Paroxetine aurovitas

Package leaflet: Information for the user

Paroxetine Aurovitas, 20 mg, film-coated tablets
Paroxetinum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Paroxetine Aurovitas is and what it is used for
2. What you need to know before taking Paroxetine Aurovitas
3. How to take Paroxetine Aurovitas
4. Possible side effects
5. How to store Paroxetine Aurovitas
6. Contents of the pack and other information

1. What Paroxetine Aurovitas is and what it is used for

Paroxetine Aurovitas is used to treat depression and (or) anxiety disorders in adults.
The anxiety disorders treated with Paroxetine Aurovitas include:
obsessive-compulsive disorder (recurring, obsessive thoughts with uncontrollable
behaviors), panic disorder with or without agoraphobia (panic attacks, including those caused by agoraphobia,
which is fear of open spaces), social phobia (fear of or avoidance of social situations),
post-traumatic stress disorder (anxiety resulting from a traumatic event), and
generalized anxiety disorder (generalized feelings of anxiety or nervousness).
Paroxetine Aurovitas belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs).
The exact way in which Paroxetine Aurovitas and other SSRIs work is not fully understood, but they may increase the levels of serotonin in the brain.
Proper treatment of depression and anxiety disorders is important to help the patient feel better.

2. Important information before using Paroxetine Aurovitas

When not to use Paroxetine Aurovitas:

• if the patient is allergic to paroxetine or any of the other ingredients of this medicine (listed in section 6).
• if the patient is taking medicines called monoamine oxidase inhibitors (MAO inhibitors, including moclobemide and methylene blue chloride) or has taken them within the last two weeks. The doctor will advise the patient on how to start taking Paroxetine Aurovitas after stopping MAO inhibitors.
• if the patient is taking antipsychotic medicines, such as thioridazine or pimozide.
• if any of the above situations apply to the patient, contact the treating doctor and do not take Paroxetine Aurovitas.

Warnings and precautions
Before starting Paroxetine Aurovitas, discuss this with your doctor or
pharmacist:

• Is the patient taking any other medicines? (See Paroxetine Aurovitas and other medicines later in this leaflet)?
• Is the patient taking tamoxifen for breast cancer treatment? Paroxetine Aurovitas may reduce the effectiveness of tamoxifen, and therefore the treating doctor may recommend using another antidepressant.
• Does the patient have kidney, liver, or heart problems?
• Does the patient have abnormal heart conduction on electrocardiogram (ECG), known as QT interval prolongation?
• In the patient’s family history, is there QT interval prolongation, heart disease such as heart failure, slow heart rate, or low potassium or low magnesium levels?
• Does the patient have epilepsy or has the patient had seizures in the past?
• Has the patient ever experienced episodes of mania (excessively active behaviour or racing thoughts)?
• Is the patient receiving electroconvulsive therapy?
• Has the patient had bleeding problems in the past, or is the patient pregnant (see Pregnancy, breastfeeding and fertility) or taking other medicines that may increase the risk of bleeding (including blood-thinning medicines such as warfarin, antipsychotics such as perphenazine or clozapine, tricyclic antidepressants, pain and anti-inflammatory medicines called non-steroidal anti-inflammatory drugs (NSAIDs), such as acetylsalicylic acid, ibuprofen, celecoxib, etodolac, diclofenac, meloxicam)?
• Does the patient have diabetes?
• Is the patient on a low-sodium diet?
• Does the patient have glaucoma (increased pressure in the eye)?
• Is the patient pregnant or planning to become pregnant? (See Pregnancy, breastfeeding and fertility later in this leaflet.)
• Is the patient under 18 years of age? (See Children and adolescents later in this leaflet.)
• If the patient is taking medicines containing buprenorphine. Taking these medicines together with Paroxetine Aurovitas may lead to serotonin syndrome, a potentially life-threatening condition (see Paroxetine Aurovitas and other medicines).

