Paroxetine Orion - Paroxetine uses, dose and side effects

Depression (actual depression)
Obsessive-compulsive disorder (obsessive-compulsive disorder and obsessive-compulsive disorder)
Panic disorder, with or without fear of squares (eg fear of leaving home, going into business, or fear of public places)
Social phobia (overwhelming fear of or avoidance of everyday situations)
Generalized anxiety (more permanent anxiety with pronounced, constantly present nervous anxiety).
Post-traumatic stress disorder (anxiety caused by a traumatic event).

The paroxetine contained in Paroxetine Orion may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.

What you need to know before you take Paroxetine Orion

Do not take Paroxetine Orion

– if you are allergic to paroxetine or any of the other ingredients of this medicine (listed in section 6).
if you are taking, or have taken monoamine oxidase inhibitors ( MAOIs ) in the last two weeks. MAO inhibitors are a group of drugs used, for example, to treat depression and Parkinson’s disease. Talk to your doctor about when you can start taking Paroxetine Orion.
if you are going to start taking MAO inhibitors. You should take a break of at least one week after stopping taking Paroxetine Orion before starting treatment with MAOIs. Consult your doctor.
if you are taking thioridazine or pimozide (medicines used to treat psychosis ).

Warnings and cautions

Talk to your doctor or pharmacist before taking Paroxetine Orion

– Use in children and adolescents under 18 years of age:

Paroxetine Orion should not normally be used in children and adolescents under 18 years of age. You should also be aware that patients under the age of 18 are at increased risk of side effects such as suicide attempts, suicidal thoughts, and hostility (especially aggression, defiance, and anger) when taking this type of medicine. Despite this, doctors may prescribe Paroxetine Orion to patients under 18 years of age because he/she believes it is still beneficial for the patient. If your doctor has prescribed Paroxetine Orion to a patient under the age of 18 and you want to discuss it, you should contact your doctor again. You should inform your doctor if any of the symptoms mentioned above occur or worsen when a patient under the age of 18 takes ParoxetineOrion. In addition, long-term effects on growth, maturity, and cognitive and behavioral development have not been studied for this group.

– If you start to feel worse and have thoughts of harming yourself

You who are depressed and/or suffer from worry/anxiety can sometimes have thoughts of harming yourself or committing suicide. These symptoms may worsen when you start using antidepressants, as it takes time for drugs of this type to take effect, usually about 2 weeks, sometimes longer.

These thoughts may be common:

– if you have previously had thoughts of harming yourself or committing suicide,

– if you are younger than 25 years. Studies have shown that young adults (younger than 25 years) with mental illness who are treated with antidepressant drugs have an increased risk of suicidal thoughts and thoughts of harming themselves.

Contact a doctor as soon as possible or go to the nearest hospital if you have thoughts of injuring yourself or committing suicide.

It can be helpful to tell a relative or close friend that you are depressed and/or suffering from anxiety. Feel free to ask them to read this leaflet. You can also ask them to tell you if they think you are feeling worse or if they think your behavior is changing.

Discuss with your doctor if you are experiencing or have ever experienced any of the following:

– if you experience an inner feeling of restlessness and psychomotor agitation such as an inability to stand or sit still, usually combined with an experience of agitation ( akathisia ). This usually occurs during the first weeks of treatment. Increasing the dose of Paroxetine Orion may make these feelings worse (see ‘Possible side effects)

– if you get a high fever, muscle cramps, and become confused and anxious because these symptoms can be signs of so-called “serotonergic syndrome”

– if you have previously had mania (overactive behavior or overactive thinking). If you enter a manic period, stop taking Paroxetine Orion. Consult your doctor.

– if you have heart, liver, or kidney problems. For patients with severe renal or hepatic impairment, dose reduction is recommended.

– if you have diabetes. Paroxetine Orion may increase or decrease your blood sugar level. Your insulin dose or dose one for oral antidiabetic medicines may need to be adjusted. In addition, your blood sugar levels may rise as Paroxetine Orion and pravastatin are taken at the same time.

