Omeprazol Teva

Package Leaflet: Information for the Patient

Omeprazole Teva, 20 mg, Gastro-Resistant Capsules, Hard

Omeprazolum

Read the Package Leaflet Carefully Before Taking the Medication Because it Contains Important Information for the Patient.

Keep this package 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet:

• 1.What is Omeprazole Teva and What is it Used For
• 2.Important Information Before Taking Omeprazole Teva
• 3.How to Take Omeprazole Teva
• 4.Possible Side Effects
• 5.How to Store Omeprazole Teva
• 6.Contents of the Package and Other Information

1. What is Omeprazole Teva and What is it Used For

Omeprazole Teva contains the active substance omeprazole, which belongs to a group of medicines called proton pump inhibitors. Their action is to reduce the production of stomach acid.

Using Omeprazole Teva:

Omeprazole Teva is used to treat the following diseases and disorders: In adults: Gastro-oesophageal reflux disease (GORD). This is when stomach acid flows back into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.

• Ulcers in the upper part of the small intestine (duodenal ulcers) or stomach (gastric ulcers).
• Ulcers caused by bacteria called Helicobacter pylori. In this case, the doctor may also prescribe antibiotics to treat the infection and allow the ulcers to heal.
• Ulcers caused by drugs called non-steroidal anti-inflammatory drugs (NSAIDs). Omeprazole Teva can also be used to prevent ulcers when taking NSAIDs.
• Too much acid in the stomach due to a growth in the pancreas (Zollinger-Ellison syndrome).

In children: Children over 1 year of age and ≥ 10 kg body weight

• Gastro-oesophageal reflux disease (GORD). This is when stomach acid flows back into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn. In children, symptoms of this disorder may include reflux of stomach contents into the mouth, vomiting, and poor weight gain.

Children and adolescents over 4 years of age

• Ulcers caused by bacteria called Helicobacter pylori. If the child has this disease, the doctor may also prescribe antibiotics to treat the infection and allow the ulcers to heal.

2. Important Information Before Taking Omeprazole Teva

When Not to Take Omeprazole Teva

If you are allergic to omeprazole or any of the other ingredients of this medicine (listed in section 6)

• If you have ever had an allergic reaction to other proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole); If you are taking a medicine containing nelfinavir (used to treat HIV infection).

Do not take Omeprazole Teva if any of the above applies to you. If you are in doubt, consult your doctor or pharmacist before taking Omeprazole Teva.

Warnings and Precautions

Before taking Omeprazole Teva, consult your doctor or pharmacist. Omeprazole Teva may mask the symptoms of other diseases. Therefore, if you experience any of the following before or while taking Omeprazole Teva, contact your doctor immediately:

• Unexplained weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting blood or black tarry stools.
• Severe or persistent diarrhea, as omeprazole is associated with a small increased risk of infectious diarrhea.
• Severe liver problems.
• In patients with reduced body stores or risk factors for reduced vitamin B12 absorption during long-term treatment with omeprazole. Omeprazole, like all medicines that reduce stomach acid, may reduce the absorption of vitamin B12.
• If the patient has ever had a skin reaction after taking a medicine that reduces stomach acid.
• If the patient is going to have a specific test (chromogranin A).

During long-term treatment with Omeprazole Teva (more than 1 year), the patient will likely remain under regular medical supervision. During the visit to the doctor, all new and unusual symptoms and circumstances should be reported. During the use of proton pump inhibitors, such as Omeprazole Teva, especially for a period longer than one year, there may be an increased risk of fractures of the hip, wrist, and spine. You should inform your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis). If you experience a skin rash, especially in areas exposed to sunlight, you should tell your doctor as soon as possible, as it may be necessary to stop taking Omeprazole Teva. You should also report any other side effects, such as joint pain. Children: Some children with chronic diseases may require long-term treatment, although this is not recommended. Do not give this medicine to children under 1 year of age or under 10 kg.

Other Medicines and Omeprazole Teva

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, including those obtained without a prescription. This is important because Omeprazole Teva may affect the way some other medicines work, and some other medicines may affect the way Omeprazole Teva works. Do not take Omeprazole Teva if you are taking a medicine containing nelfinavir (used to treat HIV infection). Tell 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 rhythm disorders)
• diazepam (used to treat anxiety, to reduce muscle tension, or to treat epilepsy)
• phenytoin (used to treat epilepsy). If you are taking phenytoin, your doctor will need to monitor your condition when starting or stopping Omeprazole Teva
• Medicines used to reduce blood clotting, such as warfarin or other vitamin K antagonists. Your doctor will need to monitor your condition when starting or stopping Omeprazole Teva
• 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)
• erlotinib (used to treat certain types of cancer)
• methotrexate (a medicine used in chemotherapy in high doses to treat cancer) - if you are taking high doses of methotrexate, your doctor may temporarily stop Omeprazole Teva treatment

If your doctor has prescribed you antibiotics amoxicillin and clarithromycin and Omeprazole Teva to treat ulcers caused by Helicobacter pylori infection, it is very important that you tell your doctor about any other medicines you are taking.

