BENKETOL 30 mg /Ml Roztwór Do Wstrzykiwań

Treść ulotki

1. BENKETOL 30 mg/ml injectable solution
   1. What is BENKETOL and what is it used for
   2. What you need to know before taking BENKETOL
   3. How to use BENKETOL
   4. Possible side effects
   5. How to store BENKETOL
   6. Contents of the pack and other information
2. BENKETOL 20 mg/ml oral drops, solution
   1. What is BENKETOL and what is it used for?
   2. What you need to know before you take BENKETOL
   3. How to take BENKETOL
   4. Possible side effects
   5. How to store BENKETOL
   6. Contents of the pack and other information

BENKETOL 30 mg/ml injectable solution

Ketorolac trometamol
Generic medicine

Read this leaflet carefully before you start to use 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 or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is BENKETOL and what is it used for

This medicine contains the active ingredient ketorolac trometamol, belonging to a group of
medicines called non-steroidal anti-inflammatory drugs (“NSAIDs”), used to reduce pain
caused by inflammation.
BENKETOL is indicated for the treatment:

• of short duration (maximum two days) of acute moderate-to-severe pain after surgical operations (post-operative pain);
• of pain caused by renal colic.

This medicine is also used, when administered intravenously, in addition to pain-relieving medicines
derived from opium or similar to it (opioid analgesics), for the treatment of very intense pain or in cases of
long-lasting surgical procedures (major surgery).

2. What you need to know before taking BENKETOL

Do not take BENKETOL

• if you are allergic to ketorolac or any of the other ingredients of this medicine (listed in section 6);
• if you have previously had an allergic reaction after taking acetylsalicylic acid, medicines that block the synthesis of inflammatory substances (prostaglandins) or other non-steroidal anti-inflammatory drugs;
• if you suffer from nasal polyps, a disease of the respiratory system characterized by the presence of polyps in the nose;
• if you have swelling of the face, lips, mouth, tongue or throat that can cause difficulty in breathing and swallowing (angioedema);
• if you have difficulty breathing (bronchospasm);
• if you suffer from asthma (asthmatic attacks);
• if you suffer from, have suffered from or suspect you suffer from a problem with your stomach or intestines (peptic ulcer, perforation);
• if you have had bleeding in the stomach or intestines;
• if you have a severe heart problem (severe heart failure);
• if you have moderate or severe kidney problems or if you are at risk of kidney problems due to reduced blood volume (hypovolemia) or lack of water (dehydration);
• if you have a severe liver disease (liver cirrhosis or severe liver failure);
• if you have a predisposition to bleeding (haemorrhagic diathesis) or a problem due to a defect in blood coagulation;
• if you have or suspect a cerebral haemorrhage (stroke), or if you have had one in the past;
• if you have undergone surgery with a high risk of bleeding or incomplete cessation of blood loss (incomplete haemostasis);
• if you have any other bleeding problems (coagulation disorders);
• if you are taking lithium salts (used for mood disorders), probenecid (used to reduce uric acid levels in the blood), diuretics (used to eliminate fluids with urine), anticoagulants such as pentoxifylline (used to prevent blood clots in the vessels) (see section “Other medicines and BENKETOL”);
• for the prevention of pain (analgesia) before or during surgery, because this medicine increases the risk of bleeding;
• if the person who is to take this medicine is a child or adolescent under the age of 16;
• if you are in the last 3 months of pregnancy, near or during childbirth;
• if you are breastfeeding. Warning:use for injections via the epidural or intrathecal route (neuraxial route) is contraindicated because it contains ethanol.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using BENKETOL.
Use BENKETOL only under strict medical supervision because this medicine should not be
used in the treatment of mild or chronic pain.
Avoid the concomitant use with other non-steroidal anti-inflammatory drugs (NSAIDs). Use this
medicine at the lowest doses and for short periods of time to reduce the occurrence of
undesirable effects.
Use this medicine with great caution and under strict medical supervision if:

