FORTACIN 150 mg /Ml Спрей

Содержание инструкции

1. Fortacin 150 mg/ml + 50 mg/ml cutaneous spray, solution
   1. What is Fortacin and what is it used for
   2. What you need to know before using Fortacin
   3. How to use Fortacin
   4. Possible side effects
   5. How to store Fortacin
   6. Contents of the pack and other information

Fortacin 150 mg/ml + 50 mg/ml cutaneous spray, solution

lidocaine/prilocaine

Read this leaflet carefully before you use this medicine because it contains important
information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Talk to your doctor if you do not get better or if your symptoms worsen.

Contents of this leaflet:

• 1. What Fortacin is and what it is used for
• 2. What you need to know before you use Fortacin
• 3. How to use Fortacin
• 4. Possible side effects
• 5. How to store Fortacin
• 6. Contents of the pack and other information

1. What is Fortacin and what is it used for

Fortacin is a combination of two medicines: lidocaine and prilocaine. These belong to a
group of medicines known as local anesthetics.
Fortacin is indicated for the treatment of premature ejaculation present from the first sexual encounter
in adult men (from 18 years of age). This condition occurs when ejaculation occurs, always or
almost always, within one minute of the start of sexual intercourse, with negative emotional effects.
Fortacin works by reducing the sensitivity of the glans to prolong the time before ejaculation.

2. What you need to know before using Fortacin

Do not use Fortacin

• if you or your partner are allergic to lidocaine, prilocaine or any of the other ingredients of this medicine (listed in section 6);
• if you or your partner have a history of allergy or sensitivity to other local anaesthetics with a similar structure (known as amide local anaesthetics).

Warnings and precautions
Talk to your doctor or pharmacist before using Fortacin

• if you, or your partner, have been diagnosed with a genetic disease or another condition affecting red blood cells (glucose-6-phosphate deficiency, anaemia or methemoglobinemia);
• if you have a history of sensitivity to medicines, particularly if you are not sure which medicine causes such sensitivity;
• if you suffer from severe liver problems.

Premature ejaculation may be caused by a condition that requires medical supervision.
Consult a doctor if this product, used according to the instructions, does not provide relief.

Use with condoms

• Fortacin should not be used with non-latex male or female condoms made of polyurethane, as these condoms may deteriorate if used together with Fortacin, thus risking failure to protect against sexually transmitted diseases or pregnancy. Fortacin can be used with condoms made of latex, polyisoprene, nitrile and silicone, as these materials have not shown signs of deterioration. Carefully check the material of your or your partner's condom before using this product. If in doubt, consult your pharmacist.
• If you use Fortacin with condoms, you are more likely to have difficulty achieving or maintaining an erection. You may also be more likely to experience reduced sensitivity on the penis or in the surrounding area.

Avoid accidental contact

• When using this medicine, especially during triggering of the container, keep it away from your face to avoid accidental contact with your ears, eyes, nose and mouth.
• If the medicine accidentally comes into contact with your eyes or your partner's eyes, immediately rinse them with cold water or sodium chloride solution and keep them closed as much as possible, until any effects, such as numbness, disappear. Remember that normal protective mechanisms, such as blinking, or the sensation of a foreign body in the eye may not occur before the numbness disappears.
• Fortacin should not come into contact with a damaged eardrum.

Contact with other mucous membranes

• Fortacin may also come into contact with other mucous membranes such as your mouth, nose or throat (or those of your partner), causing a slight sensation of numbness for a short period. Since this reduces the ability to feel pain in these areas, you should be more careful not to injure them until the numbness disappears.

Possible transfer to partner, e.g. to the vagina or anus

• During sexual intercourse, a reduced amount of this medicine may be transferred, for example, to the vagina or anus. Therefore, you and your partner may experience a slight numbness for a short period and it is important that you are careful not to injure yourselves, especially during sexual activity. For further information regarding possible adverse effects in sexual partners, see section 4.

If you or your partner develop a rash or irritation, stop using Fortacin. If the symptoms
persist, consult a doctor.

Children and adolescents
This medicine should not be given to children or adolescents under the age of 18 years.

Other medicines and Fortacin
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. It is important to particularly talk to your doctor before using Fortacin
if you are taking any of the following medicines that may interact with Fortacin:

• other local anaesthetics such as benzocaine and procaine
• medicines for the treatment of heart disorders (antiarrhythmic medicines such as mexiletine and amiodarone)
• fluvoxamine, cimetidine or beta-blockers, which can cause an increase in blood levels of lidocaine.
• medicines known to increase the risk of developing a disorder that reduces the amount of oxygen in the blood (methemoglobinemia), including those listed below:
• Benzocaine - a local anaesthetic used to treat pain and itching
• Chloroquine, primaquine, quinidine, quinine - used to treat malaria
• Metoclopramide - used to treat nausea and vomiting, even in patients with migraine
• Glycerol trinitrate (GTN, nitroglycerin), isosorbide mononitrate, erythrityl tetranitrate, pentaerythritol tetranitrate and other nitrates and nitrites - used to treat angina (chest pain caused by the heart)
• Sodium nitroprusside, isosorbide dinitrate - used to treat hypertension and heart failure
• Nitrofurantoin - an antibiotic used to treat urinary and kidney infections
• Sulphonamides (also called sulfa drugs), for example sulfamethoxazole - an antibiotic used to treat urinary infections and sulfasalazine - used to treat Crohn's disease, ulcerative colitis and rheumatoid arthritis
• Dapsone - used to treat skin conditions such as leprosy and dermatitis and to prevent malaria and pneumonia in high-risk patients
• Phenobarbital, phenytoin - used to treat epilepsy
• Para-aminosalicylic acid (PAS) - used to treat tuberculosis

The risk of methemoglobinemia may also increase with the use of certain dyes (aniline
dyes), or the pesticide naphthalene, so tell your doctor if you work in contact with dyes or
chemical pesticides.

Pregnancy, breastfeeding and fertility
Fortacin is not approved for use by women.
Ask your doctor or pharmacist for advice before taking any medicine.

Pregnancy
Fortacin should not be used when your partner is pregnant, unless she uses an
effective male condom, as indicated previously in section 2 “Use with condoms”, to
avoid exposure of the foetus.

Breastfeeding
You can use this medicine if your partner is breastfeeding.

Fertility
Fortacin may reduce the possibility of pregnancy. Therefore, patients seeking pregnancy
should avoid using Fortacin or, if necessary to achieve penetration, wash the glans
as thoroughly as possible five minutes after applying Fortacin, but before sexual
intercourse.

Driving and using machines
Fortacin does not impair or negligibly impairs the ability to drive and operate machines
when used at the recommended doses.

3. How to use Fortacin

Use this medicine following the instructions provided in this leaflet exactly. If you have any doubts,
consult your doctor or pharmacist.
The recommended dose of Fortacin is 3 sprays (3 sprays = 1 dose) on the glans at least 5 minutes before
sexual intercourse. A maximum of 3 doses can be used within 24 hours, at intervals of
at least 4 hours.
The maximum recommended dose (3 doses within 24 hours) must not be exceeded.

Instructions for use

• Before initial use, shake the spray container briefly, then activate the pump mechanism by dispensing three sprays into the air. Keep the container away from your face to avoid contact with your eyes, nose, mouth and ears.
• Before each subsequent dose, shake the spray container briefly, then reactivate the pump by dispensing one spray into the air.
• Retract the foreskin from the glans. Holding the container in a vertical position (with the valve facing upwards), apply 1 dose (3 sprays) of Fortacin to the glans, covering one third with each spray.
• Wait 5 minutes, then dry off any excess spray before sexual intercourse. It is important to dry off any excess spray even if you are using a condom (see also section 2 for other important information regarding use with condoms).

If you use more Fortacinthan you should
If you apply too much, remove it by drying the area.
The symptoms related to excessive use of Fortacin are listed below. Consult your doctor or
pharmacist if you experience any of them. However, it is very unlikely that they will occur if the
medicine is used as directed:

• feeling of dizziness or lightheadedness
• tingling of the skin around the mouth and numbness of the tongue
• altered sense of taste
• blurred vision
• ringing in the ears
• there is also a risk of developing a condition that reduces the amount of oxygen in the blood (methemoglobinemia). This is more likely if taken at the same time as certain medicines. If this occurs, the skin will become bluish-grey due to lack of oxygen.

In severe cases of overdose, symptoms may include convulsions, hypotension, slowed
breathing, respiratory arrest and altered heartbeat. Such effects could be
life-threatening.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have been reported with the use of Fortacin in male patients:
Common (may affect up to 1 in 10 people)

• inability to achieve or maintain an erection
• decreased sensitivity on the penis and in the surrounding area
• burning sensation on the penis and in the surrounding area

Uncommon (may affect up to 1 in 100 people)

• headache
• local irritation of the throat (if inhaled)
• skin irritation
• redness on the penis and in the surrounding area
• inability to ejaculate during sexual intercourse
• abnormal orgasm
• tingling on the penis and in the surrounding area
• pain or discomfort on the penis and in the surrounding area
• itching on the penis and in the surrounding area
• high fever

The following side effects have been reported in sexual partners with the use of Fortacin:
Common (may affect up to 1 in 10 people)

• burning sensation on the vagina and in the surrounding area
• decreased sensitivity on the vagina and in the surrounding area

Uncommon (may affect up to 1 in 100 people)

• headache
• local irritation of the throat (if inhaled)
• vaginal candidiasis
• discomfort in the anus and rectum
• loss of mouth sensitivity
• difficulty or pain in urination
• vaginal pain
• discomfort or itching of the vulva and vagina

Reporting of side effects
If you or your sexual partner experience any side effects, including those not
listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects
directly through the national reporting system detailed in Annex V.
By reporting side effects you can help to provide more information on the safety of
this medicine.

