Paroxetine 10 Mg Film-Coated Tablets
Package leaflet: Information for the patient
Paroxetine lOmg film-coated tablets Paroxetine
Read all of this leaflet carefully before you start taking this
medicine because 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4
Eight important things you need to know about Paroxetine
• Paroxetine treats depression and anxiety disorders. Like all medicines it can have unwanted effects. It is therefore important that you and your doctor weigh up the benefits of treatment against the possible unwanted effects, before starting treatment
• Paroxetine is not for use in children and adolescents under 18. See section 2, Children and adolescents under 18, inside this leaflet
• Paroxetine won’t work straight away. Some people taking antidepressants feel worse before feeling better. 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 feeling better. See section 3 inside this leaflet
• Some people who are depressed or anxious think of harming or killing themselves. If you start to feel worse, or think of harming or killing yourself, see your doctor or go to a hospital straight away. See section 2, inside this leaflet
• Don’t stop taking Paroxetine tablets without talking to your doctor. If you stop taking Paroxetine tablets suddenly or miss a dose, you may get withdrawal effects. See section 3, inside this leaflet
• If you feel restless and feel like you can’t sit or stand still, tell your doctor. Increasing the dose of Paroxetine tablets may make these feelings worse. See section 4, inside this leaflet.
• Taking some other medicines with Paroxetine tablets can cause problems. You may need to talk to your doctor. See other medicines and Paroxetine, inside this leaflet.
• If you are pregnant or planning to get pregnant, talk to your doctor. See Pregnancy and breastfeeding and fertility, inside this leaflet
What is in this leaflet
1. What Paroxetine tablets are and what they are used for
2. What you need to know before you take Paroxetine tablets
3. How to take Paroxetine tablets
4. Possible Side effects.
5. How to store Paroxetine tablets
6. Contents of the pack and other information
|l. What Paroxetine tablets are and what they are used for
Paroxetine hydrochloride hemihydrate film-coated tablets contain the active ingredient Paroxetine and belong to a group of medicines called SSRIs (selective serotonin reuptake inhibitors), used in the treatment of depression (major depressive episodes), obsessive compulsive disorder (repetitive, obsessive thoughts with uncontrollable behaviour), panic disorders with and without agoraphobia, which is a fear of open spaces, social anxiety disorders/social phobias (fear or avoidance of social situations), generalized anxiety disorders (generally feeling very anxious or nervous), post-traumatic stress disorders (anxiety caused by a traumatic event).
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 Paroxetine 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.
2. What you need to know before you take Paroxetine tablets:
Do not take Paroxetine tablets
• If you are allergic to Paroxetine or any of the other ingredients of this medicine (listed in section 6)
• If you are taking medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide and methylthioninium chloride (methylene blue)), or have taken them at any time within the last two weeks. Your doctor will advise you how you should begin taking Paroxetine once you have stopped taking the MAOI
• If you are taking a anti-psychoticcalled thioridazine
• If you are taking an anti-psychotic called pimozide
If you have previously had an allergic reaction to Paroxetine or any of the other tablet ingredients listed. See section 6, Contents of the pack and other information, inside this leaflet.
If any of these apply to you, tell your doctor without taking Paroxetine tablets.
Warnings and precautions
Talk to your doctor or pharmacist before taking Paroxetine tablets if:
• You are taking any other medicines (see other medicines and Paroxetine, inside this leaflet)
• You are taking tamoxifen to treat hreast cancer or fertility problems? Paroxetine tablets may make tamoxifen less effective so your doctor may recommend you take another antidepressant.
• You have kidney, liver or heart trouble
• You have epilepsy or have a history of fits
• You have episodes of mania (overactive behaviour or thoughts)
• You having electro-convulsive therapy (ECT)
• You have a history of bleeding disorders, or you are taking other medicines that may increase the risk of bleeding (these include medicines used to thin the blood, such as warfarin, antipsychot-ics 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)
• You have diabetes
• You on a low sodium diet
• You have glaucoma (pressure in the eye)
• You pregnant or planning to get pregnant (see Pregnancy and breastfeeding and fertility inside this leaflet)
• You are under 18 years old (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 Paroxetine tablets.
