AKIS 50 mg Injectable Solution in Pre-filled Syringe

Introduction

Package Leaflet: Information for the User

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

Diclofenac sodium

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• In this leaflet, Akis 25, 50 and 75 mg solution for injection in pre-filled syringe will be referred to as Akis.

Contents of the pack

1. What is Akis and what is it used for
2. What you need to know before you use Akis
3. How to use Akis
4. Possible side effects
5. Storage of Akis
6. Contents of the pack and other information

1. What is Akis and what is it used for

This medicine contains the active substance diclofenac sodium. Akis belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Other NSAIDs include aspirin and ibuprofen. These medicines reduce pain and inflammation.

Akis, given by injection into a muscle or under the skin, is used to treat a number of painful conditions, including:

• Painful attacks in the joints or back
• Gout attacks
• Pain caused by kidney stones
• Pain caused by injuries, fractures or trauma
• It is also used to prevent or treat pain after an operation

Given by injection into a vein, this medicine is used in hospitals to prevent or treat pain after an operation.

2. What you need to know before you use Akis

Do not use Akis

• if you are allergic to diclofenac, aspirin, ibuprofen or other NSAIDs; if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6 at the end of this leaflet)
• if you have had bleeding in your stomach or intestines after taking NSAIDs
• if you have had two or more episodes of stomach (gastric) or duodenal (peptic) ulcers or bleeding in the digestive tract. This can include blood in your vomit or when you empty your bowels, or black, tarry stools
• if you have or have had severe liver failure
• if you have or have had severe heart failure
• if you have 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 an operation to remove a blockage or do 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, hives or acute rhinitis (allergy) caused by taking NSAIDs or aspirin
• if you have any blood clotting disorder or are taking anticoagulants (such as warfarin) at the same time
• if you are more than 6 months pregnant (see also Pregnancy, breast-feeding and fertility)
• if you are under 18 years of age

In addition, do not use this medicine by injection into a vein:

• if you are using another NSAID or anticoagulant (including low-dose heparin)
• if you have a history of bleeding tendency, in particular, cerebral haemorrhage
• if you have had an operation with a high risk of bleeding
• if you have a history of asthma
• if you have moderate or severe kidney problems
• if you are dehydrated
• if you have lost a lot of blood

Be especially careful with Akis

Make sure your doctor knows before taking diclofenac:

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

Side effects can be minimised by using the lowest effective dose for the shortest possible time.

Consult your doctor before starting to take Akis

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

Other special warnings

• medicines like Akis may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke. Any risk is more likely with high doses and with long-term treatment. Do not exceed the recommended dose or duration of treatment
• this is an anti-inflammatory medicine, 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 tell them that you are taking Akis
• elderly patients are more likely to get side effects with this medicine, so tell your doctor about any unusual symptoms

Other medicines and Akis

Consult your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription (e.g. over-the-counter medicines or herbal remedies). Some medicines may interfere with 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 inflammation or pain)
• medicines for diabetes
• anticoagulants (blood-thinning tablets, such as warfarin or heparin)

• anti-platelet medicines (to prevent blood clotting)
• diuretics (water tablets)
• lithium (a medicine for certain types of depression)
• phenytoin (a medicine for epilepsy)
• cardiac glycosides (e.g. digoxin; medicines for heart problems)
• methotrexate (a medicine for certain types of inflammation and cancer)
• ciclosporin and tacrolimus (medicines for certain types of inflammation and after organ transplants)
• quinolone antibiotics (medicines used to treat certain infections)
• corticosteroids (medicines for inflammation and for treating problems with the immune system)
• colestyramine (a medicine used to lower cholesterol)
• colestipol (a medicine used to treat liver problems and Crohn's disease)
• sulfinpyrazone (a medicine used to treat gout)
• voriconazole (a medicine used to treat fungal infections)
• pemetrexed (a chemotherapy medicine used to treat certain types of cancer)
• deferasirox (a medicine used in patients who receive long-term blood transfusions)
• mifepristone (a medicine used during the termination of pregnancy)
• medicines for heart problems or high blood pressure, e.g. beta blockers or ACE inhibitors
• tacrolimus (a medicine that reduces the action of 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 for HIV infection)

Pregnancy and breast-feeding

• Do not take Akis if you are in the last 3 months of pregnancy, as it may harm your baby or cause problems during delivery. It may cause kidney or heart problems in your baby. It may affect you and your baby's ability to clot and prolong labour. You should not take Akis during the first 6 months of pregnancy unless clearly necessary and as directed by your doctor. 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 the 20th week of pregnancy, Akis may cause kidney problems in your baby if taken for more than a few days, which may lead to low levels of the fluid that surrounds 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 monitoring.

• You should tell your doctor if you are breast-feeding. If you are breast-feeding, your doctor will consider whether you should use this medicine

Driving and using machines

This medicine may make some people feel dizzy, tired, drowsy or affect their vision. Do not drive or use tools or machines if you are affected in this way.

This medicine contains less than 1 mmol sodium (23 mg) per dose unit, i.e. essentially "sodium-free".

3. How to use Akis

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

This medicine must not be given by intravenous infusion (i.v.).

