Affex tablets

Affex

  • Active Ingredient: Fluoxetine
  • 20 mg, 10 mg
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What is Affex?

The active ingredient of Affex brand is fluoxetine. Fluoxetine is a selective serotonin reuptake inhibitors (SSRI) antidepressant. Fluoxetine affects chemicals in the brain that may be unbalanced in people with depression, panic, anxiety, or obsessive-compulsive symptoms. C17H18F3NO•HCl M.W. 345.79 Fluoxetine hydrochloride, USP is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each tablet contains Fluoxetine hydrochloride, USP equivalent to 10 mg (32.3 μmol) of Fluoxetine. In addition, each tablet also contains the following inactive ingredients: D&C Yellow #10 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Yellow #6 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized corn starch, talc, and titanium dioxide.

Used for

Affex is used to treat diseases such as: Anxiety and Stress, Binge Eating Disorder, Body Dysmorphic Disorder, Borderline Personality Disorder, Bulimia, Depression, Dissociative Identity Disorder, Dysautonomia, Fibromyalgia, Hot Flashes, Intermittent Explosive Disorder, Major Depressive Disorder, Obsessive Compulsive Disorder, PANDAS Syndrome, Panic Disorder, Persistent Depressive Disorder, Postpartum Depression, Premature Ejaculation, Premenstrual Dysphoric Disorder, Schizoaffective Disorder, Somatoform Pain Disorder, Trichotillomania, Vulvodynia.

Side Effect

Possible side effects of Affex include: loss of appetite; drowsiness; stomach cramps, gas, or pain; red or irritated eyes; large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs.

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Before taking this medicine

Do not use Affex if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine. You must wait at least 14 days after stopping an MAO inhibitor before you can take Affex. You must wait 5 weeks after stopping Affex before you can take thioridazine or an MAOI.

You should not use Affex if you are allergic to it, if you also take pimozide or thioridazine, or if you are being treated with methylene blue injection.

Tell your doctor about all other antidepressants you take, especially Celexa, Cymbalta, Desyrel, Effexor, Lexapro, Luvox, Oleptro, Paxil, Pexeva, Symbyax, Viibryd, or Zoloft.

Some medicines can interact with Affex and cause a serious condition called serotonin syndrome. Be sure your doctor knows about all other medicines you use. Ask your doctor before making any changes in how or when you take your medications.

To make sure Affex is safe for you, tell your doctor if you have:

cirrhosis of the liver;

seizures or epilepsy;

bipolar disorder (manic depression);

a history of drug abuse or suicidal thoughts; or

if you are being treated with electroconvulsive therapy (ECT).

Some young people have thoughts about suicide when first taking an antidepressant. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Taking an SSRI antidepressant during pregnancy may cause serious lung problems or other complications in the baby. However, you may have a relapse of depression if you stop taking your antidepressant. Tell your doctor right away if you become pregnant. Do not start or stop taking Affex during pregnancy without your doctor's advice.

Affex can pass into breast milk. Tell your doctor if you are breast-feeding a baby.

Affex is not approved for use by anyone younger than 18 years old.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Affex can stay in your body for many weeks after your last dose and may interact with many other medications. Before using any medication, tell your doctor or pharmacist if you have taken Affex in the previous 5 weeks.

Some products that may interact with this drug include: other drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, NSAIDs such as ibuprofen, "blood thinners" such as warfarin).

Taking MAO inhibitors with his medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for 2 weeks before and at least 5 weeks after treatment with this medication. Ask your doctor when to start or stop taking this medication.

This medication can slow down the removal of other medications from your body, which may affect how they work. Examples of affected drugs include pimozide, thioridazine, vinblastine, antiarrhythmics (such as propafenone, flecainide), tricyclic antidepressants (such as desipramine, imipramine), among others.

Aspirin can increase the risk of bleeding when used with this medication. However, if your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually at dosages of 81-325 milligrams a day), you should continue taking it unless your doctor instructs you otherwise.

The risk of serotonin syndrome/toxicity increases if you are also taking other drugs that increase serotonin. Examples include street drugs such as MDMA/"ecstasy," St. John's wort, certain antidepressants (including other SSRIs such as citalopram/paroxetine, SNRIs such as duloxetine/venlafaxine), tryptophan, among others. The risk of serotonin syndrome/toxicity may be more likely when you start or increase the dose of these drugs.

Tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, marijuana (cannabis), antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, and narcotic pain relievers (such as codeine). Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

This medication may interfere with certain medical/laboratory tests (including brain scan for Parkinson's disease), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

Tell your doctor and pharmacist if you are allergic to Affex or any other drugs.

