PERPHENAN 8 MG

PATIENT PACKAGE INSERT IN

ACCORDANCE WITH THE PHARMACISTS’

REGULATIONS (PREPARATIONS) - 1986

The medicine is dispensed with

a doctor’s prescription only

PERPHENAN 4 mg,

PERPHENAN 8 mg,

Tablets

Tablets

The active ingredient

The active ingredient

and its quantity:

and its quantity:

Each tablet contains:

Each tablet contains:

Perphenazine 4 mg

Perphenazine 8 mg

For the list of inactive ingredients, please see

section 6.

Read this leaflet carefully in its entirety before using

the medicine. This leaflet contains concise information

about the medicine. If you have further questions, refer

to the doctor or pharmacist.

This medicine has been prescribed to treat you. Do not

pass it on to others. It may harm them even if it seems

to you that their medical condition is similar.

Do not give this medicine to infants and children under

the age of 14.

1. WHAT IS THE MEDICINE INTENDED FOR?

∙ Tranquilizer

∙ Anti-emetic

Therapeutic group: phenothiazine derivative,

antipsychotic

2. BEFORE USING THE MEDICINE:

Do not use the medicine:

if you are sensitive )allergic) to the active ingredient

)perphenazine) or any of the other ingredients of

the medicine.

if you are suffering from blood disorders or have a

low white blood cell count.

if you are taking medicines, such as ciprofloxacin

or lisinopril, which may cause bone marrow

suppression.

in states of unconsciousness )coma).

Special warnings regarding use of the medicine:

∙ Before treatment with Perphenan, tell the doctor if:

you are suffering from a liver or kidney problem.

you are suffering from high blood pressure

due to an adrenal tumor )a condition known as

phaeochromocytoma).

you have breathing problems.

you are suffering from an underactive thyroid

)hypothyroidism).

you are suffering from any disease involving the

heart and blood vessels )cardiovascular disease)

including chest pain )angina pectoris), heart

failure and personal or family history of irregular

heartbeat.

you are suffering from a brain disorder causing

tremors, rigidity and slowing of movement

)Parkinson’s disease).

you are suffering from fits )epilepsy) or you have

a condition that might lead to an epileptic attack

)such as brain damage or alcohol withdrawal).

you are suffering from an eye disease called

narrow-angle glaucoma which causes increased

intra-ocular pressure or anyone in your family has

suffered from this condition.

you are suffering from abnormal muscle weakness

)myasthenia gravis).

you are suffering from prostate enlargement.

you are exposed to extreme temperature changes,

as this medicine may affect body temperature

control.

you are an elderly or frail person, as this medicine

can affect body temperature control especially in

extreme heat or cold.

you or someone else in your family has a history of

blood clots, as medicines like these are associated

with formation of blood clots.

∙ Do not use Perphenan alone when depression is the

primary symptom.

∙ Dizziness may occur when taking this medicine; be

careful when getting up suddenly from a lying or

sitting position.

∙ This medicine may cause particular sensitivity upon

exposure to the sun: therefore, avoid extensive

exposure to the sun.

∙ A slight increase has been reported in the number

of cases of death in elderly patients suffering from

dementia taking an antipsychotic, in comparison to

those who did not take an antipsychotic. If you are

taking Perphenan Tablets, your doctor will check your

progress regularly to make sure that undesirable side

effects are not developing.

∙ Perphenan Tablets may lead to a false-positive

pregnancy test.

If you are taking, or have recently taken, other

medicines, including non-prescription medicines

or nutritional supplements, tell the doctor or

pharmacist, especially if you are taking:

∙ medicines used to treat depression and mental

illnesses )such as: fluoxetine, paroxetine, other

phenothiazines, tricyclic antidepressants, lithium,

antipsychotics).

∙ medicines which may cause bone marrow

suppression.

∙ sedatives and sleep medicines.

∙ antihistamines )used to treat allergies).

∙ corticosteroids, such as: prednisolone.

∙ strong pain killers )such as: codeine, tramadol).

∙ medicines to lower blood pressure )such as:

guanethidine).

∙ anticholinergic medicines used to reduce saliva and

lung secretions )such as: atropine, procyclidine).

∙ anticonvulsants.

∙ medicines for Parkinson’s disease )such as: levodopa)

or Alzheimer’s )memantine).

∙ medicines to treat heart problems )such as: quinoline,

digoxin).

∙ blood thinning medicines )anticoagulants, such as:

warfarin).

∙ medicines to treat diabetes.

∙ ritonavir )antiviral medicine to treat HIV).

