CIPRAMIL 10MG FILM-COATED TABLETS

Active substance: CITALOPRAM HYDROBROMIDE

View full screen / Print PDF » Download PDF ⇩

Transcript
Package leaflet: Information for the user

Cipramil® 10 mg film-coated tablets
Cipramil® 20 mg film-coated tablets
Cipramil® 40 mg film-coated tablets
citalopram (as hydrobromide)
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, please 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 you doctor or pharmacist. This
includes any possible side effects not listed in this leaflet.

What is in this leaflet:
1.
2.
3.
4.
5.
6.

What Cipramil is and what it is used for
What you need to know before you take Cipramil
How to take Cipramil
Possible side effects
How to store Cipramil
Contents of the pack and other information

1. What Cipramil is and what it is used for
How does Cipramil work?
Cipramil is a Selective Serotonin Reuptake Inhibitor (SSRI) and belongs to
a group of medicines known as antidepressants. These medicines help
to correct certain chemical imbalances in the brain that are causing the
symptoms of your illness.
What is Cipramil used for?
Cipramil contains citalopram and is used for the treatment of depression
and, when you feel better, to help prevent these symptoms recurring.
Cipramil is also used for long-term treatment to prevent the occurrence of
new episodes of depression if you have recurrent depression.
Cipramil is also beneficial in relieving symptoms if you tend to suffer from
panic attacks.

2. What you need to know before you take Cipramil
Do not take Cipramil
• if you are allergic to citalopram or to any of the other ingredients of
this medicine (listed in section 6). Consult your doctor if you think you
might be.
• at the same time as taking medication known as monoamine
oxidase inhibitors (MAOIs). MAOIs include medicines such as
phenelzine, iproniazid, isocarboxazid, nialamide, tranylcypromine
and moclobemide (used for the treatment of depression), selegiline
(used in the treatment of Parkinson’s disease) and linezolid (an
antibiotic). Even if you have finished taking one of the following
MAOIs: phenelzine, iproniazid, isocarboxazid, nialamide or
tranylcypromine you will need to wait 2 weeks before you start taking
your Cipramil tablets. One day must elapse after you have finished
taking moclobemide. After stopping Cipramil you must allow 1 week
before taking any MAOI.
• if you are born with or have had an episode of abnormal heart rhythm
(seen at ECG; an examination to evaluate how the heart is functioning).
• if you take medicines for heart rhythm problems or that may affect the
heart’s rhythm (see Other medicines and Cipramil below).

000000

Warnings and precautions
Please tell your doctor if you have any medical problems, especially if you
have
• Liver disease.
• Kidney disease.
• Diabetes (you may need an adjustment of your antidiabetic therapy).
• Epilepsy or a history of seizures or fits.
• A bleeding disorder or have ever suffered from bleeding in the stomach
or intestine.
• Mania or panic disorder
• Low blood levels of sodium
• ECT (electroconvulsive therapy)
• Problems with your eyes, such as certain kinds of glaucoma.
• Suffered or suffer from heart problems or have recently had a heart
attack.
• A low resting heart-rate and/or you know that you may have salt
depletion as a result of prolonged severe diarrhoea and vomiting
(being sick) or usage of diuretics (water tablets).
• Experienced a fast or irregular heartbeat, fainting, collapse or dizziness
on standing up which may indicate abnormal functioning of the heart
rate.
Please consult your doctor, even if these statements were applicable to
you at any time in the past.
Please note:
Some patients with manic-depressive illness may enter into a manic
phase. This is characterized by unusual and rapidly changing ideas,
inappropriate happiness and excessive physical activity. If you experience
this, contact your doctor.
Symptoms such as restlessness or difficulty in sitting or standing still
can also occur during the first weeks of the treatment. Tell your doctor
immediately if you experience these symptoms.
Special information relating to your disease
As with other medicines used to treat depression or related diseases,
the improvement is not achieved immediately. After the start of
Cipramil treatment it may take several weeks before you experience any
improvement. In the beginning of the treatment certain patients may
experience increased anxiety, which will disappear during continued
treatment. Therefore, it is very important that you follow exactly your
doctor’s orders and do not stop the treatment or change the dose without
consulting your doctor.
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.
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.