Moreover, please inform your doctor and pharmacist what prescription and non-prescription drugs you are taking or have taken within the last 2 weeks, especially anticoagulants ; antidepressants; antihistamines; antipsychotics such as haloperidol (Haldol®) or clozapine (Clozaril®); buspirone (BuSpar®); carbamazepine (Tegretol®); cyclosporine (Neoral®, Sandimmune®); levodopa (Larodopa®, Sinemet®); lithium (Eskalith®, Lithobid®); MAO inhibitors ; tranquilizers; tryptophan; and vitamins. You should not take phenelzine (Nardil®), tranylcypromine (Parnate®), or thioridazine until at least 5 weeks after you stop taking Affex.

Also, let your doctor know if you have or have ever had glaucoma, an enlarged prostate, difficulty urinating, seizures, diabetes, an overactive thyroid gland, or liver or heart disease.

Additionally, tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking Affex, call your doctor immediately.

If you are having surgery, including dental surgery, tell the doctor or dentist that you are taking Affex.

You should know that this drug may make you drowsy. Do not drive a car or operate machinery until you know how this drug affects you. Remember that alcohol can also add to the drowsiness caused by this drug.

Tell your doctor if you use tobacco products. Cigarette smoking may decrease the effectiveness of this drug.

What should I do if I forget a dose?

If you take several doses per day, take the missed dose as soon as you remember it and take any remaining doses for that day at evenly spaced intervals. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule.

If you take Affex once a day at bedtime and do not remember to take it until the next morning, skip the missed dose.

Never take a double dose to make up for a missed one.

What side effects can this medication cause?

Important information

You should not use Affex if you also take pimozide or thioridazine, or if you are being treated with methylene blue injection.

Do not use Affex if you have used an MAO inhibitor in the past 14 days (such as isocarboxazid, rasagiline, selegiline, phenelzine, or transcypromine). Do not use Affex with thioridazine, linezolid, pimozide, or methylene blue injection.

You must wait at least 14 days after stopping an MAO inhibitor before you can take Affex. You must wait 5 weeks after stopping Affex before you can take thioridazine or an MAOI.

Some young people have thoughts about suicide when first taking an antidepressant. Stay alert to changes in your mood or symptoms.

Affex could impair judgment, thinking, or motor skills. Use caution when operating machinery.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Q: How does bourbon interact with Prozac? Can it cause excessive bruising?

A: Prozac (Affex) is in a class of drugs called selective serotonin reuptake inhibitors (SSRIs). Prozac is used to treat depression, obsessive-compulsive disorder, certain eating disorders, and panic attacks. Prozac works by increasing the amount of serotonin in the brain. Serotonin is a natural chemical that assists in maintaining mental balance. Generally speaking, drug interactions fall into three main categories: Drug-drug (i.e., prescription, over-the-counter, herbals, dietary supplements) interactions occur when two or more drugs react with each other. Drug-diet (food/drink) interactions result from drugs reacting with foods or drinks. Drug-disease interactions may occur when an existing medical condition makes certain drugs potentially harmful. No significant interactions between Prozac and bourbon (specifically) were identified; however, this does not necessarily mean no interactions exist. However, according to Prozac

Q: Would taking Prozac cause me to have a delay in speaking or studder?

A: According to the prescribing information available for Prozac (Affex), change in speech and stuttering are reported as possible side effects. If you are experiencing this side effect, and it is not tolerable, you may want to consult your doctor to see if an alternative medication may be better for you. There are many antidepressants available, and some work better than others for people. For more information on depression: //www.everydayhealth.com/depression/guide/ Patti Brown, PharmD

Q: Have you heard of Prozac being prescribed for menstrual migraines?

A: Although menstrual migraine is not an FDA-approved indication for Prozac (Affex), it is sometimes prescribed for menstrual migraines. Prozac is approved for premenstrual dysphoric disorder (PMDD). Headaches are a symptom of PMDD. PMDD symptoms typically occur after the middle of a monthly cycle after ovulation and usually gets worse during the week before menses. Prozac can be an effective headache prevention between ovulation and menses. If migraines continue to break through even while on Prozac, the dose can be increased right before menstruation. Dosing will have to be determined by a doctor and it is always good to speak with your health care provider regarding any concerns that you may have. Megan Uehara, PharmD

Urgent advice: Call a doctor straight away if:

You've taken too much Affex by accident and experience symptoms such as:

  • being sick (vomiting)
  • shaking
  • feeling sleepy
  • feeling agitated
  • heart problems
  • lung problems
  • fits (seizures)

If you need to go to a hospital accident and emergency (A&E) department, do not drive yourself - get someone else to drive you or call for an ambulance.

Take the Affex packet, or the leaflet inside it, plus any remaining medicine with you.

Like all medicines, Affex can cause side effects in some people, but many people have no side effects or only minor ones. Some of the common side effects of Affex will gradually improve as your body gets used to it.

