DOLOFAST 10% Gel

Зміст інструкції

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

DOLOFAST

Ibuprofen lysine salt10% gel
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 would like 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 get worse. Contents of this leaflet:
• 1. What DOLOFAST is and what it is used for
• 2. What you need to know before using DOLOFAST
• 3. How to use DOLOFAST
• 4. Possible side effects
• 5. How to store DOLOFAST
• 6. Contents of the pack and other information

1. What is DOLOFAST and what is it used for

DOLOFAST contains lysine ibuprofen salt which belongs to the class of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) for external use.
DOLOFAST is indicated in the local treatment of bruises, sprains, muscle aches (myalgias), muscle tears,
and stiff neck.
See a doctor if you do not feel better or if you feel worse.

2. What you need to know before using DOLOFAST

Do not use DOLOFAST

• 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 had hypersensitivity reactions (e.g. bronchospasm, asthma, cold, urticaria) or other allergic manifestations following the use of acetylsalicylic acid or other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs),
• if you are pregnant.
• in children under 12 years of age (see subsection “Children”).

Warnings and precautions
Consult your doctor or pharmacist before using DOLOFAST.
It is advisable to avoid applying DOLOFAST to open wounds or skin lesions.
Avoid contact with eyes, lips and mucous membranes. Do not use DOLOFAST for occlusive dressings.
For external use only (on the skin only).
The use, especially if prolonged, of topical medications can cause sensitization and local irritation. In this case, discontinue treatment and consult your doctor to establish appropriate therapy.
In patients using ibuprofen who suffer from or have previously suffered from bronchial asthma or allergic disease, bronchospasm may occur.
Although the systemic absorption of ibuprofen applied locally is lower than that of oral dosage forms, some complications may occur in rare cases:

• the gel should be used with caution in patients with impaired renal function or a history of renal failure. Topical NSAIDs have been associated with renal failure.
• the gel should be used with caution in patients with impaired liver function.
• patients with an active history or a history of peptic ulcer, intestinal inflammation or bleeding diathesis should consult a doctor before using this product. Excipients: methyl-p-hydroxybenzoate, ethyl-p-hydroxybenzoate may cause allergic reactions (including delayed reactions)

To avoid any hypersensitivity or photosensitization (sensitivity to light) phenomena, avoid exposure to direct sunlight, including solariums, during treatment and for the following two weeks.

Children
DOLOFAST should not be used in children under the age of 12 (see subsection “Do not use DOLOFAST”).

Other medicines and DOLOFAST
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
It is advisable to consult your doctor if undergoing treatment with anticoagulants.
Non-steroidal anti-inflammatory drugs (NSAIDs) can interact with antihypertensive drugs (used to lower blood pressure) and may potentially increase the effects of anticoagulants, although the possibility of this occurring with a topical preparation is extremely rare. The use of DOLOFAST together with acetylsalicylic acid or other NSAIDs may cause an increased likelihood of developing adverse reactions.

Pregnancy, breastfeeding and fertility
DOLOFAST should not be used during pregnancy and is not recommended during breastfeeding.
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.

Driving and operating machinery
No effects on driving and operating machinery.

DOLOFAST contains Sodium Methyl-p-hydroxybenzoate and Sodium Ethyl-p-hydroxybenzoate.It may
cause allergic reactions (including delayed reactions).

3. How to use DOLOFAST

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.
Adults and children over 12 years: the recommended dose is 2-4 applications per day on the painful area.
Do not exceed the indicated doses without your doctor's advice and use only for short periods of treatment.
After each application, wash your hands thoroughly and for a prolonged period.
Consult your doctor if the disorder occurs repeatedly or if you notice any recent change in its characteristics.

If you use more DOLOFAST than you should
Overdosage with topical ibuprofen-based medicines is extremely rare. Symptoms of severe ibuprofen overdosage (for example, following oral ingestion of the drug) include headache, vomiting, drowsiness and hypotension.
Your doctor may advise you to take appropriate corrective measures to control any electrolyte disorders (i.e. of certain substances present in the blood).
In case of accidental ingestion/intake of an excessive dose of DOLOFAST, immediately inform your doctor or go to the nearest hospital.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects can be minimised by using the lowest effective dose for the shortest duration necessary to
control the symptoms.
The systemic availability of ibuprofen for local use is very low compared to NSAIDs administered orally.
The following side effects have been reported in post-marketing experience. Frequencies are defined as
follows: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare
(≥1/10,000, <1/1,000); very rare (<1/10,000); not known (frequency cannot be estimated from the available
data).
Gastrointestinal disorders:
Not known: abdominal pain, dyspepsia (difficulty digesting food)
Immune system disorders:
Not known: urticaria, angioedema
Skin and subcutaneous tissue disorders:
Not known: erythema (redness), pruritus (itching), irritation, photosensitivity reactions (increased
sensitivity to light), a sensation of heat or burning in the application area, contact dermatitis, purpura (reddish
spots), blistering skin diseases (including erythema multiforme, epidermal necrolysis and Stevens-Johnson
syndrome)
Renal and urinary disorders:
Not known: renal failure (see section 4.4)
Adverse events, particularly those affecting the gastrointestinal tract such as abdominal pain and
difficulty digesting food, are less common with the use of topical ibuprofen.
If photosensitivity reactions (increased sensitivity to light) occur, treatment should be discontinued.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. You can
also report side effects directly through the national reporting system at
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa .
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store DOLOFAST

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the packaging.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.
It is important to always have the information about the medicine available, therefore keep both the box

6. Contents of the pack and other information

What DOLOFAST contains

• The active ingredient is lysine ibuprofen salt. 100 g of gel contain 10 g of lysine ibuprofen salt.
• The other ingredients are isopropyl alcohol, hydroxyethylcellulose, Methyl paraben sodium salt, Ethyl paraben sodium salt, Glycerol, Lavender essence, Purified water q.s.

Description of the appearance of DOLOFAST and contents of the pack
DOLOFAST is presented in gel form.
Pack containing an aluminum tube.
The content of the tube is 50 g at 10%.

Marketing Authorisation Holder
Dompé farmaceutici S.p.A. Via San Martino 12 - 20122 Milano

Manufacturer
Lisapharma S.p.A. - Via Licinio, 11 - 22036 Erba (Como)