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MOTIFENE 75MG CAPSULES

Active substance(s): DICLOFENAC SODIUM

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Package Leaflet: Information for the user

Motifene® 75 mg Capsules
diclofenac sodium
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 any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to anyone else. 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:
1. What Motifene is and what it is used for
2. What you need to know before you take Motifene
3. How to take Motifene
4. Possible side effects
5. How to store Motifene
6. Contents of the pack and other information
1. WHAT MOTIFENE IS AND WHAT IT IS USED FOR
Diclofenac sodium, the active ingredient in Motifene, is one of a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs) and is used to reduce pain and inflammation. Some of
the pellets inside the Motifene capsule shell release diclofenac quickly to give a rapid effect (gastroresistant pellets). The remainder of the pellets dissolve more slowly to produce a longer lasting
effect (prolonged release pellets).
Motifene can be used for the treatment of pain and inflammation due to:
• Acute attacks of gout
• Acute musculo-skeletal disorders (for example frozen shoulder, inflamed tendons)
• Dental or other minor surgery
• Joint disorders (such as ankylosing spondylitis, osteoarthritis, rheumatoid arthritis)
• Traumatic conditions (including sprains, strains, dislocations, fractures)
• Low back pain.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MOTIFENE
Do not take Motifene:
• if you have had an allergic reaction to any of the ingredients in Motifene (see ‘What Motifene
contains’ below in section 6)
• if you have had an allergic reaction to ibuprofen, aspirin or other NSAIDs
• if you have severe liver, kidney or heart failure
• if you have established heart disease and /or cerebrovascular disease e.g. if you have had a heart
attack, stroke, mini-stroke (TIA) or blockages to blood vessels to the heart or brain or an operation
to clear or bypass blockages
• if you have or have had problems with your blood circulation (peripheral arterial disease)
• if you are in the last three months of pregnancy
• if you have a peptic ulcer (ulcer in your stomach or duodenum) or bleeding in your stomach (for
example, passed black tarry or bloody stools or vomited blood or dark particles that look like coffee
grounds), or have had two or more episodes of peptic ulcers, stomach bleeding or perforation.
If you think any of these apply to you, or you are unsure, do not take the capsules. Talk to your
­doctor first and follow the advice given.
Warnings and precautions
Talk to your doctor or pharmacist before taking Motifene, particularly if you have any of the following
health problems:
• Smoking
• Diabetes
• Angina, blood clots, high blood pressure, raised cholesterol or raised triglycerides
Talk to your doctor before taking Motifene if you are also taking other NSAIDs, as Motifene should
not be used at the same time as other NSAIDs.
If you have any of the following health problems, you may need to take special care while taking the
medicine as your condition could get worse:
• A
 sthma, hay fever or other allergies, polyps in your nose, difficulty breathing (COPD), long term
respiratory infections
• Crohn’s disease or ulcerative colitis
• SLE (Systemic Lupus Erythematosus), an inflammation of the connective tissue
• Heart, kidney or liver problems (your doctor may want to carry out some tests while you are taking
the capsules)
• High blood pressure
• Acute porphyria
• Blood clotting problems
Tell your doctor if you are about to have major surgery.
Because Motifene is a NSAID, it can make the symptoms of an infection (such as fever, pain) less
noticeable.
Medicines such as Motifene may be associated with a small increased risk of heart attack
­(“myocardial infarction”) or stroke. Any risk is more likely with high doses and prolonged treatment.
Do not exceed the recommended dose or duration of treatment.
Side effects may be minimised by using the lowest effective dose for the shortest duration necessary.
Older people
If you are older (65 years and over), your doctor may want to monitor you carefully while you are
taking Motifene.
Children and adolescents
Motifene is not recommended for children and adolescents under the age of 18.
Other medicines and Motifene
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, tell your doctor or pharmacist about any of the following:
• O
 ther painkillers or anti-inflammatory drugs (NSAIDs), including aspirin, or any other medicines
used to prevent platelet clumping
• Medicines to lower blood pressure (anti-hypertensives)
• Anti-coagulants, such as warfarin (to “thin” the blood)
• Anti-diabetic tablets
• Certain antibiotics, such as ciprofloxacin
• C
 iclosporin or tacrolimus (immunosuppressive medicines, used to dampen down the body’s
­immune reactions)
• Corticosteroids
• Mifepristone (for early termination of pregnancy)
• Heart drugs, such as digoxin
• Diuretics (“water tablets”), including the potassium-sparing type
• Lithium (a medicine used to treat mood swings and some types of depression)
• S
 elective serotonin reuptake inhibitors (SSRIs) (medicines used to treat some types of depression)
• Methotrexate (a medicine used to treat arthritis and some types of cancer)
• Zidovudine (a medicine used to treat HIV and AIDs)
• Phenytoin (used to treat epilepsy)
• Colestipol or cholestyramine (medicines used to lower cholesterol levels)
• Voriconazole (used to treat fungal infections)
• Sulfinpyrazone (used to treat gout)
Taking Motifene with food and drink
Motifene is best taken with or after food.
Pregnancy and breast-feeding
Tell your doctor before taking Motifene if you are pregnant or breast-feeding. As with other
non-steroidal anti-inflammatory drugs, Motifene may make it more difficult to become pregnant.
You should inform your doctor if you are planning to become pregnant or if you have problems
­becoming pregnant.
Motifene must not be taken during the last three months of pregnancy (see “Do not take Motifene”
above). It is not usually recommended at other stages of pregnancy, but you may be able to take it
if your doctor advises that it is necessary for you.
Motifene should be avoided if you are breast-feeding, as small amounts of the medicine may pass
into breast milk.
GB 112933

