Active ingredients: Diclofenac (diclofenac diethylammonium)
Voltaren Emulgel 1% gel
The package inserts of Voltaren emulgel are available for pack sizes:- Voltaren Emulgel 1% gel
- Voltaren Emulgel 2% gel
Why is Voltaren emulgel used? What is it for?
Voltaren Emulgel contains the active ingredient diclofenac diethylammonium. Diclofenac belongs to the class of non-steroidal anti-inflammatory drugs (NSAIDs) and is used to reduce pain and inflammation.
Voltaren Emulgel is indicated for the local treatment of painful and inflammatory conditions of a rheumatic or traumatic nature affecting:
- joints, eg. osteoarthritis and arthritis
- muscles, eg. contractures or injuries
- tendons and ligaments, eg. tendinitis
Talk to your doctor if you don't feel better or if you feel worse after 7 days.
Contraindications When Voltaren emulgel should not be used
Do not use Voltaren Emulgel
- if you are allergic to diclofenac diethylammonium or any of the other ingredients of this medicine (listed in section 6)
- if you have ever had attacks of asthma, hives or acute inflammation of the nose (rhinitis) after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs)
- if you are in the third trimester of pregnancy (see section "Pregnancy and breastfeeding")
- if the patient is a child or adolescent under 14 years of age.
Precautions for use What you need to know before taking Voltaren emulgel
Talk to your doctor or pharmacist before using Voltaren Emulgel.
Pay particular attention:
- do not ingest Voltaren Emulgel;
- do not apply Voltaren Emulgel to injured, diseased skin or skin with open wounds;
- prevent Voltaren Emulgel from coming into contact with the eyes or mucous membranes such as the mouth or vagina. If this happens, wash the area immediately with running water and contact your doctor;
- do not use Voltaren Emulgel with an occlusive bandage ie covering the diseased area with a plastic film that does not allow air to pass. You can instead use Voltaren Emulgel with a gauze that allows air to pass;
- if you get a rash on your skin, stop taking Voltaren Emulgel;
- if you use diclofenac on large areas of skin and for long periods of time, you may experience side effects that affect the whole body.
Children and adolescents
Voltaren Emulgel should not be used in children and adolescents under 14 years of age.
Interactions Which drugs or foods can modify the effect of Voltaren emulgel
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including those obtained without a prescription.
Voltaren Emulgel is unlikely to interact with other medicines.
Warnings It is important to know that:
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Diclofenac should not be used during the first and second trimester of pregnancy unless clearly needed.
If you want to get pregnant or are in the first or second trimester of pregnancy and need to use diclofenac, take the lowest dose of diclofenac for the shortest possible time.
Diclofenac should not be used during the third trimester of pregnancy as it can cause harm to the baby and mother if taken during this time.
Feeding time
Diclofenac passes into breast milk in small amounts. You should not use Voltaren Emulgel while breastfeeding unless you have first consulted your doctor.
If you are breastfeeding, do not apply Voltaren Emulgel to breasts, large areas of skin and for long periods of time.
Driving and using machines
Voltaren Emulgel does not affect the ability to drive or use machines.
Voltaren Emulgel contains propylene glycol and benzyl benzoate.
Voltaren Emulgel contains propylene glycol which can cause skin irritation.
Voltaren Emulgel contains benzyl benzoate which may be mildly irritating to the skin, eyes and mucous membranes.
Dose, Method and Time of Administration How to use Voltaren emulgel: Posology
Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Use in adults
Apply Voltaren Emulgel 3 or 4 times a day to the area to be treated and rub lightly. The amount of medicine to use depends on the extent of the area to be treated (variable amount between a cherry and a walnut).
Wash your hands after applying Voltaren Emulgel to avoid the action of the medicine also on the hands.
Only use Voltaren Emulgel for short periods of time.
Use in adolescents between 14 and 18 years of age
Apply Voltaren Emulgel 3 or 4 times a day to the area to be treated and rub lightly. The amount of medicine to use depends on the extent of the area to be treated (variable amount between a cherry and a walnut).
