Omeprazole biofarm

Package leaflet: Information for the user

Omeprazol Biofarm
20 mg, hard gastro-resistant capsules
Omeprazol Biofarm
40 mg, hard gastro-resistant capsules
Omeprazolum
Read this leaflet carefully before using 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 personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

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

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

Omeprazol Biofarm contains the active substance omeprazole and belongs to a group of medicines called proton pump inhibitors (PPIs). These medicines reduce the amount of hydrochloric acid produced in the stomach.

Omeprazol Biofarm is used to treat the following conditions:

In adults:

• Gastro-oesophageal reflux disease (GORD). In this condition, acidic stomach juice flows back into the oesophagus (the part of the digestive tract connecting the throat to the stomach), causing pain, inflammation and heartburn.
• Ulcers in the first part of the small intestine (duodenal ulcers) or in the stomach (gastric ulcers).
• Ulcers associated with infection by the bacterium Helicobacter pylori. In this case, your doctor may also prescribe antibiotics to eliminate the infection and help heal the ulcers.
• Ulcers caused by taking non-steroidal anti-inflammatory drugs (NSAIDs). Omeprazol Biofarm may also be used to prevent the development of ulcers during treatment with NSAIDs.
• Zollinger-Ellison syndrome, a condition in which excessive amounts of hydrochloric acid are produced in the stomach due to a tumour in the pancreas.

In children:

Children above 1 year of age and weighing ≥ 10 kg

• Gastro-oesophageal reflux disease. In this condition, acidic stomach juice flows back into the oesophagus (the part of the digestive tract connecting the throat to the stomach), causing pain, inflammation and heartburn. In children, symptoms of reflux disease may include regurgitation of stomach contents into the mouth, vomiting, and poor weight gain.

Children and adolescents above 4 years of age

• Ulcers caused by infection with the bacterium Helicobacter pylori. In this case, your doctor may also prescribe antibiotics for the child to eliminate the infection and help heal the ulcer.

2. Important information before using Omeprazol Biofarm

When not to use Omeprazol Biofarm

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

If in any doubt before using Omeprazol Biofarm, contact a doctor or pharmacist.
Warnings and precautions
Before starting treatment with Omeprazol Biofarm, discuss it with your doctor or
pharmacist.
Omeprazol Biofarm may mask symptoms of other diseases. Therefore, if any of the following conditions occur before or during treatment with Omeprazol Biofarm, contact your doctor immediately:

• unexplained weight loss and difficulty swallowing,
• stomach pain or indigestion,
• vomiting of food or blood,
• passing black stools (blood-stained faeces),
• severe or persistent diarrhoea, as there is a slightly increased risk of infectious diarrhoea associated with the use of omeprazole,
• severe liver problems.

Before starting treatment with Omeprazol Biofarm, consult your doctor:

• if the patient has ever had a skin reaction to a medicine similar to Omeprazol Biofarm that reduces stomach acid secretion;
• if the patient is scheduled for a specific blood test (chromogranin A levels).

If the patient develops a skin rash, especially in areas exposed to sunlight, inform the doctor as soon as possible, as discontinuation of Omeprazol Biofarm may be necessary. Also report any other adverse reactions occurring, such as joint pain.
If Omeprazol Biofarm is used long-term (longer than 1 year), the patient will likely require close and regular medical monitoring. During visits to the doctor, report any new or unusual symptoms or circumstances.
When taking proton pump inhibitors such as Omeprazol Biofarm, especially for longer 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 been diagnosed with osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).
Children and adolescents
Detailed information on the use of Omeprazol Biofarm in children and adolescents is provided in section 3, "How to take Omeprazol Biofarm".
Omeprazol Biofarm and other medicines
Tell your doctor or pharmacist about any medicines the patient is currently taking, has recently taken, or plans to take, including those obtained without a prescription. This is important because Omeprazol Biofarm may affect the action of certain other medicines, and some other medicines may affect the action of Omeprazol Biofarm.
Do not take Omeprazol Biofarm if the patient is using a medicine containing nelfinavir (used in the treatment of HIV infection).
Inform your doctor or pharmacist if the patient is taking any of the following medicines:

• ketoconazole, itraconazole, or voriconazole (used to treat fungal infections);
• digoxin (used to treat heart disorders);
• diazepam (used to treat anxiety, to reduce muscle tension, or in epilepsy);
• phenytoin (used to treat epilepsy). If the patient is taking phenytoin, the doctor will need to monitor the patient's condition when starting and stopping treatment with Omeprazol Biofarm.
• medicines used to reduce blood clotting, such as warfarin or other vitamin K antagonists. The doctor will need to monitor the patient's condition when starting and stopping treatment with Omeprazol Biofarm.
• 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).