If the answer is YES to any of the above questions and the patient has not yet contacted
their doctor, the patient should go back to the treating doctor and ask how to take
Paroxetine Aurovitas.
Children and adolescents
Paroxetine Aurovitas should not be used in children and adolescents under 18
years of age. Patients under 18 years of age are at increased risk of adverse effects, such
as suicidal attempts, suicidal thoughts, and hostility (particularly aggression, defiant behaviour, and anger) while taking Paroxetine Aurovitas. If the doctor has prescribed Paroxetine Aurovitas to a patient under 18 years of age and there are any doubts, contact the treating doctor. If the mentioned symptoms occur or worsen during treatment with Paroxetine Aurovitas, inform the doctor. Furthermore, there is currently no long-term safety data available regarding growth, puberty, cognitive development, and behavioural development in this age group.
In clinical trials of Paroxetine Aurovitas in patients under 18 years of age, common adverse reactions occurring in less than 1 in 10 patients were:
increased frequency of suicidal thoughts and suicide attempts, deliberate self-harm, hostility, aggressive or hostile behaviour, loss of appetite, tremors, abnormal sweating, excessive activity (displaying excess energy), restlessness, emotional lability (including tearfulness and mood swings), and unusual bruising or bleeding (such as nosebleeds). These trials also showed that similar symptoms occurred, although less frequently, in children and adolescents receiving placebo (sugar pills) instead of Paroxetine Aurovitas.
In some patients under 18 years of age in these trials, symptoms related to discontinuation of Paroxetine Aurovitas occurred. These symptoms were very similar to those observed in adults after stopping Paroxetine Aurovitas (see section 3).
Additionally, in patients under 18 years of age, abdominal pain, feeling of agitation, and emotional lability (including tearfulness, mood changes, self-harm attempts, suicidal thoughts, and suicide attempts) also occurred frequently (in less than 1 in 10 patients).

Suicidal thoughts and worsening of depression or anxiety symptoms
Patients with depression and (or) anxiety disorders may sometimes experience thoughts of self-harm or suicidal thoughts. These may be intensified at the beginning of treatment with antidepressants, as it may take some time before the medicines start working, usually about two weeks, and sometimes longer.
The patient may be more likely to have such thoughts:

• if the patient previously had suicidal thoughts or thoughts of self-harm.
• if the patient is a young adult. Clinical studies have shown an increased risk of suicidal behaviour in adults (under 25 years of age) with psychiatric disorders who were treated with antidepressants. If the patient ever experiences thoughts of self-harm or suicide, contact the doctor or the nearest hospital emergency department immediately.
  It may be helpful to inform a relative or friend about the patient's depression or anxiety disorder and ask them to read this leaflet. The patient may ask them to inform the patient if they notice that the depression or anxiety disorder worsens or if there are worrying changes in behaviour.

Important adverse effects observed during treatment with Paroxetine Aurovitas
In some patients taking Paroxetine Aurovitas, symptoms called akathisia may develop. They feel restless and cannot sit or stand still. In other patients, a condition called serotonin syndrome or neuroleptic malignant syndrome may develop, in which patients experience some or all of the following symptoms: intense restlessness or irritability, confusion (disorientation), anxiety, fever, sweating, tremors, chills, hallucinations (strange visions or hearing strange sounds), muscle stiffness, sudden muscle contractions, or rapid heartbeat. Symptoms may worsen, leading to loss of consciousness. If the patient notices any of these symptoms, they should contact the doctor. More information about these or other adverse effects of Paroxetine Aurovitas is provided in section 4.
Medicines such as Paroxetine Aurovitas (so-called SSRIs/SNRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Paroxetine Aurovitas and other medicines
Some medicines may affect the action of Paroxetine Aurovitas or increase the risk of adverse effects. Paroxetine Aurovitas may also affect the action of other medicines. These include:

• medicines called monoamine oxidase inhibitors (MAO inhibitors, including moclobemide and methylene blue chloride) – see section When not to use Paroxetine Aurovitas;
• medicines known to increase the risk of changes in electrical activity of the heart (e.g. antipsychotics thioridazine or pimozide) – see section When not to use Paroxetine Aurovitas;
• acetylsalicylic acid, ibuprofen, or other medicines called non-steroidal anti-inflammatory drugs (NSAIDs), such as celecoxib, diclofenac, etodolac, and meloxicam, used for pain and inflammatory conditions;
• tramadol, buprenorphine, and pethidine, painkillers;
• buprenorphine in combination with naloxone, used in opioid substitution therapy;
• medicines called triptans, such as sumatriptan, used for migraine;
• other antidepressants, called SSRIs and tricyclic antidepressants, such as clomipramine, nortriptyline, and desipramine;
• a dietary supplement called tryptophan;
• mivacurium and suxamethonium (used for general anaesthesia);
• medicines such as lithium, risperidone, perphenazine, clozapine (called antipsychotics) used to treat certain psychiatric disorders;
• fentanyl, a medicine used during anaesthesia and for chronic pain;
• the combination of fosamprenavir and ritonavir, used for treatment of human immunodeficiency virus (HIV) infection;
• St. John's wort, used as an adjunct in depression;
• phenobarbital, phenytoin, sodium valproate, or carbamazepine used to treat seizures or epilepsy;
• atomoxetine, used to treat attention deficit hyperactivity disorder (ADHD);
• procyclidine used to treat tremors, particularly in Parkinson's disease;
• warfarin or other medicines (called anticoagulants) used to thin the blood;
• propafenone, flecainide, and medicines used to treat irregular heartbeat;
• metoprolol, a beta-blocker used to treat high blood pressure and heart problems;
• pravastatin used to treat high cholesterol levels;
• rifampicin used to treat tuberculosis and acne;
• linezolid – an antibiotic;
• tamoxifen, used for breast cancer treatment or fertility problems;
• some medicines may worsen adverse effects of Paroxetine Aurovitas and sometimes cause very serious reactions. While taking Paroxetine Aurovitas, do not take any other medicines without prior consultation with a doctor, especially:
  – medicines containing buprenorphine. These medicines may interact with Paroxetine Aurovitas and cause symptoms such as involuntary, rhythmic muscle contractions, including those of the eye muscles, restlessness, hallucinations, coma, excessive sweating, tremors, increased reflexes, increased muscle tone, and body temperature above 38°C. If the patient experiences such symptoms, contact the doctor.

If the patient is currently taking or has recently taken any of the listed medicines
and has not yet discussed this with the doctor, the patient should contact the doctor again
and ask what to do. The dose of the medicine may need to be changed, or it may be necessary to take a different medicine.
Tell the doctor or pharmacist about all medicines currently or recently taken,
as well as any medicines the patient plans to take, including over-the-counter medicines.

Paroxetine Aurovitas with food, drink, and alcohol
While taking Paroxetine Aurovitas, alcohol should not be consumed. Alcohol may worsen symptoms of the illness or adverse effects. Taking Paroxetine Aurovitas in the morning with food reduces the likelihood of nausea.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
There are some reports indicating that congenital developmental abnormalities, particularly heart defects, may occur in children whose mothers took Paroxetine Aurovitas during the first few months of pregnancy. In the general population, about 1 in 100 children is born with a heart defect. This number increases to 2 in 100 children if the mother takes Paroxetine Aurovitas. The doctor, together with the patient, will decide whether it is better during pregnancy to switch to another medicine or gradually discontinue Paroxetine Aurovitas. In certain circumstances, the doctor may also suggest that it is better for the patient to continue taking Paroxetine Aurovitas.
Ensure that the midwife or doctor is informed that the patient is taking
Paroxetine Aurovitas. Taking Paroxetine Aurovitas towards the end of pregnancy may increase the risk of serious vaginal bleeding shortly after delivery, especially if the patient has a history of blood clotting disorders. If the patient is taking Paroxetine Aurovitas, she should inform her doctor or midwife so they can provide appropriate advice. Medicines such as Paroxetine Aurovitas taken during pregnancy, especially in the later stages, may increase the risk of serious complications in the newborn, known as persistent pulmonary hypertension of the newborn (PPHN).
In PPHN, blood pressure in the blood vessels between the baby's heart and lungs is too high. If the patient takes Paroxetine Aurovitas during the last three months of pregnancy, other symptoms may also occur in the newborn, usually within the first 24 hours after birth. These include:

• breathing difficulties
• skin blueness or unstable body temperature
• blueness of the lips
• vomiting or difficulty feeding
• fatigue, difficulty sleeping, or increased crying
• stiff or floppy muscles
• tremors, jitteriness due to agitation, or seizures
• increased reflexes.