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 years with psychiatric conditions who were treated with an antidepressant.
If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.
Children and adolescents under 18
Paroxetine should not be used for children and adolescents under 18 years because it has not been proven to be an effective medicine for this age group. 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 Paroxetine. If your doctor has prescribed Paroxetine 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 Paroxetine. Also, the long-term safety effects, concerning growth, maturation and cognitive and behavioural development, of Paroxetine in this age group have not yet been demonstrated.
In studies of Paroxetine tablets in under 18s, common side effects that affected less than 1 in 10 children/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) and unusual bruising or bleeding (such as nose bleeds). These studies also showed that the same symptoms affected children and adolescents taking sugar pills (placebo) instead of Paroxetine, although these were seen less often.
Some patients in these studies of under 18s 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 Paroxetine tablets in this leaflet). In addition, patients under 18 also commonly (affecting less than 1 in 10) experienced stomach ache, feeling nervous and changing emotions (including crying, changes in mood, trying to hurt themselves, thoughts of suicide and attempting suicide).
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.
Important side effects seen with Paroxetine
Some patients who take Paroxetine 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 they have 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 Paroxetine, see section 4, Possible side effects, inside this leaflet.
Other medicines and Paroxetine
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Some medicines can affect the way Paroxetine tablets works, or make it more likely that you’ll have side effects. Paroxetine tablets can also affect the way some other medicines work. These include:
• Medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide and methylthioninium chloride (methylene blue)) - see Do not take Paroxetine tablets, inside this leaflet
• Thioridazine or pimozide, which are anti-psychotics - see Do not take Paroxetine tablets, inside this leaflet
• Aspirin (acetylsalicyclic acid), ibuprofen or other medicines called NSAIDs (non-steroidal anti-inflammatory drugs) like celecoxib, etodolac and meloxicam, used for pain and inflammation
• Tramadol and pethidine, painkillers
• Medicines called triptans, such as sumatriptan, used to treat migraine
• Other antidepressants including other SSRIs, tryptophan 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
• Fentanyl, used in anaesthesia or to treat chronic pain
• 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 pressure and heart problems
• Rifampicin, used to treat tuberculosis (TB) and leprosy
• Linezolid, an antibiotic
• Tamoxifen, which is used to treat breast cancer or fertility problems
If you are taking 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.
Some medicines may affect the way others work. Always tell your doctor about all the medicines you are taking. This means medicines you have bought yourself as well as medicines on prescription from a doctor. Paroxetine with food and alcohol
Do not drink alcohol while you are taking Paroxetine tablets. Alcohol may make your symptoms or side effects worse. Pregnancy, breastfeeding and fertility
Talk to your doctor as soon as possible if you’re pregnant, if you
might be pregnant, or if you’re planning to become pregnant. In babies whose mothers took Paroxetine tablets during the first few months of pregnancy, there have been some reports showing an increased risk of birth defects, in particular those affecting the heart. In the general population, about 1 in 100 babies are bom with a heart defect. This increased to about 2 in 100 babies in mothers who took Paroxetine tablets. You and your doctor may decide that it is better for you to gradually stop taking Paroxetine tablets while you are pregnant. However, depending on your circumstances, your doctor may suggest that it is better for you to keep taking Paroxetine tablets. Make sure your midwife or doctor knows you’re taking Paroxetine tablets. When taken during pregnancy, particularly late pregnancy, medicines like Paroxetine tablets 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 the lungs is too high. If you take Paroxetine tablets during the last 3 months of pregnancy, your newborn baby might also have other conditions, which usually begin during the first 24 hours after birth.
Symptoms include:
• trouble with breathing
• a blueish skin or being too hot or cold
• blue lips
• vomiting or not feeding properly
• being very tired, not able to sleep or crying a lot
• stiff or floppy muscles
• tremors, jitters or fits.
• exaggerated reflexes.
If your baby has any of these symptoms when it is bom, or you are concerned about your baby’s health, contact your doctor or midwife who will be able to advise you.
