10 mg, 20 mg, 30 mg and 40 mg film-coated tablets

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

– Save this information, 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 only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information.

In this leaflet: 
1. What Citalopram Mylan is and what it is used for 
2. What you need to know before you use Citalopram Mylan 
3. How to use Citalopram Mylan 
4. Possible side effects 
5. How to store Citalopram Mylan 
6. Other information

What Citalopram Mylan is and what it is used for

What is Citalopram Mylan used for?

Citalopram Mylan belongs to the group of selective serotonin reuptake inhibitors ( SSRIs ). This type of medicine corrects the chemical imbalance in the brain that causes the symptoms of your disease. Depression / panic disorder is considered to be due to a lack of various neurotransmitters in the brain, including serotonin. Citalopram increases the level of serotonin.

Citalopram Mylan is used to treat depression and prevent recurrence of depression and to treat panic disorder with or without agoraphobia (fear of public places or situations).

What you need to know before you use Citalopram Mylan

Do not use Citalopram Mylan

  • if you are allergic to citalopram or any of the other ingredients of this medicine (listed in section 6).
  • if you are also being treated with so-called MAO inhibitors ( monoamine oxidase inhibitors ) which are used to treat depression or Parkinson’s disease. The MAO inhibitor selegiline can be used in combination with Citalopram Mylan but at a maximum dose of 10 mg per day.
  • if you have recently been treated with MAOIs. Depending on the type of MAOIyou used, you may need to wait up to 14 days after stopping the MAOI before taking Citalopram Mylan. Your doctor will tell you how long you have to wait. If you stop taking Citalopram Mylan, you must wait at least 7 days before using an MAOI.
  • if you are being treated at the same time with a medicine that contains linezolid (used to treat infections ). If your doctor has decided that you can use CitalopramMylan while you are being treated with linezolid, your blood pressure will be checked regularly.
  • if you have congenital or have had an abnormal heart rhythm (as seen on ECG, a test to see how the heart works)
  • If you are taking medicines for heart rhythm problems or that may affect your heart rhythm, see section “Other medicines and Citalopram Mylan”.

Warnings and cautions

Talk to your doctor or pharmacist before using Citalopram Mylan:

  • if you have liver or kidney disease.
  • if you have a psychotic illness
  • if you have previously suffered from mania. Treatment with citalopram should be discontinued if you enter a manic phase.
  • if you have had an abnormal tendency to bleed or a condition that leads to bleeding (see “Other medicines and Citalopram Mylan”)
  • if you suffer from seizures or if you have epilepsy
  • if you have diabetes
  • if you have heart disease or abnormal heart rhythm
  • if you are receiving electroconvulsive therapy (ECT)
  • if you have or have had high pressure in the eyes ( glaucoma )
  • if you have reduced sodium in your blood. Tell your doctor if you start to feel unwell with muscle weakness or feel confused during treatment with CitalopramMylan.
  • if you have or have had heart problems or have recently had a heart attack
  • if you have a slow heart rhythm at rest and/or if you know that you may have anemia due to prolonged severe diarrhea and vomiting or the use of diuretics ( diuretics )
  • if you experience rapid or irregular heartbeat, fainting, collapse, or dizziness when standing up. This may indicate an abnormal function of the heart rhythm

Drugs such as Citalopram Mylan (so-called SSRIs / SNRIs) may cause symptoms of decreased sexual desire (see section 4). In some cases, these symptoms have continued after the end of treatment.

Children and young people

Citalopram Mylan 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, Citalopram Mylan 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 worsen in a patient under the age of 18 taking Citalopram Mylan.

The long-term effects on growth, maturity, and cognitive and behavioral development have not yet been determined for children and adolescents under 18 years of age.

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.

Symptoms such as restlessness, agitation, or difficulty sitting or standing still may also occur during the first weeks of treatment. In some cases, you may be unaware of the above symptoms and therefore it may be beneficial to ask someone close to you to help you observe any abnormal behavior.

Isolated cases of “serotonergic syndrome” have been reported in patients treated with this type of antidepressant ( SSRI ). If you experience high fever, muscle twitching, confusion, and anxiety, consult your doctor, as these symptoms may be signs of this condition.

Contact a doctor as soon as possible or see the nearest hospital if you have painful thoughts or experiences, or when any of the above symptoms occur during treatment.