Use in children and adolescents under 18 years of age
Cipramil 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 interests. If your doctor has prescribed Cipramil 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 Cipramil. Also, the
long-term safety effects concerning growth, maturation and cognitive and
behavioural development of Cipramil in this age group have not yet been
demonstrated.
Other medicines and Cipramil
Medicines may affect the action of other medicines and this can
sometimes cause serious adverse reactions. Please tell your doctor
or pharmacist if you are taking, have taken or might take any other
medicines. This includes other medicines for depression (see Do not take
Cipramil above).

GB-615215 (069-22) REG
0640

• The herbal remedy St John’s wort (Hypericum perforatum). This should
not be taken at the same time as Cipramil.
• Monoamine oxidase inhibitors (MAOIs). These should not be taken at
the same time as Cipramil (see Do not take Cipramil above).
Tell your doctor if you are taking any of the following medicines:
• Linezolid (an antibiotic).
• Sumatriptan (used to treat migraine) or tramadol (a pain killer). If you
feel unwell when using these medicines with Cipramil you should see
your doctor.
• Lithium (used to prevent and treat mania) and tryptophan (an antidepressant).
• Pimozide (a neuroleptic). This should not be taken at the same time as
Cipramil.
• Imipramine and desipramine (used to treat depression).
• Medicines containing selegiline (used to treat Parkinson’s disease)
• Cimetidine (used to treat stomach ulcers).
• Mefloquine (used to treat malaria).
• Bupropion (used to treat depression).
• Medicines known to affect the blood platelets (e.g. anticoagulant
drugs used to treat or prevent blood clots; aspirin and non-steroidal
anti-inflammatory drugs (NSAIDs) such as ibuprofen and diclofenac
used as painkillers and some antipsychotic drugs and tricyclic
antidepressants).
• Metoprolol, a beta blocker used to treat migraine, some heart
conditions and high blood pressure. The effects of either drug could be
increased, decreased or altered.
• Neuroleptics (used in the treatment of schizophrenia).

190x400

GB-615214 (069-22) /126266

Black

000000

GB-615215 REG

2014-04-15 / 12:30 / HESP

Do not take Cipramil if you take medicines for heart rhythm problems or
medicines that may affect the heart’s rhythm, e.g. such as Class IA and III
antiarrhythmics, antipsychotics (e.g. phenothiazine derivatives, pimozide,
haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g.
sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, anti-malarial
treatment particularly halofantrine), certain antihistamines (astemizole,
mizolastine). If you have any further questions about this you should
speak to your doctor.
Taking Cipramil with food, drink and alcohol
Cipramil can be taken with or without food (see section 3 “How to take
Cipramil”).
As with all antidepressants, it is sensible to avoid drinking alcohol whilst
receiving treatment although Cipramil has not been shown to increase
the effects of alcohol.
Pregnancy
Ask your doctor or pharmacist for advice before taking any medicine. If
you are pregnant, think you might be pregnant, or are trying to become
pregnant, tell your doctor. Do not take Cipramil if you are pregnant unless
you and your doctor have discussed the risks and benefits involved.
Make sure your midwife and/or doctor know you are on Cipramil. When
taken during pregnancy, particularly in the last 3 months of pregnancy,
medicines like Cipramil may increase the risk of 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/or doctor
immediately. Also, if you take Cipramil 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 hot or cold,
feeding difficulties, vomiting, low blood sugar, stiff or floppy 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/or doctor immediately.
Breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
If you are breast-feeding, ask your doctor for advice. You should not
breast-feed your baby when taking Cipramil because small amounts of the
medicine can pass into the breast milk.
Fertility
Citalopram 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
Cipramil does not usually affect the ability to carry out normal daily
activities. However, if you feel dizzy or sleepy when you start to take this
medicine, you should be careful when driving, operating machinery or
performing jobs that need you to be alert until these effects wear off.
Important information about some of the ingredients of Cipramil
This product contains lactose.
If you have been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicinal product.

3. How to take Cipramil
How much to take
Always take this medicine exactly as your doctor or pharmacist has told
you. Check with your doctor or pharmacist if you are not sure.
Adults
Depression
The usual dose is 20 mg per day. This may be increased by your doctor to a
maximum of 40 mg per day.
Panic disorder
The starting dose is 10 mg per day for the first week before increasing the
dose to 20-30 mg per day. The dose may be increased by your doctor to a
maximum of 40 mg per day.
Elderly patients (above 65 years of age)
The starting dose should be decreased to half of the recommended dose,
e.g. 10-20 mg per day. Elderly patients should not usually receive more
than 20 mg per day.

2
6

Children and adolescents (less than 18 years of age)
Cipramil should not be given to children or adolescents. For further
information, please see section 2, What you need to know before you
take Cipramil.
Patients with special risks
Patients with liver complaints should not receive more than 20 mg per day.
How and when to take Cipramil
Cipramil is taken every day as a single daily dose. Cipramil can be taken
any time of the day with or without food. Swallow the tablets with a drink
of water. Do not chew them (they have a bitter taste).
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 Cipramil
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 for a long time and if you
stop your treatment too soon your symptoms may return.
Patients who have recurrent depression benefit from continued treatment,
sometimes for several years, to prevent the occurrence of new depressive
episodes.
Never change the dose of the medicine without talking to your doctor first.
If you take more Cipramil than you should
If you think that you or anyone else may have taken too many Cipramil
tablets contact your doctor or nearest hospital emergency department
immediately. Do this even if there are no signs of discomfort or poisoning.
Take the Cipramil box/container with you if you go to a doctor or hospital.
Some of the signs of an overdosage could be life-threatening.
Symptoms of overdosage may include:
• Irregular heart beat
• Seizures
• Changes in heart rhythm
• Feeling sick (nausea)
• Vomiting
• Sweating
• Drowsiness
• Unconsciousness
• Fast heart beats
• Tremor
• Changes in blood pressure
• Serotonin syndrome (see Section 4)
• Agitation
• Dizziness
• Enlarged eye pupils
• Bluish skin
• Breathing too quickly
If you forget to take Cipramil
If you forget to take a dose, take the next dose at the usual time. Do not
take a double dose.
Effects when treatment with Cipramil is stopped
Stopping this medicine quickly may cause symptoms such as dizziness,
nausea and numbness or tingling in hands or feet, sleep disturbances
(vivid dreams, nightmares, inability to sleep), feeling anxious, headaches,
feeling or being sick, sweating, feeling restless or agitated, tremor,
feeling confused or disorientated, feeling emotional or irritable, diarrhoea
(loose stools), visual disturbances, fluttering or pounding heartbeat
(palpitations). These are usually non-serious and disappear within a few
days. When you have completed your course of treatment, the dose of
Cipramil is usually reduced gradually over a couple of weeks.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.

4. Possible side effects
Like all medicines this medicine can cause side effects, although not
everybody gets them. Several of the effects listed below can also be
symptoms of your illness and may disappear as you start to get better.

000000

Serious side effects
Stop taking Cipramil and seek medical advice immediately if you have any
of the following symptoms:
• Difficulty in breathing.
• Swelling of the face, lips, tongue or throat that causes difficulty in
swallowing or breathing.
• Severe itching of the skin (with raised lumps).
• Fast, irregular heart beat, fainting which could be symptoms of a
life-threatening condition known as torsades de pointes.
If you notice any of the following symptoms you should contact your doctor
immediately as your dose may need to be reduced or stopped:
• You start having fits for the first time or fits that you have suffered from
in the past become more frequent.
• Your behaviour changes because you feel elated or over excited.
• You experience high fever, agitation, confusion, trembling or abrupt
contractions of muscles. These may be signs of a rare condition called
serotonin syndrome.
• Tiredness, confusion and twitching of your muscles. These may be
signs of a low blood level of sodium (hyponatraemia).
If you have thoughts of harming or killing yourself at any time, contact
your doctor or go to a hospital straight away.
The following side effects are often mild and usually disappear after a few
days’ treatment.
The following side effects are often mild and usually disappear after a
few days’ treatment.
Very common side effects (may affect more than 1 in 10 people)
• Sleepiness
• Difficulty in sleeping
• Headache
• Changes in your sleeping pattern
• Loss of body strength, weakness
• Increased sweating
• Dry mouth (a dry mouth increases the risk of tooth decay, so be sure
to clean your teeth more often than usual)
• Feeling sick (nausea)
Common side effects (may affect up to 1 in 10 people)
• Lack of appetite
• Agitation
• Decreased sex drive
• Anxiety
• Nervousness
• Confusion
• Abnormal dreams
• Reduced emotions, indifference (apathy)
• Tremor
• Tingling or numbness in the hands or feet
• Dizziness
• Problems concentrating
• Migraine

