Rikedol

Package leaflet: Information for the patient

RIKEDOL 20 mg/ml oral drops, solution

ketorolac tromethamine
Generic medicine
Please read all of this leaflet carefully before you take 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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Rikedol is and what it is used for

This medicinal product contains the active substance ketorolac tromethamine, which belongs to a group of
medicines called non-steroidal anti-inflammatory drugs (“NSAIDs”), used to reduce pain caused by
inflammation.
Rikedol is indicated only for short-term treatment (up to five days) of moderate pain following surgical
procedures (post-operative pain).

2. What you need to know before taking Rikedol

Do not take Rikedol

• if you are allergic to ketorolac tromethamine, to similar medicines (“NSAIDs”) or to any of the other ingredients of this medicine (listed in section 6);
• if you have previously had an allergic reaction after taking acetylsalicylic acid (aspirin) or medicines that block the synthesis of inflammatory substances (prostaglandins);
• if you have a respiratory disease characterized by the presence of nasal polyps (complete or partial nasal polyposis syndrome);
• if you have swelling due to fluid accumulation around the mouth and eyes (angioedema);
• if you have contraction of bronchial muscles (bronchospasm);
• if you suffer from asthma, cold (rhinitis), skin irritation (urticaria);
• if you currently have or have previously had a stomach or intestinal problem (active peptic ulcer);
• if you have had gastrointestinal bleeding, ulceration, or perforation;
• if you have a serious heart condition (severe heart failure);
• if you have moderate or severe kidney problems (renal failure with serum creatinine values greater than 442 µmol/L) or if you are at risk of kidney problems due to reduced blood volume (hypovolemia) or lack of water (dehydration);
• if you are in the last 3 months of pregnancy, close to or during childbirth;
• if you have a serious liver disease (hepatic cirrhosis or severe hepatitis);
• if you have a tendency to bleed (hemorrhagic diathesis) or a condition due to a blood coagulation disorder;
• if you have or suspect you have a brain hemorrhage (a stroke);
• if you have undergone surgical procedures with a high risk of bleeding or incomplete stopping of blood loss (incomplete hemostasis);
• if you have any other bleeding disorder;
• if you are taking acetylsalicylic acid (aspirin), other non-steroidal anti-inflammatory drugs, medicines to prevent blood clot formation in vessels (anticoagulants, e.g. pentoxifylline), medicines for mood disorders (lithium salts), medicines used to reduce uric acid levels in blood (probenecid), medicines to eliminate fluids via urine (diuretics), or methotrexate (a chemotherapeutic agent) (see section “Other medicines and Rikedol”);
• for prevention of pain (analgesia) before or during surgical procedures, because this medicine increases the risk of bleeding;
• if the person who is to take this medicine is a child or adolescent under 16 years of age;
• if you are breastfeeding.

Warning: This medicine is not indicated for mild or chronic pain.
Warnings and precautions
Talk to your doctor or pharmacist before taking Rikedol.
Take Rikedol under medical supervision because this medicine must not be used for the treatment of mild or chronic pain.
Avoid consecutive or simultaneous use with other non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 inhibitors.
Take this medicine at the lowest possible dose and for the shortest duration necessary to reduce the occurrence of adverse effects.
Inform your doctor if you have recently undergone or are about to undergo stomach or intestinal surgery before receiving/using/taking Rikedol, as Rikedol may sometimes impair wound healing in the intestine following surgery.
Take this medicine with great caution and under strict medical supervision:

• if you currently have or have previously had stomach or intestinal disorders (peptic ulcer, gastrointestinal bleeding, ulcerative colitis, Crohn's disease);
• if you are elderly or debilitated, as this increases the risk of potentially fatal stomach or intestinal injuries or bleeding. In such cases, your doctor may decide to reduce the dose or increase the interval between doses (see section “How to use Rikedol”);
• if you have blood circulation disorders (coagulation disorders);
• if you currently have or are predisposed to bronchial inflammatory disease called bronchial asthma, as you may experience respiratory attacks (bronchospasm) or allergic reactions;
• if you have previously experienced swelling due to fluid accumulation around the mouth and eyes (angioedema), asthma, bronchospasm, or a respiratory disease characterized by nasal polyps (complete or partial nasal polyposis syndrome), as you may experience severe, potentially fatal allergic reactions;
• if you currently have or have previously had heart problems (congestive heart failure, chronic ischemic heart disease, cardiac decompensation), high blood pressure (hypertension), reduced blood flow to the legs (peripheral arterial disease), or reduced oxygen supply to the brain (cerebrovascular disease), or if you think you may be at risk of these conditions (e.g. if you have high blood pressure, diabetes, high cholesterol levels, or if you smoke). Inform your doctor before taking Rikedol, as it may increase the risk of heart attack or stroke;
• if you currently have or have previously had certain kidney problems (nephrotoxicity, renal hypoperfusion, glomerulonephritis, interstitial nephritis, papillary necrosis, nephrotic syndrome, acute renal failure, reduced kidney function);
• if you currently have or have previously had liver problems (hepatic cirrhosis or severe liver failure).

Avoid taking this medicine if you are taking other non-steroidal anti-inflammatory drugs (NSAIDs).
Be especially careful and inform your doctor if you experience any of the following during treatment:

• swelling due to fluid accumulation around the mouth and eyes (angioedema), bronchial muscle contractions (bronchospasm), allergic reactions (hypersensitivity), or a respiratory disease characterized by nasal polyps (complete or partial nasal polyposis syndrome), as you may experience severe, potentially fatal allergic reactions;
• liver problems;
• a severe, potentially fatal skin reaction (exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis).

Stop treatment with this medicine and consult your doctor if:

• you experience bleeding (hemorrhages), or lesions (ulcers) in the stomach or intestine;
• liver function becomes impaired;
• you develop skin irritation or peeling, blisters, or bleeding of lips, eyes, mouth, nose, and genitals, or any other symptom of an allergic reaction.

Cases of bruising (hematomas) after surgery (post-operative period) and bleeding from wounds following the use of Rikedol before or after surgery (peri-operative period) have been reported. Therefore, inform your doctor if you are scheduled for surgical tonsil removal, prostate surgery (prostate resection), or cosmetic surgery.
Rikedol may cause stomach and intestinal problems, especially when used for prolonged periods and without observing proper warnings and precautions.
Children and adolescents
This medicine is not recommended for children.
Other medicines and Rikedol
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Do not take Rikedol if you are taking non-steroidal anti-inflammatory drugs (NSAIDs), acetylsalicylic acid (aspirin), as they increase the adverse effects of Rikedol.
If you are taking any of the following medicines, inform your doctor, as they may interact with Rikedol:

• corticosteroids, medicines used to treat inflammatory conditions; because they increase the risk of gastrointestinal toxicity from Rikedol;
• anticoagulants (warfarin, heparin, dextrans, antiplatelet agents, aspirin, pentoxifylline), medicines used to prevent blood clot formation in vessels, or selective serotonin reuptake inhibitors, medicines used to treat mood disorders, because they may increase the risk of gastrointestinal bleeding;
• lithium, used to treat depression and similar disorders, or methotrexate, a chemotherapeutic agent, because their toxicity may increase;
• antihypertensives or diuretics, medicines used to control blood pressure or heart conditions, because Rikedol may reduce their effectiveness. In this case, the risk of developing kidney problems (acute renal failure) may increase if kidney function is already impaired (e.g. if you are elderly or dehydrated). In such cases, consult your doctor, as dose adjustments, increased fluid intake, and kidney function monitoring may be necessary;
• probenecid, a medicine used to promote urinary excretion of uric acid.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take Rikedol during the last 3 months of pregnancy, close to or during childbirth, as it may cause problems for your baby. 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 labor beyond the expected duration. You should not take Rikedol during the first 6 months of pregnancy unless absolutely necessary and under medical advice. If treatment is required during this period or during attempts to conceive, the lowest possible dose for the shortest possible time should be used. From week 20 of pregnancy, Rikedol may cause kidney problems in the fetus if taken for more than a few days, reducing the levels of amniotic fluid surrounding the baby (oligohydramnios) or constricting a blood vessel (ductus arteriosus) in the fetal heart. If treatment for more than a few days is required, your doctor may recommend additional monitoring.
Breastfeeding
Do not take this medicine if you are breastfeeding, as it passes into breast milk.
Fertility
Rikedol may cause fertility problems in women. Therefore, if you plan to become pregnant, inform your doctor, as this medicine may reduce fertility.
Your doctor will advise you on appropriate contraceptive measures.
Driving and use of machines
This medicine may cause drowsiness. If this occurs, avoid driving vehicles and operating machinery.
Rikedol contains methyl-parahydroxybenzoate and propyl-parahydroxybenzoate
This medicine contains methyl-parahydroxybenzoate and propyl-parahydroxybenzoate, which may cause allergic reactions (including delayed reactions).
Rikedol contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’.

3. How to take Rikedol

Take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Warning: treatment duration must not exceed 5 days.
Instructions for opening and using the bottle:

• to open the bottle, press down on the cap and simultaneously unscrew it;
• hold the bottle in an upright position and pour the drops into a glass. Do not shake the bottle. If drops do not flow easily, tap the bottom of the bottle gently;
• replace the cap and screw it on tightly to close the bottle.

Method of administration: Do not take this medicine for more than 5 days. The recommended dose in
adults is 10 mg (10 drops), every 4–6 hours. Your doctor will determine the appropriate dose based on your condition. The maximum dose is 40 mg per day. Do not exceed the recommended maximum dose.
If your body weight is less than 50 kg, the dose should be reduced.
Use in elderly patients over 65 years of age
Your doctor will determine the dose and assess whether dose reduction is necessary.
Use in children and adolescents
Do not administer this medicine to children and adolescents under 16 years of age. The safety and efficacy in children have not been established.
If you take more Rikedol than you should
If you (or someone else) have taken an excessive dose of Rikedol, or if you suspect that a child may have taken this medicine, contact your doctor immediately or go to the nearest hospital Emergency Department.
After taking an excessive dose of this medicine, abdominal pain, nausea, vomiting, increased breathing rate (hyperventilation), stomach or intestinal problems (peptic ulcer, erosive gastritis, gastrointestinal bleeding), kidney problems, and severe allergic reactions (anaphylactoid reactions) may occur. Rare cases of increased blood pressure (hypertension), impaired lung function (respiratory depression), and coma have been reported. Your doctor will decide on appropriate treatment.
Take this leaflet, the bottle, and its container with you to the hospital or doctor so that they know which medicine has been taken.
If you forget to take Rikedol
Do not take a double dose to make up for a forgotten dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects that may occur with Rikedol are:
Not known (frequency cannot be estimated from the available data)

