ALEVAL (ZOLOFT) INDICATIONS
Aleval is used for treating depression or obsessive-compulsive disorder (OCD). It may be used to treat panic disorder or posttraumatic stress disorder (PTSD). It may also be used to treat premenstrual dysphoric disorder (PMDD; a severe form of premenstrual syndrome) or social anxiety disorder. Aleval 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.
ALEVAL (ZOLOFT) INSTRUCTIONS
Use Aleval as directed by your doctor.
- Take Aleval by mouth with or without food.
- Taking Aleval at the same time each day will help you remember to take it.
- Continue to take Aleval even if you feel well. Do not miss any dose.
- Do not suddenly stop taking Aleval without checking with your doctor. Side effects may occur. They may include mental or mood changes, numbness or tingling of the skin, dizziness, confusion, headache, trouble sleeping, or unusual tiredness. You will be closely monitored when you start Aleval and whenever a change in dose is made.
- If you miss a dose of Aleval, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Aleval.
ALEVAL (ZOLOFT) STORAGE
Store Aleval at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Aleval out of the reach of children and away from pets.
ALEVAL (ZOLOFT) MORE INFO:
Active Ingredient:Sertraline hydrochloride.
Do NOT use Aleval if:
- you are allergic to any ingredient in Aleval
- you are taking or have taken a monoamine oxidase inhibitor (MAOI) (eg, phenelzine), selegiline, or St. John's wort within the last 14 days
- you are taking a fenfluramine derivative (eg, dexfenfluramine), an H1
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Aleval. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you or a family member has a history of bipolar disorder (manic-depression), other mental or mood problems, suicidal thoughts or attempts, or alcohol or substance abuse
- if you have a history of seizures, heart problems, liver problems, stomach or bowel bleeding, or metabolism problems
- if you are dehydrated, have low blood sodium levels, or drink alcohol
- if you will be having electroconvulsive therapy (ECT).
Some medicines may interact with Aleval. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Anorexiants (eg, phentermine), fenfluramine derivatives (eg, dexfenfluramine), linezolid, MAOIs (eg, phenelzine), metoclopramide, nefazodone, selegiline, serotonin 5-HT1
- Anticoagulants (eg, warfarin), aspirin, or nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen) because the risk of bleeding, including stomach bleeding, may be increased
- Diuretics (eg, furosemide, hydrochlorothiazide) because the risk of high or low blood sodium levels may be increased
- Tramadol because the risk of seizures may be increased
- Carbamazepine or cyproheptadine because they may decrease Aleval's effectiveness
- Aripiprazole, clozapine, digoxin, flecainide, lithium, phenytoin, pimozide, propafenone, risperidone, tricyclic antidepressants (eg, amitriptyline), or valproate (eg, valproic acid) because the risk of their side effects may be increased by Aleval.
This may not be a complete list of all interactions that may occur. Ask your health care provider if Aleval may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Important safety information:
- Aleval may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Aleval with caution. Do not drive or perform other possible unsafe tasks until you know how you react to it.
- Do not drink alcohol while you are taking Aleval.
- Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are taking Aleval; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
- Several weeks may pass before your symptoms improve. Do NOT take more than the recommended dose, change your dose, or use Aleval for longer than prescribed without checking with your doctor.
- Children and teenagers who take Aleval may be at increased risk for suicidal thoughts or actions. Adults may also be affected. The risk may be greater in patients who have had suicidal thoughts or actions in the past. The risk may also be greater in patients who have had bipolar (manic-depressive) illness, or if their family members have had it. Watch patients who take Aleval closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
- If your doctor tells you to stop taking Aleval, you will need to wait for several weeks before beginning to take certain other medicines (eg, MAOIs, nefazodone). Ask your doctor when you should start to take your new medicines after you have stopped taking Aleval.
- Aleval may rarely cause a prolonged, painful erection. This could happen even when you are not having sex. If this is not treated right away, it could lead to permanent sexual problems such as impotence. Contact your doctor right away if this happens.
- Serotonin syndrome is a possibly fatal syndrome that can be caused by Aleval. Your risk may be greater if you take Aleval with certain other medicines (eg, "triptans," MAOIs). Symptoms may include agitation; confusion; hallucinations; coma; fever; fast or irregular heartbeat; tremor; excessive sweating; and nausea, vomiting, or diarrhea. Contact your doctor at once if you have any of these symptoms.
- Neuroleptic malignant syndrome (NMS) is a possibly fatal syndrome that can be caused by Aleval. Symptoms may include fever; stiff muscles; confusion; abnormal thinking; fast or irregular heartbeat; and sweating. Contact your doctor at once if you have any of these symptoms.
- Caution is advised when using Aleval in the elderly; they may be more sensitive to its effects, especially low blood sodium levels.
- Caution is advised when using Aleval in children; they may be more sensitive to its effects, especially increased risk of suicidal thoughts or actions.
- Aleval should be used with extreme caution in children younger 6 years; safety and effectiveness in these children have not been confirmed.
- Aleval may cause weight changes. Children and teenagers may need regular weight and growth checks while they take Aleval.
- Pregnancy and breast-feeding: Aleval may cause harm to the fetus if it is used during the last 3 months of pregnancy. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Aleval while you are pregnant. It is not known if Aleval is found in breast milk. If you are or will be breast-feeding while you use Aleval, check with your doctor. Discuss any possible risks to your baby.
All medicines may cause side effects, but many people have no, or minor, side effects.
Check with your doctor if any of these most common side effects persist or become bothersome:
Anxiety; constipation; decreased sexual desire or ability; diarrhea; dizziness; drowsiness; dry mouth; increased sweating; loss of appetite; nausea; nervousness; stomach upset; tiredness; trouble sleeping; vomiting; weight loss.
Seek medical attention right away if any of these severe side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bizarre behavior; black or bloody stools; chest pain; confusion; decreased bladder control; decreased concentration; decreased coordination; exaggerated reflexes; fainting; fast or irregular heartbeat; fever; hallucinations; memory loss; new or worsening agitation, panic attacks, aggressiveness, impulsiveness, irritability, hostility, exaggerated feeling of well-being, restlessness, or inability to sit still; persistent or severe ringing in the ears; persistent, painful erection; red, swollen, blistered, or peeling skin; seizures; severe or persistent anxiety or trouble sleeping; severe or persistent headache; stomach pain; suicidal thoughts or attempts; tremor; unusual bruising or bleeding; unusual or severe mental or mood changes; unusual weakness; vision changes; worsening of depression.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider.