Bravera control

Poland
Brand name Bravera control
Form spray, topical solution
Active substance / Dosage
lidocaine · 96 mg/g
Prescription type Over-the-counter
ATC code
N01BB02
Registration number 100386663
Manufacturer Aflofarm Farmacja Polska Limited
Bravera control spray, topical solution

Table of Contents

Package leaflet: Information for the patient

Bravera Control
96 mg/g, cutaneous aerosol, solution
Lidocaine
Please read all of this leaflet carefully before using this medicine because it contains important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

  • Keep this leaflet so that you can read it again if necessary.
  • If you need advice or further information, please consult your pharmacist.
  • If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
  • If your condition does not improve or worsens, contact your doctor.

Contents of the leaflet

  1. What Bravera Control is and what it is used for
  2. Important information before using Bravera Control
  3. How to use Bravera Control
  4. Possible side effects
  5. How to store Bravera Control
  6. Contents of the pack and other information

1. What Bravera Control is and what it is used for

Bravera Control contains lidocaine. Lidocaine acts as a local anaesthetic.
The anaesthetic effect of the medicine reduces the sensitivity of the glans penis in order to prolong the time to ejaculation.
The medicine is indicated for use before intercourse in cases of premature ejaculation, to reduce penile sensitivity to touch and to delay ejaculation.
If there is no improvement or if the patient feels worse, medical advice should be sought.

2. Information before using Bravera Control

When not to use Bravera Control:

  • if the patient or their partner has hypersensitivity to lidocaine or any of the other ingredients of this medicine (listed in section 6);
  • if the patient or their partner has hypersensitivity to other amide-type local anaesthetics;
  • if the patient's partner is pregnant;
  • on damaged or inflamed skin.

Warnings and precautions
Before starting to use Bravera Control, discuss this with a doctor or pharmacist.

  • If the patient has or has ever had liver or kidney function disorders, they should consult a doctor before using this medicine.
  • If a rash or irritation occurs in the patient or their partner during use, stop using the medicine and consult a doctor.

Avoid contact of the medicine with the eyes and mucous membranes of the mouth, nose, or throat of the patient or their partner.
If the medicine comes into contact with the eyes, rinse them immediately with cold water.
During use, the medicine may also come into contact with mucous membranes of other body areas, such as the mouth, nose, or throat of the patient or their partner, causing temporary numbness. Since the medicine reduces the ability to feel pain in these areas, particular caution should be exercised until the numbness subsides to avoid injury to these areas.
During sexual intercourse, a small amount of the medicine may pass into, for example, the vagina or rectum. As a result, partners may temporarily experience numbness and should exercise caution to avoid injury, especially during sexual activity.

Children and adolescents
Bravera Control must not be used in children and adolescents under 18 years of age.

Bravera Control and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently using or has recently used, as well as any medicines they plan to use.
Interactions may occur with:

  • cardiac medicines (antiarrhythmics);
  • antiepileptic medicines;
  • anticholinergic medicines (e.g. used to relieve stomach spasms, in the treatment of Parkinson's disease, or to prevent motion sickness);
  • antihypertensive medicines;
  • barbiturates (e.g. sedatives and those used in epilepsy treatment);
  • beta-blockers (medicines used to treat high blood pressure and regulate heart rhythm);
  • muscle relaxants;
  • sympathomimetic medicines (e.g. used in heart failure, asthma, or colds).
    An effect on diagnostic blood enzyme tests has also been reported.

Pregnancy and breastfeeding
If the patient's partner is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, consult a doctor or pharmacist before using this medicine.
This medicine is not indicated for use in women.
Do not use this medicine if the patient's partner is pregnant.

Driving and operating machinery
Bravera Control has no influence on the ability to drive or operate machinery.

3. How to use Bravera Control

This medicine should always be used exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Method of administration
For topical application (locally on the shaft and glans of the penis).
Adults
The recommended dose is 3 to 7 pump actuations, applied to cover the shaft and glans of the penis, 5 to 15 minutes before intercourse.
If excess product remains on the penis after 5 minutes, it should be removed before intercourse.
The amount and duration of application should be adjusted according to individual needs.
Always use the lowest effective dose.
An interval of at least 4 hours should be maintained between doses.
Do not exceed 22 pump actuations within 24 hours.
This medicine should not be used for longer than 1 month without medical supervision.
Instructions for use of Bravera Control
Before first use, hold the container upright and press the spray pump at least 10 times to prime it and ensure proper spray function. If the spray pump has not been used for at least 10 days, re-prime by actuating three times into the air.
Orient the container away from the face to avoid accidental contact of the medicine with eyes, ears, nose, or mouth.
Retract the foreskin from the glans. Holding the container upright (with the valve pointing upwards), apply 3 to 7 pump actuations evenly over the entire surface of the glans and penile shaft, 5 to 15 minutes before intercourse.
If excess product remains on the penis after 5 minutes, remove it before intercourse.

Three panels with instructions: spray with the number 3-7, close-up of a finger with a blue layer, and a clock with the text 5-15 min before intercourse

Use in children and adolescents
This medicine must not be used in children and adolescents under 18 years of age.
Use in elderly individuals
This medicine is not recommended for use in elderly individuals.
Use of a higher than recommended dose of Bravera Control
Since this medicine is applied to the surface of the penis, the risk of overdose is low.
If too much product is applied, local skin irritation at the site of application may occur.
In case of overdose, remove any excess medicine and consult a doctor.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
Local skin irritation or rash may very rarely occur after application of the medicine.
In such a case, use of the medicine should be discontinued.
No other adverse reactions have been reported following the application of recommended doses to the skin.
When higher doses are used or in case of hypersensitivity to lidocaine, the adverse reactions listed below may occur:
Very rare (occur in less than 1 person in 10,000):

  • symptoms of central nervous system disturbances, excitation, nervousness;
  • symptoms of central nervous system depression. Dizziness, drowsiness, seizures, loss of consciousness.

Frequency unknown (cannot be estimated from the available data):
Cardiac muscle weakness, bradycardia (slowing of heart function), cardiac arrest, hypotension, respiratory paralysis.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in the leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions enables further information on the safety of the medicine to be collected.

5. How to store Bravera Control

Keep the medicine out of the sight and reach of children.
Store below 25°C. Keep in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the label and carton. The expiry date refers to the last day of the stated month.
Period of use after first opening: 3 months.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Bravera Control contains

  • The active substance is lidocaine. 1 g of aerosol contains 96 mg of lidocaine. Each pump actuation delivers 0.085 ml of solution (corresponding to 81.98 mg of aerosol containing 7.87 mg of lidocaine).
  • The other ingredients are: stearic acid, isopropyl myristate, ethylene glycol monoethyl ether.

What Bravera Control looks like and contents of the pack
Bravera Control 96 mg/g, cutaneous aerosol, solution, is a colourless to yellow solution.
The medicinal product is contained in an HDPE bottle with a spray pump composed of polypropylene (PP), polyethylene (PE), polyoxymethylene (POM) and steel, containing 8 ml of solution, and presented in a cardboard box with a leaflet.

Marketing Authorisation Holder and Manufacturer
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
tel. (42) 22-53-100