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SIDELENA-D (Sildenafil 100 mg + Dapoxetine 60 mg)

SIDELENA-D

(Sildenafil 100 mg + Dapoxetine 60 mg)

Prescription drug.
Read the leaflet carefully before using.
Keep this medicine out of the sight and reach of children.
Immediately notify your doctor or pharmacist of adverse reactions encountered when using medicine.

INGREDIENTS AND CONTENT
Each film coated tablet contains
Active ingredientst
SIDELENA-D (Sildenafil 100 mg and Dapoxetine 60 mg film coated Tablet):
Sildenafil citrate equivalent to Sildenafil ............................100 mg
Dapoxetine hydrochloride equivalent to Dapoxetine ........60 mg
Excipients just enough: Microcrystalline cellulose 102, lactose monohydrat 100, copovidon, crosspovidon XL, silica K200, magnesi stearat, talc, colorcoat FC4WS-H (hydroxy propyl methyl cellulose 15 cps, hydroxy propyl methyl cellulose 5 cps, Talc, titan dioxid, precipitate silic, dibutyl sebacat, silic oil), opadry blue AMB (polyvinyl alcohol, titan dioxid, polyethylen glycol, talc, FD&C blue, Black iron oxide is not radiation)
DESCRIPTION ABOUT PRODUCT
SIDELENA-D (Sildenafil 100 mg and Dapoxetine 60 mg film coated Tablet ):
Film coated tablet is gray-blue, glossy, teardrop-shape (almond), camber sides, one side with “HERA” word, the other with grooves, intact edge and walls.
PACKAGING:
SIDELENA-D (Sildenafil 100 mg and Dapoxetine 60 mg film coated ):
Box of 1 blister x 4 Tablets.
WHAT IS THE MEDICINE USED FOR
SIDELENA-D is indicated for the treatment of erectile dysfunction and premature ejaculation in men aged 18 to 64 years.
HOW TO TAKE THIS MEDICINE AND DOSAGE
Dosage:
The usual dose used in 50 mg sildenafil and 30 mg dapoxetine each time, using in 1-3 hours before sexual activity, no more than once in 24 hours. The dose will be adjusted by the doctor based on the ability to respond for each patient. The maximum dose of sildenafil should not exceed 100 mg/day and dapoxetine should not exceed 60 mg/day.
How to use:
Should be taken with water, without breaking or chewing.
WHEN SHOULD NOT TAKE THIS MEDICINE?
Do not use Sidelena-D when:
  - Hypersensitivity to any active ingredients or any of the ingredients.
  - Cardiovascular disease such as heart failure (NYHA II-IV), abnormal conduction (grade 2 or 3, antrioventricular blockage, sinus node syndrome) are not treated with a permanent pacemaker, cardiac valve disease.
  - Concomitant treatment with (MAOI) inhibitor monoamine oxidase, or discontinuation of MAOI treatment within 14 days. Do not take MAOI for 7 days after stopping dapoxetine.
  - Concomitant treatment with thioridazine or discontinue treatment with thioridazine within 14 days. Do not take thioridazine 7 days after stopping dapoxetine.
  - Concomitant treatment with selective serotonin reuptake inhibitor (SSRI), selective serotonin-norepinephrine reuptake inhibitor (SNRI), tricyclic antidepressant (TCA) or other herbal medications that work on serotonin (L-tryptophan, triptan, linezolid, liti, St. John’s Wort), or discontinue treatment with these drugs/herbs within 14 days. Do not take these medicines/herbs for 7 days after stopping dapoxetine.
  - Moderate and severe hepatic impairment.
  - Sildenafil has been shown to have antihypertensive effects of nitrate, contraindicated in patients using regular or irregular organic nitrates.
UNDESIRABLE EFFECTS
Just like other drugs, Sidelena-D can cause undersirable effects, but not everyone is affected.
Dapoxetine:
Very common (can affect more than 1 in 10 people):
  - Nervous system disorders: dizziness, headache.
  - Gastrointestinal disturbances: nausea.
Common (can affect 1 in 10 people)
  - Mental Disorders: anxiety, agitation, restlessness, insomnia, irregular dreams, decreased desire.
  - Nervous system disorders: drowsiness, attention disorder, tremor, paresthesia
  - Eye disorders: vision dim
  - Ear disorder: tinnitus
  - Vascular disorders: the skin is reddened due to the concentration of blood under the skin  
  - Respiratory, thoracic and mediastinal disorders: sinusitis, yawning.
  - Gastrointestinal disorders: diarrhea, vomiting, constipation, abdominal pain, gastrointestinal disorders, flatulence, stomach upset, abdominal distention, dry mouth.
