Leaflet: information for the user

Akis 25, 50 and 75 mg pre-filled syringe solution

Diclofenac sodium

Read this leaflet carefully before you start using this medicinebecause it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.See section 4.
• In this leaflet, Akis 25, 50 and 75 mg pre-filled syringe solution will be referred to as Akis.

1.What is Akis 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.Storage of Akis

6.Contents of the pack and additional information

This medication contains the active ingredient diclofenac sodium. Akis belongs to a type of medication called nonsteroidal anti-inflammatory drugs (NSAIDs). Other NSAIDs include aspirin and ibuprofen. These medications reduce pain and inflammation.

Akis, administered via intramuscular or subcutaneous injection,is used to treat a number of painful conditions, including:

Administered via intravenous injection, this medication is used in a hospital setting to prevent or treat pain after surgery.

Do not use Akis

• if you are allergic to diclofenac, aspirin, ibuprofen or other NSAIDs; if you are allergic to the active ingredient or any of the other components of this medication (listed in section 6 at the end of this leaflet)
• if you have a history of bleeding in your stomach or intestines after taking NSAIDs
• if you have had two or more episodes of stomach ulcers (gastric) or duodenal (peptic) ulcers or bleeding in the digestive tract. This may include blood in your vomit, bleeding when you empty your bowels or black and tar-like stools
• if you have or have had liver failure
• if you have or have had severe heart failure
• if you have a established cardiovascular disease and/or cerebrovascular disease, for example, if you have had a heart attack, stroke, mini-stroke (TIA) or blockages in the blood vessels of the heart or brain, or a surgery to remove some obstruction or make a coronary bypass
• if you have or have had problems with blood circulation (peripheral arterial disease)
• if you have or have had severe kidney failure
• if you have asthma, urticaria or acute rhinitis (allergy) caused by the use of NSAIDs or aspirin
• if you have any coagulation disorder or are currently taking anticoagulants (such as warfarin)
• if you are more than 6 months pregnant(see also Pregnancy, breastfeeding and fertility)
• if you are less than 18 years old

In addition, do not use this medication by intravenous injection:

• if you are using another NSAID or anticoagulant (including low-dose heparin)
• if you have a history of hemorrhagic diathesis, specifically cerebral hemorrhage
• if you have undergone a high-risk surgery for hemorrhage
• if you have a history of asthma
• if you have moderate or severe renal impairment
• if you are dehydrated
• if you have suffered a significant loss of blood

Be especially careful with Akis

Make sure before taking diclofenac, that your doctor knows

• if you smoke
• if you have diabetes
• if you have angina, blood clots, high blood pressure, high cholesterol or high triglycerides.

The adverse effects can be minimized by using the lowest effective dose for the shortest possible period.

Consult your doctor before starting to take Akis

• if you think you may be allergic to diclofenac, acetylsalicylic acid, ibuprofen or any other NSAID, or to any of the other components of Akis (listed at the end of the leaflet). The signs of a hypersensitivity reaction are swelling of the face and mouth (angioedema), breathing difficulties, chest pain, runny nose, skin rash or any other allergic reaction.
• if you have ever had a stomach or intestinal ulcer, or gastrointestinal bleeding. Your symptoms may include blood in your vomit or when you empty your bowels, or black and tar-like stools
• if you have any intestinal disorder that includes ulcerative colitis or Crohn's disease
• if you have, or have had, any kidney or liver problems
• if you have, or have had, any bleeding or hemorrhagic disorder
• if you have, or have had, chronic obstructive pulmonary disease (COPD), nasal polyps or seasonal rhinitis or asthma
• if you have lupus (systemic lupus erythematosus or SLE) or any similar condition
• if you are planning to become pregnant, as this medication interferes with your ability to become pregnant
• if you have recently undergone or are about to undergo a surgical intervention on your stomach or intestines before receiving/taking/using Akis, as Akis may sometimes worsen the healing of intestinal wounds after a surgical intervention.

Other special warnings

• medications like Akis may be associated with a small increase in the risk of heart attack ("myocardial infarction") or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment
• this is an anti-inflammatory medication, so it may reduce the symptoms of infection, such as headache or fever. If you do not feel well and need to see a doctor, remember to inform him that you are taking Akis
• patients over 65 years old are more prone to adverse effects associated with this medication, so inform your doctor about any unusual symptoms

Other medications and Akis

Consult your doctor or pharmacist if you are taking or have recently taken any other medication, including over-the-counter medications (such as pain relievers or cold medications). Some medications may interfere with your treatment.

