Flectorin

PACKAGE LEAFLET: INFORMATION FOR THE USER

FlectorIn 25, 50, 75 mg/mL injectable solution in pre-filled syringe

Sodium diclofenac
Please 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist.
• In this leaflet, FlectorIn 25, 50 and 75 mg/mL injectable solution in pre-filled syringe will be referred to as FlectorIn.

Contents of this leaflet:

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

1. WHAT FLECTORIN IS AND WHAT IT IS USED FOR

FlectorIn contains the active substance sodium diclofenac. FlectorIn belongs to a class of non-steroidal anti-inflammatory drugs (NSAIDs). Other NSAIDs include aspirin and ibuprofen.
These medicines reduce pain and inflammation.
FlectorIn administered by intramuscular or subcutaneous injection is used for the symptomatic treatment of conditions such as:

• Joint inflammations or back pain
• Gout attacks
• Pain caused by kidney stones
• Pain caused by injuries, fractures or trauma

It is also used to prevent or treat postoperative pain.
FlectorIn administered by intravenous injection is used in hospital settings to prevent or treat postoperative pain.

2. What you need to know before using FlectorIn

Do not use FlectorIn:

• If you are allergic to diclofenac, aspirin, ibuprofen, or other NSAIDs (non-steroidal anti-inflammatory drugs)
• If you are allergic to any of the other ingredients of this medicine (listed in section 6)
• If you have a history of gastrointestinal bleeding after taking anti-inflammatory medicines (NSAIDs)
• If you have had two or more separate episodes of gastric (stomach) or peptic (duodenal) ulcer or gastrointestinal bleeding (including blood in vomit or during bowel movements, or black, tarry stools)
• If you currently suffer from or have previously suffered from liver failure
• If you currently suffer from or have previously suffered from severe heart failure
• If you have established heart disease and/or cerebrovascular disease, e.g., you have had a heart attack, stroke, mini-stroke (TIA), or blockage of blood vessels leading to the heart or brain, or undergone a procedure to remove or prevent such blockages
• If you currently suffer from or have previously suffered from blood circulation problems (peripheral arterial disease)
• If you currently suffer from or have previously suffered from severe kidney failure
• If you have asthma, hives, or acute rhinitis (allergy) caused by the use of NSAIDs or aspirin
• If you have blood clotting disorders or are taking anticoagulants (such as warfarin)
• If you are more than six months pregnant (see also “Pregnancy and breastfeeding”)
• If you are under 18 years of age.

Additionally, do not use FlectorIn intravenously:

• If you are taking other NSAIDs or anticoagulants (including low-dose heparin)
• If you have a history of haemorrhagic diathesis, particularly cerebrovascular bleeding
• If you have undergone a high-risk surgery for bleeding
• If you have a history of asthma
• If you have moderate to severe kidney damage
• If you are dehydrated
• If you have experienced significant blood loss

Be especially careful with FlectorIn
Before taking diclofenac, make sure your doctor knows:

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

Undesirable effects can be minimized by using the lowest effective dose for the shortest necessary duration.
Contact your doctor before using FlectorIn:

• If you think you are allergic to diclofenac, aspirin, ibuprofen, or any other NSAID, or to any other component of FlectorIn. (A list of ingredients is available at the end of this leaflet.) Signs of hypersensitivity reactions include swelling of the face and mouth (angioedema), breathing difficulties, chest pain, runny nose, skin rash, or any other allergic-type reaction
• If you have had oesophageal, gastric, or duodenal ulcers, or gastrointestinal bleeding. Symptoms may include blood in vomit or during bowel movements, or black, tarry stools
• If you have intestinal diseases, including ulcerative colitis and Crohn’s disease
• If you currently have or have previously had kidney or liver problems
• If you have had or currently have blood disorders or bleeding problems
• If you currently suffer from or have previously suffered from asthma, chronic obstructive pulmonary disease (COPD), nasal polyps, or hay fever
• If you have lupus (systemic lupus erythematosus or SLE) or similar conditions
• If you have ever developed severe skin rash or skin peeling, or skin rash with blisters and/or mouth ulcers after taking FlectorIn or other painkillers
• If you are planning a pregnancy, as FlectorIn may interfere with fertility
• If you have recently undergone or are about to undergo stomach or intestinal surgery before receiving/using/taking FlectorIn, as FlectorIn may sometimes impair wound healing in the intestine following surgery.

Warnings and precautions

• Medicines such as FlectorIn may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. The risk is higher with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment.
• FlectorIn is an anti-inflammatory medicine and may therefore reduce symptoms of infection such as headache or fever. If you feel unwell and need to see a doctor, remember to tell them you are using FlectorIn.
• Elderly patients are more likely to experience side effects associated with FlectorIn: inform your doctor if you experience unusual symptoms.

