JOINTRAL 100 mg /G Gel

Зміст інструкції

1. JOINTRAL 100 mg/g gel
   1. What is JOINTRAL and what is it used for
   2. What you need to know before using JOINTRAL
2. JOINTRAL should not be used during the first 6 months of pregnancy unless clearly
   1. How to use JOINTRAL
   2. Possible side effects
   3. How to store JOINTRAL
   4. Contents of the pack and other information

JOINTRAL 100 mg/g gel

Ibuprofen lysine

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 want 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 worsen.

Contents of this leaflet:

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

1. What is JOINTRAL and what is it used for

JOINTRAL contains ibuprofen lysine which is an analgesic that belongs to the class of
Non-Steroidal Anti-Inflammatory Drugs, for external use.
JOINTRAL is indicated in the local treatment of contusions, sprains, myalgias (muscle
pain), muscle tears, torticollis.

2. What you need to know before using JOINTRAL

Do not use JOINTRAL

• 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.
• If you are pregnant, especially in the last 3 months of pregnancy (see section “Pregnancy, breastfeeding and fertility”).
• If you are breastfeeding.
• In the case of children and adolescents under the age of 14 years.

Warnings and precautions
Consult your doctor or pharmacist before using JOINTRAL.
Do not apply JOINTRAL to open wounds or skin lesions.
The use of JOINTRAL, especially if prolonged, may lead to local sensitization phenomena: 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 phenomena of hypersensitivity or photosensitization (sensitivity
to light), do not expose yourself to direct sunlight, including solariums, during treatment
and for the two weeks following.
In association with treatment with ibuprofen, serious skin reactions have been reported including
exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal
necrosis, drug reaction with eosinophilia and systemic symptoms (DRESS),
acute generalized exanthematous pustulosis (AGEP). Stop using JOINTRAL and contact
your doctor immediately if you notice any of the symptoms related to these serious skin
reactions described in section 4.
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 also advisable to consult your doctor in cases where these disorders
have occurred in the past.
Consult your doctor in case of concomitant treatment with anticoagulants (see Other

medicines and JOINTRAL).

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

Other medicines and JOINTRAL
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
Ibuprofen, the active ingredient of JOINTRAL, may increase the effects of anticoagulants
such as warfarin. No clinically relevant interactions have been found with 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 taking this
medicine as it may cause adverse effects on pregnancy and/or the development of
the child 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 the dose and duration of therapy.
Oral forms (e.g., tablets) of ibuprofen can cause adverse effects in
the newborn.
If you use ibuprofen 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-hydramnios (reduction of fluid in the amniotic 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. It is not known if the same risk occurs with JOINTRAL when used on the skin.

Do not use JOINTRAL if you are in the last 3 months of pregnancy.

JOINTRAL should not be used during the first 6 months of pregnancy unless clearly

necessary and as directed by your doctor.
If treatment is necessary during this period, the lowest possible dose should be used for
the shortest possible time.
Do not use JOINTRAL during breastfeeding.
The use of JOINTRAL, as with any drug that inhibits prostaglandin and
cyclooxygenase synthesis, is therefore contraindicated if you are planning to become pregnant.
If you have fertility problems or are undergoing fertility investigations, discontinue the
administration of JOINTRAL.

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

JOINTRAL contains methyl paraben.It may cause allergic reactions
(including delayed reactions).

JOINTRAL contains ethyl paraben.It may cause allergic reactions
(including delayed reactions).

3. How to use JOINTRAL

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.
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 and use the medicine for the shortest possible period.
Elderly patients should adhere to the minimum dosages indicated above.
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 JOINTRAL 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, ringing in the ears (tinnitus), dizziness, uncontrolled body movements (convulsions) and loss of consciousness.
The symptoms of an overdose may appear within 4-6 hours of taking ibuprofen.
Rarely, you may experience uncontrolled eye movements (nystagmus), increased acids in the blood (metabolic acidosis), decreased body temperature (hypothermia), effects on the kidneys, bleeding of the stomach and intestines, profound loss of consciousness (coma), temporary cessation of breathing (apnea), diarrhea, reduced activity of the nervous system (central nervous system depression) and respiratory activity (respiratory system depression).
Furthermore, you may also experience disorientation, a state of excitement, fainting, low 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 liver.
In case of accidental ingestion/taking of an excessive dose of JOINTRAL, immediately inform your doctor or go to the nearest hospital.
If you have any doubts about the use of JOINTRAL, 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 minimised by using the lowest effective dose for the shortest duration
necessary to control the symptoms.
With some non-steroidal anti-inflammatory drugs derived from propionic acid for local or
transdermal (through the skin) use, skin reactions with erythema, itching, irritation, a
sensation of heat or burning and contact dermatitis have been reported.
Stop using ibuprofen and consult your doctor immediately if you notice any of the following
symptoms:

• reddish, non-raised, target-shaped or circular patches on the trunk, often with central blisters, skin peeling, ulcers of the mouth, throat, nose, genitals and eyes. These serious skin rashes 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 and scaly rash, with bumps under the skin and blisters, accompanied by fever. The symptoms usually appear at the beginning of treatment (acute generalised exanthematous pustulosis). Photosensitivity reactions (increased sensitivity to light - frequency not known) are possible.

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:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help to provide more information on the safety of this
medicine.

5. How to store JOINTRAL

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 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

6. Contents of the pack and other information

What JOINTRAL contains

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

Description of the appearance of JOINTRAL and contents of the pack
JOINTRAL is available in gel form.
The pack contains a tube of 50 g.

Marketing authorisation holder and manufacturer
Laboratorio Italiano Biochimico Farmaceutico LISAPHARMA S.p.A.
Via Licinio, 11
22036 ERBA (CO) – Italy
June 2024