Pizotifen 500microgram tablets

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

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Active ingredient:
Pizotifen hydrogen malate
Available from:
Rivopharm (UK) Ltd
ATC code:
N02CX01
INN (International Name):
Pizotifen hydrogen malate
Dosage:
500microgram
Pharmaceutical form:
Tablet
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 04070402; GTIN: 5060388650377
Authorization number:
PL 14682/0001

Read the complete document

Pizotifen 0.5 mg & 1.5 mg tablets – PL 14682/0001-0002 Edmond Pharma

Version October 2015

PACKAPA

flet:

PACKAGE LEAFLET: INFORMATION FOR THE USER

Pizotifen 0.5 mg Tablets

Pizotifen 1.5 mg Tablets

Pizotifen

Read all of this leaflet carefully before you start taking this medicine.

Please 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 get serious, or if you notice any side effects not listed in this leaflet, please

tell your doctor or pharmacist.

In this leaflet:

1. What Pizotifen 0.5mg & 1.5mg Tablets are and what they are used for

2. Before you take Pizotifen 0.5mg & 1.5mg Tablets

3. How to take Pizotifen 0.5mg & 1.5mg Tablets

4. Possible side effects

5. How to store Pizotifen 0.5mg & 1.5mg Tablets

6. Further information

1. WHAT PIZOTIFEN 0.5MG & 1.5MG TABLETS ARE AND WHAT THEY ARE USED

FOR

The name of your medicine is Pizotifen 0.5mg or 1.5mg Tablets. The active ingredient is pizotifen

hydrogen malate.

Pizotifen belongs to a group of medicines called anti-migraines. Pizotifen is used to help block the

actions of certain chemicals in the blood such as serotonin, histamine and tryptamine. These

chemicals act on the blood vessels in the brain and are involved in causing types of headache, such

as migraine.

If Pizotifen 0.5mg or 1.5mg Tablets are taken regularly, they can help reduce the number and severity

of headaches including the pain of cluster headaches and both common and classical migraine.

Pizotifen can also prevent some migraine attacks starting and helps make other attacks less severe.

Pizotifen does not help to relieve a migraine attack once it has started

2. BEFORE YOU TAKE PIZOTIFEN 0.5MG & 1.5MG TABLETS

Do not take this medicine if:

you have ever had an allergic reaction to any of the ingredients of Pizotifen Tablets or any other

medicines that you may have taken to treat headaches

you are pregnant, or if you are breast feeding an infant

Pizotifen must not be given to children under the age of 2 years

Take special care with this medicine and tell your doctor or pharmacist if:

you suffer from kidney problems

you are pregnant, trying to become pregnant or breast-feeding

you have difficulty passing water

you suffer with glaucoma (raised pressure in the eyes)

you suffer, or have suffered, from epilepsy

Pizotifen 0.5 mg & 1.5 mg tablets – PL 14682/0001-0002 Edmond Pharma

Version October 2015

Tell your doctor before taking this medicine if you have been told that you have an intolerance to

some sugars.

This is because Pizotifen Tablets contain lactose, a type of sugar.

Taking other medicines

Tell your doctor if you are taking any other medicines, especially the following:

medicines to treat anxiety or sleep disorders, e.g. tranquillisers and hypnotics

medicines to treat allergic reactions, e.g. anti-histamines

medicines to treat a cold

medicines called alpha- or beta- blockers

It is advisable not to drink alcohol while you are taking this medicine as it may make you sleepy.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,

including medicines obtained without a prescription.

Pregnancy and breast-feeding

Tell your doctor if you become pregnant or if you are breast-feeding.

Driving and using machines

Some people may feel drowsy while they are taking this medicine. If you find that you do get drowsy,

do not drive or operate machinery.

3. HOW TO TAKE PIZOTIFEN 0.5MG & 1.5MG TABLETS

Always take your medicine exactly as your doctor has told you. You should check with your doctor

or pharmacist if you are not sure. The tablet should be swallowed with water.

Do not wait for a migraine, before taking this medicine to treat the pain. Take Pizotifen 0.5mg or

1.5mg Tablets regularly to prevent a migraine or reduce the severity of the migraine.

The usual doses of Pizotifen 0.5mg or 1.5mg Tablets are as follows:

Adults

1.5mg daily (one 1.5mg tablet at night or 0.5mg tablets three times daily). Your doctor may increase

the number of tablets you take up to a maximum of 4.5mg (three 1.5mg tablets or nine 0.5mg tablets)

if required. You may have been told to take your tablets daily as a single dose or you may have to

take three smaller doses.

Do not take more than 3mg in a single dose.

Do not exceed the maximum daily dose of 4.5mg.

Children

For children over 2 years of age, at first this may be 0.5mg daily. This may be taken at night. The

dose can be gradually increased to a maximum dose of 1.5mg daily (three 0.5mg tablets).

The maximum single dose is 1mg (two 0.5mg tablets).

DO NOT give your child Pizotifen 1.5mg Tablets.

If you take more tablets than you should

If you accidentally take too much of your medicine, tell your doctor at once or contact your nearest

hospital casualty department immediately. Take your medicine with you.

If you forget to take your medicine

If you forget to take a dose, just take the next dose at the usual time. DO NOT take a double dose.

4. POSSIBLE SIDE EFFECTS

Pizotifen 0.5mg & 1.5mg Tablets are suitable for most people, but, like all medicines, they can

sometimes cause side effects.