Driving and using machines
These capsules can cause some people to feel dizzy or giddy, drowsy or sleepy, tired or have
­problems with their vision. If this happens, do not drive or use machines until the symptoms wear
off. Ask your doctor for advice.
3. HOW TO TAKE MOTIFENE
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist
if you are not sure.
The recommended dose is one capsule of Motifene, once or twice a day as prescribed.
It is important that the second dose is taken 8 – 12 hours after the first dose and that no more than
two capsules of Motifene are taken in any 24 hour period.
Motifene must be swallowed whole with a drink of water (about half a glass). Do not chew or break
open the capsules. The capsules are best taken with or after food. It may help you to remember to
take your capsules if you take them at the same time every day, perhaps with breakfast or an evening
meal.
If you take more Motifene than you should
If you take more capsules than you should or if a child accidentally swallows some, go to your
­doctor or nearest emergency department immediately and take your medicine pack with you.
If you forget to take Motifene
If it is a little more than 12 hours since your previous dose, take the forgotten dose and then adjust
the timing of your next dose to 8 – 12 hours later. Do not take a double dose to make up for the
forgotten dose and do not take more than two capsules in 24 hours.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them. Taking
the lowest effective dose for the shortest possible time will minimise side effects.
Some side effects can be serious. STOP taking Motifene and tell your doctor ­immediately if you
have any of the following symptoms:
• Stomach ulcer or duodenal ulcer
• Passing blood in your faeces (stools/motions)
• Bleeding from the stomach or intestines (e.g. passing black ‘tarry’ stools)
• Vomiting blood or dark particles that look like coffee grounds
• Stomach pains or other abnormal stomach symptoms
• Indigestion or heartburn
• Worsening of Crohn’s disease or of ulcerative colitis
• Allergic reactions, which can include sudden wheeziness, difficulty in breathing, swelling of the face,
lips, hands or fingers, skin rash, itching, bruising, painful red areas, peeling or blistering.
These are the other side effects known about so far with Motifene:
Common side effects (may affect up to 1 in 10 people):
Headache, dizziness or giddiness, vertigo, sickness, feeling sick, flatulence, diarrhoea, loss of ­appetite
changes in blood test results, skin rashes
Rare side effects (may affect up to 1 in 1,000 people):
Liver problems including hepatitis and jaundice (yellowing of the skin or whites of the eyes), sleepiness, rashes and spots, swelling caused by a build-up of fluid (known as ‘oedema’).
Very rare side effects (may affect up to 1 in 10,000 people):
Memory problems, pins and needles, disorientation, impaired hearing, insomnia, irritability, fits, anxiety,
nightmares, tremor, mood changes, psychotic reactions, changes in taste, stiff neck, depression,
confusion, hallucinations, bleeding in the brain, feeling unwell, tiredness, tinnitus (ringing in the ears),
blurred vision, double vision, eye pain, constipation (including blockages), problems swallowing,
hair loss, eczema, unusual bruising, kidney problems, urinary problems (e.g. any change in the
usual amount or colour of the urine), severe liver problems including liver failure, sensitivity to light,
flaky skin, blisters on the skin and sore mouth/eyes, inflammation of the pancreas, swelling of the
tongue, high blood pressure, inflammation of the blood vessels, chest pain, palpitations, heart
­failure, inflammation of the lungs, changes in blood cell levels.
Medicines such as Motifene may be associated with a small increased risk of heart attack
­(“myocardial infarction”) or stroke.
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 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 MOTIFENE
Keep this medicine out of the sight and reach of children.
Motifene should not be stored above 25ºC.
Do not use this medicine after the expiry date printed on the box and on the blister strip. The expiry
date refers to the last day of that month.
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 protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Motifene contains
The active substance is diclofenac sodium.
Each hard gelatin capsule contains 75 mg diclofenac sodium.
The other ingredients are:
Gastro-resistant pellets:
Microcrystalline cellulose, Povidone K25, colloidal anhydrous silica, methacrylic acid ethyl acrylate
copolymer, propylene glycol, talc.
Prolonged-release pellets:
Microcrystalline cellulose, Povidone K25, colloidal anhydrous silica, ammonio methacrylate copolymer A and B, triethyl citrate, talc.
Capsule shell:
Indigocarmine (E132), titanium dioxide (E171), gelatin.
Capsule body:
Gelatin, ink (containing shellac, propylene glycol, titanium dioxide (E171)).
What Motifene looks like and contents of the pack
Motifene are blue and clear capsules and are marked ‘D 75 M’.
The capsules are available in packs of 2, 4, 28 and 56.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Daiichi Sankyo UK Ltd
Chiltern Place, Chalfont Park, Gerrards Cross, Buckinghamshire, SL9 0BG, UK
Manufacturer
Temmler Werke GmbH
Swiss Caps GmbH
Weihenstephaner Straße 28
Grassingerstraße 9
D-81673 Munich
83043 Bad Aibling
Germany Germany
This leaflet was last approved in May 2015

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or audio, please call, free of charge 0800 198 5000 (UK only)
Please be ready to give the following information:
Product name:    Motifene 75 mg Capsules
Reference Number: PL 08265/0003
This is a service provided by the Royal National Institute of
Blind People.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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