• you are a woman and intend to become pregnant, as it may impair fertility;
• you are elderly or debilitated, as it increases the possibility of injury and bleeding in the stomach and intestines, which can be life-threatening. In this case, the doctor may decide to reduce the dose and increase the time interval between administrations (see section “How to use BENKETOL”);
• you suffer from or have suffered from disorders of the stomach and intestines;
• you suffer from asthma or are predisposed to it, as you may experience respiratory crises (bronchospasm), allergic reactions or shock;
• you suffer from or have suffered from heart problems, high blood pressure, reduced blood flow to the legs and the amount of oxygen to the brain. Tell your doctor before using BENKETOL as it may increase the risk of heart attack or stroke;
• you think you are at risk of cardiovascular disease (high blood pressure, diabetes, high cholesterol levels or smoke). Tell your doctor before using BENKETOL as it may increase the risk of heart attack or stroke;
• you suffer from or have suffered from kidney problems;
• you suffer from liver problems;
• you have previously suffered from swelling of the face, lips, mouth, tongue or throat that can cause difficulty in breathing and swallowing (angioedema), difficulty in breathing (e.g. asthma), nasal polyps, as you may experience severe allergic reactions that can be life-threatening.

Tell your doctor if you have recently undergone or are about to undergo surgery on the
stomach or intestinal tract before receiving/using BENKETOL, as BENKETOL may
sometimes worsen wound healing in the intestine following surgery.
Stop treatment with this medicine and see your doctor in the following cases:

• if you experience blood loss (haemorrhages) and lesions (ulcers) of the stomach and intestines;
• if an alteration of liver function occurs;
• if you experience skin rash, mucosal lesions and any other sign of an allergic reaction.
• Cases of bruising after operations and bleeding from wounds have been reported following the use of BENKETOL before or after surgery. Therefore, inform your doctor if you are to undergo tonsillectomy, prostate surgery or cosmetic surgery.

Children
This medicine is not recommended in children and adolescents under the age of 16.

BENKETOL 30 mg/ml injectable solution contains ethanol
This medicine contains 12.3 vol% ethanol, e.g. up to 100 mg of ethyl alcohol per vial,
corresponding to approximately 2.5 ml of beer and 1.0 ml of wine per dose. It may be harmful to alcoholics.
To be taken into consideration in pregnant or breastfeeding women, children and groups at
high risk such as people affected by liver disease or epilepsy. The amount of alcohol in this
medicine may alter the effects of other medicines.
The amount of alcohol in this medicine may impair your ability to drive vehicles and
use machinery.
For those engaged in sporting activity: the use of medicines containing ethyl alcohol may result in a positive
doping test in relation to the concentration limits indicated by some sports federations.

Other medicines and BENKETOL
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take
any other medicines.
Do not use this medicine if you are taking:

• non-steroidal anti-inflammatory drugs (NSAIDs), acetylsalicylic acid (aspirin), because they increase the risk of side effects. If you are taking any of the following medicines, tell your doctor because they can interact with BENKETOL:
• corticosteroids, used for the treatment of inflammatory states. This combination increases the risk of side effects on the stomach and intestines.
• anticoagulants (warfarin, heparin, dextrans, antiplatelet agents, aspirin, pentoxifylline), used to prevent blood clot formation in the vessels or selective serotonin reuptake inhibitors, used for the treatment of mood disorders, because they may increase the risk of bleeding in the stomach and intestines;
• methotrexate, a chemotherapeutic agent;
• lithium, used for the treatment of depression and similar disorders;
• digoxin, used for the treatment of heart problems;
• antihypertensives or diuretics, medicines used to control blood pressure or heart disorders, because BENKETOL may reduce their effects. In this case, the risk of developing kidney problems may increase if kidney damage is already present (e.g. if you are elderly or dehydrated). See your doctor because dose adjustments, water intake and periodic checks of kidney function may be necessary.
• probenecid, used to promote the elimination of uric acid with urine.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before using this medicine.

Fertility
BENKETOL may cause fertility problems in women. See your doctor if you are planning a
pregnancy.

