FORTACIN 150 mg/mL + 50 mg/mL CUTANEOUS SPRAY SOLUTION

2. What you need to know before you start using Fortacin

Do not use Fortacin

• if you or your partner are allergic to lidocaine or prilocaine or to any of the other components of this medicine (listed in section 6);

• if you or your partner have a history of allergy or sensitivity to other local anesthetics of similar structure (known as amide-type local anesthetics).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Fortacin

• if you or your partner have been diagnosed with a genetic disease or other disorder that affects red blood cells (glucose-6-phosphate dehydrogenase deficiency, anemia, or methemoglobinemia);

• if you have a history of sensitivity to medicines, especially if you are not sure which medicines cause sensitivity;

• if you have severe liver problems.

Premature ejaculation may be due to a disease that requires medical supervision. If this product used directly does not provide relief, consult a doctor.

Use with condoms

• Fortacin should not be used with female and male condoms made of polyurethane without latex, as deterioration has been observed when used with Fortacin, and protection against sexually transmitted diseases or pregnancy may be reduced. Fortacin can be used with latex, polyisoprene, nitrile, and silicone contraceptives, as no deterioration has been observed. Check carefully the material with which your contraceptives or those of your partner are made before using this product. Consult your pharmacist if you have any doubts.

• If you use Fortacin with condoms, there is a greater chance that you will not be able to develop or maintain an erection. It is also more likely that you will experience reduced sensitivity in the penis and surrounding areas.

Avoid accidental contact:

• When using this medicine, especially when loading the container, point it away from your face to avoid accidental contact with the ears, eyes, nose, and mouth.

• If the medicine accidentally comes into contact with your eyes or those of your partner, rinse them immediately with cold water or saline solution and keep them closed as much as possible until the effects, such as numbness, disappear. Note that normal protective mechanisms, such as blinking or the sensation of a foreign body in the eye, may disappear until the numbness passes.

• Fortacin should not come into contact with a damaged eardrum.

Contact with other mucous membranes:

• Fortacin can also come into contact with other mucous membranes, such as those of the mouth, nose, and throat, yours or your partner's, producing a slight numbness for a short time. As this numbness reduces the ability to feel pain in these areas, you should be especially careful not to injure them until the numbness has disappeared.

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

• During sexual intercourse, a small part of this medicine may pass, for example, to the vagina or anus. Therefore, both you and your partner may feel numbness for a short time and should be careful not to hurt themselves, especially during sexual activity. For more information on possible side effects in sexual partners, see section 4.

In case the patient or their partner develop skin rashes or irritation, treatment with Fortacin should be discontinued. If symptoms persist, consult a doctor.

Children and adolescents

This medicine should not be administered 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 especially important that you inform a doctor before using Fortacin if you are taking any of the following medicines that may interact with Fortacin:

• Other local anesthetics

• Heart medicines (antiarrhythmics)

• Medicines that increase the risk of a disorder that reduces the amount of oxygen in the blood (methemoglobinemia), such as those listed below:

• Benzocaine, a local anesthetic used to treat pain and itching

• Chloroquine, pamaquine, primaquine, quinine, used to treat malaria

• Metoclopramide, used to treat nausea (nausea) and vomiting, also in patients with migraine

• Glyceryl trinitrate (GTN, nitroglycerin), isosorbide mononitrate, erythritol tetranitrate, pentaerythritol tetranitrate, and other medicines with nitrates and nitrites used to treat angina pectoris (chest pain caused by the heart)

• Sodium nitroprusside, isosorbide dinitrate, used to treat arterial hypertension and heart failure

• Nitrofurantoin, an antibiotic used to treat urinary and kidney infections

• Sulfonamides, for example, sulfamethoxazole, an antibiotic used to treat urinary and kidney 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 also to prevent malaria and pneumonia in patients at risk

• Phenobarbital, phenytoin, used to treat epilepsy

• Para-aminosalicylic acid (PAS), used to treat tuberculosis

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

Pregnancy, breastfeeding, and fertility

Fortacin is not authorized for use in women.

