GLADIO 100 mg Tabletka Powlekana

Treść ulotki

1. GLADIO 100 mg coated tablets, 100 mg oral suspension powder
   1. What GLADIO is and what it is used for
   2. What you need to know before taking GLADIO
   3. How to take GLADIO
   4. Possible side effects
   5. How to store GLADIO
   6. Contents of the pack and other information
2. GLADIO 1.5 g/100 g cream
   1. What is GLADIO and what is it used for
   2. What you need to know before using GLADIO
   3. How to use GLADIO
   4. Possible side effects
   5. How to store GLADIO
   6. Contents of the pack and other information

GLADIO 100 mg coated tablets, 100 mg oral suspension powder

Aceclofenac

Read this leaflet carefully before taking 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 they have the same symptoms as you, as it may 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 GLADIO is and what it is used for
• 2. What you need to know before you take GLADIO
• 3. How to take GLADIO
• 4. Possible side effects
• 5. How to store GLADIO
• 6. Contents of the pack and other information

1. What GLADIO is and what it is used for

GLADIO contains the active ingredient aceclofenac which belongs to the category of non-steroidal anti-inflammatory drugs (NSAIDs) and antirheumatic drugs (drugs used for diseases affecting the bones, cartilages and muscles).
This medicine is indicated in adults for the treatment of:

• Rheumatic inflammatory diseases such as osteoarthritis (disease affecting the joints), rheumatoid arthritis (a progressive and chronic autoimmune disease affecting the joints), ankylosing spondylitis (a severe disabling rheumatic disease that can cause fusion of the joints).
• Extra-articular rheumatism such as periarthritis (inflammatory disease involving the fibrous tissues surrounding a joint), bursitis (inflammation of the fluid-filled sacs that act as a cushion between bones and tendons and/or muscles surrounding a joint), tendinitis (inflammation of the tendons), enthesitis (inflammation of the insertion of a muscle onto a bone).
• Acute painful conditions of different causes such as sciatica (sensation of intense pain in the leg caused by irritation of the sciatic nerve), lumbago (back pain), myalgia (muscle pain), primary dysmenorrhea (painful menstrual cycle), pain following trauma of various kinds, odontalgia (toothache).

2. What you need to know before taking GLADIO

Do not take GLADIO

• If you are allergic to aceclofenac, to other NSAIDs (including acetylsalicylic acid) or to any of the other ingredients of this medicine (listed in section 6).
• If you have experienced in the past, after taking acetylsalicylic acid or other NSAIDs, asthma attacks or other allergic reactions such as urticaria (skin reaction), rhinitis (inflammation of the nasal mucosa), edema (fluid retention), rash (sudden redness of the skin) or bronchospasm (narrowing of the bronchi). This applies to all non-steroidal anti-inflammatory drugs.
• If you have a heart and/or cerebrovascular disease (at the level of the brain vessels), for example if you have had a heart attack, a stroke (brain damage that occurs when the blood flow to the brain is suddenly interrupted), a transient ischemic attack (TIA), blockages of the blood vessels of the heart or brain or if you have undergone surgery to remove these blockages or a coronary bypass (surgery that creates an artificial bridge that allows bypassing an obstacle to blood flow).
• If you have or have had problems with blood circulation (peripheral arterial disease).
• If you have an erosion of the inner lining of the mucosa of the stomach or intestine (gastroduodenal ulcer) in progress or bleeding (hemorrhages) in the gastrointestinal tract.
• If you have active bleeding and blood loss (bleeding disorders).
• If you have had gastrointestinal bleeding or perforation caused by previous treatments with non-steroidal anti-inflammatory drugs or if you have had a recurrent gastric/peptic ulcer (two or more distinct episodes of demonstrated ulceration or bleeding in the stomach or duodenum, a part of the intestine).
• If you suffer from severe liver impairment (decreased liver function).
• If you suffer from kidney impairment (decreased kidney function).
• If you are pregnant, especially in the third trimester and during breastfeeding, unless your doctor sees valid reasons for taking it. In this case, the doctor will prescribe the minimum effective dose (see “Pregnancy, breastfeeding and fertility”).

