DOLAUT 40 mg /G Gel

Зміст інструкції

1. DOLAUT 40 mg/g gel
   1. What is Dolaut and what is it 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

DOLAUT 40 mg/g gel

Diclofenac Sodico
Read this leaflet carefully before 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.
• See a doctor if you do not feel better 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 you use 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 is Dolaut and what is it used for?

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

• 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 ingredient or to any of the other ingredients of this medicine (listed in section 6);
• if you have suffered in the past from asthma attacks, hives or acute inflammation of the nose (rhinitis) after using other medicines against inflammation (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 the age of 14.

Warnings and precautions
Consult your doctor or pharmacist before using Dolaut.
If you use the medicine on large areas of skin and for a prolonged period, the possibility of
adverse events that can affect the whole body (systemic) cannot be excluded.
Therefore, especially in patients with a history of stomach and/or intestinal (gastrointestinal) diseases,
the occurrence of side effects throughout the body cannot be excluded for Dolaut, such as
nausea, a stomach upset that causes pain or discomfort in the upper abdomen (dyspepsia),
heartburn (pyrosis), excitement, altered taste, inflammation of the eye (conjunctivitis).
Apply Dolaut (topical) only to intact, healthy skin, not on wounds or open lesions. Dolaut should not
come into contact with the eyes or mouth (mucous membranes) and should not be ingested.
Stop treatment if you observe skin redness (rash) after applying the medicine.
Dolaut can be used on the skin and possibly covered with a simple bandage, but it must not be
used with a bandage that does not allow air to pass through.
The use, especially if prolonged, of products for topical use, can give rise to allergic reactions: in this case
stop treatment and consult your doctor to start suitable therapy.

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

Other medicines and Dolaut
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
The medicine is applied to the skin and therefore the amount that reaches inside the body
(systemic absorption) is very low and it is very unlikely to interact with other medicines.

Pregnancy andbreastfeeding
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
Dolaut, being applied to the skin, reaches the body in low quantities compared to medicines
taken orally. The use of Dolaut, like other medicines of the same type (NSAIDs), is
not recommended in pregnant women, as it can have adverse effects on pregnancy and/or fetal development
(increased risk of abortion, heart and abdominal malformations). The risk increases with
increasing dose and duration of therapy.
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 if
not 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-based medicines can cause adverse effects in the
newborn. It is not known whether the same risk applies with Dolaut when used on the skin.
Breastfeeding
Like other medicines of the same type (NSAIDs), Dolaut passes into breast milk in small amounts. However,
no effects on the infant are expected at the recommended doses of Dolaut. In breastfeeding women, the medicine
should be used during breastfeeding only under the advice of a doctor. In this circumstance, Dolaut should not
be applied to the breasts of breastfeeding mothers, nor elsewhere on other large areas of skin or for a
prolonged period of time.

Driving and operating machinery
Dolaut does not impair the ability to drive vehicles or operate machinery.

Dolaut contains propylene glycol
Dolaut contains propylene glycol which can cause skin irritation.

3. How to use Dolaut

Use this medicine following exactly as described 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 or 4 times a day to the area to be treated, rubbing gently.
The amount to be applied depends on the size of the affected area. For example, 3-5 sprays of
DOLAUT are sufficient to treat an area of 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.

Use in the elderly:
The usual dosage intended for adults can be used.

Use in adolescents aged 14 to 18 years:
Apply DOLAUT 3 or 4 times a day to the area to be treated, rubbing gently. The amount to be
applied depends on the size of the affected area. For example, 3-5 sprays of DOLAUT are
sufficient to treat an area of 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:
Insufficient data are available 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.
Three to five
sprays, depend-
ing on the size
of the area to
be treated, three
to four times a
day.
Wash and
dry the
painful area
thoroughly.
Massage
gently to
promote
absorption

If you use more Dolaut than you should
Dolaut, being applied to the skin, reaches the inside of the body in low quantities, therefore it is very
unlikely that an overdose will occur.
However, undesirable effects similar to those observed after an overdose of drugs
of the same type (diclofenac) in tablets may occur if Dolaut is inadvertently ingested (1 tube
of 25 g contains the equivalent of 1 g of sodium diclofenac). In case of accidental ingestion causing
significant undesirable effects, consult your doctor, who will take the general therapeutic measures
normally adopted.

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

If you stop using Dolaut
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Adverse reactions are listed by frequency, in decreasing order.
Common side effects (may affect up to 1 in 10 people):

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

Rare side effects (may affect up to 1 in 1000 people):

• skin inflammation with blister formation (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 (angioedema)
• skin rash with pustules
• asthma
• skin reactions to light (photosensitivity).

Side effects with unknown frequency:

• burning sensation at the application site
• dry skin

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell 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 .
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 which is stated on the pack after the abbreviation
“Exp”. The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water 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 Dolaut contains
The active ingredient is diclofenac sodium. 100 g of gel contains 4 g of diclofenac sodium.

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

Description of the appearance of Dolaut and contents of the pack
Gel for external use containing 40 mg/g
bottle with applicator of 25 g.
bottle with applicator of 15 g.

Marketing Authorisation Holder and manufacturer
Marketing Authorisation Holder
NEOPHARMED GENTILI S.p.A., Via San Giuseppe Cottolengo, 15 – 20143 Milan

Manufacturer
Pharbil Waltrop GmbH Im Wirrigen, 25 - Waltrop (Germany)