Document: Paroxiflex film-coated tablet ENG PL change

• Paroxiflex film-coated tablet PL
• Paroxiflex film-coated tablet ENG PL

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Package leaflet: Information for the user

Paroxiflex* 20 mg film-coated tablet

paroxetine

Read all of this leaflet carefully before you start taking this medicinebecause it contains important information for you.

• Keep this leaflet. You may need to read it again.

• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is inthis leaflet

1. What Paroxiflex 20 mg film-coated tablet is and what it is used for

2. What you need to know beforeyou take Paroxiflex 20 mg film-coated tablet

3. How to take Paroxiflex 20 mg film-coated tablet

4. Possible side effects

6. Contents of the pack and other information

Paroxiflex is a treatment for adults with depression and/or anxiety disorders. The anxiety disorders that Paroxiflex is used to treat are: obsessive compulsive disorder (repetitive, obsessive thoughts with uncontrollable behaviour), panic disorder (panic attacks, including those caused by agoraphobia, which is a fear of open spaces), social anxiety disorder (fear or avoidance of social situations), post traumatic stress disorder (anxiety caused by a traumatic event) and generalised anxiety disorder (generally feeling very anxious or nervous).

Paroxiflex is one of a group of medicines called SSRIs (selective serotonin reuptake inhibitors). Everyone has a substance called serotonin in their brain. People who are depressed or anxious have lower levels of serotonin than others. It is not fully understood how Paroxiflex and other SSRIs work but they may help by increasing the level of serotonin in the brain. Treating depression or anxiety disorders properly is important to help you get better.

DO NOT takeParoxiflex 20 mg film-coated tablet

- If you are taking medicines called monoamine oxidase inhibitors(MAOIs, including moclobemide, linezolid, methylthioninium chloride (methylene blue), or have taken them at any time within the last twoweeks. Your doctor will advise you how you should begin taking Paroxiflex once you have stopped taking the MAOI.

- If you are taking an anti-psychotic called thioridazine or an anti-psychotic called pimozide.

- if you are allergic to paroxetine, peanut or soya, or to any of the other ingredients of this medicine (listed in section 6).

If any of these apply to you, tell your doctor without taking Paroxiflex.

Warnings and precautions

Talk to your doctor or pharmacist or nurse before taking Paroxiflexand ask yourself these questions:

- Are you taking any other medicines (see section Othermedicines and Paroxiflex)?

- Do you have kidney, liver or heart trouble?

- Do you have epilepsy or have a history of fits or seizures?

- Have you ever had episodes of mania (overactive behaviour or thoughts)?

- Are you having electro-convulsive therapy (ECT)?

- Do you have a history of bleeding disorders, or are you taking other medicines that may increase the risk of bleeding (these include medicines used to thin the blood, such as warfarin, antipsychotics such as perphenazine or clozapine, tricyclic antidepressants, medicines used for pain and inflammation called non-steroidal anti-inflammatory drugs or NSAIDs, such as acetylsalicylic acid, ibuprofen, celecoxib, etodolac, diclofenac, meloxicam?

- Do you have diabetes?

- Are you on a low sodium diet?

- Do you have glaucoma (pressure in the eye)?

- Are you pregnant or planning to get pregnant (see section Pregnancy, breast-feeding and fertility)?

- Are you under 18yearsold (see Children and adolescents under 18, inside this leaflet)?

If you answer YES to any of these questions, and you have not already discussed them with your doctor, go back to your doctor and ask what to do about taking Paroxiflex.

Thoughts of suicide and worsening of your depression or anxiety disorder

If you are depressed and/or have anxiety disorders you can sometimes have thoughts of harming or killing yourself. These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer.

You may be more likely to think like this:

- If you have previously had thoughts about killing or harming yourself.

- If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 yearswith psychiatric conditions who were treated with an antidepressant.

If youhave thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.

You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.

Children and adolescents under 18

Paroxiflex should not be used for children and adolescents under 18years.Also patients under 18 have an increased risk of side effects such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take Paroxiflex. If your doctor has prescribed Paroxiflex for you (or your child) and you want to discuss this, please go back to your doctor. You should inform your doctor if any of the symptoms listed above develop or worsen when you (or your child) are taking Paroxiflex. Also, the long-term safety effects concerning growth, maturation and cognitive and behavioural development of paroxetinin this age group have not yet been demonstrated.