Ask your doctor or pharmacist for advice before taking any medicine.

Pregnancy

Fortacin should not be used while your partner is pregnant unless you use an effective male condom, as indicated earlier in section 2 "Use with condoms", to avoid fetal exposure.

Breastfeeding

This medicine can be used while your partner is breastfeeding.

Fertility

Fortacin may reduce the possibility of pregnancy. Therefore, patients who wish to conceive should avoid using Fortacin, or if the medicine is essential to achieve penetration, they should wash the glans of the penis as thoroughly as possible five minutes after applying Fortacin but before sexual intercourse.

3. How to use Fortacin

Follow exactly the administration instructions of this medicine contained in this leaflet. In case of doubt, ask your doctor or pharmacist.

The recommended dose of Fortacin is 3 sprays (3 sprays = 1 dose) on the head of the penis at least 5 minutes before sexual intercourse. A maximum of 3 doses can be administered within 24 hours with an interval of at least 4 hours between doses.

Do not exceed the maximum recommended dose (3 doses in 24 hours).

Instructions for use

• Before the first use, briefly shake the spray container and then load the pump mechanism by spraying the valve three times into the air. Point the container away from your face to avoid contact with the eyes, nose, mouth, and ears.

• Before each subsequent dose, briefly shake the spray container and then reload the pump mechanism by spraying the valve once into the air.

• Retract the foreskin of the penis. Hold the container in a vertical position (with the valve upwards), apply 1 dose (3 sprays) of Fortacin to the entire head of the penis, covering one-third with each spray.

• Wait 5 minutes, then clean the excess spray before engaging in sexual intercourse. It is important to remove any excess spray, even if you use a condom (also see section 2 for important information on use with condoms).

If you use more Fortacin than you should

If you apply too much, wipe it off.

The following symptoms may occur when too much Fortacin is used. Contact your doctor or pharmacist if you experience any of them. It is very unlikely to happen if used according to the instructions:

• Dizziness or lightheadedness

• Tingling sensation on the skin around the mouth and numbness of the tongue

• Dysgeusia (abnormality of taste)

• Blurred vision

• Ringing in the ears

• There is also a risk of a disorder that reduces the amount of oxygen in the blood (methemoglobinemia), which is more likely when certain medicines are taken at the same time. When it occurs, the skin turns gray-blue due to lack of oxygen.

In severe cases of overdose, symptoms may include seizures, hypotension, slowed breathing, respiratory arrest, and cardiac arrhythmia. The effects can be potentially fatal.

If you have any further questions on the use of this medicine, ask 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 Fortacin in male patients:

Common (may affect up to 1 in 10 people)

• Difficulty getting or maintaining an erection

• Reduced sensitivity in the penis and surrounding areas

• Burning sensation in the penis and surrounding areas

Uncommon (may affect up to 1 in 100 people)

• Headache

• Local irritation of the throat (if inhaled)

• Skin irritation

• Redness of the penis and surrounding areas

• Difficulty ejaculating during sexual intercourse

• Abnormal orgasm

• Tingling sensation in the penis and surrounding areas

• Pain or discomfort in the penis and surrounding areas

• Itching in the penis and surrounding areas

• High temperature

The following side effects have been reported with Fortacin in sexual partners:

Common (may affect up to 1 in 10 people)

• Burning sensation in the vagina and surrounding areas

• Reduced sensitivity in the vagina and surrounding areas

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

• Numbness in the mouth

• Difficulty or pain when urinating

• Vaginal pain

• Discomfort or itching in the vulva and vagina

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 is the last day of the month stated.

Store below 25 °C. Do not freeze. The container should be discarded 12 weeks after the first use.

The metal container is pressurized. Do not pierce, break, or burn, even if it appears to be empty. A residual volume of unusable fluid will remain in the container after all doses have been administered.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container contents and additional information

Composition of Fortacin

• The active ingredients are lidocaine and prilocaine.