GLADIO should not be administered to children (see “Children and adolescents”).

Warnings and precautions
Talk to your doctor or pharmacist before taking GLADIO.
Do not take GLADIO in combination with other NSAIDs, including selective COX-2 inhibitors.
Take GLADIO with caution and tell your doctor:

• If you smoke.
• If you have diabetes (increased blood sugar concentration).
• If you suffer from angina (chest pain caused by insufficient oxygen supply to the heart).
• If you have blood clots.
• If you suffer from hypertension (high blood pressure).
• If you have a high level of cholesterol or triglycerides (fats) in the blood.
• In case of liver dysfunction (liver malfunction).
• In case of heart or kidney failure.
• If you have undergone major surgery.
• If you are elderly.

Adverse effects can be minimized by using the lowest effective dose for the shortest possible duration needed to control the symptoms (see section 3 “How to take GLADIO”).
If you are elderly, be aware that the frequency of adverse effects, especially gastrointestinal bleeding and perforation, which can be fatal, is higher (see section 3 “How to take GLADIO”).
Gastrointestinal tract (stomach and intestine)
During treatment with all NSAIDs, at any time, with or without warning symptoms or after serious gastrointestinal events (diseases at the level of the stomach or intestine), bleeding in the stomach and intestine, ulceration or perforation have been reported, which can be fatal.

Stop taking GLADIO immediatelyand consult your doctor if you experience bleeding or lesions in the stomach or intestine (gastrointestinal ulceration) while taking the medicine.
As with all NSAIDs, you must take GLADIO with particular caution and under close medical supervision if you have symptoms indicative of disorders relating to the upper or lower gastrointestinal tract, if you have had gastric or intestinal ulcers in the past, bleeding, perforation, ulcerative colitis or Crohn's disease (inflammatory bowel diseases), hematological alterations (at the level of the blood) as these conditions may be worsened (see section 4 “Possible side effects”).
If you are elderly or if you have had an ulcer in the past, especially if complicated by bleeding or perforation, the risk of gastrointestinal bleeding, ulceration or perforation is greater, especially with increased doses of NSAIDs. In these cases, your doctor will prescribe an initial treatment with the lowest effective dose in order to reduce the risk of gastrointestinal toxicity.
If you are taking low doses of acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal events (such as other NSAIDs or corticosteroids - see “Other medicines and GLADIO”), your doctor may consider prescribing you protective agents for the stomach (e.g. misoprostol or proton pump inhibitors) at the same time.
If you have suffered from gastrointestinal toxicity (i.e. problems with the stomach and intestines), in particular if you are elderly, you should report any gastrointestinal symptoms (especially gastrointestinal bleeding) to your doctor, especially in the early stages of treatment.
Tell your doctor if you are being treated with medicines that may increase the risk of ulceration or bleeding, such as systemic corticosteroids (anti-inflammatory drugs that act throughout the body), anticoagulants (medicines that delay blood clotting), antiplatelet agents (medicines that prevent platelet aggregation) or selective serotonin reuptake inhibitors (medicines for depression) (see “Other medicines and GLADIO”).
Cardiovascular (at the level of the heart vessels) and cerebrovascular (at the level of the brain vessels) system
On request of the doctor, undergo adequate monitoring and take GLADIO with caution:

• If you have had hypertension and/or congestive heart failure (inability of the heart to provide blood in adequate quantities to the needs of the body) from mild to moderate, as fluid retention and edema have been found in association with treatment with NSAIDs.
• If you have congestive heart failure and if you have significant risk factors for cardiovascular events (high blood pressure, high levels of fats in the blood, diabetes) or if you smoke.
• If you have had cerebrovascular bleeding in the past.

