Fluvoxamine 50 Mg Film-Coated Tablets
PATIENT INFORMATION LEAFLET
Fluvoxamine 50mg, 100mg Tablets
(Fluvoxamine maleate)
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
^ What Fluvoxamine 50mg, 100mg Tablets is and what it is used for
2 Before you take Fluvoxamine 50mg, 100mg tablets
3 How to take Fluvoxamine 50mg, 100mg Tablets ^ Possible side effects
5 How to store Fluvoxamine 50mg, 100mg Tablets.
6 Further information
Fluvoxamine 50mg, 100mg Tablets is an antidepressant that influences the central nervous system.
Do not take Fluvoxamine 50mg, 100mg Tablets
■ If you are allergic (hypersensitive) to fluvoxamine or any of the other ingredients in the product.
■ If you are taking or have recently taken a medicine that belongs to the group of monoamine oxidase (MAO) inhibitors (medicines to treat depression or Parkinson's disease), or if you are going to use such medicine within the next week. Depending on the type of MAO-inhibitor you must wait for up to two weeks before you can start taking Fluvoxamine 50mg, 100mg Tablets (see ’’Taking other medicines”).
Take special care with Fluvoxamine 50mg, 100mg Tablets
■ If you have diabetes control of blood sugar may be disturbed, especially in the early stages of treatment. The dose of your insulin or the anti-diabetic medicines that you take by mouth may need to be adjusted.
■ If you have reduced liver or kidney function you must tell your doctor, because it may be necessary to prescribe a lower dose for you.
■ If you have recently had a heart attack.
■ If epileptic seizures (convulsions) occur during treatment, Fluvoxamine 50mg, 100mg Tablets should be discontinued. If you already suffer from epilepsy and the frequency of seizures increases during treatment, Fluvoxamine 50mg, 100mg Tablets should also be discontinued.
■ If you have or have had episodes of overactive behaviour or thoughts (mania).
■ If you have a history of bleeding disorder e.g. cutaneous bleeding abnormalities, gynaecological or bleeding from the stomach or if you use medicines which possibly increase tendency to bleed (see section “Taking other medicines”).
■ If you are receiving electric shock treatment.
Use of Fluvoxamine 50mg, 100mg Tablets can be connected with the development of a condition of inner restlessness and inability to sit or stand still. This is most likely to occur in the first weeks of treatment. Increasing the dose can worsen such symptoms.
■ If you develop some or all of the following symptoms: high fever, rigidity, sudden jerks of the muscles, confusion, irritability, extreme agitation, rapid fluctuations in heart beat or breathing rate. If you notice these symptoms, contact your doctor immediately, because you may have something called serotonin-syndrome. Concomitant use of certain other medicines may enhance the risk of this syndrome (see “Taking other medicines”).
■ If you are at risk of a decreased sodium level in the blood (hyponatraemia) e.g. from concomitant medications. Hyponatraemia has been reported rarely during treatment with Fluvoxamine 50mg, 100mg Tablets, predominantly in the elderly.
If you are an eldery patient. Your doctor will increase your dose of Fluvoxamine 50mg, 100mg Tablets more slowly and with extra caution.
Withdrawal symptoms
After the end of therapy, withdrawal symptoms commonly occur, particularly if Fluvoxamine 50mg,
100 mg Tablets are discontinued abruptly (see section 4. “Possible side effects”).
The risk of withdrawal symptoms may be dependent on several factors including the duration of therapy and dosage and the rate of dose reduction.
Thoughts of suicide and worsening of your depression or anxiety disorder
If you are depressed and/or have anxiety disorders you can sometimes have thoughts of harming or killing yourself. These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer. You may be more likely to think like this:
■ If you have previously had thoughts about killing or harming yourself.
■ If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.
If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.
You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You might ask them to tell you if they think your depression is getting worse, or if they are worried about changes in your behaviour.
Children and adolescents of less than 18 years of age
Fluvoxamine 50mg, 100mg Tablets should normally not be used for children and adolescents under 18 years, except for patients over 8 years with obsessive compulsive disorders. Also, you should know that patients under 18 have an increased risk of side-effects such suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines. Despite this, your doctor may prescribe Fluvoxamine 50mg, 100mg Tablets for patients under 18 because he/she decides that this is in their best interests. If your doctor has prescribed Fluvoxamine 50mg, 100mg Tablets for a patient under 18 and you want to discuss this, please go back to your doctor. You should inform your doctor if any of the symptoms listed above develop or worsen when patientsunder18 aretakingFluvoxamine50mg, 100mg Tablets. Also, the long-term safety effects concerning growth, maturation and cognitive and behavioural development of Fluvoxamine 50mg, 100mg Tablets in this age group have not yet been demonstrated.