Consult your doctor if the disease does not clear up within 7 days of starting treatment with Voltaren Emulgel or if you notice a worsening of your symptoms.
Use in children under 14 years of age
Voltaren Emulgel should not be used in children under 14 years of age.
Use in elderly patients (over 65 years of age)
Elderly patients can use the doses provided for adults.
How to use Voltaren Emulgel
60g, 100g and 120g tube
To remove the seal on first use:
- unscrew and remove the cap
- use the back of the cap to remove the seal from the tube
50g pressurized container
- To release the gel, press the dispenser long enough to release the required amount of gel.
- Apply the gel directly or with a sterile cotton gauze.
- Always wash your hands after applying the gel.
If you forget to use Voltaren Emulgel
Do not use a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Overdose What to do if you have taken too much Voltaren emulgel
In case of accidental ingestion or use of an excessive dose of Voltaren Emulgel, notify your doctor immediately or go to the nearest hospital.
After application to the skin, the amount of diclofenac reaching the blood is very low so it is unlikely that you will experience effects from using an overdose.
If you accidentally ingest the contents of a tube of Voltaren Emulgel you may experience side effects similar to those seen after ingesting an overdose of diclofenac tablets.
Side Effects What are the side effects of Voltaren emulgel
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common side effects (may affect up to 1 in 10 people)
- various reactions on the skin characterized by rash, skin irritation, redness, itching and swelling (dermatitis, eczema).
Rare side effects (may affect up to 1 in 1,000 people)
- inflammation of the skin with blistering (bullous dermatitis)
Very rare side effects (may affect up to 1 in 10,000 people)
- allergic reactions including hives
- swelling of the skin, tissues and mucous membranes (angioedema)
- rash on the skin with the appearance of pustules
- asthma
- appearance of spots or redness on the skin following exposure to sunlight or sunlamps.
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 via the national reporting system at http://www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated in the pack after Expiry. The expiry date refers to the last day of that month.
60g, 100g, 120g tube and 2 60g tubes.
Store below 30 ° C. The medicine can be used for 3 years after first opening.
50g pressurized container
Store below 30 ° C. The medicine can be used for 1 year after first opening.
Mark the date you first opened the container in the space provided on the package.
Store this medicine away from light. It must not pierce and burn the container, even after use.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Deadline "> Other information
What Voltaren Emulgel contains
- The active ingredient is diclofenac diethylammonium. 100 g of gel contain 1.16 g of diclofenac diethylammonium (equal to 1 g of diclofenac sodium).
- The other ingredients are diethylamine, carbomers, macrogol cetostearyl ether, cocoyl caprylocaprate, isopropyl alcohol, liquid paraffin, Cream 45 perfume (contains benzyl benzoate), propylene glycol, purified water.
What Voltaren Emulgel looks like and contents of the pack
Voltaren Emulgel is a creamy, homogeneous, soft, white or almost white gel to be used on the skin.
60g, 100g, 120g tube and 2 60g tubes
Each pack contains one 60g or 100g or 120g tube or 2 60g tubes of 1% gel.
50g pressurized container
Each pack contains a pressurized container of 50 g of 1% gel.
Not all pack sizes may be marketed.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT -
VOLTAREN EMULGEL 1% GEL
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -
100 g of Voltaren Emulgel 1% gel contain 1.16 g of diclofenac diethylammonium, equivalent to 1 g of diclofenac sodium.
Excipients with known effects: propylene glycol, benzyl benzoate.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM -
Gel with a creamy, homogeneous, soft, white or almost white appearance.
04.0 CLINICAL INFORMATION -
04.1 Therapeutic indications -
Local treatment of painful and inflammatory conditions of a rheumatic or traumatic nature of the joints (such as osteoarthritis and arthritis), muscles (such as contractures or injuries), tendons and ligaments (such as tendinitis).
04.2 Posology and method of administration -
Adults over 18 years:
To apply Voltaren Emulgel 1% gel 3 or 4 times a day on the area to be treated, rubbing lightly. The amount to be applied depends on the size of the affected part. For example 2-4 g of Voltaren Emulgel 1% gel (quantity of variable dimensions between a cherry and a walnut) are sufficient to treat an area of 400-800 cm². After application, wash your hands, otherwise they will also be treated with the gel.
