AKIS 50 mg /Ml Solution

Contents of the leaflet

1. Package Leaflet: Information for the User
2. AKIS
   1. Read the package leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Contents of the package leaflet:
3. What AKIS is and what it is used for
4. Important information before using AKIS
   1. When not to use AKIS:
   2. Warnings and precautions
   3. Other precautions
   4. Other medicines and AKIS
   5. Pregnancy and breastfeeding
   6. Driving and using machines
5. How to use AKIS
   1. Adults
   2. Elderly patients
   3. Children and adolescents
   4. Overdose of AKIS
6. Possible side effects
   1. Stop using AKIS and tell your doctor immediately if you notice any of the following:
   2. Tell your doctor immediately if you experience any of the following side effects:
   3. Other side effects
   4. Reporting side effects
7. How to store AKIS
8. Contents of the pack and other information
   1. What AKIS contains
   2. What AKIS looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer/Importer

Package Leaflet: Information for the User

AKIS

25 mg/ml, 50 mg/ml, 75 mg/ml, solution for injection
Diclofenac sodium

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

• Keep this 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 any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Contents of the package 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 pack 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 this group are aspirin and ibuprofen. These medicines work by relieving pain and reducing inflammation.
AKIS is used to treat painful conditions, including:

• joint and back pain;
• gout attacks;
• kidney stone pain;
• pain due to injury, fracture, or trauma;

AKIS is also used to treat or prevent pain after surgery.

2. Important information before using AKIS

When not to use AKIS:

if you have peripheral arterial disease (poor circulation in the arteries);

In addition, do not use AKIS for intravenous injection:

• in case of surgical procedures with a high risk of bleeding;
• in case of asthma;
• in case of moderate or severe kidney impairment;
• in case of dehydration;
• in case of significant blood loss.

Warnings and precautions

Before taking diclofenac, tell your doctor:

To minimize the risk of side effects, use the lowest effective dose for the shortest possible time.
Before using AKIS, consult your doctor.

• If you think you may be allergic to diclofenac, aspirin, ibuprofen, or any other NSAID, or any of the other ingredients of AKIS (listed at the end of this leaflet). Symptoms of an allergic reaction include face and throat swelling, difficulty breathing, chest pain, rash, or any other allergic reactions.
• If you have ever had a stomach ulcer, stomach or intestinal bleeding, or perforation. Symptoms may include vomiting blood or black, tarry stools.
• If you have any bowel problems, such as ulcerative colitis or Crohn's disease.
• If you have kidney or liver problems.
• If you have bleeding disorders or are taking anticoagulant medicines.
• If you have asthma, chronic obstructive pulmonary disease (COPD), nasal polyps, or hay fever.
• If you have systemic lupus erythematosus (SLE) or any similar condition.
• If you are planning to become pregnant, as AKIS may affect fertility.
• If you have recently had or are scheduled to have stomach or intestinal surgery, as AKIS may delay wound healing.

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. Do not exceed the recommended dose or duration of treatment.

AKIS is an anti-inflammatory medicine, which may mask the symptoms of inflammation, such as headache or fever. If you do not feel well and need to see a doctor, tell them that you are taking AKIS.

• Elderly patients are more prone to side effects when taking AKIS. Tell your doctor about any unusual symptoms.

Other medicines and AKIS

Tell your doctor or pharmacist about all medicines you are taking, including those obtained without a prescription (e.g., over-the-counter medicines or recreational drugs). Some medicines may affect your treatment.
Tell your doctor if you are taking any of the following medicines:

• any other NSAID or COX-2 inhibitor (e.g., aspirin or ibuprofen);
• medicines for diabetes;
• anticoagulant medicines (e.g., warfarin or heparin);
• antiplatelet medicines;
• diuretics;
• lithium (for depression);
• phenytoin (for epilepsy);
• digitalis (for heart conditions);
• methotrexate (for inflammatory conditions or cancer);
• cyclosporin and tacrolimus (for inflammatory conditions or after organ transplants);
• quinolone antibiotics;
• corticosteroids;
• cholestyramine (for high cholesterol or Crohn's disease);
• sulfinpyrazone (for gout);
• voriconazole (for fungal infections);
• pemetrexed (for cancer);
• deferiprone (for iron overload);
• mifepristone (for abortion);
• medicines for heart conditions or high blood pressure (e.g., beta blockers or ACE inhibitors);
• tacrolimus (to prevent organ rejection);
• selective serotonin reuptake inhibitors (SSRIs) for anxiety or depression;
• zydovudine (for HIV infection).