In studies of paroxetinin under 18s, common side effects that affected less than 1in 10children/adolescents were: an increase in suicidal thoughts and suicide attempts, deliberately harming themselves, being hostile, aggressive or unfriendly, lack of appetite, shaking, abnormal sweating, hyperactivity (having too much energy), agitation, changing emotions (including crying and changes in mood). These studies also showed that the same symptoms affected children and adolescents taking sugar pills (placebo) instead of paroxetin, although these were seen less often.

Some patients in these studies of under18s had withdrawal effects when they stopped taking paroxetine.These effects were mostly similar to those seen in adults after stopping paroxetine(see Section 3, How to take Paroxiflex, inside this leaflet). In addition, patients under18 also commonly (affecting less than 1 in10) experienced stomach ache, feeling nervous and changing emotions (including crying, changes in mood, trying to hurt themselves, thoughts of suicide and attempting suicide).

Important side effects seen with Paroxiflex

Some patients who take Paroxiflex develop something called akathisia, where they feel restless and feel like they can’t sit or stand still. Other patients develop something called serotonin syndrome, where theyhave some or all of the following symptoms: feeling confused, feeling restless, sweating, shaking, shivering, hallucinations (strange visions or sounds), sudden jerks of the muscles or a fast heartbeat. If you notice any of these symptoms, contact your doctor. For more information on these or other side effects of Paroxiflex, see Section 4, Possible Side Effects, inside this leaflet.

Other medicines and Paroxiflex

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

Some medicines can affect the way Paroxiflex works, or make it more likely that you’ll have side effects. Paroxiflex can also affect the way some other medicines work. These include:

- Medicines calledmonoamine oxidase inhibitors(MAOIs, including moclobemide and methylthioninium chloride (methylene blue)) -see section DO NOT take Paroxiflex, inside this leaflet.

- Thioridazine or pimozide, which are anti-psychotics -see Do not take Paroxiflex, inside this leaflet.

- Linezolid, an antibiotic- see Do not take Paroxiflex, inside this leaflet.

- Acetylsalicylic acid, ibuprofen or other medicines called NSAIDs (non-steroidal anti-inflammatory drugs) like celecoxib, etodolac, diclofenac and meloxicam, used for pain and inflammation

- Tramadol, pethidine (painkillers)

- Fentanyl (used in general anaesthesia or to treat chronic pain)

- Medicines called triptans, such as sumatriptan, used to treat migraine

- Other antidepressantsincluding other SSRIs and tricyclic antidepressants like clomipramine, nortriptyline and desipramine

- A dietary supplement called tryptophan

- Medicines such as lithium, risperidone, perphenazine, clozapine (called anti-psychotics) used to treat some psychiatric conditions

- A combination of fosamprenavir and ritonavir, which is used to treat Human Immunodeficiency Virus (HIV) infection

- St John’s Wort, a herbal remedy for depression

- Phenobarbital, phenytoin, sodium valproate or carbamazepine, used to treat fits or epilepsy

- Atomoxetine which is used to treat attention deficit hyperactivity disorder (ADHD)

- Procyclidine, used to relieve tremor, especially in Parkinson’s Disease

- Warfarin or other medicines (called anticoagulants) used to thin the blood

- Propafenone, flecainide and medicines used to treat an irregular heartbeat

- Metoprolol, a beta-blocker used to treat high blood pressureand heart problems

- Pravastatin, used to treat high cholesterol

- Rifampicin, used to treat tuberculosis (TB) and leprosy

- Tamoxifen (used to treat breast cancer)

If you are taking or have recently taken any of the medicines in this list,and you have not already discussed these with your doctor, go back to your doctor and ask what to do.The dose may need to be changed or you may need to be given another medicine.

Paroxiflex with food, drink and alcohol

Do not drink alcohol while you are taking Paroxiflex. Alcohol may make your symptoms or side effects worse. Taking Paroxiflex in the morning with food will reduce the likelihood of you feeling sick (nausesa).

