Package leaflet: Information for the patient

DOLGOSIN 100 mg/2ml injectable solution for intramuscular use

Ketoprofen
Please read this leaflet carefully before 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 side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What DOLGOSIN is and what it is used for
What you need to know before using DOLGOSIN
How to use DOLGOSIN
Possible side effects
How to store DOLGOSIN
Contents of the pack and other information

1. What DOLGOSIN is and what it is used for

DOLGOSIN contains the active substance ketoprofen, which belongs to a class of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), used to relieve painful and inflammatory conditions of various origins.
DOLGOSIN is indicated for the symptomatic treatment of acute painful episodes due to inflammation of bones, muscles and joints.
.

2. What you need to know before using DOLGOSIN

Do not use DOLGOSIN

if you are allergic to ketoprofen 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 or other non-steroidal anti-inflammatory drugs (NSAIDs). There is a possibility that, if you are allergic to these substances, you may also be allergic to ketoprofen, and respiratory difficulties (bronchospasm, asthma attacks), rhinitis, urticaria, or other allergic-type reactions may occur. Severe, sudden-onset allergic reactions (anaphylactic), rarely fatal, have been reported in such patients;
if you are undergoing intensive treatment with drugs that stimulate diuresis (diuretics);
if you have severe kidney problems; if you have severe liver problems (liver cirrhosis, severe hepatitis);
if you suffer from blood disorders such as reduced number of white blood cells (leukopenia) or reduced number of platelets (thrombocytopenia);
if you have active bleeding;
if you are predisposed to hemorrhage;
if you have blood coagulation disorders;
if you are being treated with anticoagulants;
if you have severe heart problems (severe heart failure);
if you suffer from stomach or intestinal ulcers (active peptic ulcer), or if you have previously experienced gastrointestinal bleeding, lesions (ulcers), or perforation of the stomach or intestine;
in case of cerebrovascular hemorrhage or any other ongoing bleeding;
during the last three months of pregnancy (see section “Pregnancy and breastfeeding”);
if the person taking this medicine is of pediatric age.

This medicine must not be administered to children.
Warnings and precautions
Talk to your doctor or pharmacist before taking DOLGOSIN:

If you are taking other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), including selective cyclooxygenase-2 inhibitors. If you have experienced gastrointestinal toxicity, especially if you are an elderly patient. In this case, inform your doctor of any abdominal discomfort, particularly during the initial stages of treatment.
If you are taking other medicines that increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants like warfarin, antidepressants (selective serotonin reuptake inhibitors), or antiplatelet agents such as aspirin (see section “Other medicines and DOLGOSIN”).
If you experience gastrointestinal bleeding or ulcer. In this case, stop treatment immediately.
If you suffer from gastrointestinal diseases (ulcerative colitis, Crohn’s disease). The use of NSAIDs may worsen your condition (see section 4).
If you suffer from asthma or chronic rhinitis, chronic sinusitis and/or nasal polyps. These conditions may expose you to a higher risk of developing breathing difficulties (bronchospasm) and allergic reactions to anti-inflammatory drugs and aspirin (acetylsalicylic acid) (see “Other medicines and DOLGOSIN”).
If you suffer from severe kidney, heart, or liver problems, if you are taking diuretic medications, or if you are elderly. In all these cases, the use of ketoprofen may reduce blood flow to the kidneys and lead to renal impairment. Only your doctor can decide whether you may use DOLGOSIN and, if so, will subject you to careful monitoring of kidney function and tests to assess liver function.
If you suffer from heart conditions (uncontrolled hypertension, congestive heart failure, confirmed ischemic heart disease, peripheral arterial disease, and/or cerebrovascular disease) or have conditions that predispose you to cardiovascular diseases (e.g., hypertension, hyperlipidemia, diabetes mellitus), or if you smoke. The use of DOLGOSIN should be evaluated by your doctor, who will determine whether the benefits outweigh the potential risks.
If you are an elderly patient. Your age increases your risk of experiencing adverse effects from anti-inflammatory drugs, especially gastrointestinal bleeding and perforation of the stomach or intestine, sometimes even fatal. The risk increases with higher doses. Your doctor will advise you to start treatment with the lowest available dose and may recommend taking gastroprotective agents.
If you develop high potassium levels in the blood (hyperkalemia), which may occur especially if you have diabetes, renal failure, and/or are being treated with agents that promote hyperkalemia. In such cases, potassium levels should be monitored.
If you have an infection, as this medicine may mask symptoms of infection progression, such as fever. This medicine may cause:
serious heart and circulatory problems (arterial thrombotic events, heart attack, or stroke), especially at high doses and during prolonged treatment;
serious stomach and intestinal problems (bleeding, ulcers, perforations), especially at high doses. Your doctor may recommend taking medicines to protect the stomach (misoprostol or proton pump inhibitors), especially if you have previously suffered from ulcers;
severe skin and mucous membrane disorders, even fatal ones. If you develop a skin rash, mucosal lesions, or any sign of hypersensitivity, stop treatment immediately, as these may be signs of serious skin diseases, some of which are fatal, such as exfoliative dermatitis (skin peeling), Stevens-Johnson syndrome (severe skin reaction with skin peeling and swelling, blisters on skin, mouth, eyes, genitals), or toxic epidermal necrolysis (severe skin reaction with skin peeling and swelling, blisters on skin, mouth, eyes, genitals, often accompanied by malaise, chills, myalgia, and fever). These adverse effects usually occur within the first month of treatment.
vision problems such as blurred vision (see section “Possible side effects”). If you experience any of these effects, stop treatment immediately and consult your doctor right away. You can reduce the risk of side effects by taking DOLGOSIN at the lowest effective dose and for the shortest possible duration (see section “How to take DOLGOSIN”).

