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ETOLYN 600 MG PROLONGED RELEASE TABLETS

Active substance(s): ETODOLAC

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If you forget to take Etolyn®

ETOLYN 600 mg
®

If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects

PROLONGED RELEASE TABLETS

Do not take a double dose to make up for a

not listed in this leaflet.

forgotten dose. Take your tablet as soon as you
Package leaflet: Information for the patient
Etolyn®

600 mg prolonged release tablets
Etodolac

attack (myocardial infarction) or stroke. Any risk

remember and continue to take your medicine as

Reporting of side effects

is more likely with high doses and prolonged

usual, but do not take more than one tablet a day.

If you get any side effects, talk to your doctor,

treatment. Do not exceed the recommended dose

pharmacist or nurse. This includes any possible

or duration of treatment.

4. Possible side effects

side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card

Serious gastrointestinal side effects such as

Like all medicines, this medicine can cause side

Scheme at: www.mhra.gov.uk/yellowcard.

Read all of this leaflet carefully before you

bleeding, ulceration and perforation can occur at

effects, although not everybody gets them.

By reporting side effects you can help provide

start taking this medicine because it contains

any time with or without warning symptoms in

important information for you.

patients treated with NSAIDs. If any sign of

Common side effects (may affect up to 1 in 10

- Keep this leaflet. You may need to read it again.

gastrointestinal bleeding occurs, Etolyn® Tablets

people) are:

- If you have any further questions, ask your

should be stopped immediately.

- malaise, headaches, vertigo, dizziness, fatigue

more information on the safety of this medicine.

doctor or pharmacist.

5. How to store Etolyn®

- visual disturbances

Keep this medicine out of the sight and reach of

- This medicine has been prescribed for you only.

Other medicines and Etolyn®

- tinnitus

children.

Do not pass it on to others. It may harm them,

Tell your doctor or pharmacist if you are taking,

- oedema (swelling due to fluid), hypertension

even if their signs of illness are the same as yours.

have recently taken or might take any other

(high blood pressure) and cardiac failure (a heart

Do not use this medicine after the expiry date

- If you get any side effects, talk to your doctor or

medicines.

disease which happens when your heart cannot

which is stated on the carton after EXP. The

pump enough blood to the rest of your body) have

expiry date refers to the last day of that month.

pharmacist. This includes any possible side effects
not listed in this leaflet.

Tell your doctor if you are taking any of the

been reported in association with NSAID

following medicines before taking

treatment.

This medicinal product does not require any

Tablets:

- nausea, diarrhoea, flatulence (wind), abdominal

special storage conditions.

• warfarin - to reduce blood clotting

pain, constipation, vomiting, ulcerative stomatitis

1. What Etolyn is and what it is used for

• ciclosporin - following transplantation

(mouth inflammation), dyspepsia (indigestion),

Do not throw away any medicines via wastewater

2. What you need to know before you take

• digoxin - for heart problems

haematemesis (vomiting blood), melaena (dark,

or household waste. Ask your pharmacist how to

Etolyn®

• lithium - for mental illness

blood-stained stools or vomit), exacerbation of

throw away medicines you no longer use. These

3. How to take Etolyn®

• methotrexate - used to treat conditions such as

colitis (colon inflammation) and Crohn's disease

measures will help protect the environment.

4. Possible side effects

psoriasis (skin disease characterized by

(inflammatory disease of the digestive tract) (See

5. How to store Etolyn®

desquamation) or rheumatoid arthritis

section 4.4)

6. Contents of the pack and other information

6. Contents of the pack and other information

• corticosteroids (such as prednisolone)
• quinolone . antibiotics such as ciprofloxacin

Uncommon side effects (may affect up to 1 in 100

What Etolyn® contains

• aspirin

people) are:

- The active substance is etodolac.

