Paxoran 40mg Tablets
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pentamidine, anti-malarian treatment particularly haiofantnne), certain antihistamines (astemizoie, mizoiastine).
if you nave any further questions about this you should speaktoyourdoctor.
Pregnancy, breast-feeding andfertility
if you are pregnant or breast-feeding, thinkyou may be pregnant or are planning to nave a baby, askyour doctor or pharmacist for advice before taking this medicine. Your doctor will nave to decide whether treatment with Citaiopram Tablets is clearly necessary or whether an aiternativetreatmentispossibieforyou.
You should not stop treatment with Citaiopram Tablets abruptly due to pregnancy or otherreasons.
Make sure your midwife and/or doctor knowyou are on Citaiopram. When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like Citaiopram may increase the riskof 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/ordoctor immediately.
Also, if you take Citaiopram during the last 3 months of your pregnancy and until the date of birth you should be aware that the following effects may be seen in your newborn: fits, being too not or cold, breathing difficulties, blue or purple coloration of the skin or mucous membranes, feeding difficulties, vomiting, low blood sugar, stiff orfioppy muscles, overactive reflexes, tremor, jitteriness, irritability, lethargy, constant crying, sleepiness or sleeping difficulties, if your newborn baby gets any of these symptoms please contact your midwife and/ordoctor immediately.
Citaiopram is known to be found in breast milk, its effects on children taking breast milk nave not been established, if treatment with citaiopram is considered necessary, discontinuation of breastfeeding should be considered.
Citaiopram 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
Askyour doctor or pharmacist for advice before taking any medicine.
Driving and using machines:
This medicine may cause side-effects (such as feeling dizzy, sleepy, confused and having problems with eyesight) that affect now well you concentrate and now quickly you can react, if you get these side-effects, do not drive or use machines or anything else where you needtobe alert and concentrate.
Citaiopram tablets contains lactose monohydrate
intolerance to some sugars, contactyour doctor before taking this medicinal product.
3. How to take Citaiopram tablets How muchto take
it is important to take yourtabiets as instructed by your doctor.
The label will tell you now manyto take and howoften. if
oharmacist
Adults
Depression
The usual dose is 20 mg per day. This may be increased by your doctor to a maximum of40mg per day.
If you get any of the following symptoms you should stop taking Citaiopram tablets and see your doctor immediately:
• Allergic reactions
• Angioedema, such as
o swollen face, tongueor pharynx o difficulty in swallowing o hives and difficulties to breath
• Serotonin syndrome (symptoms: motor restlessness, confusion, sweating, hallucinations, increased reflexes, stiffness in muscles, shaking chills, increased heart rate andtrembiing)
• Fast, irregular heartbeat, fainting which could be symptoms of a life-threatening condition known as Torsades dePointes.
Very common: (morethan 11n 10 patients treated)
• Not sleeping well orfeeiing sleepy
• Headaches, dizziness
• Fluttering or pounding heartbeat
• Feeling sick(nausea), dry mouth
• increased sweating
• Visual disturbances
• Feeling ofweakness
Common: (fewer than 1 in 10 but more than 1 in 100 patients treated)
• Feeling agitated, nervousness
• Sleep disorders (excessive sleepiness, abnormal dreaming), impaired concentration, abnormal dreaming, loss of memory, anxiety, decreased sex drive, abnormal orgasm (female), decreased appetite, feeling of complete dissatisfaction and confusion.
• Migraine and paraesthesia (sensation of pricking, tingling, orcreeping on the skin)
• Feeling snaky (tremors)
• Changein blood pressure (can increase or drop)
• indigestion, vomiting, constipation, diarrhea (loose stools), stomach pains, increased wind and saliva
• Difficulty in urine passing, excessive secretion of urine
• Muscle pain, joint pain
• Decrease in weight
• inflammation oftne nasal passages and sinuses
• Failure of ejaculation in males, impotence, painful menstruation has been reported in some female patients.
• Pruritus (localized or generalized itching of skin)
• Probiemswith eyesight
• Ringing of ear
• Fatigue, yawning
Uncommon: (fewer than 1 In 100 but more than 1 in 1DDD patients treated)
• Aggression: seeing, feeling or nearing things that are not there (hallucination): mood of excitement, overactivity and uninhibited behaviour (mania): depersonalisation: feeling of extreme happiness and increased sexual drive
• increased appetite, increase in weight
• Abnormal heart rate
• Fainting
• Dilated pupils
• Rash, hives, hair loss, unusual bleeding or bruising undertheskin,
• Unabieto pass urine
• Heavy menstrual periods
• Coughing
• Swelling of hands, ankles orfeet
• increase sensitivity of skin to sunlight
• Allergic reactions, malaise (general feeling of being unwell)
Rare:(fewerthan1 (n 1000 but more than 11n 10000 patients treated)
• Abnormal bleeding, mostly of the skin and mucous
• Tiredness, confusion and twitching of your muscles. These may be signs of a low blood level of sodium.
• Taste abnormalities
• Fits, uncontrollable twitching, jerking or writhing
is 10 mg per day for the first week before increasing the dose to 20-30 mg per day. The dose maybe increased byyourdoctorto a maximum of 40mgperday.
Older patients (above6Syears of age)
The starting dose should be decreased to naif of the recommended dose, e.g. 10-20 mg per day. Older patients should not usually receive moretnan20mg per day.
