FELDENE GEL

Feldene gel PIL CC 251020

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Patient leaflet in accordance with the Pharmacists' Regulations (Preparations) - 1986

This medicine is dispensed without a doctor's prescription

Feldene Gel

®

Piroxicam 0.5% (5 mg/g)

Inactive ingredients and allergens: See section 2 under "Important information about some of this medicine’s

ingredients" and section 6 “Further information”.

Read the entire leaflet carefully before using this medicine. This leaflet contains concise information

about this medicine. If you have any further questions, consult your doctor or pharmacist.

Use the medicine according to the instructions in the dosing section of this leaflet. Consult your

pharmacist if you need further information. Contact your doctor if your symptoms of illness get worse or

do not improve after 4 weeks.

1.

WHAT IS THIS MEDICINE INTENDED FOR?

For application on the skin, to relieve conditions characterized by pain and inflammation, e.g., relieving

pain and reducing swelling affecting joints and muscles.

Therapeutic group:

Nonsteroidal anti-inflammatory drugs (NSAIDs)

2.

BEFORE

USING

THIS

MEDICINE

Do not use this medicine if:

Do not use the medicine without consulting a doctor before starting treatment:

If you suffer, or have suffered in the past, from impaired liver or kidney function.

Special warnings regarding use of the medicine

Use of this medicine has been reported to be associated with skin reactions that may be life-threatening (e.g.,

Stevens-Johnson syndrome and toxic epidermal necrolysis). The skin rash on the body may first appear as

red, focal spots or round patches with blisters in the middle. Additional signs to examine include ulcers in the

mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes). These life-threatening skin reactions

are usually accompanied by flue-like symptoms. The rash may spread as blisters or skin peeling. The highest

risk of the occurrence of skin reactions is in the first week of treatment.

If you developed a serious skin reaction after using piroxicam in the past, do not use it again.

In the event of symptoms of a rash or these serious skin reactions, seek immediate advice from a doctor and

tell him that you are using Feldene Gel

Nonsteroidal anti-inflammatory preparations, including Feldene Gel

, may cause kidney damage or kidney

failure.

Children and adolescents

Feldene Gel

is not intended for treating children below the age of 12 years.

Drug interactions

No drug interactions between Feldene Gel

®

and other medicines are known.

If you are taking or have recently taken, other medicines, including nonprescription medicines and

dietary supplements, tell your doctor or pharmacist.

Pregnancy, breastfeeding, and fertility

If you are trying to become pregnant or are undergoing fertility tests, cessation of treatment with this preparation

should be considered. Feldene Gel

may increase the risk of miscarriages in the early stages

of pregnancy.

If you are pregnant, are planning to become pregnant, or if you are breastfeeding, consult a doctor before

starting treatment.

you are sensitive (allergic) to the active ingredient or to any of the other ingredients contained in the

medicine (see section 6).

you are sensitive (allergic) to aspirin preparations or to other anti-inflammatory preparations or if these

preparations caused side effects such as difficulty breathing, nasal polyps, skin irritation and

inflammation.

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Driving and using machines

Use of Feldene Gel

is not expected to affect your ability to drive or use machines.

Important information about some of this medicine’s ingredients

Feldene Gel

®

contains propylene glycol and benzyl alcohol

Feldene Gel

contains 200 mg/g propylene glycol, which may cause skin irritation. Since this medicine contains

propylene glycol, do not use it on open wounds or large areas of broken or damaged skin (such as burns)

without checking with your doctor or pharmacist.

Feldene Gel

contains 10mg/g benzyl alcohol, which may cause mild local irritation.

Benzyl alcohol may cause allergic reactions.

3.

HOW TO USE THIS MEDICINE?

Always use this preparation according to your doctor's or pharmacist's instructions.

Check with the doctor or pharmacist if you are uncertain and need further information.

Attention: Do not swallow!

Feldene Gel

®

is intended for external use only, for application on the skin.

Pierce the tube by reversing the cap and screwing down to break the seal on the tube.

The usual dosage, unless instructed otherwise by the doctor:

Apply 1 gram (approximately 3 cm) of the gel on the affected area 3-4 times a day.

If there is no improvement in the symptoms, inform the doctor.

Instructions for use:

Apply the gel and rub it in until absorbed into the skin. If the gel is not fully absorbed, mild temporary staining of

the skin and staining of the clothing may occur. Do not use this preparation for a period exceeding four weeks

without informing the pharmacist or doctor.

Do not apply near the eyes, nose, mouth, genitals or rectum, on mucous tissues or in places where the skin is

damaged, for example: wounds, scratches, infections or dermatitis. If the preparation comes into contact with

these areas, wash the area thoroughly with water.

Do not cover/bandage the area treated with Feldene Gel

After using the preparation: Recap the tube and wash your hands.

Do not exceed the recommended dose.

If you used an excessive amount (too high a dosage) or if the medicine was accidentally swallowed

It is unlikely that use of an excessive amount of the preparation will cause side effects.

If someone accidentally swallowed some of the medicine, immediately contact a doctor or proceed to a hospital

emergency room and bring the package of the medicine with you.

If you forgot to use the medicine at the scheduled time, use it as soon as you remember, unless it is time for

the next application. Never use a double amount!

If you stop using this medicine, the pain may return.

Do not take medicines in the dark! Check the label and dose each time you take medicine. Wear glasses

if you need them.

If you have any further questions about using this medicine, consult your doctor or pharmacist.

4.

SIDE EFFECTS

As with any medicine, use of Feldene Gel

may cause side effects in some users. Do not be alarmed by this list

of side effects; you may not experience any of them.

Stop taking this medicine and contact a doctor immediately if you experience any of the following

effects:

Sudden wheezing, breathing difficulties, fever, swelling of the eyelids, face or lips, widespread rash or itching on

the entire body.

These effects are rare, but they may be serious.

Severe skin reaction that may be life-threatening and is characterized by a skin rash, sometimes accompanied

by blisters and sores (e.g., Stevens-Johnson syndrome and toxic epidermal necrolysis) – very rare.

Additional side effects:

Redness, rash and/or local itching at the application site (e.g., eczema, contact dermatitis), skin reaction upon

exposure to sunlight.

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Additional side effects that occur infrequently:

Nausea, digestive system discomfort and disturbances.

These effects should resolve upon discontinuing use of the preparation. If the digestive system disturbances

continue after discontinuing use of the preparation, consult your doctor or pharmacist.

If you experience any side effect, if any side effect gets worse, or if you experience a side effect not

mentioned in this leaflet, consult your doctor.

You can report side effects to the Ministry of Health by following the link ‘Reporting Side Effects of Drug

Treatment' on the Ministry of Health home page (www.health.gov.il) which links to an online form for reporting

side effects or by using the link: https://sideeffects.health.gov.il

5.

HOW TO STORE THE MEDICINE?

Prevent poisoning! This and any other medicine should be kept in a closed place, out of the reach

and sight of children and/or infants to avoid poisoning. Do not induce vomiting unless explicitly

instructed to do so by a doctor.

Do not use the medicine after the expiry date (exp. date) which is stated on the package. The expiry

date refers to the last day of that month.

Store below 25°C.

The preparation should be used within 6 months after first opening, and in any event no later than the

expiry date.

6.

FURTHER INFORMATION

In addition to the active ingredient, this medicine also contains:

Purified water, ethanol 96%, propylene glycol, diisopropanol amine, benzyl alcohol, carbopol 980, hydroxyethyl

cellulose.

What the medicine looks like and contents of the pack:

A clear, slightly yellowish gel with a characteristic alcohol scent.

Each Feldene Gel

tube contains 25, 50 or 100 gram of gel.

Not all pack sizes may be marketed.

Registration holder and address: Pfizer PFE Pharmaceuticals Israel Ltd., 9 Shenkar St., Herzliya

Pituach 46725.

Manufacturer’s name and address: Farmasierra, Madrid, Spain.

Registration number of the medicine in the National Drug Registry of the Ministry of Health:

Feldene Gel

: 113.55.26646

Revised in 10/2020.

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SUMMARY OF PRODUCT CHARACTERISTICS

NAME OF THE MEDICINAL PRODUCT

FELDENE GEL

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each gram contains 5mg piroxicam (0.5% w/w).

Excipient with known effect:

Propylene glycol 200mg/g

Benzyl alcohol 10 mg/g

For the full list of excipients, see section 6.1.

PHARMACEUTICAL FORM

Gel for topical application.

CLINICAL PARTICULARS

Therapeutic indications

Feldene

indicated

variety

conditions

characterized

pain

inflammation such as osteoarthritis of superficial joints, acute musculoskeletal injuries,

periarthritis, tendinitis and tenosynovitis.

Posology and method of administration

Posology

Adults

No occlusive dressings should be employed. Apply 1g of Gel, corresponding to 5mg of

piroxicam, and rub into the affected site three to four times daily leaving no residual

material on the skin. Therapy should be reviewed after 4 weeks.

Paediatric population

Dosage recommendations and indications for the use of Feldene Gel in children have not

been established.

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Elderly

No special precautions are required.

Method of administration

Feldene Gel is for external use only.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

potential

exists

cross

sensitivity

aspirin

other

non-steroidal

anti-

inflammatory agents

(NSAIDs)

. Feldene Gel should not be given to patients in whom

aspirin and other non-steroidal anti-inflammatory agents induce the symptoms of asthma,

nasal polyps, angioneurotic oedema or urticaria.

Special warnings and precautions for use

Life-threatening cutaneous reactions (Stevens-Johnson syndrome (SJS) and toxic epidermal

necrolysis (TEN)) have been reported with the systemic administration of piroxicam.

These reactions have not been associated with topical piroxicam, but the possibility of

occurring with topical piroxicam cannot be excluded.

Patients should be advised of the signs and symptoms and monitored closely for skin

reactions. The highest risk for occurrence of SJS or TEN is within the first week of

treatment.

If signs or symptoms of SJS or TEN (e.g. progressive skin rash often with blisters or

mucosal lesions) are present, piroxicam treatment should be discontinued.

The best results in managing SJS and TEN come from early diagnosis and immediate

discontinuation of any suspect drug. Early withdrawal is associated with a better prognosis.

If the patient has developed SJS or TEN with the use of piroxicam, piroxicam must not be

re-started in this patient at any time.

Keep away from the eyes and mucosal surfaces. Do not apply to any sites affected by open

skin lesions, dermatoses or infection.

NSAIDs, including piroxicam, may cause interstitial nephritis, nephrotic syndrome and

renal failure. There have also been reports of interstitial nephritis, nephrotic syndrome

and renal failure with topical piroxicam, although the causal relationship to treatment

with topical piroxicam has not been established. As a result, the possibility that these

events may be related to the use of topical piroxicam cannot be ruled out.

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This medicinal product contains propylene glycol and may cause skin irritation. If local irritation

develops, the use of the Feldene Gel should be discontinued and appropriate therapy instituted as

necessary. Because this medicine contains propylene glycol, Feldene Gel should not be used on

open wounds or large areas of broken or damaged skin (such as burns).

This medicinal product contains benzyl alcohol which may cause mild local irritation.

Benzyl alcohol may cause allergic reactions.

Interaction with other medicinal products and other forms of interaction

None known.

Fertility, pregnancy and lactation

Fertility:

Based on the mechanism of action, the use of NSAIDs, including piroxicam

may delay or prevent rupture of ovarian follicles, which has been associated with

reversible infertility in some women. In women who have difficulties conceiving or who

are undergoing investigation of infertility, withdrawal of NSAIDs, including topical

piroxicam should be considered.

Pregnancy:

There are no studies of the use of topical piroxicam in pregnant women. Studies in animals have

shown reproductive toxicity with the systemic formulations (see section 5.3), but their relevance

to the use of topical formulations in pregnant women is unknown. As a precautionary measure, it

is preferable to avoid the use of topical piroxicam in pregnant women.

Inhibition

prostaglandin

synthesis

might

adversely

affect

pregnancy.

Data

from

epidemiological studies suggest an increased risk of spontaneous abortion after the use of

prostaglandin synthesis inhibitors in early pregnancy.

In animals, administration of

prostaglandin synthesis inhibitors has been shown to result in increased pre- and post-

implantation loss.

Therefore, the use of Feldene Gel during pregnancy is not recommended.

Breast-feeding

Feldene Gel is not recommended for use in nursing mothers as clinical safety has not been

established.

Effects on ability to drive and use machines.

Not relevant.