∙ medicines used to treat indigestion )antacids,

such as: kaolin), nausea or vomiting )such as:

metoclopramide).

∙ medicines which may affect your heartbeat )such

as: amiodarone, erythromycin, haloperidol); extra

monitoring may be necessary if you are taking any

of these medicines together with Perphenan.

Use of the medicine and food:

The medicine may be taken with or without food. Do

not take this medicine with coffee or tea.

Use of the medicine and alcohol consumption:

Do not drink wines or alcoholic beverages during the

course of treatment with the medicine.

Pregnancy and breastfeeding:

Do not use this medicine if you are pregnant, think

you are pregnant or are planning to become pregnant,

unless your doctor decided that the treatment is

essential.

Stop breastfeeding if you are taking this medicine.

If you are pregnant or breastfeeding, consult the doctor

or pharmacist before using medicines.

The following symptoms may occur in newborn babies

of mothers who used Perphenan in the last trimester

of pregnancy )the last three months of pregnancy):

shaking, muscle stiffness and/or weakness, sleepiness,

agitation, breathing problems and difficulty in feeding.

If your baby develops any of these effects, consult

the doctor.

Driving and using machines:

Use of this medicine may cause drowsiness, dizziness

or blurred vision. Do not drive or operate machines

when you first start using this medicine until you are

certain that you do not suffer from these side effects.

If you are unsure, refer to the doctor before you drive

or operate machines. Children should be cautioned

against riding a bicycle or playing near the road and

the like.

Important information about some of the

ingredients in the medicine:

This preparation contains lactose. If you have been

told by a doctor that you have an intolerance to

certain sugars, refer to the doctor before using this

medicine.

3. HOW SHOULD yOU USE THE MEDICINE?

Always use according to the doctor’s instructions.

Check with the doctor or pharmacist if you are

uncertain.

The dosage and treatment regimen will be

determined by the doctor only, according to your

age, condition and previous response to treatment.

The usual dosage is generally:

Adults: The normal adult dosage is 4 mg, three times a

day. It may be necessary to adjust the dosage upwards

or downwards, in accordance with the response. Do

not exceed a total daily dosage of 24 mg.

Elderly: Elderly patients need to take one quarter to

half of the adult dosage.

Children: Do not give Perphenan to children under 14

years of age.

Do not exceed the recommended dosage.

∙ Do not chew, halve or crush!

∙ Swallow the medicine with a glass of water.

∙ Do not take this medicine with antacids.

Tests and follow up -

Your doctor will closely monitor your condition if you

have a problem with the function of any of the following

organs: liver, heart, chest, kidneys, thyroid, prostate

or adrenal gland, or if you have epilepsy, Parkinson’s

disease or glaucoma.

If you accidentally took a higher dosage, or if a child

accidentally swallowed the medicine, immediately refer

to a doctor or proceed to a hospital emergency room

and bring the package of the medicine with you.

If you forgot to take this medicine at the required

time, do not take the forgotten dose. Wait until the

next dose and then continue as usual. Never take two

doses together!

Adhere to the treatment regimen recommended by

the doctor.

Even if there is an improvement in your health, do not

stop treatment with the medicine without consulting

the doctor.

If you stop taking the medicine

Continue to take Perphenan even if you no longer feel

ill. Do not stop treatment with this medicine without

consulting the doctor, especially if you have taken high

dosages for a long time. When discontinuing treatment,

your doctor will decrease the dosage gradually, as

stopping the tablets suddenly may cause ill-effects,

such as: nausea, vomiting, sweating, restlessness,

involuntary twisting or jerking of the limbs, fits and

sleeping difficulties.

For mood disorders and schizophrenia, it may take

several weeks for you to feel the full benefit of this

medicine. If you stop taking the medicine suddenly,

your symptoms may come back.

Do not take medicines in the dark! Check the label

and the dose each time you take the medicine. Wear

glasses if you need them.

If you have further questions regarding use of the

medicine, consult the doctor or pharmacist.

4. SIDE EFFECTS:

As with any medicine, use of Perphenan may cause

side effects in some users. Do not be alarmed when

reading the list of side effects. You may not suffer from

any of them.

Refer to a doctor immediately if you are suffering

from any of the following side effects:

∙ All medicines can cause allergic reactions although

serious allergic reactions are rare. If you experience

sudden wheezing, breathing difficulties, swelling of

the eyelids, face or lips, rash or itching )especially

if it affects your whole body), report to the doctor

immediately.