Other warnings

  • Serotonin syndrome warning: This drug can cause a life-threatening condition called serotonin syndrome. This syndrome happens when medications cause too much serotonin to build up in your body. Symptoms can include agitation, hallucinations (seeing or hearing something that isn’t there), problems with coordination, and a racing heart rate. They can also include overactive reflexes, fever, nausea, vomiting, or diarrhea. Call your doctor right away if you have any signs of this condition.
  • Mania warning: This drug may cause mania. Symptoms include greatly increased energy, extreme irritability, talking more or faster than usual, racing thoughts, or severe trouble sleeping.
  • Low salt levels warning: This drug may cause you to have dangerously low salt levels in your blood. Symptoms include headache, weakness, confusion, trouble concentrating, memory problems, and feeling unsteady. Call your doctor right away if you have any symptoms of this condition.

Affex is a prescription drug. It comes as a capsule, delayed-release capsule, tablet, and solution. All forms are taken by mouth. (A delayed-release capsule is released into your body more slowly.)

Affex oral capsule is available as the brand-name drugs Prozac and Prozac Weekly. It’s also available as a generic drug. Generic drugs usually cost less than brand-name versions. In some cases, they may not be available in every strength or form as brand-name drugs.

Affex oral capsule may be used as part of a combination therapy. This means you may need to take it with other medications. For the treatment of depressive episodes related to bipolar I disorder and treatment-resistant depression, this drug must be used with olanzapine.

Q: Currently I take Prozac and Abilify. Then I take Centrum and sometimes fish oil and vitamin E oil. Is this a safe combination?

A: Prozac (Affex) is a selective serotonin reuptake inhibitor (SSRI) approved for the treatment of major depression (including pediatric depression), obsessive-compulsive disorder (in both adult and pediatric populations), bulimia nervosa, panic disorder and premenstrual dysphoric disorder. Abilify (aripiprazole) is an atypical antipsychotic and antidepressant used in the treatment of schizophrenia, bipolar disorder, and clinical depression. Generally speaking, drug interactions fall into three main categories: Drug-drug (i.e., prescription, over-the-counter, herbals, dietary supplements) interactions occur when two or more drugs react with each other. Drug-diet (food/drink) interactions result from drugs reacting with foods or drinks. Drug-disease interactions may occur when an existing medical condition makes certain drugs potentially harmful. With Abilify and Prozac, the concomitant use of two or more drugs that have the potential to depress CNS function (either as a therapeutic intention or a side effect) is often clinically appropriate. However, it is important to recognize that the risk of unwanted effects may increase with such use. It is important to monitor for additive CNS-depressant effects if two or more CNS depressants are concomitantly used. For more detailed information, consult with your physician or pharmacist for guidance based on your specific condition and current medications, particularly before taking any action. Shereen A. Gharbia, PharmD

Q: I temporarily increased my dose of Affex from 10 mg to 30 mg before having sex for the first time in 18 months to combat premature ejaculation. It worked great the first time I had sex with my girlfriend, but the second, 3rd and 4th times last weekend, I couldn't climax. Did I overdose on it? I'm back to 10 mg per day now, 2,500 miles from my girlfriend.

A: Prozac (Affex) is a medication that is used to treat depression, anxiety or panic disorders. It is in a class of drugs called selective serotonin reuptake inhibitors (SSRIs) and is commonly related to sexual disorders. The prescribing information on Affex states that up to 11 percent of patients taking this medication experience a decrease in sex drive. This medication also causes ejaculation issues in up to 7 percent of patients taking Affex. For more information on Affex, click on this link: //www.everydayhealth.com/drugs/prozac There is no way to know if you will experience sexual side effects from a medication before taking it. Sometimes, a patient will not experience any issues until the dosage of a medication is raised. The usual course of action is to decrease the dosage or switch to another medication to try to alleviate the issue. The best thing to do is have a discussion with your physician about your side effects and he or she will be better enabled to help you resolve the problem. For more specific information, consult with your doctor or pharmacist for guidance based on your health status and current medications, particularly before taking any action. Lori Poulin, PharmD

Serious allergic reaction

In rare cases, it's possible to have a serious allergic reaction (anaphylaxis) to Affex.

Q: Does Prozac have any side effects? If yes, what is the alternative? Is it possible to take Prozac for my whole life, as being advised to?

A: All medications have potential side effects and everyone responds to medications differently. Although many side effects may be listed you may get one, several, or none of the listed side effects. Prozac (Affex) is a selective serotonin reuptake inhibitor antidepressant used for the treatment of depression, eating disorders, premenstrual dysphoric disorder, and panic disorder. It is possible to take an antidepressant indefinitely. The most common side effects with Prozac are insomnia, heachache, drowsiness, nausea, and anorexia. Other side effects with Prozac include diarrhea, dry mouth, anxiety, and weakness. This is not a complete list of the side effects associated with Prozac. Laura Cable, PharmD

6. How to cope with s >

You can reduce the chance of having a side effect if you take Affex in the evening so that you're asleep when the level of medicine in your body is highest.

