RABEPRAZOL TEVA-RATIO 20 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the User

Rabeprazol Teva-ratio 20 mg Gastro-resistant Tablets EFG

sodium rabeprazole

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

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

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

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

Rabeprazol Teva-ratio contains the active substance sodium rabeprazole. This 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 Teva-ratio gastro-resistant tablets are used for the treatment of:

• “Gastro-oesophageal reflux disease” (GORD), which may include symptoms of acid reflux. The cause of GORD is acid and food flowing back into the oesophagus from the stomach.
• Stomach ulcers or ulcers of the upper part of the intestine (duodenal ulcers). If these ulcers are infected with a bacterium called “Helicobacter pylori” (H. pylori), you will also need to take antibiotics. Taking Rabeprazol Teva-ratio and antibiotics together will get rid of the infection and the ulcer will heal. It will also stop the infection and the ulcer coming back.
• Zollinger-Ellison syndrome, a disease where very high amounts of acid are produced in the stomach.

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

Do not take Rabeprazol Teva-ratio

• if you are allergic (hypersensitive) to sodium rabeprazole or 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 breast-feeding.

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

See also the section on Pregnancy and breast-feeding.

Children

Rabeprazol Teva-ratio should not be given to children.

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Rabeprazol Teva-ratio:

• If you are allergic to proton pump inhibitors or “substituted benzimidazoles”.
• If liver or blood problems have been seen in some patients but often get better 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 used to treat HIV infection.
• If you have reduced body stores or risk factors for low vitamin B12 and are taking long-term treatment with sodium rabeprazole. As with all acid-reducing agents, sodium rabeprazole may lead to a reduced absorption of vitamin B12.
• If you are due to have a specific blood test (Chromogranin A)
• If you have ever had a skin reaction with a medicine used to reduce stomach acid.

If you get a rash, especially in areas of skin exposed to the sun, tell your doctor as soon as possible, as you may need to stop treatment with Rabeprazol Teva-ratio. Also, remember to mention any other symptoms you might notice, such as joint pain.

If you are in doubt about any of the above, consult your doctor or pharmacist before taking Rabeprazol Teva-ratio.

Your doctor may have done an additional examination called endoscopy to diagnose your condition and/or rule out a malignant disease. Before starting treatment, it must be excluded that you have a tumour in the stomach or oesophagus.

If you experience severe diarrhoea with blood and mucus, or severe abdominal pain, stop taking Rabeprazol Teva-ratio and see a doctor immediately.

During treatment with rabeprazole, kidney inflammation can occur. Signs and symptoms include: decreased urine output or blood in the urine and/or hypersensitivity reactions such as fever, rash and joint stiffness. You should inform your doctor of these signs.

If you are taking proton pump inhibitors like rabeprazole, especially over a period of more than one year, it may slightly increase the risk of hip, wrist and spine fractures. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

If you take this medicine for a long time (more than one year), your doctor will probably keep you under regular surveillance. When you attend a follow-up visit, 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 take any other medicines, including those obtained without a prescription, including herbal medicines.

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

• Ketoconazole or itraconazole, medicines used to treat fungal infections. Rabeprazol Teva-ratio may decrease the amount of these medicines in the blood. Your doctor may need to adjust the dose.
• Atazanavir, a medicine used to treat HIV infection. Rabeprazol Teva-ratio can decrease the amount of this type of medicine in the blood, so they 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 in doubt whether any of the above applies to you, consult your doctor or pharmacist before taking Rabeprazol Teva-ratio.

Pregnancy and breast-feeding

• Do not take Rabeprazol Teva-ratio if you are pregnant or if you think you may be pregnant.
• Do not take Rabeprazol Teva-ratio during breast-feeding or if you plan to start breast-feeding.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

You may feel drowsy while taking this medicine. If this happens, do not drive or use tools or machines.

Rabeprazol Teva-ratio contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult him before taking this medicine.

Rabeprazol Teva-ratio contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per gastro-resistant tablet, i.e., essentially “sodium-free”.

3. How to take Rabeprazol Teva-ratio

Follow the exact instructions for administration of this medicine as indicated by your doctor. Consult your doctor or pharmacist if you are unsure.

Taking this medicine

• Only remove a tablet from the blister when it is time to take your medicine.
• Swallow the tablet whole with a little water. Do not chew or crush the tablet.
• Your doctor will tell you the number of tablets to take and the length of your treatment, 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 “gastro-oesophageal reflux disease” (GORD)

Treatment of moderate to severe symptoms (symptomatic GORD)

• The recommended dose is one Rabeprazol Teva-ratio 10 mg gastro-resistant tablet once daily for up to 4 weeks.
• Take the tablet in the morning before eating.
• If your symptoms come back after 4 weeks of treatment, your doctor will tell you to take one Rabeprazol Teva-ratio 10 mg tablet when you need it.