∙ Blood clots in the veins especially in the legs )the

symptoms include swelling, pain and redness in

the legs), which may travel through blood vessels

to the lungs and cause chest pains and breathing

difficulties. If you notice any of these symptoms,

refer to the doctor immediately.

∙ Heart changes including fast heartbeat, unusual

heartbeat, heart attack. The symptoms of a heart

attack are: chest pain which may spread to the

shoulders, neck or arms and shortness of breath.

If you suffer from any of these effects, refer to an

emergency room immediately.

∙ If you have angina pectoris and your pain gets

worse.

∙ Slurred speech, odd movements of the face,

particularly of the tongue, eyes, head or neck )such

as: twisting of the neck which causes an unnatural

positioning of the head), muscle stiffness, tremors

or restlessness and difficulty in sitting still. Certain

patients )especially those on high dosages of this

medicine) experience problems with muscle control

which may last for years. These patients may

experience constant chewing or tongue movements

or other gentle movements of the neck, head or trunk.

Uncontrollable movements of the hands and legs

have also been reported in these patients.

∙ Jaundice )yellowing of skin and whites of the eyes),

eye problems, skin discoloration )pigmentation).

∙ Sore throat, high fever, tiredness, pallor, bruises

and nose bleeds. These effects may indicate blood

problems which develop as a result of using this

medicine.

∙ Neuroleptic malignant syndrome, signs of which are

a high temperature, muscle stiffness, drowsiness,

occasional loss of consciousness.

Tell the doctor if you are suffering from any of the

following side effects:

∙ Difficulty or inability to pass urine or a high fever.

∙ Breast enlargement in men, milk production in women,

unassociated with childbirth or breastfeeding or

altered menstrual cycle )e.g. periods stop), impaired

sexual function.

∙ Feeling of heaviness or restlessness.

∙ Feeling very cold or hot especially if you are frail or

elderly.

∙ Weakness, tiredness, drowsiness, dizziness,

restlessness, excitement, confusion, sleeping

difficulties.

∙ High blood sugar or cholesterol levels.

∙ Dry mouth, stuffy nose.

∙ Blurred vision, rolling of the eyeballs, deposits in

cornea and lens of the eye, pigmented retinopathy.

∙ Muscle weakness.

∙ Constipation, nausea, changes in saliva, loss of

appetite.

∙ Low blood pressure, fainting upon standing up.

∙ Skin rashes )including increased sensitivity to the

sun).

∙ Weight gain, excess sweating, fluid retention causing

swelling.

∙ Systemic lupus erythematosus )an autoimmune

disease). The symptoms include fever, fatigue, joint

pain and weakness.

If a side effect occurs, if one of the side effects worsens

or if you suffer from a side effect not mentioned in this

leaflet, consult with the doctor.

Side effects can be reported to the Ministry of Health

by clicking on the link “Report Side Effects of Drug

Treatment” found on the Ministry of Health homepage

)www.health.gov.il) that directs you to the online form

for reporting side effects, or by entering the link:

https://forms.gov.il/globaldata/getsequence/getsequ

ence.aspx?formType=AdversEffectMedic@moh.gov.il

5. HOW SHOULD THE MEDICINE BE STORED?

∙ Avoid poisoning! This medicine, and any other

medicine, should be kept in a safe place out of the

reach and sight of children and/or infants in order

to avoid poisoning. Do not induce vomiting unless

explicitly instructed to do so by the doctor.

∙ Do not use the medicine after the expiry date )exp.

date) that appears on the package. The expiry date

refers to the last day of that month.

∙ Store in a cool and dry place, below 25°C.

∙ Do not discard medicines in the wastewater or waste

bin. Ask the pharmacist how to dispose of medicines

no longer in use. These measures will help protect

the environment.

6. FURTHER INFORMATION:

In addition to the active ingredient, the medicine

also contains:

Perphenan 4 mg:

Lactose monohydrate, corn starch, microcrystalline

cellulose, gelatin and magnesium stearate

Coating:

Polyvinyl alcohol – partially hydrolyzed, titanium

dioxide, PEG 3350 and talc

Perphenan 8 mg:

Lactose monohydrate, corn starch, microcrystalline

cellulose, gelatin, sodium starch glycolate and

magnesium stearate

Coating:

Hypromellose, titanium dioxide, polydextrose, PEG

and black iron oxide

Each Perphenan 4 mg tablet contains 93 mg lactose

monohydrate

Each Perphenan 8 mg tablet contains 158 mg lactose

monohydrate and 0.15 mg sodium.

