Akis

Leaflet accompanying the packaging: information for the user

AKIS

25 mg/ml, 50 mg/ml, 75 mg/ml, solution for injection in a pre-filled syringe
Diclofenac sodium

You should read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• You should consult a doctor or pharmacist if you have any further doubts.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If any of the side effects get worse or if you notice any side effects not listed in the leaflet, you should tell your doctor or pharmacist.

Contents of the leaflet:

• 1. What AKIS is and what it is used for
• 2. Important information before using AKIS
• 3. How to use AKIS
• 4. Possible side effects
• 5. How to store AKIS
• 6. Contents of the packaging and other information

1. What AKIS is and what it is used for

The active substance of the medicine is diclofenac sodium. AKIS belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Other medicines in the NSAID group are aspirin and ibuprofen. These medicines have analgesic and anti-inflammatory effects.
AKIS administered by intramuscular or subcutaneous injection is used to treat painful conditions, including:

• attacks of joint and back pain;
• attacks of gout;
• pain caused by kidney stones;
• pain resulting from injuries, fractures, or trauma;

AKIS administered by intravenous injection in a hospital setting is used to treat or prevent pain after surgical procedures.

2. Important information before using AKIS

When not to use AKIS:

• if the patient is allergic to diclofenac, aspirin, ibuprofen, or other NSAIDs; if the patient is allergic to any of the other ingredients of AKIS (listed in section 6 at the end of this leaflet);
• if the patient has had gastrointestinal bleeding after taking NSAIDs;
• if the patient has had two or more episodes of stomach or duodenal ulcers or gastrointestinal bleeding (including if the patient has vomited blood, had blood in their stools, or had black, tarry stools);
• if the patient has or has had liver failure;
• if the patient has or has had severe heart failure;
• if the patient has or has had a heart condition and/or cerebrovascular disease, such as a heart attack, stroke, transient ischemic attack (mini-stroke), or vascular occlusion of the heart or brain, or has undergone a procedure to clear blocked vessels;

if the patient has or has had circulatory disorders (peripheral vascular disease);

• if the patient has or has had severe kidney failure;
• if the patient has asthma, urticaria, or acute rhinitis (allergy) that may be triggered by NSAIDs or aspirin;
• if the patient has a blood clotting disorder or is currently taking anticoagulant medicines (such as warfarin);
• if the patient is more than 6 months pregnant (see section "Pregnancy and breastfeeding");
• if the patient is under 18 years old.

In addition, AKIS should not be used for intravenous injection:

• if the patient is taking other NSAIDs or anticoagulant medicines (including low doses of heparin)
• if the patient has or has had a tendency to bleed, especially in the brain
• in cases of surgical procedures with a high risk of bleeding
• in cases of asthma
• in cases of moderate or severe kidney impairment
• in cases of dehydration
• in cases of significant blood loss

Warnings and precautions

Before taking diclofenac, the patient should inform their doctor:

• if the patient smokes
• if the patient has diabetes
• if the patient has angina, blood clots, high blood pressure, high cholesterol, or high triglycerides

The risk of side effects can be minimized by using the lowest effective dose for the shortest possible time.
Before using AKIS, the patient should consult a doctor.

• If the patient thinks they may be allergic to diclofenac, acetylsalicylic acid, ibuprofen, or any other NSAID, or to any of the other ingredients of AKIS (listed at the end of this leaflet). Symptoms of hypersensitivity include swelling of the face and lips (angioedema), difficulty breathing, chest pain, runny nose, and skin rash or any other allergic reaction.
• If the patient has ever had a stomach ulcer or gastrointestinal bleeding. Symptoms may include vomiting blood, blood in the stool, or black, tarry stools.
• If the patient has any bowel disorders, including ulcerative colitis or Crohn's disease.
• If the patient has or has had kidney or liver problems.
• If the patient has or has had blood disorders or bleeding.
• If the patient has or has had asthma, chronic obstructive pulmonary disease (COPD), nasal polyps, or hay fever.
• If the patient has systemic lupus erythematosus (SLE) or any similar condition.
• If the patient is planning to become pregnant, as AKIS may affect fertility.
• If the patient has recently undergone or is scheduled to undergo stomach or gastrointestinal surgery, as AKIS may sometimes cause delayed wound healing in the gut after surgery.

Other precautions

• Taking medicines like AKIS may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. This risk increases with high doses and long-term treatment. The recommended dose should not be exceeded and treatment should not be prolonged.

AKIS is an anti-inflammatory medicine, so it may also reduce the symptoms of inflammation, such as headache or high temperature. If the patient does not feel well and needs to consult a doctor, they should tell the doctor that they are taking AKIS.

• Older patients are more prone to side effects when taking AKIS, so they should tell their doctor about any unusual symptoms.

