LOSEC 10 mg Enteric-Coated Hard Capsules

Зміст інструкції

1. Losec 10 mg hard gastro-resistant capsules, 20 mg hard gastro-resistant capsules, 40 mg hard gastro-resistant capsules
   1. What Losec is and what it is used for
   2. What you need to know before taking Losec
   3. How to take Losec
   4. Possible side effects
   5. How to store Losec
   6. Contents of the pack and other information

Losec 10 mg hard gastro-resistant capsules, 20 mg hard gastro-resistant capsules, 40 mg hard gastro-resistant capsules

Omeprazole

Read 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. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Losec is and what it is used for

Losec contains the active ingredient omeprazole. It belongs to a group of medicines called
‘proton pump inhibitors’, which work by reducing the amount of acid produced by the stomach.
Losec is used for the treatment of the following conditions:
In adults:

• ‘Gastro-oesophageal reflux disease’ (GERD). This disease occurs when acid leaks from the stomach and passes into the oesophagus (the tube that connects the throat to the stomach) causing pain, inflammation and heartburn.
• Ulcers in the upper part of the intestine (duodenal ulcer) or of the stomach (gastric ulcer).
• Ulcers infected by a bacterium called ‘ Helicobacter pylori’. If you suffer from this disease, your doctor may also prescribe you antibiotics to treat the infection and allow the ulcer to heal.
• Ulcers caused by medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Losec can also be used to prevent the formation of ulcers if you are taking NSAIDs.
• Excessive acid in the stomach caused by an overgrowth of tissue in the pancreas (Zollinger-Ellison syndrome).

In children:

Children over 1 year of age and with a body weight of 10 kg or more

• ‘Gastro-oesophageal reflux disease’ (GERD). This disease occurs when acid leaks from the stomach and passes into the oesophagus (the tube that connects the throat to the stomach) causing pain, inflammation and heartburn. In children, the symptoms of this disease also include the return of stomach contents into the mouth (regurgitation), discomfort (vomiting) and poor weight gain.

Children over 4 years of age and adolescents
Ulcers infected by a bacterium called ‘ Helicobacter pylori’. If the child suffers from this disease,
the doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

2. What you need to know before taking Losec

Do not take Losec:

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

Do not take Losec if you fall into any of the above categories. If you have any doubts, ask your doctor or pharmacist before taking Losec.

Warnings and precautions
Talk to your doctor or pharmacist before taking Losec.
Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP), have been reported in association with Losec treatment. Stop using Losec and consult your doctor immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.
Losec may mask the symptoms of other diseases. Therefore, if you experience the symptoms described below before taking Losec or while taking it, contact your doctor immediately:

• Unexplained weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting of food or blood.
• Darkening of the stools (presence of blood in the stools).
• Severe or persistent diarrhoea, because omeprazole has been associated with a slight increase in infectious diarrhoea.
• Serious liver problems.
• If you have ever had a skin reaction after treatment with a medicine similar to Losec that reduces stomach acid.
• You are to undergo a specific blood test (Chromogranin A).

If you notice the appearance of a skin rash, especially in areas exposed to sunlight, contact your doctor as soon as possible, as you may need to stop treatment with Losec. Also remember to report any other side effects such as joint pain.
If you take Losec for a long time (more than 1 year), your doctor will prescribe regular check-ups. Tell your doctor if you notice the appearance of new and unusual symptoms.
If you are taking a proton pump inhibitor such as Losec, especially for a period longer than one year, there may be a slight increase in the risk of fractures of the hip, wrist or spine. If you suffer from osteoporosis or are taking corticosteroids (which can increase the risk of osteoporosis), consult your doctor.

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

Other medicines and Losec
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Including over-the-counter medicines. This is important because Losec can affect the way some medicines work and, in turn, some medicines can affect the action of Losec.
Do not take Losec if you are taking a medicine containing nelfinavir(used for the treatment of HIV infections).
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 for the treatment of heart problems)
• Diazepam (used for the treatment of anxiety, to relax muscles or for epilepsy)
• Phenytoin (used for epilepsy). If you are taking phenytoin, your doctor will monitor you at the beginning and end of treatment with Losec
• Medicines used to thin the blood, such as warfarin or other vitamin K antagonists. Your doctor will monitor you at the beginning and end of treatment with Losec
• Rifampicin (used for the treatment of tuberculosis)
• Atazanavir (used for the treatment of HIV infection)
• Tacrolimus (used in organ transplantation)
• St. John's Wort (Hypericum perforatum) (used for the treatment of mild depression).
• Cilostazol (used for the treatment of intermittent claudication)
• Saquinavir (used for the treatment of HIV infection)
• Clopidogrel (used to prevent blood clots (thrombi))
• Erlotinib (used for the treatment of cancer)
• Methotrexate (a chemotherapeutic medicine used at high doses for the treatment of cancer) - if you are taking methotrexate at high doses, your doctor may temporarily interrupt your treatment with Losec.

