need to stop treatment with Rabeprazol Kern Pharma. Also remember to mention any other adverse effects such as joint pain.
• If you are scheduled to have a specific blood test (chromogranin A).
• During treatment with rabeprazole, inflammation of the kidney 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 report these signs to your doctor.

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

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

• Extreme tiredness or lack of energy
• Tingling sensation
• Sore or red tongue, mouth ulcers
• Muscle weakness
• Changes in vision
• Memory problems, confusion, depression

Children

Rabeprazol Kern Pharma is not recommended for use in children.

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

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

Taking Rabeprazol Kern Pharma with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes medicines purchased without a prescription, including herbal medicines.

• Ketoconazole or itraconazole (used to treat fungal infections). Rabeprazole may reduce the amount of these medicines in your blood. Your doctor may need to adjust your dose.
• Atazanavir (used to treat HIV infection). Rabeprazole may decrease the amount of this medicine in your blood and should not be used together.
• Methotrexate (a chemotherapy medicine used at high doses to treat cancer and inflammatory conditions) – if you are taking a high dose of methotrexate, your doctor may temporarily discontinue your rabeprazole treatment.

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

Pregnancy, breastfeeding and fertility

• Do not use rabeprazole if you are pregnant or think you may be pregnant.
• Do not use rabeprazole if you are breastfeeding or plan to breastfeed.

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

Driving and using machines

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

Rabeprazol Kern Pharma 10 mg gastro-resistant tablets contain sodium:

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

3. How to take Rabeprazol Kern Pharma

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

Taking this medicine

• Only remove a tablet from the blister pack when it is time to take your medicine.
• Swallow the tablets whole with a glass of water. Do not chew or crush the tablets.
• Your doctor will tell you how many tablets you should take and for how long. This will depend on your condition.
• If you are taking this medicine for a prolonged period, your doctor will want to monitor you.

Adults and elderly:

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

For "gastroesophageal reflux disease" (GERD)

Treatment of moderate to severe symptoms (symptomatic GERD)

• The usual dose is one 10 mg rabeprazole tablet once daily for up to 4 weeks.
• Take the tablet in the morning before eating.
• If your condition recurs after 4 weeks of treatment, your doctor may instruct you to take one 10 mg rabeprazole tablet as needed.

Treatment of more severe symptoms (erosive or ulcerative GERD)

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

Long-term treatment of symptoms (GERD maintenance therapy)

• The usual dose is one 10 mg or 20 mg rabeprazole tablet once daily for the duration 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 dosage.

For stomach ulcers (peptic ulcers)

• The usual dose is one 20 mg rabeprazole tablet once daily for 6 weeks.
• Take the tablet in the morning before eating.
• Your doctor may instruct you to continue taking rabeprazole for another 6 weeks if your condition does not improve.

For intestinal ulcers (duodenal ulcers)

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

For ulcers caused by H. pylori infection and to prevent their recurrence

• The usual dose is one 20 mg rabeprazole 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 refer to the individual product information leaflets.

Zollinger-Ellison syndrome, where excess stomach acid is produced

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

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

Patients with liver problems: You should consult your doctor, who will exercise special caution when starting treatment with rabeprazole and during continued treatment with rabeprazole.

If you take more Rabeprazol Kern Pharma than you should

Do not take more tablets per day than prescribed. In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20 (indicating the medicine and amount ingested).

If you forget to take Rabeprazol Kern Pharma

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, skip the missed dose and continue with your regular schedule.

If you forget to take your medicine for more than 5 days, call 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 Rabeprazol Kern Pharma

Symptom relief usually occurs before the ulcer has completely healed. It is important that you do not stop taking the tablets unless instructed to do so by your doctor.

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 will experience them.

Side effects are usually mild and improve without you having to stop taking this medicine.

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

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

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

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

Other possible side effects:

Frequent adverse effects(may affect up to 1 in 10 people):**

• Infection
• Difficulty sleeping
• Headache or dizziness
• Cough, runny nose, or sore throat (pharyngitis)
• Stomach or intestinal problems such as stomach pain, diarrhoea, gas (flatulence), discomfort (nausea), vomiting, or constipation
• Aches or back pain
• Weakness or flu-like syndrome
• Benign polyps in the stomach
• Benign polyps in the stomach

Uncommon adverse effects(may affect up to 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 pain in the legs or joints
• Fractures of the hip, wrist, or spine
• Bladder infection (urinary tract infection)
• Chest pain
• Chills, fever

Changes in liver function (shown in blood tests).

Rare adverse effects(may affect up to 1 in 1,000 people):**

• Loss of appetite (anorexia)
  • Depression
  • Hypersensitivity (including allergic reactions)
  • Vision disturbances
  • Mouth pain (stomatitis) or altered taste
  • Stomach discomfort or stomach pain
  • Liver problems, including yellowing of the skin and whites of the eyes (jaundice)
  • Skin rash with itching or blistering
  • Sweating
  • Kidney problems
  • Weight gain
  • Changes in white blood cells (shown in blood tests) which may lead to frequent infections

Reduction in blood platelets causing bleeding or bruising more easily than normal.

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

• Breast enlargement in men
• Fluid retention
• Inflammation of the intestine (causing 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 (a brain disorder)
• Rash, possibly with joint pain

If you are taking rabeprazole for more than three months, your blood magnesium levels may decrease. Low magnesium levels may cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, consult your doctor immediately. Low magnesium levels may also lead to decreased levels of potassium and calcium in the blood. Your doctor may decide to carry out periodic blood tests to monitor your magnesium levels.

• Rash, possibly with joint pain.
  • Inflammation of the intestine (leading to diarrhoea).

Do not be alarmed by this list of side 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 an effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Rabeprazol Kern Pharma

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

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date is the last day of the month indicated.

Do not store above 25°C. Keep in the original packaging.

Do not use this medicine if you notice the container damaged or showing signs of tampering.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rabeprazol Kern Pharma

The active substance is rabeprazol sodium.

Each Rabeprazol Kern Pharma 10 mg gastro-resistant tablet contains 10 mg of rabeprazol sodium, equivalent to 9.42 mg of rabeprazol.

The other components are:

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

Subcoating: ethylcellulose (E462), magnesium oxide (E530).

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

Appearance of the product and pack contents

Pink, biconvex, coated (gastro-resistant) tablets.

The packs contain aluminum blisters with 1, 5, 7, 14, 15, 25, 28, 30, 50, 56, 75, 98 and 120 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder:

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer:

Laboratorios LICONSA, S.A.

Avda. Miralcampo, Nº7, Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara)

Spain

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

Date of the most recent review of this leaflet: March 2023

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/