• Loss of memory (amnesia)
• Ringing in the ears (tinnitus)
• Palpitations
• Yawning
• Blocked or runny nose (rhinitis)
• Diarrhoea
• Vomiting
• Constipation
• Stomach pain
• Flatulence (wind)
• Increase in saliva (drooling)
• Itching
• Pain in muscles and joints
• For men, problems with ejaculation and erection
• For women, failing to reach an orgasm
• Tiredness
• Prickling of the skin
• Loss of weight
Uncommon (may affect up to 1 in 100 people)
• Bruising easily
• Increased appetite
• Aggression
• Hallucinations
• Mania
• Fainting
• Large pupils (the dark centre of the eye)
• Fast heart beat
• Slow heart beat
• Nettle rash
• Loss of hair
• Rash
• Sensitivity to sunlight
• Difficulties urinating
• Excessive menstrual bleeding
• Swelling of the arms or legs
• Increased weight
Rare (may affect up to 1 in 1000 people)
• Increased sex drive
• Convulsions
• Involuntary movements
• Taste disturbances
• Bleeding
• Coughing
• Hepatitis
• Feeling unwell (malaise)
Some patient have reported (frequency not known)
• Thoughts of harming or killing themselves, see also section 2 “What
you need to know before you take Cipramil“
• An increase in bleeding or bruising caused by a decrease in blood
platelets (thrombocytopenia)
• Rash (hypersensitivity)
• Low potassium levels in the blood (hypokalaemia), which can cause
muscle weakness, twitching or abnormal heart rhythms
• Panic attack
• Grinding teeth
• Restlessness
• Unusual muscle movements or stiffness
• Involuntary movements of the muscles (akathisia)
• Low blood pressure
• Nosebleed
• Bleeding disorders including skin and mucosal bleeding
(ecchymosis)
• Sudden swelling of skin or mucosa
• In men, painful erections
• Flow of breast milk in men or in women who are not breast-feeding
(galactorrhoea)
• Irregular menstrual periods
• Abnormal liver function tests
• An increased risk of bone fractures has been observed in patients
taking this type of medicines
• Abnormal heart rhythm
SSRIs can, very rarely, increase the risk of bleeding, including stomach or
intestinal bleeding. Let your doctor know if you vomit blood or develop
black or blood stained stools.
Also let your doctor know if you continue to have other symptoms
associated with your depression. This might include hallucinations,
anxiety, mania or confusion.
Any side effects that do occur will usually disappear after a few days. If
they are troublesome or persistent, or if you develop any other unusual
side effects while taking Cipramil, please tell your doctor.
If you get any side effects please talk to your doctor or pharmacist. This
includes any possible side-effects not mentioned in this leaflet.

5. How to store Cipramil
• Always keep this medicine out of the sight and reach of children.
• Store your tablets at or below 25°C (room temperature).
• Do not use this medicine after the expiry date which is stated on the
label or carton. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use.
These measures will help to protect the environment.

6. Contents of the pack and other information
What Cipramil contains
The active substance is citalopram (as hydrobromide). Each Cipramil
film-coated tablets contain 10 mg, 20 mg, or 40 mg citalopram.
The other ingredients are maize starch, lactose monohydrate,
microcrystalline cellulose, copovidone, glycerol, croscarmellose sodium,
magnesium stearate, methylhydroxypropyl-cellulose, macrogol and the
white colour E 171 (titanium dioxide).
What Cipramil looks like and contents of the packs
The 10 mg tablets are round, white, film-coated, marked “CL”.
The 20 mg tablets are oval, white, scored, film-coated, marked with “C”
and “N”.
The 40 mg tablets are oval, white, scored, film-coated, marked with “C”
and “R”.
All the strengths are available in blister packs of 28 tablets.
These tablets are manufactured by:
H. Lundbeck A/S - Ottiliavej 9 - 2500 Valby - Denmark
For any information about this medicine, please contact the Marketing
Authorisation holder:
Lundbeck Limited
Lundbeck House
Caldecotte Lake Business Park
Caldecotte
Milton Keynes MK7 8LG
UK
This leaflet was last revised in 04/2014

000000

GB-615215 REG

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web3)