RABEPRAZOL KERN PHARMA 20 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the Patient

Rabeprazole Kern Pharma 20 mg Gastro-Resistant Tablets EFG

Rabeprazole 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. See section 4.

Contents of the pack:

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

1. What is Rabeprazole Kern Pharma and what is it used for

Rabeprazole Kern Pharma contains the active substance rabeprazole sodium. It belongs to a group of medicines called “Proton Pump Inhibitors” (PPIs).

These work by reducing the amount of acid produced by the stomach.

Rabeprazole Kern Pharma tablets are used to treat the following conditions:

• "Gastro-oesophageal reflux disease" (GORD), which can include heartburn. GORD is when acid and food from the stomach escape up into the oesophagus (food pipe).
• Ulcers in the stomach or in the upper part of the intestine. If these ulcers are infected with a bacteria called "Helicobacter pylori" (H. Pylori), you will also be given antibiotics. Using Rabeprazole Kern Pharma tablets and antibiotics together gets rid of the infection and heals the ulcer. It also stops the infection and ulcer coming back.
• Zollinger-Ellison syndrome, where your stomach produces too much acid.

You should consult your doctor if you do not feel better or worsen.

2. What you need to know before you take Rabeprazole Kern Pharma

Do not take Rabeprazole Kern Pharma:

• If you are allergic (hypersensitive) to rabeprazole sodium 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 use rabeprazole if you are in any of the above situations. If you are not sure, talk to your doctor or pharmacist before using rabeprazole.

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Rabeprazole Kern Pharma.

• If you are allergic to proton pump inhibitors or to “substituted benzimidazoles”. Blood and liver problems have been seen in some patients but often get better when you stop taking rabeprazole.
• You have a stomach tumour.
• If you have severe liver disease.
• If you are taking a medicine called atazanavir (for HIV infection);
• If you have reduced body stores or risk factors for low vitamin B12 and are taking long-term treatment with rabeprazole sodium. Like all acid-reducing agents, rabeprazole sodium may lead to a reduced absorption of vitamin B12.
• If you have ever had a skin reaction after treatment with a medicine similar to rabeprazole to reduce stomach acid.
• If you get a rash on your skin, especially in areas exposed to the sun, tell your doctor as soon as possible, as you may need to stop treatment with Rabeprazole Kern Pharma. Also, remember to mention any other side-effects like joint pain.
• If you are due to have a specific blood test (Chromogranin A).
• 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 pain stiffness. You should inform your doctor of these signs.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using rabeprazole.

Children

Rabeprazole Kern Pharma is not recommended for children.

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

Taking a proton pump inhibitor like Rabeprazole, especially over a period of more than one year, may slightly increase your risk of fracture of the hip, wrist or spine. Consult your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

Taking Rabeprazole Kern Pharma with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that you have bought without a prescription, including herbal medicines.

• Ketoconazole or itraconazole (used to treat fungal infections). Rabeprazole may increase the amount of this type of medicine in your blood. Your doctor may need to adjust your dose.
• Atazanavir (used to treat HIV infection). Rabeprazole may decrease the amount of this type of medicine in your blood and they should not be used together.
• Methotrexate (a chemotherapy medicine used at high doses to treat cancer and rheumatoid arthritis) – if you are taking high doses of methotrexate, your doctor may temporarily stop your treatment with rabeprazol.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using rabeprazole.

Pregnancy, breast-feeding and fertility

• Do not use rabeprazole if you are pregnant or think you may be pregnant.
• Do not use rabeprazole if you are breast-feeding or planning to breast-feed.

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 rabeprazole. If this happens, do not drive or use tools or machines.

Rabeprazole Kern Pharma 20 mg gastro-resistant tablets contain sodium:

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

3. How to take Rabeprazole Kern Pharma

Follow the instructions for administration of this medicine exactly as told by your doctor or pharmacist. 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 tablets whole with a glass of water. Do not chew or crush the tablets.
• Your doctor will tell you how many tablets to take and for how long. This will depend on your condition.
• If you are taking this medicine for a long time, your doctor will want to check you regularly.

Adults and the elderly:

The following doses are usually recommended for adults and the elderly. Do not change the dose or duration of treatment yourself.

For "gastro-oesophageal reflux disease" (GORD)

Treatment of moderate to severe symptoms (symptomatic GORD)

• The usual dose is one 10 mg rabeprazole tablet once a day for up to 4 weeks.
• Take the tablet in the morning before eating.
• If your condition returns after 4 weeks of treatment, your doctor may tell you to take one 10 mg rabeprazole tablet when you need it.

Treatment of more severe symptoms (erosive or ulcerative GORD)

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

Long-term treatment of symptoms (maintenance of GORD)

• The usual dose is one 10 mg or 20 mg rabeprazole tablet once a day for as long as your doctor tells 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 usual dose is one 20 mg rabeprazole tablet once a day for 6 weeks.
• Take the tablet in the morning before eating.
• Your doctor may tell you to take rabeprazole for another 6 weeks if your condition does not improve.

