Paroxetine 20mg Tablets
|
Number of Tablets lo Take | |
|
10 mg |
Half a 20 mg tablet |
|
One 20 mg tablet | |
|
30 mg |
One 20 mg tablet - Half a 20 mg tablet |
|
40 mg |
Two 20 mg tablets |
|
50 mg |
Two 20 mg tablets * Half a 20 mg tablet |
|
60 mg |
Three 20 mg tablets |
PATIENT INFORMATION LEAFLET
PAROXETINE 20 mg TABLETS
Read aU of this leaflet carefully before you atari taking tbit
medicine.
• Keep this leaflet You may need to read il again
• If you have further question*, please ask your doctor or your pharmacist
- This medicine has been presefibed for you personally and
you should noi pass il on lo others. It may harm them, even if their symptoms arc the same a* yours.___
In this leaflet
I What Paroxetine 20 mg tablets arc and what they arc used for
2. Before you take Paroxetine 20 mg tablets
3. How to take Paroxetine 20 mg tablets
4. Possible side effects
5 Storing Paroxetine 20 mg tablets
Paroxetine 20 mg film-coated tablets
The active substance in Paroxetine 20 mg tablets is paroxetine
hydrochloride Each tablet contains 22.2 mg paroxetine
hydrochloride equivalent to 20 mg paroxetine
The other ingredients in this tablet arc magnesium stearate, sodium
starch glycolatc. anhydrous lactose, the tablet film-coating contains
hydroxy propyl cellulose, hypromcllosc. macrogol and colourant
titanium dioxide (El 71).
Marketing Authorisation Holder Apotex Europe Limited. 41 London Street. Reading. Berkshire RGI 4PS. United Kingdom Manufacturer responsible for release Chandle Medical Limited. Loughrea. Co Galway. Ireland.
Distributed by: Ncolsb. 57 High Street. Odiham, Hants RG29 ILF
1. WHAT PAROXETINE 20 MG TABLETS ARE AND WHAT THEY ARE USED FOR
Paroxetine 20 mg tablets arc oval and white, with the markings -'20" and a brcaklinc on one side The tablets arc available in pack sizes of 30 tablets.
Paroxetine 20 mg tablets belong to a group of medicines called selective serotonin icuplakc inhibitors (SSRIs) Everyone has the substance called serotonin in their body Low levels of serotonin arc thought to be a cause ol depression and other related conditions. Paroxetine works by bringing the levels of serotonin back to normal Paroxetine is used to treat:
• the symptoms of depression and any associated anxiety
• obsessions and compulsions including, obsessive compulsive disorder (OCO)
• panic attacks in patients who may or may not also suffer from a fear of going into public places (agoraphobia)
II is important that you continue to take your tablets, even when you start to feel belter. Do not stop taking these tablets unless your doctor tells you lo.
For information on the use of Paroxetine in children and adolescents under IK years of age. please see the section at the end of this leaflet called “Can Paroxetine be used m children-’"
2. BEFORE YOU TAKE PAROXETINE 20 MG TABLETS
Do not fake Paroxetine 20 mg tablets:
• If you ore hypersensitive (allergic) to paroxetine hydrochloride or any of the other ingredients of paroxetine 20 mg tablets
- If you are taking or have taken at any lime within the last two weeks, any medicines known as monoamine oxidase inhibitors (also called MAOli)
• If you are taking thioridazine (a major tranquilliser)
If yon answer YES to any of the following questions listed below and you hnve no! already discussed (best with your doctor, go bark lo your doctor and ask what to do:
• Arc you pregnant or might you become pregnant soon?
- Arc you breast-feeding?
• Do you have eye. kidney, liver or heart trouble-’
- Do you suffer from epilepsy or have a history of fits'*
- Do you suffer from episodes of mama (ovcractivc behaviour or
thoughts)-’
- Arc you having electro-convulsive therapy (ECT)?
- Do you have a history of bleeding disorders-’
■ Do you suffer from diabetes?
