Berlind 75 Retard – patient leaflet, side effects, dosage

1. What Berlind is and what it is used for

Berlind modified-release capsules contain a medicine called indometacin which belongs to a group of medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). Berlind is a pain-reliever and works by reducing inflammation, swelling and stiffness in the joints and muscles.

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

Berlind is used to treat the following conditions:

• Rheumatoid arthritis, osteoarthritis
• Ankylosing spondylitis (arthritis in the spine)
• Musculo-skeletal disorders such as sprains and strains
• Lower back pain
• Joint and tendon disorders (bursitis, tendinitis, synovitis, tenosynovitis and capsulitis)
• Inflammation, pain and swelling following bone, muscle or joint operations
• Period pain (primary dysmenorrhoea)
• Disease of the hip joint

2. What you need to know before you take Berlind

Do not take Berlind:

• If you are allergic to Indometacin, other NSAIDs or any of the other ingredients of this medicine (listed in section 6)
• If you have taken other NSAIDs before (including aspirin, ibuprofen, diclofenac and naproxen) and had an allergic reaction, such as asthma (wheezing), runny nose, swelling of the face, lips, tongue or throat (angioedema), skin rashes (see section 4 “Possible side effects”)
• If you are in the third trimester (last 3 months) of pregnancy (see ’Pregnancy’ section)
• If you currently have or have had a history (two or more episodes) of peptic ulcer (ulcer in your stomach or duodenum) or bleeding in your stomach or intestines. Symptoms may include vomiting particles that look like coffee-grounds, black tarry stools and blood in your faeces (stools/motions)
• If you have severe liver, kidney or heart problems
• If you have a history of stomach or intestinal bleeding or perforation after taking NSAIDs
• If you have a growth in your nose (nasal polyps)
• If you are taking any other NSAIDs (e.g. COX-2 inhibitors such as celecoxib, etoricoxib or lumiracoxib)
• If you have a blood clotting disorder

Berlind must not be used in children.

Warnings and precautions

Talk to your doctor before taking Berlind:

• If you are taking other NSAIDs such as aspirin (see “Other medicines and Berlind” section)
• If you suffer from or have a history of bronchial asthma
• If you have a history of ulcers, inflammatory bowel or intestinal disease (such as ulcerative colitis, diverticulitis, Crohn’s disease or cancer) as these conditions may become worse whilst taking Berlind. Treatment should commence on the lowest dose possible. Combination treatment with protective medicines should be considered and also if you require a low dose of aspirin, or other medicines likely to increase risk of stomach problems
• If you have bleeding disorders, blood clotting disorders or you have just had an operation
• If you suffer from liver problems
• If you have problems with your kidneys, as you should be closely monitored and a lower daily dose should be used
• If you are taking a medicine which is damaging to the kidneys such as cisplatin or vancomycin
• If you suffer from or have a history of heart problems, including high blood pressure, heart failure and heart disease or are at risk of heart disease (high cholesterol, diabetic, smoker). 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 suffer from conditions prone to fluid retention, as the use of NSAIDs may result in deterioration of kidney function and may cause fluid retention and swelling which may further aggravate these conditions. Your dose of Berlind should be kept as low as possible and kidney function should be monitored
• If you have Systemic Lupus Erythematosus (SLE) or mixed connective tissue disorders
• If you are a woman trying to conceive a baby or undergoing investigation for infertility (see ’Pregnancy and breast-feeding and fertility’ section). 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
• If you are elderly, as you are more at risk of having side effects, especially stomach bleeding and perforation. Treatment should commence on the lowest dose possible
• If you currently have an infection (treated or not) or you are receiving treatment with live vaccine as Berlind may mask the signs and symptoms of an infection, so antibiotic therapy should be started promptly if an infection occurs during treatment with Berlind
• If you are taking diuretics, have diabetes, low blood volume or a serious blood infection (sepsis)
• If you suffer from a mental disorder, epilepsy or parkinsonism (tremor, stiffness and shuffling) as Berlind may aggravate these disorders
• If you have rheumatoid arthritis as eye changes may occur and periodic eye examinations are recommended

• If you are taking corticosteroids, Selective Serotonin-Reuptake Inhibitors (SSRI’s), anticoagulants such as

  warfarin or anti-platelet medicines such as clopidogrel (see “Other medicines and Berlind” section)

  • If you have a decreased amount of fluid around the cells of the body (extracellular volume depletion)
  • If you have peripheral arterial disease (a problem with the circulation in the legs)

Taking painkillers for headaches too often or for too long can make them worse.