– if you have epilepsy.

– if you have seizures during treatment with Paroxetine Orion. In that case, you should stop taking Paroxetine Orion and consult your doctor.

– if you are being treated for depression with ECT (electroconvulsive therapy)

– if you have glaucoma ( glaucoma, increased pressure in the eye)

– if you are at risk of lowering your blood sodium levels ( hyponatremia ), for example, due to other medications or cirrhosis. Hyponatremia has been reported rarely in treatment with Paroxetine Orion, especially in the elderly.

– if you are taking tamoxifen (for breast cancer). Paroxetine Orion may reduce the effectiveness of tamoxifen, so your doctor may recommend that you take another antidepressant instead.

– if you have or have had any blood disease (eg abnormal skin or stomach bleeding), or if you are pregnant (see “Pregnancy”).

– if you are taking medicines that may increase the risk of bleeding (see “Other medicines and Paroxetine Orion”).

Drugs such as Paroxetine Orion (so-called SSRIs / SNRIs) can cause symptoms of sexual dysfunction. In some cases, these symptoms have persisted after discontinuation of treatment.

Other medicines and Paroxetine Orion

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Interaction means that drugs used at the same time can affect each other’s effects and/or side effects. The following may also apply to medicines you have used before or will start using. The interaction may occur when using Paroxetine Orion with:

tricyclic antidepressant drugs (for depression), such as clomipramine, nortriptyline, and desipramine
SSRIs, such as citalopram and fluoxetine
L-tryptophan (for insomnia)
MAO inhibitors (eg for depression or Parkinson’s disease ) (see “Do not take Paroxetine Orion”)
lithium (for mental illness)
buprenorphine
St. John’s wort (Hypericum perforatum)
triptans (for migraines ) eg sumatriptan
tramadol (strong painkiller)
linezolid ( antibiotics ).
methylthioninium chloride (methylene blue) (used eg as an antidote or antiseptic)
pethidine ( potent painkiller)
fentanyl (used in anesthesia or chronic pain).

Concomitant use of the above drugs may lead to “serotonergic syndrome” by potentiating the serotonergic effects of Paroxetine Orion (see “Warnings and Precautions”).

perphenazine, risperidone, atomoxetine, thioridazine, pimozide, and clozapine ( antipsychotics )
propafenone and flecainide (medicines for irregular heartbeat)
metoprolol (medicine for heart failure ).
pravastatin (a drug for high cholesterol )

Concomitant use of the above drugs may increase the risk of them causing side effects, including heart side effects. These side effects can be serious (see “Do not take Paroxetine Orion”).

phenobarbital, carbamazepine, and phenytoin (for epilepsy )
rifampicin ( antibiotic )
fosamprenavir and ritonavir as combination therapy (for HIV infection )

Concomitant use of the above products may impair the efficacy of Paroxetine Orion by increasing paroxetine metabolism.

tamoxifen, which is used to treat breast cancer.

Concomitant use of tamoxifen and Paroxetine Orion may reduce the effectiveness of tamoxifen therapy.

NSAIDs (eg ibuprofen, diclofenac ), COX-2 inhibitors, and acetylsalicylic acid (painkillers)
warfarin (anticoagulant).

Concomitant use of the above products results in increased bleeding or bleeding time (see “Take special care with Paroxetine Orion”).

procyclidine (for Parkinson’s disease ). Due to increased procyclidine concentrations in the blood, there is an increased risk of side effects from procyclidine.
mivacurium and suxamethonium (used in anesthesia).

Please note that the above medicines may also be available under other names, often brand-specific names. In the above section, only the name of the active substance or treatment area in which the medicinal product is used and not the brand-specific name. Always read the package leaflet and the package leaflet for medicines you are already using to find out the active substance and the treatment area in which the medicine is used.

Paroxetine Orion with food, drink, and alcohol

Food: The tablets should be taken in the morning at breakfast. This is to reduce the risk of side effects.

Alcohol: Do not drink alcohol while taking Paroxetine Orion. Alcohol can worsen your symptoms or side effects.

Pregnancy, breastfeeding, and fertility

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

As the risk of congenital malformations (cardiovascular malformations) is slightly increased if you take Paroxetine Orion during the first three months of pregnancy, you must inform your doctor if you are planning to become pregnant or are already pregnant. Your doctor must decide if treatment with Paroxetine Orion is necessary or if an alternative treatment can be used.

Tell your midwife or doctor that you are using Paroxetine Orion. When drugs such as Paroxetine Orion are used during pregnancy, especially during the last three months, they may increase the risk of a serious condition called persistent pulmonary hypertension in the newborn (PPHN). This condition causes the baby to breathe faster and look blue. The symptoms usually appear within 24 hours of the baby being born. If this affects your baby, contact a midwife or doctor immediately.

You should not abruptly discontinue treatment with Paroxetine Orion.

Tell your doctor if you are using Paroxetine Orion during the last three months of pregnancy as your baby may have symptoms of treatment at birth. These symptoms usually appear during the first 24 hours after delivery. Symptoms may include the inability to sleep or eat enough, difficulty breathing, bluish skin or elevated or lowered body temperature, vomiting, persistent crying, stiff or limp muscles, lethargy, tremors, nervousness, or seizures. If your baby has any of these symptoms at birth, talk to your doctor.

If you take Paroxetine Orion at the end of your pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should be informed that you are taking Paroxetine Orion so that they can advise you on this.

Breast-feeding

Small amounts of Paroxetine Orion may pass into breast milk. Talk to your doctor before breastfeeding your baby if you are taking Paroxetine Orion.

Fertility

In animal studies, it has been shown that paroxetine reduces the quality of semen. In theory, this could affect fertility, but no such reducing effect of paroxetine on fertility has yet been demonstrated in humans.

Driving and using machines

Paroxetine Orion can cause side effects (such as dizziness, drowsiness, and confusion) that affect your ability to concentrate and react. If you get these side effects, do not drive, use machines or perform any other activity where you need to be alert and focused.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Important information about some of the ingredients of Paroxetine Orion

This medicine contains 9.5 mg of lactose (monohydrate). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Other ingredients

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’.

How to take Paroxetine Orion

Always take Paroxetine Orion exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

The recommended dose is:

Adults

Depression

The recommended dose is 20 mg daily. Depending on the treatment response, the dose may be increased gradually up to 50 mg daily in increments of 10 mg.

Usually, the patient begins to improve after one week, but it may take two weeks until the improvements are noticed. The treatment should last for at least 6 months.

Obsessive-compulsive disorder and obsessive-compulsive disorder (obsessive-compulsive disorder)

The starting dose is 20 mg daily. Depending on the treatment response, the dose may be increased gradually up to 40 mg daily in increments of 10 mg. The recommended dose is 40 mg daily. The maximum dose is 60 mg daily. The treatment should last for several months.

Panic syndrome

The starting dose is 10 mg daily. Depending on the treatment response, the dose may be increased gradually up to 40 mg daily in increments of 10 mg. The recommended dose is 40 mg daily. The maximum dose is 60 mg daily. The treatment should last for several months.

Social phobia, generalized anxiety disorder, and post-traumatic stress disorder

The recommended dose is 20 mg daily. Depending on the treatment response, the dose may be increased gradually up to 50 mg in increments of 10 mg. The maximum dose is 50 mg daily.

Use in children and adolescents

Paroxetine should not be used in children and adolescents under 18 years of age.

Use in the elderly

Depending on the response to treatment, the dose may be increased up to 40 mg daily. The maximum dose is 40 mg daily.

Severe renal impairment

Your doctor will prescribe a dose that is right for you.

Hepatic impairment

Your doctor will prescribe a dose that is right for you.

Take the medicine with a glass of water, preferably in the morning with a meal. The tablets or tablet halves should be swallowed rather than chewed.

If you take more Paroxetine Orion than you should

If you have ingested too much medicine or if, for example, a child has ingested medicine by mistake, contact a doctor or hospital in Sweden) for risk assessment and advice.

Symptoms of overdose include vomiting, dilated pupils, fever, changes in blood pressure, headache, involuntary muscle contractions, agitation, anxiety, and rapid pulse.

If you forget to take Paroxetine Orion

If you forget to take Paroxetine Orion, skip the missed dose and take the next dose at the right time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Paroxetine Orion

Do not stop taking Paroxetine Orion without consulting your doctor even if you are feeling well.

If you suddenly stop after taking this medicine for a long time, you may experience withdrawal symptoms. You may feel dizzy, have sensory disturbances (numbness or tingling, so-called paresthesia, feeling of electric shock and ringing in the ears), difficulty sleeping (including intense dreams), nausea, diarrhea, headache, rapid and irregular heartbeat ( palpitations), tremors, increased sweat production, visual disturbances or feeling of upset, anxiety, irritation or confusion about where you are (disorientation). These symptoms are mostly mild to moderate and disappear within two weeks. For some patients, however, the symptoms become more severe and persist longer. The symptoms usually appear within a few days after you stop taking the medicine. See “Discontinuation symptoms upon discontinuation of paroxetine therapy”.

When stopping treatment with Paroxetine Orion, your doctor will help you gradually reduce your dose over some weeks or months to reduce the risk of withdrawal symptoms. One way to do this is to gradually reduce your dose by 10 mg every week.

If you experience withdrawal symptoms during the tapering period, your doctor may slow down the tapering rate. Contact your doctor if you experience severe withdrawal symptoms when you stop taking Paroxetine Orion. He or she may ask you to start taking the tablets again and then reduce the dose more slowly.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You should contact your doctor immediately if you experience symptoms such as:

Swelling of the face, swollen tongue and/or throat and/or difficulty swallowing or hives and difficulty breathing ( angioedema )
High fever, muscle cramps, confusion, and anxiety, these symptoms can be signs of so-called “serotonergic syndrome”.

If you have suicidal ideation when you are treated with Paroxetine Orion, especially during the first 2 – 4 weeks, contact your doctor immediately.

Very common (may affect more than 1 user in 10):

nausea
sexual disability.

Common (may affect up to 1 in 10 people):

decreased appetite elevated cholesterol levels
drowsiness, insomnia, agitation, abnormal dreams (including nightmares)
headache
dizziness, tremors
concentration difficulties
dimsyn
yawning
constipation, diarrhea, vomiting, dry mouth
increased sweat production
weakness ( asthenia ), increased body weight.

Uncommon (may affect up to 1 in 100 people):

abnormal bleeding, especially in the skin and mucous membranes (including large bruises and unexplained vaginal bleeding)
confusion, hallucinations
slow and/or involuntary movements (extrapyramidal disturbances)
fast heartbeat
temporarily raised blood pressure or temporarily lowered blood pressure which may make you feel dizzy or faint if you get up suddenly. Temporary hypertension or decreased blood pressure has been reported with paroxetine treatment, usually in patients who already had high blood pressure ( hypertension ) or in patients with anxiety
dilated pupil is
rash, itching
inability to urinate ( urinary retention ), involuntary urine leakage (urinary incontinence).
If you have diabetes, your blood sugar levels may be affected if you take Paroxetine Orion. Talk to your doctor about adjusting the dose of one of your insulin or diabetes medicines.

Rare (may affect up to 1 in 1,000 people):

the decreased sodium level in the blood ( hyponatremia ). Hyponatremia has been reported mainly in elderly patients and some cases is due to SIADH (inappropriate ADH secretion syndrome)
manic reactions, anxiety, feeling detached (depersonalization), panic attacks, restlessness, and feeling unable to stand or sit still (see section 2 “Warnings and caution”). These symptoms may also be due to the underlying disease
seizures, restless legs syndrome
slow heart rate
elevated liver enzyme levels
joint pain, muscle pain
hyperprolactinemia (abnormally high blood levels of the hormone et prolactin ) / secretion from the breasts.
menstrual disorders (including heavy or irregular menstrual bleeding, menstrual bleeding, and absence or delayed menstruation.

Very rare (may affect up to 1 in 10,000 people):

lack of platelets
allergic reactions, which may be severe for Paroxetine Orion, with hives and swelling of the eyelids, face, lips, tongue, or throat with difficulty breathing or difficulty swallowing ( angioedema )
the feeling of weakness or dizziness leading to collapse or unconsciousness, contact your doctor or see a hospital immediately
increased secretion of antidiuretic hormone (inappropriate ADH secretion syndrome), leading to hyponatremia with symptoms such as headache, nausea, and vomiting
serotonergic syndrome (symptoms may include restlessness, confusion, increased sweat production, hallucinations, increased reflexes, muscle cramps, chills, rapid heartbeat, and tremors)
acute glaucoma ( glaucoma, eye disease that damages the optic nerve )
gastrointestinal bleeding
liver disease (such as hepatitis ), in some cases with jaundice and/or liver failure). Since paroxetine was first approved, reports of liver disease (such as hepatitis, in some cases with jaundice and/or hepatic failure) have been reported in very rare cases. Discontinuation of paroxetine should be considered if a persistent increase in hepatic function values is observed.
severe skin side effects (including erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis,
increased sensitivity to sunlight
a prolonged erection (priapism)
swelling due to fluid retention.

Has been reported (occurs in an unknown number of users):

thoughts of self-harm or suicide. Suicidal ideation or suicidal ideation has been reported during treatment with paroxetine or early after discontinuation of treatment (see section 2 “Warnings and precautions”).
Some patients have experienced wheezing, hissing, whistling, ringing, or other stubborn sounds ( tinnitus ) when taking Paroxetine Orion.
aggression
gnashing of teeth
inflammation of the colon (which causes diarrhea).
severe vaginal bleeding shortly after delivery ( postpartum hemorrhage), see “Pregnancy” in section 2 for more information.

Withdrawal symptoms when paroxetine is discontinued

Common: dizziness, sensory disturbances, ringing in the ears ( tinnitus ), sleep disturbances, anxiety, headache.

Uncommon: agitation, nausea, tremors, confusion, increased sweat production, emotional imbalance, visual disturbances, palpitations, diarrhea, irritability.

See “If you stop taking Paroxetine Orion”.

An increased risk of bone fractures has been seen in patients taking this type of drug.

Reporting of side effects ar

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly via:

By reporting side effects, you can help increase drug safety information.

How to store Paroxetine Orion

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister. The expiration date is the last day of the specified month.

This medicine does not require any special storage instructions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Contents of the pack and other information

Content declaration

The active substance is paroxetine.

Each film-coated tablet contains 20 mg of paroxetine (as paroxetine hydrochloride hemihydrate).

The other ingredients in the tablet core are calcium hydrogen phosphate dihydrate, calcium hydrogen phosphate, lactose monohydrate, sodium starch glycolate (type A), and magnesium stearate

The other ingredients in the film coating are titanium dioxide (E171), hypromellose, macrogol 400, and polysorbate 80.

What the medicine looks like and the contents of the pack

White to off-white, film-coated capsule-shaped, biconvex tablets imprinted with “56” on one side and “C” with a deep incision on the other side. The tablet can be divided into two equal doses.

Pack sizes:

20, 30, 60, and 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

Manufacturer

Orion Corporation, Orion Pharma