Digavar

Package Leaflet: Information for the User

Digavar, 100 mg, Coated Tablets

Aceclofenac

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

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

Table of Contents of the Package Leaflet

• 1. What is Digavar and what is it used for
• 2. Important information 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 is Digavar and what is it used for

The active substance of 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:

• Arthritis (degenerative joint disease). This condition often occurs in people over 50 years of age and is a cause of cartilage and bone tissue loss in the joint.
• An autoimmune disease that causes chronic joint inflammation (rheumatoid arthritis).
• Spinal joint inflammation, which can lead to spinal fusion (ankylosing spondylitis).

2. Important information before taking Digavar

When not to take Digavar:

• if you are allergic to aceclofenac or any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to acetylsalicylic acid or any other NSAID (such as ibuprofen, naproxen, or diclofenac)
• if you have had any of the following symptoms after taking acetylsalicylic acid or any other NSAID:
• asthma attack
• rhinitis, itching, and (or) sneezing (nasal irritation)
• raised, red, circular patches on the skin, which may be itchy, burning, or blistering
• severe allergic reaction (anaphylactic shock). Symptoms include difficulty breathing, wheezing, pain, and vomiting
• if you have had stomach or intestinal ulcers in the past, currently have them, or suspect you have them
• if you have severe kidney disease
• if you have heart or brain blood vessel disease, such as if you have had a heart attack, stroke, mini-stroke (transient ischemic attack), or have had an operation to improve or bypass blocked blood vessels in the heart or brain
• if you have circulatory problems (peripheral arterial disease)
• if you have liver failure or suspected liver failure
• in the last three months of pregnancy
• if you are pregnant (unless your doctor considers it necessary)
• if you have active bleeding or bleeding disorders.

Digavar is not recommended for use in children.

Warnings and precautions

Before taking Digavar, talk to your doctor if:

• you smoke
• you have diabetes
• you have angina, blood clots, high blood pressure, high cholesterol, or high triglycerides (lipids) in the blood
• you have any kidney or liver disease
• you have any of the following gastrointestinal disorders:
• inflammatory bowel disease (ulcerative colitis)
• chronic inflammatory bowel disease (Crohn's disease)
• you have ever had rectal bleeding
• you have ever had bloody vomiting
• you have asthma or other breathing difficulties
• you have a blood disorder called porphyria
• you have chickenpox or shingles, you should avoid taking this medicine, as there is a risk of rare, severe skin infections associated with taking aceclofenac
• you have recently undergone major surgery
• you are elderly (your doctor will prescribe the smallest effective dose for the shortest possible time).

Taking medicines like Digavar can be associated with an increased risk of heart attack ("myocardial infarction") or stroke.
There may be hypersensitivity reactions and, very rarely, severe allergic reactions (see section 4
"Possible side effects"). This risk is higher during the first month of treatment.
Stop taking Digavar at the first sign of any hypersensitivity symptoms.
Side effects can be minimized by using the smallest 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, which means that the medicine is considered "sodium-free".

Digavar and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take, including those available without a prescription.
You should inform your doctor if you are taking:

• antidepressants or medications for bipolar disorder (lithium)
• medicines for heart failure and arrhythmias (cardiac glycosides)
• antihypertensive medicines
• quinolone antibiotics
• medicines to increase urine production (diuretics)
• blood-thinning medicines (anticoagulants), such as warfarin, heparin
• methotrexate, used to treat 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 to lower blood sugar (glucose) levels (antidiabetic)
• any other NSAIDs (aspirin, ibuprofen, naproxen).

Do not take Digavar with other NSAIDs, including selective cyclooxygenase-2 inhibitors.

Digavar with food and drink

Digavar is best taken with food or after food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Digavar in the last three months of pregnancy, as it may harm the unborn baby or cause problems during delivery. Digavar may cause kidney and heart problems in the unborn baby. It may also increase the risk of bleeding in you and your baby and prolong labor.
Do not take Digavar during the first six months of pregnancy, unless your doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, use the smallest dose for the shortest possible time.
If you take Digavar for more than a few days starting from the 20th week of pregnancy, Digavar may cause kidney problems in the unborn baby. This can lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the baby's heart. If treatment is required for a longer period, your doctor may recommend additional monitoring.
You should not take Digavar if you are breastfeeding. It is not known whether this medicine passes into breast milk. It is not recommended to take this medicine while breastfeeding, unless your doctor considers it necessary.
Tell your doctor if you have problems getting pregnant. Taking non-steroidal anti-inflammatory drugs may cause difficulties getting pregnant.

Driving and using machines

If you experience dizziness, drowsiness, fatigue, or any visual disturbances after taking Digavar, do not drive or operate machinery.

3. How to take Digavar

Always take this medicine exactly as your doctor has told you. Your doctor will prescribe the smallest effective dose for the shortest possible time, to minimize side effects. If you are not sure, ask your doctor or pharmacist.
The recommended daily dose for adults is 200 mg (two 100 mg Digavar tablets). Take one 100 mg tablet in the morning and one in the evening.
Swallow the tablets whole with a large amount of water, during or after meals. Do not crush or chew the tablets.
Do not exceed the prescribed daily dose.

Elderly patients

Elderly patients are more likely to experience serious side effects (listed in section 4 "Possible side effects").
If your doctor prescribes Digavar, you will receive the smallest effective dose for the shortest possible time.

Use in children

This medicine is not recommended for use in children.

Patients with kidney disease

Your doctor will determine the dosage and regularly monitor your condition.

Patients with liver disease

The recommended dose is one 100 mg tablet per day.

Overdose of Digavar

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

Missed dose of Digavar

If you miss a dose, there is no need to worry, just take the next dose at the usual time.
Do not take a double dose to make up for a missed dose.

Stopping treatment with Digavar

Do not stop taking Digavar unless your doctor tells 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, Digavar can cause side effects, although not everybody gets them.

Stop taking Digavar and tell your doctor immediately if you experience any of the following side effects:

if you experience any of the following side effects, tell your doctor IMMEDIATELY:

• medicines like Digavar may be associated with an increased risk of heart attack ("myocardial infarction") or stroke.
• severe allergic reaction (anaphylactic shock). Symptoms can develop rapidly and 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 can be life-threatening and involve blistering and peeling of the skin. The rash may appear in the mouth, throat, or eyes. Fever, headache, and joint pain usually occur at the same time.
• symptoms similar to meningitis, such as fever, headache, vomiting, red spotted rash, stiff neck, sensitivity to light or intolerance to light. These may be caused by a condition known as aseptic meningitis.
• kidney failure.

If you experience any of the following symptoms at any time during treatment, STOP TAKINGDigavar and SEEK MEDICAL HELP IMMEDIATELY:

• blood in your stools (feces)
• black tarry stools
• vomiting blood or dark particles that look like coffee grounds.

STOP TAKINGDigavar and contact your doctor if you experience:

• indigestion or heartburn
• abdominal pain or other unusual symptoms related to the stomach
• extreme fatigue, shortness of breath, joint pain, repeated infections, and pale skin: these symptoms may indicate a decrease in blood cell production or other blood disorders.

If any of the followingside effects get worse or if you experience any side effects not listed in this leaflet, tell your doctor or pharmacist.

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

• dizziness
• nausea
• diarrhea
• increased liver enzyme activity in the blood.

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

• flatulence (bloating)
• inflammation or irritation of the stomach lining (gastritis)
• constipation
• vomiting
• mouth ulcers
• itching
• rash
• skin inflammation
• raised, red, circular patches on the skin, which may be itchy, burning, or blistering (hives)
• increased urea levels in the blood
• increased creatinine levels in the blood.

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

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

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

• low white blood cell count
• low platelet count
• abnormal decrease in red blood cell count (anemia)
• high potassium levels in the blood
• depression
• nightmares
• insomnia
• tingling, numbness, or prickling sensation of the skin
• uncontrolled shaking (tremors)
• drowsiness
• headaches
• taste disturbances
• feeling of spinning while standing still
• rapid or forceful heartbeat (palpitations)
• hot flushes
• breathing difficulties
• wheezing
• mouth inflammation
• stomach ulcers
• pancreatitis
• liver inflammation
• yellowing of the skin (jaundice)
• spontaneous bleeding into the skin (purpura)
• blisters
• fluid retention and swelling
• fatigue
• leg cramps
• increased alkaline phosphatase activity in the blood
• weight gain.

Other side effects that have been reported for this type of medicine (NSAIDs) include:

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

If any of the side effects get worse or if you experience any side effects not listed in this leaflet, tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Digavar

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the month.
There are no special storage requirements for this medicine.
Medicines should 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 pack 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 carmellose, copovidone (K28), talc, colloidal anhydrous silica, glycerol distearate (type I) Tablet coating:hypromellose 2910 6 mPa (E464), microcrystalline cellulose, titanium dioxide (E 171), polyoxyethylenglycerides 40 (macrogol) (Type I).

What Digavar looks like and contents of the pack

Digavar 100 mg is a white, round, biconvex coated tablet.
It is available in OPA/Aluminum/PVC/Aluminum blisters in a cardboard box.
The pack contains: 20, 30, and 60 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and importer

Marketing authorization holder

Actavis Group PTC ehf.
Dalshraun 1
220 Hafnarfjörður
Iceland

Importer

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

For more information on this medicine and its authorized names in the Member States of the European Economic Area, contact the representative of the marketing authorization holder:

Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel. (22) 345 93 00.
Date of last revision of the leaflet:May 2023