PARDELPRIN MR CAPSULES 75MG

Active substance: INDOMETHACIN

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Pardelprin MR 75mg capsules
Indometacin modified release capsules
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, ask your doctor or pharmacist.
If any of the side effects gets serious or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to others. It may harm
them, even if their symptoms are the same as yours.
In this leaflet:
1.
What Pardelprin MR capsules are and what they are used for
2.
Before you use Pardelprin MR capsules
3.
How to use Pardelprin MR capsules
4.
Possible side effects
5.
How to store Pardelprin MR capsules
6.
Further information

1.

What Pardelprin MR capsules are and what they are used for

Pardelprin MR capsules belong to a group of medicines called non-steroidal anti-inflammatory drugs
(NSAIDs). These medicines are pain killers which reduce swelling.
Pardelprin MR capsules are for:
inflammatory diseases of the joints such as rheumatoid arthritis, osteoarthritis and degenerative
hip disease
disorders occurring around a joint such as inflammation of:
- fluid surrounding a joint (bursitis)
- tendons (tendinitis)
- a joint membrane (synovitis)
- the lining of a tendon (tenosynovitis)
- the capsule surrounding a joint (capsulitis)
pain and stiffness in the backbone (ankylosing spondylitis)
sprains and strains (acute muscle and bone disorders)
lower back pain
pain and swelling following muscle or bone surgery
period pain.

2.

Before you take Pardelprin MR capsules

Do not take Pardelprin MR capsules if you:
are in the last three months of pregnancy
are allergic (hypersensitive) to indometacin or any of the ingredients of Pardelprin MR capsules
(see section 6)
are allergic (hypersensitive) to aspirin, ibuprofen or other NSAIDs or you have developed signs
of asthma (wheezing), runny nose, swelling of the face, lips, tongue or throat or a skin rash with
pale or red irregular raised patches with severe itching, when taking these medicines
are taking other NSAIDs (e.g. Naproxen) or COX II inhibitors (e.g. Celecoxib)
suffer with angioneurotic oedema (swelling of the face, lips, tongue or throat)
have or have had a history of two or more episodes of peptic ulcer (ulcer in your stomach or
duodenum) or bleeding in your stomach or intestines in the past. Symptoms may include
vomiting particles that look like coffee-grounds, black tarry stools and blood in your faeces
(stools/motions)
have severe liver, kidney or heart problems
have had bleeding in your stomach or intestines or perforation after taking NSAIDs
have nasal obstruction (nasal polyps).

Pardelprin MR capsules must not be used in children.

Check with your doctor before taking Pardelprin MR capsules if you are:
elderly (see Other warnings)
to have a vaccination with a live vaccine
a woman trying to become pregnant or undergoing investigation for infertility. Indometacin
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
taking a medicine which is poisonous to the kidneys such as cisplatin or vancomycin.

or if you have:
a history of high blood pressure or congestive heart failure
a bleeding or blood clotting disorder
mental health problems e.g. mood changes
epilepsy
Parkinson’s Disease (tremor, stiffness and shuffling)
any infection or sepsis (severe infection)
any liver, kidney or heart problems
fluid retention which may be caused by diseases of the heart or kidneys
asthma or a history of asthma
have or have a history of gastrointestinal diseases such as ulcerative colitis or Crohns disease
systemic lupus erythematosus (SLE) or other connective tissue disorders
diabetes
a decreased amount of fluid around the cells of the body (extracellular volume depletion)
peripheral arterial disease (a problem with the circulation in the legs).
Other warnings
If you are elderly or you have previously had stomach ulcers, you have a higher risk of getting
side effects, especially from the stomach. Your doctor should therefore prescribe the lowest dose
that gives you sufficient relief. If you experience any unusual symptoms from the stomach, you must
tell your doctor about it.
Medicines such as indometacin 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.
If you have heart problems, previous stroke or think 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 a pain killer too often or for too long can make headaches worse.

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, particularly:
other non-steroidal anti-inflammatory drugs (NSAIDs) including aspirin, naproxen or COX II
inhibitors (e.g. celecoxib) or diflunisal (for pain and inflammation)
quinolone antibiotics e.g. ciprofloxacin (to treat infections)
medicines which thin the blood or which prevent blood clotting, such as warfarin or antiplatelet
drugs such as clopidogrel
selective serotonin reuptake inhibitors (SSRIs) e.g. fluoxetine (for depression)
metformin or sulphonylureas e.g. gliclazide (for diabetes)
phenytoin (for epilepsy)
diazepam (for anxiety, difficulty sleeping, alcohol withdrawal, seizures and muscle spasm)
medicines used to treat high blood pressure such as beta blockers (e.g. atenolol), alpha blockers
(e.g. prazosin), ACE inhibitors (e.g. lisinopril), angiotensin II receptor antagonists (e.g.
valsartan), hydralazine (vasodilator) or nifedipine
haloperidol (an antipsychotic drug)