The use of GLADIO may be associated with an increased risk of myocardial infarction (heart attack) (see section 4 “Possible side effects”).
Since the cardiovascular risks of GLADIO may increase with dose and duration of treatment, your doctor will prescribe you the lowest effective daily dose for the shortest period necessary. The response to therapy and the need for symptom improvement should be reassessed periodically.
Hypersensitivity reactions (allergy) and skin reactions (of the skin)
Avoid the use of GLADIO in case of chickenpox; in some cases, chickenpox can cause serious infectious complications of the skin and soft tissues and the role of NSAIDs in worsening these infections cannot be excluded (see section 4 “Possible side effects”).
As with other NSAIDs, allergic reactions, including anaphylactic/anaphylactoid reactions (rapidly occurring allergic reactions), even without previous exposure to aceclofenac, may occur in rare cases (see section 4 “Possible side effects”).
Severe skin reactions (at the level of the skin), some of which are fatal, including exfoliative dermatitis (irritation of the skin with scaling), Stevens-Johnson syndrome (acute allergic reaction involving the skin and mucous membranes) and toxic epidermal necrolysis (or “Lyell's syndrome”, a serious skin disease induced by an allergy to certain drugs, characterized by the destruction of the skin epithelium and mucous membranes), have been reported very rarely in association with the use of NSAIDs (see section 4 “Possible side effects”). The risk appears to be higher in the early stages of therapy as the onset of the reaction occurs in most cases within the first month of treatment.
Stop taking GLADIO at the first appearance of skin rash, mucous membrane lesions or any other signs of hypersensitivity (allergy).
Kidney function
Take GLADIO with caution and tell your doctor:

• In case of mild to moderate renal impairment as the use of NSAIDs may determine a deterioration of renal function. In these cases, your doctor will prescribe the minimum effective dose and you will undergo regular checks of kidney function.
• If you are concomitantly treated with diuretics (medicines that increase urine production).
• If your heart function is impaired.
• If you suffer from liver dysfunction
• If you have undergone major surgery
• If you are elderly.

The effects on kidney function are generally reversible with discontinuation of aceclofenac.
Liver function (of the liver)
Your doctor will stop the treatment with GLADIO if liver function parameters are persistently altered or worsened, if clinical or symptomatic signs consistent with hepatopathy (liver disease) develop, or if other manifestations such as eosinophilia (elevated number of a type of white blood cells in the blood) or rash (sudden redness of the skin) occur. Hepatitis (inflammation of the liver) can occur with the use of GLADIO without warning symptoms.
Take GLADIO with caution if you have hepatic porphyria (rare disease in which there is a deficiency of liver enzymes), as it may trigger an attack.
Your doctor will ask you to undergo regular checks in case of mild-moderate impairment of liver function.
Hematological problems (at the level of the blood)
Aceclofenac may temporarily block platelet aggregation (see “Other medicines and GLADIO”).
Respiratory disorders
Pay particular attention when taking GLADIO if you suffer from or have suffered in the past from bronchial asthma (disease caused by obstruction of the bronchi) as NSAIDs may worsen bronchospasm (constriction of the bronchi).
Long-term treatments
As a preventive measure, if you are undergoing long-term treatment with NSAIDs, your doctor will evaluate the blood cell count and parameters of your kidney and liver function.

Children and adolescents
Currently, there are no clinical data on the use of the drug in children, therefore its administration is not recommended (see “Do not take GLADIO”).

Other medicines and GLADIO
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Be careful when taking GLADIO with:

• Diuretics (medicines used to increase urine production); aceclofenac, like other NSAIDs, can inhibit the activity of diuretics. In the case of concomitant administration with potassium-sparing diuretics, your doctor will ask you to monitor potassium levels in your blood.
• Antihypertensives (medicines used to reduce blood pressure); NSAIDs can reduce the effect of blood pressure lowering medicines. If your kidney function is impaired (for example if you have lost a lot of fluids or if you are elderly) the simultaneous administration of antihypertensive medicines such as ACE inhibitors or angiotensin II receptor blockers and NSAIDs can increase the risk of acute renal failure, generally reversible. In these cases, your doctor will tell you to take an adequate amount of fluids and will assess whether it is appropriate to monitor your kidney function after starting concomitant therapy, and subsequently periodically.
• Corticosteroids (medicines with anti-inflammatory action); there may be an increased risk of gastrointestinal ulceration or bleeding (see “Warnings and precautions”).
• Anticoagulants (medicines that delay blood clotting); like other NSAIDs, aceclofenac can increase the activity of anticoagulant medicines such as warfarin (see “Warnings and precautions”) and therefore, in case of combined therapy, your doctor will subject you to careful monitoring.
• Antiplatelet agents (medicines that prevent platelet aggregation) and selective serotonin reuptake inhibitors (SSRIs) (medicines used for depression); concomitant use with NSAIDs may increase the risk of gastrointestinal bleeding (see “Warnings and precautions”).
• Antidiabetics (medicines used for the treatment of diabetes). Isolated cases of hypoglycemic (reduction of blood sugar levels) and hyperglycemic (increase of blood sugar levels) effects have been reported; therefore, your doctor will consider the possibility of adjusting the dosage of hypoglycemic agents (medicines that reduce blood sugar levels) in conjunction with aceclofenac.
• Methotrexate, an antineoplastic and antirheumatic drug, used for the treatment of some diseases such as leukemia (blood cancer), lymphomas (cancer of the immune system), rheumatoid arthritis (rheumatic disease), lupus (disease of the immune system) and psoriasis (skin disease); the possible interaction between NSAIDs and methotrexate should be considered even when low doses of methotrexate are administered, especially if you have reduced kidney function. During combination therapy, your doctor will monitor your kidney function. Use particular caution when taking concomitant medication within 24 hours of NSAIDs and methotrexate, as this may determine an increase in the concentrations of the antitumor agent in the blood with a consequent increase in the toxicity of the latter.
• Lithium (a mood stabilizer, used in the treatment of depression and bipolar disorder) and digoxin (a medicine that stimulates heart function); several NSAIDs inhibit the elimination of lithium and digoxin, determining an increase in their concentration in the blood. The combination should therefore be avoided unless frequent monitoring of lithium and digoxin levels is possible.
• Other NSAIDs; concomitant use of acetylsalicylic acid and other NSAIDs may increase the frequency of adverse effects.
• Cyclosporine and tacrolimus (immunosuppressant drugs); it is believed that the administration of NSAIDs in conjunction with cyclosporine or tacrolimus may increase the risk of nephrotoxicity (toxicity at the level of the kidneys). During combination therapy it is therefore important that your doctor carefully monitors your kidney function.
• Zidovudine (antiviral drug); when NSAIDs are administered with zidovudine, the risk of hematological toxicity (of the blood) increases; there is evidence of increased risk of hemarthrosis (bleeding into a joint) and hematoma in HIV-positive hemophiliacs treated concomitantly with zidovudine and ibuprofen (a drug belonging to the NSAID category).

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take GLADIO in the last 3 months of pregnancy, as it may harm the fetus or
cause problems during childbirth. It can cause problems with the heart, lungs or kidneys of the fetus.
It may affect your and your baby's tendency to bleed and delay or prolong
labor more than expected. You should not take GLADIO in the first 6 months of pregnancy, unless
absolutely necessary and under the advice of your doctor. If treatment is needed during this
period or during attempts to conceive, the minimum dose should be used for the
shortest possible time. From the 20th week of pregnancy, GLADIO can 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 narrowing a blood vessel (ductus arteriosus) in the heart of the
baby. If treatment is needed for more than a few days, your doctor may
recommend additional monitoring.
The inhibition of prostaglandin synthesis caused by NSAIDs can negatively affect
pregnancy and/or the development of the embryo and fetus. Results of epidemiological studies suggest
an increased risk of abortion and cardiac malformation and gastroschisis (defect of the abdominal wall in which the intestine and sometimes other organs develop outside the abdomen
of the fetus) after the use of a prostaglandin synthesis inhibitor in the early stages of pregnancy.
The absolute risk of cardiac malformations increased from less than 1%, to about 1.5%. It
is believed that the risk increases with the dose and duration of therapy.
Breastfeeding
Do not take GLADIO if you are breastfeeding, to avoid unwanted effects in the infant unless the
potential benefit for the mother outweighs the possible risk to the fetus (see “Do not take
GLADIO”).
Fertility
NSAIDs can impair fertility and use is not recommended in women planning to become
pregnant. The administration of aceclofenac should be discontinued in women who have
fertility problems or are undergoing fertility investigations.
If you take GLADIO in these cases, the dose should be kept as low as possible and the duration
of treatment should be as short as possible.