Omeprazole Teva with Food and Drink

See Section 3.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Omeprazole passes into breast milk but is unlikely to affect the breastfed baby if you are taking the recommended dose. Whether you can take Omeprazole Teva while breastfeeding will be decided by your doctor.

Driving and Using Machines

Omeprazole Teva is unlikely to affect your ability to drive or use machines. However, side effects such as dizziness and blurred vision (see section 4) may occur. If affected, you should not drive or operate machinery.

Omeprazole Teva Contains Sucrose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Omeprazole Teva Contains Sodium

This medicine contains less than 1 mmol sodium (23 mg) per capsule, which is essentially 'sodium-free'.

3. How to Take Omeprazole Teva

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist. Your doctor will tell you how many capsules to take and for how long. This will depend on your condition and age. The usual doses are given below. Adults: Treatment of GORD symptoms, such as heartburn and acid reflux:

• If your doctor has found that your oesophagus is slightly damaged, the recommended dose is 20 mg once a day for 4-8 weeks. Your doctor may tell you to take 40 mg for a further 8 weeks if your oesophagus has not yet fully healed.
• The recommended dose to maintain healing of the oesophagus is 10 mg once a day.
• If your oesophagus has not been damaged, the recommended dose is 10 mg once a day.

Treatment of duodenal ulcers:

• The recommended dose is 20 mg once a day for 2 weeks. Your doctor may tell you to take the same dose for another 2 weeks if the ulcer has not yet fully healed.
• If the ulcer does not fully heal, the dose may be increased to 40 mg once a day for 4 weeks.

Treatment of gastric ulcers:

• The recommended dose is 20 mg once a day for 4 weeks. Your doctor may tell you to take the same dose for another 4 weeks if the ulcer has not yet fully healed.
• If the ulcer does not fully heal, the dose may be increased to 40 mg once a day for 8 weeks.

Prevention of duodenal and gastric ulcers:

• The recommended dose is 10 mg or 20 mg once a day. Your doctor may increase the dose to 40 mg once a day.

Prevention of duodenal and gastric ulcers in patients taking non-steroidal anti-inflammatory drugs (NSAIDs):

• The recommended dose is 20 mg once a day for 4-8 weeks.

Prevention of duodenal and gastric ulcers in patients taking non-steroidal anti-inflammatory drugs (NSAIDs):

• The recommended dose is 20 mg once a day.

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

• The recommended dose of omeprazole is 20 mg twice a day for one week.
• Your doctor will also prescribe two antibiotics called amoxicillin and clarithromycin.

Treatment of too much acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison syndrome):

• The recommended dose is 60 mg a day.
• Your doctor will adjust the dose according to your individual needs and decide how long you need to take the medicine.

Use in Children and Adolescents:

Treatment of GORD symptoms, such as heartburn and acid reflux:

• Children over 1 year of age and ≥ 10 kg body weight can take omeprazole. The dose for children is based on their body weight and will be decided by your doctor.

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

• Children over 4 years of age can take omeprazole. The dose for children is based on their body weight and will be decided by your doctor.
• Your doctor will also prescribe two antibiotics called amoxicillin and clarithromycin.

How to Take Omeprazole Teva

• It is recommended to take the capsules in the morning.
• The capsules can be taken with or without food.
• Swallow the capsules whole with half a glass of water. Do not chew or crush the capsules. This is important because the capsules contain coated pellets which prevent the medicine from being broken down by the acid in the stomach. It is important that the pellets are not damaged.

What to Do if You Have Difficulty Swallowing the Capsules (in Adults or Children)

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 glass of non-fizzy water, acidic fruit juice (e.g. apple, orange, or grapefruit), or apple sauce.
• Always mix just before drinking (the mixture will not be clear). Drink the mixture straight away or within 30 minutes.
• To make sure that you or your child get the full dose, rinse the glass with half a glass of water and drink it. The solid pieces contain the medicine - do not chew or crush them.

What to Do if You Take More Omeprazole Teva Than You Should

If you have taken more Omeprazole Teva than you should, contact your doctor or pharmacist immediately.

What to Do if You Forget to Take Omeprazole Teva

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 a forgotten dose.

What to Do if You Stop Taking Omeprazole Teva

Do not stop taking Omeprazole Teva without first talking to your doctor or pharmacist. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, Omeprazole Teva can cause side effects, although not everybody gets them.

If You Experience Any of the Following Serious Side Effects, Stop Taking Omeprazole Teva and Contact Your Doctor Immediately:

• Sudden wheezing, swelling of the lips, tongue, and throat or body, rash, fainting, or difficulty swallowing (severe allergic reaction).
• Reddening of the skin with blistering or peeling. There may also be severe blisters and bleeding in the lips, eyes, mouth, nose, and genitals. This could be Stevens-Johnson syndrome or toxic epidermal necrolysis.
• Yellowing of the skin, dark urine, and tiredness, which can be signs of liver problems.

Other side effects include:

Common Side Effects: May Affect Up to 1 in 10 People

• Headache
• Effects on the stomach or intestines: diarrhea, stomach pain, constipation, gas (bloating)
• Nausea or vomiting
• Mild gastric polyps.

