RABEPRAZOL TECNIGEN 20 mg GASTRO-RESISTANT TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Rabeprazol TecniGen 20 mg gastro-resistant tablets EFG

Rabeprazol sodium

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.

Contents of the pack:

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

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

Rabeprazol TecniGen contains the active substance rabeprazol sodium. Rabeprazol 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 is used for the treatment of:

• “Gastroesophageal reflux disease” (GERD), which may include the occurrence of

acidity. The cause of GERD is the passage of acid and food from the stomach into the

esophagus.

• 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 need

to take antibiotics. By taking Rabeprazol TecniGen and antibiotics together, the infection

will be eradicated 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.

2. What you need to know before you take Rabeprazol TecniGen

Do not take Rabeprazol TecniGen

• If you are allergic to rabeprazol sodium or any of the other ingredients of Rabeprazol TecniGen (listed in section 6).
• If you are pregnant or think you may be pregnant.
• If you are breast-feeding.

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

See also the section on Pregnancy and breast-feeding.

Children

It should not be given to children.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Rabeprazol TecniGen:

• If you are allergic to proton pump inhibitors or “substituted benzimidazoles”.

If liver and blood problems have been seen in some patients but often improve when treatment with Rabeprazol TecniGen is stopped.

• If you have a stomach tumor.
• If you have ever had liver problems.
• If you are taking atazanavir, a medicine used to treat HIV.
• If you have ever had a skin reaction after treatment with a medicine similar to Rabeprazol TecniGen to reduce stomach acid.
• If you are scheduled to have a specific blood test (Chromogranin A)

If you get a skin rash, especially in areas of skin exposed to the sun, consult your doctor as soon as possible, as it may be necessary to stop treatment with Rabeprazol TecniGen. Remember to mention any other symptoms that you may notice, such as joint pain.

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

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

During treatment with rabeprazol, kidney inflammation may occur. The signs and symptoms include: decreased urine output 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.

Use of Rabeprazol TecniGen with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including herbal medicines.

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

• Ketoconazole or itraconazole, medicines for fungal infections. Rabeprazol 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. Rabeprazol may decrease the amount of this type of medicine in the blood, so they should not be used together.

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

Pregnancy, breast-feeding, and fertility

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

Consult your doctor or pharmacist before using any medicine during pregnancy or breast-feeding.

Driving and using machines

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

Warnings about excipients:

It may produce a mild laxative effect because it contains mannitol.

3. How to take Rabeprazol TecniGen

Follow the instructions for administration of Rabeprazol TecniGen indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

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 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 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 TecniGen 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 TecniGen 10 mg tablet as needed (“on demand”).

Treatment of more severe symptoms (erosive or ulcerative GERD)

• The recommended dose is one Rabeprazol TecniGen 20 mg tablet once a day for 4 to 8 weeks.
• Take the tablet in the morning before eating.

Long-term treatment of symptoms (maintenance GERD)

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

For ulcers of the intestine (duodenal ulcers)

• The recommended dose is one Rabeprazol TecniGen 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 TecniGen for another 4 weeks if your symptoms do not improve.

For ulcers caused by H. Pylori infection and to prevent relapse

• The recommended dose is one Rabeprazol TecniGen 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 the other medicines used to treat H. pylori, read the package leaflet of each of them.

Zollinger-Ellison syndrome where there is an excess of acid in the stomach

• The recommended dose is three Rabeprazol TecniGen 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 and symptom review.

Use in children.It should not be given to children.

Patient with liver problems.Consult your doctor, who will take special care when starting and during treatment with Rabeprazol TecniGen.

If you take more Rabeprazol TecniGen than you should

If you take more Rabeprazol TecniGen 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 the Toxicology Information Service (Telephone: 91 5620420).

If you forget to take Rabeprazol TecniGen

• If you forget to take a tablet, as soon as you remember, take one 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 medicine for more than 5 days, consult your doctor before taking more medicine.
• Do not take a double dose (two doses at the same time) to make up for the missed dose.

If you stop taking Rabeprazol TecniGen

Relief of symptoms usually occurs before the ulcer has 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 TecniGen can cause side effects, although not everybody gets them.