Pregnancy
Do not take BENKETOL during the last trimester of pregnancy. It can cause problems for the baby
and childbirth. It can cause problems with the kidneys and heart of the unborn child. It may affect your and
your baby's tendency to bleed and cause a late or prolonged labour.
You should not take BENKETOL during the first 6 months of pregnancy unless it is
absolutely necessary and recommended by your doctor. If you need treatment during this
period or while planning a pregnancy, the lowest dose should be used for the
shortest possible time. If taken for more than a few days from the 20th week of pregnancy onwards,
BENKETOL may cause kidney problems in the fetus that can lead to 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 monitoring.

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

Driving and using machines
This medicine can cause drowsiness, dizziness, vertigo, sleep disturbances (insomnia) or
mood disorders (depression). If any of these effects occur, avoid driving vehicles and
using machinery.

3. How to use BENKETOL

Use this medicine following exactly the instructions of your doctor, pharmacist or
nurse. If you have any doubts, consult your doctor, pharmacist or nurse.
This medicine will be administered to you by a doctor or a nurse, through injection into the
muscle (intramuscular) or injection into a vein (intravenous). Intravenous injection can only be performed
in hospitals and other medical facilities.
Do not use BENKETOL for epidural or intrathecal administrations 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) and 1 day if the dose is administered via infusion
(continuous infusion).
Use this medicine at the lowest effective dose in relation to your condition.

Use in adults
The recommended initial dose for intramuscular or intravenous administrations is 10 mg; subsequently the
dose will be 10-30 mg every 4-6 hours. Your doctor will indicate the dose according to your conditions. 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 must be reduced.
For renal colic, the recommended dose is one 30 mg vial, for intramuscular or
intravenous administration.

Use in elderly patients over 65 years of age
The doctor will determine the dose and assess whether to reduce the dosage. Do not exceed the maximum dose of 60 mg per
day.

Use in children and adolescents
This medicine should not be administered to children and adolescents under 16 years of
age. Safety and efficacy in children have not been established.

If you use more BENKETOL than you should
If you (or someone else) have taken an excessive dose of BENKETOL or if you think a child may
have taken this medicine, immediately notify your doctor or go to the Emergency Room
of the nearest hospital.
Following the administration of an excessive dose of this medicine, abdominal pain may occur,
nausea, vomiting, increased breathing rate (hyperventilation), stomach and
intestinal problems, kidney problems (of varying severity) and severe allergic reactions. Rare cases of
increased blood pressure, respiratory depression and coma have been reported.

If you forget to use BENKETOL
Do not use a double dose to make up for a missed dose.

If you have any doubts about the use of this medicine, ask your doctor, pharmacist or
nurse.

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 BENKETOL are:

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

• infection of the central nervous system (aseptic meningitis);
• reduced number of platelets (thrombocytopenia);
• nosebleed (epistaxis);
• severe allergic reactions (anaphylactic/anaphylactoid reactions), allergic reactions (hypersensitivity reactions): difficulty breathing (bronchospasm), increased blood vessel volume (vasodilation), skin irritation (rash), decreased blood pressure (hypotension);
• swelling of the throat (laryngeal edema);
• loss of appetite (anorexia), increased potassium in the blood (hyperkalemia), decreased sodium in the blood (hyponatremia);
• abnormal thoughts, mood disorder (depression), sleep disorder (insomnia), feelings of worry or fear (anxiety), irritability, nervousness, mental disorders (psychotic reactions), abnormal dreams (abnormal dream activity), hallucinations, feeling of well-being (euphoria), difficulty concentrating, drowsiness, confusion;
• headache, dizziness, convulsions, sensory disturbance of legs and arms or other parts
• of the body (paresthesia), increased movements (hyperkinesia), altered taste;
• visual disturbances;
• ringing in the ear (tinnitus), hearing loss, vertigo;
• increased perception of heartbeat (palpitations), decreased heartbeat (bradycardia), inability of the heart to pump an adequate amount of blood (heart failure), swelling in different parts of the body due to fluid accumulation in the body (edema), heart disorders (hypertension and heart failure), decreased blood pressure (hypotension), bruising (hematomas), sudden feeling of warmth (hot flashes), decreased skin color (pallor), blood loss from wounds after surgery (post-operative wound bleeding), heart attack, stroke;
• increased 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 can be life-threatening, nausea, vomiting, diarrhea, emission of gas from the intestine (flatulence), constipation, digestive difficulties (dyspepsia), abdominal pain/discomfort, feeling of fullness, emission of dark stools (melena), blood loss from the rectum, vomiting blood (hematemesis), inflammation of the mouth (stomatitis and ulcerative stomatitis), inflammation of the esophagus (esophagitis), noisy emission of stomach gas through the mouth (eructation), inflammation of the pancreas (pancreatitis), dry mouth, worsening of inflammation of the intestine (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), increased sweating, red spots on the skin (maculo-papular rash), skin irritation (urticaria), itching, rupture of capillaries under the skin (purpura), appearance of blisters on the skin (bullous reactions);
• muscle pain (myalgia);
• increased urine production (polyuria), emission of small amounts of urine with high frequency (pollakiuria), decreased urine output (oliguria), problems with the

