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Patient Information Leaflet

Mobiflex¹

20 mg Tablets

Tenoxicam

In this leaflet:

1.    What Mobiflex is and what it is used for

2.    Before you take Mobiflex

3.    How to take Mobiflex

4.    Possible side effects?

5.    How to store Mobiflex?

6.    Further information

1. WHAT MOBIFLEX IS AND WHAT IT IS USED FOR

Mobiflex contains a medicine called tenoxicam. This is a 'Non Steroidal Anti Inflammatory Drug' or NSAID.

Mobiflex can lessen pain, swelling, redness and heat (inflammation) in:

•    Problems with your muscles, joints and tendons, like strains, sprains or injuries.

•    Arthritis.

2. BEFORE YOU TAKE MOBIFLEX

Do not take Mobiflex if you are allergic (hypersensitive) to:

•    Tenoxicam or any of the other ingredients of Mobiflex (see Section 6).

•    Aspirin, or any other NSAIDs (such as ibuprofen or diclofenac).

Do not take Mobiflex if:

•    You now have or have ever had any problems with your stomach or gut (intestine) like an ulcer or bleeding.

•    You have previously experienced bleeding or perforation in your stomach while taking NSAIDs.

•    You have severe problems with your kidneys, liver or heart.

•    You are in the last three months of pregnancy.

Do not take Mobiflex if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Mobiflex.

Take special care with Mobiflex

If you have heart problems, previous stroke or think that you might be at risk of these conditions (for example if you have high blood pressure, diabetes or high cholesterol or are a smoker) you should discuss your treatment with your doctor or pharmacist.

Check with your doctor or pharmacist before taking Mobiflex if any of the following apply to you:

•    Asthma or allergies (like hayfever) or have had swelling of the face, lips, eyes or tongue in the past.

•    You are elderly (you are more likely to suffer problems).

•    Problems with your kidneys or liver.

•    Problems with the way that your blood clots.

•    Low blood volume (caused by bleeding or severe dehydration).

•    Problems with the blood vessels (arteries) anywhere in your body.

•    Too much fat (lipid) in your blood (hyperlipi-daemia).

•    An autoimmune condition, such as 'systemic lupus erythematosus' (SLE, causes joint pain, skin rashes and fever) and ulcerative colitis or Crohn's disease (conditions causing inflammation of the bowel, bowel pain, diarrhoea, vomiting and weight loss).

•    You are going to have an operation, such as a replacement hip or other major surgery.

If any of the above apply to you, or if you are not sure, talk to your doctor or pharmacist before you take Mobiflex.

Taking other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.

This includes medicines that you buy without a prescription and herbal medicines. In particular, tell your doctor or pharmacist if you are taking:

•    Other NSAIDs, like aspirin, ibuprofen or diclofenac.

•    Medicines to stop your blood clotting, like warfarin, heparin or clopidogel.

•    Sulfonamide medicines, like hydrochlorothiazide, acetazolamide, indapamide and including sulfonamide antibiotics (for infections).

•    A sulfonylurea (for diabetes), like glimepiride or glipizide.

•    An 'ACE inhibitor' or any other medicine for high blood pressure like cilazapril, enalapril or propranolol.

•    A diuretic (water tablet) for high blood pressure, like furosemide.

•    A 'cardiac glycoside' (for heart problems), like digitoxin.

•    A steroid (for swelling and inflammation), like hydrocortisone, prednisolone and dexameth-asone.

•    A 'quinolone antibiotic' (for infections), like ciprofloxacin or moxifloxacin.

•    Lithium (for mental health problems).

•    Methotrexate (used to treat skin problems, arthritis or cancer).

•    Ciclosporin or tacrolimus (for skin problems or after an organ transplant).

•    Zidovudine (used to treat AIDS and HIV infections).

•    Mifepristone (used to end pregnancy or to bring on labour if the baby has died).

•    SSRI's (medicines used to treat depression such as fluoxetine, citalopram, paroxetine, fluvoxa-mine).

•    Antacids (used to treat conditions such as indigestion, heartburn).

If any of the above apply to you, or if you are not sure, talk to your doctor or pharmacist before you take Mobiflex.

Pregnancy and breast-feeding

•    Do not take Mobiflex if you are in the last three months of pregnancy, as it can harm your baby.

•    Talk to your doctor before taking Mobiflex if you are pregnant, think you are pregnant, plan to get pregnant or are breast-feeding. Your doctor will decide if you should take Mobiflex.

•    Mobiflex may make it more difficult to become pregnant. You should tell your doctor if you are planning to become pregnant or if you have problems becoming pregnant.

Driving and using machines:

Mobiflex may make you tired, drowsy, dizzy, have problems with your eyesight and balance, depressed or have difficulty sleeping. Talk to your doctor if any of these happen to you and do not drive or use any tools or machines.

Important information about some of the ingredients of Mobiflex:

This medicine contains lactose, which is a type of sugar. If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine.

3. HOW TO TAKE MOBIFLEX

Medicines such as Mobiflex may be associated (linked) with a small increased risk of heart attack ('myocardial infarction') or stroke. Any risk is more likely with higher doses and prolonged (longer term) treatment. Do not exceed (take more than) the recommended dose or duration (length) of treatment. Check with your doctor if you are not sure.

Swallow the tablets whole with a little water, preferably with or after food, at the same time each day.

While you are taking Mobiflex your doctor will want to see you to check you are on the right dose for you and look for any side effects. This is particularly important if you are elderly.

Children

Mobiflex is not recommended for use in children.

Adults

•    The usual dose is 1 tablet each day.

•    For sprains and strains, the usual length of treatment is up to 7 days (maximum 14 days).

The elderly and people with liver and kidney problems

Your doctor will decide your dose, it will usually be lower than that for other adults.

If you take more Mobiflex than you should

If you take more Mobiflex than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you.

If you forget to take Mobiflex

•    I f you forget to take a dose, skip the missed dose. Then take your next dose as normal.

•    Do not take a double dose to make up for a forgotten dose.

4. POSSIBLE SIDE EFFECT

Like all medicines Mobiflex can cause side effects, although not everyone will get them. Medicines such as Mobiflex may be associated with a small increased risk of heart attack ('myocardial infarction') or stroke.

Important side effects to look out for:

Stop taking Mobiflex and tell a doctor straight away if any of the following side effects happen. You may need urgent medical treatment:

Serious stomach or gut problems, signs include:

•    Bleeding from the stomach, seen as vomit which has blood in it, or bits that look like coffee grounds.

•    Bleeding from your back passage (anus), seen as passing black sticky bowel motions (stools) or bloody diarrhoea.

•    Ulcers or holes forming in your stomach or gut. Signs include upset stomach, stomach pain, fever, feeling or being sick.

•    Problems with your pancreas. Signs include severe stomach pain which spreads to your back.

•    Worsening of ulcerative colitis or Crohn's disease, seen as pain, diarrhoea, vomiting and weight loss.

Allergic reactions, signs include:

•    Sudden swelling of your throat, face, hands or feet.

•    Difficulty breathing, tightness in your chest.

•    Skin rashes, blisters or itching.

Severe skin rashes, signs include:

•    A severe rash that develops quickly, with blisters or peeling of your skin and possibly blisters in your mouth, throat or eyes. Fever, headache, cough and aching body may happen at the same time.

Liver problems, signs include:

•    Yellowing of your skin or the whites of your eyes (jaundice).

•    Feeling tired, loss of appetite, feeling or being sick and pale coloured stools (hepatitis) and problems (including hepatitis), shown in blood tests.

Heart attack, signs include:

•    Chest pain which may spread to your neck and shoulders and down your left arm.

Stroke, signs include:

•    Muscle weakness and numbness. This may only be on one side of your body.

•    A suddenly altered sense of smell, taste, hearing or vision, confusion.

Meningitis, signs include:

•    Fever, feeling or being sick, a stiff neck, headache, sensitivity to bright light and confusion (most likely in people with autoimmune conditions such as 'systemic lupus erythematosus'.

