Microsoft word - seror pil_180908.doc

PACKAGE LEAFLET: INFORMATION FOR THE USER
Seror 20mg and 40 mg film-coated tablets

Read all of this leaflet carefully before you start taking this medicine.
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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. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Seror is and what it is used for
2. Before you take Seror
3. How to take Seror
4.
WHAT SEROR IS AND WHAT IT IS USED FOR

Seror is an antidepressant. It belongs to a group of medicines called selective serotonin re-uptake inhibitors
(SSRIs) which work in the brain by blocking the re-uptake of the neurotransmitter called serotonin. Seror is
used to treat the symptoms of depression and, when you are feeling better, to help prevent these symptoms
recurring.
Seror is also beneficial in relieving symptoms in patients prone to panic attacks.
Treatment for depression is usually continued for at least six months and for panic disorder for at least three
months.
2.
BEFORE YOU TAKE SEROR

Do not take Seror
- if you are allergic (hypersensitive) to citalopram or any of the other ingredients of Seror.
- if you are taking an antidepressant medicine of the type called monoamine oxidase inhibitors (MAOIs).

Take special care with Seror
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if you have ever thought about or attempted taking your own life. if you suffer from mania (great excitement, hallucinations, difficulty in concentrating or staying still). if you have any mental illnesses such as schizophrenia. if you are diabetic. Your diabetic treatment may need to be adjusted. if you are suffering from epilepsy. If you have epilepsy you may receive more regular check-ups to ensure your epilepsy remains well controlled. If you start having more fits than usual stop taking Seror and see your doctor immediately. if you have liver damage or liver disease. Your doctor may take blood tests to monitor your liver function. if you suffer from heart problems or an abnormal heart rhythm. if you are having electro-convulsive therapy (ECT). if you have a history of abnormal bleeding.
Taking other medicines
Seror should NOT be taken if you are taking an antidepressant medicine of the type called monoamine
oxidase inhibitors (MAOIs). MAOIs typically prescribed are phenelzine, isocarboxazid & tranylcypromine.
Even if you have finished taking the MAOI medicine you will need to wait 2 weeks before starting your
Seror tablets. You must wait at least one day between stopping the reversible monoamine oxidase inhibitor
(RIMA) moclobemide and starting Seror.
If your doctor asks you to take an MAOI you will be asked to stop taking your Seror at least seven days before starting the MAOI. The herbal remedy St John's Wort (Hypericum perforatum) should not be taken at the same time as this medicine. If you already take a St John's Wort preparation stop taking the St John's Wort and mention it to your doctor at your next visit. Please tell your doctor if you are taking, or have recently taken, any other medicines. In particular, tell your doctor if you are taking lithium or tryptophan medication (which is sometimes prescribed for people with depression or for people prone to attacks of mania). Your doctor may monitor lithium levels in your blood more frequently Tell your doctor if you are taking drugs to control fits (anticonvulsants) or if your fits have increased whilst taking Seror, if you are taking insulin or medicines for diabetes (you might need to change your dose of diabetes medicine). Talk to your doctor if you are taking medicines to thin your blood (anticoagulants), aspirin, pain relief medicines called nonsteroidal anti-inflammatory drugs such as ibuprofen or if you have a bleeding disorder. Also let your doctor know if you have a stomach ulcer or have had any bleeding in the stomach or intestine in the past. Serotonergic drugs, such as a medicine used to relieve pain, called tramadol and a migraine medicine called sumatriptan can be taken with Seror. However, if you feel unwell after taking tramadol or sumatriptan do not take these again. Continue to take your Seror and tell your doctor. Unless you have recently discussed this with your doctor, please tell him or her if you have a medical condition (such as a heart problem, epilepsy, liver or kidney complaint).
Taking Seror with food and drink
As with all antidepressants, you should avoid taking alcohol whist receiving treatment.

