Package Leaflet: Information for the user

Rabeprazol Teva-ratio 10 mg gastro-resistant tablets EFG

rabeprazol sodium

Read this leaflet carefully before you start taking the medicine because it contains important information for you.

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

1. What Rabeprazol Teva-ratio is and what it is used for

2. What you need to know before taking Rabeprazol Teva-ratio

3. How to take Rabeprazol Teva-ratio

4. Possible side effects

5. Storage of Rabeprazol Teva-ratio

6. Contents of the pack and additional information

Rabeprazol Teva-ratio contains the active ingredient rabeprazol sodium. This belongs to a class of medicines known as “Proton Pump Inhibitors” (PPIs), which act by reducing the amount of acid produced by the stomach.

Rabeprazol Teva-ratio enteric-coated tablets are used for the treatment of:

• “Gastroesophageal reflux disease” (GERD), which may include the occurrence of acid reflux. 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 Teva-ratio and the antibiotics together will clear 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 Teva-ratio

• if you areallergic (hypersensitive)torabeprazol sodium, or to any of the other components of this medication (listed in section 6).
• if you arepregnantor think you may be pregnant.
• if you arebreastfeeding.

Do not take Rabeprazol Teva-ratio if you are in any of the above situations. If you are unsure, consult your doctor or pharmacist before taking Rabeprazol Teva-ratio.

See also the section on Pregnancy and breastfeeding.

Children

Rabeprazol Teva-ratio should not be administered to children.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Rabeprazol Teva-ratio:

• if you are allergic to proton pump inhibitors or to “substituted benzimidazole compounds”.
• if you have experienced liver and blood problems in some patients but often improve when treatment with Rabeprazol Teva-ratio 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 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 can lead to reduced B12 absorption.
• if you are scheduled to have a specific blood test (Cromogranin A)
• if you have ever had a skin reaction after treatment with a similar medication to Rabeprazol Teva-ratio for reducing stomach acid.

If you experience a skin rash, especially in sun-exposed areas, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with Rabeprazol Teva-ratio. Remember to mention any other symptoms you may notice, such as joint pain.

If you are unsure about the above, consult your doctor or pharmacist before taking Rabeprazol Teva-ratio.

Your doctor may have performed or may have performed an additional examination called endoscopy to diagnose your condition and/or rule out malignant disease. Before starting treatment, it is essential to exclude the possibility of the presence of tumors in the stomach and esophagus.

If you experience severe diarrhea (watery or bloody) with symptoms such as fever, abdominal pain, or sensitivity, stop taking Rabeprazol Teva-ratio and see your doctor immediately.

During treatment with rabeprazol, inflammation in your kidneys may occur. Among the signs and symptoms are: 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 taking proton pump inhibitors such as rabeprazol, especially for a period of more than one year, your risk of fracture of the hip, wrist, and spine may increase slightly. Inform your doctor if you have osteoporosis or are taking corticosteroids (which can increase the risk of osteoporosis).

If you take this medication for a long time (more than one year), your doctor will likely monitor you regularly. When you visit, you should inform them of any new or different symptoms.

Other medications and Rabeprazol Teva-ratio

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicationincluding over-the-counter medications and herbal supplements.

Particularly, inform your doctor or pharmacist if you are taking any of the following

medications:

• Ketoconazole or itraconazole, medications for fungal infections. Rabeprazol Teva-ratio may reduce the amount of these medications in the blood. Your doctor may need to adjust your dose.
• Atazanavir, a medication used to treat HIV infection. Rabeprazol Teva-ratio may reduce the amount of this type of medication 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 rabeprazol.

If you are unsure about the above, consult your doctor or pharmacist before taking Rabeprazol Teva-ratio.

Pregnancy and breastfeeding

• Do not take Rabeprazol Teva-ratio if you are pregnant or think you may be pregnant.
• Do not take Rabeprazol Teva-ratio during breastfeeding or if you 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 operating machinery

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

Rabeprazol Teva-ratio contains lactose

If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Rabeprazol Teva-ratio contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per gastro-resistant tablet; this is, essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Administration of this medication

• Only remove one 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

Gastroesophageal reflux disease (GERD)

Symptomatic treatment of moderate to severe symptoms (GERD symptomatic)

• The recommended dose is one Rabeprazol Teva-ratio 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 Teva-ratio 10 mg tablet as needed.

Treatment of more severe symptoms (GERD erosive or ulcerative)

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

For duodenal ulcers

• The recommended dose is one Rabeprazol Teva-ratio 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 Teva-ratio 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 Teva-ratio 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 package inserts for each one.

Zollinger-Ellison syndrome, where excessive acid is produced in the stomach

• The recommended dose is three Rabeprazol Teva-ratio 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.

Use in children

This medication should not be administered to children.

Patients with liver problems

Consult your doctor, who will have special care in the initiation and during treatment with this medication.

If you take more Rabeprazol Teva-ratio than you should

If you take more Rabeprazol Teva-ratio than you should, talk to your doctor or go to the hospital immediately. Bring the medication with you.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91-562 04 20, indicating the medication and the amount ingested.

If you forget to take Rabeprazol Teva-ratio

• 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 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 taking more medication.
• Do not take a double dose (two doses at the same time) to compensate for the missed dose.

If you interrupt treatment with Rabeprazol Teva-ratio

Relief of symptoms usually occurs before the ulcer is 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, Rabeprazol Teva-ratio can cause side effects, although not everyone will experience them. Side effects are usually mild and improve without you stopping treatment.

Stop taking Rabeprazol Teva-ratio and see 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 easy bleeding.
• Yellowing of your skin, dark urine and fatigue, which may be symptoms of liver problems.

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

• Severe blisters on your 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), being sick (vomiting) or constipation.
• Pain or back pain.
• Weakness or flu-like symptoms (pseudogripals).
• Benign polyps in the stomach.

Rare (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.
• Fracture of the hip, wrist or 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 disorders.
• Stomach problems or stomach pain.
• Liver problems that include yellowing of the skin and the white of the eyes (jaundice).
• Eruption with itching or blisters.
• Sweating.
• Kidney 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.
• Patients who have previously had liver problems, may develop very rarely a encephalopathy (brain disease).

Frequency unknown (cannot be estimated from available data)

• Swelling of the breasts in men.

• Fluid retention.
• Inflammation in the intestine (may cause diarrhea).
• Low sodium levels in the blood that may cause fatigue and confusion, muscle spasms, convulsions and coma.
• skin rash, possibly with joint pain.

If you are taking rabeprazol for 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 your doctor immediately. Low levels of magnesium may also cause a decrease in potassium and calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.

Reporting 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 leaflet. You can also report them directly 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. Store below 25°C.

Store in the original packaging to protect it from moisture.

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.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Rabeprazol Teva-ratio

- The active ingredient is rabeprazol sodium.

Cada comprimido gastrorresistente contains 10 mg of rabeprazol sodium.

- The other components (excipients) are:

Core: Mannitol, low-substituted hydroxypropylcellulose, magnesium oxide, hydroxypropylcellulose, magnesium stearate.

Covering:

Hypromellose (E464), microcrystalline cellulose, stearic acid, titanium dioxide (E171), hypromellose phthalate, triethyl citrate, lactose monohydrate, macrogol 4000, iron oxide red (E172), iron oxide yellow (E172).

Printing ink:

Shellac, iron oxide black (E172), ammonium hydroxide, propylene glycol.

Appearance of the product and contents of the package:

Rabeprazol Teva-ratio 10 mg gastro-resistant tablets are pink, round tablets, printed on one face of the tablet with black ink "N" and "10".

Rabeprazol Teva-ratio is available in packages of 7, 14, 28, 30, 50, 56, and 98 gastro-resistant tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer:

Marketing authorization holder

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B 1st floor

28108 Alcobendas. Madrid (Spain)

Responsible manufacturer

Pharmachemie B.V.

Swensweg 5,

2031 GA Haarlem Netherlands

or

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen

Hungary

or

TEVA PHARMA, S.L.U.

C/ C, n° 4, Industrial Estate Malpica,

Zaragoza, 50016

Spain

or

Teva Czech Industries s.r.o.

Ostravská 29, Opava-Komárov 74770

Czech Republic

or

Merckle GmbH

Ludwig-Merckle-Strasse 3,

89143 Blaubeuren-Weiler

Germany

or

Teva Operations Poland Sp. z.o.o,

ul. Mogilska 80, 31-546 Kraków,

Poland

Last review date of this leaflet: October 2022

Further detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/