Faverin 100 mg Film-Coated Tablets

FAVERIN belongs to a group of medicines called selective serotonin re - uptake inhibitors (SSRI). FAVERIN contains a substance called fluvoxamine. This is an antidepressant. It is used to treat depression (major depressive episode). FAVERIN can also treat people who have obsessive - compulsive disorder (OCD).

Do not take FAVERIN:

• If you are allergic (hypersensitive) to fluvoxamine maleate or any of the other ingredients of FAVERIN (listed in section 6).
• If you are taking medicines called monoamine oxidase inhibitors (MAOI) used to treat depression or anxiety. Treatment with FAVERIN should only be started at least 2 weeks after stopping treatment of an MAOI. At least one week should elapse between stopping FAVERIN and starting treatment with an MOAI. Your doctor will advise you how you should begin taking FAVERIN once you have stopped taking the MAOI.
• If you are taking tizanidine, a medicine often used as a muscle relaxant.
• If you are pregnant or breastfeeding.
• If you are under the age of 18 years.
• If you have liver or kidney function problems.
• If you suffer from epilepsy.
• If you are taking pimozide, a medicine used for the treatment of schizophrenia and other psychiatric diseases.

Warnings and precautions

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 or anxiety is getting worse, or if they are worried about changes in your behaviour. Tell your doctor immediately if you have any distressing thoughts or experiences.

Take special care with FAVERIN:

• If you recently had a heart attack.
• If you have epilepsy.
• If you have a history of bleeding problems or if you regularly use medicines which increase the risk of bleeding, such as common pain killers, or if you are pregnant.
• If you have diabetes (high blood sugar levels).
• If you are having treatment with electroconvulsive therapy (ECT).
• If you ever had mania (a feeling of elation or over - excitement).
• If you have liver or kidney problems.
• If you have high pressure in your eyes (glaucoma).

If any of the above applies to you, your doctor will tell you whether it is safe for you to start taking FAVERIN. Occasionally, thoughts of restlessness for example, you cannot sit or stand still (akathisia) may occur or may increase during the first few weeks of treatment with FAVERIN, until the antidepressant effect has started working. Tell your doctor immediately if you experience these symptoms.

Medicines like FAVERIN (so called SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have continued after stopping treatment. On rare occasions development of a serotonin syndrome or neuroleptic malignant syndrome - like events have been reported in association with treatment of FAVERIN, particularly when given in combination with other serotonergic and/or neuroleptic medicines. Inform your doctor immediately if you experience symptoms such as high fever, stiffness, feeling unstable with possible rapid fluctuations of vital signs, mental status changes including confusion, irritability, extreme agitation progressing to delirium and coma.

Children and adolescents

Children and adolescents under 18 years of age should not take FAVERIN.

Other medicines and FAVERIN

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.) Your doctor or pharmacist will check if you are taking other medicines to treat your depression or other related mental disorders, these may include:

• benzodiazepines (e.g. triazolam, midazolam, alprazolam and diazepam)
• tricyclic antidepressants (such as amitriptyline)
• neuroleptics (such as chlorpromazine) or antipsychotics (such as clozapine)
• lithium
• selective serotonin reuptake inhibitors
• tryptophan
• monoamine oxidase inhibitors (MAOIs) such as moclobemide
• pimozide.

Tell your doctor or pharmacist if you are already taking any of the following medicines:

• terfenadine or astemizole (used to treat allergies)
• cisapride (used to treat stomach disorders such as heartburn)
• tacrine (used to treat Alzheimer’s disease)
• theophylline (used to treat asthma and bronchitis)
• methadone (used to treat pain or medicine withdrawal symptoms)
• mexiletine (used to treat abnormal heart rhythms)
• warfarin or other oral anticoagulants (used to prevent blood clots)
• thioridazine (used to treat mental disorders)
• propranolol or atenolol (used to treat high blood pressure and heart disorders)
• ropinirole (used to treat Parkinson’s disease)
• phenytoin or carbamazepine (used to treat epilepsy)
• ciclosporin (used to reduce the activity of the immune system)
• caffeine - containing beverages (see section FAVERIN with food, drink and alcohol below)
• digoxin (used to treat heart disorders)
• other serotonergic agents (including sumatriptan used to treat migraines, tramadol used to treat pain, St John’s Wort, a herbal remedy used to treat mood disorders)
• aspirin or aspirin - like medicines, used to treat pain and inflammation (arthritis)
• sildenafil (used to treat erectile dysfunction)
• alcohol (see section FAVERIN with food, drink and alcohol below).

Do not share medicines prescribed for you with any other person. Always take FAVERIN exactly as your doctor or pharmacist has instructed you. You should check with your doctor or pharmacist if you are unsure.

If you have the impression that the effect of FAVERIN is too strong or too weak, tell your doctor or pharmacist.

Major depressive episodes

The usual daily dose usually varies between 100 mg and 200 mg up to a maximum of 300 mg.

Obsessive - compulsive disorder

The usual daily dosage usually varies between 100 mg and 200 mg up to 300 mg per day.

FAVERIN tablets should be swallowed with water and without chewing the tablets. These tablets are for you. Please do not give them to anyone else, even they have the same symptoms as you.

If you take more FAVERIN than you should

In the event of an overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. Take this leaflet and the remaining tablets with you so the doctor knows what you have taken.

If you forget to take FAVERIN

If you forget to take a tablet, do not take a double dose to make up for a forgotten tablet but continue as prescribed.

If you stop taking FAVERIN

You should not discontinue treatment with FAVERIN abruptly. Withdrawal symptoms, including headache, paraesthesia, nausea, dizziness and anxiety, have been reported after abrupt discontinuation of FAVERIN. Consult your doctor for advice.

FAVERIN can have side effects. Not all side effects reported for this medicine are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking this medicine, please consult your health care provider for advice.

If any of the following happens, stop taking FAVERIN and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing
• rash or itching
• fainting.

These are all very serious side effects. If you have them, you may have had a serious reaction to FAVERIN. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following:

Frequent side effects:

• agitation
• anxiety
• constipation
• diarrhoea
• difficulty sleeping (insomnia)
• dizziness
• dry mouth
• very fast heartbeat
• feeling drowsy (somnolence)
• feeling unwell (malaise)
• headache
• indigestion
• loss of appetite (anorexia)
• nervousness
• stomach pain
• sweating
• tremor
• muscle weakness (asthenia)
• feeling sick (nausea)
• being sick (vomiting).

Less frequent side effects:

• allergic skin reactions (including swelling of face, lip or tongue, rash or itching)
• confusion
• delayed ejaculation
• dizziness when standing up too quickly
• hallucinations
• lack of coordination
• muscle or joint pain
• convulsions
• liver problems
• mania (a feeling of elation or over - excitement)
• sensitivity to sunlight
• unexpected milk flow.

Other side effects reported (frequency not known):

• akathisia (restlessness)
• abnormal taste
• anorgasmia (failure to achieve orgasm)
• disorders with menstruation (monthly bleeding) in female patients
• heavy vaginal bleeding shortly after birth (postpartum haemorrhage)
• micturition disorders (such as the need to urinate frequently during the day and/or the night, the sudden lack of control over urination during the day and/or the night, or the lack of ability to urinate)
• paraesthesia (tingling or numbness)
• glaucoma (increased pressure in eye)
• dilated pupils
• increase in the hormone prolactin (a hormone that supports milk production in a nursing mother)
• weight changes.

An increased risk of bone fractures has been observed when taking this type of medicine. If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: http://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of FAVERIN.

• Store at or below 30 °C in original packs, protected from direct sunlight.

• Do not take the tablets after the expiry date printed on the packet.

• If you don’t need to take this medicine anymore, take it to your doctor or nearest pharmacy who will dispose of it.

• Store all medicines out of reach of children.