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Adaporin

Adaporin

dapoxetine

Manufacturer:

World Medicine

Distributor:

SB Pharma
Full Prescribing Info
Contents
Dapoxetine hydrochloride.
Description
Adaporin Tablets 60 mg is light grey colored, debossed with "60" inside a triangle on one side, convex and round film-coated tablets.
The active substance is dapoxetine. Each tablet contains 60 mg dapoxetine as a hydrochloride salt.
Excipients/Inactive Ingredients: The other ingredients are: Lactose monohydrate, Microcrystalline cellulose, Croscarmellose sodium, Colloidal anhydrous silica, Magnesium stearate.
Film-coating: HPMC 2910/Hypromellose, Lactose Monohydrate, Titanium Dioxide, Triacetin, Ferrosoferric Oxide/Black Iron Oxide, Iron Oxide Yellow, Iron Oxide Red.
Action
Adaporin contains an active substance called 'dapoxetine'. This belongs to a group of medicines called 'selective serotonin reuptake inhibitors' (SSRIs). Adaporin may also be known as a 'urological' medicine.
Adaporin increases the time it takes to ejaculate and can improve the control over the ejaculation. This may reduce the frustration or worry about fast ejaculation.
Indications/Uses
Adaporin is used to treat premature ejaculation in adult men aged 18 to 64 years.
Premature ejaculation is when a man ejaculates with little sexual stimulation and before the man wants. This can cause problems for the man and may cause problems in sexual relationships.
Dosage/Direction for Use
Always take this medicine exactly as prescribed. Patients must be advised to check with a doctor or pharmacist if they are not sure.
The recommended dose is 30 mg. The dose may be increased to 60 mg. Note that only Adaporin Tablets 60 mg are available. Consider other suitable commercial oral preparation for recommended dosages other than 60 mg.
The medicine should only be taken 1 to 3 hours before sexual activity is anticipated.
This medicine should not be taken more than once every 24 hours or every day.
The tablets should be swallowed whole to avoid a bitter taste, with at least one full glass of water. This may help lower the chance of fainting (see Fainting and low blood pressure under Side Effects).
This medicine can be taken with or without food.
This medicine should not be used by men under 18 or over 65 years of age.
Patients must be advised to discuss the Adaporin treatment with their doctor after the first 4 weeks or after 6 doses to see whether the treatment should be continued. If treatment is continued, patients must be advised to see the doctor again to discuss this at least every six months.
Stopping intake of Adaporin: Patients must be advised to talk to the doctor before stopping intake of this medicine. They may have problems sleeping and feel dizzy after stopping intake of this medicine, even if they have not taken it every day.
Patients must be advised if they have any further questions on the use of this medicine.
Overdosage
Patients must be advised to inform the doctor or pharmacist if they have taken more tablets than they should. Patients may feel sick or be sick.
Contraindications
Adaporin should not be taken if the patient: is allergic to dapoxetine or any of the other ingredients of this medicine (listed in Description); has heart problems, such as heart failure or problems with the heart rhythm; has a history of fainting; has ever had mania (symptoms include feeling over-excited, irritable or not being able to think clearly) or severe depression; has moderate or severe liver problems.
Adaporin should not be taken if the patient is taking: Medicines for depression called 'monoamine oxidase inhibitors' (MAOIs); Thioridazine used for schizophrenia; Other medicines for depression; Lithium - a medicine for bipolar disorder; Linezolid - an antibiotic used to treat infections; Tryptophan - a medicine to help the patient sleep; St John's wort - a herbal medicine; Tramadol - used to treat serious pain; Medicines used to treat migraines.
Adaporin should not be taken at the same time as any of the medicines listed previously. If any of these medicines have been taken, the patient will need to wait 14 days after they stop taking it before they can start taking Adaporin. Once they have stopped taking Adaporin, they will need to wait 7 days before taking any of the medicines listed previously. If the patient is not sure about what to do, they must be advised to talk to the doctor or pharmacist before taking this medicine.
Certain medicines for fungal infection, including ketoconazole and itraconazole; Certain medicines for HIV, including ritonavir, saquinavir, nelfinavir and atazanavir; Certain antibiotics for treating infection, including telithromycin; Nefazodone - an antidepressant.
See also Interactions.
This medicine should not be taken if any of the previously mentioned apply to the patient. If they are not sure, they must be advised to talk to the doctor or pharmacist before taking this medicine.
Special Precautions
Patients must be advised to talk to the doctor, pharmacist or nurse before taking Adaporin if the patient: has not been diagnosed with premature ejaculation; also has another sexual problem, such as erectile dysfunction; has a history of dizziness from low blood pressure; use recreational drugs such as ecstasy, LSD, narcotics or benzodiazepines; drinks alcohol (see Adaporin with food, drink and alcohol under Interactions); has ever had a mental health problem such as depression, mania (symptoms include feeling over-excited, irritable or not being able to think clearly), bipolar disorder (symptoms include serious mood swings between mania and depression) or schizophrenia (a psychiatric disease); has epilepsy; has a history of bleeding or blood clotting problems; has kidney problems; has, or are at risk of, high pressure in the eye (glaucoma).
If any of the previously mentioned apply to the patient (or if the patient is not sure), advise the patient to talk to the doctor or pharmacist before taking this medicine.
Before starting this medicine, a test should be performed to make sure that the blood pressure doesn't drop too much when the patient stands up from lying down.
Adaporin contains lactose: This medicine contains lactose (a type of sugar). If the patient has been told by the doctor to have an intolerance to some sugars, advise the patient to contact the doctor before taking this medicinal product.
Driving and using machines: The patient may feel sleepy, dizzy, faint, have difficulty concentrating and blurred vision while taking this medicine. If any of these or similar effects have been experienced, the patient must be advised to avoid driving or operating hazardous machinery. The effects of alcohol may be increased if taken with this medicine and the patient may be more at risk of injury from fainting or from other side effects if this medicine is taken with alcohol.
Use in Children: This medicine should not be used in children or adolescents under age 18 years.
Use In Pregnancy & Lactation
This medicine should not be taken by women.
Side Effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Patients must be advised to stop taking Adaporin and see the doctor straight away if they: have fits (seizures); faint or feel light-headed when standing up; notice any changes in their mood; have any thoughts of suicide or harming themself.
If the patient notices any of the previously mentioned, advise the patient to stop taking this medicine and see the doctor straight away.
Fainting and low blood pressure: This medicine can make the patient faint or make the blood pressure drop when standing up. To help lower the chance of this happening: This medicine should be taken with at least one full glass of water; This medicine should not be taken if the patient is dehydrated (not having enough water in the body).
This can happen if the patient: has not had anything to drink in the past 4 to 6 hours; has been sweating for a long time; has an illness where one has a high temperature, diarrhoea or being sick.
If the patient feels like they might faint (such as feeling sick, feeling dizzy, light-headed, confused, sweaty or an abnormal heartbeat), or feel light-headed when they stand up, immediately lie down so the head is lower than the rest of the body or sit down with the head between the knees until the patient feels better. This will stop the patient from falling and hurting themself if they do faint.
The patient should not stand up quickly after they have been sitting or lying down for a long time.
The patient should not drive or use any tools or machines if they feel faint when taking this medicine.
Patients must be advised to inform the doctor if they faint when taking this medicine.
Very common side effects (may affect more than 1 in 10 men): Feeling dizzy; Headache; Feeling sick.
Common side effects (may affect up to 1 in 10 men): Feeling irritable, anxious, agitated or restless; Feeling numb or having 'pins and needles'; Difficulty getting or keeping an erection; Sweating more than normal or flushing; Diarrhoea, constipation or having wind; Stomach pain, bloating or being sick; Problems sleeping or strange dreams; Feeling tired or sleepy, yawning; Blocked nose (nasal congestion); A rise in blood pressure; Difficulty concentrating; Shaking or trembling; Lower interest in sex; Ringing in the ears; Blurred vision; Indigestion; Dry mouth.