  - Skin and subcutaneous tissue disorders: increased sweating
  - Reproductive system disorders and mammary glands: impotence
  - General disorders: fatigue, irritability
  - Survey: increased blood pressure
Uncommon (can affect 1 in 100 people):
  - Mental disorders: Depression, mood depression, mood swings, mood changes, stress, indiference, confusion, disorientation, abnormal thoughts, increased alertness, abnormal sleep disorders, insomnia at first, isomnia at midnight, nightmares, grinding teeth, decreased sexual desire, orgasm disorder.
  - Nervous system disorders: syncope, vasovagal syncope, dizziness, restless legs syndrome, taste disturbance, sleep a lot, neuroleptic, decrease consciousness.
  - Eye disorders: pupil dilated, eye pain, vision problems
  - Ear disorders: dizziness
  - Cardiovascular disorders: sinus congestion, sinus bradycardia, fast heart rate.
  - Vascular disorders: hypotension, systolic hypertension, burning sensation  
  - Gastrointestinal disorders: abdominal discomfort, epigastric discomfort  
  - Skin and subcutaneous tissue disorders: itching, cold sweat
  - Reproductive system disorders and mammary glands: ejaculation failure, orgasm disorders in men, paraesthesiae in male genitalia
  - General disorders: debilitating, felling hot, felling restless, felling abnormal, felling drunk
  - Survey: increase heart rate, increased diastolic blood pressure, high blood pressure in standing posture
Rare (can affect 1 in 1000 people):
  - Neurological disorders: dizziness after exertion, sudden sleepiness
  - Gastrointestinal disturbances: defecating urgently
Sildenafil:
Very common (can affect 1 in 10 people):
  - Nervous system: headache
Common (can affect 1 in 1000 people)
  - Nervous system: dizziness
  - Eye: astigmatism, look color is unknown
  - Blood vessels: red
  - Respiratory system, chest, mediastinum: stuffy nose
  - Digestive system: difficult to digest
Rare (can affect 1 in 1000 people):
  - Nervous system: tired, tactile reduction
  - Eye: conjunctivitis, eye disorders, tearing disorders, other eye disorders
  - Ear: dizziness, tinnituss
  - Heart: palpitations, fast heart beat
  - Gastrointestinal system: nausea, vomiting, dry mouth
  - Musculoskeletal and connective tissue: muscle pain
  - Skin, soft tissue: rash
  - Body: chest pain, fatigue
  - Tests: Tachycardia
Rare (can affect 1 in 1000 people):
  - Immune system: hypersensitivity reaction
  - Nervous system: stroke, syncope
  - Ear: deaf
  - Blood vessels: increase/lower blood pressure
  - Heart: myocardial infarction, atrial fibrillation
  - Respiratory system, chest and mediastinal: nosebleeds
Unspecified frequency:
  - Reproductive system: erectile penis, prolonged erection
  - Skin and soft tissue: Steven-Johnson syndrome, toxic epidermal necrolysis (TEN)
  - Heart: ventricular arrhythmias, unstable angina, sudden cardiac death
  - Eyes: Nonarteritic anterior ischemic optic neuropathy (NAION), retinal vein occlusion, visual impairment.
  - Nervous system: transient anemia, epilepsy, recurrent seizures
AVOID TAKING MEDICATION OF FOOD WHEN USING MEDICATION
Do not use dapoxetine at the same time as the following:
  - Drugs for depression of monoamine oxidase (MAOIs)
  - Thioridazine for schizophrenia
  - Other drugs for depression
  - Lithium: bipolar disorder medication
  - Linezolide: antibiotic treatment for infection
  - Tryptophan: help sleep
  - St John’s wort: a herbal medicine
  - Tramadol: is used to treat severe pain
  - Drugs used to treat migraines
Don’t take dapoxetine at the same time as any of the drugs listed above. If you have taken any of these medications, you should wait 14 days after stopping them before taking dapoxetin. Once you stop taking dapoxetine, you should wait 7 days before taking any of the drugs listed above.
  - Some medicines treatment fungal infections, including ketoconazole và itraconazole.
  - Some medicines for HIV, including: ritonavir, saquinavir, nelfinavir and atazanavir
  - Some antibiotics treat infections, including telithromycin
  - Nefazodon, antidepressants
Don’t taking alcohol while taking dapoxetine. The effects of alcohol such as dizziness, sleepiness, slow response can be increased with the same dapoxetine. Increased risk of injury from fainting or other side effects.
Other drugs and Sildenafil
Sildenafil can affect some medicines, especially medicines for angina.  In case of an operation, talk to your doctor about when and how you are taking sildenafil. Don’t take sildenafil with any medicine without your doctor’s consent.
Don’t take sildenafil with nitrate drugs, as combination with these drugs can cause severe hypotension. Always talk to your doctor or pharmacist if you are taking conventional medicines to treat angina.
Don’t use sildenafil if you are taking nitric oxide such as amyl nitrite, as this combination can reduce your blood pressure.
If you are taking Protease inhibitors, such as HIV medicines, your doctor may order you to start with  minium of 25 mg of sildenafil.
Some patients taking alpha blockers to treat high blood pressure or prostate  hypertrophy may feel dizziness, which is caused by low blood pressure when sitting up or standing up too fast. Some patients experience these symptoms when taking sildenafil with alpha blockers. These symptoms mostly occur about 4 hours after taking sildenafil. To reduce the possibility of these symptoms, you should take alpha-blockers at regular daily doses before taking sildenafil. Your doctor may recommend the lowest dose (25 mg) of sildenafil .
Sildenafil wtih food, water and alcohol
Sildenafil can be used with or without food. However, you can see the effects of sildenafil last longer when taking medicine after a larger meal.
Drinking alcohol can temporarily impair your erectile function. For best results, do not drink too much alcohol before using sildenafil.
WHAT TO DO WHEN ONE TIME FORGETS TO TAKE MEDICINE 
Sidelena-D is used when intending to have sex so it does not affect, continue to use the next dose.
STORAGE
Store in a cool, dry place, temperature below 30oC.
SIGNS AND SYMPTOMS OF OVERDOSE
Overdose may increase the undesirable effects.
WHAT TO DO WHEN OVERDOSE IS RECOMMENDED
Tell your doctor or pharmacist when to use over recommended dosage.
THINGS TO TAKE CAUTION WHEN TAKING THIS DRUG
  - Use with addictive drug:
Do not take dapoxetin with other addictive drug. Addictive serotonin  mediated drugs such as ketamine, methylenedioxymethamphetamine (MDMA) and lysergic acid diethylamide (LSD) can lead to serious reactions when combined with dapoxetine. These reactions include arrhythmias, hyperthermia and serotonin syndrome. Use of dapoxetine with addictive drug such as narcotic and benzodiazepine can increase moodiness and dizziness.
  - Ethanol
Combination of alcohol with dapoxetine may increase neuronal alcohol-related effects and neurological side effects such as unconsciousness, increasing the risk of accidents that may occur, so patients should be advised to avoid use alcohol while using dapoxetine.
  - Fainting
The frequency of unconsciousness in clinical study of dapoxetine varies depending on the dose taken from 0,06% (30 mg) to 0,23% (60 mg) for patients who participated in a phase 3 placebo-controlled clinical trial and  0,64% (all combined doses) in a phase 1 study in healthy volunteers with no early ejaculation. Signs that can be anticipated, such as nausea, dizziness, anxiety, depression and sweating, occur within 3 hours after taking the medication that usually occurs prior to unconsciouness. Patients should be aware that they may be unconscious at any time, with or without warning signs during treatment with dapoxetine. If the patient is experiencing symptoms of an immediate need to lie down immediately, head lower than the rest of the body or sit down with the head between the knees until this symptom goes away, and should be careful to avoid injuries can occur while driving or operating machinery, possibly unconscious or affecting the central nervous system.
  - Hypotension of standing posture
Tests in the standing posture may be performed prior to initiation of treatment. In the event of a history of medical history or a suspected postural reaction, treatment with this medication should be avoided. Patients should be advised if a patient experiences a shock, such as dizziness after standing up, the patient should lie down immediately, head lower than the rest of the body or sit down with the head in the middle of the knee until this symptom goes away. Patients should not stand up quickly after lying or sitting for a long time.
  - Moderate inhibitors of CYP3A4
Caution is advised in patients taking moderately inhibitied CYP3A4 and the dosage is limited 30 mg. 
  - Substantial CYP2D6 inhibitors
Caution is advised when dosing up to 60 mg in patients on potent CYP2D6 inhibitors or if dose is increased to 60 mg in patients with known poor CYP2D6 metabolism, as this may increase the level of exposure, which can lead to higher rates and severity of dose dependent side effects.
  - Suicide or suicidal thoughts
Antidepressants, including selective serotonin reuptake inhibitors, increased risk compared to placebo for suicidal thoughts and suicide in short – term studies in childern and adolescents with depression and other mental disorders. Short-term studies did not show an increased risk of suicide with antiderpressants compared to placebo in adults older than 24 years. In clinical trials with dapoxetine for early ejaculation treatment, there are no obvious signs of emergency suicide.