Side effects are usually mild and improve without you stopping treatment.

Stop taking Rabeprazol TecniGen and see your doctor immediately if you notice any of the following side effects - you may need urgent medical treatment:

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

These side effects are rare (affect less than 1 in 1,000 people).

• Severe skin blisters or rashes, or ulcers in your mouth and throat.

These side effects are very rare (affect less than 1 in 10,000 people).

Other possible side effects:

Common (affect less than 1 in 10 people)

• Infections.
• Difficulty sleeping.
• Headache or dizziness.
• Cough, runny nose, or sore throat (pharyngitis).
• Effects on your stomach or intestine such as stomach pain, diarrhea, gas (flatulence), feeling sick (nausea), being sick (vomiting), or constipation.
• Pain or back pain.
• Weakness or flu-like symptoms.
• Benign stomach polyps

Uncommon (affect less than 1 in 100 people)

• Feeling nervous or drowsy.
• Chest infection (bronchitis).
• Sinusitis.
• Dry mouth.
• Indigestion or belching.
• Skin rash or redness.
• Muscle pain, leg pain, or joint pain.
• Urinary tract infection (urinary tract infection).
• Chest pain.
• Chills or fever.
• Changes in liver function (shown in blood tests).
• If you are taking proton pump inhibitors like Rabeprazol TecniGen, especially for more than a year, you may have a slightly increased risk of hip, wrist, and spine fractures. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

Rare (affect less than 1 in 1,000 people)

• Lack of appetite (anorexia).
• Depression.
• Hypersensitivity (including allergic reactions).
• Visual disturbances.
• Inflamed mouth (stomatitis) or taste disorders.
• Stomach disorder or stomach pain.
• Liver problems including yellowing of the skin and whites of the eyes (jaundice).
• Itchy rash or blisters.
• Sweating.
• Kidney problems.
• Weight gain.
• Changes in white blood cells (shown in blood tests) that can cause frequent infections.
• Decrease in blood platelets that can cause bleeding or bruising more easily than normal.

Other possible side effects (frequency not known)

• Breast swelling in men.
• Fluid retention.
• Low sodium levels in the blood that can cause tiredness and confusion, muscle spasms, convulsions, and coma.
• Patients who have previously had liver problems may very rarely develop encephalopathy (brain disease).
• If you are taking Rabeprazol TecniGen for more than three months, it is possible that your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you have any of these symptoms, see your doctor immediately. Low magnesium levels can also cause a decrease in blood potassium and calcium levels. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.
• Skin rash, possibly with joint pain.
• Inflammation of the intestine (leading to diarrhea)

Do not worry about the list of side effects. You may not experience any of them.

If you experience side effects, consult your doctor or pharmacist, even if it is a side effect not listed in this leaflet.

5. Storage of Rabeprazol TecniGen

Keep out of sight and reach of children.

Do not store above 30 ºC.

Do not refrigerate.

Do not use Rabeprazol TecniGen after the expiration date stated on the packaging and on the blister after EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and medicines you no longer need in the SIGRE Collection Point (or any other pharmaceutical waste collection system) at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Rabeprazol TecniGen

-The active substance is rabeprazol sodium. Each Rabeprazol TecniGen tablet contains 10 milligrams of rabeprazol sodium as the active substance

-The other ingredients (excipients) are: Core: mannitol, trisodium phosphate, magnesium oxide, hydroxypropylmethylcellulose, low-substituted hydroxypropylcellulose, crospovidone, colloidal silicon dioxide, magnesium stearate. Coating; ethylcellulose, magnesium oxide, Eudragit L100 55, triethyl citrate, talc, titanium dioxide (E171), red iron oxide (E 172).

Appearance of the product and packaging contents

Rabeprazol TecniGen 10 mg gastro-resistant tablets are presented as pink, biconvex, round tablets without scoring in packs of 28 tablets.

Other presentations:

Rabeprazol TecniGen 20 mg gastro-resistant tablets: packs of 14 and 28 tablets.

Marketing authorization holder and manufacturer:

Marketing authorization holder

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, nº 13. 3ºD

28108 - Alcobendas (Madrid)

Manufacturer:

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid

This leaflet was approved in September 2022.

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