What to do about:

  • feeling sick (nausea) - try taking Affex with or after food. It may also help to stick to simple meals and avoid rich or spicy food.
  • headaches - make sure you rest and drink plenty of fluids. Do not drink too much alcohol. Ask your pharmacist to recommend a painkiller. Headaches should usually go away after the first week of taking Affex. Talk to your doctor if they last longer than a week or are severe.
  • being unable to sleep - take Affex first thing in the morning
  • diarrhoea - drink plenty of water or other fluids to avoid dehydration. Signs of dehydration include peeing less than usual or having dark strong-smelling pee. Do not take any other medicines to treat diarrhoea or vomiting without speaking to a pharmacist or doctor.
  • feeling tired or weak - if Affex makes you feel tired or weak, stop what you're doing and sit or lie down until you feel better. Do not drive or use tools or machinery if you're feeling tired. Do not drink alcohol as it will make you feel worse. If these symptoms don't go away after a week or two, ask your doctor for advice.

Q: Can you tell me more about Prozac?

A: Prozac (Affex) is used to treat depression or obsessive-compulsive disorder (OCD) in adults and children. It is also used to treat bulimia and panic disorder in adults. It may also be used for other conditions as determined by your doctor. Prozac is a selective serotonin reuptake inhibitor (SSRI). It works by restoring the balance of serotonin, a natural substance in the brain, which helps to improve certain mood problems. All medicines may cause side effects, but many people have no, or minor, side effects with Affex. The most common side effects of Prozac are drowsiness, dizziness, anxiety, abnormal dreams, decreased sexual desire or ability, diarrhea, dry mouth, flu-like symptoms, flushing, sweating, loss of appetite, nausea, and trouble sleeping. Some medicines may interact with Affex. Tell your physician if you are taking any other medicines. Do not suddenly stop taking Affex without checking with your doctor. Withdrawal symptoms such as mood changes, numbness or tingling of the skin, dizziness, confusion, headache, trouble sleeping, or unusual tiredness may occur. For more information visit the Everyday Health Depression Center at: //www.everydayhealth.com/depression/guide/ or to submit another question return to //www.everydayhealth.com/drugs/. Burton Dunaway, PharmD

What Other Drugs Interact with Affex?

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

Severe Interactions of Affex include:

Affex has serious interactions with at least 101 different drugs.

Affex has moderate interactions with at least 235 different drugs.

Affex has mild interactions with at least 43 different drugs.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Q: Is Prozac really safe to take for a lifetime at 50 mg daily? I am male and 66. Is it safe with natural nutrient/supplement blood-thinners like fish oils, vitamin E, and others? The fact sheet says, "Proceed with caution with anything which affects platelet-action." Is it safe if you are also a heavy cocoa drinker in view of cocoa's relatively high content of tryptophan and monoamine oxidase inhibitor?

A: Your question regards if Prozac (Affex) //www.everydayhealth.com/drugs/prozac is safe to take for a lifetime at 50 mg per day. You also asked if it is safe to take with natural blood thinners and if you are a heavy cocoa drinker. According to Lexi-Comp, Prozac is dosed anywhere between 20 mg to 60 mg per day depending on the indication. The maximum amount that is recommended is 80 mg/day. Unfortunately, I can not say one way or the other if the medication will be safe to take for your entire lifetime. There are a lot of factors that play into this. I will say though that when evaluating taking a medication, the patient and the physician must take into consideration the benefits and the risks associated with the medication. If you begin experiencing adverse reactions from the medication or if it is not an effective treatment, then you and your physician may need to consider another therapy. According to Lexi-Comp, Prozac can interact with medications that thin the blood or have anti-platelet effects. Please talk to your health care provider to see if you should be on the fish oils and vitamin E while taking Prozac. According to Lexi-Comp, recommendation on management of this interaction if it is necessary for the patient to be on the combination is to closely monitor the patient for signs and symptoms of bleeding or excessive bruising. The therapy should be monitored by your physician. I understand your reasoning with concerns about cocoa and Prozac, but could not find any well-documented information regarding this. Lexi-Comp did not mention anything in the dietary considerations specific to cocoa and Prozac. However, there is mention that caffeine should be avoided while on the medication and sometimes cocoa contains caffeine. I did come across a research article that hypothesized that after a patient taking Prozac ate chocolate he developed a rash that may have been attributed to the patient being very sensitive to activity in the serotonergic system at the dermal and epidermo-dermal junctional area. As always, talk with your health care provider regarding questions you have about your medications and interactions between medications and supplements. Always talk with your health care provider before beginning to take over-the-counter supplements so that it can be determined if the supplement is appropriate for you. Jen Marsico RPh


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