Xetanor 20 mg. 28 tablets

1. What Xetanor is and what it is used for

Xetanor is used to treat adult patients with depression and/or anxiety disorders. The anxiety disorders for which this medicine is used are: obsessive-compulsive disorder (repeated intrusive thoughts with uncontrollable behaviour), panic disorder (panic attacks, including those caused by agoraphobia, which is a fear of open spaces), social anxiety disorder (fear of or avoidance of social situations), post-traumatic stress disorder (anxiety after a traumatic experience) and generalised anxiety disorder (constant feeling of anxiety or nervousness).

Xetanor belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs). It is not fully understood how this medicine and other serotonin reuptake inhibitors work, but they may help by increasing the levels of serotonin in the brain. Proper treatment of depression or anxiety disorders is important to help you improve your condition.

2. What you need to know before you take Xetanor

Do not take Xetanor

if you are taking medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide and methylthioninium chloride (methylene blue)), or have taken them in the last two weeks. Your doctor will advise you on how to start taking Xetanor after you stop taking MAOIs.

if you are taking an antipsychotic called thioridazine or an antipsychotic called pimozide

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

If any of the above apply to you, tell your doctor before taking this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before taking Xetanor

Are you taking any other medicines? (see section "Other medicines and Xetanor" in this leaflet)

Are you taking tamoxifen for breast cancer or fertility problems? Xetanor may reduce the effectiveness of tamoxifen and your doctor may recommend that you take another antidepressant.

Do you have kidney, liver or heart problems?

Do you have a heart abnormality known as a prolonged QT interval, which is seen on an electrocardiogram (ECG)?

Do you have a family history of QT prolongation, heart disease such as heart failure, low heart rate or low potassium levels or low magnesium levels?

Do you have epilepsy or have you had seizures in the past?

Have you had manic episodes (over-reactive behaviour or thoughts)?

Are you receiving electroconvulsive therapy (ECT)?

Do you have a history of bleeding disorders or are you taking medicines that may increase the risk of bleeding (this includes blood thinners such as warfarin, antipsychotic medicines such as perphenazine or clozapine, tricyclic antidepressants, medicines used to treat 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 salt-restricted diet (low-sodium diet)?

Do you have glaucoma (increased pressure in the eye)

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

Are you under 18 years of age? (see below “Children and adolescents under 18 years of age”).

If the answer to any of these questions is YES and you have not already discussed it with your doctor, ask your doctor for advice on taking Xetanor.

Children and adolescents under 18 years of age

Xetanor should not be used in children and adolescents under 18 years of age. Also, patients under 18 years of age are at increased risk of side effects such as suicidal thoughts and attempts and hostility (mainly aggression, oppositional behaviour and rage) when taking paroxetine. If your doctor has prescribed this medicine for you (or your child) and you want to discuss this, please go back to your doctor. You should tell your doctor if any of the symptoms listed above develop or worsen while you (or your child) are taking this medicine. In addition, the long-term safety effects of paroxetine on growth, maturation and cognitive and behavioural development have not yet been established in this age group.

In trials of paroxetine in people under 18 years of age, common side effects affecting less than 1 in 10 children/adolescents were: increased thoughts and attempts of suicide, deliberate self-harm, hostility, aggression and unfriendliness, loss of appetite, tremor, abnormal sweating, hyperactivity (having too much energy), agitation, changes in emotions (including crying and mood swings) and unusual bruising and bleeding (such as nosebleeds). The trials

showed that the same symptoms affected children and adolescents taking sugar tablets (placebo) instead of paroxetine, although they were seen less often.

Some patients under 18 years of age in these studies experienced withdrawal symptoms when paroxetine was stopped. These effects were similar to those seen in adults after paroxetine was stopped (see section 3). In addition, stomach pain, nervousness and changes in emotions (including crying, mood swings, self-harming, thoughts and attempts at suicide) were also commonly (in less than 1 in 10 patients) in patients under 18 years of age.

