10 mg, 20 mg film-coated tablets
Citalopram
What Cipramil is and what it is used for
Cipramil belongs to a group of antidepressant medicines called selective serotonin reuptake inhibitors ( SSRIs ). These drugs affect the serotonin system in the brain by increasing serotonin levels. Disorders of the serotonin system are considered an important factor in the development of depression and related diseases.
Cipramil contains citalopram and is used to treat depression, panic disorder, obsessive-compulsive disorder and to prevent relapse or new episodes of depression. Your doctor may have prescribed Cipramil for another illness. Ask your doctor if you have any questions about why Cipramil has been prescribed for you.
2. What you need to know before you use Cipramil
Do not use Cipramil
- if you are allergic to citalopram or any of the other ingredients of Cipramil (listed in section 6).
- if you are taking other medicines that belong to a group called MAO inhibitors. For MAO inhibitors include drugs such as phenelzine, iproniazide, isocarboxazid, nialamide, tranylcypromine, selegiline (used for the treatment of Parkinson’s disease ), moclobemide (used to treat depression) or linezolid (an antibiotic ).
- if you have been born with or have had a period of abnormal heart rhythm (as observed with ECG, a method that examines how the heart works).
- if you are taking medicines for heart rhythm problems or that may affect your heart rhythm (see section 2 “Other medicines and Cipramil”).
Even if you have stopped taking MAOIs, you will have to wait 2 weeks before you can start treatment with Cipramil.
One day must pass after you stop taking the drug moclobemide before you can start treatment with Cipramil.
After stopping treatment with Cipramil, you must wait 1 week before taking any MAOI.
Warnings and cautions
Talk to your doctor or pharmacist before taking Cipramil. Tell your doctor if you have other diseases. This is especially true:
- if you have episodes of mania or panic disorder.
- if you have impaired liver or kidney function. Your doctor may need to adjust the dose of Cipramil.
- if you have an increased tendency to bleed, or if you are pregnant (see “Pregnancy, breast-feeding and fertility”)
- if you have diabetes. Treatment with Cipramil may affect your blood sugar level. The dose of one of the insulin and/or blood sugar-lowering tablets may need to be changed.
- if you have epilepsy. Cipramil treatment should be discontinued if you experience seizures or if the seizures occur at more frequent intervals (see section 4 “Possible side effects”).
- if you have decreased levels of sodium in your blood.
- if you are receiving treatment with electric shocks.
- if you suffer from psychosis is. Treatment of psychotic patients with depressive episodes may worsen the psychotic symptoms.
- if you suffer from or have suffered from heart problems or recently had a heart attack.
- if you have a low resting heart rate and/or know that you have a salt deficiency due to prolonged severe diarrhea and vomiting or the use of diuretics ( diuretics ).
- if you experience a fast or irregular heartbeat, fainting, collapse, or dizziness when you get up, which may indicate abnormal functioning of the heartbeat.
- if you have or have had eye problems, e.g. different types of glaucoma (increased pressure in the eyes).
Note!
Some patients with manic-depressive illness may go into a manic phase. This is characterized by unusual and rapidly changing thoughts, unmotivated joy, and excessive physical activity. Contact your doctor if you experience these symptoms.
Symptoms such as restlessness and difficulty sitting or standing still can also occur during the first weeks of treatment. Contact your doctor immediately if you experience these symptoms.
Children and young people
Cipramil should not normally be used in the treatment of children and adolescents under 18 years of age. The risk of side effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, defiance, and anger) is greater in patients under 18 years of age when taking drugs of this type. Despite this, Cipramil can be prescribed by a doctor to patients under 18 years of age, if the doctor deems it appropriate. If you are under 18 years of age and want to discuss why you were given this medicine, consult your doctor again. You should also tell your doctor if you notice any of the above symptoms or if they get worse. The long-term effects on growth, maturity, and cognitive and behavioral development have not yet been established for children and adolescents under 18 years of age.
Drugs such as Cipramil (so-called SSRIs / SNRIs) can cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after discontinuation of treatment.
If you start to feel worse and have thoughts of harming yourself
You who are depressed and/or suffer from worry/anxiety may sometimes have thoughts of harming yourself or committing suicide. These symptoms may worsen when you start using antidepressants, as it takes time for this type of medicine to take effect, usually about 2 weeks, sometimes longer.
These thoughts may be common:
- if you have previously had thoughts of harming yourself or committing suicide
- if you are younger than 25 years. Studies have shown that young adults (younger than 25 years) with mental illness who are treated with antidepressant drugs have an increased risk of suicidal thoughts and thoughts of harming themselves.