• infection of the central nervous system (aseptic meningitis);
• reduction in platelet count (thrombocytopenia), nosebleed (epistaxis);
• severe allergic reactions (anaphylactic/anaphylactoid reactions), allergic reactions (hypersensitivity reactions): bronchial muscle contraction (bronchospasm), widening of blood vessels (vasodilation), flushing, skin irritation (rash), reduction in blood pressure (hypotension), throat swelling (laryngeal edema);
• loss of appetite (anorexia), increased potassium in the blood (hyperkalemia), reduced sodium in the blood (hyponatremia);
• disturbances in thinking, mood disorder (depression), sleep disorder (insomnia), feelings of worry or fear (anxiety), irritability, mental disorders (psychotic reactions), abnormal dreams, hallucinations, feeling of well-being (euphoria), difficulty concentrating, drowsiness, confusion, state of lethargy (stupor);
• headache (cephalalgia), dizziness, seizures, disturbances in sensation of arms, legs or other body parts (paresthesia), increased motor activity (hyperkinesia), taste disturbances;
• visual disturbances;
• ringing in the ear (tinnitus), hearing loss, vertigo;
• increased awareness of heartbeat (palpitations), reduced heart rate (bradycardia), swelling in various parts of the body due to fluid accumulation (edema), heart disorders (hypertension, heart failure and cardiac decompensation), reduction in blood pressure (hypotension), bruising (hematomas), loss of skin color (pallor), bleeding from wounds after surgery (post-operative wound bleeding), heart attack, stroke;
• accumulation of fluid in the lungs (pulmonary edema), difficulty breathing (dyspnea), asthma;
• stomach or intestinal disorders (peptic ulcers), perforation or bleeding from the stomach or intestine, sometimes fatal, nausea, vomiting, diarrhea, passage of intestinal gas (flatulence), constipation, digestive difficulties (dyspepsia), abdominal pain/discomfort, feeling of fullness, passage of dark stools (melena), rectal bleeding, vomiting blood (hematemesis), inflammation of the mouth (stomatitis and ulcerative stomatitis), inflammation of the esophagus (esophagitis), noisy release of gas from the stomach through the mouth (eructation), inflammation of the pancreas (pancreatitis), dry mouth (xerostomia), worsening of intestinal inflammation (colitis and Crohn's disease), inflammation of the stomach (gastritis);
• liver problems (hepatitis, liver failure), reduced bile flow from the liver to the intestine with yellowing of the skin (cholestatic jaundice);
• swelling due to fluid accumulation around the mouth and eyes (angioedema), skin lesions (exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis), sweating, red spots on the skin (maculopapular rash), skin irritation (urticaria), itching (pruritus), rupture of small blood vessels under the skin (purpura), appearance of blisters on the skin (bullous reactions);
• muscle pain (myalgia);
• increased urine production (polyuria), frequent urination, reduced urine excretion (oliguria), kidney problems (acute kidney failure), blood and kidney disorders (hemolytic-uremic syndrome), inflammation of the kidneys (interstitial nephritis), inability of the bladder to empty (urinary retention), loss of protein in urine (nephrotic syndrome), flank pain (with or without presence of blood in urine (hematuria) or increase/decrease in non-protein nitrogen levels in blood (azotemia), increased creatinine and potassium levels;
• female infertility;
• reduction in muscle strength (asthenia), fever, injection site reactions, swelling (edema), chest pain (thoracic pain), excessive thirst;
• laboratory test abnormalities: prolonged bleeding time, increased serum urea, increased creatinine, alterations in liver function tests.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rikedol

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Store in the original packaging to protect the product from light.
The product should be used within 4 months after first opening the bottle.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Rikedol contains

• The active substance is ketorolac tromethamine: 1 ml of solution contains 20 mg of ketorolac tromethamine.
• The other ingredients are: citric acid monohydrate, dibasic sodium phosphate dihydrate, sodium methyl parahydroxybenzoate, sodium propyl parahydroxybenzoate, purified water.

Description of the appearance of Rikedol and package contents
Pack containing one 10 ml vial.
Marketing Authorization Holder
Fidia Farmaceutici S.p.A. – Via Ponte della Fabbrica, 3/A - 35031 Abano Terme (PD)
Manufacturer
Doppel Farmaceutici S.r.l. – Via Martiri delle Foibe, 1 - 29016 Cortemaggiore (PC)

Package leaflet: Information for the user

RIKEDOL 30 mg/ml solution for injection

ketorolac tromethamine
Equivalent medicinal product
Please read this leaflet carefully before using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What Rikedol is and what it is used for

This medicinal product contains the active substance ketorolac tromethamine, belonging to a group of
medicines called non-steroidal anti-inflammatory drugs ("NSAIDs"), used to reduce pain caused by
inflammation.
Rikedol is indicated for the treatment:

• of short-term (up to two days) moderate to severe acute pain following surgical procedures (postoperative pain);
• of pain caused by renal colic.

