FORTACIN

Patient Information Leaflet: Information for the User

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

lidocaine/prilocaine
Please read this leaflet carefully before using 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 instructed you.

• Keep this leaflet. You may need to read it again.
• If you would like more information or advice, please ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, please contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement 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 using 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 Fortacin is and what it is used for

Fortacin is a combination of two medicines: lidocaine and prilocaine. These belong to a group of medicines known as local anaesthetics.
Fortacin is indicated for the treatment of lifelong premature ejaculation in adult men (from 18 years of age). This condition occurs when ejaculation happens always or almost always within one minute from the start of sexual intercourse, causing negative emotional effects.
Fortacin works by reducing the sensitivity of the glans penis, thereby prolonging the time to 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-type 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 disorder or other condition affecting red blood cells (glucose-6-phosphate deficiency, anaemia, or methaemoglobinaemia);
• if you have a history of drug sensitivity, especially if you are unsure which medicine causes this sensitivity;
• if you have severe liver problems.

Premature ejaculation may be caused by an underlying condition requiring medical supervision.
Consult a doctor if this product, when used according to instructions, does not provide relief.
Use with condoms

• Fortacin must not be used with non-latex male or female condoms made from polyurethane, as these condoms may deteriorate when used together with Fortacin, thereby failing to protect against sexually transmitted infections or pregnancy. Fortacin can be used with contraceptives made from latex, polyisoprene, nitrile, and silicone, as these materials have not shown signs of deterioration. Before using this product, carefully check the material of your contraceptive or your partner’s. If in doubt, consult your pharmacist.
• If you use Fortacin with condoms, you may be more likely to experience difficulty achieving or maintaining an erection. You may also have an increased likelihood of reduced sensitivity on the penis or surrounding area.

Avoid accidental contact

• When using this medicine, especially during priming of the container, keep it away from your face to avoid accidental contact with 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 until the numbness wears off.
• Fortacin must 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 mild numbing sensation for a short period. Since this reduces the ability to feel pain in these areas, extra care must be taken to avoid injury until the numbness has gone.

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

• During sexual intercourse, a small amount of this medicine may be transferred, for example, to the vagina or anus. Therefore, you and your partner may experience mild numbness for a short time, and it is important that you take care not to injure yourselves, particularly during sexual activity. For further information about possible side effects in sexual partners, see section 4.

If you or your partner develop a rash or irritation, stop using Fortacin. If symptoms
persist, consult a doctor.
Children and adolescents
This medicine must not be given to children or adolescents under 18 years of age.
Other medicines and Fortacin
Tell your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines. It is particularly important to talk to a doctor before using Fortacin
if you are taking any of the following medicines, which may interact with Fortacin:

• other local anaesthetics such as benzocaine and procaine
• medicines for heart conditions (antiarrhythmics such as mexiletine and amiodarone)
• fluvoxamine, cimetidine, or beta-blockers, which may increase blood levels of lidocaine
• medicines known to increase the risk of developing a disorder that reduces the amount of oxygen in the blood (methaemoglobinaemia), including those listed below:
• Benzocaine – a local anaesthetic used to treat pain and itching
• Chloroquine, primaquine, pamaquine, quinine – used to treat malaria
• Metoclopramide – used to treat nausea and vomiting, including in patients with migraine
• Glyceryl trinitrate (GTN, nitroglycerin), isosorbide mononitrate, erythrityl tetranitrate, pentaerythritol tetranitrate, and other nitrates and nitrites – used to treat angina (chest pain caused by heart problems)
• Sodium nitroprusside, isosorbide dinitrate – used to treat hypertension and heart failure
• Nitrofurantoin – an antibiotic used to treat urinary and kidney infections
• Sulphonamides (also known as sulfa drugs), for example sulfamethoxazole – an antibiotic used to treat urinary tract 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 methaemoglobinaemia may also increase with the use of certain dyes (aniline dyes) or the pesticide naphthalene; therefore, inform your doctor if you work 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 must not be used when your partner is pregnant unless an effective male condom is used, as described earlier in section 2 “Use with condoms”, to avoid fetal exposure.
Breastfeeding
You may use this medicine if your partner is breastfeeding.
Fertility
Fortacin may reduce the chance of pregnancy. Therefore, patients seeking pregnancy should avoid using Fortacin or, if use is necessary to achieve penetration, wash the glans as thoroughly as possible five minutes after application of Fortacin, but before sexual intercourse.
Driving and using machines
Fortacin does not affect or has negligible effect on the ability to drive vehicles and use machines when used at the recommended doses.