Tests

Your doctor may want to carry out tests to monitor your kidney and liver function, your sight, the levels of blood cells and the effects on your stomach and intestines (especially if you are elderly). If you have or have a history of high blood pressure or heart failure (when the heart is unable to pump blood effectively around the body) 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.

Other medicines and Berlind

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription. This includes herbal medicines. Berlind should not be taken with the following:

• Other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as diflunisal, aspirin, ketorolac, ibuprofen, naproxen or COX-2 inhibitors e.g. celecoxib
• Ritonavir, used to treat HIV and AIDS
• Triamterine, used to treat high blood pressure and water retention (diuretic)

Other medicines which may interact with Berlind:

• Cardiac glycosides, such as digoxin, used to treat heart conditions
• Ciclosporin, tacrolimus or muromonab-CD3, used to suppress the body’s immune system after an organ transplant
• Mifepristone, used in the termination of pregnancy. Berlind should not be used for 8−12 days after mifepristone has been given as it can reduce the effect of mifepristone
• Quinolone antibiotics, such as ciprofloxacin, used to treat bacterial infections
• Methotrexate or penicillamine, used to treat some cancers, psoriasis and rheumatoid arthritis
• Medicines used to thin the blood, such as warfarin (anticoagulants) and clopidogrel (antiplatelet)
• Diuretics, such as furosemide, thiazides, such as bendroflumethiazide, potassium-sparing diuretics such as amiloride, spironolactone
• Probenecid, used to treat gout
• Medicines for high blood pressure, such as doxazosin, prazosin (alpha blockers), captopril, lisinopril (ACE inhibitors), atenolol (beta blockers), losartan, valsartan (angiotension II antagonists), hydralazine, iloprost (vasodilators) and nifedipine (calcium channel blockers)
• Corticosteroids, such as hydrocortisone, prednisolone used to reduce inflammation
• Lithium and haloperidol, used to treat mental illness
• Selective Serotonin Reuptake Inhibitors (SSRIs), such as fluoxetine, paroxetine or venlafaxine, used to treat depression
• Zidovudine, zalcitabine used to treat viral infections
• Medicines used to treat diabetes such as metformin and sulfonylureas, such as glibenclamide
• Phenytoin used to treat epilepsy
• Diazepam, used to treat anxiety, as a sedative or for alcohol withdrawal
• Baclofen, used as a muscle relaxant
• Cyclophosphamide or erlotinib, 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 poor circulation
• Sibutramine (used to treat obesity)
• Phenylpropanolamine used to treat nasal congestion associated with colds, allergies, hayfever or other respiratory illness

Effects on laboratory tests

Berlind may cause a false-negative result in the Dexamethasone Suppression Test (DST).

Berlind with food, drink or alcohol

• Berlind should be taken with food, milk in order to reduce the risk of stomach problems.
• Avoid drinking alcohol as it may increase the risk of bleeding in the stomach.

Pregnancy and Breast-feeding and Fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

Do not take indometacin if you are in the last 3 months of pregnancy as it could harm your unborn child or cause problems at delivery. It can cause kidney and heart problems in your unborn baby. It may affect your and your baby's tendency to bleed and cause labour to be later or longer than expected. You should not take indometacin during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If you need treatment during this period or while you are trying to get pregnant, the lowest dose for the shortest time possible should be used. If taken for more than a few days from 20 weeks of pregnancy onward, indometacin can cause kidney problems in your unborn baby that may lead to low levels of amniotic fluid that surrounds the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the heart of the baby. If you need treatment for longer than a few days, your doctor may recommend additional monitoring.

Breast-feeding

If you are breast-feeding, you should ask your doctor for advice before taking Berlind, as small amounts of Indometacin (the active ingredient) can pass into breast milk, therefore, it should be avoided whilst breast-feeding.

Fertility

• 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
• If Berlind is used when attempting to conceive, the dose should be kept as low and duration of treatment as short as possible.