Contact a doctor as soon as possible or see the nearest hospital if you have thoughts of injuring yourself or committing suicide.
It may be helpful to tell a relative or close friend that you are depressed and/or suffering from anxiety. Feel free to ask them to read this leaflet. You can also ask them to tell you if they think you are feeling worse or if they think your behavior is changing.
Other medicines and Cipramil
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines. The treatment effect may be affected if this medicine is taken at the same time as certain other medicines.
Be especially careful to tell your doctor about the following medications:
- Non-selective monoamine oxidase inhibitors ( MAOIs ) containing phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine as active substance. If you have taken any of these medicines, you must wait 14 days before starting Cipramil. After stopping treatment with Cipramil, you must wait 7 days before taking any of these medicines.
- Reversible, selective MAO-A inhibitors containing moclobemide (antidepressants).
- Linezolid, an antibiotic .
- Lithium (medicine for manic depressive illness) and tryptophan.
- Imipramine and desipramine (antidepressants).
- Irreversible MAO-B inhibitors containing selegiline (medicines for Parkinson’s disease ). These increase the risk of side effects .
- Metoprolol (medicine for high blood pressure and cardiovascular disease). Doseone of Cipramil may need to be adjusted.
- Sumatriptan and similar medicines (medicines for migraines ) and tramadol (medicines for severe pain). These increase the risk of side effects .
- Cimetidine, lansoprazole and omeprazole (used to treat stomach ulcers ), fluconazole (used to treat fungal infections), and fluvoxamine (antidepressant) and ticlopidine (used to reduce the risk of blood clots). These can cause increased levels of citalopram in the blood.
- Drugs that increase the risk of bleeding, e.g. anticoagulants (medicines that inhibit the ability of the blood to clot), NSAIDs (medicines for pain and/or inflammation) (eg ticlopidine and dipyridamole) and salicylic acid derivatives (eg acetylsalicylic acid ) can cause skin and mucous membrane bleeding if given at the same time with Cipramil.
- (Traditional) herbal medicines containing St. John’s wort (Hypericum perforatum). St. John’s wort may increase the risk of side effects .
- Mefloquine (anti- malarial drug ) and bupropion (anti-depressant and anti-smoking drug) due to a possible risk of lowering the seizure threshold.
- Neuroleptics (medicines for schizophrenia, psychosis ) due to a possible risk of lowering the seizure threshold, and antidepressants.
- Drugs that lower blood levels of potassium or magnesium, as these conditions increase the risk of severe heart rhythm disorders.
Do not take Cipramil if you are taking medicines for heart rhythm problems or medicines that can affect your heart rhythm, such as Class 1A and III antiarrhythmics, antipsychotics (eg phenothiazine, pimozide, haloperidol ), tricyclic antidepressants, certain antimicrobial medicines (eg sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, treatment for malaria, especially halofantrine), certain antihistamines(astemizole, mizolastine). If you have any further questions on the use of this product, ask your doctor.
Cipramil with food, drink and alcohol
Cipramil can be taken with or without food (see section 3 “How to use Cipramil”).
As with many other medicines, the use of alcohol during treatment with Cipramil is not recommended, although Cipramil is not expected to interact with alcohol.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Abrupt discontinuation of treatment should be avoided during pregnancy.
If you are taking Cipramil during the last three months before delivery, you should be aware that the following symptoms may be seen in your newborn: difficulty breathing, bluish skin, cramps, difficulty regulating body temperature, difficulty breastfeeding, vomiting, low blood sugar, tense or slack muscles, overactive reflexes, tremors, jerkiness, irritability, listlessness, persistent crying, increased sleepiness and difficulty sleeping. These symptoms are transient. If your child gets any of these symptoms, contact your doctor or midwife as soon as possible.
Tell your midwife or doctor that you are taking Cipramil. When similar drugs such as Cipramil are used during pregnancy, especially during the last three months, they may increase the risk of a serious condition called persistent pulmonary hypertension in the newborn (PPHN). This condition causes the baby to breathe faster and look blue. The symptoms usually appear within 24 hours of the baby being born. If this affects your baby, contact a midwife or doctor immediately.
If you take Cipramil at the end of your pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should be informed that you are taking Cipramil so that they can advise you on this.
Citalopram passes into breast milk. There is a risk that a breastfed baby may be affected. Do not use Celexa during lactation except on certain prescriptions from the doctor.
