Milpran Special Precautions

Abnormal bleeding/haemorrhage: SSRIs/SNRIs may increase the risk of postpartum haemorrhage.
Sexual Dysfunction: Selective serotonin reuptake inhibitors (SSRIs)/Serotonin-norepinephrine reuptake inhibitors (SNRIs) may cause symptoms of sexual dysfunction. There have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of SSRIs/SNRIs.
Suicidal thoughts and worsening of depression or anxiety disorder: If the patient suffers from depression and/or anxiety disorders, he/she can sometimes have thoughts of self-injury (hurting him/herself) or suicide. These symptoms may worsen when first starting treatment with antidepressants, as these medicines do not take effect immediately but only after 2 weeks of treatment or more.
Patient is more likely to have these types of symptoms in the following cases: if he/she has had suicidal thoughts or thoughts of self-injury in the past; if he/she is a young adult. Clinical studies have shown an increased risk of suicidal behaviour in adults under the age of 25 with a psychiatric illness and being treated with an antidepressant.
If patient has suicidal thoughts or thought of self-injury, he/she should contact the doctor or go directly to hospital. Advise patient that he/she can get help from a friend or relative, explaining that he/she is depressed or that has anxiety disorder, and ask a friend/relative to read the product leaflet. The friend/relative can tell the patient if they think the depression or anxiety is getting worse, or if they are worried about changes in patient's behaviour.
Advise patient to talk to the doctor before taking Milpran, especially if he/she has history of bleeding disorders or if she is pregnant (see Use in Pregnancy & Lactation).
Be advised in the event of: Serotonin syndrome: It may include digestive symptoms (diarrhoea), changes in psychiatric status and behaviour (agitation, confusion, weakened form of mania), motor dysfunction (tremor, rigidity, muscle twitch, overactive reflexes, disturbance of the motion coordination) or autonomic instability (labile blood pressure, fast heartbeat, shivering, increased body temperature, possible coma).
Insomnia or nervousness at the beginning of treatment.
Kidney failure: Daily dose may need to be changed.
An enlarged prostate (benign prostatic hyperplasia) or difficulty urinating or other genito-urinary disorders.
High blood pressure (hypertension) or heart disease.
Vision disorders related to an increase in the pressure of the fluid in the eyes (narrow-angle glaucoma).
Epilepsy or a history of epilepsy.
Mania.
Jaundice (yellowing of the skin and the whites of the eyes) or liver dysfunction.
Due to the risk of hyponatremia (a reduction in the level of sodium in the blood): Caution is advised in elderly, patients taking diuretics or other treatment known to induce hyponatremia, patients with cirrhosis or malnutrition.
Advise patient to talk to the doctor or pharmacist if he/she has any further questions on the use of this product.
Driving and using machines: This medicine may cause dizziness, especially at the beginning of treatment. Advise patient to not drive vehicles or operate machines which require attention if he/she experiences this side effect.
Use in children: Milnacipran should not be used in children and adolescents under 18 years.
It is also important to know that patients under 18 have an increased risk of side effects such as attempting suicide, suicidal thoughts and hostile behaviour (predominantly aggressiveness, oppositional behaviour and anger) when treated with this group of drugs. However, Milpran may be prescribed to patients under 18 if this is in the patient's interest. Be advised if a patient under 18 taking Milpran develops any of the symptoms listed previously or if they worsen. Long-term safety of Milnacipran in terms of growth, maturation and cognitive and behavioural development has not yet been established in this age group.