This medicinal product is also used, when administered intravenously, in addition to opioid or opioid-like
analgesic medicines, for the treatment of severe pain or in cases of prolonged surgical procedures (major
surgery).

2. What you need to know before using Rikedol

Do not use Rikedol

• if you are allergic to ketorolac tromethamine or to any of the other ingredients of this medicine (listed in section 6);
• if you have previously experienced an allergic reaction after taking acetylsalicylic acid, medicines that block the synthesis of inflammatory substances (prostaglandins), or other non-steroidal anti-inflammatory drugs (NSAIDs);
• if you suffer from nasal polyps, a respiratory disease characterized by the presence of nasal polyps;
• if you have swelling due to fluid accumulation around the mouth and eyes (angioedema);
• if you have difficulty breathing (bronchospasm);
• if you suffer from asthma (asthmatic attacks), skin irritation (urticaria), or nasal congestion (rhinitis);
• if you currently have, have had, or suspect you may have a stomach or intestinal problem (peptic ulcer or gastrointestinal bleeding);
• if you have had gastrointestinal bleeding;
• if you have a severe heart condition (severe heart failure);
• if you currently have, have had, or suspect you may have had a brain hemorrhage (stroke);
• if you have undergone high-risk surgical procedures with potential for bleeding or incomplete hemostasis;
• if you have any other bleeding disorders;
• if you have moderate or severe kidney problems (renal failure with serum creatinine levels greater than 442 µmol/L) or are at risk of kidney problems due to reduced blood volume (hypovolemia) or lack of water (dehydration);
• if you have severe liver disease (liver cirrhosis or severe hepatic insufficiency);
• if you have a tendency to bleed (hemorrhagic diathesis) or a condition caused by a blood coagulation defect;
• if you are taking acetylsalicylic acid, other non-steroidal anti-inflammatory drugs (NSAIDs), mood disorder medications (lithium salts), medications used to reduce uric acid levels in the blood (probenecid), diuretics (medicines used to eliminate fluids via urine), or anticoagulants (medicines used to prevent blood clotting in vessels, e.g., pentoxifylline) (see section “Other medicines and Rikedol”);
• for prevention of pain (analgesia) before or during surgical procedures, as this medicine increases the risk of bleeding;
• if the person using this medicine is a child or adolescent under 16 years of age;
• during the last three months of pregnancy, close to or during childbirth;
• if you are breastfeeding.

Warning: This medicine is not indicated for mild or chronic pain.
Warning: This medicine must not be used for epidural or intrathecal (neuraxial) injections because it contains ethanol.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Rikedol.
Use Rikedol under medical supervision, as this medicine should not be used for the treatment of mild or chronic pain.
Avoid consecutive or simultaneous use with other non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors.
Use this medicine at the lowest effective dose and for the shortest possible duration to minimize the risk of adverse effects.
Inform your doctor if you have recently undergone or are scheduled to undergo surgery on the stomach or intestinal tract before receiving/using Rikedol, as Rikedol may impair wound healing in the intestine following surgery.

Use this medicine with great caution and under strict medical supervision:

• if you currently have or have had gastrointestinal disorders (peptic ulcer, gastrointestinal bleeding, ulcerative colitis, Crohn's disease);
• if you are elderly or debilitated, as this increases the risk of gastrointestinal injury or bleeding, which may be life-threatening. In such cases, your doctor may consider reducing the dose or increasing the interval between doses (see section “How to use Rikedol”);
• if you currently have or are predisposed to bronchial inflammatory disease called bronchial asthma, as you may experience respiratory crises (bronchospasm) or allergic reactions;
• if you have blood circulation disorders (coagulation disorders);
• if you have previously experienced swelling due to fluid accumulation around the mouth and eyes (angioedema), asthma, bronchospasm, or a respiratory disease characterized by nasal polyps (complete or partial aspirin-sensitive asthma syndrome), as you may develop severe, potentially life-threatening allergic reactions;
• if you are a woman planning to become pregnant, as this medicine may impair fertility;
• if you currently have or have had heart conditions (congestive heart failure, chronic ischemic heart disease, cardiac decompensation), high blood pressure (hypertension), reduced blood flow to the legs (peripheral arterial disease), or reduced oxygen supply to the brain (cerebrovascular disease), or if you believe you may be at risk for these conditions (e.g., if you have high blood pressure, diabetes, high cholesterol levels, or smoke). Inform your doctor before using Rikedol, as it may increase the risk of heart attack or stroke;
• if you currently have or have had certain kidney problems (nephrotoxicity, renal hypoperfusion, glomerulonephritis, interstitial nephritis, papillary necrosis, nephrotic syndrome, acute renal failure, or reduced kidney function);
• if you currently have or have had liver problems (liver cirrhosis or severe hepatic insufficiency).

Pay special attention and inform your doctor immediately if, during treatment, you experience:

• swelling due to fluid accumulation around the mouth and eyes (angioedema), difficulty breathing (bronchospasm), allergic reactions (hypersensitivity), or a respiratory disease characterized by nasal polyps (complete or partial nasal polyposis syndrome), as you may develop severe, potentially life-threatening allergic reactions;
• liver problems;
• a severe, potentially fatal skin reaction (exfoliative dermatitis, Stevens-Johnson syndrome, or toxic epidermal necrolysis).

Stop treatment with this medicine and contact your doctor immediately if:

• you experience bleeding (hemorrhages) or ulcers in the stomach or intestine;
• you notice any signs of impaired liver function;
• you develop skin irritation or peeling, blisters, or bleeding of the lips, eyes, mouth, nose, or genitals, or any other symptoms of an allergic reaction.

Cases of bruising (hematomas) after surgery (post-operative period) and bleeding from surgical wounds following the use of Rikedol before or after surgery (peri-operative period) have been reported. Therefore, inform your doctor if you are scheduled for tonsillectomy, prostate surgery (prostate resection), or cosmetic surgery.
Rikedol may cause stomach and intestinal problems, particularly when used for prolonged periods or without observing the necessary warnings and precautions.

Children and adolescents
This medicine is not recommended for children and adolescents under 16 years of age.

Other medicines and Rikedol
Inform your doctor, pharmacist, or nurse if you are currently using, have recently used, or might use any other medicines.

Do not use Rikedol if you are taking:

• non-steroidal anti-inflammatory drugs (NSAIDs) or acetylsalicylic acid (aspirin), as these increase the risk of adverse effects from Rikedol.

If you are taking any of the following medicines, inform your doctor, as they may interact with Rikedol:

• corticosteroids, medicines used to treat inflammatory conditions, because they increase the risk of gastrointestinal toxicity from Rikedol;
• anticoagulants (warfarin, heparin, dextrans, antiplatelet agents, aspirin, pentoxifylline), medicines used to prevent blood clots in vessels, or selective serotonin reuptake inhibitors (SSRIs), medicines used to treat mood disorders, because they may increase the risk of gastrointestinal bleeding;
• lithium, used to treat depression and similar disorders, or methotrexate, a chemotherapeutic agent, because their toxicity may increase;
• antihypertensives or diuretics, medicines used to control blood pressure or heart conditions, because Rikedol may reduce their effectiveness. In such cases, the risk of developing kidney problems (acute renal failure) may increase if kidney function is already impaired (e.g., in elderly or dehydrated patients). In such cases, consult your doctor, as dose adjustments, increased fluid intake, and monitoring of kidney function may be necessary;
• probenecid, a medicine used to promote urinary excretion of uric acid.

Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.