For duodenal ulcers

• The usual dose is one 20 mg rabeprazole tablet once a day for 4 weeks.
• Take the tablet in the morning before eating.
• Your doctor may tell you to take rabeprazole for another 4 weeks if your condition does not improve.

For ulcers caused by H. Pylori infection and to stop them coming back

• The usual dose is one 20 mg rabeprazole 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, see the individual package leaflets.

Zollinger-Ellison syndrome where the stomach produces too much acid

• The usual dose is three 20 mg rabeprazole tablets once a day to start with.
• Your doctor may adjust your dose depending on how you respond to treatment.

If you are on long-term treatment, you will need to go for regular check-ups with your doctor to review your tablets and symptoms.

Patients with liver problems. You should consult your doctor, who will take special care when starting treatment with rabeprazole and while you are being treated with rabeprazole.

If you take more Rabeprazole Kern Pharma than you should

Do not take more tablets per day than prescribed. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20 (indicating the medicine and the amount taken).

If you forget to take Rabeprazole Kern Pharma

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 for your next dose, skip the missed tablet and continue as usual.

If you forget to take your medicine for more than 5 days, call your doctor before taking any more medicine.

Do not take a double dose (two tablets at the same time) to make up for missed doses.

If you stop taking Rabeprazole Kern Pharma

Relief of symptoms will usually occur before the ulcer has healed completely. It is important that you do not stop taking the tablets 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, this medicine can cause side effects, although not everybody gets them.

Side effects are usually mild and improve without you having to stop taking this medicine.

Stop taking rabeprazole 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: swelling of the face, difficulty breathing or low blood pressure which may cause dizziness or fainting
• Frequent infections, such as sore throat or high temperature (fever), or ulcers in the mouth or throat.
• Bruising or bleeding more easily.

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

• Severe skin blistering or skin rash, pain or ulcers in the mouth and throat.

Other possible side effects:

Common side effects(may affect up to 1 in 10 people):

• Infection
• Difficulty sleeping
• Headache or dizziness.
• Cough, runny nose or sore throat (pharyngitis)
• Effects on your stomach or intestines such as stomach pain, diarrhoea, wind (flatulence), feeling sick (nausea), vomiting or constipation.
• Back pain or pain

• Weakness or flu-like syndromeBenign polyps in the stomach

Uncommon side effects(may affect up to 1 in 100 people):

• Feeling anxious or depressed
• Chest infection (bronchitis)
• Painful sinuses (sinusitis)
• Dry mouth
• Indigestion or belching.
• Redness of the skin or rash
• Muscle pain in the legs or joints
• Fractures of the hip, wrist and spine.
• Urinary tract infection (infection of the urine system)
• Chest pain
• Chills, fever

Changes in how your liver is working (shown in blood tests).

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

• Lack of appetite (anorexia)
  • Depression
  • Hypersensitivity (including allergic reactions)
  • Changes in vision
  • Mouth pain (stomatitis) or changes in taste
  • Stomach upset or stomach pain
  • Liver problems including yellowing of the skin and the whites of the eyes (jaundice).
  • Itchy skin rash or blistering of the skin
  • Sweating
  • Kidney problems
  • Weight increase
  • Changes in white blood cells (shown in blood tests) which can lead to frequent infections.

Reduction in the number of blood platelets, which can result in bleeding or bruising more easily than normal.

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

• Swelling of the breasts in men
• Fluid retention
• Inflammation of the intestine (leading to diarrhoea)
• Low levels of sodium in the blood which can cause tiredness and confusion, muscle cramps, convulsions and coma.
• Prior liver disease patients may very rarely develop encephalopathy (a brain disease) "
• 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 magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you experience any of these symptoms, please contact your doctor promptly. Low magnesium levels can also lead to a reduction 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.

Do not worry about this list of side effects. You may not get any of them.

Reporting of side effects

If you get 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 Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Rabeprazole Kern Pharma

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

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

Do not store above 25°C. Store in the original package.

Do not use this medicine if you notice the packaging is damaged or shows signs of tampering.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Container Content and Additional Information

Composition of Rabeprazol Kern Pharma

The active ingredient is sodium rabeprazole.

Each Rabeprazol Kern Pharma 20 mg gastro-resistant tablet contains 20 mg of sodium rabeprazole, equivalent to 18.85 mg of rabeprazole.

The other components are:

Core of the tablet:mannitol (E421), heavy magnesium oxide (E530), hydroxypropylcellulose (E463), magnesium stearate (E572).

Subcoating:ethylcellulose (E462), heavy magnesium oxide (E530).

Enteric coating:hypromellose phthalate, dibutyl sebacate, yellow iron oxide (E172), titanium dioxide (E171), talc.

Appearance of the Product and Container Content

Gastro-resistant (coated) tablets of yellow color, biconvex.

The containers contain aluminum blister strips of 1, 5, 7, 14, 15, 25, 28, 30, 50, 56, 75, 98, and 120 tablets.

Not all presentations may be marketed.

Marketing Authorization Holder:

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer:

Laboratorios LICONSA, S.A.

Avda. Miralcampo, Nº7, Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara)

Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the Last Revision of this Leaflet: June 2021

Detailed and updated 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/