Film-coated tablet 25 mg
(Agomelatine Anpharm 25 mg film-coated tablets are oblong, orange-yellow with a blue company logo printed on one side.)
What Agomelatine Anpharm is and what it is used for
Agomelatine Anpharm contains the active substance agomelatine. It belongs to a group of medicines called antidepressants and you have been given Agomelatine Anpharm to treat your depression.
Agomelatine Anpharm is used in adults.
Depression is a persistent disorder of the 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 Anpharm are to reduce and eventually eliminate the symptoms associated with your depression.
Agomelatine contained in Agomelatine Anpharm 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 using Agomelatine Anpharm
Do not take Agomelatine Anpharm
- 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 Anpharm 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 Anpharm 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 Anpharm.
During treatment with Agomelatine Anpharm:
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 Anpharm. Follow-up samples must therefore be taken at the following times:
| before startor dose increase | after approxThree weeks | after approx6 weeks | after approx12 weeks | after approx24 weeks | |
| Blood tests | x | x | x | x | x |
Based on the evaluation of these tests, your doctor will decide whether to start using or continue to use Agomelatine Anpharm (see also How to take Agomelatine Anpharm 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 urge you to stop taking this medicine.
The efficacy of Agomelatine Anpharm has not been established in patients 75 years of age and older. Therefore, Agomelatine Anpharm 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 Anpharm is not intended for use in children and adolescents (under 18 years of age).
Other medicines and Agomelatine Anpharm
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
You should not take Agomelatine Anpharm at the same time as certain medicines (see also “ Do not take Agomelatine Anpharm” 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 Anpharm with alcohol
Alcohol consumption during treatment with Agomelatine Anpharm 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 Anpharm.
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 Anpharm contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Agomelatine Anpharm.
3. How to use Agomelatine Anpharm
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 Anpharm 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 Anpharm begins to have symptoms of depression within two weeks of starting treatment. Your doctor may continue to give you Agomelatine Anpharm even if you feel better about preventing your depression from returning.
How to switch from an antidepressant drug (SSRI / SNRI) to Agomelatine Anpharm?
If your doctor wants you to switch from your previous SSRI / SNRI antidepressant to Agomelatine Anpharm, he/she will tell you how to discontinue the previous medicine when starting treatment with Agomelatine Anpharm.
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 Anpharm 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 Anpharm.
Always discuss with your doctor how to best discontinue your previous antidepressant when starting treatment with Agomelatine Anpharm.
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 Anpharm 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 Anpharm.
Method of administration
Agomelatine Anpharm is for oral use. The tablet should be swallowed with water. Agomelatine Anpharm can be taken with or without food.
Treatment time
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.
Experience with overdose with Agomelatine Anpharm 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 take Agomelatine Anpharm
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 with the tablets will help you remember when you last took an Agomelatine Anpharm tablet
If you stop taking Agomelatine Anpharm
You should discuss this with your doctor before stopping taking this medicine.
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 10 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, 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, muscle pain.
- Rare side effects (may affect up to 1 in 1,000 people): 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 Anpharm
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. 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. Contents of the packaging and other information
Content declaration
- The active substance is agomelatine. One film-coated tablet contains 25 mg of agomelatine.
- Other ingredients are:
- lactose monohydrate, corn starch, povidone K30, sodium starch glycolate type A, stearic acid, magnesium stearate, colloidal anhydrous silica, hypromellose, glycerol, macrogol 6000, yellow iron oxide (E172), and titanium dioxide (E171).
- printing ink: shellac, propylene glycol, concentrated ammonia solution, and indigo carmine (E132).
- lactose monohydrate, corn starch, povidone K30, sodium starch glycolate type A, stearic acid, magnesium stearate, colloidal anhydrous silica, hypromellose, glycerol, macrogol 6000, yellow iron oxide (E172), and titanium dioxide (E171).
What the medicine looks like and the contents of the pack
Agomelatine Anpharm 25 mg film-coated tablets are oblong, orange-yellow with a blue company logo printed on one side.
Agomelatine Anpharm 25 mg film-coated tablets are available in blisters. The calendar packs contain 14, 28, 56, 84, or 98 tablets. Calendar packs of 100 film-coated tablets for hospital use are also available.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Anpharm Przedsiebiorstwo Farmaceutyczne SA
ul. Annopol 6B
03-236 Warsaw
Poland
Manufacturer
The Laboratories Servier Industrie
905, route de Saran
45520
France
Servier (Ireland) Industries Ltd
Gorey road
Arklow – Co. Wicklow
Ireland
Anpharm Przedsiebiorstwo Farmaceutyczne SA
ul. Annopol 6B
03-236 Warsaw
Poland
Servier Laboratorios, SL
Avda. de los Madroños, 33
28043 Madrid
Spain
This medicinal product is authorized under the European Economic Area under the names:
Denmark: Agomelatine Anpharm
Finland: Agomelatine Anpharm 25 mg
France: AGOMELATINE BIOGARAN 25 mg, compressed pelleted
Greece: Agomelatine Biogaran 25 mg Reciprocating Disease With Disease
Latvia: Agomelatine Anpharm 25 mg apvalkotās tablets
Lithuania: Agomelatine Anpharm 25 mg tablets are available in tablets
Poland: Agomelatyna Egis
Portugal: Agomelatina Biogaran 25 mg compresses by pill
Slovakia: Agomelatine Anpharm 25 mg film orally tablets
Slovenia: Agomelatin Anpharm 25 mg film-free tablet
Spanien: Agomelatina Danval 25 mg compresses obtained with film
Germany: Agomelatin Anpharm 25 Mg Film Tablet
Hungary: Agomelatin Anpharm 25 mg film tablet