If your doctor has prescribed you the antibiotics amoxicillin and clarithromycin together with Losec for the treatment of ulcers caused by Helicobacter pyloriinfections, it is very important that you tell your doctor if you are taking any other medicines.

Losec with food and drink
See section 3.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine. The doctor will decide if you can take Losec during this period.
Omeprazole is excreted in breast milk but it is unlikely to have an effect on the baby when used at therapeutic doses. The doctor will decide if you can take Losec during breastfeeding.

Driving and using machines
It is unlikely that Losec will affect your ability to drive or operate tools or machinery. Adverse reactions to the medicine such as dizziness and visual disturbances may occur (see section 4). If you suffer from these, do not drive or use machinery.

Losec capsules contains lactose
Losec capsules contains lactose. If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking this medicine.
Losec capsules contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially ‘sodium-free’.

3. How to take Losec

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask 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 recommended dose is given below.

Use in adults
For the treatment of GERD symptoms, such as heartburn and acid reflux:

• If your doctor has told you that your esophagus is slightly damaged, the recommended dose is 20 mg once a day for 4-8 weeks. Your doctor may increase the dose to 40 mg for another 8 weeks if the esophagus is not yet completely healed.
• The recommended dose once the esophagus has healed is 10 mg once a day.
• If the esophagus is not damaged, the usual dose is 10 mg once a day.

For the treatment of ulcers in the upper part of the intestine(duodenal ulcer):

• The recommended dose is 20 mg once a day for 2 weeks. Your doctor may extend the intake of this 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 a day for 4 weeks.

For the treatment of stomach ulcers(gastric ulcer):

• The recommended dose is 20 mg once a day for 4 weeks. Your doctor may extend the intake of this 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 a day for 8 weeks.

To preventthe recurrence 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.

For the treatment of duodenal and gastric ulcers caused by taking NSAIDs(Non-Steroidal
Anti-inflammatory Drugs):

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

To prevent the formation of duodenal and gastric ulcersif you are using NSAIDs:

• The recommended dose is 20 mg once a day.

For the treatment of ulcers caused by infection with Helicobacter pyloriand prevention of their
recurrence:

• The recommended dose is 20 mg of Losec twice a day for one week.
• Your doctor will also tell you to take two antibiotics, such as amoxicillin, clarithromycin and metronidazole.

For the treatment of excessive acid in the stomach caused by an increase in
tissue in the pancreas (Zollinger-Ellison syndrome):

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

Use in children and adolescents
For the treatment of GERD symptoms, such as heartburn and acid reflux:

• Losec can be taken by children over 1 year of age and weighing more than 10 kg. The dose for children is based on the child's weight and the exact dose will be decided by the doctor.

For the treatment and prevention of the recurrence of ulcers causedby infection with Helicobacter
pylori:

• Losec can be taken by children over 4 years of age. The dose for children is based on the child's weight and the exact dose will be decided by the doctor.
• Your doctor will also prescribe two antibiotics called amoxicillin and clarithromycin to your child.

Taking this medicine

• It is recommended to take the capsules in the morning.
• The capsules can be taken with food or on an empty stomach.
• The capsules should be swallowed whole with half a glass of water. The capsules must not be chewed or crushed, as they contain granules coated in such a way as to prevent the medicine from being broken down by the acid in the stomach. It is important not to damage the granules.

What to do if you or the child has difficulty swallowing the capsules

• If you or the child has difficulty swallowing the capsules:
• Open the capsules and swallow the contents directly with half a glass of water or pour the contents into a glass of water (non-carbonated), acidic fruit juice (e.g. apple, orange or pineapple) or applesauce.
• Always shake the contents before drinking (the mixture will not be clear), then drink the preparation immediately or within 30 minutes.
• To be sure you have taken all the medicine, rinse the glass very well with half a glass of water and drink the contents. The solid particles contain the medicine - do not chew or crush them.

If you take more Losec than you should
If you take a quantity of Losec greater than that prescribed by your doctor, contact your
doctor or pharmacist immediately.

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

If you stop taking Losec
Do not stop taking Losec without first talking to your doctor or pharmacist.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• Sudden wheezing, swelling of the lips, tongue and throat or body, skin rash, fainting or difficulty swallowing (severe allergic reaction). (rare)
• Reddening of the skin with the appearance of blisters or peeling. Severe blistering with bleeding of the lips, eyes, mouth, nose and genitals may also occur. This could be “Stevens-Johnson syndrome” or “toxic epidermal necrolysis”. (very rare)
• Widespread skin rash, high temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). (rare)
• A widespread red and scaly skin 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 may be symptoms of liver problems. (rare)

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, passing gas (flatulence).
• Feeling unwell (nausea) or feeling sick (vomiting).
• Benign polyps in the stomach.