Pregnancy
Do not use Rikedol during the last three months of pregnancy, close to or during childbirth, as it may cause problems for your baby. 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 labor beyond normal duration. You should not use Rikedol during the first six months of pregnancy unless absolutely necessary and under medical advice. If treatment is required during this period or during attempts to conceive, the lowest possible dose for the shortest possible time should be used. From week 20 of pregnancy, Rikedol may cause fetal kidney problems if used for more than a few days, leading to reduced amniotic fluid levels surrounding the baby (oligohydramnios) or constriction of a blood vessel (ductus arteriosus) in the fetal heart. If treatment for more than a few days is required, your doctor may recommend additional monitoring.

Breastfeeding
Do not take this medicine if you are breastfeeding, as it passes into breast milk.

Fertility
Rikedol may cause fertility problems in women. Therefore, if you are planning a pregnancy, inform your doctor, as this medicine may reduce fertility.
Your doctor will advise you on appropriate contraceptive measures.

Driving and use of machines
This medicine may cause drowsiness, dizziness, vertigo, sleep disturbances (insomnia), or mood disorders (depression). If you experience these effects, avoid driving or operating machinery.

Rikedol contains ethanol and sodium
This medicine contains 100 mg of alcohol (ethanol) per vial, equivalent to 100 mg/ml (10% w/v). The amount in one vial is equivalent to less than 3 ml of beer or 2 ml of wine. The small amount of alcohol in this medicine is unlikely to produce significant effects.
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e., essentially “sodium-free.”

3. How to use Rikedol

Use this medicine exactly as directed by your doctor, pharmacist, or nurse. If you have any doubts, consult your doctor, pharmacist, or nurse.
This medicine will be administered by a doctor or a nurse via intramuscular injection (into the muscle) or intravenous injection (into the vein). Intravenous injection can only be performed in hospitals and other medical facilities.
Do not use Rikedol for epidural or intrathecal administration, and do not mix this medicine in the same syringe with morphine, meperidine, promethazine, or hydroxyzine.
Do not use this medicine for more than 2 days if the dose is administered all at once (bolus administration), or for more than 1 day if the dose is administered by infusion (continuous infusion).

Use in adults
The recommended initial dose for intramuscular or intravenous administration is 10 mg. Subsequently, the dose is 10–30 mg every 4–6 hours. Your doctor will determine the appropriate dose based on your condition. The maximum dose is 90 mg per day. Do not exceed the recommended maximum dose.
If your body weight is less than 50 kg, the dose should be reduced.
For renal colic, the recommended dose is one vial of 30 mg, administered intramuscularly or intravenously.

Use in elderly patients over 65 years of age
The doctor will determine the dose and may consider reducing it. Do not exceed the maximum daily dose of 60 mg.

Use in children and adolescents
Do not administer this medicine to children and adolescents under 16 years of age. The safety and efficacy in children have not been established.

If you use more Rikedol than you should
After administration of an excessive dose of this medicine, abdominal pain, nausea, vomiting, increased breathing rate (hyperventilation), stomach or intestinal problems (peptic ulcer, erosive gastritis, gastrointestinal bleeding), kidney problems, and severe allergic reactions (anaphylactoid reactions) may occur. Rare cases of increased blood pressure (hypertension), impaired lung function (respiratory depression), and coma have been reported. The doctor will determine appropriate treatment.
In case of accidental use or ingestion of an excessive dose of this medicine, contact your doctor immediately or go to the nearest hospital Emergency Department.