Inform your doctor if you are taking any of the following medications:

• any other NSAID or COX-2 inhibitor (cyclooxygenase-2), for example, aspirin or ibuprofen (pain relievers or anti-inflammatory medications)
• medications for diabetes
• anticoagulants (blood thinners, such as warfarin or heparin)

• antiplatelet medications (to prevent blood clotting)
• diuretics (water pills)
• lithium (a medication for some types of depression)
• phenytoin (a medication for epilepsy)
• cardiac glycosides (such as digoxin; medications for heart problems)
• methotrexate (a medication for some types of inflammation and cancer)
• ciclosporin and tacrolimus (medications for some types of inflammation and post-transplant patients)
• quinolone antibiotics (medications used to treat some infections)
• steroids (medications for inflammation and for the treatment of immune system disorders)
• colestipol (a medication used to reduce cholesterol)
• colestiramine (a medication used to treat liver problems and Crohn's disease)
• sulfinpyrazone (a medication used to treat gout)
• voriconazole (a medication used to treat fungal infections)
• pemetrexed (a chemotherapy medication used to treat some types of cancer)
• deferasirox (a medication used in patients who receive long-term blood transfusions)
• mifepristone (a medication used during pregnancy termination)
• medications for heart problems or high blood pressure, such as beta blockers or ACE inhibitors
• tacrolimus (a medication that reduces the action of the immune system, used to prevent organ rejection in certain patients)
• medications used to treat anxiety and depression, known as selective serotonin reuptake inhibitors (SSRIs)
• zidovudine (a medication for HIV infection)

Pregnancy and breastfeeding

• Do not take Akis if you are in the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in your fetus. It may affect your tendency and that of your baby to bleed and delay or prolong delivery more than expected. Do not take Akis during the first 6 months of pregnancy unless it is clearly necessary and as your doctor tells you. If you need treatment during this period or while trying to become pregnant, you should take the minimum dose for the shortest possible time. From week 20 of pregnancy, Akis may cause kidney problems in your fetus if taken for more than a few days, which may cause low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for more than a few days, your doctor may recommend additional checks.

• You should inform your doctor if you are breastfeeding. If you are breastfeeding, your doctor will consider whether this medication should be used

Driving and operating machinery

This medication may make some people feel dizzy, tired, drowsy or have blurred vision. Do not drive or use tools, or operate machinery if you are affected in this way.

This medication contains less than 1 mmol of sodium (23 mg) per dose unit; it is essentially "sodium-free".

Your doctor will decide when and how to treat you with this medication. You will be administered an intramuscular injection (an injection into a muscle, usually in the buttocks) or a subcutaneous injection (an injection under the skin, usually in the buttocks or thigh)) or an intravenous injection(an injection into a vein, usually in the arm).

This medicationmust not be administered via intravenous infusion (i.v.).

Adults:The usual initial dose is25 to75 mg, depending on the intensity of your pain. If you continue to have intense pain, your doctor may decide to administer a second injection after 6 hours.The maximum daily dose is 150 mg. You will only be administered this medication for one or two days.

Senior citizens:Your doctor may administer a dose lower than the usual dose for adults.

Childrenand adolescents:Not suitable for children (under 18 years).

A doctor, nurse, or pharmacist will prepare the injection. Normally, the injection will be administered by a nurse or a doctor. Your doctor or nurse will not inject you twice in the same site.

If you use more Akis than you should

If you have been administered too much medication, you may experience the following symptoms: nausea and vomiting, stomach pain, stomach or intestinal bleeding, rarely diarrhea, dizziness, tinnitus (buzzing, hissing, ringing, or other persistent sounds in the ear), and occasionally, seizures (muscle spasms or attacks). In severe cases, your kidneys or liver may be damaged (symptoms include difficulty swallowing water or swallowing more water than usual, muscle cramps, fatigue, swelling of the hands, feet, or face, sensation of vomiting or vomiting, yellow discoloration of your skin).

