Digavar

Package leaflet: Information for the user

Digavar, 100 mg, coated tablets
Aceclofenacum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Digavar is and what it is used for
2. What you need to know before taking Digavar
3. How to take Digavar
4. Possible side effects
5. How to store Digavar
6. Contents of the pack and other information

1. What Digavar is and what it is used for

The active substance in Digavar is aceclofenac. It belongs to a group of medicines called
non-steroidal anti-inflammatory drugs (NSAIDs).
Digavar is used to relieve pain and inflammation in adults suffering from:

• Osteoarthritis (degenerative joint disease). This condition commonly occurs in people over 50 years of age and is associated with the breakdown of cartilage and bone tissue within the joint.
• An autoimmune disease causing chronic joint inflammation (rheumatoid arthritis).
• Inflammation of the spinal joints, which may lead to fusion of the vertebrae (ankylosing spondylitis).

2. Important information before using Digavar

When not to use Digavar:

• if the patient is allergic to aceclofenac or any of the other ingredients of this medicine (listed in section 6)
• if the patient is allergic to acetylsalicylic acid or any other NSAIDs (such as ibuprofen, naproxen or diclofenac)
• if the patient has experienced any of the following symptoms after taking acetylsalicylic acid or other NSAIDs:
  • asthma attack
  • runny nose, itching and (or) sneezing (nasal irritation)
  • raised, red, circular rash with irregular shape, which may cause itching, burning or symptoms similar to insect bites
  • severe allergic reaction (anaphylactic shock). Symptoms include difficulty breathing, wheezing, pain and vomiting
• if the patient has had, currently has, or suspects having stomach ulcers or intestinal bleeding
• if the patient has severe kidney disease
• if the patient has heart and (or) cerebrovascular disease, e.g. if the patient has had a heart attack, stroke, mini-stroke (transient ischaemic attack), or blood clot in the heart or brain vessels, or has undergone surgery to unblock or bypass blocked vessels (bypass surgery)
• if the patient has current or past circulation disorders (peripheral arterial disease)
• if the patient has been diagnosed with or suspected liver failure
• during the last three months of pregnancy
• if the patient is pregnant (unless a doctor has deemed the use of the medicine necessary)
• if the patient has active bleeding or bleeding disorders.

Digavar is not recommended for use in children.
Warnings and precautions
Before starting to take Digavar, talk to your doctor if:

• the patient smokes
• the patient has diabetes
• the patient suffers from angina pectoris, blood clots, high blood pressure, elevated cholesterol or triglyceride (lipid) levels in the blood
• the patient has any kidney or liver disease
• the patient has any of the following gastrointestinal disorders:
  • inflammatory bowel disease (ulcerative colitis)
  • chronic inflammatory bowel disease (Crohn's disease)
  • ever had rectal bleeding
  • ever had bloody vomiting
• the patient has asthma or other breathing difficulties
• the patient has a blood disorder known as porphyria
• the patient has chickenpox or shingles; avoid using this medicine as there is a risk of rare, serious skin infections associated with aceclofenac use
• the patient has recently undergone major surgery
• the patient is elderly (the doctor should prescribe the lowest effective dose for the shortest possible time).

Using medicines such as Digavar tablets may be associated with an increased risk of heart attack
("myocardial infarction") or stroke.
Hypersensitivity reactions may occur and, very rarely, severe allergic reactions (see section 4
"Possible side effects"). The risk is higher during the first month of treatment.
The use of Digavar should be discontinued at the first sign of any hypersensitivity symptoms.
Side effects may be minimized by using the lowest effective dose for the shortest possible time.
Do not exceed the recommended dose or duration of treatment.
Digavar contains sodium.
This medicine contains less than 1 mmol of sodium (23 mg) per coated tablet, meaning the medicine is considered "sodium-free".
Digavar and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take, including those available without a prescription.
The patient should inform the doctor if they are taking:

• antidepressants or medicines used in bipolar affective disorder (lithium)
• medicines used in heart failure and cardiac arrhythmias (cardiac glycosides)
• antihypertensive medicines (hypotensives)
• quinolone antibiotics
• medicines used to increase urine output (diuretics)
• medicines that prevent blood clotting (anticoagulants), such as warfarin, heparin
• methotrexate, used in cancer and autoimmune diseases
• mifepristone, used as emergency contraception or to induce abortion
• any steroids (estrogens, androgens or glucocorticoids)
• medicines that suppress the immune system (cyclosporine or tacrolimus)
• medicines used to treat HIV (zidovudine)
• medicines that lower blood sugar (glucose) levels (antidiabetics)
• any other NSAIDs (aspirin, ibuprofen, naproxen).