If you forget to use Rikedol
Do not use a double dose to make up for a forgotten dose.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The side effects that may occur with Rikedol are:
Not known (frequency cannot be estimated from the available data)

• central nervous system infection (aseptic meningitis);
• reduction in platelet count (thrombocytopenia), capillary rupture under the skin (purpura), nosebleeds (epistaxis);
• severe allergic reactions (anaphylactic/anaphylactoid reactions), allergic reactions (hypersensitivity reactions): difficulty breathing (bronchospasm), widening of blood vessels (vasodilation), flushing, skin rash, reduction in blood pressure (hypotension), swelling of the throat (laryngeal edema);
• loss of appetite (anorexia), increased potassium in the blood (hyperkalemia), reduced sodium in the blood (hyponatremia);
• abnormal thoughts, mood disorders (depression), sleep disturbances (insomnia), feelings of worry or fear (anxiety), nervousness, mental disorders (psychotic reactions), abnormal dreams, hallucinations, feeling of well-being (euphoria), difficulty concentrating, drowsiness, reduced sensation and movement in the body or part of it (stupor), confusion;
• headache (cephalalgia), dizziness, seizures, altered sensation in arms, legs or other body parts (paresthesia), increased movement (hyperkinesia), taste disturbances;
• vision disorders (impaired vision);
• ringing in the ears (tinnitus), hearing loss, vertigo;
• increased awareness of heartbeat (palpitations), reduced heart rate (bradycardia), swelling in various parts of the body due to fluid accumulation (edema), heart disorders (hypertension, heart failure and cardiac decompensation), widening of blood vessels (vasodilation), reduction in blood pressure (hypotension), bruising (hematomas), flushing, paleness of the skin, bleeding from wounds after surgery (post-operative wound bleeding), heart attack, stroke;
• accumulation of fluid in the lungs (pulmonary edema), difficulty breathing (dyspnea), asthma;
• stomach or intestinal disorders (peptic ulcers), perforation or bleeding from the stomach or intestine which may be life-threatening, nausea, vomiting, diarrhea, passage of intestinal gas (flatulence), constipation, digestive difficulties (dyspepsia), abdominal pain/discomfort, feeling of fullness, passage of dark stools (melena), rectal bleeding, vomiting blood (hematemesis), inflammation of the mouth (stomatitis and ulcerative stomatitis), inflammation of the esophagus (esophagitis), noisy release of gas from the stomach through the mouth (eructation), inflammation of the pancreas (pancreatitis), dry mouth, worsening of intestinal inflammation (colitis and Crohn's disease), inflammation of the stomach (gastritis);
• liver problems (hepatitis, hepatic failure), reduced bile flow from the liver to the intestine with yellowing of the skin (cholestatic jaundice);
• swelling due to fluid accumulation around the mouth and eyes (angioedema), skin lesions (exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis), increased sweating, red spots on the skin (maculopapular rash), itching, capillary rupture under the skin (purpura), appearance of blisters on the skin (bullous reactions);
• muscle pain (myalgia);
• increased urine production (polyuria), frequent passage of small amounts of urine (pollakiuria), reduced urine excretion (oliguria), kidney problems (acute renal failure), blood and kidney problems (hemolytic-uremic syndrome), inflammation of the kidneys (interstitial nephritis), inability of the bladder to empty (urinary retention), loss of protein in urine (nephrotic syndrome), flank pain (with or without presence of blood in urine (hematuria) or increased/decreased levels of non-protein nitrogen in blood (azotemia)), increased creatinine and potassium;
• female infertility;
• fatigue (asthenia), fever, injection site reactions, swelling (edema), chest pain (thoracic pain), excessive thirst;
• laboratory test abnormalities: prolonged bleeding time, increased serum urea, increased creatinine, alterations in liver function tests.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rikedol

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Store in the original packaging to protect the product from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Rikedol contains

• The active substance is ketorolac tromethamine: each vial contains 30 mg of ketorolac tromethamine.
• The other components are: ethanol, sodium chloride, sodium hydroxide, water for injections.

Description of the appearance of Rikedol and package contents
Amber type I glass vials. Carton pack containing 3 vials of 1 ml.
Marketing Authorization Holder
Fidia Farmaceutici S.p.A. – Via Ponte della Fabbrica, 3/A - 35031 Abano Terme (PD)
Manufacturer
Doppel Farmaceutici S.r.l. – Via Volturno, 48 - Quinto de Stampi (Rozzano) - Milano