Pregnancy, breast-feedingand fertility

If you are already taking Paroxiflex and have just found out that you are pregnant, you should talk to your doctor immediately. Also if you are planning to get pregnant,talk to your doctor. This is because some studies have suggested an increase in the risk of heart defects in babies whose mothers received paroxetinein the first few months of pregnancy. These studies found that less than 2 in 100 babies (2%) whose mothers received paroxetine in early pregnancy had a heart defect, compared with the normal rate of 1 in 100 babies (1%) seen in the general population. When all types of birth defect are taken into account, there is no difference in the number of babies born with birth defects after their mothers took paroxetinewhile they were pregnant compared to the overall number of birth defects that occur in the general population. You and your doctor may decide that it is better for you to change to another treatment or to gradually stop taking Paroxiflex while you are pregnant. However, depending on your circumstances, your doctor may suggest that it is better for you to keep taking Paroxiflex.

Make sure your midwife and/or doctor know you are on Paroxiflex. When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like Paroxiflex may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), making the baby breathe faster and appear bluish. These symptoms usually begin during the first 24 hours after the baby is born. If this happens to your baby you should contact your midwife and/or doctor immediately.

If you are taking Paroxiflex in the last 3 months of pregnancy, let your midwife know as your baby might have some symptoms when it is born. These symptoms usually begin during the first 24hours after the baby is born. They include not being able to sleep or feed properly, trouble with breathing, a blue-ish skin or being too hot or cold, being sick, crying a lot, stiff or floppy muscles, lethargy, tremors, jitters or fits. If your baby has any of these symptoms when it is born and you are concerned, contact your doctor or midwife who will be able to advise you.

Paroxiflex may get into breast milk in very small amounts. If you are taking Paroxiflex, go back and talk to your doctor before you start breast-feeding.

Paroxetine has been shown to reduce the quality of sperm in animal studies. Theoretically, this could affectfertility, but impact on human fertility has not been observed as yet.

Driving and using machines

Possible side effects of Paroxiflex include dizziness, confusion, feeling sleepy or blurred vision. If you do get these side effects, do not drive or use machinery.

Paroxiflex contains soyalecithin

If you are allergic to peanut or soya, do not use this medicinal product.

Always take Paroxiflex exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Sometimes you may need to take more than one tablet or half a tablet. This table will show you how many tablets to take.		Dose	Number of tablets to take
		10 mg	Half a tablet
		20 mg	One tablet
		30 mg	One-and-a-half tablets
		40 mg	Two tablets
		50 mg	Two-and-a-half tablets
		60 mg	Three tablets

The usual doses for different conditions are set out in the table below.

		Starting dose	Recommended daily dose	Maximum daily dose
	Depression	20 mg	20 mg	50 mg
	Obsessive Compulsive Disorder	20 mg	40 mg	60 mg
	Panic Disorder	10 mg	40 mg	60 mg
	Social Anxiety Disorder	20 mg	20 mg	50 mg
	Post Traumatic Stress Disorder	20 mg	20 mg	50 mg
	Generalised Anxiety Disorder	20 mg	20 mg	50 mg

Your doctor will advise you what dose to take when you first start taking Paroxiflex.Most people start to feel better after a couple of weeks. If you don’t start to feel better after this time, talk to your doctor, who will advise you. He or she may decide to increase the dose gradually, 10 mg at a time, up to a maximum daily dose.

Take your tablets in the morning with food.

Swallow them with a drink of water.

Do not chew.

Your doctor will talk to you about how long you will need to keep taking your tablets. This may be for many months or even longer.

Older people

The maximum dose for people over 65 is 40mg per day.

Patients with liver or kidney disease

If you have trouble with your liver or severe kidney disease, your doctor may decide that you should have a lower dose of Paroxiflex than usual.

If you take more Paroxiflex 20 mg film-coated tablet than you should

Never take more tablets than your doctor recommends. If you take too many Paroxiflex tablets (or someone else does), tell your doctor or a hospital straight away. Show them the pack of tablets.

Someone who has taken an overdose of Paroxiflex may have any one of the symptoms listed in section 4, Possible side effects, or the following symptoms: being sick, widening of the pupils, fever, headache, uncontrollable tightening of the muscles.

If you forget to take Paroxiflex 20 mg film-coated tablet

Take your medicine at the same time every day.

If you do forget a dose, and you remember before you go to bed,take it straight away. Carry on as usual the next day.

If you only remember during the night, or the next day, leave out the missed dose. You may possibly get withdrawal effects, but these should go away after you take your next dose at the usual time.