Other medicines and FlectorIn
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription (e.g., over-the-counter medicines or recreational substances). Some medicines may interfere with your treatment.
Inform your doctor if you are taking any of the following medicines:

• Other NSAIDs or cyclooxygenase-2 (COX-2) inhibitors, such as aspirin or ibuprofen (anti-inflammatory or pain-relieving medicines)
• Antidiabetic medicines
• Anticoagulants (blood thinners such as warfarin or heparin)
• Antiplatelet agents (to prevent blood clots)
• Diuretics (medicines that increase urine flow)
• Lithium (a medicine used to treat certain types of depression)
• Phenytoin (a medicine used to treat epilepsy)
• Cardiac glycosides (e.g., digoxin; medicines for heart problems)
• Methotrexate (a medicine used for certain types of inflammation and cancer)
• Cyclosporine and tacrolimus (for certain types of inflammation and as immunosuppressants after organ transplants)
• Quinolone antibiotics (medicines used to treat certain infections)
• Steroids (medicines for inflammation and treatment of immune system disorders)
• Colestipol (a medicine used to lower cholesterol)
• Cholestyramine (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 for certain types of cancer)
• Deferasirox (a medicine used in patients who receive frequent blood transfusions)
• Mifepristone (a medicine used for medical abortion)
• Medicines for heart problems or high blood pressure, such as beta-blockers or ACE inhibitors
• Tacrolimus (a medicine that reduces immune system activity, used to prevent organ rejection in some patients)
• Medicines used to treat anxiety and depression, known as selective serotonin reuptake inhibitors (SSRIs)
• Zidovudine (for treatment of human immunodeficiency virus (HIV) infection).

Pregnancy and breastfeeding
Do not use FlectorIn during the last three months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in the fetus. It may affect your and your baby’s tendency to bleed and may delay or prolong labour more than expected. You should not take FlectorIn during the first six months of pregnancy unless absolutely necessary and under medical advice. If treatment is needed during this period or when trying to conceive, the lowest possible dose for the shortest possible time should be used. From week 20 of pregnancy onwards, FlectorIn may cause kidney problems in the fetus if taken for more than a few days, thereby reducing the levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing the blood vessel (ductus arteriosus) in the baby’s heart. If treatment is needed for more than a few days, your doctor may recommend additional monitoring.
If you are breastfeeding, consult your doctor, who will decide whether FlectorIn should be used.

Driving and using machines
FlectorIn may cause dizziness, drowsiness, or blurred vision. Do not drive or operate machinery if you experience these symptoms.
This medicine contains less than 1 mmol (23 mg) of sodium per dosage unit, i.e., essentially ‘sodium-free’.

3. HOW TO USE FlectorIn

Your doctor will decide when and how you should receive treatment with FlectorIn injectable solution. You will be given an intramuscular injection (into a muscle, usually in the buttocks), or a subcutaneous injection (under the skin, usually of the buttock or thigh), or an intravenous injection (an injection into a vein, generally in the arm).
FlectorIn must not be administered by intravenous infusion (i.v.).
Adults: The recommended initial dose ranges from 25 to 75 mg, depending on the severity of pain. Your doctor may decide to administer a second injection after 6 hours if severe pain persists. The maximum daily dose is 150 mg. FlectorIn may be administered for one or two days.
Elderly patients: Your doctor may determine a lower dose than that recommended for adults if you are elderly.
Children: Not suitable for children (under 18 years of age).
A doctor, nurse, or pharmacist will prepare the injection for you. A nurse or doctor will administer the injection. The injection must not be given at the same site twice consecutively.
If you receive more FlectorIn than you should
If you receive more FlectorIn than prescribed, you may experience the following symptoms: nausea, vomiting, stomach pain, gastrointestinal bleeding, rarely diarrhea, dizziness, tinnitus (ringing, buzzing, or other persistent noises in the ears), and occasionally seizures (epileptic fit or convulsion). In more severe cases, kidney or liver damage may occur (symptoms include difficulty urinating or increased urination, muscle cramps, fatigue, swelling of the hands, feet, and face, nausea or vomiting, yellowing of the skin (jaundice)).
Inform your doctor or nurse immediately if you think you have been given more FlectorIn than intended.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, FlectorIn can cause adverse reactions, although not everyone experiences them.
Some adverse reactions may be serious.

Stop taking FlectorIn and inform your doctor immediately if you notice:

• Mild abdominal cramps and tenderness occurring shortly after starting treatment with FlectorIn, followed by rectal bleeding or bloody diarrhoea, usually within 24 hours of the onset of abdominal pain (frequency not known, cannot be estimated from available data).
• A severe skin allergic reaction that may include widespread red and/or dark patches, skin swelling, blisters, and itching sensation (Fixed generalized bullous eruption due to drugs).

