GINENORM Granules

GINENORM 0.1% VAGINAL SOLUTION
GINENORM 1 g POWDER FOR VAGINAL SOLUTION
Ibuprofen isobutanolammonio
PHARMACOTHERAPEUTIC CATEGORY
Non-steroidal anti-inflammatory drug for vaginal administration.

THERAPEUTIC INDICATIONS
Vulvovaginitis and cervicovaginitis of any origin and nature.
Pre- and post-operative treatment in gynecological surgery.
Use the ready-to-use solution or the sachets according to the intensity of the inflammation s.p.m.

CONTRAINDICATIONS
Hypersensitivity to the active ingredient or to any of the excipients.
The use of the product is not intended in pediatric age, unless judged by the doctor in cases of absolute necessity.
Contraindicated in pregnancy and breastfeeding (see Precautions for use).

PRECAUTIONS FOR USE
The preparation should not be used in severe specific or non-specific vulvovaginitis.

INTERACTIONS
Inform your doctor or pharmacist if you have recently taken any other medicines, including those
available over the counter.
No interaction studies have been conducted.

SPECIAL WARNINGS
The use, especially if prolonged, of topical products can lead to sensitization phenomena. In
such cases, it is necessary to interrupt the treatment and institute appropriate therapy.
Severe skin reactions, some of which fatal, including exfoliative dermatitis, Stevens-Johnson syndrome
and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs
(see Undesirable effects). In the early stages of therapy, patients appear to be at higher risk:
the onset of the reaction occurs in most cases within the first month of treatment.
Ginenorm should be discontinued at the first appearance of skin rash, mucosal lesions or any other
sign of hypersensitivity.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Contraindicated during pregnancy and breastfeeding.
Important information on some excipients.
The medicine contains parabens as preservatives and therefore may cause
allergic reactions (even delayed) and propylene glycol and therefore may cause skin irritation.
Effects on ability to drive and operate machinery
Ginenorm does not impair the ability to drive vehicles or operate machinery.

DOSAGE, ADMINISTRATION AND DURATION OF TREATMENT
1 or 2 vaginal irrigations a day, as directed by your doctor, using either the bottle containing the ready-to-use
substance, or by dissolving the contents of 1-2 sachets in one liter of water for each vaginal irrigation.

INSTRUCTIONS FOR USE
The solution can be used at room temperature or lukewarm by placing the bottle under a stream
of warm water.

• 1) Remove the guarantee and seal by pushing it laterally.
• 2) Extract the sterile cannula from its protective sheath and insert it into the bottle until it is securely positioned.
• 3) Position yourself so that the solution can perform its cleansing and therapeutic action.
• 4) Gently insert the cannula into the vagina and compress the bottle until completely empty.
• 5) Hold the liquid in the vagina for a few minutes to allow the solution to perform its therapeutic action. Also follow any instructions from your treating doctor.

OVERDOSE
If you have taken more X –GINENORM than you should, or if your child has taken this medicine by
mistake, always contact a doctor or the nearest hospital to get an opinion on the risk and
advice on the actions to be taken.
Symptoms may include nausea, stomach pain, vomiting (possibly with traces of
blood), headache, ringing in the ears, confusion and involuntary eye movements. At high doses,
drowsiness, chest pain, palpitations, loss of consciousness, convulsions
(especially in children), weakness and dizziness, blood in the urine, feeling cold and respiratory problems have been reported.
In case of ingestion/accidental intake of an excessive dose of Ginenorm, immediately notify
your doctor or go to the nearest hospital.
IF YOU HAVE ANY DOUBTS ABOUT THE USE OF GINENORM, ASK YOUR DOCTOR OR
PHARMACIST

UNDESIRABLE EFFECTS
Like all medicines, Ginenorm can cause side effects, although not everyone will
experience them.
It is possible to experience a serious skin reaction known as DRESS syndrome. The symptoms of DRESS
include: skin rash, fever, swollen lymph nodes and increased eosinophils (a type of white blood cells).
Very rarely, blistering reactions including Stevens-Johnson syndrome and Toxic
Epidermal Necrolysis have been reported.
If any of the side effects worsen, or if you notice any side effect

EXPIRY DATE AND STORAGE
“Expiry date: see the expiry date printed on the packaging”.
“The expiry date refers to the product in intact packaging, stored correctly”.
“Warning: do not use the medicine after the expiry date printed on the packaging”.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use, this will help protect the environment.
“Keep the medicine out of the reach and sight of children”
COMPOSITION
GINENORM 0.1% Vaginal Solution
100 ml contain:

Active ingredient: Ibuprofen isobutanolammonio g 0.1
equivalent to Ibuprofen g 0.0698

Excipients:2-Phenoxyethanol-p-hydroxybenzoates of methyl-ethyl-propyl-butyl, Polysorbate 20, Propylene glycol,
Floral essence, Deionized water.

GINENORM 1 g Powder for vaginal solution
One sachet contains:

Active ingredient: Ibuprofen isobutanolammonio g 1
equivalent to Ibuprofen g 0.698

Excipients:Imidazolidinyl urea, Sodium chloride.

PHARMACEUTICAL FORM AND CONTENT

• 0.1% Vaginal Solution 5 Bottles of 100 ml
• 1 g Powder for vaginal solution, 10 sachets

MARKETING AUTHORISATION HOLDER
AESCULAPIUS FARMACEUTICI S.r.l. - Via Cefalonia, 70 - 25124 BRESCIA.

MANUFACTURER- MITIM S.r.l. Via Cacciamali 34-36-38 - 25125 Brescia.

DRUG
March 2017February 2018