VEGETALLUMINA 10% Gel

Зміст інструкції

1. VEGETALLUMINA Antidolore 10% gel
   1. What is VEGETALLUMINA Antidolore and what is it used for
   2. What you need to know before using VEGETALLUMINA Antidolore
2. VEGETALLUMINA Antidolore contains methyl para-hydroxybenzoate sodium and ethyl para-
   1. How to use VEGETALLUMINA Antidolore
   2. Possible side effects
   3. How to store VEGETALLUMINA Antidolore
   4. Contents of the pack and other information

VEGETALLUMINA Antidolore 10% gel

Ibuprofen lysine salt

Read this leaflet carefully before taking 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 any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Talk to your doctor if you do not feel better or if your symptoms get worse

Contents of this leaflet:

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

1. What is VEGETALLUMINA Antidolore and what is it used for

VEGETALLUMINA Antidolore contains ibuprofen lysine which is an analgesic that belongs to the class of
Non-Steroidal Anti-Inflammatory Drugs for external use.
VEGETALLUMINA Antidolore is indicated in the local treatment of contusions, sprains, myalgias (muscle
pain), muscle tears, stiff neck.
Consult your doctor if you do not notice any improvement or if your symptoms worsen.

2. What you need to know before using VEGETALLUMINA Antidolore

Do not use VEGETALLUMINA Antidolore

• If you are allergic to ibuprofen lysine 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 asthma, rhinitis, urticaria or other allergic reactions in the patient.
• If you are pregnant.
• If you are breastfeeding.
• In the case of children and adolescents under the age of 14.

Warnings and precautions
Consult your doctor or pharmacist before using VEGETALLUMINA Antidolore.
Do not apply VEGETALLUMINA Antidolore to open wounds or skin lesions.
The use of VEGETALLUMINA Antidolore, especially if prolonged, may lead to local sensitization: at the first appearance of skin rash, mucosal lesions or any other sign of
hypersensitivity, stop treatment and consult your doctor who may adopt appropriate therapeutic measures.
To avoid more serious hypersensitivity or photosensitization (sensitivity to light), do not
expose yourself to direct sunlight, including solariums, during treatment and for the two weeks following.
In case of more important allergic reactions (skin reactions, some of which are fatal, such as
exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis) immediately stop
therapy and consult your doctor.
If the use of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs has caused you asthma,
rhinitis, urticaria or other allergic reactions, consult your doctor before taking the medicine. It is
advisable to consult your doctor even if these disorders have occurred in the past.
Consult your doctor in case of concomitant treatment with anticoagulants (see Other medicines and

VEGETALLUMINA Antidolore).

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

Other medicines and VEGETALLUMINA Antidolore
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Do not take VEGETALLUMINA Antidolore together with another NSAID or, in any case, do not use more than one
NSAID at a time.
Ibuprofen, the active ingredient of VEGETALLUMINA Antidolore, may increase the effects of
anticoagulants such as warfarin.
No clinically relevant interactions have been found with the occasional use of ibuprofen.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before using this medicine.
Do not take VEGETALLUMINA Antidolore during pregnancy and breastfeeding as it may cause
adverse effects on pregnancy and/or fetal development such as risk of abortion, cardiac malformation
and gastroschisis (defect of the abdominal wall which determines the leakage of abdominal organs). The risk increases with dose and duration of therapy.
If you use this medicine during the third trimester of pregnancy, you 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 (reduction of fluid in the gestational sac that surrounds the fetus);
• yourself and the newborn, at the end of pregnancy, to:
• possible prolongation of bleeding time, and anti-aggregating effect that can occur even at very low doses;
• inhibition of uterine contractions resulting in delayed or prolonged labor.

The use of VEGETALLUMINA Antidolore, like any drug that inhibits the synthesis of
prostaglandins and cyclooxygenase, is therefore contraindicated if you intend to become pregnant.
If you have fertility problems or are undergoing fertility investigations, stop taking
VEGETALLUMINA Antidolore.

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

Important information about some excipients
Vegetallumina Antidolore contains lavender essencewhich in turn contains citral, citronellol, coumarin,
eugenol, evernia furfuracea extract, evernia prunastri extract, geraniol, limonene, linalool.
Citral, citronellol, coumarin, eugenol, geraniol, limonene, linalool may cause allergic reactions.

VEGETALLUMINA Antidolore contains methyl para-hydroxybenzoate sodium and ethyl para-

hydroxybenzoate sodium.
Methyl hydroxybenzoate sodium and ethyl hydroxybenzoate sodium may cause allergic reactions (even
delayed).

3. How to use VEGETALLUMINA Antidolore

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 2-4 applications per day on the painful area.
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.
Do not exceed the indicated doses.
Elderly patients should adhere to the minimum dosages indicated above.
Use the medicine for the shortest possible period.
If the disorder recurs or if you notice any recent change in its characteristics
consult your doctor.
After a short period of treatment without appreciable results, consult your doctor.

If you use more VEGETALLUMINA Antidolore than you should
If you take an excessive dosage (overdose) of ibuprofen, you may more commonly experience the following
symptoms: nausea, vomiting, stomach pain, a state of deep sleep with reduced response to normal stimuli
(lethargy), drowsiness, headache, dizziness, ringing in the ears (tinnitus), uncontrolled movements of the
body (convulsions) and loss of consciousness. Symptoms of an overdose may appear within 4 – 6
hours of taking ibuprofen.
Rarely, it may present: uncontrolled eye movements (nystagmus), increased acids in the blood
(metabolic acidosis), lowering of body temperature (hypothermia), effects on the kidney,
bleeding of the stomach and intestines, profound loss of consciousness (coma), temporary
cessation of breathing (apnea), diarrhea, reduction of the activity of the nervous system (depression of the Central
Nervous System) and respiratory activity (depression of the respiratory system).
Furthermore, it may also manifest: disorientation, a state of excitement, fainting, lowering of the
blood pressure (hypotension), decrease or increase in heartbeats (bradycardia or tachycardia).
If you take significantly high doses of ibuprofen, you may experience serious damage to the kidneys and the
liver.
In case of accidental ingestion/intake of an excessive dose of VEGETALLUMINA Antidolore,
immediately inform your doctor or go to the nearest hospital.
If you have any doubts about the use of VEGETALLUMINA Antidolore, consult your doctor or pharmacist.

4. Possible side effects

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 possible duration of treatment necessary to control the symptoms.
With some non-steroidal anti-inflammatory drugs derived from propionic acid for topical or transdermal (through the skin) use, 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 (very rarely) have also been reported.
Photosensitivity reactions are possible (the skin becomes sensitive to light) (frequency not known).

Reporting of side effects
If you get any side effect, even if 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.aifa.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 VEGETALLUMINA 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 after 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.
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 VEGETALLUMINA Antidolore contains

• The active ingredient is ibuprofen lysine salt. 100 g of gel contains 10 g of ibuprofen lysine salt.
• The other ingredients are Isopropanol, hydroxyethylcellulose, methylparaben, ethylparaben, glycerol, lavender essence, purified water.

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

Marketing Authorisation Holder
PIETRASANTA PHARMA S.p.A. Via di Caprino, 7 – 55012 Capannori (LU)

Manufacturer
Beltapharm S.p.A, Via Stelvio 66, 20095 Cusano Milanino (MI)
Lab. It. Biochim. Farm.co LISAPHARMA S.p.A, Via Licinio, 11, 22036 ERBA (CO)