Other medicines and Citalopram Mylan

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Tell your doctor if you are taking or have taken any of the following medicines in the last 14 days (see section “Do not use Citalopram Mylan”):

  • monoamine oxidase inhibitors (MAOs) for the treatment of Parkinson’s disease(eg selegiline ), infections (eg linezolid), and depression (eg moclobemide)
  • pimozide for the treatment of psychosis.

Tell your doctor if you are taking any of the following medicines:

  • antidepressants, e.g. desipramine, fluvoxamine
  • drugs for mental illness, e.g. lithium, risperidone, thioridazine, and haloperidol
  • drugs that increase the risk of bleeding (eg drugs that prevent blood coagulation ( warfarin, ticlopidine, dipyridamole), salicylic acid derivatives ( acetylsalicylic acid ), NSAIDs (drugs used for pain and inflammation, eg ibuprofen, diclofenac )). Use with Citalopram Mylan may increase the risk of skin and mucosal bleeding.
  • an herbal medicine containing St. John’s wort (Hypericum perforatum)
  • metoprolol (medicine for heart disease and high blood pressure )
  • cimetidine (medicine for stomach ulcers )
  • omeprazole, esomeprazole, lansoprazole (for the treatment of stomach ulcers )
  • fluconazole (used to treat fungal infections)
  • drugs for the treatment of certain heart diseases, e.g. flecainide, propafenone
  • drugs that lower the levels of potassium or magnesium in the blood
  • mefloquine (anti-malarial drug ) and bupropion (smoking cessation drug) due to a possible risk of lowering the seizure threshold.
  • sumatriptan or other triptans (medicines for migraines ), opioids (eg buprenorphine and tramadol (painkillers), or tryptophan (for depression) These medicines may interact with Citalopram Mylan and may cause a life-threatening condition called serotonergic syndrome (for symptoms see section 4 (Possible side effects).

Do not take Citalopram Mylan if you are taking medicines for heart rhythm problems or medicines that may affect your heart rhythm, e.g. antiarrhythmics of Class IA and III (drug for irregular cardiac activity), antipsychotics (such as phenothiazines, pimozide, haloperidol ), tricyclic antidepressants (depression), certain antimicrobial drugs (such as sparfloxacin, moxifloxacin, erythromycin IV, pentamidine , anti-malarial drugs, especially halofantrine), certain antihistamines(astemizole, mizolastine). If you have any further questions on the use of this product, ask your doctor.

Citalopram Mylan with alcohol

As with other antidepressants, it is advisable to avoid alcohol during treatment.

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.

Pregnancy

If you become pregnant while taking Citalopram Mylan, do not stop treatment without talking to a doctor.

Tell your midwife or doctor that you are taking Citalopram Mylan. When drugs such as Citalopram Mylan 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.

When Citalopram Mylan has been used during the latter part of pregnancy, the following other symptoms have been reported in the baby immediately after or shortly after birth: seizures, difficulty regulating body temperature, difficulty breastfeeding, vomiting, low blood sugar, tense or slack muscles, tremors, jerking, irritability, persistent crying, increased sleepiness and difficulty sleeping. These symptoms are usually transient. If your child gets any of these symptoms, contact your doctor or midwife as soon as possible.

Breast-feeding

Small amounts of spam pass intobreast milk. It is possible that a breastfed baby may be affected. Therefore, do not use Citalopram Mylan during breast-feeding unless specifically prescribed by a doctor.

Male fertility

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

Citalopram Mylan can cause side effects that may affect your judgment and ability to react in critical situations. Do not drive or use machines if you experience side effects such as drowsiness or fatigue.

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.

Citalopram Mylan contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How to use Citalopram Mylan

Dosage instructions

Always take Citalopram Mylan exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

The recommended dose is:

Adults

Depression

The usual dose is 20 mg per day. Your doctor may increase the dose to a maximum of 40 mg per day.

Panic syndrome

The starting dose is 10 mg per day for the first week. Thereafter, the dose is increased one to 20-30 mg per day. Your doctor may increase the dose to a maximum of 40 mg per day.

Elderly patients (over 65 years)

The starting dose should be reduced to half the recommended dose, ie 10-20 mg per day. Elderly patients should not usually take more than 20 mg per day.

