Motifene 75mg Capsules
Motifene 75mg Capsules
(diclofenac sodium)
PACKAGE LEAFLET: INFORMATION FOR THE USER
Your medicine is available using the name Motifene 75mg Capsules, but it will be referred to as Motifene throughout this leaflet.
Read all of this leaflet carefully before you start taking this medicine.
■ 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. Do not give it to anyone else. It may harm them, even if their symptoms are the same as yours.
■ If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What is Motifene and what is it used for?
2. Before you take Motifene
3. How to take Motifene
4. Possible side effects
5. How to store Motifene
6. Further information
1. What is Motifene and what is it used for?
Diclofenac sodium, the active ingredient in Motifene, is one of a group of medicines called non-steroidal 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 (gastro-resistant 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. Before you take Motifene Do not take the capsules if
■ you have had an allergic reaction to any of the ingredients in Motifene (see '6. Further information' below)
■ you have had an allergic reaction to ibuprofen, aspirin or other NSAIDs
■ 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, ministroke (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)
■ you are in the last three months of pregnancy
■ 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.
Take special care with Motifene
Make sure your doctor knows, before you are given Motifene
■ If you smoke
■ If you have diabetes
■ If you have 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:
■ Asthma, hayfever 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.
If you have heart problems, previously had a 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
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. You may still be able to take Motifene if you are taking these medicines, but you must discuss this matter with your doctor and be advised before taking any of the medicines listed below:
■ Other 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
■ Ciclosporin 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)
■ Selective 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)
Children
These capsules are not suitable for children.
Elderly patients
If you are elderly, your doctor may want to monitor you carefully while you are taking Motifene.
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 the capsules" 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.
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 you are affected, do NOT drive or operate machinery.
3. How to take Motifene
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.
Dosage
The usual 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 Motifene are taken in any 24 hour period.
Tell your doctor if you have any concerns about your treatment.
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 missed 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 one you forgot and do not take more than two capsules in 24 hours.
4. Possible side effects
Like all medicines, Motifene 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 notice 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.
You should tell your doctor or pharmacist if you notice any of the side effects listed below or any others not mentioned. You will be advised if you need to stop the medicine. (If any of them is severe stop the medicine and then tell your doctor.)
Other common side effects include:
Sickness, feeling sick, flatulence, diarrhoea, constipation (including blockages), problems swallowing, loss of appetite, swelling of the tongue.
Other less common side effects include:
Kidney problems, urinary problems (e.g. any change in the usual amount or colour of the urine), liver problems, jaundice (yellowing of the skin or whites of the eyes), blurred vision, double vision, headache, pins and needles, stiff neck, depression, confusion, hallucinations, tinnitus (ringing in the ears), dizziness or giddiness, feeling unwell, tiredness, sleepiness, sensitivity to light, rashes and spots, flaky skin, changes in blood test results.
Reports of isolated cases include:
Memory problems, disorientation, impaired hearing, insomnia, irritability, fits, anxiety, nightmares, tremor, mood changes, changes in taste, hair loss, eczema and unusual bruising.
Very rare reports include:
Skin rashes, blisters on the skin and sore mouth/eyes, inflammation of the pancreas.
Other effects:
Medicines such as Motifene may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke. Other side effects reported in association with non-steroidal antiinflammatory drugs include swelling caused by a build-up of fluid (known as 'oedema'), high blood pressure palpitations, chest pain and heart failure.
Your doctor may require you to have occasional check-ups while you are taking Motifene.
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
Do not store above 25°C.
Keep out of the sight and reach of children.
Do not take these capsules after the expiry date indicated on the carton and blister labels. The expiry date refers to the last day of that month. Return any unused capsules to your pharmacist for safe disposal.
If your capsules become discoloured or show any signs of deterioration, take them to your pharmacist who will advise you.
If your doctor tells you to stop taking the capsules, please take them back to the pharmacist. Only keep the capsules if your doctor tells you to.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Further information What Motifene contains
Each modified-release capsule contains diclofenac sodium 75mg (25mg as enteric coated pellets & 50mg as sustained-release pellets).
Your capsules also contain the following inactive ingredients: microcrystalline cellulose, polyvidone K-value 25, silicon dioxide colloidal, methacrylic acid copolymer Type C, propylene glycol, talc, eudragit RS 100, eudragit RL 100, triethyl citrate, indigotine E132, titanium oxide E171, purified water, gelatine, printing ink (shellac, soy lecithin, antifoam DC 1510).
What Motifene looks like and contents of the pack
Motifene are hard gelatine capsules with a light blue opaque cap and a colourless transparent body marked in white print with 'D75M'.
They are available in packs of 30 and 60 capsules.
Manufacturer
Manufactured by: Temmler Werke GmbH, Weihenstephaner Str. 28, 81673 Munich, Germany.
Or
Temmler Ireland Ltd., Killorglin, County Kerry, Banshagh, Ireland.
Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: BR Lewis Pharmaceuticals Ltd.,
Kirk Sandall, Doncaster, DN3 1QR.
PL No: 08929/0264 POM
Leaflet issue and revision date (Ref): 13.02.15
Motifene® is a registered trademark of Temmler Werke GmbH.
To listen to or request a copy of this leaflet in Braille, large print or audio contact 01302 365000 and ask for the Regulatory Department.
Please be ready to give the following information:
Product name Motifene 75mg Capsules
Reference number 08929/0264
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