  - Mania
Dapoxetine should not be used in patients with mild mania or bipolar disorder and should be discontinued in any patient with symptoms of these disorders.
  - Convulsions
Given the potential of SSRIs to reduce the seizure threshold, dapoxetine should be discontinued in any patient who develops seizures and should be avoided in patients with unstable seizures. Patients with controlled epilepsy should be monitored carefully.
  - Depression and/or mental disorder
Men with signs and symptoms of underlying depression should be evaluated before treatment with dapoxetine to rule out undiagnosed depression. Co-administration of dapoxetine with antidepressants, including selective serotonin reuptake inhibitors (SSRI) and serotonin - norepinephrine reuptake inhibitors (SNRIs), are contraindicated.
Stopping treatment for depression or anxiety continuously to begin with dapoxetine in the treatment of premature ejaculation is not advisable.  Dapoxetine is not indicated for mental disorders and should not be used in men with these disorders, such as schizophrenia, or in people with morbid depression. This may be a result of underlying mental disorder or may be a result of treatment from the drug product. Doctors should encourage patients to report any thoughts or feelings of depression develop during treatment, discontinue dapoxetin.  
  - Hemorrhage
There have been reports of abnormal bleeding with SSRIs. Caution should be exercised in patients taking dapoxetine, especially in the concomitant use of drugs known to affect platelet function (eg, atypical antipsychotics, and phenothiazin, acetylsalicylic acid, nonsteroidal anti-inflammatory drugs [NSAID], platelet aggregation agents) or anticoagulants (eg: warfarin), as well as in patients with a history of bleeding or clotting disorders.
  - Effect when stopping the drug
Sudden prolonged SSRI used in the treatment of chronic depressive disorder have been reported with the following symptoms: irritability, anxiety, dizziness, sensory disturbances (eg, paresthesia such as feeling electric shock), anxiety, puzzled, headache, indifference, emotional disturbance, insomnia and mania.
  - Lactose intolerance
Patients with rare genetic problems with galactose intolerance, Lapp Lactose deficiency or glucose-galactose malabsorption should not take this medication.
  - Risk factors for cardiovascular
Prior to any treatment for erectile dysfunction, doctors should review the patient’s cardiovascular status, as this is also a risk factor for the heart asociated with sex active. Sildenafil causes vasodilatation, leading to mild to moderate hypontension. Prior to Sildenafil, doctors  should consider carefully whether the patient is in a condition that may be affected by a vasodilatation, particularly when combined with sex active. Patients with increased sensitivity to vasodilators include aortic stenosis, heart muscle hypertrophy causes congestion, or those with rare systemic as multipe system atrophy (MSA) expression of the automatic blood pressure control system is severely impaired.  
  - Prolonged ejaculation and priapisme
Erection penis for more than 4 hours and penile erection (erection pain more than 6 hours) were reported infrequently when sildenafil circulated in the market. In the case, erections that last for more than 4 hours, patients needing medical assistance, penile tissue damage and permanent loss of function may occur.
Affects the bleeding
Studies on human platelets indicate that sildenafil has the same anti-platelet activity as sodium prusside in vitro. Safety information on sildenafil in patients with bleeding disorders or peptic ulceration is not avaliable. Therefore, sildenafil is only used in these patients after the doctor has assessed the benefit-risk carefully.
Children and adolescents
Sidelena-D is not for children and teens under the age of 18.
Patients with liver and kidney failure
Dosage reduction may be considered in patients with hepatic or renal inpairment.
Fertility, pregnant and lactating women
Sidelena-D is not indicated for treatment in women.
No exact undersirable effects were found in studies of reproductive performance in rats and rabbits when using by oral.
Ability to drive or operate machinery:
Dapoxetine has little or no effect on the ability to drive and operate machines. Dizziness, attention disturbances, fainting, blurred vision and drowsiness have been reported in subjects taking dapoxetine in clinical trials. Therefore, you need to be careful to avoid the possibility of injury, including the risk of driving or operating machinery.
Combination of alcohol with dapoxetine may increase the effect on alcohol-related neuronal awareness and may also enhance consciousness  related side effects such as temporary loss, thereby increasing the risk of injury by accident. Therefore, do not drink alcohol while taking dapoxetine.
WHEN TO CONSULT A DOCTOR, PHARMACIST
When you have any unwanted effects of the drug, no treatment response or symptoms become worse. Consult your doctor or pharmacist for more information.
SHELF LIFE:  24 months from date of manufacture.
Manufactured by:
HERA BIOPHARMACRUTICAL CO. LTD.
Lot A17, Tu Ha Industrial zone, Tu Ha Ward, Huong Tra Town, Thua Thien Hue Province, Viet Nam.