Tilomep 40mg Gastro-Resistant Capsules Omeprazole
Package leaflet: Information for the patient
Tilomep 10mg, 20mg and 40mg gastro-resistant Capsules
(Omeprazole)
Read all of 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 further questions, ask your doctor or your pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet (See Section 4).
What is in this leaflet:
j What Tilomep is and what it is used for H Possible side effects
2 What you need to know before you take Tilomep S How to store Tilomep
3 How to take Tilomep Q Contents of the pack and other information
□ What Tilomep is and what it is used for
The name of your medicine is Tilomep (Omeprazole) 10mg, 20mg and 40mg gastro-resistant Capsules (called Tilomep throughout this leaflet). It belongs to a group of medicines called Proton Pump Inhibitors.
Tilomep works by reducing the amount of acid in your stomach.
Tilomep is used to treat:
■ Oesophageal reflux disease including reflux oesophagitis. This happens when acid from your stomach leakes into your gullet (oesophagus) causing inflammation and pain
■ Ulcers in your stomach (gastric) or gut (duodenum)
■ Treatment and prevention of ulcers caused by NonSteroidal Anti-Inflammatory Drugs (NSAIDs), e.g. aspirin, ibuprofen, ketoprofen, piroxicam
■ Zollinger-Ellison syndrome (where the
stomach makes large amounts of acid). This can cause diarrhoea pain and weight loss
■ Relief of pain of indigestion or heartburn caused by too much acid in the stomach (acid-related dyspepsia)
■ Prevention of acid aspiration (damage to the lungs by breathing in stomach fluid during general anaesthesia)
■ Prevention and treatment of ulcers which are infected with a bacteria called Helicobacter pylori (Hp)
What you need to know Before you take Tilomep
Do not take Tilomep:
■ If you are allergic (hypersensitive) to Omeprazole, substituted benzimidazoles or any of the other ingredients of this medicine (see Section 6 "Contents of the pack and other information")
■ If you are taking medicines called atazanvir or nelfinavir (used to treat HIV - see Section 2 'Taking other medicines')
Warnings and precautions:
Talk to your doctor before taking Tilomep:
■ If there is a possibility that you may have a malignant growth (tumour) in your stomach. This possibility should be excluded first as treatment with Tilomep may alleviate symptoms and delay diagnosis. Possible symptoms of a malignant tumour may include: significant weight loss without trying, being sick (vomiting) possibly with blood, having pain &/or difficulty swallowing or dark tarry stools.
■ If you are on long term treatment and have or are at risk of having reduced levels of vitamin B12 in your body
■ If you are on long term treatment (especially over a period of one year) you should be regularly monitored by your doctor as this may slightly increase your risk of fracture in the hip, wrist or spine.
■ Tilomep may cause interference with laboratory tests. Increased CgA level may interfere with investigations for neuroendocrine tumours. To avoid this interference the Tilomep treatment should be temporarily stopped five days before CgA measurements.
■ If you have ever had a skin reaction after treatment with a medicine similar to Tilomep that reduces stomach acid.
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 Tilomep. Remember to also mention any other ill-effects like pain in your joints.
Other medicines and Tilomep
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. This includes herbal medicines.
Medicines which may interact with Tilomep:
■ Atazanavir, nelfinavir or saquinavir (used to treat HIV). Nelfinavir must not be taken with Tilomep. Atazanavir should only be taken with Tilomep if unavoidable and should be closely monitored
■ Clopidogrel (used to prevent blood clots)
■ Digoxin (used to treat heart problems)
■ Ketoconazole, itraconazole, voriconazole or posaconazole (used to treat fungal infections)
■ Erlotinib, Methotrexate (used to treat cancers). In high-dose methotrexate treatment a temporary withdrawal of Tilomep may need to be considered
■ Diazepam (used to relieve anxiety)
■ Phenytoin (used to treat epilepsy). You should be monitored during the first two weeks after starting
treatment with Tilomep and your doctor should reduce your dose of phenytoin
■ Cilostazol (used to treat intermittent claudication; a cramping pain in your legs when you walk)
■ Warfarin (used to thin the blood) and other Vitamin K blockers. Your doctor may need to monitor you and reduce your dose or Wafarin/Vitamin K Blockers
■ Tacrolimus (used to reduce the body's immunity when receiving organ transplant)
■ Clarithromycin, rifampicin (used to treat bacterial infections)
■ St John's Wort (herbal remedy, used to treat depression)
Pregnancy and Breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Pregnancy
Tilomep can be used during pregnancy as there is no evidence of adverse effects during pregnancy or on the health of the foetus/newborn child.
Breast-feeding
Tilomep is passed into the breast milk but is not likely to affect the child when therapeutic doses are used.
Driving and using machines
Tilomep is not likely to affect you being able to drive or use machinery. However, occasionally patients may feel dizzy or have visual problems whilst taking this medicine. If this is experienced, it is necessary to avoid driving or operating machinery.
Tilomep contains sucrose
If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.
How to take Tilomep
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
■ Swallow your capsules whole with a glass of water, before a meal. Do not crush or chew the capsules.
The recommended doses for adults and the older people are:
Oesphageal reflux disease, reflux oesophagitis:
■ 20mg once daily for 4 weeks.
■ If necessary your doctor may extend this treatment for a further 4 - 8 weeks.
■ In reflux oesophagitis which does not respond to other treatment, a dose of 40mg once daily may be given. Symptoms usually clear up within 8 weeks. Your doctor may tell you to continue with a dosage of 20mg once daily.
Acid reflux disease
10mg once daily for long term management. The dose may be increased to 20mg, if symptoms return.
Stomach and duodenal ulcers:
■ 20mg once daily for 4 weeks (duodenal ulcers) or 8 weeks (stomach ulcers).
■ For severe or recurrent ulcers, the dose may be increased to 40mg once daily.
■ 20mg once daily is recommended for long-term therapy in patients with a history of recurrent duodenal ulcer.
■ For prevention in patients with a duodenal ulcer, the recommended dose is 10mg once daily, increasing to 20mg once daily, if symptoms return. The following patients are at risk from recurrent ulcers: patients less than 60 years old, those whose symptoms continue for more than 1 year, smokers, patients with Helicobacter pylori infection. These patients will require initial longterm therapy with 20mg once daily, reducing to 10mg once daily, if necessary.
Indigestion caused by too much acid (acid-related dyspepsia):
10mg or 20mg once daily for 2-4 weeks
Ulcers of the stomach and duodenum caused by an NSAID:
20mg once daily Symptoms usually clear up within 4 weeks of treatment.
Preventing a stomach/duodenum ulcer and relief of symptoms while taking NSAIDs:
20mg once daily
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