Thoughts of suicide and worsening of your depression or anxiety disorder

If you are depressed and/or have an anxiety disorder you may sometimes have thoughts of harming or killing yourself. These thoughts may be more likely when you first start taking antidepressants, as all these medicines take time to work - usually around two weeks, but sometimes longer.

Pregnancy, breast-feeding and Fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. There have been reports of an increased risk of birth defects, particularly affecting the heart, in babies whose mothers have taken paroxetine during the first few months of pregnancy. In the general population, about 1 in 100 babies are born with a heart defect. In babies whose mothers have taken paroxetine, this rate increases to 2 in 100 babies. You and your doctor may decide that it is better for you to switch to another treatment or to gradually stop taking this medicine while you are pregnant. However, depending on your circumstances, your doctor may decide that it is better for you to continue taking this medicine.

Make sure your midwife or doctor knows that you are taking Xetanor. If you take this medicine towards the end of your pregnancy, there may be an increased risk of heavy vaginal bleeding soon after birth, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking this medicine so that they can advise you. When taken during pregnancy, especially in late pregnancy, medicines like Xetanor may increase the risk of a serious condition in babies called persistent pulmonary hypertension of the newborn (PPHN). In PPHN, the blood pressure in the blood vessels between the baby’s heart and lungs is very high. If you have taken this medicine in the last 3 months of your pregnancy, your baby may also have other symptoms, which usually appear in the first 24 hours after birth. Symptoms include:

breathing problems,

skin that is bluish or too warm or cold,

blue lips,

vomiting or refusing to eat,

very tired, unable to sleep or cry a lot,

stiff or loose muscles,

trembling, nervousness or fits,

very strong reflexes.

If your baby has any of these symptoms when they are born, or you are concerned about their health, contact your doctor or midwife who will advise you what to do.

Xetanor may pass into breast milk in very small amounts. If you are taking this medicine, go back and talk to your doctor before you start breast-feeding. You and your doctor may decide that you can breast-feed while taking this medicine.

Paroxetine has been shown to reduce sperm quality in animal studies. Theoretically, this could have an effect on fertility, but no effect on fertility has been observed in humans.

Driving and using machines

Possible side effects of Xetanor include dizziness, confusion, drowsiness and blurred vision. Do not drive or use machines if you experience these side effects.

Xetanor contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, i.e. it can be said to be practically sodium-free.

Xetanor contains soya lecithin

If you are allergic to peanuts or soya, do not use this medicine.

3. How to take Xetanor

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Sometimes you may need to take more than one tablet or half a tablet. The usual doses for different conditions are given in the table below:

Starting dose

Recommended daily dose

Maximum daily dose

Depression 20 mg (1 tablet) 20 mg (1 tablet) 50 mg (2 ½ tablets)

Obsessive-compulsive disorder 20 mg (1 tablet) 40 mg (2 tablets) 60 mg (3 tablets)

Panic disorder 10 mg (½ tablet) 40 mg (2 tablets) 60 mg (3 tablets)

Social anxiety disorder 20 mg (1 tablet) 20 mg (1 tablet) 50 mg (2 ½ tablets)

Post-traumatic stress disorder 20 mg (1 tablet) 20 mg (1 tablet) 50 mg (2 ½ tablets)

Generalized anxiety disorder 20 mg (1 tablet) 20 mg (1 tablet) 50 mg (2 ½ tablets)

Your doctor will advise you on the dose for you. is needed when you first start taking Xetanor. Most people start to feel better after a few weeks. If you do not start to feel better after this period, talk to your doctor and he or she will advise you what to do. Your doctor may decide to gradually increase your dose by 10 mg, up to the maximum daily dose.

Take the tablets in the morning with food

Swallow them with water.

Do not chew them.

The tablet can be divided into two equal doses.

Your doctor will tell you how long you will need to take the tablets. This may be for many months or even longer.

Elderly patients

The maximum dose for people over 65 years of age is 40 mg a day.