Driving and operating machinery
The administration of aceclofenac, as occurs with other NSAIDs and in particularly
predisposed patients, may give rise to dizziness, vertigo or other central nervous system disorders.
You must be informed of these possible effects before driving a vehicle or operating
machinery requiring integrity of the degree of alertness.

GLADIO 100 mg powder for oral suspension contains sorbitol.
This medicine contains 2639 mg of sorbitol in each sachet. Sorbitol is a source of
fructose. If your doctor has told you that you are intolerant to some sugars, or if you have a diagnosis of
hereditary fructose intolerance, a rare genetic disease in which patients cannot
transform fructose, talk to your doctor before taking this medicine.

GLADIO 100 mg powder for oral suspension contains aspartame.
This medicine contains 10 mg of aspartame in each sachet. Aspartame is a source of
phenylalanine. It may be harmful if you suffer from phenylketonuria, a rare genetic disease that
causes the accumulation of phenylalanine because the body cannot dispose of it properly.

GLADIO 100 mg powder for oral suspension.
This medicine contains less than 1 mmol of sodium (23 mg) per sachet, that is
essentially "sodium-free".

GLADIO 100 mg coated tablets.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, that is
essentially "sodium-free".

3. How to take GLADIO

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have doubts, consult your doctor or pharmacist.
GLADIO 100 mg coated tablets

Adults
The recommended dose is 2 tablets per day (200 mg per day), 1 tablet every 12 hours.
Swallow the tablets with a sufficient amount of water.
Take the medicine during meals.
GLADIO 100 mg powder for oral suspension
The recommended dose is 2 sachets per day (200 mg per day), 1 sachet every 12 hours.
Dissolve the contents of one sachet in a glass of water (40-60 ml) and swallow
immediately.
Take the medicine during meals.

Elderly
It is not considered necessary to modify the dosage.

Patients with hepatic impairment
In patients with liver problems (hepatic impairment), it is advisable to reduce the initial dose to
100 mg per day.
However, as with other NSAIDs, take GLADIO with caution if you are elderly and have impaired
renal function (if the kidneys do not work well) or hepatic function (if the liver does not work well),
cardiovascular dysfunction (if the heart does not work well) or if you are undergoing simultaneous
other pharmacological treatments.
Adverse effects can be minimized by administering the minimum effective dose for the
minimum duration necessary to control the symptoms (see “Warnings and precautions”).

If you take more GLADIO than you should
In case of accidental ingestion/administration of an excessive dose of GLADIO, inform
your doctor immediately or go to the nearest hospital.
Currently, there is insufficient information available regarding the clinical picture resulting from
overdose with GLADIO.

If you forget to take GLADIO
Do not take a double dose to make up for the missed dose.

If you stop taking GLADIO
If you have any doubts 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.

Stop treatment with GLADIOand contact your doctor immediately if you experience any of the following side effects:

• Gastrointestinal bleeding or a lesion at the level of the stomach or intestine (ulceration).
• Worsening or persistent alteration of tests evaluating liver function, clinical signs or symptoms typical of liver disease.
• Increased number of white blood cells in the blood (eosinophilia).
• Skin rash (sudden redness of the skin), lesions of the mucous membranes or any other sign of allergy.

Possible side effects that may occur following the intake of GLADIO are:

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

• Dizziness (vertigo).
• Increased levels of some liver enzymes.
• Nausea, diarrhea, abdominal pain, dyspepsia (digestive pain).

