Dolin 5 mg/10 mg/20 mg Tablets

The active substance is escitalopram oxalate. DOLIN 5 mg: Each film-coated tablet contains escitalopram oxalate equivalent to 5 mg escitalopram. DOLIN 10 mg: Each film-coated tablet contains escitalopram oxalate equivalent to 10 mg escitalopram. DOLIN 20 mg: Each film-coated tablet contains escitalopram oxalate equivalent to 20 mg escitalopram. The other ingredients of DOLIN are butylhydroxyanisole, butylhydroxytoluene, cellulose microcrystalline, croscarmellose sodium, hypromellose, macrogol 400, magnesium stearate, silica colloidal anhydrous, silicified microcrystalline cellulose, talc and titanium dioxide (C.I. No. 77891).

DOLIN belongs to a group of antidepressants called selective serotonin reuptake inhibitors (SSRIs). DOLIN are used to treat depression (major depressive episodes).

Do not take DOLIN:

• If you are hypersensitive (allergic) to escitalopram, or any of the other ingredients of DOLIN.
• If you are under 18 years of age – Because the safety and effectiveness of DOLIN have not been determined in children.
• If you take other medicines which belongs to a group called MAO (monoamine oxidase) inhibitors. If you have taken any of these medicines you will need to wait 14 days before you start taking DOLIN. After stopping DOLIN, you must allow 7 days before taking any of these medicines.

Take special care with DOLIN: Before taking DOLIN, tell your doctor:

• If you have or have had mania. Some patients with a history of mania/hypomania may enter a manic phase. If you experience this, contact your doctor.
• If you have epilepsy. Treatment with DOLIN should be stopped if seizures occur or if there is an increase in seizure frequency.
• If you have diabetes. Insulin and/or oral medication dosage may need to be adjusted.
• If you are receiving electroconvulsive treatment.
• If you have liver disease. Your doctor may need to adjust your dosage.
• If you have kidney disease.
• If you have or have ever had bleeding problems.
• If you are an elderly patient.

- If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away. If you are depressed you can sometimes have thoughts of harming or killing yourself. Since DOLIN may take time to work, an improvement may not occur during the first few weeks or more of treatment.

- Some patients with panic disorder may experience increased anxiety symptoms when they start to take DOLIN. These anxiety symptoms usually decrease within two weeks of continued treatment.

Taking DOLIN with food and drink: DOLIN can be taken with or without food.

Always take DOLIN 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 DOLIN is too strong or too weak, talk to your doctor or pharmacist.

Adults: Depression:

• The normal recommended dose of DOLIN is 10 mg taken as one daily dose.
• The dose may be increased by your doctor to a maximum of 20 mg per day.
• It may take 2 to 4 weeks before you start to feel better. Continue to take DOLIN even if it takes some time before you feel an improvement in your condition.

Elderly patients (above 65 years of age): Your doctor may consider a lower starting dose and maximum dose.

Patients with kidney disease: It is usually not necessary to adjust the dosage in mild or moderate kidney impairment.

Patients with liver disease: Your doctor should consider a lower dosage.

If you stop taking DOLIN: When you have completed your course of treatment, it is generally advised that the dose of DOLIN should be gradually reduced.

DOLIN 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, sudden swelling of skin or mucosa (angioedema). Call your doctor at once if you have any of these serious side - effects: • DOLIN may cause a very serious condition called serotonin syndrome. Symptoms of serotonin syndrome include: Confusion, mania, agitation, hyperactivity (excessively increased activity), shivering, high fever, tremor (shake), eye movements, twitchy muscles, loss of coordination. • Seizures (fits) or convulsions. • Hallucinations (seeing things or hearing voices that do not exist) or mania (unusual excitement). • Difficulties urinating.

Other side - effects include: increase in the amount of urine excreted; low level of sodium in the blood; sexual disturbances (ejaculation problems, loss of male sexual ability, decreased sexual drive and women may experience difficulties achieving orgasm); confusion; agitation; anxiety; panic attacks; nervousness; dizziness; inability to sleep; sleepiness; tremor (shake); movement disorders (involuntary movements of the muscles); problems with vision; dizziness when you stand up due to low blood pressure (postural hypotension); blocked or runny nose (sinusitis); yawning; taste disturbances; diarrhoea (frequent or loose watery stools); constipation; dry mouth; nausea; vomiting; lack of appetite; abnormal liver function tests (increased amounts of liver enzymes in the blood); increased sweating; bruise, bleeding into the skin; itching; joint pain; muscle pain; flow of milk in women that are not nursing; fatigue; inability to sleep; dizziness; drowsiness; fever.

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 DOLIN. Not all side - effects reported for DOLIN are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking DOLIN, please consult your doctor, pharmacist or other healthcare professional for advice.