In animal studies, citalopram has been shown to reduce sperm quality. In theory, this could affect fertility, but no such degrading effect of citalopram on fertility has yet been demonstrated in humans.
Driving and using machines
Cipramil may impair the ability of some people to react, which should be taken into account at times when increased attention is required, e.g. driving and other precision work.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Cipramil contains Lactose
The tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to use Cipramil
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Adults
Depression
The usual dose is 20 mg once a day. Your doctor may increase the dose one to a maximum of 40 mg per day.
Panic disorder
The starting dose is 10 mg once daily for the first week, after which the dose can be increased to 20-30 mg per day. Your doctor may increase the dose to a maximum of 40 mg per day.
Obsessive-compulsive disorder
The starting dose is 20 mg once daily. Your doctor may increase the dose to a maximum of 40 mg per day. The effect can be seen after 2-4 weeks and further improvement is seen during continued treatment.
Preventive treatment
In preventive treatment, the treatment time is individual, often years. When treatment is stopped, it should be done under close supervision to avoid recurrence.
Elderly patients (over 65 years)
The starting dose should be half of the recommended dose, ie 10-20 mg daily. Elderly patients should not usually be treated with more than 20 mg daily.
Patients at particular risk
Patients with hepatic impairment should not be treated with more than 20 mg daily.
Children and adolescents (under 18 years)
Cipramil should not be given to children and adolescents under 18 years of age. For more information, see section 2 “Before using Cipramil”.
Cipramil is taken once a day, at any time of the day, with or without food. Swallow the tablets with half a glass of water.
If you have the impression that the effect of Cipramil is too strong or too weak, talk to your doctor or pharmacist.
Once you have started taking Cipramil
Like other medicines of this type, Cipramil does not provide immediate relief of symptoms, but generally only after a few weeks.
Do not change the dosage one without first talking to your doctor.
Keep taking Cipramil for as long as your doctor recommends it. If you stop treatment too soon, the symptoms may return. It is recommended that you continue treatment for at least 6 months after feeling well again. The underlying disease may persist for a long time and if you stop treatment too soon, the symptoms may return.
Patients with recurrent depression may need to be treated for several years to avoid relapse.
Signs of overdose may include life-threatening irregular heartbeat, seizures, disturbed heart rhythm, drowsiness, coma, vomiting, tremors, decreased blood pressure, increased blood pressure, nausea, serotonergic syndrome (see section 4), agitation, dizziness, enlarged pupils, sweating, bluish ski, hyperventilation.
If you forget to use Cipramil
Do not take a double dose to make up for a forgotten dose . If you forget to take a dose and you remember this before going to bed, take one dose at a time. Continue as usual the next day. If you forget during the night or the next day that you have missed a dose, do not miss the dose and continue as usual.
If you stop taking Cipramil
Do not stop taking Cipramil until your doctor tells you to. Usually, your doctor will advise you to slowly reduce your dose for a few weeks. When you stop taking Cipramil and especially if it happens quickly, there is a risk of so-called withdrawal symptoms.
If you stop using Cipramil
Withdrawal symptoms at the end of treatment
So-called withdrawal symptoms are common when treatment with Cipramil is stopped. The risk may be increased if Cipramil has been used for a longer period of time or in higher doses, or if the dose has been reduced too quickly. In most cases, these symptoms are transient within two weeks.
Your doctor may recommend that you reduce the dose gradually. If it is not gradually reduced, the risk of withdrawal symptoms is greater. Contact a doctor if you experience severe withdrawal symptoms after stopping treatment. Your doctor may ask you to start taking the tablets again, then to discontinue them more slowly. If you experience withdrawal symptoms, this does not mean that you are addicted or will not be able to stop taking Cipramil.
Withdrawal symptoms: dizziness (feeling unsteady or difficult to balance), sensory disturbances such as ant crawling, burning sensation and, less commonly, feeling of electric shock (including such feelings in the head), sleep disturbances (with vivid dreams, nightmares, inability to sleep), feeling of anxiety, headache, nausea, sweating (including night sweats), feeling of restlessness or agitation, tremor(tremors), feeling confused or disoriented, emotional instability or irritability, diarrhea, visual disturbances, palpitations.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some patients have reported the following serious side effects. If you experience any of the following symptoms, stop taking Cipramil and contact your doctor immediately:
Has been reported (occurs in the unknown number of users):
- High fever, anxiety, confusion, tremors and sudden muscle contractions: may be signs of a rare condition called serotonergic syndrome that has been reported with the concomitant use of several antidepressants.
