Apo-Duloxetine

Apo-Duloxetine

duloxetine

Manufacturer:

Apotex

Distributor:

Hind Wing
Full Prescribing Info
Contents
Duloxetine hydrochloride.
Description
Each capsule contains 30mg or 60mg of duloxetine (as hydrochloride) as the active ingredient.
This medicine is gluten-free, lactose-free, sucrose-free, tartrazine-free and free of other azo dyes.
Excipients/Inactive Ingredients: It also contains the following inactive ingredients: methylcellulose, poloxamer, hypromellose, purified talc, polyvinyl acetate phthalate, purified water, dibutyl sebacate, titanium oxide, indigo carmine, gelatin, titanium dioxide.
30 mg: green ink.
60 mg: iron oxide yellow, white ink.
Action
Duloxetine belongs to a group of medicines called serotonin and noradrenaline reuptake inhibitors (SNRIs). SNRIs are believed to work by their action on serotonin and noradrenaline in the brain. Serotonin and noradrenaline are the chemical messengers responsible for controlling the psychological and painful symptoms of depression.
Indications/Uses
APO-Duloxetine is used to treat: major depressive disorder (MDD); generalised anxiety disorder (GAD) - excessive worry.
Ask the doctor if there are any questions about why this medicine has been prescribed. The doctor may have prescribed this medicine for another reason.
This medicine is available only with a doctor's prescription.
Dosage/Direction for Use
Follow carefully all directions given by the doctor. Their instructions may be different to the information in this monograph.
How much to take: The doctor will tell how much of this medicine should be taken. This will depend on the condition and whether the patient is taking any other medicines.
Do not stop taking the medicine or change the dosage without first checking with the doctor.
For major depressive disorder, the recommended dose is usually one 60mg capsule once daily.
For generalised anxiety disorder, the recommended dose is 30mg to 120mg, taken once daily.
The patient may be started on a lower dose to help reduce side effects. If the patient has severe kidney disease, the recommended starting dose is one 30mg capsule once daily.
How to take it: Swallow the capsule whole with a full glass of water.
Do not open the capsules and crush the pellets inside because the medicine may not work as well. Duloxetine may be taken with or without meals.
When to take it: Take this medicine at the same time each day. Taking it at the same time each day will have the best effect and will also help remember when to take it.
It does not matter if the patient has taken it before, with or after food.
How long to take it for: Continue taking the medicine for as long as the doctor tells to.
Make sure to have enough to last over weekends and holidays.
If the patient forgets to take it: If it is almost time to take the next dose, skip the missed dose and take the next dose at the usual time. Otherwise the patient should take it as soon as remembered and then go back to taking the medicine as the patient would normally.
Do not take a double dose to make up for missed doses.
This may increase the chance of experiencing side effects.
If having trouble remembering to take the medicine, ask the pharmacist for some hints to help remember.
Overdosage
If the patient thinks that he/she or anyone else may have taken too much of this medicine, immediately telephone the doctor or the Poisons Information Centre for advice. Alternatively go to the Accident and Emergency Department at the nearest hospital.
Do this even if there are no signs of discomfort or poisoning. The patient may need urgent medical attention.
Symptoms of an overdose may include drowsiness, convulsions and vomiting. They may also include feeling confused, feeling restless, sweating, shaking, shivering, hallucinations, muscle jerks, or fast heartbeat.
Contraindications
When the patient must not take it: This medicine must not be taken if: The patient has or has had liver disease.
The patient is taking a medicine called a monoamine oxidase inhibitor (MAOI), including moclobemide which is a reversible MAOI (RIMA), or has been taking a MAOI within the last 14 days. Check with the doctor if unsure whether or not taking a MAOI.
The patient is taking a medicine that is a potent inhibitor of CYP1A2, such as fluvoxamine or ciprofloxacin. Check with the doctor if unsure whether or not taking a potent inhibitor of CYP1A2.
The patient is hypersensitive to, or has had an allergic reaction to, duloxetine or any of the ingredients listed in Description. Symptoms of an allergic reaction may include cough, shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue, throat or other parts of the body, rash, itching or hives on the skin; fainting or hayfever-like symptoms. If the patient thinks he/she is having an allergic reaction, the patient must not take any more of the medicine and contact the doctor immediately or go to the Accident and Emergency department at the nearest hospital.