3. How to use Fortacin

Use this medicine exactly as stated in this leaflet. If you have any doubts, consult your doctor or pharmacist.
The recommended dose of Fortacin is 3 sprays (3 sprays = 1 dose) applied to the glans at least 5 minutes before sexual intercourse. A maximum of 3 doses may be used within 24 hours, spaced at least 4 hours apart.
The maximum recommended dose (3 doses within 24 hours) must not be exceeded.

Instructions for use

• Before first use, shake the spray container briefly, then prime the pump mechanism by releasing three sprays into the air. Hold the container away from the face to avoid contact with the eyes, nose, mouth and ears.
• Before each subsequent dose, shake the spray container briefly, then re-prime the pump by releasing one spray into the air.
• Retract the foreskin from the glans. Holding the container in an upright position (with the valve facing upwards), apply 1 dose (3 sprays) of Fortacin to the glans, covering one-third of it with each spray.
• Wait 5 minutes, then wipe off any excess spray before sexual intercourse. It is important to wipe off any excess spray even if a condom is used (see also section 2 for further important information regarding use with condoms).

If you use more Fortacin than you should
If you apply too much, remove it by wiping the area.
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 these will occur if the medicine is used as directed:

• feeling dizzy or lightheaded
• 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 certain medicines are taken concomitantly. If this occurs, the skin may become bluish-grey due to lack of oxygen.

In severe cases of overdose, symptoms may include seizures, hypotension, slowed breathing, respiratory arrest and irregular heartbeat. These effects could be life-threatening.
If you have any doubts about how to use 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
• reduced sensitivity on the penis and surrounding area
• burning sensation on the penis and 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 surrounding area
• inability to ejaculate during sexual intercourse
• abnormal orgasm
• tingling sensation on the penis and surrounding area
• pain or discomfort on the penis and surrounding area
• itching on the penis and 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 in the vagina and surrounding area
• reduced sensitivity in the vagina and 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 during urination
• vaginal pain
• discomfort or itching of the vulva and vagina

Reporting of side effects
If you or your sexual partner experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system detailed in Annex V. Reporting side effects can help 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 stated on the label of the spray container and on the carton after "Exp.". The expiry date refers to the last day of that month.
Store below 25 °C. Do not freeze. Discard the container 12 weeks after first use.
The metal container is pressurized. Do not pierce, break, or burn it, even when it seems empty. After administration of all doses, a residual volume of liquid remains in the container which cannot be used.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What Fortacin contains

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

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

• Each 6.5 ml spray container contains at least 20 doses.
• Each 5 ml spray container contains at least 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 about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

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

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

Česká republika Magyarország
Herbacos Recordati s.r.o. Recordati Ireland Ltd.
Tel: + 420 466 741 915 Tel.: + 353 21 4379400

Danmark Malta
Recordati Ireland Ltd. Recordati Ireland Ltd.
Tlf: + 353 21 4379400 Tel: + 353 21 4379400

Deutschland Nederland
Recordati Pharma GmbH Recordati Ireland Ltd.
Tel: + 49 (0) 731 7047 0 Tel: + 353 21 4379400

Eesti Norge
Recordati Ireland Ltd. Recordati Ireland Ltd.
Tel: + 353 21 4379400 Tlf: + 353 21 4379400

Ελλάδα Österreich
Recordati Hellas Pharmaceuticals A.E. Recordati Ireland Ltd.
Τηλ: + 30 210-6773822 Tel: + 353 21 4379400

España Polska
Casen Recordati, S.L. RECORDATI POLSKA sp. z o.o.
Tel: + 34 91 659 15 50 Tel.: + 48 22 206 84 50

France Portugal
Laboratoires BOUCHARA-RECORDATI Jaba Recordati, S.A.
Tél: + 33 1 45 19 10 00 Tel: + 351 21 432 95 00

Hrvatska România
Recordati Ireland Ltd. Recordati România S.R.L.
Tel: + 353 21 4379400 Tel: + 40 21 667 17 41

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

Ísland Slovenská republika
Recordati Ireland Ltd. Herbacos Recordati s.r.o.
Sími: + 353 21 4379400 Tel: + 420 466 741 915

Italia Suomi/Finland
Recordati Industria Chimica e Farmaceutica Recordati Ireland Ltd.
S.p.A. Puh/Tel: + 353 21 4379400
Tel: + 39 02 487871

Κύπρος Sverige
Recordati Ireland Ltd. Recordati Ireland Ltd.
Τηλ: + 353 21 4379400 Tel: + 353 21 4379400

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