PATIENT INFORMATION LEAFLET

BERLIND 75 RETARD

Indometacin 75mg Modified Release Capsules

The name of this medicine is Berlind 75 Retard, which will be referred to as Berlind throughout this leaflet.

Important things you need to know about this medicine:

■    Do not take Berlind if you have a peptic ulcer (ulcer in your stomach or duodenum) or bleeding in your stomach, or have had two or more episodes of peptic ulcers, stomach bleeding or perforation.

(See Section 2, 'Do not take').

■    Berlind can cause serious side effects in some people. (See Section 4, 'Possible side effects')

If you suffer from any of the following at any time during your treatment STOP TAKING the medicine and seek immediate medical help:

■    Pass blood in your faeces (stools/motions)

■    Pass black tarry stools

■    Vomit any blood or dark particles that look like coffee grounds.

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

■    Do not take Berlind in the last 3 months of pregnancy. If you are pregnant, planning to get pregnant or if you are breast-feeding, talk to your doctor. (See Section 2, 'Do not take' and 'Pregnancy and breast-feeding')

In this leaflet:
□	What Berlind is and what is it used for	4	Possible side effects
2	Before you take Berlind	5	How to store Berlind
3	How to take Berlind	6	Further information

|1 What Berlind is and what is it used for

Berlind belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAID). It is a painkiller and works by reducing inflammation and relieving pain, swelling and stiffness in the joints and muscles.

There are a number of painful conditions that can affect your joints and muscles, which can be helped by taking Berlind. These conditions include:

■    rheumatoid arthritis (inflammatory joint disease, which causes joints to become swollen, tender, warm and stiff)

■    osteoarthritis (degenerative joint disease which affects the cartilage, causing stiffness, pain and loss of movement in the joint)

■    ankylosing spondylitis (arthritis in the spine)

■    musculo-skeletal disorders

■    low back pain

■    joint disorders involving swelling (bursitis, tendinitis, synovitis, tenosynovitis and capsulitis)

■    control of pain and swelling after orthopaedic surgery

■    period pain (primary dysmenorrhoea)

■    degenerative disease of the hip

Before you take Berlind

Do not take Berlind:

■    If you are allergic (hypersensitive) to Indometacin, any of the other ingredients in these capsules (these are listed in section 6) or other NSAIDs

■    If you have taken other non-steroidal anti-inflammatory drugs (NSAIDs) before (including aspirin and ibuprofen) and had an allergic reaction, such as asthma, runny nose, swelling of the face or throat, redness and itching of the skin

■    If you are in the third trimester (last 3 months) of pregnancy (see 'Pregnancy and breast-feeding', Section 2)

■    If you have a peptic ulcer (ulcer in your stomach or duodenum) or bleeding in your stomach, or have had two or more episodes of peptic ulcers, stomach bleeding or perforation

■    If you have severe liver or kidney problems

■    If you have a history of stomach bleeding or perforation, which is related to taking NSAIDs

■    If you have a growth in your nose (nasal polyps)

■    If you have severe heart failure, which causes breathlessness, tiredness or you can feel your heart beat with the slightest exercise

■    If you are a child, or a parent wanting to give it to a child

Take special care with Berlind:

■    If you suffer from bronchial asthma or from allergies

■    If you have any problems with your stomach or intestine

■    If you have a history of inflammatory bowel or intestine disease such as ulcerative colitis or Crohn's disease, as these conditions may become worse whilst taking Berlind

■    If you have bleeding disorders or problems with your blood not clotting

■    If you have problems with your liver or kidneys.

■    If you have heart problems, high blood pressure or conditions which cause fluid retention

■    If you have systemic lupus erythematosus (SLE) or mixed connective tissue disorders with symptoms such as joint pain, skin rash or fever

■    If you are elderly, as you are more at risk of having side effects, especially stomach bleeding and perforation or kidney problems. You should start treatment on the lowest effective dose and treatment should last the shortest time possible.

■    If you experience scaling of the skin, blistering of the skin, mouth, eyes and genitals

■    If you currently have an infection (treated or not) or you are receiving treatment with live vaccines

■    If you are taking diuretics, have diabetes, low blood volume (symptoms include cold hands and feet, light headedness, infrequent urination, increased heart rate and weakness) or a serious blood infection (sepsis)

■    If you suffer from a mental disorder, epilepsy or parkinsonism (tremor, stiffness and shuffling)

■    If you have rheumatoid arthritis as eye changes may occur and periodic eye examinations are recommended

■    If you are receiving oral corticosteroids and selective serotonin-reuptake inhibitors (SSRI's)

Tell your doctor if any of the above applies to you.

Please note: Medicines such as Berlind 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 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, or any of the following:

■    Berlind should not be taken with the following:

■    Other non-steroidal anti-inflammatory drugs (NSAIDs) such as diflunisal, aspirin, ibuprofen, naproxen, diflofenac, used to treat psoriasis, rheumatoid arthritis and tumours.

