Paroxetine Actavis uses, dose and side effects

obsessive-compulsive disorder (repeated obsessive-compulsive disorder with uncontrollable behavior),
panic disorder (attacks of panic disorder, including those arising from agoraphobia, ie fear of open spaces),
social phobia (fear of or avoidance of social situations),
post-traumatic stress disorder (anxiety after a traumatic experience)
generalized anxiety disorder (generalized severe anxiety or worry).

Paroxetine Actavis belongs to a group of medicines called selective serotonin reuptake inhibitors ( SSRIs ). All people have a neurotransmitter in the brain called serotonin. Those who suffer from depression or anxiety have abnormally low levels of serotonin. How Paroxetine Actavis and other SSRIs work is not completely known but it could be because they raise the levels of serotonin in the brain. Proper treatment of your depression or anxiety is important to help you improve.

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

What you need to know before you use Paroxetine Actavis

Do not use Paroxetine Actavis

if you are taking medicines called monoamine oxidase inhibitors ( MAOIs, including moclobemide and methylthionine chloride (methylene blue)) or have taken them at any time during the last two weeks. Your doctor will advise you on how to start taking Paroxetine Actavis after you stop taking MAOIs.
if you are taking an antipsychotic medicine that contains either thioridazine or pimozide.
if you are allergic to paroxetine, soy, peanuts, or any of the other ingredients of this medicine (listed in section 6).

If any of the above applies to you, tell your doctor before taking Paroxetine Actavis.

Warnings and cautions

Talk to your doctor or pharmacist before using Paroxetine Actavis

Are you taking any other medicines (see Other medicines and Paroxetine Actavis in this leaflet)?
Are you taking tamoxifen to treat breast cancer? Paroxetine Actavis may make tamoxifen less effective and your doctor may therefore recommend that you take other antidepressant medicines.
Do you have kidney, liver, or heart problems?
Do you have epilepsy or have previously had seizures or seizures?
Have you ever had manic episodes (overactive behavior or thoughts)?
Do you receive electroconvulsive therapy (ECT)?
If you have had a bleeding disorder, are you pregnant (see Pregnancy, breast-feeding and fertility ) or are you taking any other medicines that may increase the risk of bleeding (blood-thinning medicines such as warfarin, antipsychotics such as perfenazine or clozapine, tricyclic antidepressants, painkillers) and inflammation, so-called NSAIDs (non-steroidal anti-inflammatory drugs), such as acetylsalicylic acid, ibuprofen, celecoxib, etodolac, diclofenac, meloxicam)?
Do you have diabetes?
Are you on a salt-reduced diet?
Do you have glaucoma ( glaucoma, increased pressure in the eye)?
Are you pregnant or planning to become pregnant (see Pregnancy, breast-feeding, and fertility in this leaflet)?
Are you under 18 (see Children and adolescents under 18 in this leaflet)?

If you answer YES to any of these questions and have not previously discussed this with your doctor, consult your doctor again and ask how to apply Paroxetine Actavis.

Children and young people under 18 years of age

Paroxetine Actavis should not be used in children and adolescents under 18 years of age. The risk of side effects such as suicide attempts, suicidal ideation, and hostility (mainly aggression and anger) is greater in patients under 18 years of age using Paroxetine Actavis. If your doctor has prescribed Paroxetine Actavis for you (or your child) and you want to discuss this, you should see your doctor again. You should inform your doctor if you notice any of the above symptoms or if such symptoms worsen

while you (or your child) are taking Paroxetine Actavis. The long-term effects on growth, maturity, and mental and behavioral development have not yet been determined for children and adolescents under 18 years of age.

In studies with paroxetine in patients under 18 years of age, common adverse reactions that occurred in less than 1 in 10 children/adolescents were the following: increased suicidal ideation and suicide attempts, self-harming behavior, hostile, aggressive, or unfriendly behavior, loss of appetite, tremors, abnormal sweating, hyperactivity (excess energy), agitation, emotional changes (including crying and mood swings) and unusual bruising or bleeding (eg nosebleeds). The studies showed that the same symptoms also occurred in children and adolescents who received a placebo (an inactive substance) instead of paroxetine, but less often.