Patients with liver or kidney disease

If you have liver problems or severe kidney disease, your doctor may decide that you should take a lower dose of this medicine than usual.

If you take more Xetanor than you should

Never take more tablets than your doctor has told you to. If you have taken too many Xetanor tablets (or someone else has taken more tablets), tell your doctor or go to a hospital straight away. Show them the tablet pack.

If someone takes an overdose of Xetanor, they may experience some of the symptoms listed in section 4 "Possible side effects" or the following symptoms: fever, uncontrollable muscle tightening.

If you forget to take Xetanor

Take your medicine at the same time every day.

If you miss a dose of the medicine and remember before going to bed, take it straight away. The next day, continue as usual.

If you remember during the night or the next day, leave out the missed dose. You may experience withdrawal symptoms, but these should go away when you take your next dose at the usual time.

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

What to do if you do not feel better

Xetanor will not relieve your symptoms straight away - all antidepressants take time to work. Some people start to feel better after a few weeks, but

for others it may take longer. Some people who take antidepressants initially get worse and then get better. If you do not feel better after a few weeks, go back to your doctor and he or she will advise you what to do. Your doctor should arrange a follow-up visit a few weeks after you first start treatment. Tell your doctor if you do not start to feel better.

If you stop taking Xetanor

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

When you stop taking Xetanor, your doctor will help you to reduce your dose gradually, over a period of several weeks or months, which should reduce the chance of you experiencing withdrawal effects. One way to do this is to gradually reduce the dose you are taking by 10 mg per week. Most people find that the symptoms of stopping Xetanor are mild and go away on their own within two weeks. In some people, these symptoms may be more severe or last longer.

If you get withdrawal symptoms when you reduce your tablets, your doctor may decide that you should reduce them more slowly. Please contact your doctor if you get severe withdrawal effects when you stop taking this medicine. Your doctor may

may tell you to start taking the medicine again and reduce the dose more slowly.

If you experience withdrawal symptoms, you can still stop taking Xetanor.

Possible withdrawal symptoms when stopping treatment

Studies have shown that 3 in 10 patients notice one or more symptoms when stopping treatment with paroxetine. Some withdrawal symptoms are more common than others.

Common side effects

These may affect up to 1 in 10 patients

feeling dizzy, unsteady or off balance;

tingling, burning sensation and (less commonly) electric shock sensation, including in the head, and buzzing, whistling, whistling, ringing or other intrusive noise in the ears (tinnitus);

sleep disturbances (vivid dreams, nightmares, inability to sleep);

feeling restless;

headache.

Uncommon side effects

These may affect up to 1 in 100 people

nausea;

sweating (including at night);

restlessness or anxiety;

tremor (shaking);

confusion or disorientation;

diarrhoea (disorder);

increased emotionality or irritability;

visual disturbances;

irregular or fast heartbeat (palpitations).

Please contact your doctor if you are concerned about the effects of stopping Xetanor.

If you have any further questions on the use of this product, please 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 occur during the first few weeks of taking this medicine.

See your doctor if you experience any of the side effects listed below during treatment.

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

Uncommon side effects

These may affect up to 1 in 100 people

Contact your doctor or go to hospital straight away if you have unusual bruising or bleeding, including if you vomit blood or have blood in your stools.

Contact your doctor or go to hospital straight away if you find that you are unable to urinate.

Rare side effects

These may affect up to 1 in 1,000 people

Contact your doctor or go to hospital straight away if you experience fits (seizures).

If you feel like you cannot find a place to sit or stand still, you may have a condition called akathisia. Increasing your dose may make these feelings worse. Contact your doctor if you feel this way.

If you feel tired, weak or confused and your muscles ache, are stiff or you cannot coordinate them, the cause may be a low level of sodium in your blood. Contact your doctor if you have these symptoms.

Very rare side effects

These may affect up to 1 in 10,000 people

Allergic reactions to Xetanor, which can be severe. Contact your doctor or go to hospital straight away if you get: a red and raised skin rash, swelling of the eyelids, face, lips, mouth or tongue, if you get itching or have difficulty breathing (shortness of breath) and swallowing and feel weak or dizzy which may lead to collapse (fainting) or loss of consciousness.

