Rabeprazole Almus 20 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Rabeprazol Almus 20 mg gastro-resistant tablets EFG

Rabeprazole sodium

Read the entire leaflet carefully before you start taking this medicine, because 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 only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet.

Leaflet contents:

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

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

Rabeprazol Almus belongs to a class of medicines known as "Proton Pump Inhibitors" (PPIs), which work by reducing the amount of acid produced by the stomach. This prevents irritation of the stomach lining, allowing gastric ulcers to heal and relieving the pain and discomfort caused by ulcers.

Rabeprazol Almus is used for the treatment of:

• Gastro-oesophageal reflux disease (GORD), which may include heartburn. GORD is caused by the backflow of acid and food from the stomach into the oesophagus.
• 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), you will need to take antibiotics. Taking Rabeprazol Almus together with antibiotics will eliminate the infection and allow the ulcer to heal. It will also prevent recurrence of the infection and ulcer.
• 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 Almus

Do not take Rabeprazol Almus:

• if you are allergic (hypersensitive) to sodium rabeprazole or to any of the other excipients in this medicine (see list in section 6)
• if you are pregnant or think you may be pregnant
• if you are breastfeeding

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Rabeprazol Almus:

• if you are allergic to proton pump inhibitors or to "substituted benzimidazoles"
• if liver or blood problems have been observed in some patients, which often improve when treatment with Rabeprazol Almus 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 low body reserves or risk factors associated with low vitamin B12 levels and are receiving long-term treatment with sodium rabeprazole. Like all agents that reduce acidity, sodium rabeprazole may lead to reduced absorption of vitamin B12
• if you have ever had a skin reaction after treatment with a medicine similar to Rabeprazol Almus used to reduce 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 Almus. Remember to mention any other symptoms you may notice, such as joint pain
• if you are scheduled to have a specific blood test (chromogranin A)
• 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 must report these signs to your doctor.

If you are unsure whether any of the above apply to you, consult your doctor or pharmacist before taking Rabeprazol Almus.

Children

Rabeprazol Almus must not be given to children.

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

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

Taking Rabeprazol Almus with other medicines

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

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

• Ketoconazole or itraconazole, medicines used to treat fungal infections. Rabeprazol Almus may decrease the blood levels of these medicines. Your doctor may need to adjust your dose.
• Atazanavir, a medicine used to treat HIV infection. Rabeprazol Almus 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 Rabeprazol Almus.

If you are unsure whether any of the above apply to you, consult your doctor or pharmacist before taking Rabeprazol Almus.

Pregnancy, breastfeeding, and fertility

Do not take Rabeprazol Almus if you are pregnant or planning to become pregnant.

Do not take Rabeprazol Almus if you are 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 Rabeprazol Almus. If this occurs, do not drive or operate tools or machinery.

Rabeprazol Almus contains sodium

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

3. How to take Rabeprazol Almus

Follow exactly the instructions for using Rabeprazol Almus as given by your doctor. If in doubt, consult your doctor or pharmacist again.

How to take this medicine

• Only remove one tablet from the blister when it is time to take your medicine.
• Swallow the tablet whole with some water. Do not crush or chew the tablet.
• Your doctor will tell you how many tablets to take and how long your treatment should last, depending on your condition.
• If you are taking this medicine for a long time, your doctor will want to monitor you regularly.

Adults and elderly patients

For gastroesophageal reflux disease (GERD)

Treatment of moderate to severe symptoms (symptomatic GERD)

• The usual dose is one Rabeprazol Almus 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 may instruct you to take one Rabeprazol Almus 10 mg tablet as needed (“on-demand”).

Treatment of more severe symptoms (erosive or ulcerative GERD)

• The usual dose is one Rabeprazol Almus 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 usual dose is one Rabeprazol Almus 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 monitor your symptoms and dosage.

For stomach ulcers (peptic ulcers)

• The usual dose is one Rabeprazol Almus 20 mg tablet once daily for 6 weeks.
• Take the tablet in the morning before eating.
• Your doctor may instruct you to continue taking Rabeprazol Almus for another 6 weeks if your symptoms have not improved.