Children and adolescents (< 18 years)
Citaiopram should not be given to children and adolescents. For further information, please see section 2whatyou need to know before you take Citaiopram. Patients with special risks
Patients with liver complaints should not receive more than 20 mg perday.
How and whento take Citaiopram
Citaiopram is taken every day as a single daily dose. Citaiopram can be taken anytime oftne day with or without food. Swallow the tablets with a drink of water.
Duration of treatment
Like other medicines for depression and panic disorder these tablets may take a few weeks before you feel any improvement. Continue to take Citaiopram even if it takes some time before you feel any improvement in your condition.
The duration of treatment is individual, usually at least 6 months. Continue to take the tablets for as long as your doctor recommends. Do not stop taking them even if you begin to feel better, unless you are told to do so by your doctor. The underlying illness may persist fo long time and if you stop your treatment too soon yi symptomsmayretum.
Patients who nave recurrent depression benefit frr continued treatment, sometimes for several years, preventthe occurrence of new depressive episodes.
Neverchangethe dose oftne medicine withouttaikingto your doctor first.
• Feverorhightemperature.
Very rare: (fewer than 1 in 10000 patients treated,
Rapid rhythm of heart ^ increased prolactin levels
lot known
Bleeding or bruising more easilythan normal
Overproduction of a hormone causing fluid retention,
resulting in weakness, tiredness or confusion
Lowpotassium levels in the blood
Panic attack, grinding of the teeth, restlessness,
suicidal ideation, suicidal behaviour
Abnormal involuntary movements (extrapyramidal
RpotlPoo'n'poo or difficulty sitting still, movement h standing up due to
Abnormal liverfunctlon test Persistent painful er without sexual arousal Abnormal production of bi
;n reported in patients aged 50
Reporting of side effects
if you get any side effects, taikto 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 Yellow Card Scheme at: www.mhra.gov.ukfyeiiowcard By reporting side effects you can help provide more information on the safety of this medicine.
Do not use this medicine afterthe expiry date which stated on the carton and blister strip. The expiry da refers to the last day of that month.
if you nave the impression that the effect of Citaiopram tablets is too strong ortoo weak, taikto your doctor or pharmacist.
If you take more CltalopramTabletsthanyou should:
Nevertake more tablets than your doctor recommends, if you nave taken too many tablets, or if someone accidentally swallows some, contactyour doctor or the nearest hospital for advice. Snow them the pack of tablets. The most likely signs of taking too many tablets (overdose) are: feeling dizzy or drowsy, sweating, very high fever, bluish or purplish tinge to the skin and mucous membranes, serotonin syndrome, feeling or being sick (nausea or vomiting), headache, dilated pupils, rapid or deep breathing, having abnormal heartbeats, abnormal heart rhythm, high or low blood pressure, heart attack, uncontrollable muscle spasms affecting the eyes, head, neck and body, shaking or tremors, fits, feeling agitated or anxious and coma.
If you forget totake CltalopramTablets
if you forget to take your dose of this medicine, simply carry on with the next dose as usual.
Do not take a double dose to make up for a forgotten individual dose.
If you stop taking Citaiopram Tablets
Do not stop taking this medicine until your doctor tells you to, even ifyou feel better.
if you stop suddenly aftertaking this medicine fora long time you can experience withdrawal effects, symptoms such as dizziness, diarrhoea, numbness and tingling, sweating, headache, fast or irregular heartbeats, emotional instability, irritability, agitation or anxiety, sleep disturbances including inability to sleep and/or intense dream, shaking or tremor confusion, visual disturbances, nausea and vomiting may occur. These symptoms are generally non-serious and disappear within a few days. Citaiopram should always be stopped gradually over 1-2 weeks period.
ifyou get withdrawal effects when you are coming off come off them more slowly.
Do not throw away any medicines via wastewater or household waste. Askyour pharmacist now to throw away medicines you no longer use. These measures will help protectthe environment.
6. Contents of the packand other information
What Citaiopram Tablets contains
The active substance is Citaiopram hydrobromide.
Each 10mg film-coated tablet contains 12.5 mg citaiopram hydrobromide equivalent to 10 mg citaiopram.
Each 20mg film-coated tablet contains 25 mg
citaiopram hydrobromide equivalent to 20 mg citaiopram.
Each 40mg film-coated tablet contains 50 mg
citaiopram hydrobromide equivalent to 40 mg citaiopram.
The other ingredients are lactose monohydrate, microcrystalline cellulose, maize starch, copovidone, croscarmeiiose sodium and magnesium stearate. The ingredients of the film-coating material, Opadry White 20H 58983 comprise of hypromellose,titanium dioxide (E171), propylene glycol, nydroxypropyl cellulose and
What Citaiopram Tablets looks like and contents of thepack
Citaiopram Tablets are white to off-white, circular biconvex flim-coated tablets.
- 10mg tablets are marked with “10" on one side and plain on the other side.
- 20mg tablets are marked with “20" on one side and a score line ontheotherside.
-40mg tablets are marked with “40" on one side and a score line ontheotherside.
Citaiopram Tablets are available as blister strips in pack sizes of 1,14, 20, 28, 30, 50, 56, 98,100 or 250
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
if you nave any further questions on the ust medicine, askyour doctor, pharmacist or nurse.
They are most prominent during th weeks of treatment am depression improves.
Building4,Chiswic 566 ChiswickHign
Ranbaxy Ireland Limited Spafieid, CorkRoad, Cashel,, Co. Tipperary Republic of Ireland