□ What Fluvoxamine 50mg, 100mg Tablets is and what it is used for
Fluvoxamine 50mg, 100mg Tablets is used for:
■ depressive illness (major depressive episodes)
■ obsessive thoughts and obsessive actions (obsessive compulsive disorders).
Before you take Fluvoxamine 50mg, 100mg Tablets
Taking other medicines
Certain other medicines can affect or be affected by Fluvoxamine 50mg, 100mg Tablets. Please ask your doctor for advice if you are taking:
■ Medicines that belong to the group of MAO inhibitors (MAOI).
If your doctor changes your medicine from a MAOI to Fluvoxamine 50mg, 100mg Tablets, there must be an interval of
- at least 2 weeks after stopping an irreversible MAOI (e. g. selegiline)
- one day after stopping a reversible MAOI (e.g. moclobemide)
Therapy with any MAOI should not be started for at least 1 week after stopping intake of Fluvoxamine 50mg, 100mg Tablets.
■ Other medicine for depression: other serotonin reuptake inhibitors.
■ Medicines containing lithium (antipsychotic) or the dietary supplement tryptophan.
■ Medicines against migraine (triptane).
■ Tramadol (pain-killer).
■ Herbal remedy St.John's Wort (Hypericum perforatum).
Concomitant use of above mentioned medicinal products may e. g. lead to serotonine syndrome or neuroleptic malignant syndrome (see “Do not take Fluvoxamine 50mg, 1o0mg Tablets” and “Take special care with Fluvoxamine 50mg, 100mg Tablets”).
■ Other medicine for depression: tricyclic antidepressants (e. g. clomipramine, imipramine, amitriptyline)
■ Neuroleptics such as clozapine, olanzapine or thioridazine (used to treat schizophrenia).
■ Tizanidine for treatment of muscle disorders. The duration and intensity of its effect may be increased, correlated with increased blood pressure and heart rate.
■ Tacrine (used to treat dementia), Theophylline (used to treat asthma and bronchitis), Methadon (commonly used to treat drug dependence) and Mexiletine (used to treat heart disorders).
■ Propranolol (against high blood pressure).
■ Ropinirole (used to treat Parkinson's Disease).
■ Caffeine (found in tea or coffee). The consumption of high quantities of caffeine-containing beverages should be avoided.
■ Phenytoin (used to treat epilepsy or certain heart rhythm disorders)
■ Terfenadine, astemizole (used to treat allergic reaction) or cisapride (for gastrointestinal disorders). Concomitant use with Fluvoxamine 50mg, 100mg Tablets can lead to disorders of heart rate and these medicinal products should therefore not be used simultaneously.
■ Ciclosporin (used after organ transplant).
■ Carbamazepine (used to treat epilepsy).
■ Benzodiazepines such as triazolam, midazolam, alprazolam and diazepam (uses include treatment of anxiety and epilepsy).
Fluvoxamine 50mg, 100mg Tablets may increase the blood levels of above mentioned medicinal products, which can result in adverse effects. Your doctor may need to adjust the dose of the above mentioned products.
■ Anti-inflammatory medicines/painkillers (e.g. ibuprofen, diclofenac) and acetylsalicylic acid. Warfarin (to prevent blood clotting) and other medcines known to effect blood clotting, e. g. antipsychotics and tricyclic antidepressants.
Concomitant use of above mentioned medicinal products may lead to increased/prolonged bleeding (see “Take special care with Fluvoxamine 50mg, 100mg Tablets“).
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Taking Fluvoxamine 50mg, 100mg Tablets with food and drink
Drink: The film-coated tablets should be swallowed with water.
Alcohol: You should avoid consumption of alcohol during therapy with Fluvoxamine 50mg, 100mg Tablets.
Pregnancy and breast-feeding
There is only limited data available regarding use of fluvoxamine in pregnant women. Therefore Fluvoxamine 50mg, 100mg Tablets should be used with caution during pregnancy. If Fluvoxamine 50mg, 100mg Tablets is used at the end of pregnancy the newborn child may suffer from withdrawal symptoms.
Make sure your midwife and/or doctor know you are on Fluvoxamine. When taken during pregnancy, similar drugs (SSRIs) may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the new born (PPHN), making the baby breathe faster and appear bluish. These symptoms usually begin during the first 24 hours after the baby is born. If this happens to your baby you should contact your midwife and/or doctor immediately.
Fluvoxamine passes into breast milk. Therefore do not take Fluvoxamine 50mg, 100mg Tablets while breastfeeding.
Fluvoxamine has been shown to reduce the quality of sperm in animal studies. Theoretically, this could affect fertility, but impact on human fertility has not been observed as yet.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
In individual cases, the ability to drive and use machines can be reduced.