Uncommon Side Effects: May Affect Up to 1 in 100 People

• Swelling of the feet and ankles
• Sleep disturbances (insomnia)
• Dizziness, tingling, or numbness
• Vertigo (dizziness)
• Changes in liver function tests
• Skin rash, hives, or itching
• General feeling of being unwell and lack of energy
• Fracture of the hip, wrist, or spine.

Rare Side Effects: May Affect Up to 1 in 1,000 People

• Blood problems, such as a reduced number of white blood cells or platelets. This can lead to weakness, bruising, or increased risk of infection.
• Allergic reactions, sometimes severe, including swelling of the lips, tongue, and throat, fever, wheezing
• Low levels of sodium in the blood. This can lead to weakness, vomiting, and muscle cramps
• Agitation, confusion, or depression
• Changes in taste
• Vision problems, such as blurred vision
• Sudden onset of wheezing or shortness of breath (bronchospasm)
• Dry mouth
• Oral thrush
• Fungal infection which can affect the intestines and is caused by a fungus
• Liver problems, including jaundice, which can cause yellowing of the skin, dark urine, and tiredness
• Hair loss (alopecia)
• Skin rash that may occur with joint pain
• Pain in the joints (arthralgia) or muscles (myalgia)
• Severe kidney problems (interstitial nephritis)
• Increased sweating.

Very Rare Side Effects: May Affect Up to 1 in 10,000 People

• Changes in blood count, including agranulocytosis (lack of white blood cells)
• Aggression
• Seeing, hearing, or feeling things that are not there (hallucinations)
• Severe liver problems leading to liver failure and encephalopathy
• Sudden onset of a severe rash or blistering or peeling of the skin. This may be accompanied by fever, joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis)
• Muscle weakness
• Breast enlargement in men.

Frequency Not Known: Cannot be Estimated from the Available Data

• Colitis (causing diarrhea)
• Hypomagnesemia. If you take Omeprazole Teva for more than 3 months, it is possible that your magnesium level may decrease. Low magnesium levels can cause fatigue, muscle cramps, disorientation, seizures, or a rapid heartbeat. If you experience any of these symptoms, contact your doctor immediately. Low magnesium levels can also lead to a decrease in potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor magnesium levels.
• Skin rash that may occur with joint pain

In very rare cases, Omeprazole Teva may affect the number of white blood cells in the blood, leading to a lack of immunity. If you experience an infection with symptoms such as fever with a severe deterioration in general health or fever with local infection symptoms such as pain in the neck, throat, or mouth, or difficulty urinating, consult your doctor as soon as possible to rule out a lack of white blood cells (agranulocytosis) based on a blood test result. It is important that you inform your doctor that you are taking Omeprazole Teva.

Reporting Side Effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system listed in the package leaflet. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to Store Omeprazole Teva

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 30°C. Store in the original package. Keep the bottle tightly closed to protect from moisture. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the Package and Other Information

What Omeprazole Teva Contains

• The active substance is omeprazole. Each capsule contains enteric-coated granules containing 20 mg of omeprazole.
• The other ingredients are: sucrose, sugar spheres (sucrose and maize starch), sodium carboxymethylcellulose (type A), sodium lauryl sulfate, povidone K30, disodium phosphate dodecahydrate, sodium hydroxide, hypromellose, methacrylic acid - ethyl acrylate copolymer (1:1), triethyl citrate, titanium dioxide (E 171), talc. Capsule shell:erythrosine (E127), titanium dioxide (E171), gelatin, indigo carmine (E 132). Body of the capsule:erythrosine (E 127), quinoline yellow (E 104), titanium dioxide (E 171), gelatin. Ink:shellac, anhydrous ethanol, isopropyl alcohol, propylene glycol, n-butanol, povidone K30, sodium hydroxide, titanium dioxide (E 171).

What Omeprazole Teva Looks Like and Contents of the Package

20 mg capsules: orange body and blue cap, marked "O20" The following pack sizes are available: 20 mg: HDPE bottle of 14 or 28 capsules, in a cardboard box.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Teva B.V. Swensweg 5 2031 GA Haarlem, Netherlands Tel: (22) 345 93 00

Manufacturer

Teva Operations Poland Sp. z o.o., ul. Mogilska 80, 31-546 Kraków Teva Pharma SLU., Poligono Malpica, c/C no. 4.50016 , Saragossa, Spain Merckle GmbH, Ludwig-Merckle- Straße 3, 89143 Blaubeuren, Germany

This Medicinal Product is Authorised in the Member States of the European Economic Area Under the Following Names

Czech Republic – TULZOL 10 mg, 20 mg & 40 mg, Ireland – Omeprazole Teva Pharma 10, 20, 40 mg Gastro-resistant Capsules, Germany – Omeprazol-ratiopharm NT 10 mg / 20 mg / 40 mg magensaftresistente Hartkapseln, Poland - Omeprazol Teva, Slovakia - Tevazol 10 mg, 20 mg & 40 mg capsules

Date of Revision of the Package Leaflet: February 2020