• other NSAIDs e.g. ibuprofen, naproxen,

- thrombocytopenia (low blood platelet count),

Each tablet contains 600mg of etodolac. In this

Etolyn® is used to treat the symptoms of

diclofenac

neutropenia (low levels of neutrophils, a type of

tablet, the medicine is released slowly which

rheumatoid arthritis (a disease of the joints) and

• drugs to control high blood pressure

white blood cell), granulocytopenia (low levels of

means that you only have to take one tablet each

osteoarthritis (long-term disease causing damage

• mifepristone (a drug to induce abortion) in the

granulocytes, a type of white blood cell), aplastic

day.

and pain in the joints) by reducing inflammation,

last 12 days

anaemia (reduced or stopped red blood cell

What is in this leaflet
®

1. What Etolyn is and what it is used for
®

Etolyn®

swelling, stiffness and joint pain.
Etolyn®

is one of a group of medicines called

“non-steroidal anti-inflammatory drugs”

production) and haemolytic anaemia (premature

- The other ingredients are:

If you have a blood or urine test, tell your doctor

destruction of red blood cells).

Tablet core: Lactose Monohydrate,

that you are taking

insomnia, drowsiness.

Hydroxypropyl methylcellulose, Povidone,

- gastritis

Mannitol, Colloidal silicon dioxide, Magnesium

- photosensitivity (light sensitivity)

stearate, Talc

Etolyn®

Tablets, as the drug

may affect the results.

(NSAIDs) which are usually taken to relieve the
pain, stiffness, inflammation and swelling which

Pregnancy, breast-feeding and fertility

is often associated with arthritis.

If you are pregnant or breast-feeding, think you

Very rare side effects (may affect up to 1 in

may be pregnant or are planning to have a baby,

10,000 people,) are:

2. What you need to know before you take

ask your doctor or pharmacist for advice before

- pancreatitis (inflammation of the pancreas)

What Etolyn® looks like and contents of the

Etolyn®

taking this medicine.

- bullous reactions including Stevens Johnson

pack

Do not take Etolyn®:

Do not use Etolyn® Tablets if you are pregnant or

skin, mouth, around the eyes or genitals) and toxic

Blue, biconvex, oval shaped film-coated tablets

- if you are allergic to etodolac or any of the other

likely to be pregnant, unless your doctor has

epidermal necrolysis (inflammation of the skin

impressed on one side with 600.

ingredients of this medicine (listed in section 6).

advised you.

that can lead to potentially life-threatening skin

Film-coating: Hipromelose, Titanium Dioxide
(E171), Polyethylene glycol, FD&C Blue#2

Syndrome (a serious illness with blistering of the

- if you have had an allergic reaction or asthmatic

reaction).

type reaction (e.g. wheezing, itching or skin rash)

Do not use Etolyn® Tablets if you are

after taking aspirin, etodolac or another NSAID

breast-feeding.

PVDC/PVC/aluminium foil Blisters: Packs
with10 or 30 prolonged release tablets.

Not known (cannot be estimated from the

- if you have a peptic ulcer (a small erosion or

available data)

Not all pack sizes may be marketed.

hole in the stomach or duodenum) or bleeding in

Etolyn® Tablets may make it more difficult to

- Hypersensitivity reactions have been reported

your stomach, or have had two or more episodes

become pregnant. You should inform your doctor

following treatment with NSAIDs. These may

Marketing Authorisation Holder and

of peptic ulcers, stomach bleeding or perforation.

if you are planning to become pregnant or if you

consists of non-specific allergic reactions and

Manufacturer

- if you have severe heart failure (a heart disease

have problems becoming pregnant.

anaphylaxis (severe allergic reactions), respiratory

which happens when your heart cannot pump

tract reactivity comprising asthma, aggravated

Marketing Authorisation Holder

asthma, bronchospasm or dyspnoea (laboured

Abdi Farma Unipessoal Lda.

breathing), or assorted skin disorders, including

Quinta da Fonte, Rua dos Malhões,

rashes of various types, pruritus (itching),

Edifício D. Pedro I

or abnormal vision. If you find that you are

urticaria, purpura (blood spots, bruising and

2770 – 071 Paço de Arcos, Portugal

affected in this way, you should not drive or

discolouring to skin), angioedema (swelling

abdifarma@abdiibrahim.com.tr

children.

operate machinery whilst taking Etolyn® Tablets.

beneath the skin).
- paraesthesia (unusual sensations like pins and

Manufacturer

Warnings and precautions

Etolyn® prolonged release tablets contain

needles), reports of aseptic meningitis (especially

GE Pharmaceuticals Ltd.