Adults:the usual initial dose is 25 to 75 mg, depending on the severity of your pain. If you are still in severe pain, your doctor may decide to give you a second injection after 6 hours. The maximum daily dose is 150 mg. You will only be given this medicine for one or two days.

Elderly:your doctor may give you a lower dose than the usual dose for adults.

Children and adolescents:not suitable for children (under 18 years).

A doctor, nurse or pharmacist will prepare the injection. The injection will usually be given by a nurse or doctor. Your doctor or nurse will not inject you twice in the same place.

If you use more Akis than you should

If you have been given too much medicine, you may experience the following symptoms: nausea and vomiting, stomach pain, stomach or intestinal bleeding, rarely diarrhoea, dizziness, ringing in the ears (tinnitus), and occasionally, convulsions (fits or seizures). In severe cases, your kidneys or liver may be damaged (symptoms include difficulty swallowing water or drinking more water than usual, muscle cramps, tiredness, swelling of the hands, feet or face, feeling sick or vomiting, yellowing of the skin).

In case of overdose or accidental administration, consult your doctor or nurse immediately or go to the emergency department of the nearest hospital, taking this leaflet with you, or call the Toxicology Information Service, telephone 91 562 04 20, stating the medicine and the amount administered.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor immediately if you notice any of the following:

• serious allergic reactions which can include: swelling of the face, throat or tongue, difficulty breathing, wheezing, runny nose, skin rash
• stomach pain, indigestion, acidity, gas, feeling sick or vomiting
• any sign of bleeding in the stomach or intestines, for example, blood when you empty your bowels, black, tarry stools or blood in your vomit
• serious skin rashes, itching, hives, bruising, red or painful areas, peeling or blistering of the skin. These conditions can also affect the mouth, lips, eyes, nose and genitals
• yellowing of your skin or the whites of your eyes
• persistent sore throat or fever
• an unexpected change in the amount of urine you produce and/or its appearance
• bruising more easily than usual or frequent sore throats or infections

• chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome

• reactions at the injection site, including pain, redness, swelling, a hard lump, ulcers or bruising at the injection site. These symptoms can develop into blackening and necrosis of the skin and underlying tissues around the injection site, leaving a scar when healed. This complication is also known as Nicolau syndrome.

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

• Pain, redness or lumps at the injection site

Common side effects(may affect up to 1 in 10 people)

• Feeling sick, feeling unwell at the injection site

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

• Dizziness and headache
• Diarrhoea, vomiting and constipation
• Inflammation of the stomach lining that causes pain, sickness and loss of appetite
• Liver problems

• Skin rash, 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 increased risk of heart attack ("myocardial infarction") or stroke.
• High blood pressure, heart attack, fast or irregular heartbeat, chest pain and swelling of the body, hands or feet.
• Asthma, shortness of breath.
• Blood disorders, such as anaemia (reduced number of red blood cells). Symptoms include tiredness, headache, dizziness and paleness.

Effects on the stomach and digestive system

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

• Inflammation of the pancreas or stomach lining (whose symptoms include severe stomach pain that can spread to the back or shoulders).

Effects on the nervous system

• Numbness or tingling, pins and needles in hands and feet or limbs, blurred or double vision, loss or alteration of hearing, ringing in the ears (tinnitus), and occasionally, convulsions (fits or seizures).
• Hallucinations (seeing or hearing things that are not there), depression, disorientation, sleep problems, irritability, anxiety, memory problems and convulsions (fits or seizures).
• Inflammation of the layers covering the brain. Whose symptoms include stiffness in the neck, headache, nausea, vomiting, fever or disorientation and extreme sensitivity to bright light.

Effects on the liver and kidneys

• Liver disorders. Symptoms can include sickness, loss of appetite, general feeling of being unwell, sometimes with jaundice.
• Kidney disorders or kidney failure. Symptoms include blood in the urine, frothy urine, swelling of the feet and hands or body.

Effects on the skin and hair

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

Effects on the immune system

• Hypersensitivity reaction

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Akis

• Keep this medicine out of the sight and reach of children
• Do not use this medicine after the expiry date which is stated on the carton and on the syringe after CAD.
• Store below 25°C. Do not refrigerate or freeze. Keep in the original packaging to protect from light
• Use immediately after opening. Discard any unused contents
• Do not use this medicine if it is cloudy or if small particles can be seen

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Akis

The active ingredient is: sodium diclofenac.

Each 1 ml syringe contains:

25 mg of sodium diclofenac or

50 mg of sodium diclofenac or

75 mg of sodium diclofenac

The other ingredients are: hydroxypropyl-beta-cyclodextrin, polysorbate 20, water for injectable preparations.

Appearance of the Product and Package Contents

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

Package sizes of 1, 3, and 5 pre-filled syringes.

This medicine is also supplied in glass ampoules in package sizes of 1, 3, or 5 ampoules.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

IBSA Farmaceutici Italia Srl

Via Martiri di Cefalonia 2

26900 Lodi

Italy

Tel + 39(0) 371 617292

Email: [email protected]

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

Instituto Bioquimico Iberico IBSA S.L.

Avenida Diagonal 605,

Planta 8, Local 1,

08028 Barcelona (Spain)

Date of Last Revision of this Leaflet:February 2023

Other Sources of Information

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

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