zalcitabine, zidovudine or ritonavir (for viral infections)
cardiac glycosides e.g. digoxin (for heart failure and irregular heart beat)
ciclosporin, tacrolimus or muromonab-CD3 (to suppress the immune system)
corticosteriods e.g. prednisolone (used in many different diseases)
cyclophosphamide or methotrexate (to treat some types of cancer and rheumatoid arthritis)
desmopressin (for diabetes insipidus and frequent urination during the night)
diuretics (water tablets) such as triamterene, thiazides (e.g. bendroflumethiazide) or
furosemide
lithium (for some mental health problems)
mifepristone (for termination of pregnancy). Pardelprin MR capsules should not be taken within
8-12 days of taking mifepristone
baclofen (a muscle relaxant)
pentoxifylline (for blood vessel disease and leg ulcers)
probenecid (for gout)
tiludronic acid (for Paget’s disease of bone).

Pregnancy and breast-feeding
If you are in the last three months of pregnancy you must not take Pardelprin MR capsules. You
should only take Pardelprin MR capsules in the first six months of pregnancy or if you are breastfeeding under medical supervision. Always ask your doctor before taking any medicine.

Driving and using machines
Pardelprin MR capsules may make you feel drowsy, dizzy or affect your vision. Make sure you are
not affected before you drive or operate machinery.

Sugar intolerance
If a doctor has told you that you have an intolerance to some sugars, contact your doctor before
taking this medicine, as it contains sucrose and lactose.

Tests
Your doctor may want to carry out tests to monitor your kidney and liver function, the levels of
blood cells and the effects on your stomach and intestines (especially if you are elderly). If you have
or have had a history of high blood pressure or heart failure your doctor may also want to monitor
you. If you have rheumatoid arthritis you may be advised to have regular eye tests to check your
sight.

Surgery
If you are about to have, or have recently had surgery, please contact your doctor before using this
medicine.

3.

How to take Pardelprin MR capsules

Always take Pardelprin MR capsules exactly as your doctor has told you. If you are not sure, check
with your doctor or pharmacist.
Swallow the capsules with or after food or milk to reduce side effects on the stomach and
intestines.
Dose
Adults:
One capsule once or twice a day, depending on your response. For period pain, take one capsule a
day starting when cramps or bleeding begin and continue for as long as symptoms last.
Elderly:
If you are elderly, your doctor will give you the lowest effective dose for the shortest amount of
time.
Children:
Pardelprin MR capsules must not be used in children.

If you take more Pardelprin MR capsules than you should
It is important not to take too many capsules. Contact your doctor or nearest hospital casualty
department immediately, if you have taken more capsules than you should or a child
accidentally swallows any. Symptoms of overdose are pain in the upper part of the stomach,
bleeding in the stomach or intestines, diarrhoea, disorientation, excitation, coma, dizziness, ringing
or buzzing in the ears, fainting, fits, liver damage, feeling or being sick, stomach pain, loss of
appetite, drowsiness, headache, restlessness, agitation and kidney failure.

If you forget to take Pardelprin MR capsules
If you forget to take your capsules, take the missed dose as soon as you remember, unless it is
nearly time for your next dose. Do not take a double dose to make up for one you have missed.

4.

Possible side effects

Like all medicines, Pardelprin MR capsules can cause side effects, although not everybody gets
them.
STOP TAKING the medicine and seek immediate medical help if you develop any of the following
at any time during your treatment:
signs of bleeding in the stomach:
- Pass blood in your faeces (stools/motions)
- Pass black tarry stools
- Vomit any blood or dark particles that look like coffee grounds
signs of an allergic reaction:
- difficulty breathing or swallowing, asthma, sudden decrease in blood pressure
- swelling of the face, lips, tongue or throat.
STOP TAKING the medicine and tell your doctor if you experience:
indigestion or heartburn
abdominal pain (pains in your stomach) or other abnormal stomach symptoms
effects on the stomach such as feeling or being sick, inflammation of the stomach lining, small
intestine or mouth, constipation, diarrhoea, wind, perforation of previous intestinal damage,
narrowing of or blockage in the intestine.
abnormal liver function (as seen in blood tests)
liver disease: yellowing of the skin or whites of the eyes (jaundice), inflammation of the liver
(hepatitis) causing fatigue, weakness, loss of appetite, weight loss, abdominal pain, fever
skin reactions such as itching, pale or red irregular raised patches with severe itching (hives),
disorder characterised by blood spots, bruising and discolouring of the skin (purpura), blisters or
skin that is red, flaky or peeling such as severe rash involving reddening, peeling and swelling of
the skin that resembles severe burns (toxic epidermal necrolysis), circular, irregular red patches
on the skin of the hands and arms (erythema multiforme), severe form of skin rash with
flushing, fever, blisters or ulcers (Stevens Johnson syndrome)
aseptic meningitis (stiff neck, headache, feeling or being sick, fever, disorientation) especially
in those who already have an auto-immune disease such as systemic lupus erythematosus or
mixed connective tissue disease.
Medicines such as Indometacin may be associated with a small increased risk of heart attack
(“myocardial infarction”) or stroke.
Tell your doctor if you notice any of the following side effects:
Blood:
- small purple red spots, nosebleeds, bruising, disorder characterised by blood spots, blood
clotting throughout the body, disturbance of blood count, reduction in blood cell production
by the bone marrow. If you notice increased bruising, nosebleeds, sore throats, infections,
excessive tiredness, breathlessness on exertion, or abnormal paleness of the skin, you
should tell your doctor who may want you to have a blood test.
Metabolism:
- high blood sugar