If any of these symptoms occur in the child after birth or if there are concerns about the child's health, contact the doctor or midwife for advice.
Paroxetine may pass into breast milk in very small amounts. If the patient is taking Paroxetine Aurovitas, she should consult her doctor before starting breastfeeding. The doctor, together with the patient, may decide that the patient can breastfeed while taking Paroxetine Aurovitas.
Animal studies have shown that paroxetine reduces semen quality. This may theoretically affect fertility; however, the effect on human fertility has not yet been established.

Driving and operating machinery
Possible adverse effects caused by Paroxetine Aurovitas include: dizziness, disorientation, drowsiness, and visual disturbances. If such adverse effects occur, the patient should not drive or operate machinery.

Paroxetine Aurovitas contains lactose
Paroxetine Aurovitas contains a small amount of lactose. If the doctor has diagnosed the patient with an intolerance to certain sugars, contact the doctor before taking this medicine.

Paroxetine Aurovitas contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Paroxetine Aurovitas

This medicine should always be taken exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The table below indicates how many Paroxetine Aurovitas tablets correspond to each dose.

The usual doses used for various diseases are given below.

The prescribing doctor will advise on the starting dose of Paroxetine Aurovitas.
Most patients begin to feel better after a few weeks. If there is no improvement by then,
you should consult your doctor. The doctor may decide to gradually increase the dose by 10 mg,
up to the maximum daily dose.
The tablets should be taken in the morning, during a meal.
Swallow them with water.
Do not chew.
Your doctor will discuss with you how long you should continue taking the tablets. Treatment may last
for several months or even longer.

Elderly patients
The maximum dose for patients over 65 years of age is 40 mg per day.

Patients with liver or kidney disease
In patients with liver disease or severe kidney disease, the doctor may prescribe a lower dose of
Paroxetine Aurovitas than normally used.

Taking more Paroxetine Aurovitas than prescribed
Never take more tablets than your doctor has prescribed. If you (or someone else) have taken too many
tablets of Paroxetine Aurovitas, contact your doctor immediately or go to the nearest hospital emergency
department. Take the tablet packaging with you.
Symptoms of overdose with Paroxetine Aurovitas may include those listed in section 4: Possible side effects,
or the following symptoms: fever, involuntary muscle contractions.

If you miss a dose of Paroxetine Aurovitas
Take the medicine at the same time every day.
If you forget to take a dose but remember before going to bed, take it immediately.
The next day, take your usual dose at the usual time.
If you remember during the night or the following day, do not take the missed dose.
You may experience withdrawal symptoms, but these should quickly resolve once you take the next dose
at the usual time.
Do not take a double dose to make up for a missed dose.

What to do if there is no improvement
Paroxetine Aurovitas does not relieve symptoms immediately – all antidepressant medicines take time to work.
Some patients begin to feel better after a few weeks, others later. Some patients taking antidepressants may feel worse
before they start to feel better. If you do not feel better after a few weeks of treatment, you should consult your doctor.
Your doctor should schedule a follow-up visit a few weeks after you start taking the medicine for the first time.
Inform your doctor if you have not started to feel better.

Stopping Paroxetine Aurovitas
Do not stop taking Paroxetine Aurovitas unless your doctor tells you to.
When stopping Paroxetine Aurovitas, your doctor will advise you to gradually reduce the dose over several weeks
or months – this should help reduce the possibility of withdrawal symptoms. One way is to gradually reduce the dose
of Paroxetine Aurovitas by 10 mg per week. In most patients, withdrawal symptoms are mild and resolve on their own
within two weeks. However, in some patients, symptoms may be more severe or last longer.
If you experience withdrawal symptoms after stopping the tablets, your doctor may decide that you should taper
the dose more slowly. If you experience severe symptoms while stopping Paroxetine Aurovitas, contact your doctor.
They may recommend restarting the tablets and tapering more slowly.
Even if you experience withdrawal symptoms, it is still possible to stop taking Paroxetine Aurovitas.