If the doctor has prescribed antibiotics—amoxicillin and clarithromycin—along with Omeprazol Biofarm for the treatment of ulcers caused by Helicobacter pylori infection, it is very important that the patient informs the doctor about any other medicines being taken.
Omeprazol Biofarm with food and drink
The capsules may be taken with food or on an empty stomach.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine. The doctor will decide whether she can take Omeprazol Biofarm during this time.
The decision on whether a breastfeeding woman can take Omeprazol Biofarm will be made by the doctor.
Driving and using machines
Omeprazol Biofarm does not affect the ability to drive or operate machinery.
However, adverse reactions such as dizziness and visual disturbances may occur (see section 4 of this leaflet). If these occur, the patient should not drive or operate machinery.
Omeprazol Biofarm contains sucrose and anhydrous lactose
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should contact the doctor before starting this medicine.

3. How to take Omeprazol Biofarm

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your
doctor or pharmacist.
Your doctor will inform you how many capsules to take and for how long.
This will depend on your medical condition and age.
The usual doses of Omeprazol Biofarm are given below.

Adults

Treatment of symptoms of gastro-oesophageal reflux disease, such as heartburn and regurgitation of
acidic stomach contents:

• If your doctor has diagnosed that your oesophagus has been slightly damaged, the usual dose is 20 mg once daily for 4–8 weeks. Your doctor may recommend taking 40 mg for an additional 8 weeks if the oesophagus has not yet healed.
• After healing of the oesophagus, the usual maintenance dose is 10 mg once daily.
• If the oesophagus is not damaged, the usual dose is 10 mg once daily.

Treatment of duodenal ulcers (ulcers in the upper part of the intestine):

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

Treatment of gastric ulcers (ulcers in the stomach):

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

Prevention of recurrence of gastric 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 gastric and duodenal ulcers caused by NSAIDs (non-steroidal anti-inflammatory drugs):

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

Prevention of recurrence of gastric and duodenal ulcers during NSAID treatment:

• The usual dose is 20 mg once daily.

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

• The usual dose of Omeprazol Biofarm is 20 mg twice daily for 1 week.
• Your doctor will also prescribe two antibiotics (amoxicillin, clarithromycin or metronidazole).

Treatment of Zollinger-Ellison syndrome (a condition in which excessive amounts of hydrochloric acid
are produced in the stomach due to a tumour in the pancreas):

• The usual dose is 60 mg per day.
• Your doctor will adjust the dose according to individual needs and determine how long treatment with Omeprazol Biofarm should continue.

Children and adolescents

Treatment of symptoms of gastro-oesophageal reflux disease, such as heartburn and regurgitation of
acidic stomach contents:

• Children above 1 year of age and weighing more than 10 kg may take Omeprazol Biofarm. The dose for children depends on body weight, and the appropriate dose will be determined by the doctor.

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

• Children above 4 years of age may take Omeprazol Biofarm. The dose for children depends on body weight, and the appropriate dose will be determined by the doctor.
• Your doctor will also prescribe two antibiotics: amoxicillin and clarithromycin.

How to take Omeprazol Biofarm

• It is recommended to take the capsules in the morning.
• The capsules may be taken with food or on an empty stomach.
• 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 that protect the medicine from being broken down by stomach acid. It is essential that the pellets remain intact.

What to do if you have difficulty swallowing the capsules (in adults or children)

• If an adult or child has difficulty swallowing the capsules:
• Open the capsule and swallow the contents directly with a glass of water, or mix the contents with a glass of still (non-carbonated) water, any acidic fruit juice (e.g. apple, orange or pineapple juice), or with apple sauce.
• Always mix the mixture immediately before drinking (the mixture will not be clear). Drink the mixture immediately or within 30 minutes after preparation.
• To ensure that the patient receives the full dose of Omeprazol Biofarm, rinse the glass thoroughly with half a glass of water and drink this liquid. The solid particles contain the medicine – do not chew or crush them before swallowing.
• DO NOT USE carbonated water or milk.

Taking more Omeprazol Biofarm than prescribed
If you take more Omeprazol Biofarm than prescribed by your doctor, contact your doctor or pharmacist immediately.

If you forget to take Omeprazol Biofarm
If you miss a dose because you forgot to take it, 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 missed dose.

Stopping Omeprazol Biofarm
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If any of the following rare but serious side effects occur,
stop taking Omeprazol Biofarm immediately and contact your doctor without delay:

• Sudden wheezing, swelling of the lips, tongue and throat, rash, fainting or difficulty swallowing (severe allergic reaction).
• Reddening of the skin with formation of blisters or peeling. Large blisters and bleeding around the lips, eyes, mouth, nose and genital organs may also occur. These may be signs of Stevens-Johnson syndrome or toxic epidermal necrolysis.
• Yellowing of the skin, dark urine and tiredness, which may indicate liver function disorders.

