Package leaflet: Information for the user

JOINTRAL 100 mg/g gel

Ibuprofen lysine
Please read this leaflet carefully before using this medicine, as 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 need more information or advice, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice improvement or if your symptoms worsen.

Contents of this leaflet:

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

1. What JOINTRAL is and what it is used for

JOINTRAL contains ibuprofen lysine, an analgesic belonging to the class of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), for topical use.
JOINTRAL is indicated for the local treatment of bruises, sprains, myalgia (muscle pain), muscle tears, and 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 (painkillers), antipyretics (fever reducers), or non-steroidal anti-inflammatory drugs (NSAIDs) that have previously caused asthma, rhinitis, urticaria, or other allergic reactions.
If you are pregnant, particularly during the last 3 months of pregnancy (see section “Pregnancy, breastfeeding and fertility”).
If you are breastfeeding.
In children and adolescents under 14 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before using JOINTRAL.
Do not apply JOINTRAL on open wounds or damaged skin.
The use of JOINTRAL, especially if prolonged, may lead to local sensitization reactions: at the first appearance of a skin rash, mucosal lesions, or any other sign of hypersensitivity, stop treatment and consult your doctor, who may take appropriate therapeutic measures.
To avoid more serious hypersensitivity or photosensitization reactions (sensitivity to light), avoid exposure to direct sunlight, including sunbeds, during treatment and for two weeks afterwards.
Serious skin reactions have been reported with ibuprofen use, 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 JOINTRAL and contact your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
If acetylsalicylic acid or other non-steroidal anti-inflammatory drugs have previously caused you asthma, rhinitis, urticaria, or other allergic reactions, consult your doctor before taking this medicine. It is advisable to consult your doctor even if such conditions occurred in the past.
Consult your doctor if you are undergoing concomitant treatment with anticoagulants (see Other medicines and JOINTRAL).

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

Other medicines and JOINTRAL
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Ibuprofen, the active ingredient in JOINTRAL, may enhance the effects of anticoagulants such as warfarin. No clinically relevant interactions have been observed with occasional use of ibuprofen.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine, as it may cause adverse effects on pregnancy and/or fetal development, such as risk of miscarriage, cardiac malformations, and gastroschisis (an abdominal wall defect causing abdominal organs to protrude).
The risk increases with dose and duration of treatment.
Oral forms (e.g., tablets) of ibuprofen may cause adverse effects in the newborn.
If you use ibuprofene 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- or anhydramnios (reduced amniotic fluid surrounding the fetus);
yourself and the newborn, at the end of pregnancy, to:
- possible prolonged bleeding time and antiplatelet effects, which may occur even at very low doses;
- inhibition of uterine contractions leading to delayed or prolonged labor. It is unknown whether the same risk applies with JOINTRAL when applied to the skin.

Do not use JOINTRAL during the last 3 months of pregnancy.
JOINTRAL must 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.
Do not use JOINTRAL during breastfeeding.
The use of JOINTRAL, like any drug that inhibits prostaglandin synthesis and cyclooxygenase, is therefore contraindicated if you intend to start a pregnancy.
If you have fertility problems or are undergoing fertility investigations, discontinue JOINTRAL treatment.

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

JOINTRAL contains methyl para-hydroxybenzoate sodium. It may cause allergic reactions (including delayed reactions).
JOINTRAL contains ethyl para-hydroxybenzoate sodium. It may cause allergic reactions (including delayed reactions).

3. How to use JOINTRAL

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.
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 gentle massage.
Wash your hands thoroughly and for a prolonged period after application.
Do not exceed the recommended doses and use the medicine for the shortest possible duration.
Elderly patients should adhere to the lower doses indicated above.
If symptoms recur repeatedly or if you notice any recent changes in their characteristics, consult your doctor.
If there is no noticeable improvement after a short period of treatment, consult your doctor.

If you use more JOINTRAL than you should
If you take an excessive dose (overdose) of ibuprofen, you may commonly experience the following symptoms: nausea, vomiting, stomach pain, deep drowsiness with reduced response to normal stimuli (lethargy), drowsiness, headache, ringing in the ears (tinnitus), dizziness, uncontrolled body movements (convulsions), and loss of consciousness.
Symptoms of overdose may appear within 4-6 hours after taking ibuprofen.
Rarely, you may experience uncontrolled eye movements (nystagmus), increased acid levels in the blood (metabolic acidosis), lowered body temperature (hypothermia), kidney-related effects, gastrointestinal bleeding, deep unconsciousness (coma), temporary interruption of breathing (apnea), diarrhoea, reduced activity of the nervous system (central nervous system depression), and reduced respiratory activity (respiratory depression).
Additionally, disorientation, excitement, fainting, low blood pressure (hypotension), decreased or increased heart rate (bradycardia or tachycardia) may occur.
If you take significantly high doses of ibuprofen, you may develop severe kidney and liver damage.
In case of accidental ingestion or overdose of JOINTRAL, contact your doctor immediately or go to the nearest hospital.
If you have any doubts about how to use JOINTRAL, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Side effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.
With some topical or transdermal (through the skin) propionic acid-derived non-steroidal anti-inflammatory drugs, skin reactions such as erythema, itching, irritation, sensation of warmth or burning, and contact dermatitis have been reported.

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

Flat, red, target-shaped or circular spots on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital, or eye ulcers. 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, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually occur at the beginning of treatment (acute generalized exanthematous pustulosis). Photosensitivity reactions (increased sensitivity to light – frequency not known) are possible.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You may also report side effects directly via the national reporting system at the following website:
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 JOINTRAL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after
Exp. 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 no longer in use. This will help protect the environment.
It is important to always keep the medicine information available; therefore, retain
both the packaging and the package leaflet.

6. Package contents and other information

What JOINTRAL contains

The active substance is ibuprofen lysine. 100 g of gel contain 10 g of ibuprofen lysine.
The other ingredients are isopropyl alcohol, hydroxyethylcellulose, methyl parahydroxybenzoate sodium, ethyl parahydroxybenzoate sodium, glycerol, lavender essence, purified water.

Description of the appearance of JOINTRAL and pack contents
JOINTRAL is presented as a gel.
The pack contains one 50 g tube.
Marketing Authorization Holder and Manufacturer
Laboratorio Italiano Biochimico Farmaceutico LISAPHARMA S.p.A.
Via Licinio, 11
22036 ERBA (CO) – Italy
June 2024