Omeprazole Almus 40 mg gastro-resistant hard capsules

Patient Information Leaflet

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Omeprazol Almus 40 mg gastro-resistant hard capsules

Read the entire leaflet carefully before you start taking 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 only; do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What is Omeprazol Almus and what is it used for?

Omeprazol Almus contains the active substance omeprazole. It belongs to a group of medicines known as "proton pump inhibitors". These medicines work by reducing the amount of acid produced by the stomach.

Omeprazole is used to treat the following conditions:

In adults:

• “Gastroesophageal reflux disease” (GERD). In this disorder, stomach acid flows back into the esophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
• Ulcers in the upper part of the intestine (duodenal ulcer) or in the stomach (gastric ulcer).
• Ulcers infected with a bacterium called "Helicobacter pylori". If you have this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.
• Ulcers caused by a group of medicines called NSAIDs (non-steroidal anti-inflammatory drugs). Omeprazol Almus can also be used to prevent the formation of ulcers if you are taking NSAIDs.
• Excess stomach acid caused by a tumor in the pancreas (Zollinger-Ellison syndrome).

In children:

Children over 1 year of age and ≥10 kg

• “Gastroesophageal reflux disease” (GERD). In this disorder, stomach acid flows back into the esophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn. In children, symptoms of the disease may include regurgitation of stomach contents into the mouth, vomiting, and inadequate weight gain.

Children over 4 years of age and adolescents

• Ulcers infected with a bacterium called "Helicobacter pylori". If your child has this condition, the doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

2. What you need to know before taking Omeprazol Almus

Do not take Omeprazol Almus

• if you are allergic to omeprazole or to any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to medicines containing proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole).
• if you are taking a medicine containing nelfinavir (used for HIV infection).

Warnings and precautions

Talk to your doctor or pharmacist before taking Omeprazol Almus.

Severe skin reactions have been reported with Omeprazol Almus treatment, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). Stop taking Omeprazol Almus and contact your doctor immediately if you experience any of these symptoms related to severe skin reactions described in section 4.

Omeprazole may mask symptoms of other diseases. Therefore, if you experience any of the following conditions before starting or during treatment with Omeprazol Almus, consult your doctor immediately:

• Unintentional weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting food or blood.
• Black stools (blood-stained faeces).
• Severe or persistent diarrhoea, as omeprazole has been associated with a slight increase in infectious diarrhoea.
• Severe liver problems.
• If you have ever had a skin reaction after treatment with a medicine similar to Omeprazol Almus used to reduce stomach acid.
• If you are scheduled to have a specific blood test (chromogranin A).

Kidney inflammation may occur while taking omeprazole. Signs and symptoms may include decreased urine volume or blood in the urine and/or hypersensitivity reactions such as fever, skin rash, and joint stiffness. Inform your treating doctor if you notice any of these signs.

If you take Omeprazol for a long period (more than 1 year), your doctor will likely schedule periodic check-ups. Report any new or unusual symptoms or circumstances during your visits.

Taking a proton pump inhibitor such as Omeprazol Almus, especially for more than one year, may slightly increase 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).

If you develop a skin rash, especially in areas of skin exposed to sunlight, consult your doctor as soon as possible, as treatment with Omeprazol Almus may need to be discontinued. Remember to mention any other symptoms you may notice, such as joint pain.

Children

Some children with chronic conditions may require long-term treatment, although this is not recommended. Do not give this medicine to children under 1 year of age or weighing <10 kg.

Taking Omeprazol Almus with other medicines

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. Omeprazole may affect how some medicines work, and some medicines may affect omeprazole.

Do not take Omeprazol if you are taking a medicine containing nelfinavir (used to treat HIV infection).

Inform your doctor or pharmacist if you are taking any of the following medicines:

• Ketoconazole, itraconazole, or voriconazole (used to treat fungal infections)
• Digoxin (used to treat heart problems)
• Diazepam (used to treat anxiety, relax muscles, or in epilepsy)
• Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when starting or stopping Omeprazol treatment
• Medicines used to prevent blood clots, such as warfarin or other vitamin K antagonists. Your doctor will need to monitor you when starting or stopping Omeprazol treatment
• Rifampicin (used to treat tuberculosis)
• Atazanavir (used to treat HIV infection)
• Tacrolimus (used in organ transplantation)
• St John's wort (Hypericum perforatum) (used to treat mild depression)
• Cilostazol (used to treat intermittent claudication)
• Saquinavir (used to treat HIV infection)
• Clopidogrel (used to prevent blood clots (thrombi))
• Erlotinib (used to treat cancer)
• Methotrexate (a chemotherapy medicine used in high doses to treat cancer) – if you are taking a high dose of methotrexate, your doctor will need to temporarily stop treatment with Omeprazol Almus

If your doctor has prescribed you the antibiotics amoxicillin and clarithromycin along with Omeprazol to treat ulcers caused by Helicobacter pylori infection, it is very important that you inform them about any other medicines you are taking.