The injectable form of Dolgosin cannot be considered a simple analgesic and must be used under strict medical supervision. Moreover, once the acute painful episode has passed, it is advisable to switch to non-injectable formulations.
Elderly patients
Elderly patients have a higher frequency of developing adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal (see section 3).
Children
The safety and efficacy of ketoprofen have not been studied in children.
Other medicines and DOLGOSIN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Some medicines may alter the effect of DOLGOSIN, or the effect of these medicines may be altered by DOLGOSIN. This type of interaction may reduce the effect of one or both medicines. Alternatively, it may increase the risk or severity of adverse effects.
Avoid using DOLGOSIN with:

other non-steroidal anti-inflammatory drugs (including selective cyclooxygenase-2 inhibitors) and high-dose salicylates due to increased risk of gastrointestinal ulcers and bleeding;
anticoagulants (heparin and warfarin): NSAIDs may enhance the effects of anticoagulants such as warfarin and heparin;
antiplatelet agents such as ticlopidine, clopidogrel: increased risk of gastrointestinal bleeding (see “Warnings and precautions”);
lithium: risk of increased lithium blood levels;
methotrexate at doses exceeding 15 mg/week: increased risk of blood toxicity caused by methotrexate. There must be a 12-hour interval between discontinuation or initiation of ketoprofen treatment and methotrexate administration.

Exercise particular caution when using DOLGOSIN if you are taking the following medicines:

medicines that may increase potassium levels in the blood (e.g., potassium salts, potassium-sparing diuretics, ACE inhibitors and angiotensin II antagonists, NSAIDs, heparins (low molecular weight or unfractionated), cyclosporine, tacrolimus, and trimethoprim);
corticosteroids (used for allergies and inflammation): concomitant use may increase the risk of gastrointestinal ulceration or bleeding (see “Warnings and precautions”);
diuretics: NSAIDs may reduce the effect of diuretics and other blood pressure-lowering drugs (antihypertensives). In patients, especially dehydrated patients taking diuretics, there may be a high risk of developing kidney dysfunction. These patients should be adequately rehydrated before starting concomitant treatment with NSAIDs, and their kidney function should be monitored when treatment begins (see “Warnings and precautions”);
pentoxifylline (used to inhibit blood clot formation in vessels): these drugs increase the risk of bleeding when taken together with ketoprofen. Your doctor will perform more frequent clinical checks and monitor bleeding time;
blood pressure-lowering drugs (ACE inhibitors and angiotensin II antagonists): if you have impaired kidney function (e.g., if you are dehydrated or an elderly patient), concomitant administration of a blood pressure-lowering drug such as an ACE inhibitor or angiotensin II antagonist with an NSAID may lead to further worsening of kidney function. You should be adequately hydrated and your kidney function should be properly monitored;
methotrexate (used in the treatment of neoplasms and autoimmune diseases) at doses below 15 mg/week. During the first weeks of combination therapy, a complete blood count should be performed weekly;
tenofovir: concomitant administration with NSAIDs may increase the risk of kidney failure;
cardiac glycosides: NSAIDs may exacerbate heart failure, reduce glomerular filtration rate, and increase cardiac glycoside levels.

