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PATIENT INFORMATION LEAFLET

Tilomep 10mg, 20mg and 40mg gastro-resistant Capsules

(Omeprazole)

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.

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 elderly 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

continued....

Peptic ulcer disease infected with Helicobacter pylori (Hp) bacteria:

40mg once daily or 20mg twice daily in association with anti-microbial agents.

Preventing acid aspiration:

(for patients at risk of aspiration of the stomach contents during general anaesthesia)

40mg the evening before surgery and another 40mg 2-6 hours before surgery.

Zollinger-Ellison syndrome:

■    60mg once daily.

■    Your doctor will adjust your dose and length of treatment depending on how you respond to treatment.

■    In doses above 80mg daily, the dose should be divided and taken twice daily.

Patients with liver problems

A daily dose of 10-20 mg may be sufficient.

Use in Children:

In children over 2 years old with severe ulcerating oesophagitis. Tilomep is recommended for healing and relief of symptoms within the dose range 0.7-1.4mg/kg, to a maximum 40mg/day, for 4-12 weeks.

Treatment should be initiated by a hospital based paediatrician.

If you take more Tilomep than you should

If you accidentally take too many capsules, contact your doctor or nearest hospital emergency department immediately for advice. Remember to take this leaflet or any remaining capsules with you.

The symptoms of overdose include: feeling or being sick, dizziness, stomach pain, diarrhoea, headache. Also listlessness, depression and confusion have been reported in single cases.

If you forget to take Tilomep

Take it as soon as you remember, unless it is time for your next dose.

If you miss a dose do not take a double dose to make up for a forgotten dose.

If you stop taking Tilomep

It is important that you keep taking Tilomep until the prescribed dose has finished. Do not stop taking the capsules even though you may feel better. Do not stop or change your treatment before talking to your doctor.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects

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

Stop taking Tilomep and seek medical advice immediately if you develop the following symptoms:

Allergic reactions

■    Allergic reactions: swelling of the face, throat or tongue, fever, difficulty in breathing, dizziness

■    Severe blistering of the skin, mouth, eyes and genitals (Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis(TEN), erythema multiforme)

Common Side Effects (may affect up to 1 in 10 people)

■    Headache

■    Stomach pain

■    Constipation

■    Diarrhoea

■    Passing wind (flatulence)

■    Feeling sick (nausea) or being sick (vomiting)

Uncommon Side Effects (may affect up to 1 in 100 people)

Difficulty sleeping (insomnia)

Dizziness, light headedness, feeling faint Abnormal skin sensations e.g.tingling (paraesthesia) Sleepiness (somnolence)

A sensation of whirling and loss of balance, feeling dizzy or giddy (vertigo)

Increase in liver enzymes (detected through blood test) Skin rash or inflammation (dermatitis), severe itching (pruritus), red, raised, itchy skin rash (urticaria)

Fracture of the hip, wrist or spine (see Section 2, "Talk to your doctor...")

Generally feeling unwell (malaise)

Swelling of the ankles, feet or hands (oedema)

Rare Side Effects (may affect up to 1 in 1,000 people)

A reduction in the number of white cells in the blood Deficiency of platelets in the blood. This causes bleeding into the tissue, bruising, and slow blood clotting after injury

Abnormally low level of sodium in the blood; associated with dehydration

Confusion (reversible when treatment stops)

Agitation Depression Abnormal taste Blurred vision

Difficulty in breathing or wheezing (bronchospasm)

Dry mouth

Inflammation of the mouth (stomatitis)

Yeast infection

Persistent watery diarrhoea (microscopic colitis) Inflammation of the liver (hepatitis)

Yellowing of the skin or whites of the eyes (jaundice) Hair loss (alopecia)

Abnormal sensitivity of the skin to sunlight (photosensitivity)

Inflammation of the kidney (interstitial nephritis)

■    Painful joints (Arthralgia) muscles (myalgia)

■    Inability to maintain an erection (impotence)

■    Increased sweating

Very Rare Side Effects (may affect up to 1 in 10,000 people)

■    A deficiency of granulocytes in the blood, causing increased risk of infection

■    An abnormal deficiency in all blood cells (red blood cells, white blood cells and platelets)

■    Aggression

■    Seeing or hearing things that are not real (hallucinations)

■    Liver failure

■    Impaired brain function in patients with liver disease

■    Muscle weakness

■    Excessive development of the male breast (gynaecomastia)

Other Side Effects (frequency not known)

If you have been treated with Tilomep for at least three months there is a possibility that you may develop a severe electrolyte disturbance in which there is an abnormally low level of magnesium in the blood (hypomagnesaemia). Symptoms such as tiredness, muscle spasms , disturbed state of mind, convulsions, dizziness and faster heartbeat can occur but they may begin inconspicuously and be overlooked.

In most cases, this should improve after magnesium replacement and discontinuation of Tilomep.

For patients expected to be on long-term treatment or who take Tilomep with digoxin, your doctor should consider measuring your magnesium levels before starting Tilomep treatment and periodically during treatment.

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 internet at www.mhra.gov.uk/yellowcard. By reporting side effectc you can help provide more information on the safety of this medicine.

How to store Tilomep

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/blister after "EXP". The expiry date refers to the last day of that month.

Do not store above 25°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

Contents of the pack and other information

What Tilomep contain:

Each 10mg capsule contains 10mg of Omeprazole Each 20mg capsule contains 20mg of Omeprazole Each 40mg capsule contains 40mg of Omeprazole

The other ingredients are: sodium laurilsulfate, crospovidone, sugar spheres 18/20 (containing sucrose and maize starch), hard fat, glyceryl monostearate 40-50, talc, hypromellose 5cps, titanium dioxide (E171), methacrylic acid-ethyl acrylate copolymer (1:1), triethyl citrate, dimeticone.gelatin, titanium dioxide (E171) and printing ink (which contains shellac, black iron oxide (E172), soya lecithin and antifoam DC 1510).

The capsules also contain:

■    Tilomep 10mg: red iron oxide (E172)

■    Tilomep 20mg: indigo carmine (E132)

■    Tilomep 40mg: quinoline yellow (E104) and indigo carmine (E132)

What Tilomep looks like and contents of the pack

Capsule containing gastro-resistant granules.

■    Tilomep 10mg; Cap: Flesh coloured, coded TIL in black. Body: White, coded OME (with a 10 underneath) in black.

■    Tilomep 20mg; Cap: Powder blue coloured, coded TIL in black. Body: White, coded OME (with a 20 underneath) in black.

■    Tilomep 40mg; Cap: Green coloured, coded TIL in black. Body: White, coded OME (with a 40 underneath) in black.

Tilomep is available in:

Tilomep Capsules are available in packs of:

■    Tilomep 10mg and 20mg Capsules: 28

■    Tilomep 40mg Capsules: 7

Marketing Authorisation holder and Manufacturer:

ZeCare Ltd.

3 Howard Road, Eaton Socon,

St Neots, Cambridgeshire PE19 8ET,

UK

Product Licence Numbers:

Tilomep (Omeprazole)10mg gastro-resistant Capsules PL 24581/0021

Tilomep (Omeprazole) 20mg gastro-resistant Capsules PL 24581/0022

Tilomep (Omeprazole) 40mg gastro-resistant Capsules PL 24581/0023

This leaflet was last revised in September 2013

ZeCare³

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