Talk to your doctor or pharmacist before taking

lactose monohydrate. If you have been told by

in patients with existing auto-immune disorders,

Industrial Zone, “Chekanitza-South” Area, 2410

Etolyn®:

your doctor that you have an intolerance to some

such as systemic lupus erythematous, mixed

Botevgrad Bulgaria

- if you suffer from kidney, heart or liver disease,

sugars, contact your doctor before taking this

connective tissue disease), with symptoms such as

or a blood disorder, especially if you are also

medicinal product.

stiff neck, headache, fever, nausea, vomiting,

Driving and using machines

- if you are pregnant, think you may be pregnant
or are breast feeding
Etolyn®

tablets are not recommended for use in

Etolyn®

Tablets may cause dizziness, drowsiness

taking diuretics (a type of medicine also known as
“water” tablets which increases the amount of

fever or disorientation (See section 4.4),
3. How to take Etolyn®

depression, confusion, hallucinations.

urine you produce). The dose should be as low as

- optic neuritis (inflammation of the optic nerve)

possible and you should have regular checks

Always take this medicine exactly as your doctor

- Clinical trial and epidemiological data suggest

- if you are already on long-term therapy with a

has told you. Check with your doctor or

that use of some NSAIDs (particularly at high

medicine other than Etodolac, since your doctor

pharmacist if you are not sure.

doses and in long term treatment) may be

will want to arrange regular check-ups, especially

associated with an increased risk of arterial

if you are elderly

The recommended dose is one

- if you suffer from fluid retention (swelling of

tablet a day. To be taken preferably with or after

infarction or stroke) (see section 4.4).

legs, ankles or feet)

food, swallowed whole with a glass of water. Do

- epigastric pain (pain in the upper abdomen area),

- if you suffer from high blood pressure or heart

not chew or crush the tablet.

indigestion, heartburn, rectal bleeding, vasculitis

Etolyn®

600mg

thrombotic events (for example myocardial

failure

(blood vessel inflammation)

- if you suffer from, or have ever suffered from,

Etolyn Tablets are not recommended for use in

- jaundice, abnormal liver function, hepatitis

asthma or breathing difficulties

children.

- abnormal urinary frequency, dysuria (painful

®

- if you have heart problems, previous stroke or
think that you might be at risk of these conditions

urination), nephrotoxicity (poisonous effect on the
If you take more Etolyn® than you should

kidney) in various forms, including interstitial

(for example if you have high blood pressure,
diabetes or high cholesterol or are a smoker)

This leaflet was last revised in 03.2015.

nephritis (allergic kidney reaction), nephrotic
If you take more tablets than you should (an

syndrome (swelling of lower limbs, generalized

overdose), seek medical attention immediately.

swelling and protein loss in urine) and renal

Medicines such as Etolyn® Tablets may be

Always take the packaging with you, even if

failure.

associated with a small increased risk of heart

empty.

Teknik kontrol amaçlıdır
Ürün Adı

ARTWORK
Abdi İbrahim İlaç Sanayi ve Ticaret A.Ş.
Reşitpaşa Mahallesi
Eski Büyükdere Caddesi
No: 4 Maslak, Sarıyer 34467 İstanbul
www.Abdiibrahim.com.tr

Ülke

İngiltere

Ebat
Renk

Etolyn

Cinsi

Prospektüs

17.03.2015

Print Kod

155 x 560 mm

A20011057/02

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A20011057/02

enough blood to the rest of your body)

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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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