Glenmark Pharmaceuticals Nordic
Film-coated tablet 25 mg
(yellow, oblong, biconvex, film-coated tablet, 9.0 x 4.5 mm)
Read all of this leaflet carefully before you start taking 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 may harm them, even if they show symptoms 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. See section 4.
In this leaflet:
1. What Agomelatin Glenmark is and what it is used for
2. What you need to know before you take Agomelatin Glenmark
3. How to take Agomelatin Glenmark
4. Possible side effects
5. How to store Agomelatin Glenmark
6. Contents of the packaging and other information
What Agomelatin Glenmark is and what it is used for
Agomelatine Glenmark contains the active substance agomelatine. It belongs to a group of medicines called antidepressants. You have been given Agomelatin Glenmark to treat your depression. Agomelatine Glenmark is used in adults.
Depression is a persistent disorder of mood that affects daily life. The symptoms of depression vary from person to person but often include deep depression, feelings of worthlessness, loss of interest in favorite activities, sleep disorders, feelings of slowness, anxiety, weight change.
The expected benefits of Agomelatin Glenmark are to reduce and eventually eliminate the symptoms associated with your depression.
Agomelatine contained in Agomelatin Glenmark may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you take Agomelatin Glenmark
Do not take Agomelatin Glenmark:
- if you are allergic to agomelatine or any of the other ingredients of this medicine (listed in section 6).
- if your liver is not functioning properly (impaired liver function).
- if you are taking fluvoxamine (another medicine used to treat depression) or ciprofloxacin (an antibiotic ).
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before taking Agomelatin Glenmark.
There may be reasons why Agomelatin Glenmark is not suitable for you:
- Taking drugs that are known to affect the liver. Ask your doctor for advice on which medicines to use.
- If you are obese or overweight, ask your doctor for advice.
- If you have diabetes, ask your doctor for advice.
- If you have elevated levels of liver enzymes before treatment, your doctor will determine if Agomelatin Glenmark is the right treatment for you.
- If you have bipolar disorder, have had or develop manic symptoms (a period of abnormally high irritability and sensitivity) talk to your doctor before taking this medicine or before continuing with this medicine (see also “Possible side effects” in section 4).
- If you suffer from dementia, your doctor will make an individual assessment of whether it is appropriate for you to take Agomelatin Glenmark.
During treatment with Agomelatin Glenmark:
To avoid any serious liver problems:
Your doctor should have checked that your liver is functioning properly before starting treatment. Some patients may have elevated levels of liver enzymes in their blood during treatment with Agomelatin Glenmark.
Follow-up samples must therefore be taken at the following times
|before start ordose increase||after approxThree weeks
||after approx6 weeks
||after approx12 weeks
||after approx24 weeks
Based on the evaluation of these tests, your doctor will decide if you should start or continue to use Agomelatin Glenmark (see also “How to take Agomelatin Glenmark” in section 3).
Pay attention to signs and symptoms that the liver is not working properly
If you notice any of these signs and symptoms of liver problems: unusual dark urine, light stools, yellow skin / yellow eyes, pain in the upper, right part of the abdomen, abnormal fatigue (especially in connection with other symptoms listed above), consult immediately doctors who may advise you to stop taking Agomelatin Glenmark.
The effect of Agomelatin Glenmark has not been documented in patients aged 75 years and older. Therefore, Agomelatin Glenmark should not be used in these patients.
If you start to feel worse and have thoughts of harming yourself
You who are depressed can 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 can be helpful to tell a relative or close friend that you are depressed. 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.
Children and young people
Agomelatine Glenmark should not be used in children and adolescents (under 18 years of age).
Other medicines and Agomelatin Glenmark
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
You should not take Agomelatin Glenmark with certain medicines (see also ‘ Do not take Agomelatin Glenmark’ in section 2): fluvoxamine (another medicine used to treat depression), ciprofloxacin (an antibiotic ) may change the expected dose of agomelatine in your blood.
Tell your doctor if you are taking any of the following medicines: propranolol (a beta-blocker used to treat high blood pressure ), enoxacin ( antibiotic ).
Tell your doctor if you smoke more than 15 cigarettes a day.
Agomelatine with alcohol
Alcohol consumption during treatment with Agomelatin Glenmark is not recommended.
Pregnancy and breastfeeding
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.
Breast-feeding should be discontinued if you are taking Agomelatin Glenmark.
Driving and using machines
You may experience dizziness or drowsiness, which may affect your ability to drive or use machines. Make sure your reactions are normal before driving or using machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. 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.
Agomelatine Glenmark contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.
How to take Agomelatin Glenmark
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose of Agomelatin Glenmark is one tablet (25 mg) before bedtime. In some cases, your doctor may prescribe a higher dose (50 mg), ie two tablets are taken together before bedtime.
Method of administration
Agomelatine Glenmark is for oral use. The tablet should be swallowed with water. Agomelatine Glenmark can be taken with or without food.
In most depressed people, Agomelatin Glenmark begins to have symptoms of depression within two weeks of starting treatment. Your depression should be treated for a sufficiently long period of at least 6 months to ensure
that you are free from symptoms.