If you notice any of the serious side effects mentioned above, stop taking Mobiflex and tell your doctor straight away.

Other possible side effects: ^{2 1}

Eyes and ears

•    Changes to your eyesight, swollen or irritated eyes.

•    Ringing in the ears (tinnitus).

•    Dizziness that causes problems with your balance.

Heart and circulation

•    Swelling of your hands, feet or legs (oedema). This may be with chest pains, tiredness, shortness of breath (cardiac failure).

•    A fluttering feeling in your heart (palpitations), slow heart beat or high blood pressure.

•    Problems with the way your heart pumps blood around the body. Signs may include tiredness, shortness of breath, feeling faint, general pain.

Chest

Difficulty breathing, including shortness of breath, wheezing or coughing.

Skin and hair

•    Skin rashes including redness, hives, pimples and blisters on your hand, body or face.

•    Itching, skin being more sensitive to the sun or hair loss (alopecia).

•    Changes to your nails.

Urinary

•    Kidney problems.

Other

•    Feeling generally unwell.

•    A sore mouth or mouth ulcers.

•    Loss of appetite.

•    Weight loss or gain.

•    Problems for women in getting pregnant

•    Nosebleeds.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE MOBIFLEX

•    Do not store above 30 °C.

•    Keep out of the reach and sight of children.

•    Do not use Mobiflex after the expiry date printed on the pack.

•    Return any left over tablets to your pharmacist so that they can be disposed of carefully. Only keep them if your doctor tells you to.

6. FURTHER INFORMATION

What Mobiflex contains

The active substance in 'Mobiflex Tablets 20 mg' is tenoxicam. Each tablet contains 20 mg (milligrams) of tenoxicam. Other ingredients are lactose, maize starch, magnesium stearate, talc, hypromellose, titanium dioxide (E171) and yellow iron oxide (E172).

What Mobiflex looks like and contents of the pack

Mobiflex tablets are oval in shape, greyish-yellow in colour and marked with 20 on one side and with a break line on the other. Mobiflex tablets are supplied in blister packs containing 30 tablets.

Marketing Authorisation Holder

Meda Pharmaceuticals Ltd Skyway House Parsonage Road Takeley

Bishop's Stortford CM22 6PU

Manufacturer responsible for batch release

Cenexi

52, rue Marcel et Jacques Gaucher 94120 Fontenay-sous-Bois France

MEDA Pharma GmbH & Co. KG Benzstrasse 1 61352 Bad Homburg Germany

This leaflet was last approved in 11/2013

56UK1955130-00-R

Studio Oberlander • Rubensstrasse 33 • 60596 Frankfurt am Main • Germany

Tel. +49 69 631520-85 • Fax +49 69 631520-87 • E-Mail: info@studio-oberiaender.de

Gebrauchsinformation mock-up			PICDA
Hersteller:	MEDA Pharma GmbH & Co. KG		Benutzte Farben:
Produkt:	Tilcotil	m	Black
	20 mg
Meda-Nr.:	56UK1955130-00-R
Herst.-Nr.:			Land: United Kingdom
Laetuscode:
GroBe:	125 x 315 mm		Korrektur: 1.
Text:	6,5 pt / 7,5 pt		Datum: 23. 01. 2014

0114_GI_Tilcotil_20mg_56UK1955130-00-R.indd 3 23.01.14 18:11

1

   Confusion or nervousness.

Nervous system

•    Headache.

•    Feeling dizzy, light-headed or sleepy.

•    Pins and needles or numbness of your hands and feet.

2

Stomach and gut

•    Heartburn, indigestion, stomach ache, feeling sick, constipation, diarrhoea, wind.

Blood

•    Blood problems, like anaemia or changes to the numbers of white blood cells.

•    High blood sugar (hyperglycaemia).

Mental illness

•    Having difficulty sleeping or changes in your patterns of dreaming.

•    Depression.

•    Seeing or possibly hearing things that are not there (hallucinations).