Torrent-Duloxetine: Uses, Side Effects and Dosage

What is Torrent-Duloxetine used for?

• Chronic (ongoing) low back pain
• Chronic (ongoing) osteoarthritis knee pain

• Diabetic nerve pain:

  • pain that may be burning, stabbing, stinging, shooting, aching or like an electric shock
  • pain may be caused by touch, heat, cold, or pressure
  • there may be loss of feeling in the affected area

• Depression:

  • feeling sad, restless, irritable, tired
  • experiencing a change in appetite or weight, difficulty concentrating or sleeping, headaches, unexplained aches and pains
• Generalized anxiety: feeling very anxious and worried

How does Torrent-Duloxetine work?

Torrent-Duloxetine belongs to a group of medicines called “serotonin and norepinephrine reuptake inhibitors” (SNRIs). Torrent-Duloxetine increases the levels of two naturally occurring chemical messengers (serotonin and norepinephrine) in your brain and other parts of your body.

Depression and Anxiety

Depression and anxiety are mental illnesses. They may happen when chemicals in the brain, such as serotonin and norepinephrine, are not in balance. Torrent-Duloxetine works to help balance these chemicals. This helps to relieve the emotional and physical symptoms of depression and anxiety.

You may notice that your depression or anxiety symptoms feel better within 1 to 4 weeks after starting Torrent-Duloxetine.

Diabetic Nerve Pain, Chronic Low Back Pain, and Chronic Osteoarthritis Knee Pain

Torrent-Duloxetine works by increasing the levels of serotonin and norepinephrine. This helps to reduce the pain in these conditions.

You may notice that your pain symptoms feel better within 1 week after starting Torrent-Duloxetine.

What are the ingredients in Torrent-Duloxetine?

Medicinal ingredient: Duloxetine hydrochloride

Non-medicinal ingredients: FD&C blue No. 2, gelatin, hydroxypropyl methylcellulose, hydroxypropyl methylcellulose acetate succinate, sodium lauryl sulphate, sucrose, sugar spheres, talc, titanium dioxide, and triethyl citrate. The 60 mg capsules also contain iron oxide yellow.

Torrent-Duloxetine comes in the following dosage forms: 30mg and 60 mg delayed-release capsules (as duloxetine hydrochloride).

Do not use Torrent-Duloxetine if:

• You are younger than 18 years of age.
• You are allergic to it or any of the ingredients in Torrent-Duloxetine (Please read “What are the ingredients in Torrent-Duloxetine?” above).
• You have liver impairment or liver disorder. A liver disorder is your liver can no longer carry out its normal function.
• You have severe kidney disease.

• You are taking or have just stopped taking any of these drugs in the last 14 days:

  • monoamine oxidase inhibitors (MAOIs) such as phenelzine or moclobemide, to treat depression
  • linezolid to treat infection(s)
• You have been given a dye called methylene blue during surgery in the last 14 days
• You are on a drug or have been on a drug to manage psychosis (serious mental illness) called thioridazine.
• You are taking a medication to treat depression, like fluvoxamine, a potent CYP1A2 inhibitor
• You are taking certain antibiotics, like ciprofloxacin or enoxacin.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Torrent-Duloxetine. Talk about any health conditions or problems you may have, including if you:

• Have or have a history of liver, kidney, or heart problems, diabetes, or seizures
• Have high blood pressure. Torrent-Duloxetine may cause increased blood pressure.
• Have low sodium levels in your blood.
• Are pregnant, thinking about getting pregnant, or are breastfeeding.
• Drink alcohol or use street drugs. Drinking a large amount of alcohol while taking Torrent-Duloxetine may lead to serious liver problems and death.
• Have an allergy to any medication.
• Have a bleeding disorder that makes you more likely to bleed, or if you have low platelets levels (a type of blood cells).
• Have problems urinating.

• Have a rare hereditary disease that means you should not eat sugar. Torrent-Duloxetine contains a type of sugar called sucrose. These diseases include:

  • Fructose intolerance
  • Glucose-galactose malabsorption
  • Sucrose-isomaltase insufficiency

Other warnings you should know about:

Angle-closure Glaucoma

Torrent-Duloxetine can cause an acute attack of glaucoma. Having your eyes examined before you take Torrent-Duloxetine could help identify if you are at risk of having angle-closure glaucoma. Seek immediate medical attention if you experience:

• eye pain
• changes in vision
• swelling or redness in or around the eye.

