pms-Duloxetine

Duloxetine.

Medicinal ingredient: Duloxetine hydrochloride.
Excipients/Inactive Ingredients: Colloidal Silicon Dioxide, Eudragit, FD&C Blue No. 2, Gelatin, Hypromellose, Plasacryl, Propylene Glycol, Shellac, Sucrose, Sugar Spheres, Talc, Titanium Dioxide, Triethyl Citrate, and Yellow Iron Oxide. The 30 mg capsules also contain Black Iron Oxide and Potassium Hydroxide. The 60 mg capsules also contain Povidone and Sodium Hydroxide.

Pharmacology: pms-DULOXETINE belongs to a group of medicines called "serotonin and norepinephrine reuptake inhibitors" (SNRIs). pms-DULOXETINE increases the levels of two chemical messengers (serotonin and norepinephrine) found naturally in the brain and other parts of the body.
Depression: Depression is mental illness. It may happen when chemicals in the brain, such as serotonin and norepinephrine, are not in balance. pms-DULOXETINE works to help balance these chemicals. This helps to relieve the emotional and physical symptoms of depression.
Symptoms of depression may get better within 1 to 4 weeks after starting pms-DULOXETINE.

Depression: feeling sad, restless, irritable, tired; experiencing a change in appetite or weight, difficulty concentrating or sleeping, headaches, unexplained aches and pains

How to take pms-DULOXETINE: Once each day, at about the same time every 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.
In case of accidental breakage or opening of capsules, do NOT touch the powder. Wash away any loose powder right away with water. If the powder gets in the eyes, rinse them with water right away and contact a healthcare professional.
Usual dose: The usual adult dose is 60 mg once daily.
The healthcare professional may adjust the dose during the course of the treatment. Only increase the amount of pms-DULOXETINE being taken if the healthcare professional tells to.
Continue to take pms-DULOXETINE for several months or longer, as directed by the healthcare professional.
Stopping pms-DULOXETINE: Do NOT stop taking pms-DULOXETINE without discussing it with the healthcare professional. This may help avoid discontinuation symptoms. Follow the healthcare professional's instructions. They may gradually reduce the dose being taken.
Missed Dose: If a dose of pms-DULOXETINE has been missed by a few hours, take the dose when remembered. If most of the day has passed, wait until the next scheduled dose. Try not to miss any more. Do NOT take a double dose to make up for a missed dose.

If too much pms-DULOXETINE has been taken than necessary, contact the healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Do not use pms-Duloxetine if: The patient is younger than 18 years of age.
The patient is allergic to any of the ingredients of pms-Duloxetine (see Description).
The patient has a liver impairment or disorder. A liver disorder is when the liver can no longer carry out its normal function.
The patient has severe kidney disease.
The patient is taking or has 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).
The patient has been given a dye called methylene blue during surgery in the last 14 days.
The patient is on a drug or has been on a drug to manage psychosis (serious mental illness) called thioridazine.
The patient is taking a medication to treat depression, like fluvoxamine, a potent CYP1A2 inhibitor.
The patient is taking certain antibiotics, like ciprofloxacin or enoxacin.

Serotonergic psychiatric drugs should not be started in a patient receiving linezolid. Wait until 24 hours after the last dose of linezolid before starting the serotonergic psychiatric drugs.

To help avoid side effects and ensure proper use, talk to the healthcare professional before taking pms-DULOXETINE. Talk about any health conditions or problems the patient may have, including if the patient: Has or has a history of liver, kidney problems or heart problems, diabetes or seizures.
Has high blood pressure. pms-DULOXETINE may raise the blood pressure.
Has low sodium levels in the blood.
Is pregnant, is thinking about getting pregnant, or is breastfeeding.
Drinks alcohol or uses street drugs. Drinking a large amount of alcohol while taking pms- DULOXETINE may lead to serious liver problems and death.
Has an allergy to any medication.
Has a bleeding disorder that makes the patient more likely to bleed, or has low platelet levels (a type of blood cell).
Has problem urinating.
Has a rare hereditary disease that means the patient should not eat sugar. pms-DULOXETINE contains a type of sugar called sucrose. These diseases include: Fructose intolerance; Glucose-galactose malabsorption; Sucrose-isomaltase insufficiency.
Angle-closure Glaucoma: pms-DULOXETINE can cause an acute attack of glaucoma. Having the eyes examined before taking pms-DULOXETINE could help identify if the patient is at risk of having angle-closure glaucoma.
Seek immediate medical attention in case of: eye pain; changes in vision; swelling or redness in or around the eye.
Changes in behaviour and feelings, thoughts and actions about suicide: Treatment with these types of medications is most safe and effective when the healthcare professional and his/her patient have good communication about how the patient feels. It is helpful for the patient to tell a relative or close friend that he/she is depressed or has an anxiety disorder. They may tell if they think the patient is getting worse or if they are worried about changes in the patient's behaviour.
Some patients may feel worse instead of better when first starting drugs like pms-DULOXETINE or when changing the dose. The patient may feel more anxious, agitated, hostile, aggressive, impulsive, and feel like he/she is not himself/herself or become less inhibited. The patient may have thoughts of suicide, hurting himself/herself or other people. Thoughts and actions about suicide can occur especially if the patient has thoughts of hurting himself/herself in the past. These changes in behaviour and feelings can happen in patients of any age treated with pms-DULOXETINE at any age. Changes in suicidal thoughts and actions may be more likely if the patient is 18 to 24 years old. If this happens, seek immediate medical help. Do NOT stop taking pms-DULOXETINE without the doctor's advice.
Risk of breaking a bone: Tell the doctor if the patient: is elderly and had a recent bone fracture; or was told that he/she has osteoporosis or risk factors for osteoporosis.
Taking pms-DULOXETINE may increase the risk of breaking a bone. This is especially true when the patient first start taking pms-DULOXETINE and soon after stopping it. Take extra care to avoid falling, especially if the patient gets dizzy or has low blood pressure.
Serotonin syndrome/neuroleptic malignant syndrome (NMS): This is a rare side effect of the group of medications like pms-DULOXETINE. It is life-threatening and can lead to death. It can cause serious changes in how the brain, muscles, digestive system and nervous system work. The reaction is more likely if the patient takes pms-DULOXETINE with certain other medications. See Side Effects.
Driving and using machines: pms-DULOXETINE may make the patient feels dizzy or tired, especially just after starting it or after the dose is increased. Wait to see how the patient feels while taking pms-DULOXETINE before driving or using machines.
Use in Pregnancy: If the patient is or becomes pregnant while taking pms-DULOXETINE, talk to the healthcare professional about the risks and benefits of various treatment options. It is very important that the patient keeps taking pms-DULOXETINE until the healthcare professional tells when to stop.
When pregnant women took drugs in the same group of medications as pms-DULOXETINE, some newborn babies 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 the hospital; had difficulty feeding or breathing, seizures, tense or overly relaxed muscles and were jittery and cried constantly.
These symptoms normally go away over time. If the baby experiences any of these symptoms, contact the healthcare professional as soon as possible.

Effects on pregnancy and newborns: If the patient is or becomes pregnant while taking pms-DULOXETINE, talk to the healthcare professional about the risks and benefits of various treatment options. It is very important that the patient keeps taking pms-DULOXETINE until the healthcare professional tells when to stop.
When pregnant women took drugs in the same group of medications as pms-DULOXETINE, some newborn babies 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 the hospital; had difficulty feeding or breathing, seizures, tense or overly relaxed muscles and were jittery and cried constantly.
These symptoms normally go away over time. If the baby experiences any of these symptoms, contact the healthcare professional as soon as possible.

These are not all the possible side effects the patient may feel when taking pms-DULOXETINE. If any side effects not listed as follows are experienced, contact the healthcare professional.
Most side effects are minor and temporary. However, some may be serious.
The most common side effects with pms-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 the belly; Sleepiness; Vomiting (throwing up).
These side effects have been shown to decrease with continued treatment.
Tell the healthcare professional if: any of the side effects discussed previously affect the patient severely; the patient experiences other side effects not previously listed.
Some of these side effects may be related to the dose being taken. The healthcare professional will decide if the dose needs to be changed.
Depression and anxiety may decrease the sexual desire, performance, and satisfaction. This medication may further decrease sexual enjoyment.
The patient may also have symptoms after stopping the intake of pms-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 the healthcare professional right away if the patient has these or other symptoms.

Tell the healthcare professional about all the medicines the patient takes, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with pms-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 depression 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 disorder 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 medications used to treat patients with irregular heartbeats like flecainide and encainide.
Some medications 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 opioids, like fentanyl, tramadol, tapentadol, meperidine, methadone and pentazocine.
Some medications used to treat cough, like dextromethorphan (a cough syrup).
In general, drink only small amounts of alcohol while taking pms-DULOXETINE.

Keep capsules in their original package.
Store below 25°C.

Antidepressants

N06AX21 - duloxetine ; Belongs to the class of other antidepressants.

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