Uncommon side effects (may affect up to 1 in 100 people)

• Gastritis (inflammation of the stomach), mouth ulcers (aphthae), flatulence (presence of gas in the intestine), constipation, vomiting.
• Urticaria (skin condition), rash (sudden redness of the skin), itching, dermatitis (inflammation of the skin).
• Increased levels of urea and creatinine in the blood.
• Constipation.

Rare side effects (may affect up to 1 in 1,000 people)

• Anemia (reduction in hemoglobin concentration in the blood).
• Angioedema (sudden swelling of the skin or mucous membranes).
• Vision disorders.
• Hypertension (high blood pressure).
• Anaphylactic reaction (rapidly occurring allergic reaction) including shock (decreased blood flow to tissues), allergy.
• Heart failure (inability of the heart to provide an adequate amount of blood for the needs of the entire body).
• Dyspnea (difficulty breathing).
• Melena (emission of blood with feces), ulcer (lesion) and gastrointestinal bleeding (of the stomach and intestine) (peptic ulcers (of the stomach), perforation or gastrointestinal bleeding (bleeding) may occur, sometimes fatal, especially in the elderly - see “Warnings and precautions”).

Very rare side effects (may affect up to 1 in 10,000 people)

• Thrombocytopenia (decrease in the number of platelets in the blood), hemolytic anemia (decrease in hemoglobin concentration in the blood caused by the destruction of red blood cells), granulocytopenia (severe decrease in the number of granulocytes in the blood, a

type of white blood cells), bone marrow depression (decrease in the functionality of the bone marrow that produces blood cells).

• Depression, insomnia, abnormal dreams.
• Paresthesia (altered sensitivity), dysgeusia (altered taste), headache, drowsiness.
• Tinnitus (ringing in the ears), vertigo.
• Palpitations (perception of heartbeat).
• Flushing.
• Vasculitis (inflammation of blood vessels), hot flashes.
• Bronchospasm (decrease in the caliber of the bronchi).
• Worsening of ulcerative colitis or Crohn's disease (inflammatory bowel diseases), stomatitis (inflammation of the oral mucosa), pancreatitis (inflammation of the pancreas), intestinal perforation, hematemesis (emission of blood with vomiting).
• Stevens-Johnson syndrome (acute allergic reaction involving the skin and mucous membranes), toxic epidermal necrolysis (or “Lyell's syndrome”, a serious skin disease induced by an allergy to certain drugs, characterized by the destruction of the epithelium skin and mucous membranes), purpura (lesion similar to a bruise, resulting from the rupture of capillaries under the surface of the skin), exanthema (skin rash).
• Renal failure, nephrotic syndrome (a set of symptoms and clinical signs caused by an alteration of the kidneys that involves the loss of protein in the urine).
• Liver injuries (of the liver) including hepatitis (inflammation of the liver), increased alkaline phosphatase in the blood.
• Edema (fluid accumulation), fatigue.
• Weight gain.

Aceclofenac is similar to diclofenac, for which more studies are available showing an increased risk of thrombotic events (formation of blood clots inside blood vessels that can cause, for example, myocardial infarction or stroke). Studies have also indicated an increased risk of acute coronary syndrome (heart disease) and non-fatal myocardial infarction following the use of aceclofenac (see “Warnings and precautions”).
Exceptionally, severe skin and soft tissue infections have been reported during chickenpox in conjunction with treatment with NSAIDs. To date, it is not possible to exclude the role of NSAIDs in worsening these infections (see “Warnings and precautions”).
If one or more of the side effects described above occur, it is recommended to stop treatment with aceclofenac and contact your doctor.