Fluvoxamine 50mg, 100mg Tablets can cause somnolence as an undesirable effect. Therefore patients should be aware of this at the start of treatment.
Important information about some of the ingredients of Fluvoxamine 50mg, 100mg Tablets
Fluvoxamine 50mg, 100mg Tablets contain lactose.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
continued....
0How to take Fluvoxamine 50mg, 100mg Tablets
Always take Fluvoxamine 50mg, 100mg Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The film-coated tablets should be swallowed without chewing and with water.
The usual dose is:
Major depressive episodes Adults:
Starting dose: 1 or 2 tablets (50mg fluvoxamine maleate) or % or 1 tablet (100 mg) taken as a single dose in the evening. Your doctor may increase the dose gradually until an effective dose is reached.
Usual effective daily dose: 2 tablets (50mg fluvoxamine maleate) or 1 tablet (100 mg). Your doctor will adjust the dose to your individual response.
A daily dose in excess of 3 tablets (50mg fluvoxamine maleate) or 1 % tablets (100mg) should be divided into several doses.
Maximum dose: 6 (50mg fluvoxamine maleate) or 3 tablets (100mg), daily.
Children and adolescents of less than 18 years of age
Fluvoxamine 50mg, 100mg Tablets should not be used in children and adolescents of less than 18 years of age (see “Take special care with Fluvoxamine 50mg, 100mg Tablets”).
Obsessive-compulsive disorders Adults:
Starting dose: 1 tablet (50mg fluvoxamine maleate) or % tablet (100 mg) per day for 3-4 days .
Your doctor may increase the dose gradually until an effective dose is reached.
Usually effective dose: 2-6 tablets (50 mg fluvoxamine maleate) or 1-3 tablets (100 mg) per day.
Maximum daily dose: 6 tablets (50mg fluvoxamine maleate) or 3 tablets (100mg).
The tablets should be taken preferably in the evening as a single dose. A daily dose in excess of 3 tablets (50 mg fluvoxamine maleate) or 1 % tablets (100 mg) should be taken in 2 or 3 divided doses.
Children and adolescents over 18 years of age
For children over 8 years and adolescents the starting dose is % tablet (50 mg fluvoxamine maleate) per day. Your doctor will increase the dose every 4-7 days in % tablet (50 mg fluvoxaine maleate) as tolerated until an effective dose is achieved.
A total daily dose of more than 1 tablet (50 mg fluvoxamine maleate) or % tablet (100mg) should be given in two divided doses. If doses are not equal, the larger dose should be given at bedtime.
Maximum dose: 4 tablets (50mg fluvoxamine maleate) or 2 tablets (100mg).
Patients with hepatic and renal insufficiency should commence treatment at a low dose.
Duration of treatment
The duration depends on the course of the disease and is determined by your doctor.
Major depressive episodes It may take a few weeks or more until you start feeling better. After the symptoms have disappeared treatment should be continued for at least 6 month.
Obsessive-compulsive disorders If no improvement is observed after 10 weeks your doctor may decide to stop prescribing Fluvoxamine for you. If you respond well to Fluvoxamine, your doctor will most likely continue treatment with Fluvoxamine. He/she will then periodically reassess the need for treatment.
Before terminating treatment, gradual dose reduction is to be taken into consideration.
If you take more Fluvoxamine 50mg, 100mg Tablets than you should
If you have taken too much Fluvoxamine 50mg, 100mg Tablets you should contact your doctor or a hospital.
Symptoms of overdose:
Nausea, vomiting and diarrhoea, sleepiness, dizziness, rapid heart beat, slow heart beat and low blood pressure, liver function disturbances, seizures and coma.
If you forget to take Fluvoxamine 50mg, 100mg Tablets
Do not take a double dose to make up for a forgotten dose. Continue intake as prescribed by your doctor.
If you stop taking Fluvoxamine 50mg, 100mg Tablets
Please speak with your doctor if you want to terminate or interrupt treatment.
Withdrawal symptoms may occur when you stop taking Fluvoxamine 50mg, 100mg Tablets (see section 4 “Possible side effects"). Since the risk of withdrawal symptoms is higher when you stop taking Fluvoxamine 50mg, 100mg Tablets abruptly, your doctor will gradually reduce the dose over a period of at least 1-2 weeks.