5. How to store Fortacin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the label of the spray container
and on the box after “Exp.”. The expiry date refers to the last day of that month.
Store at a temperature below 25 °C. Do not freeze. Dispose of the container 12 weeks after
the first use.
The metal container is pressurised. Do not puncture, break or burn it, even when it appears
empty. After administering all doses, a residual volume of unusable liquid remains in the container.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Fortacin contains

• The active ingredients are lidocaine and prilocaine.
• Each ml of solution contains 150 mg of lidocaine and 50 mg of prilocaine.
• Each spray delivers 50 microlitres of product and contains 7.5 mg of lidocaine and 2.5 mg of prilocaine.
• 1 dose is equivalent to 3 sprays.
• The other component is norflurane.

Description of the appearance of Fortacin and contents of the pack
Fortacin is a solution in the form of a cutaneous spray, from colourless to light yellow, contained in an
aluminium container with a metering valve.
The components of the metering valve are stainless steel, POM, TPE, polypropylene, rubber
chlorobutylated and HDPE.
Each pack contains 1 spray container with 6.5 ml or 5 ml of solution.

• Each 6.5 ml spray container contains a minimum of 20 doses.
• Each 5 ml spray container contains a minimum of 12 doses.

Marketing Authorisation Holder
Recordati Ireland Limited
Raheens East
Ringaskiddy Co. Cork P43 KD30
Ireland

Manufacturer
Genetic S.p.A.
Via Canfora, 64
84084 Fisciano (SA)
Italy
Recordati Industria Chimica e Farmaceutica S.p.A.
Via Matteo Civitali 1
20148 Milano
Italy
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Recordati Ireland Ltd.
Tél/Tel: + 353 21 4379400

Lietuva
Recordati Ireland Ltd.
Tel: + 353 21 4379400

България
Recordati Ireland Ltd.
Teл.: + 353 21 4379400

Luxembourg/Luxemburg
Recordati Ireland Ltd.
Tél/Tel: + 353 21 4379400

Česká republika
Herbacos Recordati s.r.o.
Tel: + 420 466 741 915

Magyarország
Recordati Ireland Ltd.
Tel.: + 353 21 4379400

Danmark
Recordati Ireland Ltd.
Tlf: + 353 21 4379400

Malta
Recordati Ireland Ltd.
Tel: + 353 21 4379400

Deutschland
Recordati Pharma GmbH
Tel: + 49 (0) 731 7047 0

Nederland
Recordati Ireland Ltd.
Tel: + 353 21 4379400

Eesti
Recordati Ireland Ltd.
Tel: + 353 21 4379400

Norge
Recordati Ireland Ltd.
Tlf: + 353 21 4379400

Ελλάδα
Recordati Hellas Pharmaceuticals A.E.
Τηλ: + 30 210-6773822

Österreich
Recordati Ireland Ltd.
Tel: + 353 21 4379400

España
Casen Recordati, S.L.
Tel: + 34 91 659 15 50

Polska
RECORDATI POLSKA sp. z o.o.
Tel.: + 48 22 206 84 50

France
Laboratoires BOUCHARA-RECORDATI
Tél: + 33 1 45 19 10 00

Portugal
Jaba Recordati, S.A.
Tel: + 351 21 432 95 00

Hrvatska
Recordati Ireland Ltd.
Tel: + 353 21 4379400

România
Recordati România S.R.L.
Tel: + 40 21 667 17 41

Ireland
Recordati Ireland Ltd.
Tel: + 353 21 4379400

Slovenija
Recordati Ireland Ltd.
Tel: + 353 21 4379400

Ísland
Recordati Ireland Ltd.
Sími: + 353 21 4379400

Slovenská republika
Herbacos Recordati s.r.o.
Tel: + 420 466 741 915

Italia
Recordati Industria Chimica e Farmaceutica
S.p.A.
Tel: + 39 02 487871

Suomi/Finland
Recordati Ireland Ltd.
Puh/Tel: + 353 21 4379400

Κύπρος
Recordati Ireland Ltd.
Τηλ: + 353 21 4379400

Sverige
Recordati Ireland Ltd.
Tel: + 353 21 4379400

Latvija
Recordati Ireland Ltd.
Tel: + 353 21 4379400

United Kingdom (Northern Ireland)
Recordati Ireland Ltd.
Tel: + 353 21 4379400

Other sources of information
More detailed and up-to-date information on this medicinal product is available by scanning the
QR code below or on the outer packaging with a smartphone.
The same information is also available at the following web address: www.fortacin.eu
QR Code www.fortacin.eu
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, http://www.ema.europa.eu .