- If you experience swelling of the skin, tongue, lips, or face, or have difficulty breathing or swallowing ( angioedema ).
- Bleeding in the stomach or intestines.
- Fast, irregular heartbeat, and fainting, which can be symptoms of a life-threatening condition known as Torsade de Pointes.
Rare (may affect up to 1 in 1,000 people):
- Hyponatremia: low blood sodium levels which can cause fatigue, confusion, and muscle twitching.
The following side effects are usually mild and disappear after a few days of treatment. Be aware that several of the symptoms may also be due to your illness and therefore will subside as you begin to feel better. Contact your doctor if any of the side effects are bothersome or last longer than a few days.
Dry mouth increases the risk of caries. You should brush your teeth more often than usual.
Very common (may affect more than 1 user in 10):
- Somnolence
- Difficulty sleeping
- Increased sweating
- Dry mouth
- Nausea
- Headache
Common (may affect up to 1 in 10 people):
- Decreased appetite
- Agitation
- Decreased sexual desire
- Anxiety
- Nervousness
- Confusion
- Unusual dreams
- Tremors
- Stinging sensation or numbness in hands and feet
- Dizziness
- Affected level of consciousness
- Earrings ( tinnitus )
- Yawning
- Diarrhea
- Vomiting
- Constipation
- Itching
- Muscle and joint pain
- Men may experience problems with ejaculation and erection
- Women may experience difficulty reaching orgasm
- Fatigue
- Stinging sensation in the skin
- Weight loss
Uncommon (may affect up to 1 in 100 people):
- Bleeding in the skin (bruising easily)
- Increased appetite
- Aggression
- Depersonalization
- Hallucinations
- Mania
- Fainting
- Enlarged pupils you
- Palpitation
- Slow heartbeat
- Hives
- Hair loss
- Rash
- Photosensitivity
- Difficulty urinating
- Abundant menstrual bleeding
- Swollen arms and legs
- Weight gain
Rare (may affect up to 1 in 1,000 people):
- Cramps
- Involuntary movements
- Taste change
- Bleeding
- Hepatitis
- Fever
Has been reported (occurs in an unknown number of users):
- Thoughts of self-harm or suicide, see also section 2 “Warnings and Precautions”
- Reduced platelet count, which increases the risk of bleeding and bruising
- Hypersensitivity (rash)
- A severe allergic reaction which causes difficulty breathing and dizziness
- Increased urine output
- Hypokalaemia: low potassium levels which can cause muscle weakness, twitching and affected heart rhythm
- Panic attacks
- Tooth grinding
- Restlessness
- Unusual muscle movements or stiffness
- Akathisia (involuntary muscle movements)
- Visual disturbances
- Low blood pressure
- Nasal blood
- Bleeding diseases including skin and mucous membrane bleeding ( ecchymosis )
- Severe vaginal bleeding shortly after delivery ( postpartum hemorrhage), see “Pregnancy, breast-feeding and fertility” in section 2 for more information.
- Sudden swelling of the skin and mucous membranes
- Painful erection er
- The flow of breast milk in men
- Irregular menstruation
- Abnormal liver function values
- An increased risk of bone fractures has been seen in patients taking this type of drug
- Disorders of the heart rhythm
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store Cipramil
Cipramil should not be stored above 25 ° C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified 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.
6. Contents of the packaging and other information
Content declaration
The active substance is citalopram (as hydrobromide). Each tablet contains citalopram hydrobromide equivalent to 10 mg and 20 mg citalopram respectively (as citalopram hydrobromide).
The other ingredients are corn starch, lactose monohydrate, microcrystalline cellulose, copovidone, glycerol 85%, croscarmellose sodium, magnesium stearate.
Coating: hypromellos 5, macrogol 400.
Color: titanium dioxide (E171).
What the medicine looks like and the contents of the pack
Cipramil is available as 10 mg and 20 mg film-coated tablets.
The tablets have the following appearance:
10 mg: Round, white, marked with CL on one side.
20 mg: Oval, white, notched marked C and N symmetrically at the incision.
Cipramil is available in the following pack sizes:
10 mg: Blister pack of 98 tablets.
20 mg: Blister pack of 98 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
H. Lundbeck A / S
Ottiliavej 9
DK-2500 Valby
Denmark
Agent
H. Lundbeck AB
Slagthuset
211 20 Malmö
Tel: 040-699 82 00