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
- Keep this leaflet. You may need to read it again.
- If you have further questions, please 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 are troubling, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Cipramil is and what it is used for
2. Before you take Cipramil
3. How to take Cipramil
4. Possible side effects
5. How to store Cipramil
6. Further information
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 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 or if you have recurrent depression.
Cipramil is also beneficial in relieving symptoms if you tend to suffer from panic attacks.
Before You Take Cipramil
Do not take Cipramil
- if you are allergic (hypersensitive) to citalopram or to any of the other ingredients of Cipramil (see What Cipramil contains, section 6). Consult your doctor if you think you might be.
- if you are also taking a medicine containing pimozide. Talk to your doctor.
- 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. These medicines are also used for the treatment of depression. 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.
Take special care with Cipramil
Please tell your doctor if you have any medical problems, especially if you have
- Liver disease.
- Severe 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.
- Problems with your eyes, such as certain kinds of glaucoma.
Please consult your doctor, even if these statements were applicable to you at any time in the past.
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.
Taking other medicines
Medicines may affect the action of other medicines and this can sometimes cause serious adverse reactions. Please tell your doctor if you are taking or have taken any other medicines (including those purchased without prescription) during the last 14 days. This includes other medicines for depression (see Do not take Cipramil above).
- 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:
- 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 anti-depressant)
- Pimozide (a neuroleptic). This should not be taken at the same time as Cipramil (see Do not take Cipramil above).
- 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.
Taking Cipramil with food and drink
Cipramil can be taken with or without food.
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 or think you might be pregnant, tell your doctor. Do not take Cipramil if you are pregnant 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.
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.
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.
Driving and using machines
Cipramil does not usually affect the ability to carry out normal daily activities. However, you should be careful when driving, operating machinery or performing jobs that need you to be alert.
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.
How To Take Cipramil
How much to take
It is important to take your tablets as instructed by your doctor.
The label will tell you how many to take and how often. If it does not, or you are not sure, ask your doctor or pharmacist.
Adults
Depression
The usual dose is 20 mg per day. This may be increased by your doctor to a maximum of 60 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 60 mg per day.
Elderly patients (above 65 years of age)
The usual dose is 20 mg per day. This may be increased by your doctor to a maximum of 40 mg per day.
Children and adolescents (< 18 years)
Cipramil is not recommended for children or adolescents. For further information, please see section 2, Before you take Cipramil.
Patients with special risks
Patients with liver problems should not receive more than 30 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.
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 casualty 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.
Symptoms of overdosage may include:
- Nausea (feeling sick)
- Vomiting
- Sweating
- Drowsiness
- Seizures
- Unconsciousness
- Fast heart beats
- Tremor
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. 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.
Cipramil Tablets Side Effects
Like all medicines, Cipramil can have side effects and some people may experience unwanted effects (side effects) whilst taking Cipramil. Several of the effects listed below can also be symptoms of your illness and may disappear as you start to get better.
Serious side effects
Stop taking Cipramil and seek medical advice immediately if you have any of the following allergic reactions:
- 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).
If you notice any of the following 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.
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.
- Vomiting (sickness)
- Nausea (feeling sick),
- Lack of appetite,
- Diarrhoea,
- Tiredness,
- Dry mouth,
- Sweating,
- Drowsiness.
Other side effects associated with Selective Serotonin Reuptake Inhibitors (SSRIs) like Cipramil include:
- Disturbed sleep
- Dizziness
- Feeling faint or light-headed on standing up
- Disturbed vision
- Large pupils (the dark centre of the eye)
- Tremor
- Movement disorders
- Restlessness
- Fits
- Difficulty passing urine
- Feeling thirsty with an increased need to pass urine
- Low blood sodium
- Allergic reactions e.g. rashes
- Itching or inflammation of the mouth or tongue
- Muscle and joint aches
- Mild liver disorder
- Reduced sexual performance
- Headache
- Weakness/lack of strength
- Change in sleeping pattern.
- Migraine
- Constipation
- Palpitations
- Taste disturbance
- Difficulty concentrating
- Loss of memory
- Loss of appetite
- Reduced emotions, indifference
- Indigestion
- Stomach pain
- Flatulence (wind)
- Too much saliva in the mouth
- Runny nose
- Increased sexual drive
- Coughing
- Feeling out-of-sorts
- Sensitivity to sunlight
- An increased risk of bone fractures has been observed in patients taking this type of medicines
Very rarely, some patients may find that they have an increased tendency to develop rashes when exposed to the sun.
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 notice any other side effects not mentioned in this leaflet please tell your doctor or pharmacist.
How To Store Cipramil
- Always keep medicines out of reach and sight of children.
- Store your tablets at or below 25°C (room temperature).
- There is an expiry date on the label. Do not use the medicine after this date.
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 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:
For any information about this medicine, please contact the Marketing Authorisation holder:
This leaflet was last approved in 07/2010
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