Avoid taking Digavar together with other NSAIDs, including selective cyclooxygenase-2 inhibitors.
Digavar with food and drink
Digavar should be taken during or after a meal.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Do not use Digavar during the last three months of pregnancy, as it may harm the unborn child or cause delivery complications. Digavar may cause kidney and heart problems in the unborn child. It may increase the tendency to bleed in both the mother and the child and may delay or prolong labour.
Do not take Digavar during the first 6 months of pregnancy unless the doctor considers its use absolutely necessary. If treatment is required during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible time.
If Digavar is taken for more than a few days starting from week 20 of pregnancy, it may result in impaired kidney function in the unborn child. This may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is required for longer than a few days, the doctor may recommend additional monitoring.
The patient should not use Digavar if she is breastfeeding. It is not known whether this medicine passes into breast milk. This medicine is not recommended during breastfeeding unless the doctor considers it necessary.
Inform your doctor if the patient has difficulty becoming pregnant. The use of non-steroidal anti-inflammatory drugs may cause difficulties in becoming pregnant.
Driving and operating machinery
If the patient experiences dizziness, drowsiness, fatigue or any visual disturbances after taking Digavar, they must not drive or operate machinery.

3. How to use Digavar

This medicine should always be taken exactly as your doctor has instructed. Your doctor will prescribe the lowest effective dose for the shortest possible time to minimize side effects. If you have any doubts, consult your doctor or pharmacist.
The recommended daily dose for adults is 200 mg (two 100 mg Digavar tablets). One 100 mg tablet should be taken in the morning and the second in the evening.
The tablets should be swallowed whole with plenty of water, during or after a meal. Do not crush or chew the tablets.
Do not exceed the recommended daily dose.

Elderly patients
Serious adverse reactions (listed in section 4, "Possible side effects") occur more frequently in elderly patients.
If your doctor prescribes Digavar, you will receive the lowest effective dose for the shortest possible duration.

Use in children
This medicine is not recommended for use in children.

Patients with kidney disease
Dosage will be determined by your doctor, who will regularly monitor your condition.

Patients with liver disease
The recommended dose is one 100 mg tablet per day.

Taking more Digavar than recommended
If you accidentally take too much Digavar, contact your doctor immediately or go to the nearest hospital emergency department. Bring this leaflet or the Digavar packaging with you so that hospital staff know what you have taken.

If you miss a dose of Digavar
If you miss a dose, there is no cause for concern. Simply take the next dose at your usual time.
Do not take a double dose to make up for a missed dose.

Stopping Digavar
Do not stop taking Digavar unless your doctor advises you to do so.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
You must immediately inform the doctor if the patient experiences any of the following
adverse reactions:
If the patient experiences any of the following adverse reactions, you should
IMMEDIATELY inform the doctor:

• Medicines such as Digavar may be associated with an increased risk of heart attack ("myocardial infarction") or stroke.
• Acute allergic reaction (anaphylactic shock). Symptoms may develop rapidly and may be life-threatening if not treated immediately, and may include: fever, difficulty breathing, wheezing, abdominal pain, vomiting, swelling of the face and throat.
• Severe skin rashes, such as Stevens-Johnson syndrome and toxic epidermal necrolysis. These conditions are potentially life-threatening and involve the formation of large blisters and peeling of sheets of skin. The rash may also appear in the mouth, throat, or eyes. Fever, headache, and joint pain usually occur at the same time.
• Symptoms resembling meningitis, such as fever, headache, vomiting, red blotchy rash, neck stiffness, light sensitivity or intolerance to light. These may be caused by a condition known as aseptic meningitis.
• Kidney failure.

