Ginenorm

GINENORM 0.1 g VAGINAL SOLUTION
GINENORM 1 g POWDER FOR VAGINAL SOLUTION
Ibuprofen isobutanolammonium

PHARMACOTHERAPEUTIC CATEGORY
Non-steroidal anti-inflammatory agent 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 sachets according to the intensity of inflammation, as directed by the physician.

CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients.
The use of this product is not intended in pediatric patients, except at the physician's discretion in cases of absolute necessity.
Contraindicated during pregnancy and breastfeeding (see Precautions for use).

PRECAUTIONS FOR USE
This preparation must not be used in severe specific or non-specific vulvovaginitis.

INTERACTIONS
Inform your doctor or pharmacist if you have recently taken any other medicinal products, including those without prescription.
No interaction studies have been conducted.

SPECIAL WARNINGS
The use, especially if prolonged, of topical products may lead to hypersensitivity reactions. In such cases, treatment must be discontinued and appropriate therapy initiated.

Skin reactions
Serious skin reactions have been reported in association with Ginenorm treatment. Discontinue use of Ginenorm and consult your doctor immediately if skin rash, mucosal lesions, blisters or other signs of allergy occur, as these may be early signs of a severe skin reaction. See section “Undesirable effects”.

Pregnancy and breastfeeding
Consult your doctor or pharmacist before taking any medicine.
Contraindicated during pregnancy and breastfeeding.

Important information about certain excipients
The medicine contains parahydroxybenzoates as preservatives and may therefore cause allergic reactions (including delayed-type reactions). It also contains propylene glycol, which may cause skin irritation.

Effects on ability to drive and use machines
Ginenorm does not affect the ability to drive vehicles or operate machinery.

DOSAGE, METHOD AND DURATION OF ADMINISTRATION
1 or 2 vaginal irrigations daily, as directed by the physician, using either the ready-to-use bottle or dissolving the contents of 1–2 sachets in one liter of water for each vaginal irrigation.

INSTRUCTIONS FOR USE
The solution may be used at room temperature or slightly warmed by placing the bottle under warm running water.

1. Remove the tamper-evident and closure seal by pushing it sideways.
2. Remove the sterile cannula from its protective packaging and attach it securely to the bottle.
3. Position yourself so that the solution can exert its cleansing and therapeutic effect.
4. Gently insert the cannula into the vagina and squeeze the bottle until completely emptied.
5. Retain the liquid in the vagina for several minutes to allow the solution to exert its therapeutic effect. Also follow any additional instructions provided by your physician.

OVERDOSE
If you have taken more Ginenorm than you should, or if your child has accidentally ingested this medicine, contact a doctor or the nearest hospital immediately to assess the risk and receive advice on necessary actions.

Symptoms may include nausea, stomach ache, vomiting (possibly with traces of blood), headache, tinnitus, confusion, and uncontrolled eye movements. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness, dizziness, blood in urine, feeling cold, and breathing difficulties have been reported.

In case of accidental ingestion/overdose of Ginenorm, contact your doctor immediately or go to the nearest hospital.

IF YOU HAVE ANY DOUBT ABOUT THE USE OF GINENORM, CONSULT YOUR DOCTOR OR PHARMACIST

UNDESIRABLE EFFECTS
Like all medicines, Ginenorm can cause undesirable effects, although not everybody will experience them.

A severe skin reaction known as DRESS syndrome may occur. 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 observed.

Frequency: Not known:
A widespread, red, scaly rash with pustules under the skin and blisters mainly localized in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (generalized pustular exanthema). Discontinue use of Ginenorm immediately if these symptoms develop and contact your doctor without delay. See also section “Special warnings”.

Skin becomes sensitive to light – frequency not known

Following the instructions in this leaflet reduces the risk of undesirable effects.

If any of the undesirable effects worsens, or if you notice any undesirable effects not listed in this leaflet, inform your doctor or pharmacist.

EXPIRY DATE AND STORAGE
“Expiry date: see the date printed on the packaging.”
“The expiry date refers to the product in its original, undamaged packaging, correctly stored.”
“Do not use this medicine after the expiry date stated on the packaging.”

Do not store above 30°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used — this helps protect the environment.
“Keep this medicine out of the reach and sight of children.”

COMPOSITION
GINENORM 0.1 g Vaginal Solution
100 ml contains:
Active substance: Ibuprofen isobutanolammonium 0.1 g
equivalent to Ibuprofen 0.0698 g
Excipients: 2-Phenoxyethanol, methyl-, ethyl-, propyl- and butyl-parahydroxybenzoates, Polysorbate 20, Propylene glycol, Floral essence, Deionized water.

GINENORM 1 g Powder for Vaginal Solution
One sachet contains:
Active substance: Ibuprofen isobutanolammonio 1 g
equivalent to Ibuprofen 0.698 g
Excipients: Imidazolidinylurea, Sodium chloride.

PHARMACEUTICAL FORM AND CONTENT

• 0.1 g Vaginal Solution – 3 bottles of 100 ml
• 0.1 g Vaginal Solution – 5 bottles of 100 ml
• 1 g Powder for Vaginal Solution – 10 sachets

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

MANUFACTURER
Laboratorio Chimico Farmaceutico “A. Sella” S.r.l. - Via Vicenza 67, 36015 Schio (VI), ITALY

REVISION OF THE PACKAGE LEAFLET BY THE ITALIAN MEDICINES AGENCY