Paroxetine may get into breast milk in very small amounts. If
you are taking Paroxetine tablets, go back and talk to your doctor before you start breast-feeding. You and your doctor may decide that you can breast-feed while you are taking Paroxetine tablets. Paroxetine has been shown to reduce the quality of sperm in animal studies. Theoretically, this could affect fertility, but impact on human fertility has not been observed as yet.
Driving and using machines
Possible side effects of Paroxetine include dizziness, confusion, feeling sleepy or changes in eyesight. If you do get these side effects, do not drive or use machinery.
Paroxetine tablets contain sodium:
The Paroxetine tablets contain sodium. To be taken into consideration by patients on a controlled sodium diet.
3. How to take Paroxetine Tablets
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
How much of your medicine to take and when to take it:
Take your tablets in the morning with food.
Swallow them with a drink of water.
Do not chew.
The tablet can be divided into equal doses Doses:
Your doctor will advise you what dose to take when you first start taking Paroxetine.The usual dose for different conditions are shown below:
• Adults
- Depression: 20 mg a day to a maximum of 50 mg
- Obsessive compulsive disorder: 20 mg a day to a maximum of 60 mg
- Panic disorder: lOmg a day to a maximum of 60 mg
- Social anxiety disorder: 20 mg a day to a maximum of 50 mg
- Post traumatic stress disorder: 20 mg a day to a maximum of 50 mg
- Generalised anxiety disorder: 20 mg a day to a maximum of 50 mg
• Older people
The maximum dose for people over 65 is 40 mg per day.
• Children and adolescents
Not recommended for use in children aged under 18 years.
• Patients with liver or kidney disease
If you have trouble with your liver or kidneys, your doctor may decide that you should have a lower dose of Paroxetine than usual. If you have severe liver or kidney disease, the maximum dose is 20 mg per day.
How long to take your medicine for:
Your doctor will advise you what dose to take when you first start taking Paroxetine tablets.
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.
Remember, your doctor will advise you on the daily dose you should take. 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.
If you take more Paroxetine Tablets than you should:
Never take more tablets than your doctor recommends. If you take too many Paroxetine tablets (or someone else does), contact your nearest hospital or tell your doctor straight away. Show them the pack of tablets. Someone who has taken an overdose of Paroxetine may have any one of the symptoms listed in section 4, Possible side effects, or the following symptoms: fever, uncontrollable tightening of the muscles.
If you forget to take Paroxetine Tablets:
Take your medicine at the same time every day. Do not take a double dose to make up for a forgotten dose.
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.
If you stop taking Paroxetine Tablets:
Do not stop taking Paroxetine tablets until your doctor tells you to. When stopping Paroxetine tablets, 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 Paroxetine you take by 10 mg a week. Most people find that any symptoms on stopping Paroxetine 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 effects when 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 Paroxetine tablets, please see your doctor. He or she may ask you to start taking your tablets again and come off them more slowly. It may be easier for you to take Paroxetine oral suspension during the time that you are coming off your medicine.
If you do get withdrawal effects, you will still be able to stop Paroxetine tablets.
Possible withdrawal effects when stopping treatment
Studies show that 3 in 10 patients notice one or more symptoms on stopping Paroxetine. Some withdrawal effects on stopping occur more frequently than others.
Common side effects, may affect 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
• Some patients have developed buzzing, hissing, whistling, ringing or other persistent noise in the ears (tinnitus) when they take Paroxetine tablets
• Sleep disturbances (vivid dreams, nightmares, inability to sleep)
• Feeling anxious
• Headaches.
Uncommon side effects, may affect 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 Paroxetine tablets.
What to do if you’re feeling no better
Paroxetine tablets 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.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. If they occur, they are likely to be temporary, and not serious. However, some may be serious and need medical attention.
Side effects are more likely to happen in the first few weeks of taking Paroxetine.
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, may affect 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, may affect 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 Paroxetine tablets 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, may affect up to 1 in 10,000 people:
• Allergic reactions to Paroxetine. 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 or swallowing, contact your doctor or go to a hospital straight away.