Treatment of more severe symptoms (erosive or ulcerative GORD)

• 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 (GORD maintenance)

• The recommended dose is one Rabeprazol Teva-ratio 10 mg or 20 mg tablet once daily for as long as your doctor has told you.
• 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 daily 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 daily 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 daily for 7 days.
• Your doctor will also tell you to take antibiotics called amoxicillin and clarithromycin.

For more information on the other medicines used to treat H. pylori, read the package leaflet for each of them.

Zollinger-Ellison syndrome where there is too much acid in the stomach

• The recommended dose is three Rabeprazol Teva-ratio 20 mg tablets once daily to start with.
• 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 a review of your dose and symptoms.

Use in children

This medicine should not be given to children.

Patients with liver problems

Consult your doctor, who will take special care 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, talk 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 Toxicological Information Service, telephone 91-562 04 20, indicating the medicine and the amount taken.

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 normal. However, if it is almost time to take the next tablet, just skip the missed tablet and continue as normal.
• If you forget 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

Relief of symptoms normally occurs before the ulcer is completely healed. It is important that you do not stop treatment until your doctor tells you to.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Rabeprazol Teva-ratio can cause side effects, although not everybody gets them. Side effects are usually mild and improve without you having to stop taking the medicine.

Stop taking Rabeprazol Teva-ratio and see a doctor immediately if you notice any of the following serious side effects - you may need urgent medical attention:

• Allergic reactions - signs may include: sudden swelling of your face, difficulty breathing or low blood pressure which may cause dizziness or fainting.
• Frequent infections, such as sore throat or high temperature (fever), or mouth ulcers.
• Bruising or easy bruising.
• Yellowing of the skin or whites of the eyes (jaundice), dark urine and tiredness, which can be symptoms of liver problems.

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

• Severe skin blistering or peeling or mouth blisters.

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

Other possible side 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 intestines such as stomach pain, diarrhoea, gas (flatulence), feeling sick (nausea), being sick (vomiting) or constipation.
• Pains or back pain.
• Weakness or flu-like symptoms.
• Benign polyps in the stomach.

Uncommon (may affect up to 1 in 100 people)

• Feeling nervous or sleepy.
• Chest infection (bronchitis).
• Painful sinuses (sinusitis).
• Dry mouth.
• Indigestion or belching.
• Rash or redness of the skin.
• Muscle pain, leg pain or joint pain.
• Fracture of the hip, wrist or spine.
• Urinary tract infection (infection of the bladder).
• Chest pain.
• Chills or fever.
• Changes in liver function (shown in blood tests).

Rare (may affect up to 1 in 1,000 people)

• Lack of appetite (anorexia).
• Depression.
• Hypersensitivity (including allergic reactions).
• Vision problems.
• Inflamed mouth (stomatitis) or taste problems.
• Stomach problems or stomach pain.
• Liver problems including yellowing of the skin and the whites of the eyes (jaundice).
• Itchy rash or blisters.
• Sweating.
• Kidney problems.
• Weight increase.
• Changes in white blood cells (shown in blood tests) which can lead to frequent infections.
• Decrease in blood platelets which can lead to bleeding or bruising more easily than normal.
• Patient who have had previous liver problems may very rarely develop encephalopathy (brain disease).

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

• Swelling of the breasts in men.

• Fluid retention.
• Inflammation of the intestine (which can lead to diarrhoea).
• Low levels of sodium in the blood which can cause tiredness and confusion, muscle spasms, convulsions and coma.
• Skin rash, possibly with pain in the joints.

If you are taking rabeprazole for more than three months, it is possible that the levels of magnesium in your blood may fall. Low levels of magnesium can cause fatigue, muscle spasms, convulsions, dizziness, fast heart rate. If you experience any of these symptoms, go to your doctor immediately. Low levels of magnesium can also lead to a decrease in the levels of potassium and calcium in the blood. Your doctor may decide to perform regular blood tests to monitor your levels of magnesium.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Rabeprazol Teva-ratio

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

Store in the original package to protect from moisture.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Content and Additional Information

Composition of Rabeprazol Teva-ratio

• The active ingredient is sodium rabeprazole.

Each gastro-resistant tablet contains 20 mg of sodium rabeprazole.

• The other components (excipients) are:

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

Coating:

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

Printing ink:

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

Appearance of the Product and Container Content:

Rabeprazol Teva-ratio 20 mg gastro-resistant tablets are yellow, round tablets, printed on one side with black ink "93" and "64", and flat on the other side.

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

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder

Teva Pharma, S.L.U.

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 Last Revision of this Prospectus: October 2022

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