kidneys (acute renal failure), blood and kidney problems (uremic-hemolytic syndrome),
inflammation of the kidneys (interstitial nephritis), inability of the bladder to empty (urinary
retention), loss of protein with urine (nephrotic syndrome), flank pain (with or
without blood in the urine (hematuria) or increase/decrease in the amount of non-protein
nitrogen in the blood (azotemia), increased creatinine and potassium;

• female infertility;
• fatigue (asthenia), fever, reactions at the injection site, swelling (edema), chest pain, excessive thirst;
• changes in laboratory tests: increased bleeding time, increased serum urea, increased creatinine, changes in liver function tests.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the
national reporting system at www.agenziafarmaco.gov.it/it/responsabili .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store BENKETOL

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 packaging after “Exp.”.
The expiry date refers to the last day of that month.
The reconstituted solution must be used immediately, and any remaining solution discarded.
Store in the original packaging to protect the medicine from light.
Do not dispose of any medicine in 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 pack and other information

What BENKETOL contains

• The active ingredient is ketorolac trometamol. Each vial contains 30 mg of ketorolac trometamol.
• The other ingredients are: ethanol, sodium chloride, water for injections.

Description of the appearance of BENKETOL and contents of the pack
Injectable solution.
Pack of 3 glass vials of 1 ml.

Marketing Authorisation Holder
Pharmaber S.r.l., Corso Magenta 32 – 20123 Milan - Italy

Manufacturer
ESSETI Farmaceutici S.r.l. - Via Campobello, 15 - 00071 Pomezia (Rome) - Italy

BENKETOL 20 mg/ml oral drops, solution

Ketorolac trometamol
Generic medicine

Read this leaflet carefully before you start to 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is BENKETOL and what is it used for?

This medicine contains the active ingredient ketorolac trometamol, which belongs to a group of
medicines called non-steroidal anti-inflammatory drugs (“NSAIDs”), used to reduce pain
caused by inflammation.
BENKETOL is indicated only for the short-term treatment (maximum five days) of moderate pain
after surgical operations (post-operative pain).