What the medicine looks like and the contents of

the package:

Perphenan 4 mg: a white, round, biconvex, plain on

both sides, film-coated tablet.

The tablets are packaged in a tray )blister). Each pack

contains 30 or 1,000 tablets.

Perphenan 8 mg: a gray, round, biconvex, plain on both

sides, film-coated tablet.

The tablets are packaged in a tray )blister). Each pack

contains 20, 30 or 1,000 tablets.

Not all package sizes may be marketed.

Manufacturer and license holder: Taro Pharmaceutical

Industries Ltd., 14 Hakitor St., P.O.B. 10347, Haifa Bay,

2624761

Registration number of the medicine in the National

Drug Registry of the Ministry of Health:

Perphenan 4 mg: 015 38 24729 00

Perphenan 8 mg: 123 49 24730 00

This leaflet was checked and approved by the Ministry

of Health in March 2016.

74349-0316

74349-0316

PERPHENAN TABLETS

Summary of Product Characteristics

1.

Name of the medicinal product

Perphenan 4mg

Perphenan 8mg

2.

Qualitative and quantitative composition

Perphenan 4mg - Each tablet contains 4mg Perphenazine

Perphenan 8mg - Each tablet contains 8mg Perphenazine

3.

Pharmaceutical form

Film coated tablet

Perphenan 4 mg - White, round, bi-convex, coated tablets.

Both sides plain.

Perphenan 8 mg - Gray, round, bi-convex, coated tablets. Both sides plain.

4.

Clinical particulars

4.1

Therapeutic indications

Tranquilizer, antiemetic

4.2

Posology and method of administration

Adults:

4 mg perphenazine three times a day

Dose may have to be adjusted upwards or downwards according to patient response.

Total daily

dose should not exceed 24mg.

Treatment should be started and dosage increased under close supervision.

Treatment should be reviewed at intervals to avoid indiscriminate or unduly prolonged use.

Elderly

One quarter or one half of the recommended adult dosage.

Perphenazine should be used with caution in the elderly, see section 4.4 for details.

Children

Perphenazine should not be given to children under the age of 14 years.

Method of administration: Oral

Withdrawal symptoms seen on discontinuation of Perphenazine:

Abrupt discontinuation should be avoided, see section 4.4 for details. If intolerable symptoms

occur following a

decrease in the dose or upon discontinuation of treatment, then resuming the

previously prescribed dose may be

considered.

Subsequently, the physician may continue decreasing the dose, but at a more gradual rate.

4.3

Contraindications

Perphenazine should not be administered to patients with leucopenia, or in association with

drugs liable to cause

bone marrow depression, or to patients in comatose states.

Perphenazine should not be administered to patients with a known hypersensitivity to

perphenazine or any of the

other excipients.

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4.4

Special warnings and precautions for use

The possibility of suicide in depressed patient's remains during treatment and until significant

remission occurs.

Perphenazine should not be used alone when depression is predominant.

Perphenazine should be used with caution in patients with liver disease; severe respiratory

disease; renal failure;

epilepsy and conditions predisposing to epilepsy such as alcohol

withdrawal or brain damage; Parkinson's disease;

patients who have shown sensitivity to

other phenothiazines; personal or family history of narrow angle glaucoma;

hypothyroidism,

myasthenia gravis; phaeochromocytoma; or prostatic hypertrophy.

Perphenazine should be used with caution in patient with cardiovascular disease, such

as cardiac arrhythmias,

congestive heart failure, and a personal or family history of QT

prolongation.

The concomitant use of other neuroleptics should be avoided because of possible potentiation

of effects.

Since temperature regulation may be impaired, care should be taken in extremely hot and in

cold weather, especially

in the elderly and frail because of risk of hypothermia.

Acute withdrawal symptoms including nausea, vomiting, sweating and insomnia have

been described after abrupt

cessation of antipsychotic drugs. Recurrence of psychotic

symptoms may also occur, and the emergence of

involuntary movement disorders (such as

akathesia, dystonia and dyskinesia) has been reported. Therefore gradual

withdrawal is

advisable.

Cases of venous thromboembolism (VTE) have been reported with antipsychotic drugs.

Since patients treated with

antipsychotics often present with acquired risk factors for

VTE, all possible risk factors for VTE should be identified

before and during treatment

with perphenazine and preventive measures undertaken.

Increased Mortality in Elderly people with Dementia

Data from two large observational studies showed that elderly people with dementia who are

treated with

antipsychotics are at a small increased risk of death compared with those who are

not treated. There are insufficient

data to give a firm estimate of the precise magnitude of the

risk and the cause of the increased risk is not known.