Nervous system disorders Common: sleepiness, sleep disturbances, feeling nervous, trembling, headache, dizziness, restlessness Uncommon: movement disorders, difficulty in co-ordinating movement and impaired tension of muscles
Rare: convulsions Cardiac disorders
Common: increased heart rate or palpitations Vascular disorders:
Uncommon: low blood pressure (when changing posture from lying to standing)
Gastrointestinal disorders:
Very common: nausea
Common: abdominal pain, digestive disorders (a feeling of pressure in the stomach, bloating, loss of appetite), constipation, diarrhoea, vomiting, dry mouth
Hepato-biliary disorders:
Rare: liver function disorders
Skin and subcutenous tissue disorders:
Common: sweating
Uncommon: allergic skin reactions such as rash, itching, swelling Rare: sensitivity to light
Reproductive system and breast disorders:
Uncommon: delayed ejaculation
Rare: milky secretion from the breast gland
(galactorrhoea)
Musculoskeletal disorders:
Uncommon: joint pain, muscle pain
Other side effects Weight gain or weight loss.
An increased risk of bone fractures has been observed in patients taking this type of medicines.
Common: weakness, feeling sick Rare: serotonin syndrome, neuroleptic-malignant syndrome, hyponatremia and abnormal bleeding (see also “Taking other medicines” and “Take special care with Fluvoxamine 50mg, 100mg Tablets”),
Very rare: taste abnormalities, sensation of pins and needles, failure to experience orgasm.
Withdrawal svmtoms
After the end of therapy commonly occur, particularly Fluvoxamine 50mg, 100mg Tablets are discontinued abruptly. The risk of withdrawal symptoms may be dependent on the duration of therapy and dosage and the rate of dose reduction.
Dizziness, sensory disturbances (including tingling in arms and legs and electric shock sensation), sleep disturbances (including intense dreams), inner restlessness or anxiety, nausea, tremor, confusion, sweating, headache, diarrhoea, palpitations, emotional instability, irritability, and visual disturbances have been reported. Most of these symptoms are mild to moderate, however, in some patients they may also be severe in intensity. They usually occur within the first few days of discontinuing treatment. Generally, these symptoms are self-limiting and spontaneously resolve within 2 weeks, though in some individuals they may be prolonged. It is therefore advised to discontinue treatment gradually by stepwise reduction in the dose over a period of several weeks or months.
How to store Fluvoxamine 50mg, 100mg Tablets
Keep out of the reach and sight of children.
Do not store above 25 °C.
Keep the blister in the carton, in order to protect from light and moisture.
Do not use Fluvoxamine 50mg, 100mg Tablets after the expiry date which is stated on the carton and the blister. The expiry date refers to the last day of that month.
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.
Further information
What Fluvoxamine 50mg, 100mg Tablets contains
■ The active substance is 50mg, or 100 mg fluvoxamine maleate in 1 film-coated tablet.
■ The other ingredients are:
Lactose monohydrate, mannitol, maize starch, hypromellose, polyethylene glycol 4000, pregelatinized starch, sodium stearyl fumarate, colloidal anhydrous silica, titanium dioxide (colouring agent E 171)
What Fluvoxamine 50mg, 100mg Tablets look like and contents of the pack
Fluvoxamine 50mg, 100mg Tablets are white, biconvex, round film-coated tablets with a score.
If intolerable withdrawal symptoms occur after dose reduction or discontinuation of the medicinal product, inform your doctor. He/she may consider to decrease your dose in smaller steps.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, Fluvoxamine 50mg, 100mg Tablets can cause side effects, although not everybody gets them.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Frequencies are defined as:
Very common: in more than 1 of 10 patients Common: in more than 1 of 100, but in less than 1 of 10 patients
Uncommon: in more than 1 of 1000, but in less than 1 of 100 patients.
Rare: in more than 1 of 10,000 , but less than 1 of 1000 patients
Very rare: in less than 1 of 10,000 patients Frequency not known: frequency cannot be estimated from the available data
Psychiatric disorders:
Common: anxiety
Uncommon: confusion, hallucinations
Rare: episodes of overactive behaviour or thoughts
(mania)
Frequency not known: Suicidal thoughts and thus related behaviour (see section “Take special care with Fluvoxamine 50mg, 100 mg Tablets”)
The tablets are packed in blisters in a carton containing 15, 20, 30, 40, 50, 60, 90, and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Tillomed Laboratories Ltd 3 Howard Road,
Eaton Socon St. Neots Cambridgeshire PE198ET United Kingdom
Manufacturer
Salutas Pharma GMBH Otto-von-Guericke-Allee 1, D-39179 Barleben,
Germany
Product Licence Number:
Fluvoxamine 50mg Tablets: PL 11311/0488
Fluvoxamine 100mg Tablets: PL 11311/0489
Til-Ver.5.1s
Date of last revision: June 2012
|
Product Name |
Fluvoxamine |
|
Strength / Form |
50 & 100mg Tablets |
|
Type |
PIL |
|
Dimensions |
165 mm x 550 mm |
|
Typefaces |
Font SansSerif - Min. Text 8pt |
|
Rev # |
Til-Ver.5.1s |
|
Last updated |
28/06/12 |
|
No. of Colours |
Pantone Black CVC |