Friday, September 30, 2016

Citalopram Tablets 10mg, 20mg, 40mg






Citalopram 10mg, 20mg



and 40mg tablets



Read all of this leaflet carefully before you start taking this medicine.


  • 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.



Index



1 What Citalopram tablets are and what they are used for

2 Before you take

3 How to take

4 Possible side effects

5 How to store

6 Further information





What Citalopram tablets are and what they are used for


Citalopram is one of a type of antidepressants known as Selective Serotonin Re-uptake Inhibitors (SSRIs). It increases the effects of the body’s
naturally occurring hormone, serotonin, by inhibiting its re-uptake in the nerve cells.


Citalopram is used to treat major episodes of depression.




Before you take



Do not take Citalopram tablets and tell your doctor if you:


  • are allergic (hypersensitive) to citalopram or any of the other ingredients (see section 6).

  • are taking, or have taken within the last two weeks, any monoamine oxidase inhibitors (MAO- inhibitors). These are medicines used depression or Parkinson’s disease (e.g. selegiline or moclobemide).

  • are taking pimozide (an antipsychotic medicine).


Check with your doctor or pharmacist before taking Citalopram tablets if you:


  • suffer from mania (great excitement, hallucinations, difficulty in concentrating or staying still).

  • suffer from any mental illnesses such as depression.

  • are diabetic.

  • suffer from epilepsy. If you start having more fits than usual stop taking citalopram and see your doctor immediately.

  • suffer from liver damage or liver disease.

  • suffer from severe kidney disease.

  • suffer from heart problems or an abnormal heart rhythm.

  • are having electro-convulsive therapy (ECT).

  • have a history of bleeding disorders.

  • are taking herbal products containing St. John’s wort (hypericum perforatum) used to treat depression.

  • are taking sumatriptan or other triptans (for migraines), oxitriptan or tryptophan (substances that may influence the level of serotonin in the brain) or tramadol (to treat moderate to severe pain).


Taking other medicines


Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.


Especially:


  • tricyclic antidepressants such as desipramine or clomipramine to treat depression.

  • medicines to thin your blood (eg warfarin), or other medicines which can cause bleeding, such as non-steroidal anti-inflammatory medicines, NSAIDs, (eg ibuprofen), aspirin, dipyridamole or ticlopidine.

  • medicines to treat mental illness (eg chlorpromazine, haloperidol, thioridazine).

  • lithium to treat mania or other mental illnesses.

  • cimetidine, omeprazole, esomeprazole, lansoprazole to treat stomach ulcers.

  • metoprolol to treat heart conditions.

  • neuroleptics to treat schizophrenia.

  • mefloquin to treat malaria.

  • flecainide or propofenone to treat heart disorders.



Use in children and adolescents under 18 years:


Citalopram tablets should normally not be used for children and adolescents under 18 years. Also, you should know that 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 this class of medicines. Despite this, your doctor may prescribe Citalopram for patients under 18 because he/she decides that this is in their best interest. If your doctor has prescribed Citalopram for a patient under 18 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 patients under 18 are taking Citalopram. Also, the long-term safety effects concerning growth, maturation and cognitive and behavioural development of Citalopram in this age group have not yet been demonstrated.




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 young adults (less than 25 years old) 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.



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.




Pregnancy and breast-feeding


If you are pregnant, planning to become pregnant or are breast-feeding ask your doctor or pharmacist for advice before taking this medicine.




Driving and using machines


Citalopram tablets may affect your ability to make judgements and to react to emergencies. Make sure you are not affected before you drive or operate machinery. If you are affected in any way, you should NOT drive or operate machinery.





How to take


Always take Citalopram tablets exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.


You are advised NOT to drink alcohol with this medicine.


Swallow these tablets with water. These tablets are taken as a single dose, with or without food, either in the morning or evening.



Doses:



  • Adults:


    A low starting dose of 20mg is recommended and depending on the response to treatment the dose may be increased to 40mg daily. The maximum daily dose is 60mg.


  • Elderly:


    Elderly patients would normally take half of the dose recommended for adults that is 10-20mg daily.


  • Children and adolescents:


    Not recommended for use in children aged under 18 years.


  • Kidney disease:


    If you suffer from severe kidney impairment, citalopram is not recommended.


  • Liver disease:


    A starting dose of 10mg daily for the first two weeks is recommended in patients with mild to moderate liver disease, the dose may be increased to 30mg daily. If you suffer from severe liver disease, your doctor will be extra careful with increasing the dose.

After starting treatment, the tablets may not take effect for at least 2 weeks. This medicine should be taken for as long as your doctor tells you to, it may be dangerous to stop the tablets without medical advice. Your doctor should continue to treat you with Citalopram tablets until you have been free of symptoms for 4-6 months.