What to do if you’re feeling no better

Paroxiflex 20 mg will not relieve your symptoms straight away -all antidepressants take time to work. Some people will start to feel better within a couple of weeks, but for others it may take a little longer. Some people taking antidepressants feel worse before feeling better. If you don’t start to feel better after a couple of weeks, go back to your doctor who will advise you. Your doctor should ask to see you again a couple of weeks after you first start treatment. Tell your doctor if you haven’t started to feel better.

If you stop taking Paroxiflex 20 mg film-coated tablet

Do not stop taking Paroxiflex until your doctor tells you to.

When stopping Paroxiflex,your doctor will help you to reduce your dose slowly over a number of weeks or months -this should help reduce the chance of withdrawal effects. One way of doing this is to gradually reduce the dose of Paroxiflex you take by 10 mg a week. Most people find that any symptoms on stopping Paroxiflex are mild and go away on their own within two weeks. For some people, these symptoms may be more severe, or go on for longer.

If you get withdrawal effectswhen you are coming off your tablets your doctor may decide that you should come off them more slowly. If you get severe withdrawal effects when you stop taking Paroxiflex, please see your doctor. He or she may ask you to start taking your tablets again and come off them more slowly.

If you do get withdrawal effects, you will still be able to stop Paroxiflex.

Possible withdrawal effects when stopping treatment

Studies show that 3in 10patients notice one or more symptoms on stopping paroxetine. Some withdrawal effects on stopping occur more frequently than others.

Common side effects, mayaffect up to 1 in 10 people:

- Feeling dizzy, unsteady or off-balance

- Feelings like pins and needles, burning sensations and (less commonly) electric shock sensations, including in the head, and buzzing, hissing, whistling, ringing or other persistent noise in the ears (tinnitus)

- Sleep disturbances (vivid dreams, nightmares, inability to sleep)

- Feeling anxious

- Headaches.

Uncommon side effects, mayaffect up to 1 in 100 people:

- Feeling sick (nausea)

- Sweating (including night sweats)

- Feeling restless or agitated

- Tremor (shakiness)

- Feeling confused or disorientated

- Diarrhoea (loose stools)

- Feeling emotional or irritable

- Visual disturbances

- Fluttering or pounding heartbeat (palpitations).

Please see your doctor if you are worried about withdrawal effects when stopping Paroxiflex.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Side effects are more likely to happen in the first few weeks of taking Paroxiflex.

See the doctor if you get any of the following side effects during treatment.

You may need to contact your doctor or go to a hospital straight away.

Uncommon side effects, mayaffect up to 1 in 100 people:

- If you have unusual bruising or bleeding, including vomiting blood or passing blood in your stools, contact your doctor or go to a hospital straight away.

- If you find that you are not able to pass water, contact your doctor or go to a hospital straight away.

Rare side effects, mayaffect up to 1 in 1,000 people:

- If you experience seizures (fits), contact your doctor or go to a hospital straight away.

- If you feel restless and feel like you can’t sit or stand still,you may have something called akathisia. Increasing your dose of Paroxiflex may make these feelings worse. If you feel like this, contact your doctor.

- If you feel tired, weak or confused and have achy, stiff or uncoordinated muscles this may be because your blood is low in sodium. If you have these symptoms, contact your doctor.

Very rare side effects, mayaffect up to 1 in 10,000 people:

- Allergic reactions,which may be severeto Paroxiflex.

If you develop a red and lumpy skin rash, swelling of the eyelids, face, lips, mouth or tongue, start to itch or have difficulty breathing(shortness of breath) or swallowing and feel weak or lightheaded resulting in collapse or loss of consciousness, contact your doctor or go to a hospital straight away.

- If you have some or all of the following symptomsyou may have something called serotonin syndrome. The symptoms include: feeling confused, feeling restless, sweating, shaking, shivering, hallucinations (strange visions or sounds), sudden jerks of the muscles or a fast heartbeat. If you feel like this contact your doctor.

- Acute glaucoma.

If your eyes become painful and you develop blurred vision, contact your doctor.

These appear initially as circular patches often with central blisters usually on arms and hands or legs and feet, more severe rashes may include blistering of the chest and back. Severe forms of rash may progress to widespread peeling of the skin which can be life threatening.

If you develop a rash or these skin symptoms, stop taking Paroxiflex and contact your doctor immediately.