-

sugar in the urine
high blood levels of potassium (muscle cramps or pain, irregular heart beat, unusual
tiredness or weakness).

Eyes:
- blurred and double vision
- inflammation of the optic nerve (which may cause eye pain and loss of vision)
- eye pain
- changes in your sight.
Ear:
- ringing or buzzing in the ears
- hearing disturbances including deafness.
Nervous system:
- headache, dizziness, lightheadedness, spinning sensation (vertigo), tiredness, fainting,
coma, fluid in the brain causing swelling, a feeling of general discomfort and illness,
drowsiness
- depression, nervousness, confusion, hallucinations, anxiety and other mental health
problems, a feeling of unreality to the self (that the mind is separated from the body),
difficulty sleeping
- speech disorder, fits or seizures, worsening of epilepsy, disorder of the nerves causing
tingling and numbness, pins and needles, uncontrolled movements, worsening of
parkinsonism (tremor, stiffness and shuffling).
Heart:
- fluid retention causing ankle swelling, chest pain, heart failure
- high or low blood pressure
- racing heart beat, irregular heart beat, palpitations
Blood vessels:
- flushing.
Breathing:
- increase in the number of white blood cells in the lungs
- narrowing of the airways in those who have a history of asthma or allergic disease.
Stomach and intestines:
- loss of appetite
- development or worsening of ulcerative colitis or Crohns disease
- inflammation of the pancreas causing pain and tenderness in the abdomen and back
(pancreatitis).
Liver:
- blocked bile flow.
Skin:
- inflammation of blood vessels
- sensitivity to sunlight or artificial light (e.g. sun beds)
- tender red lumps usually on the legs (erythema nodosum)
- hair loss, sweating
- worsening of psoriasis (itchy scaly pink patches on the elbows, knees, scalp and other parts
of the body).
Muscle and bone:
- muscle weakness, increased breakdown of cartilage.
Kidneys:
- blood in the urine

-

nephrotic syndrome (increased protein in urine and fluid retention)
too much protein in the urine
inflammation of the kidneys, reduced kidney function or kidney failure.

Reproductive system:
- bleeding from the vagina
- breast enlargement or tenderness, enlarged breasts in men.
If you notice any of these side effects, or they get worse or you notice any side effects not
listed, please tell your doctor or pharmacist.

5.

How to store Pardelprin MR capsules

Keep out of the reach and sight of children.
Store in a dry place below 25°C.
Protect from light.
Do not take Pardelprin MR capsules after the expiry date which is stated on the label/carton/bottle.
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 Pardelprin MR capsules contain
The active substance (the ingredient that makes the medicine work) is indometacin. Each
capsule contains 75mg indometacin.
The other ingredients are sucrose, corn starch, lactose, povidone, talc, magnesium stearate,
polymers of methacrylic acid, acrylic acid esters, methacrylic acid esters, titanium dioxide
(E171), erythrosine (E127), indigotine (E132), yellow iron oxide (E172), gelatin, shellac glaze,
iron oxide black (E172).

What Pardelprin MR capsules look like and contents of the pack
Pardelprin MR capsules are dark blue (head) and clear (body), hard, gelatin capsules.
Pack size is 100.
Marketing Authorisation Holder
Actavis, Barnstaple, EX32 8NS, UK.
Manufacturer
Valpharma International SpA, Via G.Morgagni, 2 Pennabilli (PU), Italy.
This leaflet was last revised in June 2013.

If you would like a leaflet with larger text, please contact 01271
311257.

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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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