Inform your doctor if you are taking the following medicines. Only your doctor can determine whether you may use DOLGOSIN together with the following medicines:

antihypertensives (beta-blockers, angiotensin-converting enzyme inhibitors, diuretics). Administration together with NSAIDs may reduce antihypertensive efficacy;
thrombolytics (used to dissolve blood clots): increase the risk of bleeding;
antiplatelet drugs: tirofiban, eptifibatide, abciximab, and iloprost. Using multiple antiplatelet agents increases the risk of bleeding;
antidepressants (Selective Serotonin Reuptake Inhibitors (SSRIs)): increased risk of gastrointestinal bleeding;
probenecid (used in the treatment of hyperuricemia and gout): concomitant administration of probenecid may significantly reduce the plasma clearance of ketoprofen;
gemeprost (used in obstetric-gynecological treatments): concurrent use with ketoprofen may reduce the effectiveness of gemeprost;
intrauterine contraceptive devices (IUDs): concurrent use may reduce the effectiveness of the device, leading to pregnancy;
mifepristone: the effectiveness of the method may theoretically decrease;
cyclosporine and tacrolimus (immunosuppressive drugs): when used with ketoprofen, they increase the risk of kidney toxicity, especially in elderly patients;
quinolone antibiotics: possible increased risk of seizures.

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 DOLGOSIN during the last trimester of pregnancy, as it may cause serious harm to your baby and during childbirth.
During the first and second trimesters of pregnancy, you may take DOLGOSIN only if necessary. If you are trying to conceive or are in the first or second trimester of pregnancy, the dose should be as low as possible and the treatment duration as short as possible.
Breastfeeding
Dolgosin is not recommended during breastfeeding.
Fertility
The use of NSAIDs may impair female fertility and is not recommended in women intending to become pregnant. In women with fertility problems or undergoing fertility investigations, discontinuation of treatment should be considered.
Driving and using machines
DOLGOSIN may cause drowsiness, dizziness, vertigo, seizures, or visual disturbances.
If you experience any of these symptoms, do not drive or operate machinery and avoid activities requiring special alertness.
Dolgosin injectable solution contains benzyl alcohol.
This medicine contains 40 mg of benzyl alcohol per vial. It must not be given to premature infants or newborns. It may cause toxic and allergic reactions in children up to 3 years of age.

3. How to take DOLGOSIN

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

The recommended dose is 50/100 mg, administered 1–2 times daily by intramuscular injection.
The maximum daily dose is 200 mg. Doses higher than 200 mg per day are not recommended.
The solution is for intramuscular use only and must not be injected intravenously.
Undesirable effects can be minimized by using the lowest effective dose for the shortest duration of treatment.

Instructions for use:
Open the vials along the designated break line. The solution must be used immediately, and the injection must be performed following strict rules of sterilization, asepsis, and antisepsis.
Injectable solutions must not be mixed with solvents having an acidic pH, such as solutions containing lidocaine.
The solution must be used immediately, and the injection must be performed following strict rules of sterilization, asepsis, and antisepsis.

Patients with renal impairment and elderly patients
If you are an elderly patient or have kidney problems, your doctor must carefully determine the dose and consider reducing the above-mentioned dosages.

Patients with hepatic impairment
If you suffer from hepatic impairment, you must be closely monitored and treated with the lowest effective daily dose (see "Warnings and precautions").

Children
The safety and efficacy of Dolgosin have not been established in children.

If you take more DOLGOSIN than you should
If you take too much Dolgosin, inform your doctor or go to the nearest hospital immediately.
Symptoms of overdose include headache, dizziness, drowsiness, nausea, vomiting, diarrhoea, and abdominal pain.