Pregnancy and breast-feeding
Do not take Seror if you are pregnant or breast-feeding unless you and your doctor have discussed the risks
and benefits involved. If you take this group of medicines (antidepressants) 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: trouble with breathing, stiff or loose muscles, jitteriness, a bluish skin or being too hot or cold. If
your newborn baby gets any of these symptoms please contact your doctor.

Driving and using machines
Seror may affect your ability to make judgements and to react to emergencies. Make sure you are not
affected in this way before you drive or operate machinery. If you are affected in any way, you should NOT
drive or operate machinery.
Important information about some of the ingredients of Seror
Seror contains a small amount of glycerol. At high doses glycerol can be harmful and can cause headache,
stomachache and diarrhoea.
HOW TO TAKE SEROR

Occasionally thoughts of suicide or self-harm may occur, or may increase, in the first few weeks of treatment
for depression, until the antidepressant effect of Seror becomes apparent. Tell your doctor immediately if you
have any distressing thoughts or experiences.
You may also have difficulty in sleeping and feel agitated when you begin treatment with Seror.
Swallow Seror with water. These tablets are taken as a single dose, with or without food, either in the
morning or evening. 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 take it, it may be dangerous to stop the
tablets without medical advice. Your doctor should continue to treat you with Seror until you have been free
of symptoms for 4-6 months. Seror should be withdrawn slowly, gradually reducing the dose over periods of
1-2 weeks.
The usual dosage(s) are described below:
Adults
A low starting dose of 20mg daily is recommended and depending on the response to treatment the dose may
be increased to 40mg daily; however 20mg daily may be sufficient for some patients. The maximum daily
dose is 60mg.
Elderly ( > 65 years of age)
Elderly patients should take half of the recommended dose , that is 10-20mg daily.
Children and adolescents ( < 18 years of age)
Seror should normally not be used for children and adolescents under 18 years except for patients with
depression. 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 medicine. Despite this, your doctor may prescribe Seror for patients under 18
because he/she decides that this is in their best interests. If your doctor has prescribed Seror 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 Seror. Also, the long-
term safety effects concerning growth, maturation and cognitive and behavioural development of Seror in
this age group have not yet been demonstrated.

Kidney Disease
For patients with mild to moderate kidney disease, no dosage adjustment is necessary. However, there is no
information on treatment for patients with severe kidney disease (creatinine clearance < 20 ml/min.).
Liver Disease
A starting dose of 10mg is recommended in patients with liver disease and the maximum daily dose should
not be above 30mg.

If you take more Seror than you should
If you take too many Seror you may feel sleepy, be sick, have seizures or develop a blue discolouration
around your lips, nails or cheeks. If you ever take too many go to the nearest hospital casualty department or
tell your doctor immediately. Take the container and any remaining tablets with you to show to the doctor.
If you forget to take Seror
If you forget to take your medicine, but remember to take it after a short time, take the next tablet normally,
when it is the time to take it. However, if a long delay has occurred (e.g. all day) skip the forgotten dose and
take the next dose the next day at the usual time. Do not take a double or a larger dose to make up with a
forgotten dose (s). Repeated skipping is to be avoided.
If you stop taking Seror
When you stop taking Seror, especially if it is abruptly, you may feel discontinuation symptoms. These are
common when treatment with Seror is stopped. The risk is higher, when Seror has been used for a long time
or in high doses or when the dose is reduced too quickly. Most people find that the symptoms are mild and
go away on their own within two weeks. However, in some patients they may be severe in intensity or they
may be prolonged (2-3 months or more). If you get severe discontinuation symptoms when you stop taking
Seror, please contact your doctor. He or she may ask you to start taking your tablets again and come off them
more slowly.
Discontinuation symptoms include: Feeling dizzy (unsteady or off-balance), feelings like "pins and needles",
burning sensations and (less commonly) electric shock sensations (including in the head), sleep disturbances
(vivid dreams, nightmares, inability to sleep), feeling anxious, headaches, feeling sick (nausea), sweating
(including night sweats), feeling restless or agitated, tremor (shakiness), feeling confused or disorientated,
feeling emotional or irritable, diarrhoea (loose stools), visual disturbances, fluttering or pounding heartbeat
(palpitations).
If you are concerned about any of these effects or get any other unusual effects, tell your doctor immediately.
Please do not be worried. Many people taking this medicine will not experience any problems.
4.
POSSIBLE SIDE EFFECTS