Attention use only for short periods of treatment
Teenagers aged 14 to 18
Apply Voltaren Emulgel 1% gel 3 or 4 times a day on the area to be treated, rubbing lightly.The amount to be applied depends on the size of the affected part. For example 2-4 g of Voltaren Emulgel 1% gel (quantity of variable dimensions between a cherry and a walnut) are sufficient to treat an area of 400-800 cm². After application, wash your hands, otherwise they will also be treated with the gel.
If this product is needed for more than 7 days to relieve pain or if symptoms worsen, consult a doctor.
Children under 14:
Insufficient data are available on efficacy and safety in children and adolescents below 14 years (see also section 4.3 Contraindications).
Therefore, the use of Voltaren Emulgel 1% gel it is contraindicated in children under six to 14 years of age.
Elderly (over 65):
The usual adult dosage can be used.
04.3 Contraindications -
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Patients who have experienced asthma attacks, urticaria or acute rhinitis after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs).
Third trimester of pregnancy.
Children and adolescents:
Use in children and adolescents under the age of 14 is contraindicated.
04.4 Special warnings and appropriate precautions for use -
The possibility of systemic adverse events with the application of topical diclofenac cannot be excluded if the preparation is used on large skin areas and for a prolonged period (see the summary of product characteristics of the systemic forms of diclofenac).
Topical diclofenac should only be applied to intact, non-diseased skin, and not to skin wounds or open lesions. It should not be allowed to come into contact with eyes or mucous membranes and should not be ingested.
Discontinue treatment if skin rash develops after application of the product.
Topical diclofenac can be used with non-occlusive dressings, but should not be used with an occlusive dressing that does not allow air to pass.
Important information about some of the excipients
Voltaren Emulgel 1% gel contains propylene glycol and benzyl benzoate which can cause skin irritation.
04.5 Interactions with other medicinal products and other forms of interaction -
Since the systemic absorption of diclofenac following topical application is very low, such interactions are very unlikely.
04.6 Pregnancy and breastfeeding -
Pregnancy
The systemic concentration of diclofenac compared with oral formulations is lower after topical administration. Referring to experience with NSAID treatment for systemic administration, the following is recommended:
Inhibition of prostaglandin synthesis may adversely affect pregnancy and / or embryo / fetal development. Results from epidemiological studies suggest an increased risk of abortion and cardiac malformation and gastroschisis after the use of a prostaglandin synthesis inhibitor in early stages of pregnancy. The absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%. The risk was considered to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to cause increased pre- and post-implantation loss and embryo-fetal mortality.
In addition, an increased incidence of various malformations, including cardiovascular, has been reported in animals given prostaglandin synthesis inhibitors during the organogenetic period. During the first and second trimester of pregnancy, diclofenac should not be administered except in strictly necessary cases. If diclofenac is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low as possible and the duration of treatment as short as possible.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose the fetus to:
- cardiopulmonary toxicity (with premature closure of the arterial duct and pulmonary hypertension);
- renal dysfunction, which can progress to renal failure with oligo-hydroamnios;
the mother and the newborn, at the end of pregnancy, to:
- possible prolongation of bleeding time, and antiplatelet effect which may occur even at very low doses;
- inhibition of uterine contractions resulting in delayed or prolonged labor.
Consequently, diclofenac is contraindicated during the third trimester of pregnancy.
Feeding time
Like other NSAIDs, diclofenac passes into breast milk in small amounts. However, at therapeutic doses of Voltaren Emulgel 1% gel no effects on the infant are anticipated. Due to the lack of controlled studies in breastfeeding women, the product should only be used during lactation under the advice of a health care professional. Voltaren Emulgel 1% gel it should not be applied to the breasts of nursing mothers, or elsewhere on large areas of skin or for an extended period of time (see section 4.4).
04.7 Effects on ability to drive and use machines -
The cutaneous application of topical diclofenac does not affect the ability to drive or use machines.
04.8 Undesirable effects -
Adverse reactions (Table 1) are listed by frequency, most frequent first, using the following convention: very common (≥1 / 10), common (≥1 / 100,
Table 1
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address: www.agenziafarmaco.gov.it/it/responsabili.
04.9 Overdose -
The low systemic absorption of topical diclofenac makes an overdose very unlikely.
However, side effects similar to those seen after an overdose of diclofenac tablets, can be expected in the event that topical diclofenac is inadvertently ingested (1 tube of 60 g contains the equivalent of 600 mg of diclofenac sodium). In case of accidental ingestion resulting in significant systemic side effects, general therapeutic measures normally taken to treat poisoning with non-steroidal anti-inflammatory drugs. Gastric decontamination and the use of activated charcoal must be considered, especially within a short time of ingestion.
05.0 PHARMACOLOGICAL PROPERTIES -
05.1 "Pharmacodynamic properties -
Pharmacotherapeutic group: topical drugs for joint and muscle pain, non-steroidal anti-inflammatory drugs for topical use.
(ATC code: M02A A15).
Mechanism of action and pharmacodynamic effects:
Diclofenac is a non-steroidal anti-inflammatory drug (NSAID) with marked analgesic, anti-inflammatory and antipyretic properties. The main mechanism of action is the inhibition of prostaglandin biosynthesis by diclofenac.
Voltaren Emulgel 1% gel is an anti-inflammatory and analgesic preparation designed for topical applications. In "inflammation of traumatic or rheumatic origin, Voltaren Emulgel 1% gel it is able to quickly relieve pain, reduce edema and shorten the recovery time of normal function.
In a double-blind, randomized, placebo-controlled clinical trial with patients with moderate to severe osteoarthritis of the knee, Voltaren Emulgel 1% gel was shown to reduce pain with peak efficacy as early as 2 weeks of treatment. In addition, in a double-blind, randomized study with patients with osteoarthritis of the fingers, Voltaren Emulgel 1% gel was shown to be as effective as a 1200 mg oral dose of ibuprofen after 3 weeks of treatment.
Clinical data have shown that Voltaren Emulgel 1% gel reduces acute pain one hour after the initial application (p Voltaren Emulgel 1% gel after 2 days of treatment versus 8% of patients treated with placebo (p Voltaren Emulgel 1% gel (p
Thanks to its hydro-alcoholic base, the gel also exerts a soothing and refreshing effect.
05.2 "Pharmacokinetic properties -
Absorption
The amount of diclofenac absorbed through the skin is proportional to the contact time and to the skin area covered with Voltaren Emulgel 1% gel; it also depends on the total topical dose applied and the degree of hydration of the skin. After topical application of 2.5 g of Voltaren Emulgel 1% gel on 500 cm² of skin, absorption is about 6% of the applied dose, determined by referring to the total renal elimination of diclofenac tablets. With an occlusive dressing lasting 10 hours, a 3-fold increase in the amount of diclofenac absorbed is obtained.
Distribution
After topical application of Voltaren Emulgel 1% gel on the hand and knee joints, diclofenac can be measured in plasma, synovial tissues and synovial fluids. Maximum plasma concentrations of topically administered diclofenac are approximately 100 times lower than those following oral administration. 99.7% of diclofenac is bound to plasma proteins and preferably to albumin (99.4%).
After application of Voltaren Emulgel 1% gel, diclofenac accumulates in the skin acting as a "reservoir", from which a gradual release of the drug takes place in the underlying tissues. Hence diclofenac is preferentially distributed and persists in deep inflamed tissues, such as joints, where it is found in concentrations up to 20 times higher than in plasma.
Biotransformation
The biotransformation of diclofenac occurs partially by glucuronation of the original molecule and mainly by single or multiple hydroxylation, giving rise to phenolic metabolites, many of which are converted to glucuronate conjugates.
Two of these phenolic metabolites are biologically active, however their concentration with respect to diclofenac is so small as to be negligible.
Elimination
Total systemic clearance of diclofenac from plasma is 263 ± 56 mL / min. The plasma half-life is 1-2 hours. Four of the metabolites, including the two pharmacologically active, have a short plasma half-life of 1-3 hours. Only one of the metabolites, 3 "-hydroxy-4" -methoxy-diclofenac, has a "longer" plasma half-life, however it is inactive. Both diclofenac and its metabolites are excreted primarily in the urine.
Characteristics in patients
Accumulation of diclofenac and its metabolites is not expected in patients with renal impairment. In patients with chronic hepatitis or with non-decompensated cirrhosis, the kinetics and metabolism of diclofenac are not modified compared to those of patients without liver disease.
Features of particular interest to the patient.
The application of Voltaren Emulgel 1% gel it satisfies the need for an effective and safe local treatment, suitable for avoiding concomitant systemic administration of anti-inflammatory drugs not recommended in elderly patients and / or gastric sufferers.
05.3 Preclinical safety data -
Preclinical data from acute and repeated dose toxicity studies, as well as from genotoxicity, mutagenicity and carcinogenicity studies with diclofenac did not reveal any specific risk for humans at the doses intended for therapeutic use. There was no evidence that the Voltaren Emulgel 1% gel has teratogenic potential in mice, rats or rabbits. The Voltaren Emulgel 1% gel in rats had no influence on the fertility of the parent animals. The prenatal, perinatal and postnatal development of the offspring was not affected.
Voltaren Emulgel 1% gel it was well tolerated in a range of studies. There was no potential for phototoxicity and the Voltaren Emulgel 1% gel did not cause any skin sensitization.
06.0 PHARMACEUTICAL INFORMATION -
06.1 Excipients -
Diethylamine, carbomers, macrogol cetostearyl ether, cocoyl caprylocaprate, isopropyl alcohol, liquid paraffin, Cream 45 perfume (contains benzyl benzoate), propylene glycol, purified water.
06.2 Incompatibility "-
Not relevant.
06.3 Period of validity "-
60 g, 100 g, 120 g and 150 g gel tube: 3 years.
After first opening: 3 years (in any case do not use after the expiry date shown on the package).
50g pressurized container: 3 years.
After first opening the pressurized container: 1 year.
06.4 Special precautions for storage -
60 g, 100 g, 120 g and 150 g gel tube: store below 30 ° C.
50g pressurized container: store at a temperature below 30 ° C. Warning: the container is under pressure: store away from direct sunlight, do not pierce or burn the container even after use.
06.5 Nature of the immediate packaging and contents of the package -
Packaging: tube containing 60 g or 100 g or 120 g or 150 g of 1% gel:
Laminate pipe (low density polyethylene / aluminum / high density polyethylene - inner layer) on which a polyethylene shoulder closed with a seal is welded. The tube is closed with a push-out polypropylene screw cap designed for removing the seal before first use.
Packaging: 50g pressurized container:
Aluminum container, under pressure, containing a multilayer internal "bag" (low density polyethylene layer in contact with the product) equipped with a titanium oxide and high density polyethylene valve, a polyoxymethylene dispenser and a protective closure.
Not all pack sizes may be marketed.
06.6 Instructions for use and handling -
Unused medicine and waste derived from this medicine must be disposed of in accordance with local regulations.
07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -
Novartis Farma S.p.A.
Largo U. Boccioni, 1 - 21040 Origgio (VA)
Dealer for sale :
GlaxoSmithKline Consumer Healthcare S.p.A.,
Via Zambeletti s.n.c.
Baranzate (MI)
08.0 MARKETING AUTHORIZATION NUMBER -
60 g gel tube: A.I.C. n ° 034548040
100 g gel tube: A.I.C. n ° 034548089
120 g gel tube: A.I.C. n ° 034548091
2 tubes of 60 g gel: A.I.C. n ° 034548103
150 g gel tube: A.I.C. n ° 034548115
50g pressurized container: A.I.C. n ° 034548038
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -
Date of first authorization: 2 April 1990
Latest Renewal Date: 1 June 2010
10.0 DATE OF REVISION OF THE TEXT -
12/2015
