Akis

Package leaflet: Information for the user

AKIS
25 mg/ml, 50 mg/ml, 75 mg/ml, solution for injection in pre-filled syringe
Diclofenacum natricum
Read the entire leaflet carefully before using the medicine, as it contains important
information for the patient.

• Keep this leaflet, as you may need to read it again.
• Consult your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are similar.
• If any of the adverse effects worsen, or if any adverse effects occur that are not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

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 pack and other information

1. What AKIS is and what it is used for

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

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

AKIS administered by intravenous injection in hospital settings is used for the treatment or prevention of postoperative pain.

2. 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 components of AKIS (listed in section 6 at the end of this leaflet);
• if the patient has experienced gastrointestinal bleeding after taking NSAIDs;
• if the patient has had two or more episodes of peptic ulcer disease of the stomach or duodenum, or gastrointestinal bleeding (including vomiting blood, blood in stools, or 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 been diagnosed with heart disease and/or cerebrovascular disease, e.g. after myocardial infarction, stroke, transient ischemic attack (TIA), or arterial embolism in the heart or brain, or after a revascularization or bypass procedure;
• if the patient currently has or has previously 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 blood clotting disorders or is currently taking anticoagulant drugs (such as warfarin);
• if the patient is in the second half of pregnancy (see section "Pregnancy and breastfeeding");
• if the patient is under 18 years of age.

Additionally, intravenous injection of AKIS should not be used:

• if the patient is taking other NSAIDs or anticoagulant drugs (including low-dose heparin);
• if the patient currently has or has previously had a tendency to bleed, especially within cerebral vessels;
• during surgical procedures associated with a high risk of bleeding;
• in patients with a history of asthma;
• in cases of moderate or severe kidney dysfunction;
• in cases of dehydration;
• in cases of significant blood loss.

Warnings and precautions
Before taking diclofenac, inform your doctor:

• if the patient smokes;
• if the patient has diabetes;
• if the patient has angina, thrombosis, hypertension, elevated cholesterol, or elevated triglycerides.

The risk of adverse effects can be minimized by using the lowest effective dose for the shortest duration necessary.
Before using AKIS, consult your doctor.

• If the patient suspects allergy to diclofenac, acetylsalicylic acid, ibuprofen, or any other NSAID, or to any of the other ingredients in AKIS (listed at the end of this leaflet). Symptoms of hypersensitivity include facial and lip swelling (angioedema), difficulty breathing, chest pain, rhinitis, rash, or any other allergic-type reactions.
• If the patient has ever had ulcers in the esophagus, stomach, or small intestine, or gastrointestinal bleeding. Symptoms may include vomiting blood, blood in stools, or black, tarry stools.
• If the patient has any intestinal 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 problems.
• If the patient has or has had asthma, chronic obstructive pulmonary disease (COPD), nasal polyps, or hay fever.
• If the patient has lupus (systemic lupus erythematosus) or any similar disorder.
• If the patient plans to become pregnant, as AKIS may affect fertility.
• If the patient has recently undergone or is scheduled for surgery of the stomach or gastrointestinal tract, as AKIS may impair intestinal wound healing after surgery.

Other precautions

• Taking medications such as AKIS may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. This risk increases with higher doses and prolonged treatment. Do not exceed the recommended dose or extend the duration of treatment.

• AKIS is an anti-inflammatory drug and may therefore reduce signs of inflammation such as headache or high temperature. If the patient feels unwell and needs to consult a doctor, they should inform the doctor about taking AKIS.

• Elderly patients are more susceptible to adverse effects associated with AKIS. Inform the doctor about any unusual symptoms.

Other medicines and AKIS
Tell your doctor or pharmacist about all medicines currently taken or recently taken, including over-the-counter medicines (e.g. medicines available without prescription or used recreationally). Some medicines may interfere with AKIS treatment.

Tell your doctor if the patient is taking any of the following medicines:

• any other NSAID or COX-2 (cyclooxygenase-2) inhibitor, e.g. aspirin or ibuprofen (anti-inflammatory or pain-relieving medicines);
• antidiabetic medicines used in diabetes treatment;
• anticoagulants (blood-thinning medicines, e.g. warfarin or heparin);
• antiplatelet medicines (medicines used to prevent blood clots);
• diuretics (water pills);
• lithium (used in the treatment of certain types of depression);
• phenytoin (used in the treatment of epilepsy);
• cardiac glycosides (e.g. digoxin; medicines used in heart disease);
• methotrexate (used in the treatment of certain inflammatory conditions and cancers);
• cyclosporine and tacrolimus (used in the treatment of certain inflammatory conditions and after organ transplantation);
• quinolone antibiotics (used to treat certain infections);
• steroids (used in the treatment of inflammatory and immune system disorders);
• colestipol (used to lower cholesterol levels);
• cholestyramine (used in the treatment of liver disease and Crohn's disease);
• sulfinpyrazone (used in the treatment of gout);
• voriconazole (used in the treatment of fungal infections);
• pemetrexed (a chemotherapy drug used in the treatment of certain cancers);
• deferasirox (used in patients undergoing long-term blood transfusions);
• mifepristone (used in pregnancy termination);
• medicines used for heart disease or high blood pressure, e.g. beta-blockers or ACE inhibitors;
• tacrolimus (an immunosuppressant used to prevent organ transplant rejection);
• medicines used to treat anxiety and depression known as selective serotonin reuptake inhibitors (SSRIs);
• zidovudine (used in the treatment of human immunodeficiency virus [HIV] infection).

Pregnancy and breastfeeding

• Do not use AKIS during the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. AKIS may cause kidney and heart problems in the unborn child. It may increase the risk of bleeding in both mother and child and may delay or prolong labor. During the first six months of pregnancy, AKIS should not be used unless the doctor considers it 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. From week 20 of pregnancy, AKIS may cause kidney dysfunction in the unborn child if taken for longer than a few days. 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.

Driving and operating machinery
In some patients, AKIS may cause dizziness, fatigue, drowsiness, and visual disturbances. Do not drive or operate machinery if these adverse effects occur.

The medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. the medicine is considered "sodium-free".

3. How to use AKIS

Your doctor will decide when and how to treat you with AKIS injection solution. AKIS is administered
by intramuscular injection (injection into the muscle, usually into the buttock) or
subcutaneous injection (injection under the skin, usually into the buttock or thigh) or
intravenous injection (injection into a vein, usually in the forearm). AKIS must not be administered
by intravenous infusion.
Adults
The usual initial dose is 25 to 75 mg, depending on the intensity of pain. If the patient continues to
experience severe pain, the doctor may decide to administer a second injection after 6 hours. The
maximum daily dose is 150 mg. AKIS is administered for only one or two days.
Elderly patients
The doctor may administer a lower than usual dose of AKIS if the patient is elderly.
Children and adolescents
This medicine is not intended for use in children and adolescents under 18 years of age.
The doctor, nurse or pharmacist will prepare the injection for the patient. The medicine is usually
then administered by a nurse or doctor. The doctor or nurse will not administer the injection twice
at the same site.
Overdose of AKIS
If a patient has received more than the recommended dose of AKIS, the following symptoms may
occur: nausea and vomiting, abdominal pain, gastrointestinal bleeding (bleeding from the stomach
and/or intestine), less commonly haemorrhage, dizziness, tinnitus (ringing, buzzing, humming,
whistling or other persistent noises in the ears) and occasionally convulsions (seizures or fits). In
severe cases, the patient's kidneys or liver may be damaged (symptoms include: problems with
urination or increased urination, muscle cramps, fatigue, swelling of the hands, feet or face, nausea
or vomiting, yellowing of the skin).
If the patient thinks that more AKIS has been administered than the recommended dose, they
should immediately inform the doctor or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will get them.
Some adverse reactions may be serious.
You must stop taking AKIS and contact your doctor immediately if the patient notices any of the following:

• mild abdominal cramps and tenderness occurring soon after starting AKIS, followed by rectal bleeding or bloody diarrhoea, usually within 24 hours of the onset of abdominal pain (frequency unknown – cannot be estimated from available data).