Some patients in studies with people under 18 years of age experienced withdrawal symptoms when they stopped taking paroxetine. These symptoms are similar to those that occur in adults after discontinuation of paroxetine (see section 3 How to use Paroxetine Actavis in this leaflet). In addition, it was common (in less than 1 in 10) that patients under the age of 18 experienced abdominal pain, nervousness, and emotional changes (including crying, mood swings, attempted self-harm, thoughts of suicide, and suicide attempts).

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 taking antidepressants, as it takes time for a drug 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 immediately 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.

Important side effects have been seen with Paroxetine Actavis

Some patients take Paroxetine Actavis to develop something called akathisia, which means that they feel restless and can not sit or standstill. Others may develop something called serotonergic syndrome or malignant neuroleptic syndrome. This is meant some or all of the following symptoms: feeling very aroused or irritated, confusion, restlessness, feeling hot, sweating, shaking, chills, hallucinations (seeing or hearing strange things), muscle stiffness, sudden muscle twitching, or rapid heartbeat. The severity can increase and lead to unconsciousness. If you experience any of these symptoms, consult a doctor. For more information about these or other side effects of Paroxetine Actavis, see section 4 Possible side effects in this leaflet.

Drugs such as Paroxetine Actavis (so-called SSRIs / SNRIs) can cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have persisted after discontinuation of treatment.

Other medicines and Paroxetine Actavis

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

Some medicines may affect the way Paroxetine Actavis works or increase the risk of side effects. Paroxetine Actavis may also affect the way other medicines work. These are:

Medicines called MAO inhibitors, including moclobemide and methylthionine chloride (methylene blue) – see Do not use Paroxetine Actavis in this leaflet.
Thioridazine or pimozide, which are antipsychotics – see Do not use Paroxetine Actavis in this leaflet.
Acetylsalicylic acid, ibuprofen, or other so-called NSAIDs (non-steroidal anti-inflammatory drugs) such as celecoxib, etodolac, diclofenac, and meloxicam, are used for pain and inflammation.
Tramadol, buprenorphine, and pethidine are painkillers
Drugs called triptans, such as sumatriptan, are used to treat migraines
Other antidepressants including other SSRIs and tricyclic antidepressants such as clomipramine, nortriptyline, and desipramine
A dietary supplement called tryptophan
Mivacurium and suxamethonium (used for anesthesia)
Drugs such as lithium, risperidone, perfenazine, clozapine (so-called antipsychotics), are used to treat certain psychiatric disorders
A combination of fosamprenavir and ritonavir used to treat HIV infection
St. John’s wort, a (traditional) herbal medicine for depression
Fentanyl, used in anesthesia or the treatment of chronic pain
Phenobarbital, phenytoin, sodium valproate, or carbamazepine for the treatment of seizures or epilepsy
Atomoxetine is a drug used to treat ADHD (Attention Deficit Hyperactivity Disorder)
Procyclidine used to relieve tremors, especially in Parkinson’s disease
Warfarin or other anticoagulants, ie blood-thinning drugs
Propafenone, flecainide, and medicines used to treat irregular heartbeat
Metoprolol, a beta-blocker used to treat high blood pressure and heart problems
Pravastatin is used to treat high cholesterol
Rifampicin used to treat tuberculosis and leprosy
Linezolid which is an antibiotic
Tamoxifen is used to treat breast cancer.

If you are taking or have recently taken any of the medicines listed above and have not already discussed this with your doctor, talk to your doctor again and ask for advice. Your dose may need to be changed or you may need another medicine. Your doctor may want to examine you continuously during treatment.

Paroxetine Actavis with food, drink, and alcohol

Do not use alcohol while taking Paroxetine Actavis. Alcohol can worsen your symptoms or side effects. Taking Paroxetine Actavis in the morning with food may reduce the risk of nausea.

Pregnancy, breastfeeding, and fertility

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.

There are reports of an increased risk of malformations, especially heart malformations in children whose mothers took Paroxetine Actavis during the first months of pregnancy. In the general population, about 1 in 100 children is born with heart malformations. The risk is higher in children whose mothers have taken Paroxetine Actavis, where the risk is 2 in 100 children. You and your doctor can decide together if it is better to switch to another treatment or if you should gradually reduce Paroxetine Actavis while you are pregnant. Depending on the circumstances, your doctor may decide that continued treatment with Paroxetine Actavis is better for you.

Tell your midwife or doctor that you are using Paroxetine Actavis. When drugs such as Paroxetine Actavis are used during pregnancy, especially late in pregnancy, they may increase the risk of a serious condition called persistent pulmonary hypertension in the newborn (PPHN). In PPHN, the blood pressure in the blood vessels between the baby’s heart and lungs is too high. If you are taking Paroxetine Actavis during the last 3 months of pregnancy, your newborn baby may also have other symptoms that usually start within the first 24 hours after birth and include:

difficulty breathing,
bluish skin or that the child is too hot or cold,
blue lips,
vomiting or the child not eating properly,
that the child is very tired, has difficulty sleeping, or cries persistently,
tense or limp muscles,
tremors, twitches or cramps,
excessive reflexes.

If your baby gets any of these symptoms after birth, or if you are worried about your baby’s health, consult a doctor or midwife for advice.

If you take Paroxetine Actavis 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 Actavis so that they can advise you on this.

Do not stop treatment without talking to a doctor. Sudden discontinuation of treatment may lead to withdrawal symptoms (see If you stop taking Paroxetine Actavis).

Paroxetine can be excreted in breast milk in very small amounts. Consult your doctor before breastfeeding. You and your doctor can decide together if you can breastfeed while taking Paroxetine Actavis.

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

Possible side effects of Paroxetine Actavis include dizziness, confusion, drowsiness, or blurred vision. If you get these side effects, do not drive or use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. 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 effects and 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.

Paroxetine Actavis contains soy lecithin, para-orange, and sodium

This medicine contains soy lecithin (E322). If you are allergic to peanuts or soy, do not take this medicine.

This medicine contains the dye para-orange (E110), which may cause allergic reactions.

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

How to use Paroxetine Actavis

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

Dose one is determined by the doctor who adjusts it individually for you. Depending on how you respond to treatment, your doctor may gradually increase or decrease your dose.

The maximum recommended dose is 50 mg and in some cases 60 mg. If you are over 65 years of age, the dose should not exceed 40 mg per day.

You should continue to take the medicine even if you do not feel better right away, as it may take a few weeks before Paroxetine Actavis works.

If you have the impression that the effect of Paroxetine Actavis is too strong or insufficient, or if you have any other problem that you think may be related to Paroxetin Actavis, talk to your doctor or pharmacist. You mustn’t change or discontinue treatment without first talking to your doctor.

Take Paroxetine Actavis in the morning with food. This reduces the risk of you feeling nauseous.

Swallow the tablets whole with a glass of water. Do not chew them.

Patients with liver or kidney disease

If you have liver problems or severe kidney disease, your doctor may decide that your dose of Paroxetine Actavis should be lower than what is normally recommended.

If you take more Paroxetine Actavis than you should

Never take more tablets than your doctor has recommended. If you have ingested too much or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.

A person who has overdosed on Paroxetine Actavis may experience side effects listed in section 4. Possible side effects or the following symptoms: fever, uncontrollable muscle contractions.

If you forget to take Paroxetine Actavis

Take your medicine at the same time each day.

If you forget to take a dose and think about it before going to bed at night, take a dose immediately. Continue as usual the next day.

If you forget to take a dose and only remember to do so overnight or the next day, do not take any extra dose. You may experience some withdrawal symptoms, but these should go away after you take your next dose at the usual time.

Do not take a double dose to make up for a forgotten dose.

If you do not feel any improvement

Paroxetine Actavis will not relieve your symptoms immediately. All antidepressant drugs require time to work. Some patients improve after a couple of weeks while for others it may take longer. Some people who take antidepressants experience a worsening before they start to feel better. If you have not started to get better after a few weeks, contact your doctor for advice. Your doctor should suggest a return visit a few weeks after you start treatment. Tell your doctor if you do not notice any improvement.

If you stop taking Paroxetine Actavis

Do not stop taking Paroxetine Actavis until your doctor tells you to.

When you stop taking Paroxetine Actavis, your doctor will help you slowly reduce your dose over several weeks or months to reduce the risk of withdrawal symptoms. One way to do this is to gradually reduce your dose of Paroxetine Actavis by 10 mg per week. Most people experience that the withdrawal symptoms are mild and go away on their own within 2 weeks. For some patients, the symptoms may be more severe or more prolonged.

If you experience withdrawal symptoms when you stop your treatment, your doctor may recommend that you discontinue Paroxetine Actavis more slowly. Contact your doctor if you experience severe withdrawal symptoms. Your doctor may ask you to start taking the tablets again, then discontinue the medicine more slowly.

Even if you experience withdrawal symptoms, it will be possible for you to stop taking Paroxetine Actavis.

Withdrawal symptoms that may occur when treatment is stopped

According to studies, 3 out of 10 patients experience one or more withdrawal symptoms when treatment with paroxetine is stopped. Some symptoms occur more often than others.

Common withdrawal symptoms (may affect up to 1 in 10 people)

dizziness (feeling of instability, balance difficulties),
sensory disturbances such as ant crawling, burning sensation, and, less commonly, the sensation of electric shock even in the head, as well as buzzing, whistling, ringing, or other persistent sounds in the ears ( tinnitus ),
sleep disorders (vivid dreams, nightmares, difficulty falling asleep),
anxiety,
headache.

Uncommon withdrawal symptoms (may affect up to 1 in 100 people)

nausea,
sweating (including night sweats),
restlessness or agitation,
tremor,
confusion or disorientation,
diarrhea,
emotional instability or irritability,
visual disturbances,
fluttering and throbbing heartbeat (palpitations).

If you are concerned about withdrawal symptoms when stopping treatment with Paroxetine Actavis, talk to your doctor.

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

Possible side effects

Like all medicines, Paroxetine Actavis can cause side effects, although not everybody gets them. Side effects occur more often during the first weeks of treatment with Paroxetine Actavis.

If you get any of the following side effects during treatment, contact your doctor immediately or consult a hospital.

Uncommon ( may affect up to 1 in 100 people)

unusual bruising or bleeding, including bloody vomiting or blood in the stool,
if you have difficulty urinating (throwing water).

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

seizures,
If you feel restless and have difficulty sitting or standing still, it may be something called akathisia. Increasing the dose of Paroxetine Actavis may worsen the symptoms.
If you feel tired, weak, or confused and have sore, stiff, or uncoordinated muscles, this may be due to too low a level of sodium in the blood.

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

allergic reaction, which may be severe, to Paroxetine Actavis. Symptoms include red and lumpy skin rash, swelling of the eyelids, face, lips, mouth, or tongue, itching or difficulty breathing (shortness of breath) or swallowing, and feeling weak or dizzy resulting in fainting or unconsciousness.
if you have one or all of the following symptoms, it could be a so-called serotonergic syndrome or malignant neuroleptic syndrome. The symptoms consist of feeling very aroused or irritated, confusion, restlessness, feeling hot, sweating, shaking, chills, hallucinations (hearing and seeing strange things), muscle stiffness, sudden muscle twitching, or palpitations. The severity can increase and lead to unconsciousness.
acute glaucoma (symptoms include pain in the eyes and blurred vision),
skin rashes that can cause blisters and look like small “targets” (a central dark spot surrounded by a paler area, with a dark ring around the edge) are called erythema multiforme.
Extremely severe and severe skin side effects such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported with paroxetine. The skin side effects may consist of rash with or without blisters. Redness of the skin, sores or swelling in the mouth, throat, eyes, nose, and around the genitals ( Stevens-Johnson syndrome ) as well as fever and flu-like symptoms may also occur. The skin rash can develop into severe widespread skin damage (skin detachment of the epidermis and superficial mucous membranes) with life-threatening consequences.

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

some people have had thoughts of harming themselves or taking their own lives while taking Paroxetine Actavis or shortly after stopping treatment (see section 2 What you need to know before you use Paroxetine Actavis ),
Some people have experienced aggression while taking Paroxetine Actavis.

Other possible side effects are during the treatment

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

nausea. Taking Paroxetine Actavis with food in the morning reduces the risk of this.
changes in sexual drive or function, such as missed orgasm, and in men, erectile dysfunction and ejaculation.

Common (may affect up to 1 in 10 people)

elevated blood cholesterol levels,
loss of appetite,
poor sleep (difficulty falling asleep) or drowsiness,
abnormal dreams (including nightmares),
dizziness or tremor,
headache,
concentration difficulties,
indignation,
unusual weakness,
dimsyn,
yawning, dry mouth,
diarrhea or constipation,
vomiting,
weight gain,
sweating.

Uncommon (may affect up to 1 in 100 people)

a short-term increase in blood pressure, or a short-term decrease that may make you feel dizzy or faint when you get up quickly,
faster pulse than normal,
movement inhibition, stiffness, shaking or abnormal movements of the mouth or tongue,
dilated pupils are,
rash,
itching,
confusion,
hallucinations (seeing and hearing strange things),
uncontrollable, involuntary urination (urinary incontinence), If you are a diabetic patient, you may experience a loss of control of your blood sugar levels while taking Paroxetine Actavis. Talk to your doctor about adjusting the dose of your insulin or your diabetes medicine.

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

abnormal production of breast milk in men and women,
slow pulse,
liver effects in the form of elevated liver function values in blood,
panic attacks,
overactive behavior or thoughts (mania),
a feeling of being outside one’s own body (depersonalization),
anxiety,
the uncontrollable need to move the legs (Restless Legs Syndrome),
joint and muscle pain,
increase in hormone and prolactin in the blood,
menstrual disorders (including heavy or irregular menstrual bleeding, bleeding between periods, and absence or delayed menstruation).

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

liver problems that cause the skin and whites of the eyes to turn yellow,
syndrome with insufficient production of antidiuretic hormone (SIADH), a condition that causes excess water and decreased sodium (salt) concentration in the body, this is due to incorrect chemical signals. Patients with SIADH may become seriously ill or may be completely asymptomatic.
accumulation of fluid or water (which may cause swelling of the arms and legs),
sensitivity to sunlight,
painful and persistent erection of the penis,
decreased number of platelets in the blood,
gastric hemorrhage.

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

Tooth grinding,
inflammation of the colon (which causes diarrhea),
tinnitus,
severe vaginal bleeding shortly after delivery ( postpartum hemorrhage), see “Pregnancy, breast-feeding and fertility” in section 2 for more information.

An increased risk of bone fractures has been observed in patients taking this type of medicine.

How to store Paroxetine Actavis

Keep out of sight and reach of children.

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

The medicine 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

1 tablet contains:

The active substance: paroxetine hydrochloride equivalent to 10 mg paroxetine.

The other ingredients are Tablet core: magnesium stearate, sodium starch glycolate, mannitol (E421), microcrystalline cellulose; Undercoating: butylated methacrylate copolymer, Film coating: polyvinyl alcohol (partially hydrolyzed), talc, soy lecithin (E322), xanthan gum (E415), indigo carmine (E132), para-orange (E110), quinoline yellow (E104) and titanium dioxide (E171).

What the medicine looks like and the contents of the pack

Paroxetine Actavis film-coated tablets are blue, biconvex, and round with a notch on one side and a diameter of 8 mm. The notch is not intended for splitting the tablet.

Blister (Aluminum / Aluminum).

Pack sizes: 20, 50, 60 and 100 tablets. Multipack containing 100 (5×20) tablets and 200 (10×20) tablets (hospital pack).

Plastic jar (HDPE) with desiccant.

Pack sizes: 20, 60, 100, 200 and 250 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Actavis Group PTC ehf.

Reykjavíkurvegur 76-78

220 Hafnarfjörður

Iceland

Manufacturer

Balkanpharma Dupnitsa AD

3 Samokovsko Shosse Str

Dupnitsa, 2600

Bulgaria

Actavis Ltd.

BLB016 Bulebel Industrial Estate

Zejtun, ZTN 3000

Malta

Actavis hf,

Reykjavikurvegur 78

Hafnarfjörður