LASONIL ANTIDOLORE 10% Gel

Зміст інструкції

1. Lasonil antidolore 10% gel
   1. What is Lasonil antidolore and what is it used for
   2. What you need to know before using Lasonil pain reliever
   3. How to use Lasonil antidolore
   4. Possible side effects
   5. How to store Lasonil antidolore
   6. Contents of the pack and other information

Lasonil antidolore 10% gel

Ibuprofen lysine salt

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 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 is Lasonil antidolore and what is it used for

This medicine contains Ibuprofene lysine salt, which belongs to a group of drugs
called non-steroidal anti-inflammatory drugs (NSAIDs), which work to relieve pain and
reduce symptoms associated with inflammation.
Lasonil antidolore is used for the local treatment of bruises, sprains, myalgias (muscle pain), muscle tears, torticollis.
See your doctor if you do not feel better or if your symptoms worsen.

2. What you need to know before using Lasonil pain reliever

Do not use Lasonil pain reliever

• 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 (pain relievers), antipyretics (fever reducers), non-steroidal anti-inflammatory drugs (NSAIDs) that have previously caused you asthma, rhinitis, urticaria or other allergic reactions.
• if you are pregnant or 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 pain reliever’).

Warnings and precautions – Pay particular attention to Lasonil pain reliever
Consult your doctor or pharmacist before using Lasonil pain reliever:

• if you suffer from or have ever suffered from asthma, allergic rhinitis, urticaria or other allergic reactions after using acetylsalicylic acid or other similar anti-inflammatory drugs.
• if you are simultaneously using anticoagulant medicines (drugs used to make the blood less dense) such as warfarin (see ‘ Other medicines and Lasonil pain reliever’)

It is advisable to avoid applying Lasonil pain reliever to open wounds or skin lesions.
Skin reactions
The use of Lasonil pain reliever, especially if prolonged, may lead to local sensitization phenomena: at the first appearance of a skin rash (skin eruption), mucous membrane lesions
or any other sign of hypersensitivity, stop treatment and consult your doctor who may
adopt appropriate therapeutic measures.
To avoid more serious hypersensitivity phenomena or photosensitization (skin erythema after
application of the product and subsequent exposure to light, solar or UV), do not expose yourself to
direct sunlight, including solariums, during treatment and for the two weeks following
(see section 4. Possible side effects.).
Severe skin reactions have been reported in association with treatment with Lasonil pain reliever.
Stop taking Lasonil pain reliever and consult your doctor immediately if you
develop a skin rash, mucous membrane lesions, blisters or other signs of allergy, as
these may be the first signs of a very serious skin reaction. See section 4.

Children and adolescents
The medicine is reserved for patients over 14 years of age only.

Other medicines and Lasonil pain reliever
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, even those available without a prescription.
The available data do not allow conclusions to be drawn regarding possible interactions with the continuous use of
ibuprofen; no clinically relevant interactions have been found with the occasional use of
ibuprofen.
However, it should be noted that Ibuprofen may increase the effects of anticoagulants (drugs
used to make the blood less dense) such as warfarin.
Lasonil pain reliever should not be used together with another NSAID or, in any case, do not use more than one
NSAID at a time.

Pregnancy, breastfeeding and fertility
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 using this medicine.

Pregnancy and breastfeeding
Do not use Lasonil pain reliever if you are pregnant or breastfeeding as it may cause
adverse effects on pregnancy and/or fetal development.
An increased risk of abortion and cardiac malformation and gastroschisis (
malformation of the abdominal wall involving the development of many organs outside the body)
has been noted after the use of anti-inflammatory drugs in the early stages of pregnancy. The risk increases with
dose and duration of therapy.
During the third trimester of pregnancy, the use of the medicine may expose:

• the fetus to:
• cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension);
• renal dysfunction, which may progress to renal failure with oligo-hydroamnios;
• the mother and newborn, at the end of pregnancy, to:
• possible prolongation of bleeding time, and antiplatelet effect that can occur even at very low doses;
• inhibition of uterine contractions resulting in delayed or prolonged labor.

Fertility
The use of Lasonil pain reliever, like any drug that inhibits the synthesis of prostaglandins and
cyclooxygenase, is not recommended in women who intend to become pregnant.
The administration of Lasonil pain reliever should be discontinued in women who have fertility problems
or who are undergoing fertility investigations.

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

Lasonil contains methyl para-hydroxybenzoate and ethyl para-hydroxybenzoate which
can cause allergic reactions (including delayed reactions).

3. How to use Lasonil antidolore

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.
Apply a thin layer of gel to the area to be treated with a light massage.
Wash your hands thoroughly and for a prolonged period after application.

The recommended dose is2-4 applications per day to the painful area.

Warning:do not exceed the indicated doses.
Elderly patients should adhere to the minimum dosages indicated above.

Duration of treatment
Use the medicine for the shortest possible period.
Consult your doctor if the disorder occurs repeatedly or if you notice any changes
in its characteristics.
After a short period of treatment without appreciable results, consult your doctor.

If you use more Lasonil than you should
No cases of overdose have been reported.
In case of accidental ingestion or use of an excessive dose of Lasonil antidolore, immediately notify
your doctor 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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Side effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment necessary to control the symptoms.
Very rare side effects: less than 1 in 10,000 people:

• With some non-steroidal anti-inflammatory drugs for topical application, skin reactions with erythema, itching, irritation, a sensation of heat or burning, and contact dermatitis have been reported. Some cases of blistering rashes of varying severity, including Stevens-Johnson syndrome, and toxic epidermal necrolysis have also been reported.

Side effects reported with unknownfrequency (frequency cannot be estimated on the basis of available data):

• A widespread, red and scaly rash, with the formation of pustules under the skin and blisters located mainly in the skin folds, on the trunk and upper limbs accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop using Lasonil Antidolore if you develop these symptoms and contact your doctor immediately. See also section 2. The skin becomes sensitive to light. Photosensitivity reactions are possible (skin redness after application of the product and subsequent exposure to light, solar or UV). See also section 2.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform 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 Lasonil antidolore

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.
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.

6. Contents of the pack and other information

What Lasonil antidolore contains

• The active ingredient is Ibuprofen lysine salt. 100 g of gel contain 10g of Ibuprofen lysine salt.
• The other ingredients are isopropyl alcohol, hydroxyethylcellulose, methyl paraben, ethyl paraben, glycerol, lavender essence, purified water.

Description of the appearance of Lasonil antidolore and contents of the pack
Lasonil antidolore is available in gel form.
The pack contains a tube of 50 g or 120 g.

Marketing Authorisation Holder
Bayer SpA – Viale Certosa, 130 – 20156 Milan

Manufacturer
Doppel Farmaceutici S.r.l. - Officina di Cortemaggiore (Piacenza) – Via Martiri delle Foibe 1