If the patient develops any of the following symptoms at any time during treatment,
you must STOP USING the medicine and seek medical help IMMEDIATELY:

• blood in the stool (faeces)
• black, tarry stools
• vomiting blood or dark particles that look like coffee grounds.

You must STOP USING the medicine and contact the doctor if the following occur:

• indigestion or heartburn
• upper abdominal pain (stomach pain) or other unusual stomach-related symptoms
• extreme fatigue, shortness of breath, joint pain, recurrent infections, and skin bruising: these symptoms may indicate reduced blood cell production or other blood disorders.

If any of the following adverse reactions worsen, or if the patient experiences
any adverse reactions not listed in this leaflet, inform the doctor or
pharmacist.

Common (may affect up to 1 in 10 patients):

• dizziness
• nausea
• diarrhoea
• increased liver enzyme activity in blood.

Uncommon (may affect up to 1 in 100 patients):

• gas (bloating)
• inflammation or irritation of the stomach lining (gastritis)
• constipation
• vomiting
• mouth ulcers
• itching
• rash
• skin inflammation
• raised, red, ring-shaped rash with irregular shape, causing itching, burning, or symptoms like insect bites (urticaria)
• increased blood urea levels
• increased blood creatinine levels.

Rare (may affect up to 1 in 1,000 patients):

• low iron levels in blood
• hypersensitivity (allergic reaction)
• visual disturbances
• shortness of breath.

Very rare (may affect up to 1 in 10,000 patients):

• low white blood cell count
• low platelet count
• abnormally low red blood cell count (anaemia)
• high potassium levels in blood
• depression
• nightmares
• insomnia
• tingling, pricking, or numbness of the skin
• uncontrolled trembling (shivers)
• drowsiness
• headaches
• taste disturbances in the mouth
• sensation of spinning while standing still
• loud or rapid heartbeat (palpitations)
• hot flushes
• breathing difficulties
• wheezing
• inflammation of the mouth
• stomach ulcer
• pancreatitis
• hepatitis
• yellowing of the skin (jaundice)
• spontaneous bleeding into the skin (appearing as a rash)
• blisters
• fluid retention and swelling
• fatigue
• leg cramps
• increased alkaline phosphatase activity in blood
• weight gain.

Other adverse reactions reported for this type of medicine (NSAIDs) include:

• hallucinations
• confusion
• blurred vision, partial or complete loss of vision
• eye movement pain
• tinnitus (ringing in the ears)
• worsening of asthma
• ulcers
• perforation of the stomach or intestinal wall
• blisters and peeling of the outer layer of skin
• mild itching of reddened skin
• redness or peeling of the skin
• skin irritation (eczema)
• skin reaction to sunlight
• kidney inflammation
• general malaise
• aseptic meningitis
• exacerbation of colitis and Crohn's disease
• hypertension (high blood pressure)
• heart failure
• bone marrow suppression.

If any adverse reactions worsen, or if the patient experiences any
adverse reactions not listed in this leaflet, inform the doctor or
pharmacist.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed
in this leaflet, inform the doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store the medicine Digavar

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack. The expiry date refers to the last day of the stated month.
No special storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Digavar contains

• The active substance is aceclofenac. Each coated tablet contains 100 mg of aceclofenac.
• The other ingredients are: microcrystalline cellulose, sodium croscarmellose, copovidone (K28), talc, colloidal anhydrous silica, glycerol distearate (type I).
  Tablet coating: hypromellose 2910 6 mPa (E464), microcrystalline cellulose, titanium dioxide (E 171), polyoxyl 40 stearate (macrogol) (Type I).

What Digavar looks like and contents of the pack
Digavar 100 mg is white, round, biconvex, film-coated tablets.
It is available in blisters made of OPA/Aluminium/PVC/Aluminium, packed in a cardboard box.
Pack contents: 20, 30, and 60 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Importer
Marketing Authorisation Holder
Actavis Group PTC ehf.
Dalshraun 1
220 Hafnarfjörður
Iceland

Importer
Laboratoires BTT
Z.I. de Krafft, 67150 Erstein
France

For further information about the medicinal product and its names in the Member States of the
European Economic Area, please contact the representative of the Marketing Authorisation Holder:
Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel. (22) 345 93 00.