Contact your doctor immediately if you experience any of the following symptoms:

• Severe allergic reactions, including: swelling of the face, throat or tongue, difficulty breathing, shortness of breath, runny nose and skin rash
• Stomach pain or burning, indigestion, flatulence, nausea or vomiting
• Any signs of gastrointestinal bleeding, such as blood during bowel movements, blackish stools, or blood in vomit
• Severe skin rashes, itching, hives, bruising, pain in red areas, blistering rashes or skin peeling, giant wheals (swollen skin accompanied by itching and burning). These conditions may also affect lips, eyes, nose and genitals
• Yellowing of the skin (jaundice) or of the whites of the eyes
• Persistent sore throat or fever
• Unusual changes in the amount or appearance of urine produced
• Unusual tendency to bruise, or frequent sore throats and infections
• Chest pain, which may indicate a potentially serious allergic reaction called Kounis syndrome
• Reactions at the injection site, including pain, redness, swelling, hard nodule, ulcers and bruising. These reactions may worsen with skin darkening and death of the skin and underlying tissues surrounding the injection site, which then heal with scarring; this condition is known as Nicolau syndrome.

Very common adverse reactions (may affect up to 1 in 10 patients)

• Pain, redness or hardening at the injection site

Common adverse reactions (may affect between 1 in 100 and 1 in 10 patients)

• Nausea, discomfort at the injection site

Uncommon adverse reactions (reported in between 1 in 1000 and 1 in 100 patients)

• Dizziness and headache
• Diarrhoea, vomiting and constipation
• Inflammation of the gastric mucosa with pain, vomiting and loss of appetite
• Liver problems
• Skin rash, itching

Not known: (frequency cannot be estimated from available data)

• Tissue damage at the injection site
• A skin allergic reaction, which may include round or oval patches with redness and swelling of the skin, skin eruption with blisters, and itching sensation (Drug-induced fixed eruption). Darkening of the skin in the affected areas may also occur, which could persist after healing. A drug-induced fixed eruption usually recurs at the same site (or same sites) if the medicine is taken again.

Other adverse reactions
Patients treated with NSAIDs have reported the following list of adverse reactions.

Cardiac, thoracic and haematological disorders

• Medicines such as FlectorIn may be associated with a moderate increase in the risk of heart attack (myocardial infarction) or stroke
• Hypertension, infarction, rapid or irregular heartbeat, chest pain and body swelling, including hands and feet
• Asthma, dyspnoea
• Blood disorders such as anaemia (reduced number of red blood cells). Symptoms include fatigue, headache, dizziness and pallor.

Gastrointestinal disorders

• Gastric peptic ulcers, mouth ulcers, tongue infections, colon disorders (including intestinal inflammation and worsening of Crohn’s disease)
• Pancreatitis and inflammation of the gastric mucosa (symptoms include severe stomach pain that may extend to the back or shoulder).

Nervous system disorders

• Tingling or numbness, tingling in hands, feet or limbs, tremors, blurred vision or diplopia, hearing loss or impairment, tinnitus (ringing in the ears), somnolence, fatigue
• Hallucinations (seeing or hearing non-existent things), depression, disorientation, sleep disturbances, irritability, anxiety, memory impairment and seizures (epileptic attack or fit)
• Meningitis. Symptoms include neck stiffness, headache, nausea, vomiting, fever or disorientation and extreme sensitivity to light.

Hepatic and renal disorders

• Liver disorders. Symptoms may include nausea, loss of appetite, general malaise, occasionally with jaundice
• Renal failure or kidney disorders. Symptoms include blood in urine, foamy urine, swelling of hands, feet and body.

Skin and subcutaneous tissue disorders

• Severe skin rashes such as Stevens-Johnson syndrome and other skin conditions that may worsen with sun exposure
• Hair loss

Immune system disorders

• Hypersensitivity reaction

If any of the adverse reactions worsen, or if you notice any adverse reaction not listed in this
package leaflet, inform your doctor or pharmacist.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, please contact
your doctor or pharmacist. You may also report adverse reactions directly via the national
reporting system at the website
“http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse”. By reporting adverse
reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE FlectorIn

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the syringe after "Exp".
• Store below 25°C. Do not refrigerate or freeze. Keep in the original packaging to protect from light.
• The medicine should be used immediately after opening: any unused solution must be discarded.
• Do not use this medicine if you notice cloudiness or particles.

After administration of the correct dose, the doctor or nurse will dispose of any unused solution together with the syringe, needles, and containers.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What FlectorIn contains
The active substance 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 components are: hydroxypropylbetacyclodextrin, polysorbate 20, water for
injections.

Description of the appearance of FlectorIn and contents of the pack
This medicine is a clear or slightly amber-colored transparent injectable solution in a pre-filled glass syringe. This medicine is supplied in a pack containing two sterile needles: one for subcutaneous injection (27 gauge), grey in colour, and one for intramuscular or intravenous injection (21 gauge), green in colour.
Packs containing 1, 3 and 5 pre-filled syringes are available.
This medicine is also available in packs containing 1, 3 and 5 glass vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
IBSA Farmaceutici Italia Srl, via Martiri di Cefalonia, 2, 26900 Lodi

If this leaflet is difficult to see or read, or if you would like it in a different format,
please contact IBSA Farmaceutici Italia Srl, Via Martiri di Cefalonia 2, 26900 Lodi, Italy. (Tel
+39(0)371 617292, Email: [email protected]).