• Arc you on a low sodium diet-’
• Have you been diagnosed as having an intolerance to lactose? This medicine contains lactose as an inactive ingredient
If you are taking any of the following medicines and you have not already discussed these with your doctor, go back lo your doctor and ask what to do. The dose may need to be changed or you may need to be given another medicine
• medicines containing tryptophan
• medicines containing dextromethorphan, a cough suppressant
• phenytoin or other medicines used lo prevent fits (anticonvulsants)
• warfarin or other medicines used to thin the blood (anticoagulants)
• lithium, risperidone, perphenazine or other medicines used to treat certain psychiatric conditions (anlt-psychoites)
• medicines used to treat an irregular heartbeat
• mctoprolol (a beta-blocker used lo treat high blood pressure and heart disorders)
• triptans (a category of medicine used lo treat migraine)
• procycltdine (a medicine used to relieve tremor, especially in Parkinson's disease)
• other anitdepressanu
• aspirin or other painkillers known as “NSAIDs" (nonsteroidal anti-indammalory drugs)
• St John's wort (a herbal remedy)
If you arc taking any other medicines, not mentioned above, check with your doctor or pharmacist before taking paroxetine They will know if it is safe for you to do so.
You should avoid alcohol while you are taking this medicine Driving and using machines:
Possible side-effects w uh paroxetine arc dizziness, confusion or changes in ey esight. If you do gel ihcsc side-effects, it may mean dial your coordination. judgement or concentration arc affected so that it is not possible lo do certain things If you arc affected in this way. do nol drive or use machinery
3. IIOW TO TAKE PAROXETINE 20 MG TABLETS Always take Paroxetine 20 mg tablets exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you arc unsure about how many tablet* lo lake or when lo lake them Sometime* you may need lo take more than one tablet or half a tablet lo make up the dose required. The table below will help you decide how
Take your tablets in the morning with food Swallow the tablets with a
dnnk of water. Do nol chew
Adults
Depression
The usual dose is 20 mg per day Your doctor may decide to increase this dose gradually.
10 mg at a time, at intervals of two weeks, to a maximum dose of 50 mg per day.
Obsessive Compulsive Disorder (obsessions and compulsions)
The suiting dose is 20 mg per day Your doctor may decide to increase this daily dose by 10 mg at intervals of two weeks up to a maximum dose of 60 mg per day The usual dose is 40 mg per day.
Panic disorder (panic attacks)
The starting dose is 10 mg per day Your doctor may decide to increase this daily dose by 10 mg at intervals of two weeks up lo a maximum dose of 60 mg per day The usual dose is 40 mg per day Elderly
The maximum dose for elderly patients t* 40 mg per day 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.
For how long should you lake Paroxetine?
Like other drugs of this type, paroxetine will nol relieve your symptoms straightaway You should surt lo feel belter after a week or two. although it may take longer Occasionally, the symptoms of your illness may include thoughts of harming yourself or committing suicide Until the full effect of your medicine becomes apparent, il it possible that these symptoms may increase in the first few weeks of treatment. Tell your doctor immediately or go lo the nearest hospital if you have any distressing thoughts or experience* during this inilial period or al any other lime Even after you star! to feel belief il is important lo keep taking your tablets for as long as your doctor recommends This should be at least four to six months after you have recovered from your depression and may be even longer lor obsessions and compulsions or panic disorder What if you mist a dote?
Leave out that dose completely Take your next dose at the normal time. It is important to take the tablets each day until they ate finished.
What if you take too many tablets?
If you accidentally take too many tablets, tell your doctor immediately, or go to your nearest casualty department. Remember to Ukc this leaflet or the remaining tablets with you when you go to the hospital
When you stop taking Paroxetine
Do not stop taking paroxetine until your doctor tells you to. Your doctor will usually advise you to slowly reduce the dose over a number of weeks When you stop taking paroxetine, especially if you do so suddenly, you may have side-effects Please see the next section of this leaflet called "Possible side-effects"
4. POSSIBLE SIDE EFFECTS
Like all medicines. Paroxetine tablets can have side effects Wnh paroxetine, some patients may experience these side-effects while taking their tablets or when stopping their tablets These side-effects ate not always caused by paroxetine.
Possible tide-effects whilst on treatment
Common side-effects of Paroxetine that could happen to more than I in 100 people but less than I in 10 people taking it include:
• Nausea (feeling sick) Taking your medicine in the morning aflcr food will reduce the chance of this happening.
• Change in sex drive or function. For example lack of orgasm and. in men, abnormal erection and ejaculation
• Lack of appetite
• Being sick (vomiting)
• Not sleeping well (insomnia) or feeling sleepy
• Feeling dr/vy or shaky (tremors)
• Dry mouth, diarrhoea or constipation
• Sweating or feeling weak
• Agitation/restlessness
• Palpitations
• Headache
• Vertigo
Uncommon side-effects or Paroxetine that could happen to more than I in 1000 people but less than I in 100 people taking it include:
• Bruising easily, skin rashes or itchy skin
• Lack of movement, stiffness, shaking or abnormal movements in the mouth and tongue
• Not being able to pass water
• Blurred vision
• Abnormal production of breast milk in men and women
• Ringing in the cars
• Fast heartbeat
Rare side-effects of Paroxetine that could happen to more than I in 10.000 people but lest than I in 1000 people taking it include
• A lower than normal level of sodium in the blood. This can make you feel confused, tired or weak and give you achy, stiff or uncoordinated muscles. If you have these symptoms, please see your doctor.
