Film-coated tablet 25 mg
(Yellow, oblong, biconvex film-coated tablets 9.0 mm long, 4.5 mm wide.)
What Agomelatine STADA is and what it is used for
Agomelatine Stada contains the active substance agomelatine. It belongs to a group of medicines called antidepressants and you have been given Agomelatine Stada to treat your depression.
Agomelatine Stada 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, lost interest in favorite activities, sleep disorders, feelings of slowness, anxiety, weight change.
The expected benefits of Agomelatine Stada are to reduce and eventually eliminate the symptoms associated with your depression.
Agomelatine contained in Agomelatine Stada may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
2. What you need to know before using Agomelatine STADA
Do not take Agomelatine Stada:
- 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
There may be reasons why Agomelatine Stada 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 Agomelatine Stada is a suitable 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 Agomelatine Stada.
During treatment with Agomelatine Stada:
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 Agomelatine Stada. Follow-up samples must therefore be taken at the following times:
| Before starting or increasing the dose | After approx.Three weeks | After approx.6 weeks | After approx.12 weeks | After approx.24 weeks | |
| Blood tests | ü | ü | ü | ü | ü |
Based on the evaluation of these tests, your doctor will decide if you should start using or continue to use Agomelatine Stada (see also How to take Agomelatine Stadain 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 urge you to stop taking this medicine.
The effect of Agomelatine Stada has not been documented in patients aged 75 years and older. Therefore, Agomelatine Stada 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 Stada is not intended for use in children and adolescents (under 18 years of age).
Other medicines and Agomelatine STADA
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
You should not take Agomelatine Stada at the same time as certain medicines (see also “ Do not take Agomelatine Stada” 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 ) and if you smoke more than 15 cigarettes a day.
Agomelatine Stada with alcohol
Alcohol consumption during treatment with Agomelatine Stada 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.
Talk to your doctor if you are breast-feeding or planning to breast-feed. Breast-feeding should be discontinued if you are taking Agomelatine Stada.
Ask your doctor or pharmacist for advice before taking any medicine.
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 STADA contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.
How to use Agomelatine STADA
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 Agomelatine Stada 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.
In most depressed people, Agomelatine Stada begins to appear on depressive symptoms within two weeks of starting treatment. Your doctor may continue to give you Agomelatine Stada even if you feel better about preventing your depression from returning.
Your depression should be treated for a sufficiently long period of at least 6 months to ensure that you are free of symptoms.
You should not stop taking your medicine without consulting a doctor even if you feel better.
Agomelatine Stada is for oral use. The tablet should be swallowed with water. Agomelatine Stada can be taken with or without food.
How to switch from an antidepressant drug (SSRI / SNRI) to Agomelatine Stada?
If your doctor wants you to switch from your previous SSRI / SNRI antidepressant to Agomelatine Stada, he/she will tell you how to discontinue the previous medicine when starting treatment with Agomelatine Stada.
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 Agomelatine Stada 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 Agomelatine Stada.
Always discuss with your doctor how to best discontinue your previous antidepressant when starting treatment with Agomelatine Stada.
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 Agomelatine Stada unless your liver is working properly.
If you have kidney problems, your doctor will make an individual assessment of whether it is safe for you to take Agomelatine Stada.
Experience with overdose with Agomelatine Stada is limited but reported symptoms include upper abdominal pain, drowsiness, fatigue, hyperactivity, anxiety, tension, dizziness, decreased blood oxygenation, and diffuse discomfort.
If you forget to use Agomelatine STADA
Do not take a double dose to make up for a forgotten dose. Continue with the next dose at the usual time.
[Applies only to packs containing 7, 14, 28, 42, 56, 84, 98 tablets:]
The calendar of blisters containing the tablets should help you remember when you last took an Agomelatine Stada tablet.
If you stop using Agomelatine STADA
You should discuss this with your doctor before stopping taking this medicine.
If you have the impression that the effect of Agomelatine Stada is too strong or too weak, talk to your doctor or pharmacist.
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:
A very common side effect is (can occur in more than 1 in 10):
- headache.
Common side effects are (may affect up to 1 in 10):
- 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.
Less common side effects are (may affect up to 1 in 100):
- 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, itching, urticaria ( hives ), hyperactivity, irritability, restlessness, aggressive behavior, nightmares, mania/hypomania (see also “Warnings and Precautions” in section 2), suicidal ideation or behavior, confusion, weight loss.
Rare side effects are (may affect up to 1 in 1000):
- severe skin rash (itchy redness), facial edema (swelling) and angioedema (swelling of the face, lips, tongue, and/or throat which may cause difficulty 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 Agomelatine STADA
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.
Store in the original package. Moisture sensitive.
No special temperature 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. Contents of the packaging and other information
Content declaration
- The active substance is agomelatine. Each film-coated tablet contains the agomelatine-citric acid crystalline equivalent to 25 mg agomelatine.
- The other ingredients in the tablet core are colloidal silica, microcrystalline cellulose, mannitol, povidone, crospovidone, sodium stearyl fumarate, magnesium stearate, stearic acid.
- The other ingredients in the film coating are hypromellose, macrogol, titanium dioxide (E 171), talc, yellow iron oxide (E 172).
What the medicine looks like and the contents of the pack
Agomelatine Stada 25 mg film-coated tablets are yellow, oblong, biconvex film-coated tablets 9.0 x 4.5 mm.
Agomelatine Stada 25 mg film-coated tablets are available in blisters. Packs of: 7, 14, 28, 42, 56, 84, 98, 100 tablets or 7×1, 14×1, 28×1, 42×1, 56×1, 84×1, 98×1, 100×1 tablets (single-dose pack).
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Other manufacturers
MEDIS International as, vyrobni zavod Bolatice
Prumyslova 961/16
74723 Bolatice
Czech Republic
Local representative
STADA Nordic ApS
Marielundvej 46A
2730 Herlev
Denmark