Patients with special risk factors

Patients who have liver problems should not take more than 20 mg per day.

Method of administration

– Take the tablets in the morning or in the evening, with or without food.

– Swallow the tablets with water.

– Citalopram Mylan 20 mg and 40 mg tablets have a breaking score and can be divided into equal doses.

– Citalopram Mylan 30 mg, the breaking notch is not to divide the tablet into equal doses but only to facilitate swallowing.

Treatment time

As with all antidepressants, the improvement does not occur immediately. Once treatment has started, it may take up to 2-3 weeks for the medicine to start working. In the case of panic disorder, it may take several weeks before improvement occurs and at the beginning of treatment, some patients may react with increased anxiety that usually passes during the continued treatment. It is therefore very important that you carefully follow the doctor’s prescription and do not interrupt the treatment or change the dose without the doctor’s advice. In depression, treatment usually lasts 6 months after improvement. The treatment of the panic disorder is long-lasting. Therefore, once improvement has occurred, treatment should be continued according to your doctor’s prescription .

If you forget to use Citalopram Mylan

Do not take a double dose to make up for a forgotten dose, but just keep taking the next dose as you normally would.

If you stop taking Citalopram Mylan

Do not stop treatment with Citalopram Mylan without your doctor’s advice. If you need to stop treatment, your doctor will usually advise you to slowly reduce your dose for a few weeks. When you stop treatment with Citalopram Mylan abruptly, there is a risk of so-called withdrawal symptoms (see section 4 “Withdrawal symptoms at the end of treatment”).

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. Side effects are most common at the beginning of treatment, but they usually subside during the first few weeks. If you experience any of the following symptoms, stop taking Citalopram Mylan and see a doctor immediately:

  • rapid, irregular heartbeat, fainting which may be a symptom of a life-threatening condition called Torsades de Pointes (occurs in an unknown number of users)
  • severe allergic reaction causing swelling of the face, tongue, or throat, difficulty swallowing or breathing, and hives (occurring in an unknown number of users)
  • serotonergic syndrome (you may experience symptoms such as involuntary, rhythmic contractions of muscles, including the muscles that control movement in the eye, agitation, hallucinations, confusion, anxiety, coma, excessive sweating, tremor, excessive reflexes, increased muscle tension, body temperature above 38 ° C ) (occurs in an unknown number of users)
  • nausea, vomiting, loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes, light stools, dark-colored urine (jaundice) (frequency: rare)
  • seizures, or if you have epilepsy and you notice an increase in the number of seizures you have (frequency: rare)

In the treatment of depression, thoughts of suicide or self-harm may occur or increase in some cases during the first weeks before the effect of the drug is noticed. Tell your doctor immediately if you experience any disturbing thoughts or experiences. Patients who are prone to panic attacks may even experience a temporary period of increased anxiety after starting treatment. This usually goes away during the first 1-2 weeks.

Very common side effects (may affect more than 1 user in 10):

  • difficulty sleeping, drowsiness
  • dry mouth, nausea
  • increased sweating
  • headache

Common side effects (may affect up to 1 in 10 people):

  • changes in heart rhythm
  • agitation, nervousness, anxiety
  • difficulty concentrating, impaired attention, confusion, abnormal dreams, blunted emotions
  • dizziness
  • tremors, abnormal sensations in the skin (and crawls)
  • visual disturbances, ringing in the ears, runny nose
  • vomiting, constipation, diarrhea, abdominal pain, indigestion, increased salivation, gas
  • loss of appetite, weight loss, anorexia
  • itching
  • muscle pain, joint pain
  • ejaculation disorders, impotence, decreased sexual desire, abnormal orgasm in women
  • irregular menstruation, changes in urination
  • feeling weak, yawning, tiredness, general malaise

Uncommon side effects (may affect up to 1 in 100 people):

  • increased appetite, weight gain
  • slow heart rate, fast heart rate, fainting
  • aggression, elation, personality changes, hallucinations, the arousal that gives rise to unusual behavior
  • dilated pupil is
  • cough, shortness of breath, or shortness of breath
  • photosensitivity of the skin, rash, hives, red spots on the skin, hair loss
  • women may experience difficulty reaching orgasm
  • difficulty urinating
  • abundant menstrual bleeding
  • swelling due to too much fluid in the body