2. What you need to know before you take BENKETOL

Do not take BENKETOL

• if you are allergic to ketorolac or any of the other ingredients of this medicine (listed in section 6);
• if you have had an allergic reaction in the past after taking acetylsalicylic acid, medicines that block the synthesis of inflammatory substances (prostaglandins) or other non-steroidal anti-inflammatory drugs;
• if you have a respiratory disease characterized by the presence of polyps in the nose (nasal polyposis);
• 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;
• if you suffer from, have suffered from or suspect you suffer from a problem with your stomach or intestines (peptic ulcer, gastrointestinal bleeding or perforation), even when this has occurred following previous therapy with non-steroidal anti-inflammatory drugs;
• if you have a severe heart problem (severe heart failure);
• if you have kidney problems (moderate or severe renal insufficiency) if you are at risk of kidney problems due to reduced blood volume (hypovolemia) or water deficiency (dehydration);
• if you have a severe liver disease (liver cirrhosis or severe hepatitis);
• if you have a predisposition to bleeding (haemorrhagic diathesis) or a problem due to a defect in blood coagulation;
• if you have or suspect you have a cerebral haemorrhage (stroke) or have had one in the past; if you have undergone surgery with a high risk of bleeding or incomplete cessation of blood loss (incomplete haemostasis);
• if you have any other bleeding problems;
• if you are taking acetylsalicylic acid, other non-steroidal anti-inflammatory drugs, medicines to prevent blood clot formation in the vessels (anticoagulants, e.g. pentoxifylline), medicines for mood disorders (lithium salts), medicines used to reduce uric acid levels in the blood (probenecid), medicines to eliminate fluids with urine (diuretics) (see section “Other medicines and BENKETOL”);
• for the prevention of pain (analgesia) before or during surgical operations, because this medicine increases the risk of bleeding;
• if the person who is to take this medicine is a child or adolescent under the age of 16;
• if you are in the last 3 months of pregnancy, near or during labour;
• if you are breastfeeding;
• in cases where the pain is mild or chronic.

Warnings and precautions
Talk to your doctor or pharmacist before taking BENKETOL.
Take BENKETOL, under the direct supervision of your doctor because this medicine should not be
used in the treatment of mild or chronic pain. The doctor will prescribe the dose and duration
of the minimum therapy suitable for your problem, in order to reduce the occurrence of undesirable effects.
Tell your doctor before taking this medicine:

• if you suffer from or have suffered from stomach or intestinal disorders;
• if you are elderly or debilitated, as this increases the possibility of injury or bleeding in the stomach or intestines, which can be life-threatening. In this case, the doctor may decide to reduce the dose or increase the time interval between administrations (see section “How to use BENKETOL”);
• if you suffer from or are predisposed to an inflammatory disease of the bronchi called bronchial asthma, as you may experience breathing crises (bronchospasm) or allergic reactions;
• if you have suffered in the past from swelling due to fluid accumulation around the mouth and eyes (angioedema), asthma, bronchospasm or breathing problems (nasal polyposis), as you may experience severe allergic reactions that can be life-threatening;
• if you suffer from or have suffered from heart problems, high blood pressure (hypertension), reduced blood flow to the legs (peripheral arteriopathy) or to the brain (cerebrovascular disease) or think you may be at risk for these conditions (e.g. if you have high blood pressure, diabetes, high levels of fats in the blood or if you smoke). In these cases, the risk of heart attack or stroke may increase;
• if you suffer from or have suffered from kidney problems;
• if you are allergic to acetylsalicylic acid, other non-steroidal anti-inflammatory drugs (NSAIDs) or ketorolac, as you may experience severe allergic reactions;
• if you suffer from or have suffered from liver problems;
• if you suffer from blood coagulation disorders, as this medicine may increase the risk of blood loss;
• if you are going to undergo surgery, because this medicine interferes with blood coagulation;
• if you are a woman with fertility problems and are planning a pregnancy, as this medicine may interfere with your fertility.

Tell your doctor if you have recently undergone or are about to undergo surgery on the
stomach or intestinal tract before receiving/taking/using BENKETOL, as BENKETOL
may sometimes worsen wound healing in the intestine following surgery.

Avoid taking this medicine in the following cases:

• if you are taking medicines that can cause problems with the stomach or intestines, medicines that promote the elimination of fluids with urine (diuretics) (see section “Other medicines and BENKETOL”).

Stop treatment with this medicine and see your doctor immediately in the
following cases:

• if you experience symptoms of an allergic reaction;
• if you experience blood loss (haemorrhage), lesions (ulcers) of the stomach or intestines;
• if you experience liver problems;
• if you experience skin problems characterized by irritation, scaling, blistering and bleeding of lips, eyes, mouth, nose and genitals. Cases of bruising (haematomas) have been reported after operations (post-operative period) and blood loss from wounds following the use of BENKETOL before or after surgery (peri-operative period). Therefore, inform your doctor if you are to undergo tonsil removal surgery, prostate surgery (prostate resection) or cosmetic surgery. BENKETOL can cause problems with the stomach and intestines, especially when used for prolonged periods and without observing the due warnings and precautions.