Other medicines and AKIS

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, including those obtained without a prescription (e.g., over-the-counter medicines or recreational drugs). Some medicines may affect the patient's treatment.
The patient should tell their doctor if they are taking any of the following medicines:

• any other NSAID or COX-2 inhibitor (e.g., aspirin or ibuprofen, anti-inflammatory or pain-relieving medicines);
• anti-diabetic medicines used to treat diabetes;
• anticoagulant medicines (blood-thinning medicines, such as warfarin or heparin);
• anti-platelet medicines (medicines used to prevent blood clots);
• diuretics (water pills);
• lithium (a medicine used to treat certain types of depression);
• phenytoin (a medicine used to treat epilepsy);
• digitalis glycosides (e.g., digoxin, medicines used to treat heart conditions);
• methotrexate (a medicine used to treat certain inflammatory conditions and cancers);
• cyclosporin and tacrolimus (a medicine used to treat certain inflammatory conditions and after organ transplants);
• quinolone antibiotics (medicines used to treat certain infections);
• corticosteroids (medicines used to treat inflammatory conditions and immune system disorders);
• cholestyramine (a medicine used to lower cholesterol levels);
• colestyramine (a medicine used to treat liver disease and Crohn's disease);
• sulfinpyrazone (a medicine used to treat gout);
• voriconazole (a medicine used to treat fungal infections);
• pemetrexed (a medicine used to treat certain types of cancer);
• deferazirox (a medicine used in patients who receive long-term blood transfusions);
• mifepristone (a medicine used for abortion);
• medicines used to treat heart conditions or high blood pressure, such as beta blockers or ACE inhibitors;
• tacrolimus (a medicine that suppresses the immune system, used to prevent organ rejection in certain patients);
• medicines used to treat anxiety and depression, known as selective serotonin reuptake inhibitors (SSRIs);
• zidovudine (a medicine used to treat HIV infection).

Pregnancy and breastfeeding

• AKIS should not be used in the last 3 months of pregnancy, as it may harm the unborn baby or cause problems during delivery. AKIS may cause kidney or heart problems in the unborn baby. It may also increase the risk of bleeding in the mother and baby and prolong labor. During the first 6 months of pregnancy, AKIS should not be used unless the doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to become pregnant, the lowest effective dose should be used for the shortest possible time. From the 20th week of pregnancy, AKIS may cause kidney problems in the unborn baby if used for more than a few days. This may 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 more than a few days, the doctor may recommend additional monitoring.

If the patient's symptoms get worse or if they notice any side effects not listed in the leaflet, they should tell their doctor or pharmacist.

Driving and using machines

AKIS may cause dizziness, fatigue, drowsiness, and blurred vision in some patients. The patient should not drive or operate machinery if they experience these side effects.
The medicine contains less than 1 mmol (23 mg) of sodium per dose unit, which means it is essentially "sodium-free".

3. How to use AKIS

The doctor will decide when and how to treat the patient with AKIS solution for injection. The medicine is administered by intramuscular injection (into a muscle, usually in the buttock) or subcutaneous injection (under the skin, usually in the buttock or thigh) or intravenous injection (into a vein, usually in the forearm). AKIS should not be administered by intravenous infusion.

Adults

The usual initial dose is 25-75 mg, depending on the severity of the pain. If the patient still experiences severe pain, the doctor may decide to administer a second injection after 6 hours. The maximum daily dose is 150 mg. The medicine is administered for only one or two days.

Elderly patients

The doctor may administer a lower dose of the medicine if the patient is elderly.

Children and adolescents

This medicine is not suitable for use in children and adolescents under 18 years old.
The doctor, nurse, or pharmacist will prepare the injection for the patient. The medicine is usually administered by a nurse or doctor. The doctor or nurse will not administer the injection twice in the same place.

Using a higher dose of AKIS than recommended

If the patient takes more AKIS than recommended, they may experience the following symptoms:
nausea and vomiting, abdominal pain, gastrointestinal bleeding, and less frequently, hemorrhage, dizziness, tinnitus (ringing, buzzing, or other persistent sounds in the ears), and sometimes convulsions (seizures or fits). In severe cases, the patient's kidneys or liver may be damaged (symptoms include problems urinating or excessive urination, muscle cramps, fatigue, swelling of the hands, feet, or face, nausea, or vomiting, and yellowing of the skin).
If the patient thinks they have been given more AKIS than recommended, they should tell their doctor or nurse immediately.

4. Possible side effects

Like all medicines, AKIS can cause side effects, although not everybody gets them.
Some side effects may be serious.

The patient should stop using AKIS and contact their doctor immediately if they notice:

• mild painful stomach cramps and tenderness, starting soon after taking AKIS, followed by rectal bleeding or bloody diarrhea, usually within 24 hours of stomach pain (frequency not known - cannot be estimated from available data).

