Rosalgin 20 sobres


Indicated for local and temporary relief of itching and burning of the outer vaginal area



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Rosalgin 20 sobres

Indicated for local and temporary relief of itching and burning of the outer vaginal area

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 1. What it is Rosalgin and what it is used
It belongs to a group of medicines called anti-inflammatories for vaginal administration. This medicine is indicated for local and temporary relief of itching and burning of the outer vaginal area in adults.

 2. What you need to know before you start using Rosalgin
Do not use Rosalgin if you are allergic to benzydamine or any of the other ingredients of this medicine (listed in section 6).

Warnings and Precautions
- Ask your pharmacist before you start using Rosalgin
- This medicine is used only vaginally.
- After applying the solution, wash hands with water, as described cases of photosensitive allergic reactions following exposure of hands to sunlight, without having previously removed the product (see "4. Possible Adverse effects").
- If sensitivity or irritation, or burning or persistent itching should stop treatment and consult your doctor (see section 4 "Possible side effects").
- If symptoms worsen or remain after 5 days or notice increased vaginal discharge or changes in appearance or odor or bleeding, you should consult your doctor.

Interactions with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
No medicine interactions are known.

Pregnancy, lactation and fertility
If you are pregnant or breast feeding, or think you might be pregnant or planning to become pregnant, ask your doctor or pharmacist before using this medicine.

Driving and using machines
Using this medicine does not alter the ability to drive or use machines, since systemic absorption is practically nil or negligible.

 3. Using Rosalgin
Follow exactly the instructions of medicine administration in this leaflet or as your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.
This medicine is used ONLY vaginally.
The recommended dose is 1 or 2 external washes a day for 5 days.
The preparation of the solution is effected by dissolving the contents of two envelopes in 1 liter of water. The water may be warm.
After applying the solution, wash hands thoroughly.

If you use more than you should Rosalgin
No cases of overdose have been observed with Rosalgin used vaginally.
Accidental ingestion of benzydamine hydrochloride may have no symptoms or may feel nausea, vomiting, abdominal pain, dizziness, visual hallucinations or irritability, muscle weakness, tremors, drowsiness, headache, blurred vision, high blood pressure, among other . There is no specific antidote, however, usually subsides spontaneously once the medicine is removed. It may be necessary symptomatic treatment.
In case of overdose or accidental ingestion immediately consult your doctor or pharmacist or call the Toxicology Information Service on +34 91 562 04 20, indicating the medicine and the amount taken.

 4. Possible side effects
Like all medicines, Rosalgin can cause side effects, although not everybody gets them.
Very rare side effects (less than 1 in 10,000 people):
- Skin sensitivity to sunlight (causing rash or sunburn), burning, itching at the application site.
If you experience side effects, consult your doctor or pharmacist, even if it comes to possible side effects not listed in this leaflet.

 5. Conservation  of Rosalgin
It does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date on the carton after EXP. The expiry date is the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Place containers and medicines no longer required in Point SIGRE pharmacy. If in doubt, ask your pharmacist how to dispose of medicines no longer required. This way you will help to protect the environment.

 6. Contents of the pack and other information
Composition of Rosalgin
- The active substance is benzydamine (as benzydamine hydrochloride). Each sachet contains 500 mg of benzydamine hydrochloride.
- The other ingredients (excipients) are: tricetol, sodium chloride and povidone K-25.

Looks like and contents of the pack
Rosalgin is in the form of granules for white vaginal solution. Each box contains 20 envelopes.

Holder of the marketing authorization
C. Osi, 7
08034 Barcelona

Responsible for manufacturing
A.C.R.A.F. Spa
Via Vecchia Pinocchio, 22
60131 Ancona (Italy)

Source: Spanish Agency for Medicines and Health Products


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