Possible withdrawal symptoms after stopping treatment
Studies show that 3 out of 10 patients notice one or more withdrawal symptoms when discontinuing therapy with
Paroxetine Aurovitas. Some of these symptoms occur more frequently than others.

Common side effects (occurring in no more than 1 in 10 people):

• dizziness, unsteadiness, or difficulty maintaining balance;
• tingling sensations, burning sensations, and (less commonly) electric shock-like sensations, including in the head,
  and ringing, buzzing, whistling, or other persistent noise in the ears (tinnitus);
• sleep disturbances (vivid dreams, nightmares, insomnia);
• feeling anxious;
• headache.

Uncommon side effects (occurring in no more than 1 in 100 people):

• nausea;
• sweating (including night sweats);
• feeling restless or agitated;
• tremors;
• feeling disoriented;
• diarrhoea (loose stools);
• emotional lability or irritability;
• visual disturbances;
• palpitations or increased heart rate (tachycardia).

If you are concerned about withdrawal symptoms after stopping Paroxetine Aurovitas, contact your doctor.
If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions may occur more frequently during the first weeks of treatment with
Paroxetine Aurovitas.
You should contact your doctor if any of the following adverse reactions occur during treatment.
Immediate contact with a doctor or the nearest hospital emergency department may be necessary.

Not very common: may affect up to 1 in 100 people

• If the patient develops unusual bruising or bleeding, including vomiting blood or blood in the stool, they should contact a doctor immediately or go to hospital.
• If the patient experiences difficulty passing urine, they should contact a doctor immediately or go to hospital.

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

• If the patient has a seizure (fit), they should contact a doctor immediately or go to hospital.
• If the patient feels restless or unable to sit or stand still, they may be experiencing a condition called akathisia. Increasing the dose of Paroxetine Aurovitas may worsen these feelings. If such symptoms occur, contact the doctor.
• If the patient feels tired, weak, has pain, stiffness or lack of muscle coordination, is confused, they may have low sodium levels in the blood. If such symptoms occur, contact the treating doctor.

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

• Allergic reactions to Paroxetine Aurovitas, which may be severe. If the patient develops a red, blotchy rash, swelling of the eyelids, face, lips, mouth or tongue, itching, difficulty breathing (shortness of breath) or swallowing, or feels weak or dizzy leading to collapse or loss of consciousness, they should contact a doctor immediately or go to hospital.
• If the patient has some or all of the symptoms listed below, they may be experiencing a condition known as serotonin syndrome or neuroleptic malignant syndrome. These symptoms include: intense agitation or irritability, confusion, anxiety, feeling hot, sweating, tremors, shivering, hallucinations (strange visions or hearing strange sounds), muscle stiffness, sudden muscle spasms or rapid heartbeat. Symptoms may worsen and lead to loss of consciousness. If such symptoms occur, contact a doctor.
• Acute glaucoma. If the patient experiences eye pain and develops blurred vision, they should contact the treating doctor.

Frequency not known (frequency cannot be estimated from available data)

• In some patients, thoughts of self-harm or suicide have occurred during treatment with Paroxetine Aurovitas or shortly after stopping treatment (see Suicidal thoughts and worsening of depression or anxiety disorder symptoms in section 2).
• In some patients, aggression has occurred during treatment with Paroxetine Aurovitas.
• Severe vaginal bleeding occurring shortly after childbirth (postpartum haemorrhage), see additional information in subsection Pregnancy, breastfeeding and fertility in section 2. If such adverse reactions occur, contact the treating doctor.

Other possible adverse reactions occurring during treatment
Very common: may affect more than 1 in 10 people

• nausea. Taking Paroxetine Aurovitas in the morning with food reduces the likelihood of nausea.
• changes in sexual desire or sexual function. For example, lack of orgasm, and in men, erectile and ejaculation disorders.

