PIROXICAM 1% Крем

Содержание инструкции

1. PIROXICAM DOC 20 mg/ml injectable solution for intramuscular use
   1. What is PIROXICAM DOC and what is it used for
   2. What you need to know before using PIROXICAM DOC
   3. How to use PIROXICAM DOC
   4. Possible side effects
   5. How to store PIROXICAM DOC
   6. Contents of the pack and other information
2. PIROXICAM DOC 1% Cream
   1. What is PIROXICAM DOC and what is it used for
   2. What you need to know before using PIROXICAM DOC
   3. How to use PIROXICAM DOC
   4. Possible side effects
   5. How to store PIROXICAM DOC
   6. Contents of the pack and other information

PIROXICAM DOC 20 mg/ml injectable solution for intramuscular use

Generic medicine
Read this leaflet carefully before using the 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 to do.
• 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, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not feel better or if your symptoms worsen.

Contents of this leaflet:

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

1. What is PIROXICAM DOC and what is it used for

Before prescribing PIROXICAM DOC, your doctor will assess the benefits of this medicine
compared to the risk of side effects. The doctor may need to review you periodically
and will tell you how often a check-up will be necessary during treatment with PIROXICAM
DOC.
PIROXICAM DOC is an anti-inflammatory and analgesic medicine, which is used to
relieve some symptoms caused by osteoarthritis (osteoarthritis: degenerative joint disease),
rheumatoid arthritis and ankylosing spondylitis (spinal rheumatism), such as swelling,
stiffness and joint pain. PIROXICAM DOC does not cure arthritis and will only give you relief as
long as you continue to take it.
The doctor will prescribe PIROXICAM DOC only when other non-steroidal anti-inflammatory drugs (NSAIDs) will no longer be useful in relieving your symptoms.

2. What you need to know before using PIROXICAM DOC

Do not take PIROXICAM DOC

• if you are allergic to piroxicam or any of the other ingredients of this medicine (listed in section 6)
• if you have previously had an ulcer or bleeding or perforation of the stomach or intestine
• if you have an ulcer or bleeding or perforation of the stomach or intestine
• if you have or have had previous gastrointestinal disorders (inflammation of the stomach or intestine) that predispose to bleeding disorders such as ulcerative colitis, Crohn's disease, gastrointestinal cancer, diverticulitis (inflamed or infected pouches/cavities in the colon)
• if you are taking other NSAIDs, including selective COX-2 inhibitors and acetylsalicylic acid (present in many medicines used to relieve pain and reduce fever). Remember that many NSAIDs are also available over the counter
• if you are taking anticoagulants, such as warfarin, to prevent the formation of blood clots
• if you have previously had a severe allergic reaction to piroxicam, other NSAIDs and other medicines, in particular severe skin reactions (regardless of their intensity), such as erythema multiforme, exfoliative dermatitis (intense redness of the skin, with scaling in flakes or layers), vesiculo-bullous reactions: Stevens-Johnson syndrome, characterized by skin with red blisters, corroded, bleeding or covered with a crust, and necrolytic epidermal detachment, characterized by blisters and peeling of the superficial layer of the skin
• if you have had symptoms of asthma, rhinitis, nasal polyps, angioedema or urticaria during treatment with acetylsalicylic acid or other NSAIDs
• if you are pregnant or if you suspect you may be pregnant
• if you are breastfeeding
• if you are under 18 years of age
• if you suffer from severe liver disease
• if you suffer from severe kidney disease
• if you have moderate or severe heart failure
• if you have severe hypertension
• if you have severe blood disorders
• if you have a bleeding diathesis (a predisposition to bleed frequently).

If any of these conditions apply to you, PIROXICAM DOC should not be prescribed to you. Immediately inform your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking PIROXICAM DOC.
Be careful with PIROXICAM DOC. Like all non-steroidal anti-inflammatory drugs,
PIROXICAM DOC can cause serious reactions to the stomach and intestines such as pain,
bleeding and ulcers.
Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been
reported with the use of piroxicam, these initially appear as round red spots or
circular patches often accompanied by blisters on the central part of the trunk.
Further signs to note include ulcers in the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes
).
These potentially life-threatening skin rashes are often accompanied by flu-like symptoms. The rash may progress with the development of widespread blisters or exfoliation of the skin.
The highest risk of developing serious skin reactions occurs within the first weeks of treatment.
If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of
piroxicam, piroxicam should no longer be reused.
If you develop a rash or skin symptoms, you should immediately stop taking
PIROXICAM DOC, see a doctor immediately and tell them that you are taking this
medicine.
You should immediately stop taking PIROXICAM DOC and contact your doctor if you have
stomach pain or if you experience any signs of bleeding in the stomach or intestine,
such as the elimination of black or blood-stained stools or if you vomit blood.
You should immediately stop using PIROXICAM DOC and contact your doctor in case of
an allergic reaction such as skin rash, facial swelling, wheezing or difficulty in
breathing.
If you are over 70 years of age, your doctor may want to minimize the duration of treatment and
visit you more often when you are being treated with PIROXICAM DOC.
If you are over 70 years of age or if you are taking other medicines such as corticosteroids or some medicines for
treating depression called selective serotonin reuptake inhibitors (SSRIs), or acetylsalicylic acid to prevent the formation of blood clots, your doctor may prescribe you
together with PIROXICAM DOC a medicine to protect your stomach and intestines.
You should not take this medicine if you are over 80 years of age.
If you have or have had any medical condition or any form of allergy or if you are not sure if
you can take PIROXICAM DOC, tell your doctor before taking this medicine.
Tell your doctor if you are taking other medicines, including those available without a prescription.
Medicines such as PIROXICAM DOC may be associated with an increased risk of heart attack (“myocardial infarction”) or stroke. Any risk is more likely with high doses and prolonged treatments. Do not exceed the recommended dose or duration of treatment.
If you have heart problems, or a history of stroke or think you may be at risk for these conditions
(for example if you have high blood pressure, diabetes or high cholesterol or smoke) you should discuss your
therapy with your doctor or pharmacist.
PIROXICAM DOC, like other non-steroidal anti-inflammatory drugs, decreases platelet aggregation
and prolongs clotting time; this possibility should be remembered when performing hematological tests
and requires vigilance when undergoing concomitant treatment with drugs that inhibit
platelet aggregation.
Caution is advised if you have a history of hypertension and/or heart failure because, in association with
therapy with NSAIDs, fluid retention and edema have been reported.
Particular caution is required if you have heart failure, arterial hypertension,
reduced liver or kidney function, renal hypoperfusion, ongoing or previous blood alterations, and if you are in
diuretic therapy.
If you are asthmatic, due to the interaction of the drug with arachidonic acid metabolism, bronchospasm and possibly shock and other allergic phenomena may occur.
As ocular alterations have been detected during therapy with NSAIDs, periodic ophthalmological checks are recommended in case of prolonged treatments.
As with other substances with similar action, increases in azotemia (levels of nitrogen in the
blood) have been observed which do not progress, with continued administration, beyond a certain level. They return to
normal values once therapy is discontinued.
If you are diabetic, it is advisable to undergo frequent blood tests.
Serious allergic reactions (in particular severe skin reactions) have been reported very rarely in
association with the use of NSAIDs (see “Possible side effects”).
If you are planning a pregnancy, if you have fertility problems or if you are undergoing fertility investigations,you should discuss your therapy with your doctor.

Other medicines and PIROXICAM DOC
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines - even those bought without a prescription.
Medicines can sometimes interfere with each other. Your doctor may limit the use of
PIROXICAM DOC or other medicines, or you may need to take a different medicine. It is particularly important to report the following cases:

• if you are taking aspirin or other non-steroidal anti-inflammatory drugs to relieve pain
• if you are taking corticosteroids, medicines used to treat a variety of conditions such as allergies and hormonal imbalances
• if you are taking anticoagulants such as warfarin to prevent the formation of blood clots
• if you are taking some medicines for depression called selective serotonin reuptake inhibitors (SSRIs)
• if you are taking any medicine, such as aspirin, to prevent the formation of blood clots
• if you are taking diuretics, ACE inhibitors and angiotensin II antagonists - used in case of high blood pressure and heart disease
• if you are taking lithium - used to treat depression
• if you are taking quinolone antibacterial agents, used to treat bacterial infections
• if you are using intrauterine devices.

If any of these conditions apply to you, inform your doctor immediately.

PIROXICAM DOC with food, drinks and alcohol
It is advisable not to drink alcohol during treatment with PIROXICAM DOC.

Pregnancy, breastfeeding and fertility
Ask your doctor or pharmacist for advice before taking this medicine.

• If you have fertility problems or if you are undergoing fertility investigations, tell your doctor, asPIROXICAM DOC may not be suitable for you.
• Do not take PIROXICAM DOC if you are pregnant, as it may harm the fetus or cause problems during childbirth. NSAIDs can cause problems with the kidneys and heart of the fetus. They may affect the mother's and baby's tendency to bleed and delay or prolong labor more than expected. From the 20th week of pregnancy, NSAIDs can cause kidney problems in the fetus, reducing the levels of amniotic fluid surrounding the baby (oligohydramnios) or causing the constriction of a blood vessel (ductus arteriosus) in the baby's heart.
• If you are breastfeeding, you should not take PIROXICAM DOC. Ask your doctor for advice: it may be better to stop breastfeeding.

Driving and using machines
If you feel dizzy or unusually tired, be particularly careful when driving or using
machinery.