Taking Omeprazol Almus with food and drink

You may take your capsules with food or on an empty stomach.

Pregnancy, breastfeeding, and fertility

Before taking Omeprazol, inform your doctor or pharmacist if you are pregnant or trying to become pregnant. Your doctor will decide whether you can take Omeprazol during this time.

Omeprazole passes into breast milk but is unlikely to affect the infant when therapeutic doses are used. Your doctor will decide whether you can take Omeprazol while breastfeeding.

Driving and using machines

Omeprazol is unlikely to affect your ability to drive or use tools or machines.

Adverse effects such as dizziness and visual disturbances may occur (see section 4). If these occur, you should not drive or use machines.

Omeprazol Almus contains sucrose

If your doctor has diagnosed you with an intolerance to certain sugars, consult with them before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per capsule; this is essentially “sodium-free”.

3. How to take Omeprazol Almus

Follow exactly the administration instructions for Omeprazol given by your doctor. If in doubt, consult your doctor or pharmacist again.

Your doctor will tell you how many capsules to take and for how long. This will depend on your condition and your age.

The usual doses are indicated below.

Adults:

Treatment of GERD symptoms, such as heartburn and acid regurgitation:

• If your doctor confirms you have mild damage to the esophagus, the usual dose is 20 mg once daily for 4–8 weeks. Your doctor may prescribe a dose of 40 mg for another 8 weeks if the esophagus has not yet healed.
• Once the esophagus has healed, the usual dose is 10 mg once daily.
• If you do not have esophageal damage, the usual dose is 10 mg once daily.

Treatment of intestinal ulcers in the upper part of the gut (duodenal ulcer):

• The usual dose is 20 mg once daily for 2 weeks. Your doctor may prescribe the same dose for another 2 weeks if the ulcer has not yet healed.
• If the ulcer has not completely healed, the dose may be increased to 40 mg once daily for 4 weeks.

Treatment of stomach ulcers (gastric ulcer):

• The usual dose is 20 mg once daily for 4 weeks. Your doctor may prescribe the same dose for another 4 weeks if the ulcer has not yet healed.
• If the ulcer has not completely healed, the dose may be increased to 40 mg once daily for 8 weeks.

Prevention of recurrence of stomach and duodenal ulcers:

• The usual dose is 10 mg or 20 mg once daily. Your doctor may increase the dose to 40 mg once daily.

Treatment of stomach and duodenal ulcers caused by NSAIDs (non-steroidal anti-inflammatory drugs):

• The usual dose is 20 mg once daily for 4–8 weeks.

Prevention of stomach and duodenal ulcers during NSAID treatment:

• The usual dose is 20 mg once daily.

Treatment of ulcers caused by Helicobacter pylori infection and prevention of their recurrence:

• The usual dose is 20 mg of Omeprazol twice daily for one week.
• Your doctor will also instruct you to take two of the following antibiotics: amoxicillin, clarithromycin, and metronidazole.

Treatment of excess stomach acid caused by a pancreatic tumor (Zollinger-Ellison syndrome):

• The usual dose is 60 mg per day.
• Your doctor will adjust the dose according to your needs and will decide how long you should take the medicine.

Use in children and adolescents:

Treatment of GERD symptoms, such as heartburn and acid regurgitation:

• Children over one year of age weighing more than 10 kg may take Omeprazol. The dose for children is based on body weight, and the doctor will determine the correct dose.

Treatment of ulcers caused by Helicobacter pylori infection and prevention of their recurrence:

• Children over 4 years of age may take Omeprazol. The dose for children is based on body weight, and the doctor will determine the correct dose.
• Your doctor will also prescribe two antibiotics, amoxicillin and clarithromycin, for your child.

How to take this medicine

• It is recommended to take the capsules in the morning.
• You may take your capsules with food or on an empty stomach.
• Swallow the capsules whole with half a glass of water. Do not chew or crush the capsules, as they contain coated granules that prevent the medicine from breaking down due to stomach acid. It is important not to damage the granules.

What to do if you or your child have difficulty swallowing the capsules

• If you or your child have difficulty swallowing the capsules:

• Open the capsule and swallow the contents directly with half a glass of water, or mix the contents with a small amount of yogurt, acidic fruit juice (e.g., apple, orange, or pineapple), or apple puree.

• Always shake the mixture just before drinking (the mixture will not be transparent). Then drink the mixture immediately or within 30 minutes.

• To ensure you have taken all the medicine, fill the glass halfway with water, swirl it well, and drink the water. The solid particles contain the medicine; do not chew or crush them.

