Akis

Package leaflet: Information for the user

AKIS
25 mg/ml, 50 mg/ml, 75 mg/ml, solution for injection
Diclofenacum natricum
Read the entire leaflet carefully before using this medicine, as it contains important information for you.

• 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. This medicine may harm other people, even if their symptoms are the same.
• If any of the side effects worsen, or if you experience any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

1. What AKIS is and what it is used for
2. What you need to know 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 this group include 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:

• Recurrent joint and back pain;
• Acute attacks of gout;
• 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. 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 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 gastric or duodenal ulcer disease 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, mini-stroke (transient ischaemic attack), or arterial occlusion in the heart or brain, or after a procedure to unblock or bypass 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) which may be triggered by NSAIDs or aspirin;
• if the patient has blood clotting disorders or is currently taking anticoagulant medicines (such as warfarin);
• if the patient is in the third trimester 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 medicines (including low-dose heparin);
• if the patient has or has had a tendency to bleeding, especially within cerebral vessels;
• during surgical procedures associated with a high risk of haemorrhage;
• in patients with a history of asthma;
• in cases of moderate or severe renal impairment;
• 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 levels, or elevated triglyceride levels.

The risk of adverse effects can be reduced 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 components of 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 an ulcer in the oesophagus, 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.
• 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 pregnancy, 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 medicines 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 treatment duration.

• AKIS is an anti-inflammatory medicine and therefore may 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 from AKIS. Therefore, 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 affect the patient's treatment.

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

• any other NSAID or COX-2 inhibitor (cyclooxygenase-2), 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 (used to prevent blood clots);
• diuretics (water tablets);
• lithium (used to treat certain types of depression);
• phenytoin (used to treat epilepsy);
• cardiac glycosides (e.g. digoxin; used to treat heart conditions);
• methotrexate (used to treat certain inflammatory conditions and cancers);
• cyclosporine and tacrolimus (used to treat certain inflammatory conditions and after organ transplantation);
• quinolone antibiotics (used to treat certain infections);
• steroids (used to treat inflammatory and immune system disorders);
• colestipol (used to lower cholesterol levels);
• cholestyramine (used to treat liver diseases and Crohn's disease);
• sulfinpyrazone (used to treat gout);
• voriconazole (used to treat fungal infections);
• pemetrexed (chemotherapy used to treat certain types of cancer);
• deferasirox (used in patients undergoing long-term blood transfusions);
• mifepristone (used in pregnancy termination);
• medicines used for heart conditions 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 serotonin reuptake inhibitors (SSRIs);
• zidovudine (used to treat 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 labour. 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
AKIS may cause dizziness, fatigue, drowsiness, and visual disturbances in some patients. Do not drive or operate machinery if these adverse effects occur.

The medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning 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), 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 given as an intravenous infusion.

Adults
The usual initial dose is 25 to 75 mg, depending on the severity of 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. AKIS is administered for no more than one or two days only.

Elderly patients
The doctor may administer a lower than usual dose 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 injection will be prepared by a doctor, nurse, or pharmacist. It 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 they have been given more AKIS than the recommended dose, they should inform the doctor or nurse immediately.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Some adverse effects may be serious.
The patient must stop taking AKIS and contact a doctor immediately if they notice:

• mild abdominal cramps and tenderness occurring soon after starting treatment with 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 a doctor immediately if any of the following adverse effects 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, e.g. blood during bowel movements, black tarry stools or vomiting blood;
• severe skin rash, itching, urticaria, 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 and (or) its appearance;
• 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;
• injection site reactions, including pain at the injection site, redness, swelling, hard lump, ulceration and bruising. This may lead to blackening and tissue necrosis around the injection site, healing with scarring, a condition also known as Nicolau syndrome.

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

• pain, redness or nodules at the injection site.

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

• nausea, discomfort at the injection site

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

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

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

• tissue damage at the injection site

Other adverse effects
The following adverse effects 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, rapid 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),
• pancreatitis or gastric mucositis (symptoms include: severe abdominal pain which may radiate to the back or shoulders).

Effects on the nervous system

• itching and numbness, tingling sensation in hands or feet, or limbs, tremor, blurred or double vision, loss or disturbance of hearing, 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 lining 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, malaise, sometimes with jaundice,
• kidney disorders or kidney failure. Symptoms include: blood in urine, foamy urine, swelling of feet and hands or body.

Effects on the skin and hair

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

Effects on the immune system

• hypersensitivity reactions

If any of the adverse effects worsen or if any adverse effects occur, including those not listed in this leaflet, inform a doctor or pharmacist.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor or pharmacist. Adverse effects can be reported directly to the Department for Monitoring Adverse Drug Reactions of the Office for Registration 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
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the 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 ampoule after EXP (the expiry date refers to the last day of the specified month).
• 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 portion of the product must be discarded.
• Do not use if the solution is cloudy or if particles are visible.

After administering the correct 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 required. This will help protect the environment.

6. Contents of the pack and other information

What AKIS contains
The active substance is sodium diclofenac.
1 ml of solution in an ampoule 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 amber, transparent solution for injection contained in an ampoule made of colourless glass.
Pack sizes: 1, 3 or 5 ampoules in a cardboard box.
This medicine is also available in an ampoule-syringe.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
IBSA Farmaceutici Italia Srl
Via Martiri di Cefalonia 2
26900 Lodi
Italy

Manufacturer/Importer
IBSA Farmaceutici Italia Srl
Via Martiri di Cefalonia 2
26900 Lodi
Italy