Anafranil SR

(Clomipramine Hydrochloride SR)

The active ingredient in Anafranil SR is clomipramine hydrochloride. It is a tricyclic antidepressant that affects neurotransmitters in the central nervous system, including serotonin and norepinephrine, which may help improve symptoms of OCD and depression.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Anafranil SR. However, the following is a synopsis of the general guidelines for the use of Anafranil SR:

Anafranil SR is taken by mouth.

It can be taken with or without food.

The dosage is individualized, and dose increases should be made gradually.

Abrupt discontinuation should be avoided because withdrawal symptoms may occur, and the dose should be reduced gradually when stopping.

Anafranil sustained-release tablets may be halved to adjust the dose, but they should not be chewed.

Some mild or common side effects of Anafranil SR seen in clinical trials include:

Drowsiness.

Dry mouth.

Constipation.

Blurred vision.

Weight gain.

Sexual dysfunction such as abnormal ejaculation, decreased sexual performance, or desire.

Some individuals may experience serious side effects while using Anafranil SR. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

Suicidal thoughts or thoughts of self-harm.

Seizures.

Signs of low sodium include headache, weakness, difficulty concentrating, or coma.

Signs of serotonin syndrome include a fast heartbeat, sweating, muscle stiffness, fever, or confusion.

Signs of an allergic reaction include skin rash, swelling of the mouth, tongue, or lips, and trouble breathing.

Signs of Neuroleptic Malignant Syndrome (NMS), which is life-threatening, include high fever, severe muscle rigidity, and a fast heart rate.

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), which can affect multiple parts of the body, including your liver, kidneys, and heart.

These are not all of the possible side effects of Anafranil SR. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Anafranil SR, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including:

Heart disease, heart rhythm problems, or heart failure.

High or unstable blood pressure.

Risk of seizures or a history of epilepsy.

Risk factors for serotonin syndrome, especially if taken with SSRIs, SNRIs, or other serotonergic drugs.

Narrow-angle glaucoma, chronic constipation, or urinary retention, due to the anticholinergic effects of Anafranil.

Elderly patients.

Liver disease.

Kidney disease.

Thyroid conditions.

History of schizophrenia or bipolar disorder.

Hypersensitivity to clomipramine, other tricyclic antidepressants of the dibenzazepine group, or any excipients.

Use of MAO inhibitors, or within 21 days before or after MAO inhibitor treatment (including moclobemide).

Recent myocardial infarction.

Cardiac arrhythmias.

Congenital long QTc syndrome.

Narrow-angle glaucoma.

Acute urinary retention.

Severe hepatic disease.

Use with certain antiarrhythmics such as quinidine and propafenone (potent CYP2D6 inhibitors).

Anafranil SR may take several weeks to show full benefit. Patients should be monitored closely during early treatment and during dose changes.

When Anafranil SR is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

SSRIs (such as sertraline, paroxetine, fluoxetine, fluvoxamine), St. John’s Wort, tricyclic antidepressants (TCAs), lithium, quinidine, linezolid, MAO inhibitors, and SNRIs may increase the risk of serotonin syndrome and QT prolongation.

Medications that are CNS depressants, such as alcohol and benzodiazepines, may have an increased effect when combined with Anafranil.

Anticonvulsants such as carbamazepine, phenytoin, and barbiturates (phenobarbital) may decrease levels of Anafranil.

Medications with anticholinergic effects, such as antihistamines or medications for Parkinson’s disease, may have an increased risk of side effects when combined with Anafranil.

Diuretics may lead to low potassium and increase the risk of heart problems while on Anafranil.

It is available as 75mg film-coated tablets.

It should be stored at room temperature away from the reach of children or pets.

It is manufactured by Tzamal Bio-Pharma.

Yes, it is available from several manufacturers of generic drugs.

Do not stop Anafranil SR suddenly unless directed by your healthcare provider. The dose should be reduced gradually to help prevent withdrawal symptoms, and patients should be monitored carefully when therapy is discontinued.

Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

This medication is not recommended during lactation, as it passes into breast milk.

Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.