■    Triamterine, used for fluid retention (diueretic 'water tablet')

Other medicines which may interact:

■    Cardiac glycosides, such as digoxin, used to treat heart conditions

■    Ciclosporin, used to treat some inflammatory diseases and after transplants

■    Mifepristone, used to terminate pregnancy. Berlind should not be used for 8 - 10 days after mifepristone has been given

■    Quinolone antibiotics, such as ciprofloxacin, used to treat bacterial infections

■    Tacrolimus, used to dampen down the body's immune response and may be used for severe skin complaints and following organ transplants

■    Methotrexate, used to treat some inflammatory diseases and cancers

■    Medicines used to thin the blood, such as warfarin (anticoagulants) and clopidogrel (antiplatelet)

■    Diuretics (water tablets), such as triamterine, furosemide and thiazides

■    Probenecid, used to treat gout

■    Medicines for high blood pressure, such as doxazosin (alpha blockers), captopril (ACE inhibitors), atenolol (beta blockers), losartan (angiotension II antagonists), hydralazine (vasodilators) and nifedipine (calcium channel blocker)

■    Corticosteroids, such as hydrocortisone, used for allergic disorders and rheumatic conditions

■    Lithium and haloperidol, used to treat depressive illness

■    Selective serotonin reuptake inhibitors (SSRIs), such as paroxetine, used to treat depression

■    Zidovudine, used to treat viral infections

■    Metformin for diabetes and sulphonylureas, such as glibenclamide

■    Phenytoin for epilepsy

■    Diazepam, used to treat anxiety, epilepsy and as a sedative

■    Baclofen, used as a muscle relaxant

■    Cyclophosphamide, used to treat certain cancers (chemotherapy drug)

■    Desmopressin, used for night time bed wetting (hormone preparation)

■    Tiludronic acid, used to treat bone disease

■    Pentoxifylline, used to treat vascular disease

Taking Berlind with food or drink:

Berlind capsules should be taken with food, milk or an indigestion remedy (antacid) in order to reduce the risk of stomach problems.

Pregnancy and Breast-feeding:

Ask your doctor or pharmacist for advice before taking any medicine.

Berlind 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.

During the first and second trimester of pregnancy, Berlind should not be given unless clearly necessary. If Berlind is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible.

If you are pregnant, Berlind must not be taken during the third trimester (last 3 months) of pregnancy. It should also not be taken during labour, unless told to do so by your doctor.

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If you are breast-feeding, you should ask your doctor or pharmacist for advice before taking Berlind, as small amounts of indometacin can pass into breast milk.

Driving and using machines:

You should not drive, operate machinery or carry out other activities requiring full alertness if you feel dizzy, drowsy, light-headed or have problems with your vision, whilst taking this medicine.

Important information about some of the ingredients:

Berlind contains lactose. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.

[3 How to take Berlind

Always take Berlind exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Dosage - The capsules should be taken with food, milk or an indigestion remedy (antacid) in order to reduce the risk of stomach problems. You should swallow the capsules whole with fluid.

The normal daily dose is:

Adults:

The usual dose is one 75 mg capsule once or twice a day.

Period Pain: One 75 mg capsule a day starting with the onset of cramps or bleeding and continuing for as long as symptoms usually last.

Children: These capsules are not recommended for children.

If you take more Berlind than you should - If you take more Berlind than you should, contact your doctor or nearest hospital emergency department immediately. Take the container and remaining capsules with you.

If you forget to take Berlind - If you forget to take Berlind take the next dose as soon as you remember. If your next dose is due within 3 hours, take a single dose straight away and skip the next. Do not take a double dose to make up for a forgotten dose.

If you stop taking Berlind - Do not stop taking Berlind without talking to your doctor, even if you feel better. It is important that you take the full course of Berlind prescribed by 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, Berlind can cause side effects, although not everybody gets them.

Very serious side effects - If you suffer from any of the following at any time during your treatment STOP TAKING Berlind and seek immediate medical help:

■    Pass blood in your faeces (stools/motions)

■    Pass black tarry stools

■    Vomit any blood or dark particles that look like coffee grounds

STOP TAKING Berlind and tell your doctor if you

experience:

■    Indigestion or heartburn

■    Abdominal pain (pains in your stomach) or other abnormal stomach symptoms.

Other serious side effects - If you suffer from any of the following STOP TAKING Berlind and tell your doctor immediately:

Allergic reaction, which may cause the following:

■    difficulty in breathing and dizziness (anaphylaxis), tight chest, breathlessness, wheezing, shortness of breath, swelling and irritation inside the nose, swelling of the face, throat or tongue, sore dry itchy skin, or severe skin rashes

■    blistering of the skin, mouth, eyes and genitals, scaling or peeling of the skin (Stevens-Johnson syndrome)

Liver problems, which may cause the following:

■    high temperature, feeling tired, loss of appetite, stomach pain, being sick (hepatitis)

■    yellowing of the skin or whites of the eyes (jaundice)

■    itchy rash, dark urine, pale stools, fever, excessive sweating

Kidney failure

■    swelling, especially of the legs and feet, little or no urine output, thirst and a dry mouth, rapid heart rate, feeling dizzy when you stand up, loss of appetite, feeling or being sick, feeling confused, anxious and restless or sleepy, pain on one side of the back, just below the rib cage

Blood problems which may cause the following:

■    sudden bruising or bleeding from multiple sites in the body

■    fever, chills, extreme tiredness, bruising, bleeding (bone marrow depression)

Aseptic meningitis

■    headache, fever, stiff neck, tiredness, feeling ill and your eyes become very sensitive to bright light. If you experience any of these symptoms seek medical attention immediately.

Other possible side effects:

Rare or infrequent side effects

■    loss of appetite    ■    abdominal discomfort

■    abdominal pain or worsening of the condition in patients with ulcerative colitis or Crohns's disease or development of this condition

■    increase in blood sugar    ■    sugar in urine

■    high levels of blood potassium which can cause abnormal heart rhythm

■    flushing    ■    blurred or double    vision

■    pain in or around the    eye    ■    nose bleed

■    complete or partial loss of vision due to inflammation of the optic nerve

■    reduction in blood platelets, which increases risk of bleeding or bruising

■    severe reduction in number of white blood cells or low level which makes infections more likely

■    severe reduction in blood cells which can cause weakness, bruising or make infections more likely

■    red or purple spots on the body

■    bruising

Other side effects reported

■    feeling or being sick    ■    constipation

■    diarrhoea    ■    wind    (flatulence)

■    indigestion    ■    stomach    pain

■    hair loss

■    itching, itchy rash, skin rash resulting from bleeding into the skin from small blood vessels, tender bruise like swellings on the shins

■    inflammation of the blood vessels

■    increased sensitivity of the skin to sunlight

■    sweating

■    worsening of skin disease, which causes scaly pink patches (psoriasis)

■    low blood pressure, which may cause light headedness, fainting or dizziness, especially when going from sitting or lying position to standing up.

■    faster or irregular heart, feeling your heart beat, chest pain

■    high blood pressure

■    swelling of hands, arms, feet, ankles and legs

■    shortness of breath or ankle swelling

■    blood in urine

■    inflammation of the kidney which can cause swollen ankles or high blood pressure

■    protein in urine

■    abnormal liver function tests (detected during liver blood tests)

■    visual disturbances

■    light-headedness

■    headache (usually disappears when treatment is continued or dose reduced. If headache persists treatment should be stopped)

■    tingling or numbness in the hands or feet

■    involuntary movements

■    difficulty sleeping

■    worsening of epileptic fits and Parkinsonism (tremor, stiffness and shuffling)

■    depression

■    feeling of dizziness or "spinning" (vertigo)

■    slurred, slow speech which is difficult to understand

■    fainting

■    coma

■    swelling in the brain

■    feeling nervous or anxious

■    mental problems such as feeling as things are not real (depersonalisation)

■    fits

■    weakness, tingling, numbness

■    confusion

■    seeing or hearing things that are not real

■    ringing in the ears

■    hearing problems (rarely deafness)

■    dizziness

■    feeling unwell

■    feeling tired

■    feeling sleepy

■    muscle weakness

■    acceleration of cartilage deterioration

■    vaginal bleeding

■    enlargement or tenderness of the breasts, including enlargement of breasts in men

If you have rheumatoid arthritis and been taking indometacin for a long time, you may experience deposits in the front surface of the eye (cornea) or effects on the back surface of the eye (retina).

Patients on long term therapy should have eye tests.

If you are taking medicines to treat high blood pressure or heart failure, you may experience chest pain, palpitations, and rapid or erratic heartbeat.

Medicines such as Berlind may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke

If any side effect gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How to store Berlind

Keep out of the reach and sight of children. Do not use

Berlind after the expiry date, which is shown on the label or carton. The expiry date refers to the last day of that month. Keep the capsule in a dry place below 25°C and protected from light, and in the original packaging. 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 Berlind 75 Retard contains

The active substance is Indometacin.

The other ingredients are sucrose, corn starch, lactose, povidone, talc, magnesium stearate, polymers of methacrylic acid, acrylic acid esters and methacrylic acid esters.

The capsule shell contains titanium dioxide (E171), erythrosine (E127), indigotine (E132), yellow iron oxide (E172) and gelatin.

What Berlind 75 Retard capsules look like and contents of the pack

Your medicine comes as hard gelatin capsules, with a dark blue cap and natural transparent body. The body is marked with 'IND 75'. Each capsule contains white and pale yellow pellets.

Berlind capsules are available in plastic containers containing 28 or 100 capsules. Not all pack sizes will be marketed.

Marketing Authorisation Holder and Manufacturer:

Tillomed Laboratories Ltd,

3 Howard Road,

Eaton Socon, St. Neots,

Cambridgeshire, PE19 8ET UK

Product Licence Number:

PL 11311/0452

The leaflet was revised in December 2012

Hard to Read? Phone 0800 970 6115 for help

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