Rabeprazole Stada 10 mg gastro-resistant tablets EFG

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

Rabeprazol Stada 10 mg gastro-resistant tablets EFG

Rabeprazole sodium

Read this entire leaflet carefully before you start taking this medicine, as 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 must not be given 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 the effects are not listed in this leaflet. See section 4.

Leaflet Contents

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

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

Rabeprazol Stada contains the active substance sodium rabeprazole. It belongs to a group of medicines 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 conditions:

• Gastroesophageal reflux disease (GERD), which may include heartburn. GERD is caused by the backflow 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), antibiotic treatment will be required. Taking sodium rabeprazole together with antibiotics will eliminate the infection and allow the ulcer to heal. It will also prevent recurrence of the infection and ulcer.

Zollinger-Ellison syndrome, a condition 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 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

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

Warnings and precautions

Taking a proton pump inhibitor such as rabeprazole, especially for a period longer than one 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 (as these 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 medicines or to "substituted benzimidazoles".
• If liver or blood problems have occurred in some patients, although these often improve when treatment with sodium rabeprazole is stopped.
• If you have a stomach tumour.
• If you have ever had liver problems.
• If you are taking atazanavir, a medicine used to treat HIV infection.
• If you have reduced body stores or risk factors associated with low levels of vitamin B12 and are receiving long-term treatment with sodium rabeprazole. As with all agents that reduce acidity, sodium rabeprazole may lead to reduced absorption of vitamin B12.

This medicine may affect how 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 may indicate low vitamin B12 levels:

• Extreme tiredness or lack of energy

• Tingling sensations

• Sore or red tongue, mouth ulcers

• Muscle weakness

• Blurred vision

• Memory problems, confusion, depression

• If you have ever had a skin reaction after treatment with a medicine similar to sodium rabeprazole for reducing stomach acid.

• If you develop a skin rash, especially in areas of skin exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to stop treatment with sodium rabeprazole. 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 are unsure whether any of the above apply to you, consult your doctor or pharmacist before taking sodium rabeprazole.

Children

Rabeprazole must not be given to children.

If you experience severe diarrhoea (watery or bloody) with symptoms such as fever, abdominal pain or tenderness, stop taking sodium rabeprazole and see your doctor immediately.

Taking a proton pump inhibitor such as sodium rabeprazole, especially for longer than one year, may slightly increase the risk of fracture of the 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

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

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

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

If you are unsure whether any of the above apply to you, consult your doctor or pharmacist before taking sodium rabeprazole.

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 breastfeed.

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

Driving and using machines

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; that is, essentially "sodium-free".

3. How to take Rabeprazol Stada

Follow exactly the instructions for the use of this medicine 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 dose.
• Swallow the tablet whole with some water. Do not crush or chew the tablet.
• Your doctor will tell you how many tablets you should take and for how long your treatment should last, depending on your condition.
• If you are taking this medicine for a long time, your doctor will want to monitor you.

Adults and elderly patients

The dosing regimens indicated below are 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 recommended dose is one Rabeprazol Stada 10 mg tablet once daily for up to 4 weeks.
• Take the tablet in the morning before eating.
• If your symptoms return 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 daily for 4 to 8 weeks.
• Take the tablet in the morning before eating.

Long-term treatment of symptoms (maintenance of GERD)

• The recommended dose is one Rabeprazol Stada 10 mg or 20 mg tablet once daily for as long as your doctor has instructed.
• Take the tablet in the morning before eating.
• Your doctor will want to see you at regular intervals to check your symptoms and dosage.

For stomach ulcers (peptic ulcers)

• The recommended dose is one Rabeprazol Stada 20 mg tablet once daily for 6 weeks.
• Take the tablet in the morning before eating.
• Your doctor may tell you to continue taking 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 daily for 4 weeks.
• Take the tablet in the morning before eating.
• Your doctor may tell you to continue taking Rabeprazol Stada for another 4 weeks if your symptoms do not improve.

For ulcers caused by H. pylori infection and to prevent relapses

• The recommended dose is one Rabeprazol Stada 20 mg 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 read the package leaflets for each of them.

Zollinger-Ellison syndrome, in which excess stomach acid is produced

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

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

Patients with liver problems

Please consult your doctor, who will exercise 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, stating the medicine and the amount taken. Always bring the tablets and the cardboard carton with you to the hospital so 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 for your next dose, simply skip the missed dose and continue with your regular schedule.
• If you have missed taking your medicine 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 a missed dose.

If you stop taking Rabeprazol Stada

Symptom relief usually occurs before the ulcer has completely healed. It is important that you do not stop treatment until your doctor tells you to do so.

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.

Stop taking Rabeprazole Stada and contact your doctor immediately if you notice any of the following adverse effects – you may need urgent medical treatment:

• Allergic reactions – signs may include: sudden 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 ulcers in your mouth or throat
• Bruising or easy bleeding

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

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

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

Other possible adverse 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 intestinal problems such as stomach pain, diarrhoea, gas (flatulence), feeling sick (nausea), being sick (vomiting), or constipation
• Pain or back pain
• Weakness or flu-like symptoms (pseudoinfluenza)
• Benign polyps in the stomach

Uncommon (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, leg, or joint pain
• Fractures in the hip, wrist, or spine
• Bladder 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):

• Loss of appetite (anorexia)
• Depression
• Hypersensitivity (including allergic reactions)
• Visual disturbances
• Inflamed mouth (stomatitis) or taste disturbances
• Stomach upset or stomach pain
• Liver problems including yellowing of the skin and whites of the eyes (jaundice)
• Itchy rash or blistering
• Sweating
• Kidney problems
• Weight gain
• Changes in white blood cells (shown in blood tests) which may lead to frequent infections
• Decrease in blood platelets which may cause bleeding or bruising more easily than normal

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

• Breast swelling in men
• Fluid retention
• Inflammation of the intestine (leading to 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 (brain disease)
• Skin rash, possibly with joint pain

If you take sodium pantoprazole for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or increased heart rate. If you experience any of these symptoms, please inform your doctor immediately. Low magnesium levels may also lead to reduced levels of potassium or calcium in the blood. Your doctor may decide to carry out periodic blood tests to monitor your magnesium levels.

Do not be alarmed by this list of adverse effects. You may not experience any of them.

Reporting of adverse effects

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

5. Storage of Rabeprazole Stada

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

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

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

Do not use this medicine if the container is damaged or shows signs of tampering.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Rabeprazol Stada

The active substance 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:

Tablet core: 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 pack

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

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern

(Barcelona)

Spain

[email protected]

Manufacturer:

Laboratorios Liconsa, S.A.

Avda. Miralcampo, Nº7

Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara)

Spain

Date of the most recent revision of this leaflet: April 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/