FORTACIN 150 MG / ML + 50 MG / ML CUTANEOUS SPRAY SOLUTION - patient leaflet, side effects, dosage

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Package leaflet: Information for the user

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

Iidocaine/pri­locaine

Read all of this leaflet carefully before you start 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 have told you.

• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• You must talk to a doctor if you do not feel better or if you feel worse.

What is in 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

i.what fortacin is and what it is used for

Fortacin is a combination of two medicines: lidocaine and priiocaine. These belong to a group of medicines called local anaesthetics.

Fortacin is indicated for the treatment of premature ejaculation occurring in adult men (aged 18 years and over) from first sexual intercourse. This is when you always, or nearly always, have ejaculated within one minute of sexual intercourse and this causes you negative emotional effects. Fortacin works by decreasing the sensttivity of the head of the penis to increase time before ejaculation.

2.what you need to know before you use fortacin

during sexual intercourse, a small amount of this medicine may be transferred, e.g. to the vagina or the anus. therefore, both you and your partner may feel slight numbness for a short while and should take care not to injure yourselves, particularly during sexual activity. for more information regarding possible side effects in sexual partners, see section 4.

If you or your partner develop a rash or irritation, discontinue use of Fortacin. If symptoms persist, consult a doctor.

Children and adolescents

This medicine should not be used in 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 that you talk to a doctor before using Fortacin if you are taking any of the following medicines which may interact with Fortacin:

• other local anaesthetics
• heart medicines (anti-arrhythmic medicines)
• medicines known to increase the risk of a disorder reducing the amount of oxygen in the blood (methaemoglobi­naemia), such as those llsted below:
• Benzocaine — a locail anaesthetic used to treat pain and itching
• Chloroquine, pamaquine, primaquine, quinine — used to treat malaria
• Metoclopramide — used to treat feelings of sickness (nausea) and vomiting, including in patients with migraine
• Glyceryl trinitrate (6TN, nitroglycerin), isosorbide mononitrate, erythrityl tetranitrate, pentaerythritol tetranitrate and other nitrate and nitrite medicines — used to treat angina (chest pain caused by the heart)
• Sodium nitroprusside, isosorbide dinitrate — used to treat high blood pressure and heart failure
• Nitrofurantoin — an antibiotic used to treat urinary and kidney infections
• Sulphonamides (also called sulpha medicines), e.g. sulfamethoxazole — an antibiotic used to treat urinary infrecthons, 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 high risk patients

• Phenobarbital, phenytoin — used to treat epilepsy
• Para-aminosaiicylic acid (PAS) — used to treat tuberculosis

The risk of methaemoglobinaemia can also be increased by the use of certain dyes (aniline dyes;), or the pesticide naphthalene, so let your doctor know if you work with any 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 whilst your partner is pregnant unless you use an effective male condom, as llsted above in section 2 “Use with condoms”, to prevent exposure of the unborn child.

Breastfeeding

This medicine may be used while your partner is breast-feeding.

Fertility

Fortacin may reduce the possibility of pregnancy. Therefore, patients hoping to achieve conception should either avoid using Fortacin, or-, if this medicine is essential to achieve penetration, should wash the penis as thoroughly as possible five minutes after Fortacin has been applied, but prior to intercourse.

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3. how to use fortacin

Always use this medicine exactly as described in this leaflet. Check with your doctor or pharmacist if you are not sure.

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 used within 24 hours with at least 4 hours between coses.

The maximum recommended dose (3 doses within 24 hours) should not be exceeded.

Instructions for use

• Before initial use, briefly shake the spray container and then prime the pump mechanism by spraying the valve three times into the air. Aim the container away from faces to avoid contact with eyes, nose, mouth and ears.
• Before each subsequent dose, briefly shake the spray container and then re-prime the pump by spraying 1 time into the air.
• Retract any foreskin from the head of the penis. Holding the can upright (valve up), apply 1 dose (3 sprays) of Fortacin to the entire head of the penis, by covering one third with each spray.
• Wait 5 minutes then wipe off any excess spray prior to having sexual intercourse. It is important that you wipe off any excess spray also if you use a condom (see also section 2 for other important information regarding use with condoms).

If you use more Fortacin than you should

If you do apply too much, wipe it off.

Symptoms of using too much Fortacin are llsted below. Contact your doctor or pharmacist if you experience any of these. They are very unlikely to happen if it is used as instructed:

• Feeling light headed or dizzy
• Tingling of the skin around the mouth and numbness of the tongue
• Abnormal taste
• Blurred vision
• Ringing in the ears
• There is also a risk of a disorder reducing the amount of oxygen in the blood (methaemoglobi­naemia). This is more llkely when certain medicines have been taken at the same time. If this happens, the skin becomes bluish grey due to a lack of oxygen.

In serious cases of overdose, symptoms may include fits, low blood pressure, slowed breathing, stopped breathing and altered heart beat. These effects may be H1fe threatening.

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)

• – Inability to develop or maintain an erection – reduced feeling in and around the penis feeling of burning in and around the penis

Uncommon (may affect up to 1 in 100 people)

• headache
• local irritation of the throat (if inhaled)
• irriiation of the skin
• redness on and around the penis
• failure to ejaculate during sexual intercourse
• abnormal orgasm
• tingling in and around the penis
• pain or discomfort in and around the penis
• itching in and around the penis
• a high temperature

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

Common: (may affect up to 1 in 10 people)

• feeling of burning in and around the vagina
• reduced feeling in and around the vagina

Uncommon (may affect up to 1 in 100 people)

• headache
• local irritation of the throat (if inhaled)
• vaginal thrush (Caindida) infection
• discomfort in the anus and rectum
• loss of feeling in the mouth
• difficulty or pain passing urine
• pain in the vagina
• discomfort or itching in the vulva and vagina

Reporting of side effects

If you or your sexual partner get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: or search for MHRA Yellow Card in the Google Play or Apple App Store.. For any patients who do not have online access to report a suspected side effect to the Yellow Card scheme, call 0800 731 6789 for free, Monday to Friday between 9am and 5pm. You can leave a message outside of these hours and the team will get back to you. By reporting side effects you 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 spray container label and the carton after “EXP”. The expiry date refers to the last day of that month.

Store below 25°C. Do not freeze. You must throw away the container 12 weeks after you first use it. The metal container is pressurised. Do not puncture, break or burn it even when apparently empty. A residual volume of fluid that is not usable will remain in the container after all doses have been administered.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. contents of the pack and other information

What Fortacin contains

• The active substances are Iidorcraine and prilocaine.
• Each ml of solution contains 150 mg Iidocaine and 50 mg prilocaine
• Each spray delivers 50 microlitres which contains 7.5 mg lidocaine and 2.5 mg prilocaine.
• 1 dose is equal to 3 actuations.
• The other ingredient is norflurane

What Fortacin looks like and contents of the pack

Fortacin is a colourless to light yellow cutaneous spray, solution in an aluminium spray container with metering valve.

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

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