Perphenazine is not licensed for the treatment of dementia-related behavioural disturbances.

4.5

Interaction with other medicinal products and other forms of interaction

Drug interactions affecting Perphenazine

Plasma concentrations of antipsychotics may increase when given with ritonavir or tricyclic

antidepressants.

Metabolism of perphenazine is inhibited when taken with paroxetine.

Kaolin or antacids may decrease the absorption of perphenazine.

Memantine may reduce the

effects of perphenazine

Interactions affecting other drugs

Perphenazine may enhance the hypotensive effect of other antihypertensive medication.

Risk of sedation and/or toxicity when perphenazine is administered with CNS depressants such

as alcohol,

antipsychotics, opioids, sedatives, and antihistamines.

Tramadol when given with perphenazine may increase the risk of convulsions.

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Risk of extrapyramidal reactions/anticholinergic effects when perphenazine is administered

with Lithium,

metoclopramide, fluoxetine.

Perphenazine may antagonise the therapeutic effects of anticonvulsants

Perphenazine may antagonise the therapeutic effects of drugs used for Parkinson's disease and

other movement

disorders.

Perphenazine antagonises the hypoglycaemic effect of sulphonylureas.

Phenothiazines may

enhance the absorption of corticosteroids and digoxin.

May affect action of anticoagulants and

increase the bleeding time

Increased risk of toxicity when perphenazine is given with myelosupressive drugs.

Use with concomitant QT prolonging drugs, drugs inhibiting the metabolism of perphenazine,

and with drugs causing

electrolyte imbalance is not recommended. If the benefit is considered

to outweigh the risk in the individual patient,

co-administration should be undertaken with

caution and ECG monitoring should be considered (see section 4.4)

4.6. Pregnancy and lactation

The safety of perphenazine in pregnancy has not yet been established.

Neonates exposed to antipsychotics (including perphenazine) during the third trimester of

pregnancy are at risk of

adverse reactions including extrapyramidal and/or withdrawal

symptoms that may vary in severity and duration

following delivery. There have been reports of

agitation, hypertonia, hypotonia, tremor, somnolence, respiratory

distress, or feeding disorder.

Consequently, newborns should be monitored carefully.

Phenothiazines may be excreted in breast milk; breast feeding should be suspended during

treatment.

4.7

Effects on ability to drive and use machines

Perphenazine may impair alertness, particularly when treatment is started. This may be

potentiated by alcohol.

Perphenazine may cause sedation and patients should be advised not to

drive or operate machinery.

4.8

Undesirable effects

Not all the following side-effects have been reported with this specific drug. However

pharmacological similarities with

other phenothiazine derivatives require that each be

considered. Many of the side effects may be prevented by a

reduction in dosage. With the

piperazine group (of which perphenazine is an example), the extrapyramidal symptoms

like

Opisthotonus, trismus, torticollis, retrocollis, aching and numbness of the limbs, motor

restlessness, oculogyric

crisis, hyperreflexia, dystonia, including protrusion, discoloration,

aching and rounding of the tongue, tonic spasm of

the masticatory muscles, tight feeling in the

throat, slurred speech, dysphagia, akathisia, dyskinesia, parkinsonism

and ataxia are more

common, and others (e.g., sedation, jaundice, blood dyscrasias) are less frequent.

Frequencies of the ADRs is not defined, however the below mentioned ADRs have been

reported.

Disorders of the Blood and the Lymphatic system

Agranulocytosis; Transient leucopenia.

Cardiac disorders

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Perphenan 4 and 8 mg – SPC approved by MoH-02.03.16

Tachycardia,Ventricular arrhythmias VF ,VT. Sudden unexplained death, cardiac arrest and

Torsades de pointes, QT

prolongation.

Endocrine disorders

Hyperprolactemia.

Disorders of the eye

Oculogyric crisis; Visual disorders including blurring of vision

Corneal and lens deposits;

Pigmented retinopathy.

Gastrointestinal disorders

Nausea; Oral dryness and saliva altered.

Gastrointestinal atonic and hypomotility disorders including constipation, adynamic ileus

General disorders

Fatigue; Oedema, weight gain

Hepato-biliary disorders

Cholestasis and jaundice, Obstructive jaundice.

Disorders of the immune system

Antinuclear antibodies; Systemic lupus erythematous (SLE).

Investigations

Hyperglycemia, false positive pregnancy tests; Raised serum cholesterol

Neurological disorder:

Headaches; Choreiform movements of the extremities; Dyskinesias and movement

disorders including akathisia,

orofacial dyskinesia, extrapyramidal disorder and tardive

dyskinesias; Dystonia; Hyperreflexia; Disturbances in

consciousness including

somnolence, stupor; Dizziness. Parkinsonism; Tremors; Epileptic fits; CSF protein

abnormalities; Impaired regulation of body temperature. Neuroleptic malignant syndrome

has been reported in

patients treated with neuroleptic drugs. It is a relatively uncommon,

potentially lethal syndrome, characterized by

severe extrapyramidal dysfunction, with

rigidity and eventual stupor or coma, hyperthermia and autonomic

disturbances, including

cardiovascular effects

Psychiatric disorders

Confusional state, Agitation; Excitement; Insomnia.

Renal and urinary disorders

Urinary hesitancy or urinary retention

Disorders of the Reproductive system and breast

Menstruation with decreased bleeding Amenorrhea; Erectile dysfunction; impaired

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Perphenan 4 and 8 mg – SPC approved by MoH-02.03.16

ejaculation. Gynaecomastia;

Galactorrhoea.

Respiratory, thoracic and mediastinal disorders

Nasal stuffiness.

Skin and subcutaneous tissue disorders

Photosensitivity; Rashes; Hyperhidrosis.

Pregnancy, puerperium and perinatal conditions:

Drug withdrawal syndrome neonatal (see 4.6) – Frequency not known.

Vascular disorders

Hypotension.

Cases of venous thromboembolism, including cases of pulmonary embolism and cases of

deep vein thrombosis have

been reported with antipsychotic drugs - Frequency unknown

Reporting

suspected

adverse

reactions

after

authorisation

medicinal

product

important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

Any suspected adverse events should be reported to the Ministry of Health according to the

National Regulation by using an online form

http://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedic@mo

h.gov.il

4.9

Overdose

In patients who have overdosed, general supportive measures must be instituted.

Gastric lavage should be considered up to 2 hours after ingestion. Emetics are unlikely to be

effective because

perphenazine is a potent anti-emetic.

If hypotension is severe, fluid infusion may be needed.

Central nervous system depression is

treated conservatively.

Temperature should be monitored to detect hypothermia, and this should be treated

appropriately.

If convulsions occur, these should be managed by standard means.

Continuous monitoring of ECG should be instituted to detect any regularities of rhythm or

QT interval for at least 48

hours.

5.

Pharmacological properties

5.1

Pharmacodynamic properties

Perphenazine is a depressant which blocks dopamine receptors in the central nervous system.

5.2

Pharmacokinetic properties

Perphenazine is absorbed readily from the gastro-intestinal tract. It is distributed widely

throughout the body, and

crosses the placenta.

Perphenazine is metabolised extensively by sulphoxidaction, demethylation, hydroxylation,

N-oxidation, glucuronic

acid conjugation, and possible ring fission.

20 to 70% is excreted in the urine, very little is unchanged. 5% is excreted in the faeces.

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Perphenan 4 and 8 mg – SPC approved by MoH-02.03.16

5.3

Preclinical safety data

No further relevant data.

6.

Pharmaceutical particulars

List of excipients

Perphenan 4 mg:

Lactose monohydrate, corn starch, microcrystalline cellulose, gelatin, magnesium stearate

Coating contains: Polyvinyl alcohol-partially hydrolyzed, titanium dioxide, PEG 3350 and

talc

Perphenan 8 mg:

Lactose monohydrate corn starch, microcrystalline cellulose, gelatin, sodium starch

glycolate and magnesium stearate

Coating contains: Hypromellose, Titanium dioxide, Polydextrose, PEG and Black iron

oxide

Incompatibilities

None known

6.1

Shelf life

36 months.

6.2

Special precautions for storage

Do not store above 25°C.

6.3

Nature and contents of container

Perphenan 4 mg - PVC aluminum foil blister pack containing 30 tablets or 1000 tablets.

Perphenan 8 mg - PVC aluminum foil blister pack containing 20 tablets, 30 or 1000 tablets.

Nor all pack sizes may be marketed.

6.4

Special precautions for disposal and other handling

None.

7.

Marketing authorisation holder

Taro Pharmaceutical Industries Ltd

14 Hakitor Street

Haifa Bay, 2624761

8.

Marketing authorisation number(s

)

Perphenan 4 mg – 015.38.24729

Perphenan 8 mg – 123.49.24730

9.

Date of revision of the text

March 2016

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