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 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 GLADIO

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 pack after SCAD. The
expiry date refers to the last day of that month and to the product in intact packaging,
correctly stored.
GLADIO 100 mg coated tablets
Store at a temperature not exceeding 30°C.
GLADIO 100 mg oral suspension powder
No special storage precautions are required.
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 GLADIO contains
GLADIO 100 mg coated tablets
One coated tablet contains:
The active ingredient is aceclofenac 100 mg.
The other ingredients are: microcrystalline cellulose, sodium croscarmellose, glyceryl
palmitostearate, povidone, hypromellose, polyethylene(40) stearate, titanium dioxide.
GLADIO 100 mg oral suspension powder
One sachet contains:
The active ingredient is aceclofenac 100 mg.
The other ingredients are: sorbitol (E420), sodium saccharin, caramel flavour, cream flavour,
milk flavour, anhydrous colloidal silica, aspartame (E951), hypromellose, titanium dioxide.

Description of the appearance of GLADIO and contents of the pack
GLADIO 100 mg coated tablets

• Blisters of 10 coated tablets in a cardboard box.
• Blisters of 40 coated tablets in a cardboard box.

GLADIO 100 mg oral suspension powder
Pack of 30 sachets.

Marketing authorisation holder and manufacturer
ABIOGEN PHARMA S.p.A. – Via Meucci 36 – Ospedaletto - Pisa.

GLADIO 1.5 g/100 g cream

Aceclofenac

Read this leaflet carefully before using this medicine as it contains important
information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms get worse.

Contents of this leaflet:

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

1. What is GLADIO and what is it used for

GLADIO contains the active ingredient aceclofenac which belongs to the category of non-steroidal anti-inflammatory drugs (NSAIDs) and rheumatic drugs (drugs used for diseases affecting bones, cartilage and muscles).
This medicine is indicated in the local treatment of painful and inflammatory (inflammatory) conditions of rheumatic or traumatic nature of the joints, muscles, tendons and ligaments such as tendinitis (inflammation of the tendons), tenosynovitis (inflammation of the membrane covering the tendon), sprains, bruises, periarthritis (inflammatory diseases involving fibrous tissues surrounding a joint), dislocations (displacement of joint surfaces relative to each other), lumbago (back pain), torticollis, bursitis (inflammation of fluid-filled sacs that act as a cushion between bones and tendons and/or muscles surrounding a joint), strains and post-traumatic sequelae.
See your doctor if you do not feel better or if you feel worse.

2. What you need to know before using GLADIO

Do not use GLADIO

• If you are allergic to aceclofenac, to other NSAIDs (including acetylsalicylic acid) or to any of the other components of this medicine (listed in section 6).
• If you have experienced in the past, after taking acetylsalicylic acid, diclofenac or other NSAIDs, a worsening of asthma attacks, acute rhinitis (inflammation of the nasal mucosa) or urticaria (skin redness with intense itching).
• If you have or have had in the past hypersensitivity (allergic) reactions to diclofenac, even if cross-allergenicity with this medicine has not been demonstrated.
• If you are in the last 3 months of pregnancy and during breastfeeding (see “Pregnancy, breastfeeding and fertility”).

GLADIO is contraindicated in pediatric age (see “Children and adolescents”).

Warnings and precautions
Consult your doctor or pharmacist before using GLADIO.
Use GLADIO cream only for external use.
During treatment with GLADIO, you must avoid:

• Inappropriate exposure of the treated area to sunlight without adequate protection to prevent photosensitivity reactions (immune system reaction to sunlight).
• Applying the cream to sores or open wounds.
• Contact with the eyes, mucous membranes or any other site of application with ongoing skin lesions.

Stop treatment with GLADIO and consult your doctor for appropriate therapeutic treatment
if you experience symptoms of local irritation.
Prolonged use of dermatological products can lead to sensitization phenomena
(allergy).
As with other NSAIDs, allergic reactions, including anaphylactic/ anaphylactoid reactions (rapid-onset allergic reactions), may also occur, even without previous
exposure to aceclofenac (see section 4 “Possible side effects”).
Severe skin reactions (at the skin level), some of which are fatal, including exfoliative dermatitis
(skin irritation with scaling), Stevens-Johnson syndrome (severe disease with
lesions at the skin and mucous membranes) and toxic epidermal necrolysis (severe skin disease in
which the epidermis detaches in sheets), have been very rarely reported in association with the use
of NSAIDs (see section 4 “Possible side effects”). The risk appears to be higher in the
early stages of therapy as the reaction occurs in most cases
within the first month of treatment.
Stop taking GLADIO at the first appearance of skin rash, mucosal lesions or
any other sign of hypersensitivity (allergy).
Avoid using GLADIO in case of varicella; in some cases, varicella can cause serious
infectious complications of the skin and soft tissues and it is not possible to exclude the role of NSAIDs
in worsening these infections (see section 4 “Possible side effects”).