Uncommon side effects (may affect up to 1 in 100 men): Fainting or feeling dizzy upon standing (see previously mentioned advice); Change in mood, feeling overly excited or feelings of paranoia; Feeling confused, disoriented or unable to think clearly; Slow or irregular heartbeat or increase in heart rate; Loss of sex drive, problems reaching orgasm; Feeling weak, sedated, lethargic or fatigued; Feeling depressed, nervous or indifferent; Feeling hot, jittery, abnormal or drunk; Vision problems, eye pain or dilated pupils; Low or high blood pressure; Feeling itchy or cold sweat; Spinning sensation; Abnormal taste; Teeth grinding.
Rare side effects (may affect up to 1 in 1,000 men): Feeling dizzy following exertion; Sudden onset of sleep; Urgency of bowel action.
Reporting of side effects: If the patient gets any side effects, advise the patient to talk to the doctor, pharmacist or nurse. This includes any possible side effects not listed in this monograph. Reporting side effects can help provide more information on the safety of this medicine.
Drug Interactions
Patients must be advised to inform the doctor or pharmacist if they are taking, have recently taken, or might take any other medicines. This includes medicines gotten without a prescription, such as herbal medicines. This is because Adaporin can affect the way some other medicines work. Also some other medicines can affect the way Adaporin works. Therefore, use of other medicines may affect the maximum dose of Adaporin the patient is allowed to take.
Adaporin should not be taken at the same time as any of the following medicines: Medicines for depression called 'monoamine oxidase inhibitors' (MAOIs); Thioridazine used for schizophrenia; Other medicines for depression; Lithium - a medicine for bipolar disorder; Linezolid - an antibiotic used to treat infections; Tryptophan - a medicine to help a patient sleep; St John's wort - a herbal medicine; Tramadol - used to treat serious pain; Medicines used to treat migraines.
Adaporin should not be taken at the same time as any of the medicines listed previously. If any of these medicines have been taken, the patient will need to wait 14 days after they stop taking it before they can start taking Adaporin. Once they have stopped taking Adaporin, they will need to wait 7 days before taking any of the medicines listed previously. If the patient is not sure about what to do, they must be advised to talk to the doctor or pharmacist before taking this medicine.
Certain medicines for fungal infection, including ketoconazole and itraconazole; Certain medicines for HIV, including ritonavir, saquinavir, nelfinavir and atazanavir; Certain antibiotics for treating infection, including telithromycin; Nefazodone - an antidepressant.
Patients must be advised to inform the doctor or pharmacist if they are taking any of the following medicines: Medicines for mental health problems other than depression; Non-steroidal anti-inflammatory medicines such as ibuprofen or acetylsalicyclic acid; Medicines to thin the blood, such as warfarin; Certain medicines used to treat erectile dysfunction, such as sildenafil, tadalafil or vardenafil, as these medicines may lower the blood pressure, possibly upon standing; Certain medicines used to treat high blood pressure and chest pain (angina) (such as verapamil and diltiazem), or enlarged prostate, as these medicines may also lower the blood pressure, possibly upon standing; Certain other medicines for fungal infection, such as fluconazole; Certain other medicines for HIV, such as amprenavir and fosamprenavir; Certain other antibiotics for treating infection, such as erythromycin and clarithromycin; Aprepitant - used to treat nausea.
If the patient is not sure if any of the previously mentioned apply, they must be advised to talk to the doctor or pharmacist before taking this medicine.
Adaporin with food, drink and alcohol: Patients must be advised not to drink grapefruit juice within 24 hours prior to taking this medicine as this can increase the level of this medicine in the body.
This medicine can be taken with or without food.
This medicine should be taken with at least one full glass of water.
Avoid alcohol when taking this medicine.
The effects of alcohol such as feeling dizzy, sleepy and having slow reactions, may be increased if taken with this medicine.
Drinking alcohol while taking this medicine may increase the risk of injury from fainting or from other side effects.
Caution For Usage
Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines no longer used. These measures will help protect the environment.
Storage
Store below 25˚C.
MIMS Class
Drugs for Erectile Dysfunction & Ejaculatory Disorders
ATC Classification
G04BX14 - dapoxetine ; Belongs to the class of other urologicals.
Presentation/Packing
Form
Adaporin FC tab 60 mg
Packing/Price
2 × 3's
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