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

• Swelling of the feet and ankles.
• Disturbed sleep (insomnia).
• Dizziness, tingling, feeling sleepy.
• Feeling of spinning (vertigo).
• Changes in blood tests related to liver function.
• Skin rash, skin rash with swelling of the skin (urticaria) and itching on the skin.
• General feeling of being unwell and lack of energy.
• If you take a proton pump inhibitor like Losec, especially for a period longer than one year, there may be a slight increase in the risk of fractures of the hip, wrist or spine. If you suffer from osteoporosis or are taking corticosteroids (which can increase the risk of osteoporosis) consult your doctor.

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

• Changes in blood composition, such as a reduction in the number of white blood cells or platelets. This can cause weakness and easy bruising, or may make you more likely to get infections.
• Low levels of sodium in the blood. This can cause weakness, feeling unwell (vomiting) and cramps.
• Feeling agitated, confused or depressed.
• Changes in taste.
• Problems with vision, such as blurred vision.
• Sudden wheezing or shortness of breath (bronchospasm).
• Dry mouth.
• Inflammation inside the mouth.
• An infection called “candidiasis” that can affect the intestines and is caused by a fungus.
• Hair loss (alopecia).
• Skin rash during exposure to the sun.
• Joint pain (arthralgia) or muscle pain (myalgia).
• Serious kidney problems (interstitial nephritis).
• Increased sweating.

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

• Changes in the count of blood cells, including agranulocytosis (lack of white blood cells).
• Aggression.
• Seeing, feeling or hearing things that are not real (hallucinations).
• Serious liver problems up to liver failure and brain inflammation.
• Erythema multiforme.
• Muscle weakness.
• Enlargement of the breasts in men.

Not known (frequency cannot be estimated from the available data)

• Inflammation of the intestine (resulting in diarrhea).
• If you take Losec for more than three months, it is possible that blood levels of magnesium may decrease. Low levels of magnesium can manifest with fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you have any of these symptoms, consult your doctor immediately. Low levels of magnesium can also lead to a reduction in blood levels of potassium or calcium. The doctor should decide whether to check magnesium levels in the blood periodically.
• Reduced levels of calcium in the blood (hypocalcemia). The reduction in calcium levels in the blood may result from very low levels of magnesium.
• Reduced levels of potassium in the blood (hypokalaemia).
• Erythema, possible joint pain.

In very rare cases Losec can affect white blood cells, leading to immunodeficiency. If you should develop an infection with symptoms such as fever with a severedeterioration of general health or fever with symptoms of local infection such as sore throat, sore throat or mouth or difficulty urinating, you should consult a doctor as soon as possible, in order to rule out a lack of white blood cells (agranulocytosis) by performing a blood test. It is important in this case to inform the doctor about the medicine you are taking.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine .

5. How to store Losec

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 package, bottle or
blister after Exp. The expiry date refers to the last day of that month.
Do not store at a temperature above 30°C.
Keep this medicine in the original packaging (blister) or keep the bottle tightly closed to
protect the medicine from moisture.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Losec contains
The active ingredient is omeprazole. Each gastro-resistant hard capsule contains 10 mg, 20 mg or 40 mg
of omeprazole.
The excipients are dibasic sodium phosphate dihydrate, hydroxypropylcellulose, hypromellose, anhydrous lactose,
magnesium stearate, mannitol, methacrylic acid - ethyl acrylate copolymer (1:1) dispersion 30%,
microcrystalline cellulose, macrogol (polyethylene glycol 400), sodium lauryl sulfate, iron oxide E 172,
titanium dioxide E 171, gelatin, printing ink (contains shellac, ammonia, potassium
hydroxide and iron oxide black E 172), anhydrous colloidal silica, liquid paraffin (see section 2,
“Losec capsules contains lactose”).

Description of the appearance of Losec and contents of the pack

• Losec 10 mg capsules have a pink body, with “10” printed on it and a pink cap with “A/OS” printed on it.
• Losec 20 mg capsules have a pink body, with “20” printed on it and a reddish-brown cap with “A/OM” printed on it.
• Losec 40 mg capsules have a reddish-brown body, with “40” printed on it and a reddish-brown cap with “A/OL” printed on it.

Packs:

• 10 mg: o Blisters containing 14, 28 and 35 capsules.
• 20 mg: o Blister containing 14 capsules.
• 40 mg: o HDPE bottles containing 14 capsules

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany

Manufacturer
Saneca Pharmaceuticals a.s.
Nitrianska 100
Hlohovec, 920 27
Slovakia
or
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 23 – 24
17489 Greifswald (Germany)
or
AstraZeneca AB
Gärtunavägen
SE-151 85 Södertälje (Sweden)
or
AstraZeneca GmbH
Tinsdaler Weg 183
Wedel D-22880 (Germany)
or
Recipharm Monts
18 rue de Montbazon
F-37260, Monts (France)

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Other sources of information
More detailed information on this medicinal product is available on the website of the Italian Medicines Agency (AIFA) https://www.aifa.gov.it/.