Dolaut

Package leaflet: Information for the user

DOLAUT 40 mg/g gel

Sodium Diclofenac
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 told you to.

• Keep this leaflet. You may need to read it again.
• If you need more advice or information, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
• Talk to your doctor if you do not notice any improvement or if your symptoms worsen after 7 days.

Contents of this leaflet:

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

1. What Dolaut is and what it is used for

Dolaut contains the active substance diclofenac, which belongs to a group of medicines called
non-steroidal anti-inflammatory drugs (NSAIDs).
It is used for the local treatment of painful and inflammatory (phlogistic) conditions of rheumatic or
traumatic origin affecting:

• joints
• muscles
• tendons
• ligaments.

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 Dolaut

Do not use Dolaut

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• if you have previously experienced asthma attacks, hives, or acute nasal inflammation (rhinitis) after taking other anti-inflammatory medicines (acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs);
• if you are in the last 3 months of pregnancy;
• if you are a child or adolescent under 14 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before using Dolaut.
If you apply the medicine over large areas of skin and for prolonged periods, adverse systemic effects (affecting the entire body) cannot be ruled out.
Therefore, especially in patients with a history of stomach and/or intestinal (gastrointestinal) diseases, systemic side effects such as nausea, a stomach disorder causing pain or discomfort in the upper abdomen (dyspepsia), heartburn (gastric pyrosis), excitation, taste disturbances, or eye inflammation (conjunctivitis) cannot be excluded with Dolaut.
Apply Dolaut (topical) only to intact, healthy skin, and not on wounds or open lesions. Dolaut must not come into contact with the eyes or mouth (mucous membranes) and must not be swallowed.
Discontinue treatment if you notice skin redness (rash) after applying the medicine.
Dolaut may be applied to the skin and optionally covered with a simple dressing, but must not be used with an occlusive dressing (one that does not allow air passage).
The use, especially prolonged, of topical products may lead to allergic reactions: if this occurs, discontinue treatment and consult your doctor to start appropriate therapy.

Children and adolescents
Use in children and adolescents under 14 years of age is contraindicated.

Other medicines and Dolaut
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
This medicine is applied to the skin, so the amount absorbed into the body (systemic absorption) is very low, making interactions with other medicines highly unlikely.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Dolaut, being applied to the skin, enters the body in lower amounts compared to orally administered medicines of the same type. However, the use of Dolaut, like other medicines of the same type (NSAIDs), is not recommended during pregnancy, as it may have negative effects on pregnancy and/or fetal development (increased risk of miscarriage, cardiac and abdominal malformations). The risk increases with higher doses and longer duration of treatment.
Do not use Dolaut if you are in the last 3 months of pregnancy. Do not use Dolaut during the first 6 months of pregnancy unless strictly necessary and under medical advice. If treatment is required during this period, the lowest possible dose for the shortest possible time should be used.
Oral forms (e.g., tablets) of diclofenac-containing medicines may cause adverse effects in the newborn. It is not known whether the same risk applies to Dolaut when used topically.

Breastfeeding
Like other medicines of the same type (NSAIDs), Dolaut passes into breast milk in small amounts. However, at the recommended doses, no effects on the breastfed infant are expected. In breastfeeding women, the medicine should be used only under medical advice. In such cases, Dolaut must not be applied to the breast or to other extensive skin areas, nor for prolonged periods.

Driving and use of machines
Dolaut does not impair the ability to drive vehicles or operate machinery.

Dolaut contains propylene glycol
Dolaut contains propylene glycol, which may cause skin irritation.

3. How to use Dolaut

Use this medicine exactly as stated in this leaflet or as instructed by your
doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:
Adults over 18 years of age:
Apply Dolaut 3 to 4 times daily to the affected area, with gentle rubbing.
The amount to apply depends on the size of the area to be treated. For example, 3–5 sprays of
DOLAUT are sufficient to treat an area measuring 20 cm by 20 cm up to 20 cm by 40 cm.
After application, wash your hands; otherwise, they will also be treated with the medicine.

Wash and Dry Apply three to five Gently massage
thoroughly the painful area. sprays, depending on to promote
the size of the area absorption.
Use in elderly patients:
The standard adult dosage may be used.
Use in adolescents aged 14 to 18 years:
Apply DOLAUT 3 or 4 times daily to the affected area, with gentle rubbing. The amount to
apply depends on the size of the area involved. For example, 3–5 sprays of DOLAUT are
sufficient to treat an area measuring 20 cm by 20 cm up to 20 cm by 40 cm.
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 your
doctor.
Use in children under 14 years of age:
There is insufficient data on efficacy and safety in children and adolescents under 14 years of age (see also section “What you need to know before using Dolaut”). Therefore, the use of Dolaut is
contraindicated in children under 14 years of age.
If you use more Dolaut than you should
Since Dolaut is applied to the skin, only small amounts enter the body; therefore, overdose is very
unlikely.
However, adverse effects similar to those observed after overdose of oral medications of the same
type (diclofenac) may occur if Dolaut is accidentally ingested (one 25 g bottle contains the equivalent of 1 g of sodium diclofenac). In case of accidental ingestion causing significant adverse effects, contact your doctor, who will initiate the standard general therapeutic measures.
If you forget to use Dolaut
Do not use a double dose to make up for the missed dose.
If you stop using Dolaut
If you have any questions 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 will experience them.
Adverse reactions are listed by frequency, in decreasing order.

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

• skin rash
• skin inflammation (eczema, erythema, dermatitis, including contact dermatitis)
• itching

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

• skin inflammation with blistering (bullous dermatitis)

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

• hypersensitivity (including urticaria), rapid swelling of the skin and mucous membranes (angioneurotic edema)
• skin rash with pustules
• asthma
• skin reactions to light (photosensitivity)

Side effects not known:

• burning sensation at the 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 Dolaut

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after the abbreviation "Exp". The expiry date refers to the last day of that month.
Do not dispose of any medicine 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 Dolaut contains
The active substance is sodium diclofenac. 100 g of gel contain 4 g of sodium diclofenac.

• Other components are: propylene glycol, isopropyl alcohol, ethyl alcohol, soybean lecithin, disodium phosphate dihydrate, disodium phosphate dodecahydrate, edetate disodium, ascorbyl palmitate, peppermint essence, purified water.

Description of the appearance of Dolaut and contents of the pack
Topical gel containing 40 mg/g
25 g bottle with dispenser.
15 g bottle with dispenser.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
NEOPHARMED GENTILI S.p.A., Via San Giuseppe Cottolengo, 15 – 20143 Milan, Italy
Manufacturer
Pharbil Waltrop GmbH Im Wirrigen, 25 - Waltrop (Germany)