• Each ml of solution contains 150 mg of lidocaine and 50 mg of prilocaine.

• Each spray discharge contains 50 microliters which contain 7.5 mg of lidocaine and 2.5 mg of prilocaine.

• 1 dose is equivalent to 3 sprays.

• The other component is norflurane.

Appearance of Fortacin and container contents

Fortacin is a colorless or light yellow solution for cutaneous spray, in an aluminum spray container with a dosing valve.

Each box contains 1 spray container with 6.5 ml or 5 ml of solution.

• Each 6.5 ml spray container provides a minimum of 20 doses.

• Each 5 ml spray container provides a minimum of 12 doses.

Marketing authorization holder

Recordati Ireland Ltd.

Raheens East

Ringaskiddy Co. Cork

Ireland

Manufacturer

Pharmaserve (North West) Ltd

9 Arkwright Road

Astmoor Industrial Estate

Runcorn WA7 1NU

United Kingdom

Recordati Industria Chimica e Farmaceutica S.p.A.

Via Matteo Civitali 1

20148 Milano

Italy

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

BelgiumLithuania

Recordati Ireland Ltd. Recordati Ireland Ltd.

Tel: + 353 21 4379400 Tel: + 353 21 4379400

GreeceLuxembourg

Recordati Ireland Ltd. Recordati Ireland Ltd.

Tel: + 353 21 4379400 Tel: + 353 21 4379400

Czech RepublicHungary

Herbacos Recordati s.r.o. Recordati Ireland Ltd.

Tel: + 420 466 741 915 Tel: + 353 21 4379400

DenmarkMalta

Recordati Ireland Ltd. Recordati Ireland Ltd.

Tel: + 353 21 4379400 Tel: + 353 21 4379400

GermanyNetherlands

Recordati Pharma GmbH Recordati Ireland Ltd.

Tel: + 49 (0) 731 7047 0 Tel: + 353 21 4379400

EstoniaNorway

Recordati Ireland Ltd. Recordati Ireland Ltd.

Tel: + 353 21 4379400 Tel: + 353 21 4379400

GreeceAustria

Recordati Hellas Pharmaceuticals A.E. Recordati Ireland Ltd.

Tel: + 30 210-6773822 Tel: + 353 21 4379400

SpainPoland

Casen Recordati, S.L. RECORDATI POLSKA sp. z o.o.

Tel: + 34 91 659 15 50 Tel: + 48 22 206 84 50

FrancePortugal

Laboratoires BOUCHARA-RECORDATI Jaba Recordati, S.A.

Tel: + 33 1 45 19 10 00 Tel: + 351 21 432 95 00

CroatiaRomania

Recordati Ireland Ltd. Recordati România S.R.L.

Tel: + 353 21 4379400 Tel: + 40 21 667 17 41

IrelandSlovenia

Recordati Ireland Ltd. Recordati Ireland Ltd.

Tel: + 353 21 4379400 Tel: + 353 21 4379400

IcelandSlovakia

Recordati Ireland Ltd. Herbacos Recordati s.r.o.

Tel: + 353 21 4379400 Tel: + 420 466 741 915

ItalyFinland

Recordati Industria Chimica e Farmaceutica S.p.A. Recordati Ireland Ltd.

Tel: + 39 02 487871 Tel: + 353 21 4379400

CyprusSweden

Recordati Ireland Ltd. Recordati Ireland Ltd.

Tel: + 353 21 4379400 Tel: + 353 21 4379400

LatviaUnited Kingdom

Recordati Ireland Ltd. Recordati Pharmaceuticals Ltd.

Tel: + 353 21 4379400 Tel: + 44 (0) 1491 576 336

Date of the last revision of this leaflet:{MM/AAAA} Other sources of information

Detailed and updated information about this medication is available by scanning the QR code below and on the packaging with a smartphone.

This same information is available at the following URL: www.fortacin.eu QR code www.fortacin.eu

Detailed information about this medication is available on the website of the European Medicines Agency: http://www.ema.europa.eu.