LLOYDOL 1 % Гель

Содержание инструкции

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

LloyDol 1% GEL

Diclofenac sodico

Read this leaflet carefully before usingthis 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 you experience any side effects, 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 worsen after 7 days.

Contents of this leaflet

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

1. What is LloyDol and what is it used for

LloyDol contains the active ingredient diclofenac sodium. Diclofenac belongs to the class of non-steroidal anti-inflammatory drugs (NSAIDs) and is used to reduce pain and inflammation.
LloyDol is indicated for the local treatment of painful and inflammatory conditions of rheumatic or traumatic origin
affecting:

• joints, e.g. osteoarthritis and arthritis
• muscles, e.g. contractures or injuries
• tendons and ligaments, e.g. tendinitis

See a doctor if you do not feel better or if you feel worse after 7 days.

2. What you need to know before using LloyDol

Do not use LloyDol

• if you are allergic to diclofenac sodium or any of the other ingredients of this medicine (listed in section 6);
• if you have previously experienced symptoms of an allergic reaction such as asthma (e.g. wheezing and shortness of breath), urticaria, 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 the age of 14 years.

Warnings and precautions
Consult your doctor or pharmacist before using LloyDol
Pay particular attention:

• do not ingest LloyDol; wash your hands after use;
• do not apply LloyDol to broken, diseased skin or open wounds;
• avoid getting LloyDol in contact with your eyes or mucous membranes such as the mouth or vagina. If this occurs, wash the area immediately with running water and contact your doctor;
• do not use LloyDol with an occlusive dressing, i.e. covering the affected area with a plastic film that does not allow air to pass through. You can instead use LloyDol with a gauze that allows air to pass through;
• if you develop skin rashes, discontinue treatment with LloyDol; if you use diclofenac on large areas of skin and for long periods of time, you may experience undesirable effects involving the whole body; do not use LloyDol in larger quantities or for a longer period of time than stated in this leaflet, unless advised by your doctor.

Children and adolescents
LloyDol should not be used in children and adolescents under the age of 14 years.

Other medicines and LloyDol
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, including those available without a prescription.
It is unlikely that LloyDol will interact with other medicines.

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
Do not use LloyDol if you are in the last 3 months of pregnancy. Diclofenac should not be used during the third
trimester of pregnancy because it can cause harm to the baby and mother if taken during this period.
Do not use LloyDol during the first 6 months of pregnancy unless strictly necessary and as directed by
your doctor. If treatment is necessary during this period, the lowest dose should be used for the shortest
possible time.
Oral forms (e.g. tablets) of diclofenac can cause adverse effects in the unborn child. It is not known whether
the same risk applies when diclofenac is used on the skin/in the mouth.

Breastfeeding
Diclofenac passes into breast milk in small amounts. You should not use LloyDol during breastfeeding unless
you have first consulted your doctor.
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If you are breastfeeding, do not apply LloyDol to the breast, on large areas of skin and for long periods of time.

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

LloyDol contains flavouring
This medicine contains a flavouring which itself contains allergens (citronellol, benzyl salicylate,
geraniol, hydroxy methyl pentyl cyclohexene carboxaldehyde, hydroxycitronellal).
Allergens can cause allergic reactions.

3.How to use LloyDol

Method of administration
LloyDol is only for external use.
The gel is applied to the affected areas of the body and gently rubbed into the skin. Afterwards,
hands must be dried with a paper towel and then washed, unless the hands are the area to be
treated.
If too much gel is applied accidentally, excess gel must be dried with a paper towel.
The paper towel must be disposed of with household waste to prevent unused product from reaching
the aquatic environment.
Before applying a bandage, the gel should be allowed to dry on the skin for a few minutes.
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 LloyDol 3 or 4 times a day to the area to be treated and massage gently.
Caution: use only for short periods of treatment.
Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent change
in its characteristics.
Apply the gel either directly or with sterile gauze/cotton. After each application, wash your hands thoroughly,
otherwise they too will be treated with LloyDol.

Use in adults
The amount to be applied depends on the extent of the area to be treated. Apply each time an amount of gel
varying between a cherry and a walnut (approximately 2-4g of LloyDol).

Use in adolescents between 14 and 18 years of age
The amount to be applied depends on the extent of the area to be treated. Apply each time an amount of gel
varying between a cherry and a walnut (approximately 2-4g of LloyDol).
Consult your doctor if the condition does not resolve within 7 days of starting treatment with LloyDol or if you notice
a worsening of symptoms.

Use in children under 14 years of age
LloyDol 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 prescribed for adults.

If you use more LloyDol than you should
In case of accidental ingestion or use of an excessive dose of LloyDol, immediately inform your doctor or
go to the nearest hospital.
After application to the skin, the amount of diclofenac that reaches the blood is very low, so it is
unlikely that effects due to an excessive dose will occur.
If you accidentally ingest the contents of a tube of LloyDol, you may experience undesirable effects similar to
those observed after ingestion of an excessive dose of diclofenac tablets.

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

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

• skin reactions of various types characterized by rash, skin irritation, redness, itching and swelling (dermatitis, eczema).

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

• skin inflammation with the appearance of blisters (bullous dermatitis)

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

• allergic reactions including urticaria
• swelling of the skin, tissues and mucous membranes, e.g. swelling of the face or tongue (angioedema)
• rash with the appearance of pustules
• asthma (e.g. wheezing and shortness of breath)
• appearance of spots or redness on the skin following exposure to sunlight or solariums.

Side effects of unknown frequency (the frequency cannot be estimated based on available data)

• Burning sensation at the application site Dry skin

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform 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.
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By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store LloyDol

Keep this medicine out of the sight and reach of children.
Do not store at a temperature above 25°C.
Shelf life after first opening: 9 months.
Do not use this medicine after the expiry date which is stated on the packaging after Expiry. The expiry
date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate the
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What LloyDol contains
The active ingredient is sodium diclofenac 10 mg.
The other components are: alpha-tocopherol; carbomer; decyl oleate; octyldodecanol; lecithin/isopropyl alcohol;
ammonia, 10% solution; sodium edetate; "vert de creme" fragrance; isopropyl alcohol; purified water.

Description of the appearance of LloyDol and contents of the pack
LloyDolis presented in the form of a gel for topical use.
The pack contains 50 g of gel.

Marketing Authorisation Holder
Sandoz S.p.A.
Largo U. Boccioni 1
21040 Origgio (VA)

Sales representative:FarmAlvarion S.r.l. with sole member - Block 11.1 Interporto - Bentivoglio 40010
(BO)

Manufacturers
Salutas Pharma GmbH
Lange Göhren, 3
D-39171 Sülzetal OT Osterweddingen
Salutas Pharma GmbH
Otto-Von-Guericke-Allee 1
39179 Barleben (Germany)