Like all medicines, Seror can cause side effects, although not everybody gets them.
Side effects to Seror are generally mild and short lasting. They usually occur in the first few weeks of
treatment and get better as the depression improves. Difficulty sleeping and agitation often occur at the start
of treatment, these effects may be improved by your doctor starting treatment at a low dose, then increasing
the dose of Seror slowly.
Side effects which can occur after taking Seror include:

Very common side effects (occur 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 side effects (occur in between 1 in 100 and 1 in 10 users):
General effects and effects on the central nervous system: tingling (pins and needles), anxiety, problems with
concentration, confusion, suicide attempts, problems sleeping, abnormal dreams, tiredness, yawning,
abnormalities of vision, migraine, loss of memory, listlessness.
Effects on the cardiovascular system: feeling faint after standing, fast heart rate.
Effects on the digestive system: loss of appetite or aversion to food, increase in appetite, loss of or increase in
weight, indigestion, stomach pain, wind, vomiting, abnormalities of taste, increased salivation.
Effects on the respiratory system: runny nose, sinusitis.
Effects on the genito-urinary system: impotence and problems with ejaculation, reduced libido, problems in
reaching orgasm (women), problems with passing water, passing water frequently, period pains.
Effects on the skin: rash, itching.
Uncommon side effects (occur in between 1 in 1000 and 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, allergic reactions.

Rare (occur in between 1 in 10000 and 1 in 1000 users):
bleeding (in the skin, bruising, stomach and from the vagina), an increased bleeding time and changes in the
salt balance in your body.
Another rare effect is the serotonin syndrome. This is a serious condition that can cause fever, confusion,
abnormal movements, shivering, muscle spasms, agitation and progress to coma or loss of consciousness.
If you experience any of these effects stop taking Seror immediately and seek medical advice.
Other events reported include: hallucinations (seeing things, hearing things or feelings that are not there),
mania, feeling of unreality, panic attacks, production of breast milk, swelling of the lips, eyes or tongue,
severe allergic reaction, joint pain.
If you develop a rash, itching, swelling or have difficulty swallowing or breathing or think you are allergic to
Seror, contact your doctor straight away.


5.
HOW TO STORE SEROR

Keep out of the reach and sight of children.
Store below 250C.
Do not use Seror after the expiry date which is stated on the carton. The expiry date refers to the last day of
that month.
Do not use Seror if you notice visible changes in the appearance of the medicinal product.
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.

6. FURTHER INFORMATION
What Seror contains
-The active substance is citalopram (as citalopram hydrobromide).
-The other ingredients are cellulose microcrystalline, lactose monohydrate, croscarmellose sodium, starch
maize, glycerol, copovidone, magnesium stearate, white sepifilm 752 (consists of hypromellose, cellulose
microcrystalline, polyoxyethylene stearate 40, titanium dioxide (E171)).

What Seror looks like and contents of the pack
Film-coated tablets.
20 mg:
White, oval biconvex, film-coated tablets bearing a scoreline on one side. White, oval biconvex, film-coated tablets bearing a scoreline on one side.
Film-coated tablets are provided in PVC/ PVDC/ Aluminium blisters.
Contents of container: 28 film-coated tablets (in 7 tablets blister packs)
Marketing Authorisation Holder
Specifar S.A.
1, 28 Octovriou str.
Ag Varvara 123 51
Athens-Greece
Manufacturer
Jaba Farmacêutica S.A. Rua da Tapada Grande No 2, Abrunheira, 2710-089 Sintra Portugal The text was revised on 18.09.2008

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