If you take more than you should


If you (or someone else) swallow a lot of tablets at the same time, or you think a child may have swallowed any, contact
your nearest hospital casualty department or tell your doctor immediately. Signs of an overdose include feeling sleepy, feeling or being sick, seizures, a blue discolouration around your lips, nails or cheeks, sweating, coma, accelerated pulse rate, hyperventilation (accelerated and increased breathing) and changes in the activity of the heart muscle (ECG alterations).




If you forget to take the tablets


Do not take a double dose to make up for a forgotten dose. If you forget to take a dose take it as soon as you remember it and then take the next dose at the right time.




If you stop taking the tablets



Talk to your doctor before you stop taking the tablets and follow their advice. Citalopram tablets should be withdrawn slowly, gradually reducing the dose over periods of 1-2 weeks. If stopped suddenly, withdrawal reactions may occur including dizziness, ‘pins and needles’, headache, feeling or being sick, sleep disturbances (including insomnia and intense dreams), feeling agitated or anxious, tremor, confusion, sweating, diarrhoea, palpitations, emotional instability, irritability, and visual disturbances.





Possible side effects


Like all medicines, Citalopram tablets can cause side effects, although not everybody gets them.



Stop taking Citalopram tablets and contact your doctor at once if you


  • experience serotonin syndrome (a serious condition that can cause fever, confusion, abnormal movements, shivering, muscle spasms, agitation and progress to coma or loss of consciousness) restlessness, sweating, hallucinations, exaggeration of reflexes, muscle cramps, rapid heart rate.

  • severe hypersensitivity reactions which may result in a strong decrease in blood pressure, paleness, anxiety, a fast weak
    pulse rate, a clammy skin, decreased consciousness, tremor, breathing difficulties and sudden swelling of the lips, eyes or tongue.


Tell your doctor if you notice any of the following side effects or notice any other effects not listed:



  • Very common (occurs in more than 1 in 10 users): feeling sick, dry mouth, sleepiness, shakiness of the arms and legs, diarrhoea, headache, dizziness, visual disturbances, difficulty in sleeping, constipation, weakness, increased sweating, palpitations, agitation, nervousness.


  • Common (occurs in less than 1 in 10 users): tingling (pins and needles), anxiety, problems with concentration, confusion, problems sleeping, abnormal dreams, tiredness, yawning, abnormalities of vision, migraine, loss of memory, feeling faint after standing, fast heart rate, low or high blood pressure, loss of appetite, increase in appetite, loss of or increase in weight, indigestion, stomach pain, wind, vomiting, abnormalities of taste, increased salivation, runny nose, sinusitis, impotence and problems with ejaculation, reduced libido, problems in reaching orgasm (women), problems with passing water, passing water frequently, period pains, rash, itching.


  • Uncommon (occurs in less than 1 in 100 users): muscle pain, jerky movements, fits, ringing in the ears, false sense of wellbeing, increased desire for sex, coughing, malaise (generally feeling unwell), sensitivity to sunlight, changes in liver function, slow heart rate, fainting.


  • Rare (occurs in less than 1 in 1,000 users): bleeding (in the skin, bruising, stomach and from the vagina), changes in the salt balance in your body, psychomotor restlessness. The syndrome of inappropriate anti-diuretic hormone secretion (SIADH, symptoms are confusion, hallucinations, drowsinesss, fits, coma and breathing difficulties).


  • Very rare (occurs in less than 1 in 10,000 users): irregular heart beats/pulse rate, hallucinations (seeing things, hearing things or feelings that are not there), mania, feeling of unreality, panic attacks, production of breast milk, joint pain.


  • Not known: bile flow stoppage (cholestasis), thoughts of suicide and suicidal behaviour (see: ‘section 2’).

If you notice any side effects, they get worse, or if you notice any not listed, please tell your doctor or pharmacist.




How to store


Keep out of the reach and sight of children.


No special precautions for storage.


Do not use Citalopram tablets after the expiry date stated on the label/carton/ bottle. The expiry date refers to the last day of that month.


Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.




Further information



What Citalopram tablets contain


  • The active substance (the ingredient that makes the tablet work) is citalopram (as hydrobromide). Each tablet contains either 10mg, 20mg or 40mg of the active ingredient.

  • The other ingredients are mannitol (E421), microcrystalline cellulose (E460), colloidal silica anhydrous, magnesium stearate. The film-coat contains hypromellose (E464), macrogol, titanium dioxide (E171).



What Citalopram tablets look like and contents of the pack


Citalopram tablets are round, white film-coated tablets.


Pack size of 28.




Marketing Authorisation Holder and Manufacturer



Actavis

Barnstaple

EX32 8NS

UK




Date of revision: June 2010




Actavis

Barnstaple

EX32 8NS

UK


50416258





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