Omeprazole Tecnigen 20 mg gastro-resistant hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Omeprazol TecniGen 20 mg gastro-resistant hard capsules EFG

Omeprazole

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 questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you. It could 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.

Contents of the leaflet:

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

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

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

Omeprazol TecniGen 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 TecniGen can also be used to help prevent 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 TecniGen

Do not take Omeprazol TecniGen

• 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).

Do not take this medicine if any of the above situations apply to you. If you are unsure, talk to your doctor or pharmacist before taking Omeprazol TecniGen.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Omeprazol TecniGen.

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

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

• Unintentional weight loss and difficulty swallowing.

• Stomach pain or indigestion.

• New onset of vomiting food or vomiting 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 TecniGen 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 reduced urine volume or blood in the urine and/or hypersensitivity reactions such as fever, skin rash, and joint stiffness. You should report these signs to your treating doctor.

If you take Omeprazol TecniGen for a long period (more than 1 year), your doctor will likely perform periodic check-ups. You should report any new or unusual symptoms or circumstances during each visit.

Taking a proton pump inhibitor such as Omeprazol TecniGen, 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 TecniGen 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 despite the fact that it is not recommended. Do not give this medicine to children under 1 year of age or < 10 kg.

Taking Omeprazol TecniGen with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes medicines obtained without a prescription. Omeprazol TecniGen may affect how some medicines work, and some medicines may affect Omeprazol TecniGen.

Do not take Omeprazol TecniGen 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, posaconazole, or voriconazole (used to treat fungal infections)
• Digoxin (used to treat heart problems)
• Diazepam (used to treat anxiety, to 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 treatment with Omeprazol TecniGen
• 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 treatment with Omeprazol TecniGen
• 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 (chemotherapy medicine used in high doses to treat cancer) – if you are taking a high dose of methotrexate, your doctor will need to temporarily discontinue your treatment with Omeprazol TecniGen.

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

Omeprazol TecniGen with food and drink

See section 3.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. 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 TecniGen while breastfeeding.

Driving and using machines

Omeprazol TecniGen 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 TecniGen contains sucrose

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

Omeprazol TecniGen contains sodium

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

3. How to take Omeprazol TecniGen

Follow exactly the instructions for using Omeprazol TecniGen provided by your doctor or pharmacist. Consult your doctor or pharmacist if you have any doubts.

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

The recommended dose is:

Adults:

Treatment of symptoms of GERD (gastroesophageal reflux disease), such as heartburn and acid regurgitation:

• If your doctor confirms you have mild esophageal damage, 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 upper intestinal ulcers (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 does not fully heal, 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 does not fully heal, 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 TecniGen twice daily for one week.
• Your doctor will also instruct you to take two antibiotics from the following: amoxicillin, clarithromycin, and metronidazole.

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

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

Use in children and adolescents:

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

• Children over one year of age weighing more than 10 kg may take Omeprazol TecniGen. 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 TecniGen. The dose for children is based on body weight, and the doctor will determine the correct dose.
• The doctor will also prescribe two antibiotics for your child: amoxicillin and clarithromycin.

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 pour the contents into a glass of still water, acidic fruit juice (e.g., apple, orange, or pineapple juice), or apple puree.

• Always shake the mixture well just before drinking (the mixture will not be clear). 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 TecniGen than you should

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

If you forget to take Omeprazol TecniGen

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

If you stop taking Omeprazol TecniGen

Do not stop taking Omeprazol TecniGen without first consulting your doctor or pharmacist.

If you have any questions about the use of this medicine, consult 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 OmeprazolTecniGen and consult your doctor immediately:

• Sudden wheezing, swelling of the lips, tongue, 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 fever 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. (rare)

Other adverse effects include:

Common adverse effects (may affect up to 1 in 10 patients)

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

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

• 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 malaise and lack of energy

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

• Blood problems, such as decreased white blood cells or platelets. This may cause weakness or bruising and increase the likelihood 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 difficulty 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 (arthralgias) or muscle pain (myalgias)
• Serious kidney problems (interstitial nephritis)
• Increased sweating

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

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

Frequency not known (cannot be estimated from available data)

• Inflammation in the intestine (may cause diarrhoea)
• If you take Omeprazol TecniGen 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, inform your doctor immediately. Low magnesium levels may also lead to decreased potassium or 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, Omeprazol TecniGen 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 type of adverse effect, consult 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 Medicines at: www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Omeprazole TecniGen

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

Do not use this medicine after the expiry date stated on the packaging, vial, label, or blister after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30 °C.

Aluminium/aluminium blister: Keep in the original packaging to protect from moisture. HDPE vial: Keep the vial tightly closed to protect from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the Sigre Point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of OmeprazolTecniGen

• The active substance is omeprazole. Each capsule contains 20 mg of omeprazole.

• Capsule contents: sugar spheres (sucrose and maize starch), sodium lauryl sulfate, sodium hydrogen phosphate, mannitol, hypromellose, macrogol 6000, talc, polysorbate 80, titanium dioxide, methacrylic acid-ethyl acrylate copolymer (1:1).

• Capsule shell: gelatin. The 20 mg capsules also contain the colouring agents quinoline yellow (E 104) and titanium dioxide (E 171).

Appearance of the product and contents of the pack

Gastro-resistant hard capsule.

OmeprazolTecniGen 20 mg: opaque yellow capsule containing white-cream or almost white spherical microgranules.

Pack sizes:

Blister packs containing 7, 14, 15, 28, 30, 50, 56, and 60 capsules; hospital packs of 100, 140, 280 and 500 capsules.

HDPE plastic bottles containing 5, 7, 14, 28, 56, and 60 capsules; hospital pack with 500 capsules.

Only some pack sizes may be commercially available.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

TECNIMEDE ESPAÑA INDUSTRIA FARMACEUTICA, S.A.

Avda. de Bruselas, 13-3º D. Edificio América. Polígono Arroyo de la Vega.

28108 Alcobendas

Madrid. Spain

Manufacturer

LABORATORIOS LICONSA, S.A.

Av. Miralcampo, nº7, Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara)

SPAIN

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

“Detailed and up-to-date 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/