Losec 20mg Capsules (Pack of 28)

Losec gastro-resistant tablets contains the active substance omeprazole. It belongs to a group of medicines called ‘proton pump inhibitors’. They work by reducing the amount of acid that your stomach produces.

Losec is used to treat the following conditions:

In adults:

• ‘Gastro-oesophageal reflux disease’ (GORD). This is where acid from the stomach escapes into the gullet (the tube which connects your throat to your stomach) causing pain, inflammation and heartburn.
• Ulcers in the upper part of the intestine (duodenal ulcer) or stomach (gastric ulcer).
• Ulcers which are infected with bacteria 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 can also be used to stop ulcers from forming if you are taking NSAIDs.
• Too much acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison
  syndrome).

In children:

Children over 1 year of age and ≥ 10 kg

• ‘Gastro-oesophageal reflux disease’ (GORD). This is where acid from the stomach escapes into the gullet (the tube which connects your throat to your stomach) causing pain, inflammation and heartburn. In children, the symptoms of the condition can include the return of stomach contents into the mouth (regurgitation), being sick (vomiting) and poor weight gain.

Children and adolescents over 4 years of age

• Ulcers which are infected with bacteria called ‘Helicobacter pylori’. If your child has this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

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 people) or very rare (may
affect up to 1 in 10,000 people) but serious side effects, stop taking Losec and contact a doctor
immediately:

• A red, scaly widespread rash with bumps under the skin and blisters accompanied by fever. The
  symptoms usually appear at the initiation of treatment (acute generalized exanthematous
  pustulosis). (rare)
• Reddening of the skin with blisters 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’. (very rare)
• Sudden wheezing, swelling of your lips, tongue and throat or body, rash, fainting or difficulties
  in swallowing (severe allergic reaction). (rare)
• Widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug
  hypersensitivity syndrome). (rare)
• Yellow skin, dark urine and tiredness which can be symptoms of liver problems. (rare)

Other side effects include:

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

• Headache
• Effects on your stomach or gut: diarrhoea, stomach pain, constipation, wind (flatulence)
• Feeling sick (nausea) or being 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 feelings such as “pins and needles”, feeling sleepy
• Spinning feeling (vertigo)
• Changes in blood tests that check how the liver is working
• Skin rash, lumpy rash (hives) and itchy skin
• Generally feeling unwell and lacking energy

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or
Apple App Store. By reporting side effects, you can help provide more information on the safety of
this medicine.

Before taking any medication, it is important to read the Patient Information Leaflet. You can find information leaflets for your medicines by typing them into the search bar at medicines.org, or by contacting us.

View the Patient Information Leaflet here. 

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Use in adults

To treat symptoms of GORD such as heartburn and acid regurgitation:

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

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 Losec treatment. Stop using Losec and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

Losec may hide the symptoms of other diseases. Therefore, if any of the following happen to you

before you start taking Losec or while you are taking it, talk to your doctor straight away:

• You lose a lot of weight for no reason and have problems swallowing
• You get stomach pain or indigestion
• You begin to vomit food or blood
• You pass black stools (blood-stained faeces)
• You experience severe or persistent diarrhoea, as omeprazole has been associated with a small increase in infectious diarrhoea
• You have severe liver problems
• You have ever had a skin reaction after treatment with a medicine similar to Losec that reduces stomach acid
• You are due to have a specific blood test (Chromogranin A)

If you take Losec on a long-term basis (longer than 1 year) your doctor will probably keep you under regular surveillance. You should report any new and exceptional symptoms and circumstances whenever you see your doctor.

Taking a proton pump inhibitor like Losec, especially over a period of more than one year, may slightly increase your risk of fracture in the hip, wrist or spine. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

If you get a rash on your skin, especially in areas exposed to the sun tell your doctor as soon as you can, as you may need to stop your treatment with Losec. Remember to also mention any other illeffects like pain in your joints.

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 < 10 kg.

The active substance is omeprazole. Each gastro-resistant tablet contains omeprazole magnesium corresponding to 10 mg, 20 mg or 40 mg omeprazole.

The other ingredients are cellulose microcrystalline, glycerol monostearate 40-55, hydroxypropylcellulose, hypromellose, magnesium stearate, methacrylic acid – ethyl acrylate copolymer (1:1) dispersion 30 per cent, sugar spheres, synthetic paraffin (NF), macrogol (polyethylene glycol 6000), polysorbate 80, crospovidone, sodium hydroxide (for pHadjustment), sodium stearyl fumarate, talc, triethyl citrate, iron oxide E172, titanium dioxide
E171. (See section 2, “Losec tablets contain sucrose”.)