If you forget to take DOLGOSIN
Do not take a double dose to make up for the missed dose. Inform your doctor, who will advise you on how to continue the treatment.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The following side effects have occurred in adults, according to the following frequencies:
If you experience any of the following serious side effects, stop taking
DOLGOSIN and contact your doctor immediately or go to the nearest hospital.

Not known: frequency cannot be estimated from the available data: severe skin reactions, some of which have been fatal, such as severe skin reaction with peeling and swelling of the skin, skin blisters, mouth, eyes, genitals (Stevens-Johnson Syndrome), often accompanied by malaise, chills, myalgia and fever (toxic epidermal necrolysis) and generalized acute exanthematous pustulosis;
severe allergic reaction with sudden onset, including severe and sudden swelling of the skin or mucous membranes, for example swelling around the eyes, face, lips, mouth or throat (angioedema);
severe allergic reaction with sudden onset that may lead to collapse (anaphylactic shock);
gastrointestinal perforation or bleeding, particularly in the elderly.

The following side effects have also been reported:
Common: may affect up to 1 in 10 people

nausea
vomiting
abdominal pain
indigestion (dyspepsia)

Uncommon: may affect up to 1 in 100 people

headache
dizziness
vertigo
somnolence
constipation
diarrhoea
inflammation of the stomach (gastritis)
flatulence
skin rash
pruritus
swelling due to fluid accumulation (oedema)
fatigue

Rare: may affect up to 1 in 1,000 people

anaemia due to bleeding (haemorrhagic anaemia), decreased number of white blood cells (leucopenia)
blurred vision
altered sensation in limbs (paraesthesia)
ringing in the ears (tinnitus)
asthma attacks
mouth inflammation with lesions (ulcerative stomatitis), peptic ulcers, colitis
increased liver enzymes, increased serum bilirubin due to liver disease
weight gain
inflammation of the liver (hepatitis)
yellowish discoloration of the skin, whites of the eyes and mucous membranes due to liver problems (jaundice)

Not known: frequency cannot be estimated from the available data

kidney problems (acute renal failure, tubulo-interstitial nephritis, nephritic syndrome, nephrotic syndrome, abnormal kidney function tests),
worsening of colitis and Crohn's disease, presence of blood in stools (melena) and blood in vomit (haematemesis), inflammation of the pancreas (pancreatitis)
changes in blood cell counts (thrombocytopenia, agranulocytosis), aplastic anaemia, decreased red blood cells (haemolytic anaemia)
mood disturbances, depression, hallucinations, confusion
taste disturbances, heart failure (a condition in which the heart fails to supply adequate blood to the body), changes in heart rhythm (atrial fibrillation, palpitations and tachycardia)
increased blood pressure (hypertension)
vasodilation
inflammation of blood vessels (vasculitis)
breathing difficulties (bronchospasm, especially in people with a history of allergic reactions to other NSAIDs, and dyspnoea)
inflammation of the nasal sinuses (rhinitis)
skin rashes with itching (urticaria, erythema)
light sensitivity reactions (photosensitisation)
hair loss (alopecia)
inflammation of the meninges, the membranes covering the brain and spinal cord (aseptic meningitis)
seizures
changes in blood levels of sodium and potassium (hyponatraemia and hyperkalaemia)
reactions at the injection site, including cutaneous medicamentous embolism (Nicolau syndrome)

Please note that
The use of medicines such as DOLGOSIN (particularly at high doses and for long-term treatment) may be
associated with a small increased risk of heart attack (myocardial infarction) or stroke.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or
pharmacist. You may also report side effects directly via the national reporting system at the website: 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 DOLGOSIN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label after "Exp.". The expiry date refers to the last day of that month and applies to the product in intact original packaging that has been properly stored.
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 DOLGOSIN contains

The active substance is ketoprofen. One 2 ml vial contains 100 mg of ketoprofen.
The other components are: Arginine, benzyl alcohol, citric acid monohydrate, water for injections.

Description of the appearance of DOLGOSIN and contents of the pack
DOLGOSIN is an injectable solution for intramuscular use.
It is available in a carton containing 6 glass vials of 2 ml each.
Marketing Authorization Holder
S.F. GROUP SRL
Via Tiburtina, 1143 – 00156 Rome - Italy
Manufacturer
ESSETI Farmaceutici
Via Campobello, 15
00071 Pomezia (RM)
Italy

Patient information leaflet

DOLGOSIN

200 mg prolonged-release hard capsules
Ketoprofen
Generic medicine
Please read this leaflet carefully before taking 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, because 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:

What DOLGOSIN is and what it is used for
What you need to know before taking DOLGOSIN
How to take DOLGOSIN
Possible side effects
How to store DOLGOSIN
Contents of the pack and other information

1. What DOLGOSIN is and what it is used for

DOLGOSIN contains the active substance ketoprofen, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), used to relieve painful and inflammatory conditions of various origins.
DOLGOSIN is indicated in adults for the treatment of:

painful symptoms due to inflammation of bones, muscles and joints such as: rheumatoid arthritis, osteoarthritis, ankylosing spondylitis;
acute articular and periarticular inflammations such as bursitis, capsulitis, synovitis, tendinitis;
and low back pain (muscle strain, lumbago, sciatica, fibrositis);
musculoskeletal painful syndromes;
menstrual pain (dysmenorrhea).

2. What you should know before taking DOLGOSIN

Do not take DOLGOSIN

if you are allergic to ketoprofen 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 (aspirin) or other non-steroidal anti-inflammatory drugs (NSAIDs). There is a possibility that if you are allergic to these substances, you may also be allergic to ketoprofen, and breathing difficulties (bronchospasm, asthma attacks), rhinitis, urticaria, or other allergic-type reactions may occur. Severe, sudden-onset allergic reactions (anaphylactic), rarely fatal, have been reported in such patients;
if you are undergoing intensive treatment with diuretic drugs (diuretics);
if you have severe kidney problems; if you have severe liver problems (hepatic cirrhosis, severe hepatitis);
if you suffer from blood disorders such as reduced number of white blood cells (leukopenia) or reduced number of platelets (thrombocytopenia);
if you are experiencing active bleeding;
if you are predisposed to bleeding;
if you have blood coagulation disorders;
if you have severe heart problems (severe heart failure);
if you have a stomach or intestinal ulcer (active peptic ulcer), or if you have previously experienced gastrointestinal bleeding, lesions (ulcers), or perforation of the stomach or intestine;
if you are in the last three months of pregnancy (see section "Pregnancy and breastfeeding"). This medicine must not be administered in pediatric age.

Warnings and precautions
Talk to your doctor or pharmacist before taking DOLGOSIN:

If you are taking other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), including selective cyclooxygenase-2 inhibitors. If you have experienced gastrointestinal toxicity, especially if you are elderly. In this case, inform your doctor of any abdominal discomfort, particularly during the initial stages of treatment.
If you are taking other medicines that increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants like warfarin, antidepressants (selective serotonin reuptake inhibitors), or antiplatelet agents such as aspirin (see section "Other medicines and DOLGOSIN").
If you experience gastrointestinal bleeding or ulceration. In this case, stop treatment immediately.
If you suffer from gastrointestinal diseases (ulcerative colitis, Crohn's disease). The use of NSAIDs could worsen your condition (see section 4).
If you suffer from asthma, chronic rhinitis, chronic sinusitis and/or nasal polyps. These conditions may expose you to a higher risk of developing breathing difficulties (bronchospasm) and allergic reactions to anti-inflammatory drugs and aspirin (acetylsalicylic acid) (see "Other medicines and DOLGOSIN").
If you suffer from severe kidney, heart, or liver problems, if you are taking diuretic medicines, or if you are elderly. In all these cases, the use of ketoprofen could reduce blood flow to the kidneys and lead to renal failure. Only your doctor can decide whether you may use DOLGOSIN, and in such case will subject you to careful monitoring of kidney function and liver function tests.
If you suffer from heart conditions (uncontrolled hypertension, congestive heart failure, ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease) or if you have conditions that predispose you to cardiovascular diseases (e.g. hypertension, hyperlipidemia, diabetes mellitus) or if you smoke. The use of DOLGOSIN should be evaluated by your doctor, who will determine whether the benefits outweigh the potential risks.
If you are elderly. Your age increases your risk of experiencing adverse effects from anti-inflammatory drugs, particularly gastrointestinal bleeding and perforation, sometimes even fatal. The risk increases with high-dose use. Your doctor will advise you to start treatment with the lowest available dose and may recommend taking gastroprotective agents.
If you develop high potassium levels in the blood (hyperkalemia), which may occur especially if you have diabetes, renal failure and/or are being treated with agents that promote hyperkalemia. In such cases, potassium levels should be monitored.
If you have an infection, as this medicine may mask symptoms of infection progression, such as fever.

This medicine may cause:

serious heart and circulatory problems (arterial thrombotic events, heart attack, or stroke), especially at high doses and with prolonged treatment;
serious stomach and intestinal problems (bleeding, ulcers, perforations), especially at high doses. Your doctor may recommend taking medicines to protect the stomach (misoprostol or proton pump inhibitors), particularly if you have previously suffered from ulcers;
skin and mucous membrane disorders, even fatal ones. If you develop a skin rash, mucosal lesions, or any sign of hypersensitivity, stop treatment immediately, as these may be signs of serious skin diseases, some of which are fatal, such as exfoliative dermatitis (skin peeling), Stevens-Johnson syndrome (severe skin reaction with skin peeling and swelling, blisters on skin, mouth, eyes, genitals), and toxic epidermal necrolysis (severe skin reaction with skin peeling and swelling, blisters on skin, mouth, eyes, genitals, often accompanied by malaise, chills, myalgia, and fever). These adverse effects usually occur within the first month of treatment.
vision problems such as blurred vision (see section "Possible side effects").

If you experience any of these effects, stop treatment immediately and consult your doctor right away. You can reduce the risk of experiencing adverse effects by taking DOLGOSIN at the lowest effective dose and for the shortest duration possible (see section "How to take DOLGOSIN").

Elderly patients
Elderly patients have a higher frequency of developing adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal (see section 3).

Children
The safety and efficacy of ketoprofen have not been studied in children.

Other medicines and DOLGOSIN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Some medicines may alter the effect of DOLGOSIN, or the effect of these medicines may be altered by DOLGOSIN. This type of interaction may reduce the effect of one or both medicines. Alternatively, it may increase the risk or severity of adverse effects.

Avoid taking DOLGOSIN with:

Other non-steroidal anti-inflammatory drugs (including selective cyclooxygenase-2 inhibitors) and high-dose salicylates, due to increased risk of gastrointestinal ulcers and bleeding.
Anticoagulants (heparin and warfarin): NSAIDs may enhance the effects of anticoagulants such as warfarin and heparin.
Antiplatelet agents such as ticlopidine, clopidogrel: increased risk of gastrointestinal bleeding (see "Warnings and precautions").
Lithium: risk of increased lithium blood levels.
Methotrexate at doses above 15 mg/week: increased risk of methotrexate-induced blood toxicity. There should be a 12-hour interval between stopping or starting ketoprofen treatment and methotrexate administration.

Use DOLGOSIN with particular caution if you are taking the following medicines:

Medicines that may increase potassium levels in the blood (e.g. potassium salts, potassium-sparing diuretics, ACE inhibitors, angiotensin II antagonists, NSAIDs, heparins (low molecular weight or unfractionated), cyclosporine, tacrolimus, and trimethoprim).
Corticosteroids (used for allergies and inflammation): concomitant use may increase the risk of gastrointestinal ulceration or bleeding (see "Warnings and precautions").
Diuretics: NSAIDs may reduce the effect of diuretics and other blood pressure-lowering drugs (antihypertensives). In patients, especially dehydrated ones taking diuretics, there may be a high risk of developing kidney dysfunction. These patients should be adequately rehydrated before starting concomitant treatment with NSAIDs, and their kidney function should be monitored when treatment begins (see "Warnings and precautions").
Pentoxifylline (used to inhibit blood clot formation in blood vessels): these drugs increase the risk of bleeding when taken with ketoprofen. Your doctor will perform more frequent clinical checks and monitor bleeding time.
Blood pressure-lowering drugs (ACE inhibitors and angiotensin II antagonists): if you have impaired kidney function (e.g. if you are dehydrated or elderly), concomitant use of a blood pressure-lowering drug such as an ACE inhibitor or angiotensin II antagonist with an NSAID may lead to further worsening of kidney function. You should be adequately hydrated and your kidney function should be properly monitored.
Methotrexate (used in the treatment of malignancies and autoimmune diseases) at doses below 15 mg/week. During the first weeks of combination therapy, a complete blood count should be performed weekly.
Tenofovir: concomitant administration with NSAIDs may increase the risk of kidney failure.
Cardiac glycosides: NSAIDs may exacerbate heart failure, reduce glomerular filtration rate, and increase cardiac glycoside levels.

