Auro – Citalopram 10 mg/40 mg Tablets

The active substance is citalopram. AURO - CITALOPRAM 10 mg: Each film-coated tablet contains citalopram hydrobromide corresponding to 10 mg of citalopram. AURO - CITALOPRAM 40 mg: Each film-coated tablet contains citalopram hydrobromide corresponding to 40 mg of citalopram. The other ingredients are cellulose microcrystalline, copovidone, croscarmellose sodium, lactose monohydrate, magnesium stearate and maize starch. The coating material contains hypromellose, macrogol 400 and titanium dioxide (C.I number: 77891).

AURO - CITALOPRAM belongs to a group of antidepressants called selective serotonin reuptake inhibitors (SSRIs). AURO - CITALOPRAM is used for the treatment of depression and when you feel better, to help prevent these symptoms recurring. AURO - CITALOPRAM is also used to treat other mental conditions such as obsessive-compulsive disorder (an anxiety disorder where a person has recurrent and unwanted thoughts called obsessions and/or repetitive behaviour called compulsions), and panic attacks.

Do not take AURO - CITALOPRAM:

• If you are hypersensitive (allergic) to citalopram, or any of the other ingredients of AURO - CITALOPRAM.
• At the same time as taking a medicine known as a monoamine oxidase inhibitor (MAOI). You must wait at least 14 days after stopping a MAOI before you can take AURO - CITALOPRAM. After you stop taking AURO - CITALOPRAM, you must wait at least 7 days before taking a MAOI.
• If you have severe kidney disease.
• If you are pregnant or breast-feeding.
• In children under 18 years of age – Because the safety and effectiveness of AURO - CITALOPRAM has not been determined in children.

Take special care with AURO - CITALOPRAM:

• Before taking AURO - CITALOPRAM, tell your doctor:
• If you have or have had mania. Contact your doctor if you enter into a manic phase while taking AURO - CITALOPRAM, since AURO - CITALOPRAM should be discontinued.
• If you have epilepsy or a history of seizures or fits. If you experience seizures (convulsions or fits) while taking AURO - CITALOPRAM, consult your doctor immediately.
• If you have diabetes.
• If you are receiving electroconvulsive treatment (ECT).
• If you have liver disease. Your doctor may need to lower your dosage.
• If you have kidney disease.
• If you suffer from heart problems or an abnormal heart rate.

Always take AURO - CITALOPRAM exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. If you have the impression that the effect of AURO - CITALOPRAM is too strong or too weak, talk to your doctor or pharmacist.

• AURO - CITALOPRAM may be taken in the morning or evening.

• It may take 2 to 4 weeks before you start to feel better. AURO - CITALOPRAM should be taken for as long as your doctor tells you to. Do not stop taking AURO - CITALOPRAM 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. Your doctor should continue to treat you with AURO - CITALOPRAM until you have been free of symptoms for at least 6 months.

Depression:

• The usual starting dose of AURO - CITALOPRAM is 20 mg taken as one daily dose. This may be increased by your doctor by 20 mg a day at intervals of at least one week to a maximum of 60 mg a day, depending on how you respond to AURO - CITALOPRAM.

Panic Disorder:

• The usual starting dose of AURO - CITALOPRAM is 10 mg as one daily dose for the first week before increasing the dose to 20 mg a day. Thereafter, the dose may be further increased by your doctor to a maximum of 60 mg a day, depending on how you respond to AURO - CITALOPRAM.

Obsessive-Compulsive Disorder:

• The usual starting dose of AURO - CITALOPRAM is 20 mg as one daily dose. Thereafter, the dose may be increased by your doctor to a maximum of 60 mg a day, depending on how you respond to AURO - CITALOPRAM.

Elderly patients:

• The usual dose of AURO - CITALOPRAM is 20 mg taken as one daily dose. This may be increased by your doctor to a maximum of 30 mg a day, depending on how you respond to AURO - CITALOPRAM.

Patients with liver disease:

• The dose of AURO - CITALOPRAM in patients with liver disease should be halved.

Patients with kidney disease:

• It is not necessary to adjust the dosage in mild or moderate kidney disease.

AURO - CITALOPRAM can have side-effects. Get emergency medical help if you have any of these signs of an allergic reaction:

• hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side-effects:

• AURO - CITALOPRAM may cause a very serious condition called serotonin syndrome. Symptoms of serotonin syndrome include: Fever, confusion, abnormal movements, shivering, muscle spasms, agitation and progress to coma or loss of consciousness, restlessness, sweating, hallucinations, exaggeration of reflexes, muscle cramps, rapid heart rate.
• AURO - CITALOPRAM may cause a very serious condition called neuroleptic malignant syndrome. Symptoms of neuroleptic malignant syndrome include: Rigid, stiff muscles; muscle cramps; agitation; confusion; tremor (shakes); heavy sweating; high body temperature; fast heart rate; rapid breathing.
• Thoughts of harming or killing yourself at any time.
• Hallucinations (seeing things or hearing voices that do not exist) or mania (unusual excitement).

Other side-effects include: palpitations (rapid irregular action of heart); tremor (shake); slow heart rate; disturbed sleep; numbness, tingling, pins and needles; restlessness; sleepiness; headache; dizziness; excessive tiredness; agitation; confusion; difficulty concentrating; generally feeling unwell; loss of or increase in weight; nausea (queasiness; feeling that one is about to vomit); constipation; diarrhoea (frequent or loose watery stools); indigestion; dry mouth; too much saliva in the mouth; difficulties urinating; sexual disturbances (ejaculation problems, decreased sexual drive, problems in reaching orgasm); inflammation of the liver; lack of energy; abnormal vision; large pupils (the dark centre of the eye); stuffy nose; sweating; rash; yawning.

Tell your doctor if any of the above side-effects are severe, bothersome, do not go away or about any concerns you have while taking AURO - CITALOPRAM. Not all side-effects reported for AURO - CITALOPRAM are included in this leaflet. Should your general health worsen while taking AURO - CITALOPRAM, please consult your doctor, pharmacist or other healthcare professional for advice.

Store in a cool, dry place, at or below 25 °C (room temperature). Keep the container well closed. Do not remove the blister strip from the carton until required for use. Keep all medicines out of the reach and sight of children. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).