Losec

Package leaflet: Information for the user

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

Omeprazole
Please read this leaflet carefully before 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 give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact 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 taking 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 substance 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 to treat the following conditions:

In adults:

• 'Gastro-oesophageal reflux disease' (GERD). This condition occurs when acid leaks out of the stomach and passes into the oesophagus (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 medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Losec may also be used to prevent ulcers from forming if you are taking NSAIDs.
• Excess acid production due to overgrowth of tissue in the pancreas (Zollinger-Ellison syndrome).

In children:
Children aged over 1 year and weighing more than or equal to 10 kg

• 'Gastro-oesophageal reflux disease' (GERD). This condition occurs when acid leaks out of the stomach and passes into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn. In children, symptoms of this condition may also include regurgitation of stomach contents back into the mouth, discomfort (vomiting), and poor weight gain.

Children aged over 4 years 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 should know before taking Losec

Do not take Losec:

• If you are allergic to omeprazole or to any of the excipients 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 any of the above apply to you. If you are unsure, consult your doctor or pharmacist before taking Losec.

Warnings and precautions

Talk to your doctor or pharmacist before taking Losec.

Serious 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 treatment with Losec. Stop using Losec and contact a doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

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

• Unintentional weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting of food or blood.
• Dark-coloured stools (indicating presence of blood in stools).
• 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 Losec that reduces gastric acidity.
• If you are scheduled for a specific blood test (chromogranin A).

If you develop a skin rash, especially in areas exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with Losec. Remember to also report any other adverse effects such as joint pain.

If you have been taking Losec for a long time (more than 1 year), your doctor will prescribe regular check-ups. Inform your doctor if you notice new or unusual symptoms.

If you take a proton pump inhibitor such as Losec, especially for more than one year, there may be a slight increase in the risk of fractures of the hip, wrist, or spine. If you have osteoporosis or are taking corticosteroids (which can increase the risk of osteoporosis), consult your doctor.

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 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 those not requiring a prescription. This is important because Losec can affect how some medicines work, and some medicines can affect how Losec works.

Do not take Losec if you are taking a medicine containing nelfinavir (used to treat 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 to treat heart problems)
• Diazepam (used to treat anxiety, to relax muscles, or for epilepsy)
• Phenytoin (used for epilepsy). If you are taking phenytoin, your doctor will monitor you closely when starting and stopping treatment with Losec.
• Medicines used to thin the blood, such as warfarin or other vitamin K antagonists. Your doctor will monitor you closely when starting and stopping treatment with Losec.
• 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 chemotherapeutic agent used in high doses to treat cancer) – if you are taking high-dose methotrexate, your doctor may temporarily discontinue your treatment with Losec.

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin together with Losec for the treatment of ulcers caused by Helicobacter pylori infection, it is very important that you inform 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, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine. Your doctor will decide whether you can take Losec during this time.

Omeprazole is excreted in breast milk, but it is unlikely to affect the infant when used at therapeutic doses. Your doctor will decide whether you can take Losec while breastfeeding.

Driving and using machines

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

Losec capsules contain lactose

Losec capsules contain lactose. If you have been diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.

Losec capsules contain less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially 'sodium-free'.

3. How to take Losec

Take this medicine exactly as directed by your doctor or pharmacist. If you are unsure, consult 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 symptoms of GERD, such as heartburn and acid regurgitation:

• If your doctor has informed you that your esophagus is slightly damaged, the recommended dose is 20 mg once daily for 4–8 weeks. Your doctor may increase the dose to 40 mg for an additional 8 weeks if the esophagus has not yet fully healed.
• Once the esophagus has healed, the recommended dose is 10 mg once daily.
• If the esophagus is not damaged, the usual dose is 10 mg once daily.

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

• The recommended dose is 20 mg once daily for 2 weeks. Your doctor may extend treatment with 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 daily for 4 weeks.

For the treatment of stomach ulcers (gastric ulcer):

• The recommended dose is 20 mg once daily for 4 weeks. Your doctor may extend treatment with 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 daily for 8 weeks.

For preventing the recurrence of duodenal and gastric ulcers:

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

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

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

For preventing the formation of duodenal and gastric ulcers if you are using NSAIDs:

• The recommended dose is 20 mg once daily.

For the treatment of ulcers caused by Helicobacter pylori infection and prevention of their recurrence:

• The recommended dose is 20 mg of Losec twice daily for one week.
• Your doctor will also instruct you to take two antibiotics selected from amoxicillin, clarithromycin, and metronidazole.

For the treatment of excessive stomach acid caused by pancreatic tissue overgrowth (Zollinger-Ellison syndrome):

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

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

• Losec may be taken by children over 1 year of age and weighing more than 10 kg. The dose for children is based on body weight, and the exact dose will be determined by the doctor.