If you take more Omeprazol Almus than you should

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 Omeprazol Almus

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose. Do not take a double dose to make up for forgotten doses.

If you stop taking Omeprazol Almus

Do not stop treatment with Omeprazol Almus without first speaking to your doctor or pharmacist.

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 will experience them.

If you notice any of the following rare (may affect up to 1 in 1,000 people) or very rare (may affect up to 1 in 10,000 people) but serious side effects, stop taking Omeprazol Almus and consult your doctor immediately:

• Sudden wheezing, swelling of the lips, tongue or throat, or body, skin rash, fainting or difficulty swallowing (severe allergic reaction). (rare)
• Reddening of the skin with blistering or peeling. Severe blisters and bleeding in the lips, eyes, mouth, nose, and genitals may also occur. This could be “Stevens-Johnson syndrome” or “toxic epidermal necrolysis”. (very rare)
• Widespread rash, high temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). (rare)
• A widespread red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis). (rare)
• Yellowing of the skin, dark urine, and fatigue, which may be symptoms of liver problems.

Other adverse effects include:

Frequent adverse effects (may affect up to 1 in 10 people)

• Headache.
• Stomach or intestinal effects: diarrhoea, stomach pain, constipation, and gas (flatulence).
• Nausea or vomiting.
• Benign stomach polyps.

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

• Swelling of the feet and ankles.
• Sleep disorders (insomnia).
• Dizziness, tingling sensation, drowsiness.
• Sensation of spinning (vertigo).
• Abnormalities in blood tests used to monitor liver function.
• Skin rash, hives, and itching.
• General feeling of discomfort and lack of energy.

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

• Blood disorders, such as reduced white blood cells or platelets. This may cause weakness, bruising, and increase the risk of infections.
• Low sodium levels in the blood. This may cause weakness, vomiting, and cramps.
• Restlessness, confusion, or depression.
• Taste disturbances.
• Vision problems, such as blurred vision.
• Sudden sensation of difficult breathing (bronchospasm).
• Dry mouth.
• Inflammation inside the mouth.
• Fungal infection called “candidiasis” that may affect the intestine.
• Hair loss (alopecia).
• Skin rash upon exposure to sunlight.
• Joint pain (arthralgia) or muscle pain (myalgia).
• Serious kidney problems (interstitial nephritis).
• Increased sweating.

Very rare adverse effects (may affect up to 1 in 10,000 people)

• Blood count abnormalities, such as agranulocytosis (lack of white blood cells).
• Aggressiveness.
• Seeing, feeling, or hearing things that are not real (hallucinations).
• Severe liver problems leading to liver failure and brain inflammation.
• Erythema multiforme. Muscle weakness.
• Enlargement of the breasts in males.

Adverse effects with unknown frequency (cannot be estimated from available data)

• Inflammation of the intestine (causing diarrhoea).
• If you are taking Omeprazol Almus 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 decreased potassium and calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.
• Skin rash, possibly with joint pain.

In very rare cases, Omeprazole may affect white blood cells and cause immunodeficiency. If you develop an infection with symptoms such as fever with a very poor general condition, or fever with signs of local infection such as neck, throat or mouth pain, or difficulty urinating, you should consult your doctor as soon as possible for a blood test to rule out a deficiency in white blood cells (agranulocytosis). It is important that you inform your doctor about any medication you are taking at that time.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is an effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: Website: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Omeprazol Almus

• Keep out of the sight and reach of children.

• Do not use Omeprazol after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated. HDPE bottle: Use within 3 months after opening.

• Store below 25 ºC.

• Keep this blister pack in the original packaging or keep the bottle tightly closed to protect it from moisture. Replace the cap firmly after each use.

• Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point located at your usual pharmacy. 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 Omeprazol Almus

• The active substance is omeprazole. Omeprazol Almus capsules contain 40 mg of omeprazole.

• The other components are:

  • Capsule contents: sugar spheres (composed of corn starch and sucrose), sodium lauryl sulfate, disodium phosphate, mannitol, hypromellose 6 cP, macrogol 6000, talc, polysorbate 80, titanium dioxide (E 171), and methacrylic acid-ethyl acrylate copolymer (1:1).
  • Capsule shell: gelatin, indigo carmine (E 132), and titanium dioxide (E 171).

Appearance of the product and contents of the pack

Opaque blue and white capsule containing spherical off-white or almost white microgranules.

Pack sizes:

Blister packs of 7, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100 or 140 capsules; hospital pack of 280 or 500 capsules.

HDPE bottles of 5, 7, 14, 15, 28, 30, 50, 56, 60, 90 or 100 capsules.

Only certain pack sizes may be commercially available.

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.

Av. Miralcampo, Nº 7, Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara)

SPAIN

This medicinal product is authorized in the Member States of the European Economic Area

with the following names:

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

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