Tell your doctor immediately if any of the following adverse reactions occur:

• severe allergic reactions, including: swelling of the face, neck or tongue, breathing difficulties, wheezing, runny nose and skin rash;
• stomach pain, indigestion, heartburn, flatulence, nausea or vomiting;
• any signs of bleeding from the stomach or intestine, such as blood in stools, black tarry stools, or vomiting blood;
• severe skin rash, itching, hives, bruising, painful red spots on the skin, blistering and peeling of the skin, giant blisters (burning, itchy, swollen skin). These effects may also affect the mouth, lips, eyes, nose and genitals;
• yellowing of the skin or whites of the eyes;
• persistent sore throat or high fever;
• unexpected change in the amount or appearance of urine produced;
• easier than usual 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 at the injection site, healing with scarring, known as Nicolau's syndrome.

Very common adverse reactions (may affect more than 1 in 10 patients)

• pain, redness or nodules at the injection site.

Common adverse reactions (may affect more than 1 in 100 but less than 1 in 10 patients)

• nausea, discomfort at the injection site

Uncommon adverse reactions (may affect more than 1 in 1,000 but less than 1 in 100 patients)

• dizziness and headache,
• diarrhoea, vomiting and constipation,
• inflammation of the stomach lining causing stomach pain, nausea and loss of appetite,
• liver problems,
• skin rash, itching.

Adverse reactions with unknown frequency (cannot be estimated from available data):

• tissue damage at the injection site

Other adverse reactions
The following adverse reactions have been reported in patients treated with NSAIDs.

Effects on the heart or blood

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

Effects on the stomach and digestive system

• peptic ulcer disease (of the stomach), mouth ulcers, tongue infections, disorders of the large intestine (including colitis and exacerbation of Crohn's disease),
• inflammation of the pancreas or stomach lining (symptoms include: severe abdominal pain which may radiate to the back or shoulders).

Effects on the nervous system

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

Effects on the liver and kidneys

• liver function disorders. Symptoms include: nausea, loss of appetite, general malaise, sometimes with jaundice,
• kidney disorders or kidney failure. Symptoms include: blood in urine, foamy urine, swelling of the feet, hands or body.

Effects on the skin and hair

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

Effects on the immune system

• hypersensitivity reactions

If any of the adverse reactions worsen or if any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C
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 authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store AKIS

• Keep the medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the cardboard box and syringe following EXP.
• Store below 25°C. Do not store in a refrigerator or freeze. Keep in the original packaging to protect from light.
• Use immediately after opening. Any unused remnants of the product must be discarded.
• Do not use if the solution is cloudy or if particles are visible.

After injection of the appropriate dose, the doctor or nurse will dispose of any remaining solution, together with the syringe, needles, and containers.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.

6. Contents of the packaging and other information

What AKIS contains
The active substance is sodium diclofenac.
1 ml of solution in an ampoule-syringe contains:
25 mg of sodium diclofenac or
50 mg of sodium diclofenac or
75 mg of sodium diclofenac.
The other ingredients are: hydroxypropylbetadex, polysorbate 20, water for injections.

What AKIS looks like and contents of the pack
This medicine is a clear to slightly yellowish, transparent solution for injection contained in an ampoule-syringe made of colourless type I glass, with a protective cap made of synthetic isoprene-bromobutyl rubber and a plunger made of chlorobutyl rubber (plunger rod made of polyester).
The medicine is supplied with a sterile administration set containing:
1 subcutaneous injection needle (size 27 G), grey
1 intramuscular or intravenous injection needle (size 21 G), green

Pack sizes: 1, 3 or 5 ampoule-syringes in a cardboard box.
This medicine is also available in glass ampoules in packs containing 1, 3 or 5 ampoules.
Not all pack sizes may be marketed.

Marketing Authorisation 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