Side effects with a not known frequency (frequency can not be estimated from available data):

- If you have thoughts of suicide or thoughts of harming yourself (see section 2: Warnings and precautions).

Other possible side effects during treatment

Very common side effects, mayaffect more than 1 in 10 people:

- Feeling sick (nausea). Taking your medicine in the morning with food will reduce the chance of this happening.

- Change in sex drive or sexual function. For example, lack of orgasm and, in men, abnormal erection and ejaculation.

Common side effects, mayaffect up to 1 in 10 people:

- Lack of appetite

- Not sleeping well (insomnia) or feeling sleepy

- Abnormaldreams (including nightmares)

- Feeling dizzy or shaky (tremors)

- Headache

- Feeling agitated

- Feeling unusually weak

- Blurred vision

- Yawning, dry mouth

- Diarrhoea or constipation

- Vomiting

- Weight gain

- Sweating.

- Increases in cholesterol levels

Uncommon side effects, mayaffect up to 1 in 100 people:

- Brief increase or decrease in blood pressure, a faster than normal heartbeat

- Lack of movement, stiffness, shaking or abnormal movements in the mouth and tongue

- Skin rashes

- Feeling confused

- fall in blood pressure on standingn up which causes dizziness, lightheadedness or fainting

- Having hallucinations (strange visions or sounds)

- excessively large pupil(mydriasis)

- An inability to urinate (urinary retention) or an uncontrollable, involuntary passing of urine (urinary incontinence).

- If you are a diabetic patient you may notice a loss of control of your blood sugar levels whilst taking Paroxiflex. Please speak to your doctor about adjusting the dosage of your insulin or diabetes medications.

Rare side effects, mayaffect up to 1 in 1,000 people:

- Abnormal production of breast milk in men and women

- A slow heartbeat

- Effects on the liver showing up in blood tests of your liver function

- Panic attacks

- Overactive behaviour or thoughts (mania)

- Feeling detached from yourself (depersonalisation)

- Feeling anxious

- Pain in the joints or muscles.

- Urgeto move the legs (or other parts of the body) to stop uncomfortable sensations (restless legs syndrome).

Very rare side effects, mayaffect up to 1 in 10,000 people:

- Liver problems that make the skin or whites of the eyes go yellow

- Fluid or water retention which may cause swelling of the arms or legs

- Sensitivity to sunlight

- Painful erection of the penis that won’t go away

- Low blood platelet count.

Other possible side effects.

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

Some patients have developed buzzing, hissing, whistling, ringing or other persistent noise in the ears (tinnitus) when they take paroxetine.

If you have any concerns while you are taking Paroxiflex, talk to your doctor or pharmacist who will be able to advise you.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V*. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Paroxiflex 20 mg film-coated tablet

• 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 blister or bottle and the carton. The expiry date refers to the last day of that month.

• This medicinal product does not require any special storage conditions.

• If you are using half tablets, be careful to keep them safely in the pack.

• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Paroxiflex 20 mg film-coated tablet contains

• The active substance is paroxetine (20 mg).

• The other ingredients are:

• Core: Magnesium stearate, Sodium starch glycollate (Type A), Mannitol, Microcrystalline cellulose.

• Coat: Basic butylated methacrylate copolymer, Polyvinyl alcohol, Talc, Lecitin soya, Xanthan gum, Titan dioxide (E171).

What Paroxiflex 20 mg film-coated tablet looks like and contents of the pack

Paroxiflex 20 mg film-coated tablets are white to off-white, biconvex, round, film-coated tablet scored on both walls and sides. Marked “P” on one wall and “20” on the other wall. The tablets have a break-line on both sides.

Each pack of Paroxiflex 20 mg contains blisters (Al/Al) of 20, 50, 60 and 100 tablets, 5 x 20 and 10 x 20 tablets or tablet containers (Polypropylene with LDPE caps) with a desiccant of 100, 200 and 250 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

[To be completed nationally]

Manufacturer

[To be completed nationally]

This medicinal product is authorised in the Member States of the EEA under the following names:

Germany Paroxetin STADA 20 mg – Filmtabletten

Sweden Paroxiflex 20 mg filmdragerade tabletter

You may find it helpful to contact a self-help group, or patient organisation, to find out more about your condition. Your doctor will be able to give you details.

This leaflet was last revisedin 2015-11-18