The packaging is torn, shows signs of tampering or it does not look quite right.
Special Precautions
Before the patient starts taking this medicine, the doctor must know if: 1. The patient has allergies to: any other medicines; any other substances, such as foods, preservatives or dyes.
2. The patient has or has had any medical conditions, especially the following: glaucoma (an eye disease where the fluid pressure in the eye may be high); high blood pressure; heart problems; kidney problems; history of fits (seizures); diabetes.
3. The patient, or members of the family, have experienced bipolar disorder, depression or suicide.
4. The patient is currently pregnant or plans to become pregnant.
This medicine should not be taken whilst pregnant until the patient and the doctor have discussed the risks and benefits involved.
5. The patient is currently breast-feeding or plans to breast-feed.
This medicine should not be taken whilst breast-feeding until the patient and the doctor have discussed the risks and benefits involved.
6. The patient is planning to have surgery or an anaesthetic.
7. The patient is currently receiving or is planning to receive dental treatment.
8. The patient drinks alcohol.
People who drink excessive amounts of alcohol should not take duloxetine. Drinking too much alcohol could increase the risk of liver problems during treatment with duloxetine.
9. The patient is taking or is planning to take any other medicines.
This includes vitamins and supplements that are available from the pharmacy, supermarket or health food shop.
Things the patient must do while taking this medicine: The doctor must know if the patient: is about to start on any new medicine; is pregnant or is planning to become pregnant; is breast-feeding or is planning to breast-feed; is about to have any blood tests; is going to have surgery or an anaesthetic or is going into hospital.
Any other doctors, dentists and pharmacists who are treating the patient must be told that the patient takes this medicine.
The doctor must be told immediately if the patient has any suicidal thoughts or other mental/mood changes.
Occasionally, the symptoms of depression or other psychiatric conditions may include thoughts of harming oneself or committing suicide. These symptoms may continue or get worse during the first one or two months of treatment, until the full antidepressant effect of the medicine becomes apparent. This is more likely to occur in young adults under 25 years of age.
All mention of suicide or violence must be taken seriously. Contact the doctor or a mental health professional right away or go to the nearest hospital for treatment if the patient or someone the patient knows is showing any of the following warning signs of suicide: worsening of depression; thoughts or talk of death or suicide; thoughts or talk of self-harm or harm to others; any recent attempts of self-harm; increase in aggressive behaviour, irritability or any other unusual changes in behaviour or mood.
If any of the following is noticed, contact the doctor immediately: itchy skin; dark urine; yellowing of the skin or eyes; tenderness over the liver; symptoms of the 'flu'.
These could be signs of liver damage.
The doctor may occasionally do tests to make sure the medicine is working and to prevent side effects.
Visit the doctor regularly for a check-up.
Things the patient must not do: Do not: Give this medicine to anyone else, even if their symptoms seem similar.
Take the medicine to treat any other condition unless the doctor tells to.
Stop taking the medicine, or change the dosage, without first checking with the doctor.
Things to be careful of: The patient must be careful when driving or operating machinery until he/she knows how this medicine affects him/her. It may cause dizziness or drowsiness.
Be careful when drinking alcohol while taking this medicine.
The patient should avoid 'binge drinking' or drinking excessively during treatment with duloxetine as it can cause severe liver injury.
Drinking alcohol with duloxetine may also cause dizziness or drowsiness in some people. If any of these symptoms is present, do not drive, operate machinery or do anything else that could be dangerous.
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.
Use in children: This medicine should not be used in children and adolescents under the age of 18 years.
Side Effects
Tell the doctor as soon as possible if not feeling well while taking duloxetine or if there are any questions or concerns.
Do not be alarmed by the following lists of side effects. The patient may not experience any of them. All medicines can have side effects. Sometimes they are serious but most of the time they are not.
Tell the doctor or pharmacist if any of the following is noticed and worries the patient.