If you have some or all of the symptoms described below, you may be suffering from a condition called serotonin syndrome or neuroleptic malignant syndrome. Symptoms are: feeling very agitated or irritable, feeling confused, restless, hot flushes, sweating, chills, shaking, hallucinations (strange images and sounds), muscle stiffness, sudden muscle spasms or a fast heartbeat. The symptoms may become more severe and lead to loss of consciousness. Contact your doctor if you feel this way.

Acute glaucoma.

Contact your doctor if you experience eye pain and blurred vision.

Not known

Frequency cannot be estimated from the available data

Some people have had thoughts of harming or killing themselves while taking Xetanor or soon after stopping treatment (see Thoughts of suicide and worsening of your depression or anxiety disorder in section 2).

Some people have experienced aggression while taking this medicine.

Heavy vaginal bleeding soon after giving birth (postpartum haemorrhage), see pregnancy, breast-feeding and fertility" in section 2 for more information.

Contact your doctor if you experience these side effects.

Other possible side effects during treatment

Very common side effects

These may affect more than 1 in 10 patients:

feeling sick. Taking the medicine in the morning with food will reduce the chance of this happening.

Disruption of normal sexual function, such as inability to achieve orgasm and in men abnormal erection and ejaculation.

Common side effects

These may affect up to 1 in 10 patients

increased blood cholesterol levels

Very rare side effects

These may affect up to 1 in 10,000 people

a skin rash that may blister and look like small targets (a dark spot in the centre surrounded by a lighter area with a dark ring around it) called erythema multiforme

a widespread rash with blisters and peeling skin, especially around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome)

a widespread rash with blisters and peeling skin over a large part of the body (toxic epidermal necrolysis)

liver problems that cause the skin or whites of the eyes to turn yellow

syndrome of inappropriate antidiuretic hormone secretion (SIADH) - a condition in which the body retains too much water and has too little sodium (salt) due to incorrect hormonal regulation. Patients with SIDH may be either seriously ill or have no symptoms at all.

fluid or water retention, leading to swelling of the hands and feet

increased sensitivity to sunlight

painful erection of the penis that does not go away

low blood platelet count

Not known

The frequency cannot be estimated from the available data

inflammation of the colon (causing diarrhoea)

grinding of the teeth

Some patients experience tinnitus (buzzing, whistling, whistling, ringing or other intrusive noises in the ears) when taking paroxetine.

5. How to store Xetanor

Keep out of the reach and sight of children.

Do not use this medicine after the expiry date which is stated on the blister or bottle and carton after “EXP”. The expiry date refers to the last day of that month.

If you are using half tablets, be careful and store them safely in the packaging.

This medicine does not require any special storage conditions.

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

6. Contents of the pack and other information

What Xetanor contains:

The active substance is paroxetine. Each film-coated tablet contains 20 mg of paroxetine (as paroxetine hydrochloride).

The other ingredients are: mannitol, microcrystalline cellulose, sodium starch glycolate (type IA), magnesium stearate.

The film-coating composition: basic butylated methacrylate copolymer, partially hydrolyzed poly(vinyl alcohol) (E 1203), titanium dioxide (E 171), talc (E 553b), soya lecithin (E 322) and xanthan gum (E 415).

What Xetanor looks like and what the pack contains

The tablets are white, round, film-coated, biconvex tablets, 10 mm in diameter, with a score line on one side and the inscription "P20" on the other side.

The tablet can be divided into two equal doses.

Xetanor is available in blister packs of 10,14,20, 28,30, 50, 56, 60,98 or 100 film-coated tablets, perforated unit-dose blister packs of 10x1, 14x1,20x1,28x1, 30x1, 50x1, 56x1, 60x1, 98x1 or 100x1 tablets and a bottle of 28, 56, 100 or 250 film-coated tablets.