Lloydol

Package leaflet: Information for the patient

LloyDol 1% GEL

Diclofenac sodium
Please read this leaflet carefully before using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement 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 LloyDol is and what it is used for

LloyDol contains the active substance sodium diclofenac. Diclofenac belongs to the class of medicines called 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 arthritides
• muscles, e.g. spasms or injuries
• tendons and ligaments, e.g. tendinitis

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

Warnings and precautions
Talk to your doctor or pharmacist before using LloyDol.
Take particular care:

• do not swallow LloyDol; wash your hands after use;
• do not apply LloyDol to damaged, diseased skin or open wounds;
• avoid contact of LloyDol with eyes or mucous membranes, for example in the mouth or vagina. If this occurs, immediately rinse the area with running water and contact your doctor;
• do not use LloyDol with an occlusive dressing, i.e. covering the affected area with an airtight plastic film. You may instead use LloyDol with a gauze dressing that allows air to pass through;
• if you develop skin rashes, stop treatment with LloyDol; if you use diclofenac on large areas of skin and for prolonged periods, you may experience adverse effects affecting the whole body; do not use LloyDol in larger amounts or for longer than indicated in this leaflet, unless otherwise directed by your doctor.

Children and adolescents
LloyDol must not be used in children and adolescents under 14 years of age.
Other medicines and LloyDol
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
It is unlikely that LloyDol will interact with other medicines.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not use LloyDol during the last three months of pregnancy. Diclofenac must not be used during the third trimester of pregnancy because it may cause harm to the unborn baby and the mother if taken during this period.
Do not use LloyDol during the first six months of pregnancy unless strictly necessary and as directed by your doctor. If treatment is required during this period, the lowest effective dose for the shortest possible duration should be used.
Oral forms (e.g. tablets) of diclofenac may cause adverse effects in the unborn child. It is not known whether the same risk applies when diclofenac is used on the skin or in the mouth.
Breastfeeding
Diclofenac passes into breast milk in small amounts. You must not use LloyDol while breastfeeding unless you have first consulted your doctor.
If you are breastfeeding, do not apply LloyDol to the breast, large areas of skin, or for prolonged periods.
Driving and using machines
LloyDol does not affect the ability to drive or operate machinery.
LloyDol contains fragrance
This medicine contains a fragrance which itself contains allergens (citronellol, benzyl salicylate, geraniol, hydroxymethylpentyl cyclohexene carboxaldehyde, hydroxycitronellal).
Allergens may cause allergic reactions.

3. How to use LloyDol
Method of administration
LloyDol is for external use only.
Apply the gel to the affected areas of the body and gently rub it into the skin. Afterwards, dry your hands with a paper towel and then wash them, unless the hands themselves are the area being treated.
If too much gel is accidentally applied, wipe off the excess with a paper towel.
The paper towel should be disposed of with household waste to prevent unused product from entering the aquatic environment.
Allow the gel to dry on the skin for a few minutes before applying a bandage.
Use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Apply LloyDol 3 or 4 times daily to the affected area and gently massage it in.
Caution: use only for short-term treatment.
Consult your doctor if symptoms recur or if you have noticed any recent changes in their characteristics.
Apply the gel either directly or using sterile gauze/cotton. After each application, wash your hands thoroughly, otherwise your hands will also be treated with LloyDol.
Use in adults
The amount to apply depends on the size of the area to be treated. Apply each time a quantity of gel ranging from the size of a cherry to a walnut (approximately 2–4 g of LloyDol).
Use in adolescents aged 14 to 18 years
The amount to apply depends on the size of the area to be treated. Apply each time a quantity of gel ranging from the size of a cherry to a walnut (approximately 2–4 g of LloyDol).
Consult your doctor if the condition does not improve within 7 days of starting treatment with LloyDol or if symptoms worsen.
Use in children under 14 years of age
LloyDol must not be used in children under 14 years of age.
Use in elderly patients (over 65 years of age)
Elderly patients may use the doses recommended for adults.
If you use more LloyDol than you should
In case of accidental ingestion or overdose, contact your doctor immediately or go to the nearest hospital.
After application to the skin, the amount of diclofenac that reaches the bloodstream is very low, so it is unlikely that overdose-related effects will occur.
If you accidentally ingest the contents of a tube of LloyDol, you may experience adverse effects similar to those observed after ingestion of an overdose 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 using 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)

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

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

• skin inflammation with blistering (bullous dermatitis)

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

• allergic reactions including hives
• swelling of the skin, tissues and mucous membranes, e.g. swelling of the face or tongue (angioedema)
• skin rash with pustules
• asthma (e.g. wheezing and shortness of breath)
• skin eruptions or redness appearing after exposure to sunlight or sunlamps.

Side effects not known (frequency cannot be determined from available data)

• Burning sensation at application site Dry skin

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 LloyDol

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Use within 9 months after first opening.
Do not use this medicine after the expiry date stated on the packaging after Exp. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What LloyDol contains
The active substance is sodium diclofenac mg 10.
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
LloyDol is presented as a gel for topical use.
The pack contains 50 g of gel.
Marketing Authorization Holder
Sandoz S.p.A.
Largo U. Boccioni 1
21040 Origgio (VA)
Sales licensee: FarmAlvarion S.r.l. with sole shareholder - 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)