The patient should tell their doctor immediately if they experience any of the following side effects:

• severe allergic reactions, including swelling of the face, neck, or tongue, difficulty breathing, wheezing, runny nose, and skin rash;
• stomach pain, indigestion, heartburn, gas, nausea, or vomiting;
• any symptoms of gastrointestinal bleeding, such as blood in the stool, black, tarry stools, or vomiting blood;
• severe skin rash, itching, hives, bruising, painful red spots on the skin, blistering, and peeling of the skin. These reactions may also affect the mouth, lips, eyes, nose, and genitals;
• yellowing of the skin or whites of the eyes;
• prolonged sore throat or high temperature;
• unexpected changes in urine output or appearance;
• easy bruising or frequent sore throats or infections;
• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome;
• reactions at the injection site, including pain, redness, swelling, hard lump, ulceration, and bruising. This may lead to blackening and death of the skin and surrounding tissues, which heals with scarring, also known as Nicolau syndrome.

Very common side effects(may affect more than 1 in 10 people)

• pain, redness, or lumps at the injection site.

Common side effects(may affect more than 1 in 100 people but less than 1 in 10 people)

• nausea, discomfort at the injection site

Uncommon side effects(may affect more than 1 in 1000 people but less than 1 in 100 people)

• dizziness and headache,
• diarrhea, vomiting, and constipation,
• gastritis causing stomach pain, nausea, and loss of appetite,
• liver problems,
• skin rash, itching.

Side effects with unknown frequency(cannot be estimated from available data):

• tissue damage at the injection site

Other side effects

Patients treated with NSAIDs have reported the following side effects.
Effects on the heart or blood

• medicines like AKIS may be associated with a small increased risk of heart attack (myocardial infarction) or stroke,
• high blood pressure, heart attack, rapid or irregular heartbeat, chest pain, swelling of the body, hands, or feet,
• asthma, shortness of breath,
• blood disorders, such as anemia (low red blood cell count). Symptoms include fatigue, headache, dizziness, and pale skin.

Effects on the stomach and digestive system

• stomach ulcers, mouth ulcers, tongue infections, bowel disorders (including bowel inflammation and exacerbation of Crohn's disease),
• pancreatitis or stomach lining inflammation (symptoms include severe abdominal pain that may radiate to the back or arms).

Effects on the nervous system

• itching and numbness, tingling sensation in the hands or feet, or limbs, tremors, blurred or double vision, loss or disturbance of hearing, tinnitus (ringing in the ears), drowsiness, fatigue,
• hallucinations (seeing or hearing things that do not exist), depression, confusion, sleep disturbances, irritability, anxiety, memory problems, and convulsions (seizures or fits),
• meningitis (inflammation of the membranes surrounding the brain). Symptoms include stiff neck, headache, nausea, vomiting, fever, or confusion and extreme sensitivity to light.

Effects on the liver and kidneys

• liver problems. Symptoms include nausea, loss of appetite, general feeling of being unwell, sometimes with jaundice,
• kidney problems or kidney failure. Symptoms include blood in the urine, frothy urine, swelling of the hands, feet, or body.

Effects on the skin and hair

• severe skin rash, such as Stevens-Johnson syndrome and other skin conditions that may worsen with sun exposure,
• hair loss.

Effects on the immune system

• hypersensitivity reactions

If the patient's symptoms get worse or if they notice any side effects not listed in the leaflet, they should tell their doctor or pharmacist.

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store AKIS

• The medicine should be stored out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton and syringe after EXP.
• Store in a temperature below 25°C. Do not store in a refrigerator or freeze. Store in the original packaging to protect from light.
• Use immediately after opening. Any unused portion of the product should be disposed of.
• Do not use if the solution is cloudy or if small particles are visible.

After administering the correct dose, the doctor or nurse will dispose of any remaining solution along with the syringe, needles, and containers.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What AKIS contains

The active substance of the medicine is diclofenac sodium.
1 ml of solution in a pre-filled syringe contains:
25 mg of diclofenac sodium or
50 mg of diclofenac sodium or
75 mg of diclofenac sodium.
The other ingredients are hydroxypropylbetadex, polysorbate 20, and water for injections

What AKIS looks like and contents of the pack

This medicine is a clear to slightly brownish, transparent solution for injection contained in a pre-filled syringe made of colorless glass type I with a protective cap made of synthetic isoprene-bromobutyl and a plunger made of polyester.
The medicine is supplied with a sterile administration set containing:
1 needle for subcutaneous administration (size 27 G), gray
1 needle for intramuscular or intravenous administration (size 21 G), green
Pack sizes: 1, 3, or 5 pre-filled syringes, in a carton box.
The medicine is also available in glass ampoules in packs containing 1, 3, or 5 ampoules.
Not all pack sizes may be marketed.

Marketing authorization holder

IBSA Farmaceutici Italia Srl
Via Martiri di Cefalonia 2
26900 Lodi
Italy
[email protected]

Manufacturer/Importer

IBSA Farmaceutici Italia Srl
Via Martiri di Cefalonia 2
26900 Lodi
Italy
Date of last revision of the leaflet:April 2024