For intestinal ulcers (duodenal ulcers)

• The usual dose is one Rabeprazol Almus 20 mg tablet once daily for 4 weeks.
• Take the tablet in the morning before eating.
• Your doctor may instruct you to continue taking Rabeprazol Almus for another 4 weeks if your symptoms have not improved.

For ulcers caused by H. pylori infection and to prevent relapses

• The usual dose is one Rabeprazol Almus 20 mg tablet twice daily for seven 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 usual starting dose is three Rabeprazol Almus 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.

Patients with liver problems. Consult your doctor, who will exercise special caution when starting and during treatment with Rabeprazol Almus.

If you take more Rabeprazol Almus than you should

If you take more Rabeprazol Almus than prescribed, speak to your doctor or go to a hospital immediately. Take the medicine with you.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at: 91 562 04 20 (indicating the medicine and the amount ingested).

If you forget to take Rabeprazol Almus

If you forget to take a tablet, take one as soon as you remember, then continue as normal. However, if it is almost time for your next dose, skip the missed dose and continue with your regular schedule.

If you have missed taking your medicine for more than 5 days, consult your doctor before taking any further 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 Almus

Symptom relief usually occurs before the ulcer has completely healed. Therefore, it is important not to stop treatment with Rabeprazol Almus unless 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, this medicine can cause adverse effects, although not everyone experiences them.

Adverse effects are usually mild and improve without you needing to stop treatment.

Stop taking Rabeprazol Almus 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 your 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 increased tendency to bleed.

These adverse effects are rare (affect fewer than 1 in 1,000 people).

• Severe blistering of the skin, or sores or ulcers in your mouth or throat.

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

Other possible adverse effects:

Frequent (affect fewer than 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 (pseudoinfluenza symptoms)
• Benign polyps in the stomach

Uncommon (affect fewer than 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
• Fractures of the hip, wrist, or spine
• Bladder infection (urinary tract infection)
• Chest pain
• Chills or fever
• Changes in liver function (shown in blood tests)

Rare (affect fewer than 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
• Decreased blood platelets which may cause bleeding or bruising more easily than normal

Other possible adverse effects (frequency not known)

• Breast enlargement in men
• Fluid retention
• Inflammation of the bowel (leading to diarrhoea)
• Low levels of sodium in the blood which may cause tiredness and confusion, muscle spasms, seizures, and coma
• Patients who have previously had liver problems may very rarely develop encephalopathy (a brain disorder)
• Skin rash, possibly with joint pain

If you are taking Rabeprazol Almus for more than three months, magnesium levels in your blood 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, please inform your doctor immediately. Low magnesium levels may also lead to decreased levels of potassium and calcium in the blood. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.

Do not be alarmed by this list of adverse effects. You may not experience any of them.

Reporting of adverse effects

If you experience any 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 Pharmacovigilance System for Human Medicinal Products: http://www.notificaram.es/. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Rabeprazol Almus

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

Do not use Rabeprazol Almus after the expiry date stated on the packaging. The expiry date is the last day of the month indicated.

Do not store above 25 °C. Keep in the original packaging to protect from moisture.

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

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE Point located at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.

6. Contents of the pack and other information

Composition of Rabeprazol Almus

The active substance is sodium rabeprazole.

Each Rabeprazol Almus 20 mg tablet contains 20 mg of sodium rabeprazole.

The other components are:

Tablet core: mannitol, magnesium oxide, hydroxypropylcellulose, magnesium stearate.

Subcoating: ethylcellulose, magnesium oxide.

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

Appearance of the product and contents of the pack

Yellow, biconvex, enteric-coated tablets.

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

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Telephone: 93 739 71 80

Email: [email protected]

Manufacturer:

Laboratorios LICONSA, S.A.

Avda. Miralcampo, Nº7, Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara)

Spain

Date of the most recent review of this leaflet: November 2023

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