Driving and using machines:

Torrent-Duloxetine may make you feel dizzy or tired, especially just after you start taking it or after the dose is increased. Wait to see how you feel while taking Torrent-Duloxetine before driving or using machines.

Changes in behaviour and feelings, thoughts and actions about suicide:

Treatment with these types of medications is most safe and effective when you and your healthcare professional have good communication about how you are feeling. You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder. You might ask them to tell you if they think you are getting worse or if they are worried about changes in your behaviour.

Some patients may feel worse instead of better when first starting drugs like Torrent-Duloxetine or when changing the dose. You may feel more anxious, agitated, hostile, aggressive, impulsive, and feel like you are not yourself or become less inhibited. You may have thoughts of suicide, hurting yourself or other people. Thoughts and actions related to suicide can occur especially if you’ve had thoughts of hurting yourself in the past. These changes in behaviour and feelings can happen in patients of any age treated with Torrent-Duloxetine. Changes in suicidal thoughts and actions may be more likely if you are 18 to 24 years old. If this happens, seek immediate medical help. Do NOT stop taking Torrent-Duloxetine on your own.

Effects on Pregnancy and Newborns

If you are or become pregnant while taking Torrent-Duloxetine, talk to your healthcare professional about the risks and benefits of various treatment options. It is very important that you keep taking Torrent-Duloxetine until your healthcare professional tells you to stop.

When pregnant women took drugs in the same group of medications as Torrent-Duloxetine, some newborns had complications at birth. This happened especially when the medication was taken in the last three months of pregnancy.

Some newborns:

• required breathing support, tube feeding and a longer stay in a hospital.
• had difficulty breathing, seizures, tense or overly relaxed muscles, and were jittery and cried constantly.

These symptoms normally go away over time. If your baby experiences any of these symptoms, contact your healthcare professional as soon as possible.

Risk of breaking a bone:

You should tell your doctor if:

• you are elderly and had a recent bone fracture
• were told you have osteoporosis or risk factors for osteoporosis

Taking Torrent-Duloxetine may increase your risk of breaking a bone. This is especially true when you first start taking Torrent-Duloxetine and soon after you stop taking it. Take extra care to avoid falling, especially if you get dizzy or have low blood pressure.

Serotonin Syndrome/Neuroleptic Malignant Syndrome (NMS): This is a rare side effect of the group of medications like Torrent-Duloxetine. It is life-threatening and can lead to death. It can cause serious changes in how your brain, muscles, digestive system and nervous system work. The reaction is more likely if you take Torrent-Duloxetine with certain other medications. Please read “Serious side effects and what to do about them,” below.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements, or alternative medicines.

The following may interact with Torrent-Duloxetine:

• Medications for depression called monoamine oxidase inhibitors (MAOIs), like phenelzine and moclobemide
• An antibiotic called linezolid
• A dye called methylene blue used during surgery
• A medication to manage psychosis (serious mental illness) called thioridazine
• Some antibiotics, like ciprofloxacin or enoxacin

• Other medications to treat depressions, such as:

  • selective serotonin reuptake inhibitors (SSRIs) or SNRIs like fluoxetine, venlafaxine, and paroxetine
  • tricyclics like amitriptyline and desipramine
  • potent CYP1A2 inhibitors like fluvoxamine
• Medications used to treat schizophrenia like olanzapine and risperidone
• Medications used to treat bipolar depression like lithium

• Medications that can affect blood clotting and increase bleeding, such as:

  • oral anticoagulants like warfarin and dabigatran
  • acetylsalicylic acid or ASA
  • non-steroidal anti-inflammatory drugs (NSAIDS) used to treat pain and fever like ibuprofen and naproxen
• Some medicines used to treat patients with irregular heartbeats like flecainide and encainide

• Some medicines that affect the chemical messenger serotonin, like

  • lithium
  • medications containing tryptophan, used to treat bipolar disorder
  • St. John’s Wort (also called Hypericum perforatum), an herbal product often used to treat depression
  • a group of medications called triptans used to treat migraines, like sumatriptan and rizatriptan
• Some pain medications in a group of drugs called opiods, like fentanyl, tramadol, tapentadol, meperidine, methadone, pentazocine
• Some medications used to treat cough, like dextromethorphan (a cough syrup)

In general, drink only small amounts of alcohol while you are taking Torrent-Duloxetine.