Common: may affect up to 1 in 10 people

• increased blood cholesterol levels;
• loss of appetite;
• sleep disturbances (insomnia) or drowsiness;
• unusual dreams (including nightmares);
• dizziness or tremors;
• headache;
• difficulty concentrating;
• feeling agitated;
• feeling excessively weak;
• blurred vision;
• yawning, dry mouth;
• diarrhoea or constipation;
• vomiting;
• weight gain;
• sweating.

Not very common: may affect up to 1 in 100 people

• temporary increase or decrease in blood pressure, which may cause dizziness or fainting when standing up suddenly;
• faster than usual heartbeat;
• difficulty moving, stiffness, tremors or abnormal movements of the mouth and tongue;
• dilated pupils;
• skin rash;
• itching;
• feeling confused;
• hallucinations (strange images or sounds);
• inability to pass urine (urinary retention) or uncontrolled, involuntary passing of urine (urinary incontinence);
• in diabetic patients, treatment with Paroxetine Aurovitas may worsen blood sugar control. Discuss with your doctor whether insulin or antidiabetic medication doses need adjustment;
• decreased white blood cell count.

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

• abnormal milk production in the breast glands in men and women;
• slow heartbeat;
• liver effects shown in blood tests assessing liver function;
• panic attacks;
• excessive activity or racing thoughts (mania);
• feeling of detachment from oneself (depersonalization);
• feeling anxious;
• irresistible urge to move the legs (restless legs syndrome);
• joint or muscle pain;
• increased levels of a hormone called prolactin in the blood;
• menstrual disorders (including heavy or irregular bleeding, intermenstrual bleeding, or absence or delay of menstruation).

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

• a skin rash called erythema multiforme, which may include blisters and appear as target-like lesions (a dark spot in the centre surrounded by a lighter ring with a dark edge);
• widespread blistering rash with peeling skin, particularly around the mouth, nose, eyes and genital organs (Stevens-Johnson syndrome);
• widespread blistering rash with peeling of large areas of skin (toxic epidermal necrolysis);
• liver function disorders causing yellowing of the skin or whites of the eyes;
• syndrome of inappropriate antidiuretic hormone secretion (SIADH), in which abnormal chemical signals in the body lead to excessive water retention and low sodium (salt) levels. Such patients may have symptoms of serious illness or may show no symptoms at all;
• fluid or water retention (which may lead to swelling of the hands or feet);
• light sensitivity;
• painful, persistent penile erection;
• decreased platelet count.

Frequency not known (frequency cannot be estimated from available data)

• inflammation of the colon (causing diarrhoea);
• teeth grinding.

Some patients may experience ringing, buzzing, whistling, or other persistent noise in the ears (tinnitus) while taking Paroxetine Aurovitas.
Patients taking medicines of this type have been observed to have an increased risk of bone fractures.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Paroxetine Aurovitas

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after: EXP.
The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via the sewage system or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures will help protect
the environment.

6. Contents of the pack and other information

What Paroxetine Aurovitas contains
­ The active substance is paroxetine.
One coated tablet contains 20 mg of paroxetine (as paroxetine hydrochloride hemihydrate).
­ The other ingredients are:
Tablet core: calcium hydrogen phosphate dihydrate, calcium hydrogen phosphate, lactose monohydrate, sodium carboxymethyl starch (type A), magnesium stearate.
Tablet coating: titanium dioxide (E 171), hypromellose, polyethylene glycol 400, polysorbate 80.

What Paroxetine Aurovitas looks like and contents of the pack
Coated tablets.
Paroxetine Aurovitas 20 mg coated tablets are white or almost white, biconvex, capsule-shaped coated tablets, with the number "56" embossed on one side and the letter "C" with a deep score line dividing the tablet on the other side. The tablet can be divided into equal doses.
Paroxetine Aurovitas 20 mg coated tablets are available in packs containing 7, 10, 14, 20, 28, 30, 50, 56, 60, 98, 100 and 250 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warszawa
e-mail: [email protected]

Manufacturer/Importer:
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta