25 mg film-coated tablets
agomelatine
What Valdoxan is and what it is used for
Valdoxan contains the active substance agomelatine. It belongs to a group of medicines called antidepressants. You have been given Valdoxan to treat your depression.
Valdoxan is used in adults.
Depression is a persistent mood disorder that affects daily life. The symptoms of depression vary from person to person but often include deep sadness, feelings of worthlessness, loss of interest in favorite activities, sleep disturbances, feelings of slowness, feelings of anxiety, and weight changes.
The expected benefits of Valdoxan are to reduce and eventually eliminate symptoms associated with your depression.
What you need to know before taking Valdoxan
Do not take Valdoxan
- if you are allergic to agomelatine or any of the other ingredients of this medicine (listed in section 6).
- if your liver does not work properly (hepatic impairment).
- if you are taking fluvoxamine (another medicine to treat depression) or ciprofloxacin (an antibiotic ).
Warnings and precautions
There may be reasons why Valdoxan is not suitable for you:
- If you are taking medicines that are known to affect the liver. Ask your doctor for advice on which medicines this may apply to.
- 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 decide if Valdoxan is a suitable treatment for you.
- If you have bipolar disorder, have had or you develop manic symptoms (a period of abnormally high irritability and emotionality) 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 as to whether it is suitable for you to take Valdoxan.
During treatment with Valdoxan:
To avoid possible serious liver problems:
- Your doctor must have checked that your liver is working properly before treatment begins. Some patients may have elevated levels of liver enzymes in their blood when treated with Valdoxan. Follow-up samples must therefore be taken at the following times:
| before starting the dose increase | after approx three weeks | after approx6 weeks | after approx12 weeks | after approx24 weeks | |
|---|---|---|---|---|---|
| Blood samples | x | x | x | x | x |
Based on the evaluation of these tests, the doctor will assess whether you should start using or continue using Valdoxan (see also How to take Valdoxan in section 3).
Be aware of signs and symptoms that the liver is not working properly
If you observe any of these signs and symptoms of liver problems: o usual dark urine, light stools, yellow skin/yellow eyes, pain in the upper right side of the abdomen, abnormal tiredness (especially in conjunction with other symptoms listed above), seek advice doctor immediately who may tell you to stop taking this medicine.
The efficacy of Valdoxan has not been documented in patients aged 75 years and older. Valdoxan should therefore not be used in these patients.
If you start to feel worse and have thoughts of harming yourself
You who are depressed may sometimes have thoughts of harming yourself or committing suicide. These symptoms may worsen when you start using anti-depressant drugs, as it takes time for drugs of this type 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 antidepressants have an increased risk of suicidal thoughts and thoughts of harming themselves.
Contact a doctor or the nearest hospital immediately if you have thoughts of harming yourself or committing suicide.
It may help to tell a relative or close friend that you are depressed. Please ask them to read this leaflet. You can also ask them to tell you if they think you seem to be feeling worse or if they think your behavior is changing.
Children and young people
Valdoxan should not be used in children and adolescents (under 18 years of age).
Other medicines and Valdoxan
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
You should not take Valdoxan at the same time as certain medicines (see also “Do not take Valdoxan” in section 2): fluvoxamine (another medicine used to treat depression), ciprofloxacin (an antibiotic ) can 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 ), or enoxacin ( antibiotic ). Tell your doctor if you smoke more than 15 cigarettes a day.
Valdoxan with alcohol
Consumption of alcohol during treatment with Valdoxan is not recommended.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Breastfeeding should be discontinued if you are taking Valdoxan.
Driving ability and use of machinery
You may experience dizziness or sleepiness, which may affect your ability to drive or operate machinery. Make sure your reactions are normal before driving or using machines.
Valdoxan contains lactose and sodium
If you have an intolerance to certain sugars, you should consult your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is almost “sodium-free”.
How to take Valdoxan
Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
The recommended dose of Valdoxan is one tablet (25 mg) before bedtime. In some cases, your doctor may prescribe a higher dose (50 mg), i.e. two tablets are taken together before bedtime.
Mode of administration
Valdoxan is for oral use. The tablet should be swallowed with water. Valdoxan can be taken with or without food.
Treatment time
In most depressed people, Valdoxan starts to work on depression symptoms within two weeks of starting treatment.
Your depression should be treated for a long enough period of at least 6 months to ensure that you are free of symptoms.
Your doctor may continue to give you Valdoxan even if you feel better to prevent your depression from coming back.
If you have problems with your kidneys, your doctor will make an individual assessment of whether it is safe for you to take Valdoxan.
Monitoring of liver function (see also section 2)
Your doctor will take laboratory tests to check that your liver is working 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 50 mg, laboratory tests should be done 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 Valdoxan if your liver is not working properly.
How do you switch from an antidepressant (SSRI/SNRI) to Valdoxan?
If your doctor wants you to switch from your previous SSRI/SNRI-type antidepressant to Valdoxan, he/she will tell you how to stop the previous medicine when treatment with Valdoxan is started.
You may for a few weeks experience withdrawal symptoms associated with discontinuing your previous medication, even if the dose of your previous antidepressant is gradually reduced.
Withdrawal symptoms include dizziness, numbness, sleep disturbances, restlessness or anxiety, headache, nausea, vomiting, and tremors. Symptoms are usually mild or moderate and disappear on their own within a few days.
If treatment with Valdoxan is started while the dose of one of the previous drugs is being tapered, any withdrawal symptoms should not be confused with the absence of the early effect of Valdoxan.
Always discuss with your doctor how best to discontinue your previous antidepressant when starting treatment with Valdoxan.
If you have taken too much Valdoxan
If you have taken a larger amount of Valdoxan than you should, or if e.g. If a child has taken the medicine by mistake, you should immediately contact a doctor.
Experience of overdose with Valdoxan is limited but reported symptoms include upper abdominal pain, drowsiness, fatigue, hyperactivity, restlessness, tension, dizziness, decreased blood oxygenation, and diffuse discomfort.
If you forget to take Valdoxan
Do not take a double dose to make up for a missed dose. Continue with the next dose at the usual time.
The calendar printed on the blister card with the tablets helps you remember when you last took a Valdoxan tablet.
If you stop taking Valdoxan
You should not stop taking your medicine without consulting a doctor even if you feel better.
If you have any further questions about this medicine, ask your doctor or pharmacist.
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, sleepiness, insomnia, nausea, diarrhea, constipation, abdominal pain, back pain, tiredness, 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 in the 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 thoughts or behavior, confusion, weight loss, muscle pain.
- Rare side effects ( may affect up to 1 in 1,000 people): serious skin rash (itchy 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), inflammation of the liver, yellowing of the skin or the whites of the eyes (jaundice), liver failure*, hallucinations, inability to be still (due to physical and mental restlessness), inability to empty the bladder.
*A few cases resulting in liver transplantation or death have been reported.
How Valdoxan should be stored
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the carton and blister card. The expiration date is the last day of the specified month.
No special storage instructions.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents 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, and indigo carmine (E132).
Appearance and package sizes of the medicine
Valdoxan 25 mg film-coated tablets (tablets) are oblong, orange-yellow with a blue company logo printed on one side.
Valdoxan 25 mg film-coated tablets are available in calendar packs (blisters) of 14, 28, 56, 84, or 98 tablets. Packs of 100 film-coated tablets for hospital use are also available.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Les Laboratoires Servier
50, rue Carnot
92284 Suresnes Cedex
France
Manufacturer
Les Laboratoires Servier Industrie
905, route de Saran
45520 Judy
France
Servier (Ireland) Industries Ltd
Gorey amused
Arklow – Co. Wicklow
Ireland
Anpharm Przedsiebiorstwo Farmaceutyczne SA
ul. Annopol 6B
03-236 Warsaw
Poland
Laboratorios Servier, SL
Abda. de los Madroños, 33
28043 Madrid
Spain
Contact the representative of the marketing authorization holder if you want to know more about this medicine.
| België/Belgique/BelgienSA Servier Benelux NVPhone: +32 (0)2 529 43 11 | LithuaniaUAB “SERVIER PHARMA”Phone: +370 (5) 2 63 86 28 |
| BulgariaServie Medikal EOODTel.: +359 2 921 57 00 | Luxembourg/LuxembourgSA Servier Benelux NVPhone: +32 (0)2 529 43 11 |
| Czech RepublicServier s.r.oPhone: +420 222 118 111 | MagyarországServier Hungaria Kft.Phone: +36 1 238 7799 |
| DenmarkServier Danmark A/SPhone: +45 36 44 22 60 | MaltaVJ Salomone Pharma LtdPhone: +356 21 22 01 74 |
| DeutschlandServier Deutschland GmbHPhone: +49 (0)89 57095 01 | The NetherlandsServier Nederland Farma BVPhone: +31 (0)71 5246700 |
| EstoniaServier Laboratories OÜPhone: + 372 664 5040 | NorwayServier Danmark A/SPhone: +45 36 44 22 60 |
| GreeceΣΕΡΒΙΕ ΕΛΛΑΣ ΦΑΡΜΑΚΕΥΤΙΚΙΕΠΕTel: +30 210 939 1000 | AustriaServier Austria GmbHPhone: +43 (1) 524 39 99 |
| SpainLaboratorios Servier SLPhone: +34 91 748 96 30 | PolishServier Polska Sp. z o. oPhone: +48 (0) 22 594 90 00 |
| FranceLes Laboratoires ServierPhone: +33 (0)1 55 72 60 00 | PortugalServier Portugal, LdaTel.: +351 21 312 20 00 |
| HrvatskaServier Pharma, dooTel.: +385 (0)1 3016 222 | RomaniaServier Pharma SRLPhone: +4 021 528 52 80 |
| IrelandServier Laboratories (Ireland) Ltd.Phone: +353 (0)1 663 8110 | SlovenijaServier Pharma dooTel.: +386 (0)1 563 48 11 |
| IcelandServier Laboratoriesc/o Icepharma hfTelephone: +354 540 8000 | Slovenian RepublicServier Slovensko spol. s roTel.:+421 (0) 2 5920 41 11 |
| ItalyServier Italia SpAPhone: +39 06 669081 | Finland/FinlandServier Finland OyP./Tel: +358 (0)9 279 80 80 |
| CyprusCA Papaellinas Ltd.Phone: +357 22741741 | SwedenServier Sweden ABPhone: +46 (0)8 522 508 00 |
| LatviaSIA Servier LatviaPhone: +371 67502039 | United Kingdom (Northern Ireland)Servier Laboratories (Ireland) LtdPhone: +44 (0)1753 666409 |