PIROXICAM DOC contains propylene glycol.
This medicine contains 400 mg of propylene glycol per vial.

PIROXICAM DOC contains ethyl alcohol.
This medicine contains 100 mg of alcohol (ethanol) per vial. The amount in a vial of this
medicine is equivalent to 1 ml of wine or less than 3 ml of beer.
The small amount of alcohol in this medicine will not produce any significant effects.

PIROXICAM DOC contains benzyl alcohol.
This medicine contains 20 mg of benzyl alcohol per vial.
Benzyl alcohol can cause allergic reactions.
Ask your doctor or pharmacist if you are pregnant or breastfeeding. This is because large
amounts of benzyl alcohol can accumulate in the body and cause adverse effects (such as metabolic acidosis).
Ask your doctor or pharmacist if you have liver or kidney problems. This is because
large amounts of benzyl alcohol can accumulate in the body and cause adverse effects (such as
metabolic acidosis).

PIROXICAM DOC contains sodium.
This medicine contains less than 1 mmol (23mg) of sodium per vial, i.e. it is essentially ‘sodium-free’.

3. How to use PIROXICAM DOC

Take this medicine following the instructions of your doctor or pharmacist exactly. If you have any
doubts, consult your doctor or pharmacist.
Your doctor will check you regularly to make sure you are taking the optimal dose of
PIROXICAM DOC. Your doctor will adjust the treatment to the minimum dose that best controls your
symptoms. Under no circumstances should you change the dose without first informing your doctor.

Adults and the elderly:
The maximum daily dose of PIROXICAM DOC is 20 milligrams to be taken as a single
daily dose.
If you are over 70 years old, your doctor may prescribe a lower daily dose and reduce the duration
of treatment.
Your doctor may prescribe PIROXICAM DOC together with another medicine to protect the
stomach and intestines from possible side effects.

Do not increase the doseif you feel that the medicine is not very effective, always talk to your
doctor.

If you forget to take PIROXICAM DOC
Take the medicine as soon as you remember. If it is almost time to take the next dose, do not take the
forgotten dose, but take the next dose at the right time. Do not take a double dose.
If you take more PIROXICAM DOC than you should
Symptoms: the most indicative symptoms of overdose are headache, vomiting, drowsiness, dizziness and syncope.
In case of accidental intake of an excessive dose of PIROXICAM DOC, immediately inform
your doctor or go to the nearest hospital.

If you have any further questions about the use of this product, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking PIROXICAM DOC immediately and contact your doctor:

• if you develop blisters, redness or peeling skin (skin rash), an ulceration in any part of the body (for example skin, mouth, eyes, lips or tongue), or any other sign of an allergic reaction such as skin rash, swelling of the face, lips or tongue which may cause difficulty in breathing or wheezing
• if the skin or whites of the eyes become yellow (jaundice)
• if you experience signs of bleeding in the stomach or intestine, such as passing black or tarry stools or vomiting blood.

Below are listed all the side effects related to PIROXICAM DOC.

More common side effects

• Ulcers of the digestive tract and gastrointestinal bleeding
• Nausea, vomiting, diarrhea, flatulence, constipation, heartburn, abdominal pain, ulcerative stomatitis, inflammatory bowel diseases (colitis and Crohn's disease)
• Swelling of ankles, legs and feet (fluid retention)
• Increased blood pressure
• Heart failure (difficulty breathing and fatigue)

Less common side effects

• Heart attack (myocardial infarction)
• Stroke
• Anorexia
• Fatigue
• Anemia
• Blisters, redness or peeling skin (skin rash) or ulceration in any part of the body (for example skin, mouth, eyes, lips or tongue), or any other sign of allergic reactions such as rash, swelling of the face, lips, tongue, wheezing
• Yellowing of the skin and eyes (jaundice)
• Increased normal liver function values
• Pancreatitis
• Acute kidney failure, blood in the urine, difficulty urinating
• Increased non-protein nitrogen in the blood (increased azotemia)
• Swelling of ankles, legs and feet (fluid retention)
• Increased blood pressure (hypertension)
• Nosebleeds
• Headache
• Drowsiness
• Hearing loss or ringing in the ears
• Dizziness
• Vision disorders
• Malaise
• Alterations of the blood and lymphatic system
• Gastritis

Rare side effects

• Appearance of bruises
• Alteration of blood sugar values (hypo- and hyperglycemia)
• Sweating
• Change in body weight
• Insomnia
• Depression
• Swelling, blisters or peeling of the skin
• Photosensitivity
• Dry mouth
• Irritability
• Alterations of bladder function
• Shock
• Alopecia
• Nail growth alterations
• Fatal hepatitis

Very rare side effects

• Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported (see section 2).

Side effects with unknown frequency

• Fixed drug eruption (may appear as round or oval patches of redness and swelling of the skin), blisters (urticaria), itching.

