Lasonil for pain relief

Package leaflet: Information for the user

Lasonil antidolore 10% gel

Ibuprofen lysine salt
Please read all of this leaflet carefully before you start 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 instructed.

• 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.
• Contact your doctor if you do not notice any improvement or if your symptoms worsen.

Contents of this leaflet:

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

1. What Lasonil antidolore is and what it is used for

This medicinal product contains Ibuprofen lysine salt, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which act to relieve pain and reduce inflammation-related symptoms.
Lasonil antidolore is used for the local treatment of bruises, sprains, myalgia (muscle pain), muscle tears, and torticollis.
Consult your doctor if you do not feel better or if symptoms worsen.

2. What you need to know before using Lasonil antidolore

Do not use Lasonil antidolore

• if you are allergic to ibuprofen or to any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to other analgesics (painkillers), antipyretics (fever reducers), or non-steroidal anti-inflammatory drugs (NSAIDs) which have previously caused you asthma, rhinitis, urticaria, or other allergic reactions.
• if you are in the last 3 months of pregnancy (see 'Pregnancy, breastfeeding and fertility').
• if you are breastfeeding (see 'Pregnancy, breastfeeding and fertility').
• if you are under 14 years of age (see 'Children and adolescents').
• if you are using other NSAIDs (see 'Other medicines and Lasonil antidolore').

Warnings and precautions – Take special care with Lasonil antidolore
Consult your doctor or pharmacist before using Lasonil antidolore:

• if you suffer or have previously suffered from asthma, allergic rhinitis, urticaria, or other allergic reactions after taking acetylsalicylic acid (aspirin) or similar anti-inflammatory medicines.
• if you are simultaneously using anticoagulant medicines (drugs used to thin the blood), such as warfarin (see 'Other medicines and Lasonil antidolore').

It is advisable to avoid applying Lasonil antidolore on open wounds or skin lesions.
Skin reactions
The use of Lasonil antidolore, especially if prolonged, may cause local sensitization reactions. At the first appearance of a skin rash, mucosal lesions, or any other sign of hypersensitivity, discontinue treatment and consult your doctor, who may take appropriate therapeutic measures.
To avoid more severe hypersensitivity reactions or photosensitization (skin erythema following application of the product and subsequent exposure to light, sunlight or UV), do not expose yourself to direct sunlight, including sunbeds, during treatment and for two weeks afterwards (see section 4. Possible side effects).
Serious skin reactions have been reported in association with the use of Lasonil antidolore, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). Stop using Lasonil antidolore and contact your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

Children and adolescents
This medicine is intended only for patients over 14 years of age.

Other medicines and Lasonil antidolore
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, even those not prescribed by a doctor.
Available data do not allow conclusions regarding possible interactions with the continuous use of ibuprofen; no clinically relevant interactions have been observed with occasional use of ibuprofen.
However, keep in mind that ibuprofen may enhance the effects of anticoagulants (medicines used to thin the blood), such as warfarin.
Lasonil antidolore must not be used together with another NSAID; in any case, do not use more than one NSAID at a time.

Pregnancy, breastfeeding and fertility

If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.

Pregnancy and breastfeeding
Do not use Lasonil antidolore during the last 3 months of pregnancy.
Lasonil antidolore should not be used during the first 6 months of pregnancy unless clearly necessary and under medical advice. If treatment is required during this period, the lowest effective dose for the shortest possible duration should be used.
Oral forms of ibuprofen-containing medicines (e.g. tablets) may cause adverse effects in the unborn child. It is not known whether the same risk applies with Lasonil Antidolore when applied to the skin.

Do not use Lasonil antidolore if you are breastfeeding.

Fertility
The use of Lasonil antidolore, as with any drug that inhibits prostaglandin synthesis and cyclooxygenase, is not recommended in women attempting to conceive.
Administration of Lasonil antidolore should be discontinued in women experiencing fertility problems or undergoing fertility investigations.

Driving and using machines
This medicine does not impair the ability to drive or operate machinery.

Lasonil contains methyl parahydroxybenzoate sodium and ethyl parahydroxybenzoate sodium which may cause allergic reactions (including delayed reactions).

3. How to use Lasonil analgesic

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.
Apply a thin layer of gel to the affected area with gentle massage.
Wash your hands thoroughly and for a prolonged period after application.
The recommended dose is 2–4 applications per day to the painful area.
Caution: Do not exceed the indicated doses.
Elderly patients should follow the minimum dosages indicated above.
Duration of treatment
Use the medicine for the shortest time possible.
Consult your doctor if symptoms recur or if you notice any recent changes in their characteristics.
If there is no noticeable improvement after a short period of treatment, consult your doctor.
If you use more Lasonil than you should
Cases of overdose have not been reported.
In case of accidental ingestion or excessive use of Lasonil analgesic, contact your doctor immediately or go to the nearest hospital.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Stop using Lasonil Antidolore and consult your doctor immediately if you notice any of the
following symptoms:

• flat, reddish spots, target-shaped or circular rashes on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers. These serious skin eruptions may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• widespread rash, high body temperature and swollen lymph nodes (DRESS syndrome).
• widespread, red, scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually occur at the beginning of treatment (acute generalized exanthematous pustulosis).

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.
With some topical non-steroidal anti-inflammatory drugs, skin reactions such as erythema, itching, irritation, sensation of warmth or burning, and contact dermatitis have been reported.
The skin may become sensitive to light. Photosensitivity reactions (skin erythema after application of the product and subsequent exposure to sunlight or UV light) are possible. These side effects have been reported with an unknown frequency (i.e. the frequency cannot be estimated from the available data). See also section 2.
Following the instructions provided in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effects, 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 Lasonil antidolore

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. 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. Contents of the pack and other information

What Lasonil antidolore contains

• The active substance is Ibuprofen lysine salt. 100 g of gel contain 10 g of Ibuprofen lysine salt.
• The other components are isopropyl alcohol, hydroxyethylcellulose, methyl para-hydroxybenzoate sodium, ethyl para-hydroxybenzoate sodium, glycerol, lavender essence, purified water.

Description of the appearance of Lasonil antidolore and pack contents
Lasonil antidolore is presented as a gel.
The pack contains a tube of 50 g or 120 g.
Marketing Authorization Holder
Bayer SpA – Viale Certosa, 130 – 20156 Milan
Manufacturer
Doppel Farmaceutici S.r.l. - Cortemaggiore (Piacenza) plant – Via Martiri delle Foibe 1