Other side effects include:
Common side effects (occur in 1 to 10 of 100 people):

• headache
• effects on stomach or intestines: diarrhoea, stomach pain, constipation, bloating with gas
• nausea or vomiting
• benign gastric polyps

Uncommon side effects (occur in 1 to 10 of 1,000 people):

• swelling of feet and ankles
• sleep disturbances (insomnia)
• dizziness, tingling and pricking sensations, drowsiness
• sensation of spinning (vestibular vertigo)
• changes in liver function test results
• skin rash, nodular rash (urticaria), and itchy skin
• general malaise and lack of energy

Rare side effects (occur in 1 to 10 of 10,000 people):

• blood-related problems, such as reduced number of white blood cells or platelets, which may lead to weakness, bruising or increased risk of infection
• allergic reactions, sometimes very severe, including swelling of lips, tongue and throat, fever, wheezing
• low sodium levels in the blood, which may lead to weakness, vomiting and muscle cramps
• restlessness, disorientation or depression
• altered taste sensation
• vision problems (e.g. blurred vision)
• sudden sensation of wheezing or breathlessness (bronchospasm)
• dryness of the mouth
• inflammation of the mucous membrane of the mouth
• fungal infection known as "thrush", which may affect the intestines and is caused by fungi
• liver function disorders, including jaundice with yellowing of the skin, dark urine and feeling of weakness
• excessive hair loss (alopecia)
• skin rash occurring during exposure to sunlight
• joint pain (arthralgia) or muscle pain (myalgia)
• severe kidney problems (interstitial nephritis)
• increased sweating

Very rare side effects (occur less frequently than in 1 of 10,000 people):

• changes in blood count, including agranulocytosis (lack of white blood cells)
• aggression
• seeing, feeling or hearing things that are not real (hallucinations)
• severe liver function disorders leading to liver failure and encephalopathy
• sudden onset of severe skin rash or blisters on the skin or skin peeling. These symptoms may be accompanied by high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis)
• muscle weakness
• breast enlargement in men

Frequency not known (cannot be estimated from available data):
Rash which may be accompanied by joint pain.
If Omeprazol Biofarm has been taken for longer than three months, there is a possibility of
reduced magnesium levels in the blood. Low magnesium levels may manifest as fatigue,
involuntary muscle spasms, disorientation, seizures, dizziness, rapid heartbeat.
If any of the above symptoms are observed, inform your doctor immediately.
Low magnesium levels may lead to reduced potassium or calcium levels in the blood.
Your doctor may recommend regular blood tests to monitor magnesium levels.
In very rare cases, Omeprazol Biofarm may affect the number of white blood cells in the blood,
which may lead to immunodeficiency. If a patient develops an infection with symptoms such as
fever accompanied by severe deterioration in general condition, or fever with signs of local
infection such as neck, throat or mouth pain, or difficulty urinating, medical advice should be
sought as soon as possible to rule out possible deficiency of white blood cells (agranulocytosis),
based on blood test results. It is important that the patient informs the doctor about the
medication being taken.
Patients should not be alarmed by the list of side effects listed above. It is possible that
none of them will occur.
Reporting of side effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: +48 22 49 21 301, fax: +48 22 49 21 309
e-mail: [email protected]
Side effects may also be reported to the marketing authorization holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Omeprazol Biofarm

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
No special storage instructions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.

6. Contents of the pack and other information

What Omeprazol Biofarm contains

• The active substance is omeprazole (Omeprazolum).
  Omeprazol Biofarm, 20 mg: Each enteric hard capsule contains 20 mg of omeprazole.
  Omeprazol Biofarm, 40 mg: Each enteric hard capsule contains 40 mg of omeprazole.
• Other ingredients are: capsule contents: sucrose, pellets; anhydrous lactose, hypromellose, hydroxypropylcellulose, sodium lauryl sulfate, disodium phosphate dodecahydrate, hypromellose phthalate, diethyl phthalate.

Capsule shell:
Omeprazol Biofarm, 20 mg: gelatin, indigo carmine (E132), quinoline yellow (E104);
Omeprazol Biofarm, 40 mg: gelatin, indigo carmine (E132), erythrosine (E127).

What Omeprazol Biofarm looks like and contents of the pack
Omeprazol Biofarm, 20 mg: green hard capsules containing light yellow pellets.
Omeprazol Biofarm, 40 mg: purple hard capsules containing light yellow pellets.
The capsules are packed in aluminium/PVC/aluminium/PA blisters, placed in a cardboard box.
Pack sizes: 7, 14, 28 or 56 enteric hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Biofarm Sp. z o.o.
Wałbrzyska Street 13
60-198 Poznań
Phone: +48 61 66 51 500
Fax: +48 61 66 51 505
[email protected]

Manufacturer
Industria Química y Farmacéutica VIR, S.A.
C/ Laguna 66-68-70, Polígono Industrial Urtinsa II
28923 Alcorcón (Madrid)
Spain