In case of overdose or accidental administration, consult your doctoror nurseimmediately or go to the nearest hospital emergency department bringing this leaflet with you, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount administered.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Reportimmediatelyto your doctor if you notice any of the following:

• Severe allergic reactions that may include: facial, throat, or tongue swelling, difficulty breathing, wheezing, nasal discharge, or skin rashes
• Stomach pain, indigestion, heartburn, gas, nausea, or vomiting
• Any sign of bleeding in the stomach or intestines, for example, blood in the stool, black and tarry stools, or blood in the vomit
• Severe skin eruptions, itching, urticaria, hives, red and painful areas, peeling, or blistering of the skin, giant hives (skin burning with itching and swelling). These conditions may also affect the mouth, lips, eyes, nose, and genitals
• Yellowing of the skin or the white of the eyes
• Persistent sore throat or fever
• Un expected change in the amount of urine you produce and/or its appearance
• Appearance of hives with more ease than usual or frequent sore throats or infections

• Chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome

• Reactions at the injection site, including pain, redness, swelling, appearance of a hard lump, ulcers, or hives at the injection site. These symptoms may evolve into skin and underlying tissue necrosis and scarring, which is also known as Nicolau syndrome.

Very common side effects(may affect up to 1 in 10 patients)

• Pain, redness, or nodules at the injection site

Common side effects(may affect between 1 in 100 and 1 in 10 patients)

• Feeling of illness, discomfort at the injection site

Uncommon side effects(reported in 1 in 1,000 to 1 in 100)

• Dizziness and headache
• Diarrhea, vomiting, and constipation
• Stomach lining inflammation causing pain, illness, and loss of appetite
• Liver problems

• Skin eruption, itching

Other side effects

The following list of side effects has been reported in patients treated with NSAIDs.

Effects on the heart, chest, or blood

• Medicines like Akis may be associated with a small increase in the risk of heart attack ("myocardial infarction") or stroke.
• High blood pressure, heart attack, rapid or irregular heartbeat, chest pain, and swelling of the body, hands, or feet.
• Asthma, shortness of breath.
• Blood disorders, such as anemia (decrease in the number of red blood cells). Symptoms include fatigue, headache, dizziness, and paleness.

Effects on the stomach and digestive system

• Peptic ulcers (stomach ulcers) and mouth ulcers, tongue infections, and lower intestine disorders (including inflammation of the same and worsening of Crohn's disease).

• Pancreatitis or stomach lining inflammation (whose symptoms include severe stomach pain that may extend to the back or shoulders).

Effects on the nervous system

• Tickling or numbness, paresthesia of the hands and feet or extremities, blurred vision or double vision, hearing loss or alteration, tinnitus (ringing in the ears), drowsiness, fatigue.
• Hallucinations (seeing or hearing things that are not there), depression, disorientation, sleep problems, irritability, anxiety, memory problems, and convulsions (spasms or attacks).
• Brain layer inflammation. Symptoms include neck stiffness, headache, nausea, vomiting, fever, or disorientation and extreme sensitivity to bright light.

Effects on the liver and kidneys

• Liver disorders. Symptoms may include illness, loss of appetite, general discomfort, sometimes with jaundice.
• Renal disorders or renal insufficiency. Symptoms include blood in the urine, foamy urine, swelling of the feet and hands or body.

Effects on the skin and hair

• Severe skin eruptions, such as Stevens-Johnson syndrome and other skin conditions that may worsen when exposed to sunlight.
• Hair loss.

Effects on the immune system

-Hypersensitivity reaction

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

After the correct dose injection, your doctor or nurse will discard any remaining solution, along with the syringe, needles, and containers.

Medications should not be disposed of through drains or trash.Deposit containers and medications you no longer need at the SIGRE collection point at the pharmacy.If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Akis

The active principle is: sodium diclofenac.

Each syringe of 1 ml contains:

25 mg of sodium diclofenacor

50 mg of sodium diclofenacor

75 mg of sodium diclofenac

The other components are: hydroxypropyl-beta-cyclodextrin, polisorbate 20, water for injectable preparations.

Appearance of the product and contents of the packaging

This medicine is a transparent to slightly amber injectable solution, contained in a transparent glass pre-filled syringe. It is supplied in a packaging with two sterile needles (one 27 gauge (grey) for subcutaneous injection and one 21 gauge (green) for intramuscular or intravenous injection).

Packaging format of 1, 3 and 5 pre-filled syringes.

This medicineis also supplied in glass vials in packaging formats of 1, 3 or 5 vials.

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and manufacturer

IBSA Farmaceutici Italia Srl

Via Martiri di Cefalonia 2

26900 Lodi

Italy

Phone + 39(0) 371 617292

Email:[email protected]

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Instituto Bioquimico Iberico IBSA S.L.

Avenida Diagonal 605,

8th floor, Local 1,

08028 Barcelona (Spain)

Date of the last review of this leaflet:February 2023

Other sources of information

The detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

If this leaflet is difficult to see or read, or if you would like it in a different format, please contact the marketing authorization holder.