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

Other medicines and BENKETOL
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.

Do not take this medicine if you are taking:

• non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid (aspirin) because they increase the risk of side effects. If you are taking any of the following medicines, tell your doctor because they can interactwith BENKETOL:
• corticosteroids, medicines used for the treatment of inflammatory states, because they increase the risk of side effects to the stomach and intestines;
• anticoagulants(e.g. warfarin, heparin, dextrans, pentoxifylline), medicines used to prevent blood clot formation in the vessels, or selective serotonin reuptake

inhibitors, medicines used for the treatment of mood disorders, because they may
increase the risk of bleeding in the stomach or intestines;

• digoxin, a medicine used for the treatment of heart problems;
• lithium, used for the treatment of depression and similar disorders, or methotrexate, a chemotherapeutic agent, because their toxicity may increase;
• antihypertensivesor diuretics, medicines used for the control of blood pressure or heart disorders, because BENKETOL may reduce their effects;
• probenecid, a medicine used to promote the elimination of uric acid with urine.

BENKETOL contains methyl-parahydroxybenzoate and propyl-parahydroxybenzoate
This medicine contains methyl-parahydroxybenzoate and propyl-parahydroxybenzoate which may
cause allergic reactions (also delayed).

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Fertility
BENKETOL may cause fertility problems in women. Therefore, if you are planning to become
pregnant, you should inform your doctor because this medicine may reduce fertility.

Pregnancy
Do not take BENKETOL during the last trimester of pregnancy. It may cause problems for the baby
and labour.
It may cause problems with the kidneys and heart of the unborn baby. It may affect your and your
baby's tendency to bleed and cause a late or prolonged labour.
Do not take BENKETOL during the first 6 months of pregnancy unless absolutely
necessary and advised by your doctor. If you need treatment during this
period or while planning a pregnancy, the lowest dose should be used for the
shortest possible time. If taken for more than a few days from the 20th week of pregnancy onwards,
BENKETOL may cause kidney problems in the foetus which may lead to 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 monitoring.

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

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

3. How to take BENKETOL

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.

Do not take this medicine for more than 5 days
Use in adults:
The recommended dose is 10 mg (10 drops) every 4-6 hours. The doctor will indicate the dose according to
your condition. The maximum dose is 40 mg per day. Do not exceed the maximum
recommended dose.
If your body weight is less than 50 kg, the dose must be reduced.

Use in the elderly (over 65 years of age)
The doctor will establish the dose and assess whether to reduce the dosage.

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

Instructions for opening and using the bottle:

• 1) To open the bottle, press on the cap and simultaneously unscrew it.

• 2) hold the bottle in a vertical position and pour the drops into a glass. Do not shake the bottle. Tap on the bottom of the bottle in case of difficulty dripping.

• 3) reposition the cap and screw it on to close the bottle.

The oral drop formulation is particularly indicated in patients with difficulty swallowing.

If you take more BENKETOL than you should
If you (or someone else) have taken an excessive dose of BENKETOL or if you think a child may
have taken this medicine, immediately notify your doctor or go to the Emergency Room
of the nearest hospital. Following the intake of an excessive dose of this medicine, it may
occur abdominal pain, nausea, vomiting, increased breathing rate (hyperventilation),
problems with the stomach or intestines (peptic ulcer, erosive gastritis, gastrointestinal
bleeding), kidney problems and severe allergic reactions (anaphylactoid reactions). Rare cases of increased blood pressure (hypertension), impaired lung function (respiratory depression) and coma have been
reported. The doctor will establish an appropriate therapy.
Bring 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 BENKETOL
Do not take a double dose to make up for a missed dose.

