SS Pharmaceutical Obtains Approval for ED Drug 'Cialis®' as an OTC Medication in Japan
SS Pharmaceutical Co., Ltd. announced that it has obtained manufacturing and marketing approval for the ED treatment drug 'Cialis®' as an over-the-counter (OTC) medication (drug requiring instruction) in Japan for the first time.
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## SS Pharmaceutical Obtains Approval for ED Drug 'Cialis®' as an OTC Medication in Japan
SS Pharmaceutical Co., Ltd. (Headquarters: Shinjuku, Tokyo; President: Yoko Motoshima) announced that it has received manufacturing and marketing approval for the ED medication 'Cialis®' as an over-the-counter (OTC) drug.
'Cialis®' is an ED treatment that supports erection and maintenance only when sexual stimulation occurs; it is not a vitality booster or libido enhancer. Cialis® tablets, as a prescription medication, have been used in over 100 countries for over 20 years. Celebrating its 20th year of clinical use in Japan, this approval marks its first offering as a 'Switch OTC' drug, available with appropriate information provided by pharmacists.
### Product Information
- Product Name: Cialis®
- Category: Drug requiring instruction (OTC)
- Active Ingredient: Tadalafil 10mg
- Indication: Erectile Dysfunction
- Dosage: Adult males (18+) should take one tablet approximately one hour before sexual activity with water or lukewarm water. Do not exceed one tablet per day, and wait at least 24 hours between doses.
### Background
Large-scale surveys suggest that approximately one in two Japanese men may experience ED. However, stigma and misconceptions often hinder appropriate treatment choices. Additionally, there are risks associated with counterfeit drugs from unauthorized online imports. Through this OTC switch, SS Pharmaceutical aims to foster an environment where men can make informed choices based on correct knowledge.
SS Pharmaceutical Co., Ltd. (Headquarters: Shinjuku, Tokyo; President: Yoko Motoshima) announced that it has received manufacturing and marketing approval for the ED medication 'Cialis®' as an over-the-counter (OTC) drug.
'Cialis®' is an ED treatment that supports erection and maintenance only when sexual stimulation occurs; it is not a vitality booster or libido enhancer. Cialis® tablets, as a prescription medication, have been used in over 100 countries for over 20 years. Celebrating its 20th year of clinical use in Japan, this approval marks its first offering as a 'Switch OTC' drug, available with appropriate information provided by pharmacists.
### Product Information
- Product Name: Cialis®
- Category: Drug requiring instruction (OTC)
- Active Ingredient: Tadalafil 10mg
- Indication: Erectile Dysfunction
- Dosage: Adult males (18+) should take one tablet approximately one hour before sexual activity with water or lukewarm water. Do not exceed one tablet per day, and wait at least 24 hours between doses.
### Background
Large-scale surveys suggest that approximately one in two Japanese men may experience ED. However, stigma and misconceptions often hinder appropriate treatment choices. Additionally, there are risks associated with counterfeit drugs from unauthorized online imports. Through this OTC switch, SS Pharmaceutical aims to foster an environment where men can make informed choices based on correct knowledge.
FAQ
Is Cialis® now an over-the-counter drug?
Yes, it has been approved as a 'drug requiring instruction,' which allows purchase with pharmacist guidance without a doctor's prescription.
Can anyone buy it immediately?
It is for adult males aged 18 and over. A pharmacist's confirmation is required at the time of purchase, and medical consultation may be necessary for those with pre-existing conditions.
When will it be available?
It is currently being prepared for launch. Details and launch dates will be announced later.