This list includes the more common side effects. Mostly, these are mild: dry mouth, mouth ulcers, thirst, bad taste; burping or belching, indigestion, stomach pain, nausea, vomiting; constipation, diarrhoea, wind (flatulence); bad breath; loss of appetite, weight loss; headache; trouble sleeping; dream abnormalities; drowsiness; feeling tired or having no energy; sexual problems; dizziness; tremor; blurred vision; feeling anxious, agitated or restless; confusion and attention problems; tingling and numbness of hands, face, mouth and feet; yawning or throat tightness; difficulty urinating (passing water), urinating frequently or needing to urinate at night; irregular heart beat; hot and cold sweats; sore ears, sore throat; ringing in ears; muscle pain, stiffness or twitching; walking problems; flushing; skin rash; restless legs.
Tell the doctor as soon as possible if any of the following is noticed.
These may be serious side effects. The patient may need medical attention. Most of these side effects are rare: Signs of a possible liver problem, such as itchy skin, dark urine, yellowing of the skin or eyes, tenderness over the liver, symptoms of the 'flu'.
High pressure in the eye (glaucoma).
Feeling tired, weak or confused and having aching, stiff or uncoordinated muscles. This may be because the patient has low sodium levels in the blood (hyponatraemia or syndrome of inappropriate antidiuretic hormone).
Seeing or hearing things (hallucinations).
Dizziness or fainting when standing up, especially from a lying or sitting position.
Uncontrollable movements.
If the patient has some or all of the following symptoms he/she may have something called serotonin syndrome: feeling confused, feeling restless, sweating, shaking, shivering, hallucinations, sudden jerks in the muscles or a fast heart beat.
Stiff neck or jaw muscles (lockjaw).
Fits or seizures.
Mood of excitement, over-activity and uninhibited behaviour.
Aggression or anger especially after starting or stopping taking this medicine.
Other changes the patient may not be aware of: increased blood pressure; heart rhythm changes; underactive thyroid gland; liver function changes.
Other side effects not previously listed may occur in some patients.
Allergic reactions: If the patient thinks he/she is having an allergic reaction to duloxetine, the patient must not take any more of this medicine and tell the doctor immediately or go to the Accident and Emergency department at the nearest hospital.
Symptoms of an allergic reaction may include some or all of the following: cough, shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue, or other parts of the body; rash, itching or hives on the skin; fainting; hayfever-like symptoms.
Drug Interactions
Some medicines may interact with duloxetine. These include: Monoamine oxidase inhibitors (MAOIs), medicines used to treat some types of depression. The patient must stop taking MAOIs at least two weeks before starting duloxetine. The patient must stop taking duloxetine at least 5 days before he/she starts taking a MAOI.
Other medicines used to treat depression, panic disorder, anxiety or obsessive illnesses, including tryptophan.
Strong painkillers such as tramadol, pethidine.
A type of migraine treatment called 'triptans', such as sumatriptan or zolmitriptan.
Medicines used to treat stress urinary incontinence such as tolteridone.
Medicines used to treat heart problems such as flecainide or propafenone.
Thioridazine, a medicine used to treat schizophrenia.
Herbal medicines such as St John's Wort (Hypericum perforatum).
Warfarin, a medicine used to thin the blood (anticoagulant).
If the patient is taking any of these he/she may need a different dose or he/she may need to take different medicines.
Other medicines not previously listed may also interact with duloxetine.
Caution For Usage
Disposal: If the doctor or pharmacist tells to stop taking this medicine or it has passed its expiry date, the pharmacist can dispose of the remaining medicine safely.
Storage
Keep the medicine in its original packaging until it is time to take it.
If the patient takes the medicine out of its original packaging it may not keep well.
Keep the medicine in a cool dry place where the temperature will stay below 25°C.
Do not store the medicine, or any other medicine, in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
MIMS Class
ATC Classification
N06AX21 - duloxetine ; Belongs to the class of other antidepressants.
Presentation/Packing
Enteric cap 30 mg (hard gelatin capsule with white opaque body and blue opaque cap, imprinted "APO D30" in green ink, filled with white to off-white granules) x 30's. 60 mg (hard gelatin capsule with green opaque body and blue opaque cap, imprinted "APO D60" in white ink, filled with white to off-white granules) x 30's.
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