Children and adolescents
There is currently no data available regarding the safety and efficacy of aceclofenac in
children up to 14 years of age, therefore its administration is not recommended (see “Do not use GLADIO”).

Other medicines and GLADIO
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Use GLADIO with caution with:

• Lithium (mood stabilizer, used in the treatment of depression and bipolar disorder).
• Digoxin (a medicine that stimulates heart function).
• Oral anticoagulants (medicines that delay blood clotting).
• Diuretics (medicines used to increase urine production).
• Pain relievers (medicines used against pain).

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Oral forms (e.g., tablets) of aceclofenac can cause adverse effects in the unborn child.
It is not known whether the same risk applies to GLADIO.
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine. Do not
use GLADIO if you are in the last 3 months of pregnancy.
You should not use GLADIO during the first 6 months of pregnancy, unless it is strictly
necessary and recommended by your doctor. If treatment is needed during this period,
you should use the lowest dose for the shortest possible time.
Breastfeeding
Do not use GLADIO if you are breastfeeding.
Fertility
The use of GLADIO, like any drug that inhibits the synthesis of prostaglandins and
cyclooxygenase (anti-inflammatory drugs), is not recommended in women who intend to become
pregnant.
The administration of GLADIO should be discontinued in women who have fertility problems
or who are undergoing fertility investigations.

Driving and using machines
GLADIO does not impair the ability to drive vehicles or operate machinery.

GLADIO 1.5 g/100 g cream contains propylparaben and methylparaben.
They can cause allergic reactions (even delayed).

3. How to use GLADIO

Use this medicine following exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1.5 g - 2 g of GLADIO cream, equivalent to 4-5 cm, to be applied three times a day
to the affected area or as prescribed by your doctor.

If you use more GLADIO than you should
Cases of overdose are not known.
If you ingest/accidentally take an excessive dose of Gladio, immediately notify your doctor or go to the nearest hospital.

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

If you stop the treatment with GLADIO
If you have any doubts about using 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.
Possible side effects that may occur after taking GLADIO are:

Common side effects (may affect up to 1 in 10 people)
Mild or moderate skin irritation accompanied by redness and mild itching that
disappears with discontinuation of treatment.

Uncommon side effects (may affect up to 1 in 100 people)

• Photosensitivity (increased sensitivity to light) in case treated skin areas have been exposed to strong sunlight without adequate protection (see “Warnings and precautions”).
• Erythema (skin irritation).
• Pruritus (itching).

Very rare side effects (may affect up to 1 in 10,000 people)
Blistering reactions (including Stevens-Johnson syndrome and toxic epidermal necrolysis).
Exceptionally, severe infectious skin and soft tissue complications have been reported during chickenpox in association with treatment with NSAIDs (see “Warnings and
precautions”).

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 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 GLADIO

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 pack after SCAD. The
expiry date refers to the last day of that month and the product in intact packaging
correctly stored.
Store at a temperature not exceeding 30°C.
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 GLADIO contains
100 g of cream contains:
The active ingredient is aceclofenac 1.5 g.
The other ingredients are: emulsifying wax, liquid paraffin, propylparahydroxybenzoate,
methylparahydroxybenzoate, purified water.

Description of the appearance of GLADIO and contents of the pack
White cream.
Tube containing 50 g of cream.

Marketing authorisation holder and manufacturer
ABIOGEN PHARMA S.p.A. – Via Meucci 36 – Ospedaletto - Pisa.