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Undesirable effects

Feldene Gel is well tolerated. Mild to moderate local irritation, erythema, pruritus and

dermatitis may occur at the application site.

The systemic absorption of Feldene Gel is very low. In common with other topical non-

steroidal

anti-inflammatory

agents,

systemic

reactions

occur

infrequently

have

included minor gastro-intestinal side-effects such as nausea and dyspepsia. Cases of

abdominal pain and gastritis have been reported rarely. There have been isolated reports of

bronchospasm and dyspnoea (see also section 4.3).

Severe cutaneous adverse reactions (SCARs): Stevens-Johnson syndrome (SJS) and toxic

epidermal necrolysis (TEN) have been reported very rarely (see section 4.4).

Contact dermatitis, eczema and photosensitivity skin reaction have also been observed

from post-marketing experience.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is

important. It allows continued monitoring of the benefit/risk balance of the medicinal

product. Any suspected adverse events should be reported to the Ministry of Health

according

National

Regulation

using

online

form

http://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectM

edic@moh.gov.il

Overdose

Overdosage is unlikely to occur with this topical preparation.

PHARMACOLOGICAL PROPERTIES

Pharmacodynamic properties

Pharmacotherapeutic group: M02AA07

Piroxicam

non-steroidal

anti-inflammatory

agent

useful

treatment

inflammatory conditions. Although the mode of action for this agent is not precisely

understood, piroxicam inhibits prostaglandin synthesis and release through a reversible

inhibition

cyclo-oxygenase

enzyme.

data

presented

anti-

inflammatory and analgesic effects of Feldene Gel compared with its vehicle and

indometacin 1% Gel in rats and guinea pigs. Using established animal models of pain

and inflammation, Feldene Gel was as effective as oral Feldene and indometacin 1% Gel

and significantly more effective than its vehicle.

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Pharmacokinetic properties

On the basis of various pharmacokinetic and tissue distribution studies in animals, with

piroxicam gel 0.5%, the highest concentrations of piroxicam were achieved in the tissues

below the site of application with low concentrations being reached in the plasma.

Piroxicam gel 0.5% was continuously and gradually released from the skin to underlying

tissues, equilibrium between skin, and muscle or synovial fluid appeared to be reached

rapidly, within a few hours of application.

From a pharmacokinetic study in man, 2g of the Gel was applied to the shoulders of normal

volunteers twice daily (corresponding to 20mg piroxicam/day) for 14 days, plasma levels

of piroxicam rose slowly, reaching steady state after about 11 days. The plasma levels at

this time were between 300-400 ng/ml, or one-twentieth of those observed in subjects

receiving 20mg orally

The serum half-life of piroxicam is approximately 50 hours.

Preclinical safety data

In reproductive toxicity studies, piroxicam increases the incidence of dystocia and

delayed parturition in animals, when drug administration is continued during pregnancy.

Administration of prostaglandin synthesis inhibitors has also been shown to result in

increased pre- and post-implantation loss. These observations were made using parenteral

dosing, and as noted in section 5.2, equilibrium plasma levels of piroxicam obtained in

patients using the topical gel are only approximately 5% of those achieved using an

equivalent dose of parenteral product.

In animal studies with the topical gel, there were no treatment- related adverse effects

using 1 gram of gel daily for up to 30 days, nor was there evidence of photo-allergy or

skin sensitisation.

PHARMACEUTICAL PARTICULARS

List of excipients

Purified Water, Ethanol 96%, Propylene Glycol, Diisopropanol Amine, Benzyl Alcohol,

Carbopol 980, Hydroxyethyl Cellulose..

Incompatibilities

Not applicable.

Shelf life

The expiry date of the product is indicated on the packaging materials

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Special precautions for storage

Store below 25

After first opening the preparation can be used within 6 months, no later than the

expiration date.

Nature and contents of container

Aluminium tube containing 25g, 50g or 100g of Feldene Gel.

Special precautions for disposal and other

handling

No special requirements.

7. Manufacturer:

Farmasierra manufacturing S.L, Spain

License holder:

Pfizer PFE Pharmaceuticals Israel Ltd.

9 Shenkar St ,Hertzliya Pituach 46725.

9.

LICENSE NUMBER

113-55-26646

Revised on July 2020