For the treatment and prevention of recurrence of ulcers caused by Helicobacter pylori infection:

• Losec may be taken by children over 4 years of age. The dose for children is based on body weight, and the exact dose will be determined by the doctor.
• Your doctor will also prescribe two antibiotics called amoxicillin and clarithromycin for your child.

How to take this medicine

• 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. The capsules must not be chewed or crushed, as they contain coated granules designed to prevent the medicine from being broken down by stomach acid. 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 capsule and take the contents directly with half a glass of water, or pour the contents into a glass of water (non-carbonated), into acidic fruit juice (e.g., apple, orange, or pineapple), or apple puree.
• Always shake the mixture before drinking (the mixture will not be clear), and drink it immediately or within 30 minutes.
• To ensure you have taken the full dose, rinse the glass thoroughly with half a glass of water and drink the rinse water. The solid particles contain the medicine—do not chew or crush them.

If you take more Losec than you should
If you take more Losec than 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 for your next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.
If you stop taking Losec
Do not stop taking Losec without first discussing it with your doctor or pharmacist.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you experience 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 Losec and contact 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. There may also be severe blistering with bleeding of the lips, eyes, mouth, nose and genitals. This could be “Stevens-Johnson syndrome” or “toxic epidermal necrolysis”. (very rare)
• Widespread rash, high body 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 occur early in treatment (acute generalised exanthematous pustulosis). (rare)
• Yellowing of the skin, dark urine and tiredness could be symptoms of liver problems. (rare)

Other side effects include:
Common side effects (may affect up to 1 in 10 people)

• Headache.
• Stomach or intestinal problems: diarrhoea, stomach pain, constipation, passing wind (flatulence).
• Feeling unwell (nausea) or being unwell (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, drowsiness.
• Feeling of spinning (vertigo).
• Changes in blood tests related to liver function.
• Skin rash, skin rash with skin swelling (urticaria) and itching of the skin.
• General feeling of being unwell and lack of energy.
• If you take a proton pump inhibitor such as Losec, especially for longer than one year, there may be a slight increase in the risk of fractures of the hip, wrist or spine. If you have osteoporosis or are taking corticosteroids (which may 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 reduced numbers of white blood cells or platelets. This may cause weakness and easy bruising, or may make infections more likely.
• Low levels of sodium in the blood. This may cause weakness, feeling unwell (vomiting) and cramps.
• Restlessness, confusion or depression.
• Altered taste.
• Vision problems, such as blurred vision.
• Sudden wheezing or breathlessness (bronchospasm).
• Dry mouth.
• Inflammation inside the mouth.
• An infection called “candidiasis” which may affect the intestine and is caused by a fungus.
• Hair loss (alopecia).
• Skin rash during exposure to sunlight.
• Joint pain (arthralgia) or muscle pain (myalgia).
• Severe kidney problems (interstitial nephritis).
• Increased sweating.

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

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

Not known (frequency cannot be estimated from available data)

• Inflammation of the intestine (resulting in diarrhoea).
• If you take Losec for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as fatigue, involuntary muscle contractions, confusion, seizures, dizziness, increased heart rate. If you experience any of these symptoms, consult your doctor immediately. Low magnesium levels may also lead to reduced levels of potassium or calcium in the blood. Your doctor should decide whether to monitor your blood magnesium levels periodically.
• Reduced calcium levels in the blood (hypocalcaemia). Reduced calcium levels in the blood may result from very low magnesium levels.
• Reduced potassium levels in the blood (hypokalaemia).
• Erythema, possible joint pain.

In very rare cases, Losec may affect white blood cells, leading to immunodeficiency. If you develop an infection with symptoms such as fever with a severe deterioration in your general health, or fever with symptoms of local infection such as neck, throat or mouth pain, or difficulty urinating, you should consult your doctor as soon as possible to rule out a lack of white blood cells (agranulocytosis) by means of a blood test. It is important that in this case you inform your doctor about the medicine you are taking.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 carton, bottle, or blister after Exp. The expiry date refers to the last day of that month.
Do not store 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 via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Losec contains
The active substance 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 (containing shellac, ammonia, potassium hydroxide and black iron oxide E 172), anhydrous colloidal silica, liquid paraffin (see section 2, "Losec capsules contain lactose").

Description of the appearance of Losec and contents of the pack

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

Packs:

• 10 mg: Blister packs containing 14, 28 and 35 capsules.
• 20 mg: Blister pack containing 14 capsules.
• 40 mg: 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 European Economic Area Member States under the following names:

Other sources of information
More detailed information on this medicine is available on the website of the Italian Medicines Agency (AIFA) https://www.aifa.gov.it/.