If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The side effects that may occur with BENKETOL are:

Not known(the frequency of which cannot be estimated based on available data)

• infection of the central nervous system (aseptic meningitis);
• reduction in the number of platelets (thrombocytopenia);
• nosebleed (epistaxis)
• severe allergic reactions (anaphylactic/anaphylactoid reactions), allergic reactions (hypersensitivity reactions): difficulty breathing (bronchospasm), increased blood vessel volume (vasodilation), skin irritation (rash), decreased blood pressure (hypotension), swelling of the throat (laryngeal edema);
• loss of appetite (anorexia), increased potassium in the blood (hyperkalemia), decreased sodium in the blood (hyponatremia);
• abnormal thoughts, mood disorder (depression), sleep disorder (insomnia), feelings of worry or fear (anxiety), irritability, nervousness, mental disorders (psychotic reactions), abnormal dreams (abnormal dream activity), hallucinations, feeling of well-being (euphoria), difficulty concentrating, drowsiness, confusion;
• headache, dizziness, convulsions, impaired sensation of legs and arms or other parts of the body (paresthesia), increased movements (hyperkinesia), altered taste;
• visual disturbances;
• ringing in the ear (tinnitus), hearing loss, vertigo;
• increased perception of heartbeat (palpitations), decreased heartbeat (bradycardia), inability of the heart to pump an adequate amount of blood (heart failure), swelling in different parts of the body due to fluid accumulation in the body (edema), heart disorders (hypertension and heart failure), decreased blood pressure (hypotension), bruising (hematomas), sudden feeling of warmth (hot flashes), decreased skin color (pallor), blood loss from wounds after surgery (post-operative wound bleeding), heart attack, stroke;
• fluid accumulation 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, emission of gas from the intestine (flatulence), constipation, digestive difficulties (dyspepsia), abdominal pain/discomfort, feeling of fullness, emission of dark stools (melena), blood loss from the rectum, vomiting blood (hematemesis), inflammation of the mouth (stomatitis and ulcerative stomatitis), inflammation of the esophagus (esophagitis), noisy emission of gas from the stomach through the mouth (eructation), inflammation of the pancreas (pancreatitis), dry mouth, worsening of inflammation of the intestine (colitis and Crohn's disease), inflammation of the stomach (gastritis);
• liver problems (hepatitis, liver failure), reduced flow of bile 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 (maculo-papular rash), skin irritation (urticaria), itching, rupture of capillaries under the skin (purpura), appearance of blisters on the skin (bullous reactions);

• increased urine production (polyuria), emission of small amounts of urine with high frequency (pollakiuria), decreased urine output (oliguria), kidney problems (acute renal failure), blood and kidney problems (hemolytic uremic syndrome), kidney inflammation (interstitial nephritis), inability of the bladder to empty (urinary retention), protein loss with urine (nephrotic syndrome), flank pain (with or without blood in the urine (hematuria) or increased/decreased amount of non-protein nitrogen in the blood (azotemia), increased creatinine and potassium;
• female infertility;
• fatigue (asthenia), fever, reactions at the injection site, swelling (edema), chest pain, excessive thirst;
• changes in laboratory tests: increased bleeding time, increased serum urea, increased creatinine, alterations in liver function tests.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor or pharmacist. You can also report side effects directly through the
national reporting system at www.agenziafarmaco.gov.it/it/responsabili . By reporting side effects you can contribute to providing more information on the safety of this
medicine.

5. How to store BENKETOL

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 packaging. The expiry date refers to the last day of that month.
Store in the original packaging to protect the product from light.

Shelf life after first opening of the vial
The product must be used within 6 months from the date of first opening of the vial.
Do not dispose of any medicine in 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 pack and other information

What BENKETOL contains

• The active ingredient is ketorolac trometamol: 1 ml of solution contains 20 mg of ketorolac trometamol.
• The other components are: anhydrous citric acid, disodium hydrogen phosphate dihydrate, methylparaben, propylparaben, sodium hydroxide, purified water.

Description of the appearance of BENKETOL and contents of the pack
The pack contains a 10 ml vial.

Marketing Authorisation Holder
Pharmaber S.r.l., Corso Magenta 32 – 20123 Milan - Italy

Manufacturer
Special Product’s Line S.p.A. - Via Fratta Rotonda Vado Largo 1- 03012 Anagni (FR) - Italy