If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet,

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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 PIROXICAM DOC

Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the package and on the inner label.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What PIROXICAM DOC contains

• The active ingredient is piroxicam. Each 1 ml vial contains 20 mg of piroxicam.
• The other excipients are: propylene glycol, 95% ethyl alcohol, benzyl alcohol, nicotinamide, sodium hydroxide, concentrated hydrochloric acid, monosodium phosphate, water for injectable preparations.

Description of the appearance of PIROXICAM DOC and contents of the pack
The injectable solution for intramuscular use is contained in amber glass vials.
Each pack contains 6 vials of 1 ml.

Marketing Authorisation Holder
DOC Generici S.r.l. - Via Turati 40 - 20121 Milan - Italy.

Manufacturer and Final Control
Esseti Farmaceutici S.r.l. - Via Campobello 15 – 00071 Pomezia (Rome) – Italy.

PIROXICAM DOC 1% Cream

Equivalent medicine

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 to do.
• 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 effects 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 worsen.

Contents of this leaflet:

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

1. What is PIROXICAM DOC and what is it used for

PIROXICAM DOC contains the active ingredient piroxicam which belongs to a group of medicines
called non-steroidal anti-inflammatory drugs used locally (cutaneous use) for muscle and
joint pain.
PIROXICAM DOC is indicated for rheumatic, inflammatory, traumatic pain
affecting joints, muscles, tendons and ligaments (for example, inflammation of the limbs,
periarthritis, osteoarthritis with varying localization in the acute phase, synovitis, tendinitis, tenosynovitis,
bursitis, contusions, sprains, strains, sequelae of dislocations, myalgia, brachialgia, lumbago,
cervicalgia).
See your doctor if you do not feel better or if you feel worse.

2. What you need to know before using PIROXICAM DOC

Do not use PIROXICAM DOC

• if you are allergic to piroxicam or any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant or breastfeeding (see “Pregnancy and breastfeeding”).

If you develop a rash or skin symptoms, you should immediately stop taking
PIROXICAM DOC, immediately see a doctor and tell them that you are taking this
medicine.

Warnings and precautions
Talk to your doctor or pharmacist before using PIROXICAM DOC.

Other medicines and PIROXICAM DOC
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
No interactions between PIROXICAM DOC and other medicines have been reported. If you are taking other
medicines your doctor will need to monitor you.

Pregnancy and breastfeeding
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 using this medicine.
Do not use PIROXICAM DOC if you are pregnant or breastfeeding as it could
be dangerous (see “Do not use PIROXICAM DOC”).

Driving and operating machinery
PIROXICAM DOC does not impair the ability to drive vehicles and operate machinery.

PIROXICAM DOC contains propylene glycol
This medicine contains 7 g of propylene glycol per 100 g. It may cause skin irritation.
Because this medicine contains propylene glycol, do not use it on open wounds or large areas of damaged skin
(such as burns) without talking to your doctor or pharmacist.

PIROXICAM DOC contains cetostearyl alcohol
This medicine contains cetostearyl alcohol which may cause localized skin reactions (e.g.
contact dermatitis).

PIROXICAM DOC contains allergens
This medicine contains a flavouring which in turn contains the allergens coumarin, 3-Methyl-4-
(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one, linalool, benzyl benzoate, citronellol.
These allergens may cause allergic reactions.

3. How to use PIROXICAM DOC

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.
Apply 2 or 3 centimeters of cream to the painful area, massaging slowly until completely
absorbed. Repeat the operation 2-3 or more times a day.

If you use more PIROXICAM DOC than you should
No cases of overdose are known.
In case of ingestion/accidental intake of PIROXICAM DOC, immediately inform your
doctor or go to the nearest hospital.
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.
Reactions of sensitization or local irritation may occur, especially if you have
used this medicine for a prolonged period. In this case, stop treatment and consult your
doctor, who will indicate appropriate therapy.
Frequency not known: fixed drug eruption (may manifest as round or
oval patches of redness and swelling of the skin), blisters (urticaria), itching.

Reporting of side effects
If you get any side effects, even if 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 PIROXICAM DOC

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.
Do not dispose of any medicine in the 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 PIROXICAM DOC contains

• The active ingredient is piroxicam. 100 g of cream contains 1 g of piroxicam.
• The other ingredients are: polyethylene glycol 1000 monoethyl ether, propylene glycol, cetostearyl alcohol, phenyl ethyl alcohol, hypoallergenic fragrance, polyglycol esters of fatty acids, purified water.

Description of the appearance of PIROXICAM DOC and contents of the pack
PIROXICAM DOC is a cream contained in a tube of 50 g.

Marketing Authorisation Holder
DOC Generici S.r.l. - Via Turati 40 – 20121 Milano – Italy.

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