Your doctor may continue to give you Agomelatin Glenmark even if you feel better about preventing your depression from returning.
If you have kidney problems, your doctor will make an individual assessment of whether it is safe for you to take Agomelatin Glenmark.
Monitoring of liver function (see also section 2):
Your doctor will take laboratory tests to check that your liver is functioning properly before starting treatment and then periodically during treatment, usually after 3 weeks, 6 weeks, 12 weeks, and 24 weeks.
If your doctor increases the dose to one to 50 mg, laboratory tests should be performed at the beginning of this treatment and then periodically during treatment, usually after 3 weeks, 6 weeks, 12 weeks, and 24 weeks. Samples will then be taken if the doctor deems it necessary.
You should not take Agomelatin Glenmark unless your liver is working properly.
How to switch from an antidepressant drug (SSRI / SNRI) to Agomelatin Glenmark?
If your doctor wants you to switch from your previous SSRI / SNRI antidepressant to Agomelatin Glenmark, he/she will tell you how to discontinue the previous medicine when starting treatment with Agomelatin Glenmark.
For a few weeks, you may experience withdrawal symptoms associated with discontinuation of your previous medication, even if the dose of one of your previous antidepressant medications is gradually reduced.
Withdrawal symptoms include dizziness, numbness, sleep disturbances, worry or anxiety, headache, nausea, vomiting, and tremors. The symptoms are usually mild or moderate and go away on their own within a few days.
If treatment with Agomelatin Glenmark is started while the dose of one of the previous medicines is being reduced, any withdrawal symptoms should not be confused with the absence of the early effect of Agomelatin Glenmark.
Always discuss with your doctor how to best discontinue your previous antidepressant drug when starting treatment with Agomelatin Glenmark.
Experience with Agomelatin Glenmark overdose is limited but reported symptoms include upper abdominal pain, drowsiness, fatigue, agitation, anxiety, tension, dizziness, decreased blood oxygenation, and diffuse discomfort.
If you forget to take Agomelatin Glenmark
Do not take a double dose to make up for a forgotten dose. Continue with the next dose at the usual time.
The calendar printed on the blister card in packs of 14, 28, 84, 98 tablets will help you remember when you last took an Agomelatin Glenmark tablet.
If you stop taking Agomelatin Glenmark
You should not stop taking your medicine without consulting a doctor even if you feel better.
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.
Most side effects are mild or moderate. They usually occur during the first two weeks of treatment and are usually transient.
These side effects include:
- Very common side effects (may affect more than 1 in 10 people): headache.
- Common side effects (may affect up to 1 in 10 people): dizziness, drowsiness, insomnia, nausea, diarrhea, constipation, abdominal pain, back pain, fatigue, anxiety, abnormal dreams, increased levels of liver enzymes in your blood, vomiting, weight gain.
- Uncommon side effects (may affect up to 1 in 100 people): migraine, tingling sensation in fingers and toes, blurred vision, restless legs syndrome (a disorder characterized by an uncontrollable need to move the legs), ringing in the ears, excessive sweating, eczema, pruritus, urticaria ( hives ), agitation, irritability, restlessness, aggressive behavior, nightmares, manic symptoms, such as abnormally high irritability and sensitivity (see also “ Warnings and Precautions” in section 2), suicidal ideation or thoughts, confusion, confusion.
- Rare side effects (may affect up to 1 in 1,000 people): severe skin rash (reddening of the skin), facial edema (swelling), and angioedema (swelling of the face, lips, tongue, and/or throat which may cause difficulty in breathing or swallowing), hepatitis, yellowing of the skin or whites of the eyes (jaundice), liver failure *, hallucinations, inability to be still (due to physical and mental anxiety), inability to empty the bladder completely.
* A few cases that have resulted in liver transplantation or death have been reported.
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 Agomelatin Glenmark
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 and blister after EXP. The expiration date is the last day of the specified month.
No special temperature instructions. Store in the original package. Moisture sensitive.
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
- The active substance is agomelatine. Each film-coated tablet contains 25 mg agomelatine (as agomelatine / citric acid (1: 1)).
- The other ingredients are microcrystalline cellulose with silica, mannitol, povidone K30, crospovidone type A, sodium stearyl fumarate, magnesium stearate, colloidal anhydrous silica, stearic acid, hypromellose, macrogol 6000, titanium dioxide (E171), talc, and yellow iron oxide.
What the medicine looks like and the contents of the pack
Agomelatine Glenmark 25 mg film-coated tablets are yellow, oblong, and biconvex (9.0 mm x 4.5 mm).
Agomelatine Glenmark 25 mg film-coated tablets are supplied in blister packs. The packs contain 14, 28, 30, 84, 90 or 98 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Glenmark Arzneimittel GmbH
Industriestr. 31, 82194 Gröbenzell,
MEDIS International as,
virtuoso zavod Bolatice
747 23 Bolatice, Czech Republic
Glenmark Pharmaceuticals sro
Fibichova 143, 566 17,