Driving and using machines

You should not drive, operate machinery or carry out other activities requiring full alertness if you feel dizzy, drowsy, tired or have headaches or problems with your vision, whilst taking this medicine. Alcohol can make these symptoms worse.

Berlind contains lactose and sucrose

If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.

Till-Ver.11 PACKAGE LEAFLET:

INFORMATION FOR THE PATIENT

Berlind 75

Retard

Indometacin

As stated in design

Package leaflet

Till-Ver.11

TW259603 (SmPC)

UK

[All]

[NA]

[TBA]

9 points (Reg text)

Till-Ver.10.1 TW163719 17/08/2026 17/08/2026

Black C

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.

• These capsules are to be taken orally and should be swallowed whole.
• These capsules should be taken with food or milk in order to reduce the risk of stomach problems.
• Side effects may be minimised by using the lowest effective dose for the shortest length of time necessary to control your symptoms

Adults

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

Period pain (dysmenorrhoea)

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

Elderly

• If you are elderly, you are more prone to side-effects. The lowest effective dose should be taken and for the shortest time possible.
• Your doctor will monitor you regularly for signs of gastrointestinal bleeding.

Use in children:

These capsules are not recommended for use in children or adolescents.

If you take more Berlind than you should

If you accidentally take too many capsules, contact your doctor or nearest hospital emergency department immediately for advice. Remember to take this leaflet or any remaining capsules with you.

Symptoms of overdose include: headache, feeling or being sick, stomach pain or bleeding, diarrhoea, feeling disorientated/confused, loss of balance, feeling excited, coma, drowsiness/tiredness, dizziness, ringing in the ears (tinnitus), pins & needles sensation, fainting, fits, loss of appetite, agitation. Kidney failure and liver damage are also possible.

If you forget to take Berlind

Take it as soon as you remember, unless it is nearly time for your next dose. If you miss a dose, do not take a double dose to make up for a forgotten dose.

If you stop taking Berlind

It is important that you keep taking this medicine for as long as your doctor has told you to.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Berlind can cause side effects, although not everybody gets them.

Seek medical advice immediately if you develop the following symptoms:

• Allergic reaction: swelling of the face, throat or tongue, difficulty breathing or dizziness (anaphylaxis)

• Other allergic reactions:

  o Difficulty in breathing, wheezing, shortness of breath

  (asthma, bronchospasm, dysponea)

  o Swelling and irritation inside the nose (rhinitis)

  o Severe itching (pruritus), skin rashes with the formation

  of wheals (urticaria), skin rash caused by small blood vessels bleeding into the skin (purpura), peeling of the skin over large areas of the body/blistering of the skin (exfoliative/bullous dermatoses)

  o Swelling of parts of the body (angioedema)

• Severe blistering of the skin, mouth, eyes and genitals (Stevens-Johnson syndrome, toxic epidermal necrolysis)
• Fever, general ill feeling, itching, joint aches, multiple skin lesions (erythema multiforme)
• Frequent wheezing, breathlessness, abdominal pain, diarrhoea, fever, cough and rashes due to an increase in certain white blood cells (eosinophilia)
• Pass black stools due to a bleed from the stomach or duodenum (first part of the small intestine) (melaena)
• Vomit any blood or dark particles that look like coffee grounds (haematemesis)

Other side effects (frequency not known):

• Loss of appetite (anorexia)
• Stomach problems including stomach pain/discomfort or worsening of the condition in patients with ulcerative colitis or Crohns's disease or development of this condition. Stomach ulcers, inflammation of the stomach (gastritis), inflammation of the pancreas (pancreatitis)
• Increase in blood sugar levels (hyperglycaemia)
• Sugar in the urine (glycosuria)
• High levels of blood potassium (hyperkalaemia)
• Flushing
• Visual disturbances including complete or partial loss of vision due to inflammation of the optic nerve (optic neuritis). Blurred and/or double vision (diplopia), pain in or around the eye (orbital/periorbital)
• If you have rheumatoid arthritis and have been taking Berlind 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). If you are on long term treatment you should have eye tests
• Nose bleeds (epistaxis)
• Reduction in blood platelets, which increases risk of bleeding or bruising (thrombocytopenia)
• A reduction in white blood cells (neutropenia, leucopenia)
• Severe reduction in number of white blood cells or low level which makes infections more likely (agranulocytosis)
• Severe reduction in blood cells which can cause weakness, bruising or make infections more likely (aplastic anaemia), reduction in red blood cells which can make the skin pale yellow and cause weakness or breathlessness (haemolytic anaemia)
• Abnormal condition of the bone marrow in which it is unable to produce normal amounts of red blood cells, white blood cells, and platelets leaving the immune system in a weakened state and vulnerable to infection (bone marrow depression)
• Broken blood vessels that form tiny pin-point red/purple spots on the skin (petechiae)
• Bruising (ecchymosis)
• Feeling (nausea) or being sick (vomiting)
• Constipation
• Diarrhoea
• Wind (flatulence)
• Indigestion (dyspepsia)
• Hair loss (alopecia)
• Blood clotting disorders
• Inflammation of the blood vessels (angiitis)
• Inflammatory condition that causes red, tender lumps to form just below the skin surface that usually affects the lower legs (erythema nodosum)
• Increased sensitivity of the skin to sunlight (photosensitivity)

• Sweating

  • Worsening of skin disease which causes scaly pink patches (psoriasis)
  • Low blood pressure (hypotension)
  • Heart problems including faster heartbeat (tachycardia), irregular heartbeat (arrhythmia), feeling your heartbeat (palpitations), chest pain, heart failure
  • Medicines such as Berlind (NSAIDs) may be associated with an increased risk of heart attack (myocardial infarction) or stroke, particularly at high doses and in long term treatment
  • High blood pressure (hypertension)
  • Kidney problems including inflammation of the kidney (interstitial nephritis), protein in the urine (proteinuria), blood in the urine (haematuria)
  • Abnormal liver function tests (detected during liver blood tests)
  • Liver problems including inflammation of the liver (hepatitis), yellowing of the skin or whites of the eyes (jaundice)
  • Headache (usually disappears when treatment is continued or dose is reduced. If headache persists treatment should be stopped)
  • Tingling or numbness in the hands or feet (parasthesia)
  • Involuntary movements
  • Difficulty sleeping (insomnia)
  • Fits and/or worsening of epileptic fits and parkinsonism (tremor, stiffness and shuffling)
  • Inflammation of the lining of the brain (aseptic meningitis), especially if you suffer from existing auto-immune disorders, such as Systemic Lupus Erythematosus (SLE) or mixed connective tissue disease. Symptoms include; stiff neck, headache, feeling or being sick, fever, feeling disorientated
  • Depression
  • Feeling of dizziness or "spinning" (vertigo)
  • Slurred, slow speech which is difficult to understand (dysarthria)
  • Light-headedness, fainting (syncope)
  • Coma
  • Swelling in the brain (cerebral oedema)
  • Feeling nervous or anxious
  • Mental problems such as seeing or hearing things that are not real (hallucinations), feeling detached from yourself (depersonalisation)
  • Weakness, tingling, numbness (peripheral neuropathy)
  • Confusion
  • Ringing in the ears (tinnitus), hearing problems (rarely deafness)
  • Dizziness
  • Feeling unwell (malaise)
  • Feeling drowsy or tired/sleepy (fatigue)
  • Muscle weakness
  • Acceleration of cartilage deterioration
  • Vaginal bleeding
  • Enlargement or tenderness of the breasts, including enlargement of breasts in men (gynaecomastia)
  • Blocked bile flow

Reporting of side effects

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

5. How to store Berlind

• Keep this medicine out of the sight and reach of children.
• Store below 25°C. Store in the original package in order to protect from light.
• Do not use Berlind after the expiry date, which is shown on the label/carton after EXP. 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 to protect the environment.

6. Contents of the pack and other information

What Berlind contains

Each modified release capsule contains 75 mg of 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 looks like and contents of the pack:

Berlind 75 mg are modified release capsules, with a dark blue cap and transparent body. The body is marked with 'IND 75' on one side and plain on the other.

Berlind are available in:

Berlind 75 mg MR Capsules are available in plastic containers containing 28 or 100 capsules.

Not all pack sizes may be marketed.

Product Licence Number: PL 11311/0452

Marketing Authorisation Holder and Manufacturer:

Tillomed Laboratories Limited

220 Butterfield, Great Marlings

Luton, LU2 8DL, United Kingdom

This leaflet was last revised in August 2026

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