FLECTORARTRO 1% Gel

Зміст інструкції

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

Diclovec 1% gel
Diclofenac

Read this leaflet carefully before you start 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.
Talk to your doctor if you do not feel better or if your symptoms get worse after 4 days.

Contents of this leaflet:

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

1. What is Diclovec 1% gel and what is it used for

Diclovec contains the active ingredient diclofenac epolamine, a medicine belonging to the
non-steroidal anti-inflammatory drugs (NSAIDs).
Diclovec 1% gel is indicated for the symptomatic relief of local pain and inflammatory states
caused by post-traumatic injuries, such as bruises, sprains and tendinitis.

2. What you need to know before using Diclovec 1% gel

Do not use Diclovec 1% gel if:
you are allergic to diclofenac, acetylsalicylic acid (aspirin) or any other non-steroidal anti-
inflammatory drug (NSAID)
you are allergic to any of the other ingredients of Diclovec 1% gel (listed in section 6)
you have asthma attacks, respiratory disorders, urticaria or acute rhinitis (common cold) after
taking acetylsalicylic acid (aspirin) or other NSAIDs
you have skin lesions, including exudative or infected areas, eczema, burns or wounds
from the third trimester of pregnancy onwards (see Pregnancy and breastfeeding).
you are a child or adolescent under the age of 15 years.
If any of the above cases apply to you, consult your doctor or pharmacist.

Take special care with Diclovec 1% gel if:

• You suffer from cardiovascular diseases
• You suffer from kidney diseases
• You suffer from liver diseases
• You suffer from or have suffered in the past from a stomach ulcer (peptic ulcer)
• You suffer from an inflammatory bowel disease such as Crohn's disease or ulcerative colitis or are prone to intestinal bleeding
• You are regularly exposed to sunlight or artificial UV rays

Do not apply Diclovec to large areas or to damaged, diseased or irritated skin areas or to open
wounds.
Diclovec must not come into contact with the eyes or with the mucous membranes lining
internally certain parts of the body, for example mouth, nasal cavities (mucous membranes), and
must never be taken orally.
Stop treatment if you develop a skin rash after applying the product.
The use of gloves is recommended for the physiotherapist.

Other medicines and Diclovec
The low systemic absorption of diclofenac from topical application of the gel
makes interactions with other medicines very unlikely.
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine, including over-the-counter medicines.

Pregnancy and breastfeeding
The use of Diclovec 1% gel is not recommended during pregnancy. Do not use Diclovec 1% gel from
the beginning of the third trimester of pregnancy.
Like other NSAIDs, diclofenac is passed into breast milk in small amounts.
No adverse effects on the infant are expected with the therapeutic doses of Diclovec 1% gel, but during
breastfeeding the product should only be used under medical or pharmaceutical control.
In this case, Diclovec 1% gel should not be applied to the breasts of breastfeeding mothers or elsewhere on extensive skin areas. Always use the lowest effective dose for the shortest
duration necessary.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Topical application of Diclovec 1% gel does not impair the ability to drive vehicles and use
machinery.
Important information about certain ingredients of Diclovec:
Diclovec contains propylene glycol which can cause skin irritation. It also contains
methyl benzoate, which exerts a mild irritant effect on skin, eyes and mucous membranes.

3. How to use Diclovec 1% gel

If you have any doubts, consult your doctor or pharmacist.
The product should be applied to the skin, only in adults and adolescents over 15 years of age.
Depending on the size of the area to be treated, apply 2-4 g 2 - 4 times a day for a
maximum treatment period of two weeks. After application, wash your hands, unless
they are the area to be treated.
Diclovec 1% gel can be used with non-occlusive bandages, but should not be used with
non-breathable occlusive bandages. Do not arbitrarily change the dosage indicated in the package leaflet or
recommended by your doctor or pharmacist. Inform your doctor or pharmacist if you feel that the effect of the
medicine is too weak or too strong.

If you forget to use Diclovec 1% gel
Do not use a dose higher than the recommended daily dose.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Diclovec 1% gel can cause side effects, although not everybody gets them.
Common side effects (may affect up to 1 in 10 people)

• Skin rash, eczema, erythema (skin redness), dermatitis (allergic and contact), itching

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

• Bullous dermatitis (with blister formation)

Very rare side effects (may affect less than 1 in 10,000 people)

• Hypersensitivity (including urticaria), angioedema
• Pustular eruption
• Asthma
• Photosensitivity (reaction after exposure to sunlight or artificial UV rays)

Frequency not known:

• Anaphylactic reaction

Because Diclovec 1% gel is applied to the skin of the affected area, there is a lower risk of
developing side effects, such as stomach problems, including pain, indigestion or signs of
bleeding in the stomach or intestines, which may occur when taking
diclofenac orally. However, if Diclovec 1% gel is not used correctly, these side effects
may occur.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly through
the national reporting system at www.agenziafarmaco.gov.it/it/responsabili .
By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Diclovec 1% gel

Keep this medicine out of the sight and reach of children.
This medicine does not require particular precautions for storage.
Do not use Diclovec 1% gel after the expiry date which is reported on the packaging, tube or
container. The expiry date refers to the last day of that month.
Once the tube is opened, Diclovec 1% gel must be used within 9 months.
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 Diclovec 1% gel contains
The active ingredient is diclofenac epolamine.
100 g of gel contains 1 g of diclofenac sodium as diclofenac epolamine.
The other ingredients are soy lecithin, macrogolglycerol hydroxystearate, macrogol stearate,
carbomer, sodium hydroxide, isopropyl alcohol, fragrance (Floral PH-Y containing benzyl
acetate, phenylethyl alcohol, hydroxycitronellal, petitgrain oil of Paraguay, cinnamyl alcohol,
propylene glycol, methyl benzoate), purified water.
Compressed air (only for the pressurised container).

Description of the appearance of Diclovec 1% gel and contents of the pack
This medicine is presented as a gel ranging in colour from white to off-white, in an aluminium
tube or pressurised container. Each tube contains 50, 60 or 100 g of gel, while the
pressurised container contains 100 g of gel.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
IBSA Farmaceutici Italia S.r.l., via Martiri di Cefalonia 2, 26900 Lodi

Manufacturers responsible for batch release
IBSA Farmaceutici Italia S.r.l., via Martiri di Cefalonia 2, 26900 Lodi
and
Laboratoires Genevrier SA, 280 rue de Goa – ZI les Trois Moulins, 06600 Antibes, France

This medicinal product is authorised in the Member States of the European Economic Area with
the following denominations:
Belgium Diclotopic
France Diclamine

ItalyDiclovec