Inform your doctor if you are taking the following medicines. Only your doctor can determine whether you may take DOLGOSIN together with the following medicines:

Antihypertensives (beta-blockers, angiotensin-converting enzyme inhibitors, diuretics). Administration together with NSAIDs may reduce antihypertensive efficacy.
Thrombolytics (used to dissolve blood clots): increase the risk of bleeding.
Antiplatelet drugs: tirofiban, eptifibatide, abciximab, and iloprost. Using multiple antiplatelet agents increases the risk of bleeding.
Antidepressants (Selective Serotonin Reuptake Inhibitors - SSRIs): increased risk of gastrointestinal bleeding.
Probenecid (used in the treatment of hyperuricemia and gout): concomitant administration of probenecid may significantly reduce the plasma clearance of ketoprofen.
Gemeprost (used in obstetric-gynecological treatments): concurrent use with ketoprofen may reduce the efficacy of gemeprost.
Intrauterine contraceptive devices (IUDs): concurrent use may reduce the effectiveness of the device, potentially leading to pregnancy.
Mifepristone: the effectiveness of the method may theoretically be reduced.
Cyclosporine and tacrolimus (immunosuppressive drugs): when used with ketoprofen, they increase the risk of kidney toxicity, especially in the elderly.
Quinolone antibiotics: possible increased risk of seizures.

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

Pregnancy
Do not take DOLGOSIN during the last trimester of pregnancy, as it may cause serious harm to your baby and during childbirth.
During the first and second trimesters of pregnancy, you may take DOLGOSIN only if strictly necessary. If you are trying to conceive or are in the first or second trimester of pregnancy, the dose should be as low as possible and the treatment duration as short as possible.

Breastfeeding
DOLGOSIN is not recommended during breastfeeding.

Fertility
The use of NSAIDs may impair female fertility and is not recommended in women attempting to conceive. In women with fertility problems or undergoing fertility investigations, discontinuation of treatment should be considered.

Driving and using machines
DOLGOSIN may cause drowsiness, dizziness, vertigo, seizures, or visual disturbances.
If you experience any of these symptoms, do not drive or operate machinery and avoid activities requiring special alertness.

DOLGOSIN prolonged-release hard capsules contain sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take DOLGOSIN

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

This medicine is intended for adults only.

The recommended dose is:
1 capsule of 200 mg daily, to be taken after a meal.

The dose should be adjusted according to your body weight and the severity of symptoms.
The maximum daily dose is 200 mg. Doses higher than 200 mg per day are not recommended.
Adverse effects can be minimized by using the lowest effective dose for the shortest duration of treatment.

Patients with renal impairment and elderly patients
If you suffer from renal impairment or are an elderly patient, the initial dose should be reduced and maintenance therapy should be carried out using the lowest effective dose, with subsequent individual dose adjustments as needed.

Patients with hepatic impairment
If you suffer from hepatic impairment, you must be closely monitored and treated with the lowest effective daily dose (see "Warnings and precautions").

Children
The safety and efficacy of Dolgosin have not been established in children.

If you take more DOLGOSIN than you should
If you take too much Dolgosin, inform your doctor immediately or go to the nearest hospital.
Symptoms of overdose include headache, dizziness, somnolence, nausea, vomiting, diarrhoea, and abdominal pain.

If you forget to take DOLGOSIN
Do not take a double dose to make up for the missed dose. Inform your doctor, who will advise you on how to continue treatment.

If you have any questions about the use of 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.
If you experience any of the following serious side effects, stop taking
DOLGOSIN and contact your doctor immediately or go to the nearest hospital.
Not known: frequency cannot be estimated from the available data:

severe skin reactions, some of which may be fatal, such as severe skin reaction with peeling and swelling of the skin, skin blisters, affecting mouth, eyes, genitals (Stevens-Johnson Syndrome), often accompanied by malaise, chills, muscle pain and fever (toxic epidermal necrolysis) and generalized pustular exanthema;
severe allergic reaction with sudden onset, including severe and sudden swelling of the skin or mucous membranes, for example around the eyes, face, lips, mouth or throat (angioedema);
severe allergic reaction with sudden onset that may lead to collapse (anaphylactic shock);
gastrointestinal perforation or bleeding, particularly in the elderly.

The following side effects have also been reported:
Common: may affect up to 1 in 10 people

nausea
vomiting
stomach pain
indigestion (dyspepsia)

Uncommon: may affect up to 1 in 100 people

headache
dizziness
vertigo
drowsiness
constipation
diarrhoea
inflammation of the stomach (gastritis)
flatulence
skin rash
itching
swelling due to fluid accumulation (oedema)
fatigue

Rare: may affect up to 1 in 1,000 people

anaemia due to bleeding (haemorrhagic anaemia), decrease in the number of white blood cells (leucopenia)
blurred vision
altered sensation in limbs (paraesthesia)
ringing in the ears (tinnitus)
asthma attacks
inflammation of the mouth with lesions (ulcerative stomatitis), peptic ulcers, colitis
increased liver enzymes, increased serum bilirubin due to liver disease
weight gain
inflammation of the liver (hepatitis)
yellowish discoloration of the skin, whites of the eyes and mucous membranes due to liver problems (jaundice)

Not known: frequency cannot be estimated from the available data

kidney problems (acute renal failure, tubulo-interstitial nephritis, nephritic syndrome, nephrotic syndrome, abnormal kidney function tests)
worsening of colitis and Crohn's disease, presence of blood in stools (melena), presence of blood in vomit (haematemesis), inflammation of the pancreas (pancreatitis)
changes in blood cell counts (thrombocytopenia, agranulocytosis), aplastic anaemia, decrease in red blood cells (haemolytic anaemia)
mood disturbances, depression, hallucinations, confusion
taste disturbances, heart failure (a condition in which the heart is unable to supply sufficient blood to the body), changes in heart rhythm (atrial fibrillation, palpitations, tachycardia)
increased blood pressure (hypertension)
vasodilation
inflammation of blood vessels (vasculitis)
breathing difficulties (bronchospasm, especially in people with a history of allergic reactions to other NSAIDs, and dyspnoea)
inflammation of the nasal sinuses (rhinitis)
itchy skin rashes (urticaria, erythema)
light sensitivity reactions (photosensitisation)
hair loss (alopecia)
inflammation of the meninges, the membranes covering the brain and spinal cord (aseptic meningitis)
seizures
changes in blood levels of sodium and potassium (hyponatraemia and hyperkalaemia)

Please note that
The use of medicines such as DOLGOSIN (especially at high doses and for long-term treatment) may be
associated with a small increased risk of heart attack (myocardial infarction) or stroke (see section above
“Warnings and precautions”).
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
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 DOLGOSIN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label after "Exp.". The expiry date refers to the last day of that month.
Do not store above 25°C.
Keep in the original packaging to protect the medicine from moisture.
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 DOLGOSIN contains

The active substance is ketoprofen. One prolonged-release capsule contains 200 mg of ketoprofen.
The other components are: Sucrose and Starch microgranules, Povidone K30, Poly(methyl)methacrylates (Eudragit RS), Talc. Capsule constituents: Gelatin, Titanium dioxide (E 171).

Description of the appearance of DOLGOSIN and contents of the pack
The cardboard box contains 28 prolonged-release hard capsules, packed in blisters.

Marketing Authorization Holder
DYMALIFE PHARMACEUTICAL S.R.L, VIA BAGNULO 95, 80063 - PIANO DI SORRENTO - NAPOLI (NA)

Manufacturer
Special Product’s Line S.p.A.,
Strada Paduni, 240 - 03012 Anagni (Frosinone)