Package leaflet: Information for the user

DOLOFAST

Ibuprofen lysine salt 10% gel
Please read this leaflet carefully before using this medicine because it contains important information for you.
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 want more information or advice, consult your pharmacist.
If any side effects occur, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contact your doctor if you do not notice any improvement or if you notice a worsening of symptoms.

Contents of this leaflet:

What DOLOFAST is and what it is used for
What you need to know before using DOLOFAST
How to use DOLOFAST
Possible side effects
How to store DOLOFAST
Contents of the pack and other information

1. What DOLOFAST is and what it is used for

DOLOFAST contains ibuprofen lysine salt, which belongs to the class of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) for topical use.
DOLOFAST is indicated for the local treatment of bruises, sprains, myalgia (muscle pain), muscle strains, and torticollis.
Consult a physician 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 substance or to any of the other ingredients of this medicine (listed in section 6),
if you have experienced hypersensitivity reactions (e.g., bronchospasm, asthma, rhinitis, 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
Talk to your doctor or pharmacist before using DOLOFAST.
It is advisable to avoid applying DOLOFAST on open wounds or damaged skin.
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 medicines may lead to sensitization and local irritation. If this occurs, discontinue treatment and consult your doctor to establish appropriate therapy.
Bronchospasm may occur in patients using ibuprofen who suffer or have previously suffered from bronchial asthma or allergic diseases.
Although systemic absorption of topically applied ibuprofen is lower than with oral dosage forms, rare cases of complications may still occur:

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 hepatic function.
patients with a current or past history of peptic ulcer, intestinal inflammation, or hemorrhagic 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 possible hypersensitivity or photosensitization (light sensitivity), avoid exposure to direct sunlight, including sunbeds, during treatment and for two weeks after treatment ends.
Children
DOLOFAST must not be used in children under 12 years of age (see subsection “Do not use DOLOFAST”).
Other medicines and DOLOFAST
Inform 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 you are being treated with anticoagulants.
Non-steroidal anti-inflammatory drugs (NSAIDs) may interact with antihypertensive medicines (used to lower blood pressure) and may potentially enhance the effects of anticoagulants, although the likelihood of such interactions occurring with a topical preparation is extremely rare. The use of DOLOFAST together with acetylsalicylic acid or other NSAIDs may increase the risk of developing adverse reactions.
Pregnancy, breastfeeding, and fertility
DOLOFAST must not be used during pregnancy and is not recommended during breastfeeding.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Driving and using machines
No effects on driving or 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 exactly as stated in this leaflet or as directed 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 to the painful area.
Do not exceed the recommended doses without medical advice and use only for short-term treatment.
After each application, wash your hands thoroughly and for a prolonged period.
Consult your doctor if the condition recurs or if you notice any recent changes in its characteristics.
If you use more DOLOFAST than you should
Overdose with topical ibuprofen-containing medicines is extremely rare. Symptoms of severe ibuprofen overdose (e.g. following oral ingestion of the drug) may include headache, vomiting, drowsiness, and hypotension.
Your doctor may advise you to take appropriate corrective measures to manage possible electrolyte imbalances (i.e. disturbances in certain substances present in the blood).
In case of accidental ingestion/overdose of DOLOFAST, contact your doctor immediately or go to the nearest hospital.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Side effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.
The systemic availability of ibuprofen for topical 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 (digestive difficulties)

Immune system disorders:
Not known: urticaria, angioedema

Skin and subcutaneous tissue disorders:
Not known: erythema (redness), pruritus, irritation, photosensitivity reactions (increased sensitivity to light), sensation of warmth or burning at the application site, contact dermatitis, purpura (reddish spots), bullous 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 digestive difficulties, are less common with the use of topical ibuprofen.
If photosensitivity reactions (increased sensitivity to light) occur, treatment must be discontinued.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. You may also report side effects directly via the national reporting system at the following website:
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 stated on the packaging.
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.
It is important to always keep the medicine information available; therefore, retain both the packaging
and the leaflet.

6. Package contents and other information

What DOLOFAST contains

The active substance is ibuprofen lysinate. 100 g of gel contain 10 g of ibuprofen lysinate.
The other ingredients are isopropyl alcohol, hydroxyethylcellulose, sodium methyl-p-hydroxybenzoate, sodium ethyl-p-hydroxybenzoate, glycerin, lavender essence, purified water q.s.

Description of the appearance of DOLOFAST and contents of the pack
DOLOFAST is a gel.
Carton pack containing an aluminum tube.
The tube contains 50 g of 10% gel.
Marketing Authorization Holder
Dompé farmaceutici S.p.A. Via San Martino 12 - 20122 Milan
Manufacturer
Lisapharma S.p.A. - Via Licinio, 11 - 22036 Erba (Como)