Pregnancy and breastfeeding

• Do not use AKIS 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, do not use AKIS unless your doctor considers it essential. If treatment is necessary during this period or when trying to become pregnant, use the lowest possible dose 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 or narrowing of the ductus arteriosus in the baby's heart. If treatment is required for more than a few days, your doctor may recommend additional monitoring.

Driving and using machines

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

3. How to use AKIS

Your doctor will decide when and how to treat you with AKIS solution for injection. The medicine is given 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 arm). AKIS must not be given by intravenous infusion.

Adults

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

Elderly patients

The doctor may give a lower dose than usual if the patient is elderly.

Children and adolescents

This medicine is not suitable for children and adolescents under 18 years old.
Your doctor, nurse, or pharmacist will prepare the injection for you. The medicine is usually given by a nurse or doctor. The doctor or nurse will not give the injection twice in the same place.

Overdose of AKIS

If you have taken more AKIS than you should, you may experience the following symptoms:
nausea and vomiting, stomach pain, bleeding from the stomach and/or intestines, less frequently bleeding, dizziness, ringing in the ears (tinnitus), 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 spasms, fatigue, swelling of hands, feet, or face, nausea, or vomiting, yellowing of the skin).
If you think you have been given too much AKIS, tell your 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.

Stop using AKIS and tell your doctor immediately if you notice any of the following:

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

Tell your doctor immediately if you experience any of the following side effects:

• severe allergic reactions, including face, throat, or tongue swelling, difficulty breathing, wheezing, rash, or any other allergic reactions;
• stomach pain, indigestion, heartburn, gas, nausea, or vomiting;
• any symptoms of stomach or intestinal bleeding, such as black, tarry stools or vomiting blood;
• severe skin rash, itching, hives, bruising, painful red spots on the skin, blistering, or 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;
• persistent sore throat or high temperature;
• unexplained 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:
• injection site reactions, including pain, redness, swelling, hard lump, ulceration, and bruising. This may lead to skin necrosis and scarring, 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 1,000 people but less than 1 in 100 people)

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

Side effects with unknown frequency(cannot be estimated from the 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, fast 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 intestines

• stomach ulcers, mouth ulcers, tongue infections, bowel problems (including inflammation of the colon and worsening of Crohn's disease),
• pancreatitis or stomach inflammation (symptoms include severe stomach pain, which may radiate to the back or arms).

Effects on the nervous system

• tingling and numbness, feeling of pins and needles in the hands or feet, or limbs, trembling, blurred or double vision, hearing loss, ringing in the ears (tinnitus), drowsiness, fatigue,
• hallucinations (seeing or hearing things that do not exist), depression, confusion, sleep problems, 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, feeling unwell, and sometimes 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

• allergic reactions

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

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly to the Department of Drug Safety, 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. You can also report side effects 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 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 (expiry date stated on the ampoule).
• Store in a temperature below 25°C. Do not store in the refrigerator or freeze. Store in the original packaging to protect from light.
• Use immediately after opening. Discard any unused portion of the product.
• Do not use if the solution is cloudy or if small particles are visible.

After administering the correct dose, your doctor or nurse will dispose of any remaining solution, along with the syringe, needles, and containers.
Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What AKIS contains

The active substance is diclofenac sodium.
1 ml of solution in an ampoule 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 in an ampoule made of colorless glass.
Pack sizes: 1, 3, or 5 ampoules in a cardboard box.
The medicine is also available in a pre-filled syringe.
Not all pack sizes may be marketed.

Marketing authorization 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
Date of last revision of the leaflet:November 2022