Milpran

Milnacipran hydrochloride.

MILPRAN CAPSULES 25MG: Opaque light pink cap and body No. 4 capsule, black print of "PM020" on both cap and body.
MILPRAN CAPSULES 50MG: Light coffee cap, dark coffee body No. 3 capsule, black print of "PM021" on both cap and body.
The active substance is milnacipran hydrochloride.
Milpran capsules 25mg: each capsule contains 25mg of milnacipran hydrochloride.
Milpran capsules 50mg: each capsule contains 50mg of milnacipran hydrochloride.
Excipients/Inactive Ingredients: Dicalcium phosphate, Povidone K30, Calcium carboxymethyl cellulose, Silicon dioxide, Magnesium stearate, Micro talc, Alcohol 95%, Purified water.
The composition of the capsule shell: Gelatin, Sodium lauryl sulfate, Titanium dioxide, Brilliant blue FCF, New coccin, Tartrazine, Purified water.
The composition of the printing ink: Shellac, Iron Oxide Black, butyl alcohol, propylene glycol, isopropyl alcohol, ammonium hydroxide.

Milpran contain a medicine called milnacipran. It belongs to a group of medicines called 'antidepressants'. Milpran capsules are recommended to treat depression in adults.
The effect of Milpran is visible after a certain period of time varying from 1 to 3 weeks.

Advise patient to always take this medicine exactly as prescribed, and to check with the doctor if not sure.
The usual dose is 1 capsule of 50 mg in the morning and 1 capsule of 50 mg in the evening, preferably with a meal.
If patient suffers from renal insufficiency, the recommended dose is reduced according to the degree of alteration in renal function. In this case use the 25 mg capsules. Determine what dose is appropriate for the patient.
If patient feels that the effect of Milpran is too strong or too weak, advise patient to talk to the doctor or pharmacist.
Swallow the capsules with a glass of water preferably with food.
Duration: Treatment will usually last for several months.
Advise patient not to stop treatment even if he/she is feeling better. If necessary, treatment must be stopped gradually in accordance with the doctor's instructions (see "If patient stops taking Milpran" as follows and Side Effects).
If patient forgets to take Milpran: Do not take a double dose to make up for a forgotten dose.
Advise patient to ask the doctor or pharmacist if he/she has any further questions on the use of this product.
If patient stops taking Milpran: Advise patient not to stop taking Milpran unless prescribed. Since withdrawal symptoms may occur after the end of treatment, a gradual dose reduction is recommended. In general, the withdrawal symptoms are mild to moderate and self-limiting; however, in some patients, they may be severe in intensity and may be prolonged (2-3 months or more). Advise patient to ask the doctor or pharmacist if he/she has any further questions on the use of this product.

Advise patient to talk to a doctor or go to a hospital straight away if he/she takes more of this medicine than prescribed. Patient should take the medicine pack with him/her, even if there are no tablets left.
Medical treatment can be necessary.

Patient should not take Milpran: If he/she is allergic to milnacipran or any of the other ingredients of this medicine (see Description).
If patient is already taking other medicines for depression: irreversible MAO inhibitors (iproniazid, nialamide).
If patient is already taking certain medicines for Parkinson's disease: selective MAO-B inhibitors (selegiline).
If patient is already taking certain medicines affecting the heart (digitalis (digoxin)).
If patient is already taking certain medicines for migraines (sumatriptan and other drugs in the same group).
If patient is breast-feeding.
If patient has high blood pressure and is not being treated or if he/she has severe or unstable coronary heart disease.
Patient should not take Milpran if any of the previously mentioned applies. He/she should talk to the doctor or pharmacist before taking Milpran if not sure.
Do not generally take Milpran: If patient is already taking certain medicines affecting the cardiovascular system (adrenaline or noradrenaline taken by injection, clonidine and similar).
If patient is already taking certain other medicines for depression (moclobemide, toloxatone).
If patient has trouble in urinating due to an enlarged prostate (benign prostatic hyperplasia) or if patient has other genito-urinary disorders.

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.

Be advised if patient is pregnant or breast-feeding, thinks she may be pregnant or is planning to have a baby before prescribing this medicine.
Pregnancy: It is not recommended to take this medicine if patient is a woman of childbearing potential not using contraception and during pregnancy. Advise patient to consult a doctor if she discovers that she is pregnant during treatment, to decide whether or not treatment should be continued.
If patient is taking Milpran until delivery, the baby could present immediately or soon after delivery reversible symptoms linked to a withdrawal syndrome or exposure to milnacipran. In that case, a clinical surveillance should be performed.
Advise patient to ask the doctor or pharmacist before taking any medicines.
Observational data indicate an increased risk (less than 2-fold) of postpartum haemorrhage following SSRIs/SNRIs exposure within the month prior to birth. If patient takes Milpran near the end of pregnancy there may be an increased risk of heavy vaginal bleeding shortly after birth, especially if the patient has a history of bleeding disorders. Be aware if patient is taking Milpran.
Breast-feeding: This medicine may pass in the mother's milk. Therefore, breast-feeding is contraindicated. Advise patient to ask the doctor or pharmacist before taking any medicines.
Fertility: Animal fertility is affected by Milnacipran.
There is no available data on impact of Milnacipran on human fertility.

Like all medicines, this medicine can cause side effects, although not everybody gets them. Side effects can occur especially in the first week or the first two weeks of treatment with milnacipran.
Be immediately advised if patient has any of the following side effects: If he/she develops a rash or an allergic reaction such as itching, swollen lips and/or tongue or wheezing and/or shortness of breath, stop taking the capsules.
If patient experiences sudden weakness or numbness in the face, arms or legs, particularly on one side only, or speech difficulties (symptoms of a cerebrovascular accident).
If patient has heart problems such as chest pain (feeling of tension, tightness, squeezing).
If patient has a set of symptoms related to excess serotonin in the brain (serotonin syndrome) due to significant effects from Milpran manifested by a high fever, nausea, excessive sweating, anxiety, hot flushes, twitching or muscle tremors, palpitations and restlessness. This syndrome is seen particularly in patients taking other drugs simultaneously.
Very common (may affect more than 1 in 10 people): Headache, nausea.
Common (may affect up to 1 in 10 people): Agitation, anxiety, depression, eating disorders, sleep disorders, suicidal behaviour; Migraines, tremors, dizziness, changes in sensitivity, somnolence; Feeling the heartbeat (palpitations), faster heartbeat (tachycardia), increased blood pressure, hot flush; Abdominal pain, diarrhoea, constipation, dry mouth, indigestion, vomiting; Itching, rash, excessive sweating; Muscle pains; Inability to urinate, abnormally frequent urination (pollakiuria); Erectile dysfunction, ejaculation disorders, testicular pain; Fatigue.
Uncommon (may affect up to 1 in 100 people): Hypersensitivity; Increased lipids in the blood, weight loss; Feelings of panic, confusion, delusion, strange visions or sounds (hallucinations), hyperactive behaviour or thoughts (mania), decreased libido, abnormal dreams, suicidal thoughts; Memory problems, feeling restless (akathisia), balance problems, taste changes, syncope; Blurred vision, dry eyes, painful eyes, decreased visual acuity, dilated pupils (mydriasis), accommodation disorders; Sensation of dizziness or spinning (vertigo), ringing or buzzing in the ears (tinnitus); Heart problems, such as low blood pressure, conduction abnormalities; Poor circulation, causing numbness and discoloration in fingers and toes (Raynaud's syndrome), orthostatic hypotension; Difficulty breathing, cough, dry nose, throat conditions; Gastrointestinal disorders such as gastritis, stomatitis, abdominal discomfort, abdominal distension, ulcers, haemorrhoids, colitis; Disturbed liver function tests; Skin disease (dermatosis), allergic skin reactions (hives), skin inflammation (dermatitis); Muscle pain or stiffness; Urinary problems such as urination disorders, urinary retention, incontinence, possibly red-coloured urine; Some women may have irregular heavy menstrual bleeding or no period; Prostate disorders; Feeling abnormal, pain, chills.
Rare (may affect up to 1 in 1,000 people): Anaphylactic shock; Inappropriate secretion of a hormone controlling urine volume (syndrome of inappropriate antidiuretic hormone secretion); Psychotic disorders, derealisation (thinking abnormal); Involuntary movements (dyskinesia), parkinsonism (medical term that can include many symptoms, such as increased secretion of saliva, musculoskeletal stiffness, limited or abnormal body movements, lack of facial expression, muscle tightness, shaking), convulsion; Heart-related pain behind the sternum, which can radiate into the environment (Angina pectoris); Hepatitis, hepatocellular damage Sensitivity to sunlight (photosensitivity reaction).
The following side effects have been reported, however precise frequency cannot be identified and therefore how often these occur is classed as not known: A reduction in the level of sodium in the blood (hyponatremia); bleeding of the skin and mucous membranes; convulsions especially in patients with a history of epilepsy; Serotonin Syndrome; Aggression; Cytolytic hepatitis; Stevens-Johnson syndrome (a serious generalised illness with blistering of the skin and the mucous membranes); Takotsubo cardiomyopathy (Stress cardiomyopathy); *Heavy vaginal bleeding shortly after birth (postpartum haemorrhage), see Use in Pregnancy & Lactation.
*This event has been reported for the therapeutic class of SSRIs/SNRIs.
Some symptoms can also be caused by depression.
Reporting of side effects: Be advised if patient gets any side effects. This includes any possible side effects not listed in this monograph.

Serotonergic psychiatric drugs should not be started in a patient receiving linezolid. Wait until 24 hours after the last dose of linezolid before starting the serotonergic psychiatric drugs.
Be advised if patient is taking, has recently taken or might take any other medicines, including medicines obtained without a prescription. This includes herbal medicines. This is because Milpran can affect the way some other medicines work.
Patient must not take this medicine in combination with: Certain other medicines for depression (irreversible monoamine oxidase inhibitors (MAOI) such as iproniazid, nialamide).
Certain medicines for Parkinson's disease (B selective MAOI such as selegiline).
Patient must wait at least 14 days after he/she has stopped taking a MAOI before taking Milpran. Also, he/she needs to wait at least 7 days after stopping Milpran before taking a MAOI.
Certain medicines affecting the heart (digitalis (digoxin)).
Certain medicines for migraines (sumatriptan and other drugs in the same group).
Certain medicines affecting the cardiovascular system (adrenaline or noradrenaline taken by injection, clonidine and similar).
Some other medicine used in the treatment of depression (linezolid, moclobemide, toloxatone, methylene blue).
Except if with doctor recommendation, patient should not take this medicine in combination with: some other medicine that may increase the risk of bleeding (NSAIDs, aspirin); Lithium; some other medicines that can affect the way Milpran works; Diuretics.
Milpran with food and drink and alcohol: Consumption of alcoholic beverages or medicines containing alcohol is not recommended. This medicine should be taken with a glass of water, preferably with food.

Do not store above 25°C.
Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines no longer in use. These measures will help protect the environment.

Antidepressants

N06AX17 - milnacipran ; Belongs to the class of other antidepressants.

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