Hot to take Torrent-Duloxetine:

• Once each day, at about the same time each day

• Swallow capsules whole with a drink of water.

• Take with or without food. Taking it with food can reduce nausea at the start of treatment.
• Take exactly as prescribed. Do NOT give it to anybody else. They may have unwanted side effects that may be serious
• Do NOT chew, crush, or open the capsule. Do NOT mix with liquids or sprinkle on food or drink.
• If you accidentally break or open the capsule, do NOT touch the powder. Wash away any loose powder right away with water. If you get powder in your eyes, rinse them with water right away and contact your healthcare professional.

Usual dose:

The usual adult dose is 60 mg once daily.

Elderly patients with generalized anxiety:

The starting dose is 30 mg once daily. After 2 weeks, your healthcare professional may increase the dose to 60 mg once daily.

Your healthcare professional may adjust the dose during the course of your treatment. Only increase the amount of Torrent-Duloxetine if your healthcare professional tells you to.

You should continue to take Torrent-Duloxetine for several months or longer, as directed by your healthcare professional.

Stopping Torrent-Duloxetine:

Do not stop taking Torrent-Duloxetine without discussing it with your healthcare professional. This may help you avoid discontinuation symptoms. Follow your healthcare professional’s instructions. They may gradually reduce the dose you are taking.

Patients being treated for nerve pain caused by diabetes: Continue to see your healthcare professional regularly for proper management of your diabetes. This will help to control blood sugar levels and prevent further nerve damage. It is important that you continue to do daily foot examinations.

Overdose:

If you think you have taken too much Torrent-Duloxetine, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose:

If you miss a dose of Torrent-Duloxetine by a few hours, take the dose when you remember. If most of the day has passed, wait until your next scheduled dose. Try not to miss any more. Do NOT take a double dose to make up for a missed dose.

What are possible side effects from using Torrent-Duloxetine?

These are not all the possible side effects you may feel when taking Torrent-Duloxetine. If you experience any side effects not listed here, contact your healthcare professional.

Most side effects are minor and temporary. However, some may be serious.

The most common side effects with Torrent-Duloxetine are:

• constipation
• diarrhea
• dizziness
• dry mouth
• erectile dysfunction (trouble getting or keeping an erection)
• feeling tired
• headache
• insomnia (trouble falling asleep and/or staying asleep)
• less appetite
• more sweating
• nausea
• pain in belly
• sleepiness
• vomiting (throwing up)

These side effects have been shown to decrease with continued treatment.

Tell your healthcare professional if:

• any of the side effects discussed above affect you severely
• you experience other side effects not listed here.

Some of these side effects may be related to the dose you are taking. Your healthcare professional will decide if your dose needs to be changed.

Depression and anxiety may decrease your sexual desire, performance, and satisfaction. This medication may further decrease sexual enjoyment.

You may also have symptoms after you stop taking Torrent-Duloxetine:

• anxiety
• diarrhea
• dizziness
• feeling tired
• headache
• insomnia
• irritability
• muscle pain
• nausea
• nerve sensations (numbing, tingling, burning or prickling)
• nightmares
• sleepiness
• severe sweating
• vertigo (feeling of spinning when not moving),
• vomiting

These symptoms usually go away without treatment. Tell your health care professional right away if you have these or other symptoms.

Serious side effects and what to do about them

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Reporting Side Effects

Storage:

• Keep out of reach and sight of children.
• Keep capsules in their original package.
• Store at room temperature (15°C to 30°C or 59°F to 86°F).
• Keep the package in a dry place.
• Keep the package out of direct sunlight.
• Use the capsules before the expiry date on the box. Do NOT use tablets after the expiry date.
• Return any expired or leftover medicine to your pharmacist.

If you want more information about Torrent-Duloxetine:

• Talk to your healthcare professional

This document plus the full Product Monograph, prepared for health professionals, is available by contacting the distributor:

Distributor Address:

Torrent Pharma Canada Inc.

131 Cormorant Crescent

Woodbridge, Ontario,

Canada, L4H 2K4

Manufacturer Address:

Torrent Pharmaceuticals Limited

Ahmedabad-Mehsana Highway

Taluka-Kadi, Dist. Mehsana

Indrad-382 721, Gujarat, India http://www.torrentpharma.com

Last prepared: September 19, 2016