• Seizures (fils)
• Not being able to sit or stand still
• Problems with the liver which mean that the skin or whues of the eyes go yellow Tests of liver function may also be affected
• Sensitivity to sunlight
• Pain in the eye with blurred vision (acute glaucoma)
• Inflammation of the pancreas
Very rare suic-cffccts of Paroxetine that could happen to less than I in 10.000 people taking it include:
• Allergic reactions to paroxetine If you develop a rash or swelling, start to itch or have difficulty breathing or swallowing, contact your doctor
a A collection of symptoms called serotonin syndrome which can include symptoms like feeling restless, feeling confused, sweating, shaking, shivering, hallucinations (strange visions or sounds), sudden jerks of the muscles or a fast heartbeat
• Increased levels of a hormone (ADII) that causes fluid or
• Fibrosis of the lung which is experienced as progressive shortness of brealh with exertion
Possible side-effects when stopping treatment
Studies show that I in 4 patients notice some symptoms on slopping Paroxetine compared to I m 7 patients aflcr stopping sugar pills. For the majority of people, symptoms go away on their own within 2 weeks. When stopping Paroxetine, your doctor may ask you to reduce the dose very gradually using half tablets and then alternating days if necessary If the dose is not reduced gradually, there is more chance of experiencing side-effects If you get severe side-effects when you stop taking Paroxetine, please see your doctor. Your doctor may ask you to start taking your tablets again and come off them more slowly. Your doctor may decide that it is easier for you to take a liquid form of paroxetine during the time that you are coming off your medicine If you do gel side-effects, it docs not mean that you will not be able to stop Paroxetine.
For those people that do get side-effects when they stop taking Paroxetine, common side-effects that could happen to more than I in 100 people but less than I in 10 people arc
• Dizziness (feeling dizzy, unsteady or off-balance)
• Sensory disturbances including pins and needles, burning sensations and less commonly electric shock-like sensations (including such sensations in the head)
• Sleep disturbances (vivid dreams, nightmares, inability to sleep)
• Feeling anxious
Uncommon sidc-effeels that could happen to more than I in 1000 people but less than I in 100 people when slopping treatment arc
• Nausea (feeling sick)
• Sweating (including night sweats)
• Agitation
• Tremor (shakincss)
• Confusion (feeling confused or disorientated)
Please see your doctor If you are worried about side-effect* when taking or stopping Paroxetine.
Can Paroxetine be used in children?
Paroxetine lx not appro*ed for use in children and adolescents who are aged under 18 yean. It must not be used in the treatment of major depression in children and adolescent! under 18 yean.
In specific circumstances your doctor may have given you (or your child) this medicine for another reason You should go back lo your doctor for more details if you have any questions or concerns.
When children and adolescents under 18 years of age have been given Paroxetine, common stdc-cffcels affected more than I in 100 but fewer than I in 10 children adolescents These are: a lack of appetite, shaking, abnormal sweating, hyperactivity (having too much energy), hostile or unfriendly behaviour, agitation, changing emotions (including crying, changes in mood, trying to harm themselves, thoughts of suicide and attempting suicide Thoughts of suicide and attempting suicide mainly happened in studies in adolescents with major depression )
When children and adolescents under age 18 stop taking Paroxetine, common additional side-effects to those seen in adults, and that could affect more than I in I0O but fewer than I in 10 children adolescents arc: stomach ache, feeling nervous and changing emotions (including crying, changes in mood, trying to harm themselves, thoughts of suicide and attempting suicide).
5. STORING PAROXETINE 20 MG TABLETS
Do not use the tablets after the expiry date shown on the product packaging
Store the tablets in the original package.
If you arc using half tablets, be careful lo keep them safely in the pack Unless your doctor tells you to. do not keep medicines that you no longer need, give them back lo your pharmacist for safe disposal Keep your tablets out of the reach and sight of children.
Paroxetine 20 mg tablets: PL 15922.0026 Leaflet prepared 17* February 2004