• If you have some or all of the following symptoms you 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.
Frequency unknown
Some people have had thoughts of harming or killing themselves while taking Paroxetine tablets or soon after stopping treatment (see section 2, What you need to know before you take Paroxetine tablets).
Other possible side effects during treatment
Very common side effects, may affect 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, may affect up to 1 in 10 people:
• Increases in the level of cholesterol in the blood
• Lack of appetite
• Not sleeping well (insomnia) or feeling sleepy
• Abnormal dreams (including nightmares)
• Feeling dizzy or shaky (tremors)
• Headache
• Difficulty in concentrating
• Feeling agitated
• Blurred vision
• Yawning, dry mouth
• Diarrhoea or constipation
• Vomiting
• Weight gain
• Feeling unusually weak
• Sweating.
Uncommon side effects, may affect up to 1 in 100 people:
• A brief increase in blood pressure, or a brief decrease that may make you feel dizzy or faint when you stand up suddenly
• A faster than normal heartbeat
• Lack of movement, stiffness, shaking or abnormal movements in the mouth and tongue
• Dilated pupils
• Skin rashes
• Itching
• Feeling confused
• Having hallucinations (strange visions or sounds)
• An inability to urinate (urinary retention) or an uncontrollable, involuntary passing of urine (urinary incontinence).
Rare side effects, may affect 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
• Irresistible urge to move the legs (Restless Legs Syndrome)
• Pain in the joints or muscles
• Increase in a hormone called prolactin in the blood.
Very rare side effects, may affect up to 1 in 10,000 people:
• Skin rash, which may blister, and looks like small targets (central dark spots surrounded by a paler area, with dark ring around the edge) called erythema mutiforme
• A widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome)
• A widespread rash with blisters and skin peeling on much of the body surface (toxic epidermal necrolysis)
• Liver problems that make the skin or whites of the eyes go yellow
• Syndrome of inappropriate antidiuretic hormone production (SIADH) which is a condition in which the body develops an excess of water and a decrease in sodium (salt) concentration, as a result of improper chemical signals. Patients with SIADH may become severely ill or may have no symptoms at all.
• 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
• Unexpected bleeding, e.g. bleeding gums, blood in the urine or in vomit, or the appearance of unexpected bruises or broken blood vessels (broken veins)
Some patients have developed buzzing, hissing, whistling, ringing or other persistent noise in the ears (tinnitus) when they take Paroxetine tablets. An increased risk of bone fractures has been observed in patients taking this type of medicines.
If you have any concerns while you are taking Paroxetine tablets, 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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Paroxetine tablets
Keep this medicine out of sight and reach of children.
Store in the original package in order to protect from light.
If you are using half tablets, be careful to keep them safely in the pack.
Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last date of that month.
The medicinal product does not require any special storage conditions.
Do not through away any medicine via waste water or house hold waste. Ask your pharmacist how to through away medicines you no longer use. These measures will protect environment.
6. Contents of the pack and other information
What Paroxetine tablets contain
The active substance is Paroxetine
Each film-coated tablets contain 10 mg of paroxetine (as paroxetine hydrochloride hemihydrate)
Other excipients are Calcium hydrogen phosphate dihydrate, Sodium starch glycolate, Magnesium stearate, Iron oxide red-E172, Titanium Dioxide-E171, Hypromellose-E464, Macrogol-400 and Polysorbate 80.
What Paroxetine tablets looks like and contents of the pack
Paroxetine film-coated tablets are white to pinkish white, oval biconvex film coated tablet, 8x4 mm, debossed ‘ 10 ’ on one side and with a break line on both sides.
Paroxetine 10 mg film-coated tablets are available in packs of 14 and 28 tablets
Not all pack sizes may be marketed.
This leaflet was last revised in 11/2015
Marketing Authorisation Holder and Manufacturer
MMEDREICH PLC
Warwick House, Plane Tree Crescent, Feltham TW13 7HF, UK.
E-mail: info@medreich.co.uk
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