Rabeprazole Teva-Ratio 10 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Rabeprazol Teva-ratio 10 mg gastro-resistant tablets EFG

rabeprazole sodium

Read the entire leaflet carefully before you start using 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 and should not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

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. How to store Rabeprazol Teva-ratio
6. Contents of the pack and other information

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

Rabeprazol Teva-ratio contains the active ingredient sodium rabeprazole. This belongs to a class of medicines known as "Proton Pump Inhibitors" (PPIs), which work 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 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 Rabeprazol Teva-ratio together with antibiotics will eliminate the infection and heal the ulcer. It will also prevent recurrence of the ulcer due to the infection.

• Zollinger-Ellison syndrome, a condition characterized by the production of very high amounts of stomach acid.

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

Do not take Rabeprazol Teva-ratio

• 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.

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 must not be given to children.

Warnings and precautions

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

• If you are allergic to proton pump inhibitors or to "substituted benzimidazoles".
• If liver or blood problems have occurred in some patients, but these often improve when treatment with Rabeprazol Teva-ratio is stopped.
• If you have a stomach tumour.
• If you have ever had liver problems.
• If you are taking atazanavir, a medicine for HIV infection.
• If you have reduced body stores or have risk factors associated with low levels of 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 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 may indicate low levels of vitamin B12:
  • Extreme tiredness or lack of energy
  • Tingling or pins and needles sensation
  • Sore or red tongue, mouth ulcers
  • Muscle weakness
  • Changes in vision
  • Memory problems, confusion, depression
• If you are scheduled to have a specific blood test (chromogranin A)
• If you have ever had a skin reaction after treatment with a medicine similar to Rabeprazol Teva-ratio 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 Rabeprazol Teva-ratio. Remember to mention any other symptoms you may notice, such as joint pain.

If you are unsure whether any of the above applies to you, consult your doctor or pharmacist before taking Rabeprazol Teva-ratio.

Your doctor may have performed or may perform an additional examination called endoscopy to diagnose your condition and/or rule out malignancy. Before starting treatment, the possibility of tumours in the stomach and oesophagus must be ruled out.

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

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 should report these signs to your doctor.

If you are taking proton pump inhibitors such as rabeprazole, especially for more than one year, there may be a slightly increased risk of fractures of the hip, wrist, and spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).

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

Other medicines and Rabeprazol Teva-ratio

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

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

• Ketoconazole or itraconazole, medicines for fungal infections. Rabeprazol Teva-ratio may reduce the blood levels of these medicines. Your doctor may need to adjust your dose.
• Atazanavir, a medicine used to treat HIV infection. Rabeprazol Teva-ratio may reduce blood levels of this type of medicine and therefore should not be used together.
• Methotrexate (a chemotherapy medicine 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.

If you are unsure whether any of the above applies to you, 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 while breastfeeding or if you plan to start breastfeeding.

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 this medicine. If this occurs, do not drive or operate tools or machinery.

Rabeprazol Teva-ratio contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Rabeprazol Teva-ratio contains sodium

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

3. How to take Rabeprazol Teva-ratio

Follow exactly your doctor's instructions on how to take this medicine. If you are unsure, consult your doctor or pharmacist.

How to take this medicine

• Only remove a tablet from the blister pack when it is time to take your dose.
• 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 for how long, 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

For "gastroesophageal reflux disease" (GERD)

Treatment of moderate to severe symptoms (symptomatic GERD)

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

Treatment of more severe symptoms (erosive or ulcerative GERD)

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

For intestinal ulcers (duodenal ulcers)

• The recommended dose is one Rabeprazol Teva-ratio 20 mg tablet once daily for 4 weeks.
• Take the tablet in the morning before eating.
• Your doctor may instruct you to continue Rabeprazol Teva-ratio 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 Teva-ratio 20 mg tablet twice daily for 7 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, where excess stomach acid is produced

• The recommended starting dose is three Rabeprazol Teva-ratio 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.

Use in children

This medicine must not be given to children.

Patients with liver problems

Consult your doctor, who will exercise special caution when starting and during treatment with this medicine.

If you take more Rabeprazol Teva-ratio than you should

If you take more Rabeprazol Teva-ratio than you should, speak to your doctor or go to a hospital immediately. Take the medicine with you.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service at telephone number 91-562 04 20, indicating the medicine 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, 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 forgotten to take your medicine for more than 5 days, consult 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 Teva-ratio

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, Rabeprazol Teva-ratio can produce adverse effects, although not everyone experiences them. Adverse effects are usually mild and improve without you needing to stop treatment.

Stop taking Rabeprazol Teva-ratio and see 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 which may cause fainting or collapse.
• Frequent infections, such as sore throat or high temperature (fever), or mouth or throat ulcers.
• Bruising or bleeding easily.
• Yellowing of the skin, dark urine, and tiredness, which may be symptoms of liver problems.

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

• Severe blistering of the skin, or sores or ulcers in the 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).
• Effects on your stomach or bowel such as stomach pain, diarrhoea, gas (flatulence), feeling sick (nausea), being sick (vomiting), or constipation.
• Aches or back pain.
• Weakness or flu-like symptoms (flu-like symptoms).
• 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.
• Fracture of 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 disorder 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.
• Patients who have previously had liver problems may very rarely develop encephalopathy (brain disease).

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

• Breast enlargement in men.

• Fluid retention.

• Inflammation of the intestine (which may lead to diarrhoea).

• Low levels of sodium in the blood which may cause tiredness and confusion, muscle spasms, seizures, and coma.

• Skin rash, possibly with joint pain.

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

Reporting of adverse effects:

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish System of Pharmacovigilance 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 Teva-ratio

Keep this medicine out of the sight and reach of children. Store below 25°C.

Keep in the original packaging to protect from moisture.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rabeprazol Teva-ratio

• The active substance is rabeprazole sodium.

Each gastro-resistant tablet contains 10 mg of sodium rabeprazole (as hydrate).

• The other components (excipients) are:

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

Coating:

Hypromellose 2910 (E464), microcrystalline cellulose, stearic acid, titanium dioxide (E171), hypromellose phthalate, triethyl citrate, lactose monohydrate, macrogol 4000, red iron oxide (E172), yellow iron oxide (E172).

Printing ink:

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

Appearance of the product and contents of the pack:

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

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Marketing Authorisation Holder

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1st floor
28108 Alcobendas, Madrid (Spain)

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, Poligono Industrial 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

Date of the most recent review of this leaflet: April 2026

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included on the packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/75791/P_75791.html

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