Rare side effects (may affect up to 1 in 1,000 people):

  • low sodium levels in the blood which can cause fatigue and confusion
  • muscle twitching, uncontrolled body movements, and other disturbances of the movement pattern
  • taste changes
  • bleeding
  • fever

Adverse reactions that have been reported (occurred in an unknown number of users) :

  • feeling weak or dizzy when getting up
  • decreased number of platelets that increase the risk of bleeding and bruising, bruising, nosebleeds, gastrointestinal bleeding including bleeding from the rectum, vaginal bleeding
  • allergic reactions
  • overproduction of a hormone that causes the accumulation of fluid in the body leading to weakness, fatigue, or confusion
  • low levels of potassium in the blood that can cause muscle weakness, twitching, or abnormal heart rhythm
  • panic attacks, restlessness, or difficulty sitting still
  • gnashing of teeth (in sleep)
  • disturbances in the movement pattern
  • vision problems
  • unusual or very rapid heartbeat or chest pain
  • prolonged and painful erection
  • abnormal secretion of milk from the mammary glands in men
  • increased risk of bone fractures
  • abnormal results of liver function tests

An increased risk of bone fractures has been seen in patients taking this type of drug

Withdrawal symptoms at the end of treatment:

So-called withdrawal symptoms are common when treatment with Citalopram Mylan is stopped, especially if it occurs abruptly. When you stop taking Citalopram Mylan, your doctor may recommend that you reduce the dose gradually. If dose one is not gradually reduced, the risk of withdrawal symptoms is greater. If you experience withdrawal symptoms, it does not mean that you are addicted or will not be able to stop taking CitalopramMylan. Release symptoms that have been reported are dizziness, sensory disturbances such as ant crawling and sensation of electric shock, sleep disturbances with insomnia and vivid dreams, agitation or anxiety, nausea and/or vomiting, shaking, confusion, sweating, headache, diarrhea, palpitations, palpitations, palpitations, and visual disturbances. The symptoms are generally mild to moderate and transient, but in some, they may be more severe and prolonged. Contact a doctor if you experience severe withdrawal symptoms after stopping treatment. Your doctor may ask you to start taking Citalopram Mylan again, and then end your treatment at a slower pace.

If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information.

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 Citalopram Mylan

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.

No special storage instructions.

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

Content declaration

  • The active substance is citalopram. Each tablet contains citalopram hydrobromide equivalent to 10 mg, 20 mg, 30 mg, or 40 mg citalopram.
  • Other ingredients: Maize starch, lactose monohydrate (see section 2 “Citalopram Mylan contains lactose”), microcrystalline cellulose, povidone, crospovidone, and magnesium stearate, hypromellose (E 464), lactose monohydrate, macrogol 4000, and titanium dioxide (E 171).

What the medicine looks like and the contents of the pack

Citalopram Mylan 10 mg tablets are white round, film-coated tablets marked CM / 10 on one side and G on the other side

Citalopram Mylan 20 mg tablets are white, oval film-coated tablets marked CM / 20 on one side and G on the other side. The tablet has a break notch and can be divided into two equal doses.

Citalopram Mylan 30 mg tablets are white, oval, film-coated tablets marked CM / 30 on one side and G on the other. The breaker is only there to be able to divide the tablet to make it easier to swallow.

Citalopram Mylan 40 mg tablets are white, oval film-coated tablets marked CM / 40 on one side and G on the other side. The tablet has a break notch and can be divided into two equal doses.

Citalopram Mylan is available in blister packs of 12, 14, 20, 28, 30, 50, 56, 98, 100, 250 (only 20 mg / 30 mg / 40 mg) and 500 tablets and calendar blisters of 28 tablets or single-dose blisters of 14, 28 , 49 (10 mg only), 50, 56, 100, 250 and 500 tablets.

Citalopram Mylan is available in cans of 100, 250, 500, and 1000 tablets.

Not all pack sizes may be marketed.

Holder of approval for sale: 
Mylan AB, Box 23033, 104 35 Stockholm

Tel: 08 555 227 50

Fax: 08-555 227 51

Email: inform@mylan.se

Manufacturer: 
McDermott Laboratories Ltd. t / a Gerard Laboratories, Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland

Further information on this medicine can be obtained from the representative of the marketing authorization holder:


Muhammad Nadeem

Leave a Reply