Pizotifen 0.5 mg & 1.5 mg tablets – PL 14682/0001-0002 Edmond Pharma

Version October 2015

Some side effects can be serious. Stop taking the tablets and tell your doctor immediately if you

notice any of the following rare symptoms:

Symptoms of allergy such as a rash, itching or hives on the skin or swelling of the face.

The side effects listed below have also been reported:

More than 1 in 10 people have experienced:

Increase in appetite and weight gain. An increase in appetite may lead to an increase in bodyweight.

If you feel hungrier than usual, try to fill up on fresh low calorie foods. These are much healthier than

processed high calorie foods. Your doctor can give you advice about diet as some kinds of foods are

known to trigger migraine.

Up to 1 in 10 people have experienced:

Drowsiness, tiredness, dizziness, dry mouth, nausea. Feeling drowsy is not usually a problem as you

can take the tablets in the evening. The effect of making you drowsy will help you to sleep.

You are less likely to feel drowsy after a few weeks, as you get used to the tablets.

Up to 1 in 100 people have experienced:

Constipation.

Up to 1 in 1,000 people have experienced:

Depression, excitability or restlessness, hallucinations (seeing, hearing or feeling things that are not

there), sleep disturbances, insomnia, anxiety, tingling or numbness of the hands or feet, muscle or

joint pain.

Very rarely (less than 1 in 10,000) people have experienced:

Seizures (fits). Tell your doctor immediately if you have a fit.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects

not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme at

www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on

the safety of this medicine.

5. HOW TO STORE PIZOTIFEN 0.5MG & 1.5MG TABLETS

Do not use after the expiry date that is stated on the carton or label.

Store the tablets in the original package. Do not store above 30°C

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN

Return any unused medicine to your pharmacist.

6. FURTHER INFORMATION

What Pizotifen 0.5mg & 1.5mg Tablets contain:

The tablets are available in two different strengths containing either 0.5mg or 1.5mg of the active

substance Pizotifen (as the hydrogen malate).

The other ingredients are lactose monohydrate, microcrystalline cellulose, maize starch, povidone,

magnesium stearate, silicon dioxide, hydroxypropylmethylcellulose, polyethylene glycol, talc and

titanium dioxide.

What Pizotifen 0.5mg & 1.5mg Tablets look like and the contents of the pack

Pizotifen 0.5mg Tablets are white, film coated, embossed with ‘P’ on one side.

Pizotifen 1.5mg Tablets are white, fi lm coated, embossed with ‘PZ’ on one side.

They are packed in foil blister packs and are available in cartons of 28.

Marketing Authorisation Holder and Manufacturer

Edmond Pharma S.r.l. Strada Statale dei Giovi 131 20037 Paderno Dugnano (Mi) Italy

Pizotifen 0.5 mg & 1.5 mg tablets – PL 14682/0001-0002 Edmond Pharma

Version October 2015

Distributor

Rivopharm UK Ltd., 6th Floor, 28 Kingsway, London.

This leaflet does not contain all the available information about your medicine. If you have any

questions or are not sure about anything, ask your doctor or pharmacist.

The information in this leaflet applies only to Pizotifen 0.5mg & 1.5mg Tablets.

Date of preparation of the leaflet: October 2015

Read the complete document

Object 1

Pizotifen 0.5 mg Tablets

Summary of Product Characteristics Updated 19-Apr-2017 | Rivopharm UK Ltd

1. Name of the medicinal product

Pizotifen 0.5 mg Tablets

2. Qualitative and quantitative composition

Each tablet contains 0.725 mg pizotifen hydrogen malate BP, equivalent to 0.5 mg of pizotifen base. Each

film-coated tablet contains lactose monohydrate 32.14 mg, as excipient

For a full list of excipients, see section 6.1.

3. Pharmaceutical form

Film coated tablet.

The tablets are white, marked P on one side and plain on the reverse.

4. Clinical particulars

4.1 Therapeutic indications

Prophylactic treatment of recurrent vascular headaches, including classical migraine, common migraine

and cluster headache (periodic migrainous neuralgia).

It is not effective in relieving migraine attacks once in progress

4.2 Posology and method of administration

Adults: Usually 1.5 mg daily, This may be taken as a single dose at night or in three divided doses.

Dosage should be adjusted according to individual patient requirements, up to a maximum of 4.5 mg

daily. Up to 3 mg can be given as a single dose.

Children (aged over 2 years): Up to 1.5 mg daily, usually as a divided dose, although up to 1 mg has been

given as a single dose at night.

Elderly: As for adults.

Method of administration: oral

4.3 Contraindications

Hypersensitivity to the drug or to any of the other tablet ingredients.

Pizotifen should not be given to children under 2 years of age

4.4 Special warnings and precautions for use

Although the anticholinergic activity of Pizotifen is relatively weak, caution is required in the presence of

closed-angle glaucoma and in patients with a predisposition to urinary retention. Dosage adjustment may

be required in patients with renal insufficiency.

Pizotifen should be used with caution in patients with a history of epilepsy.

Pizotifen tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, severe

lactase deficiency or glucose-glactose malabsorption should not take Pizotifen tablets.

4.5 Interaction with other medicinal products and other forms of interaction

The central effects of sedatives, hypnotics, antihistamines (including certain common cold preparations)

and alcohol may be enhanced by pizotifen.

Pizotifen antagonises the hypotensive effect of adrenergic neurone blockers

4.6 Fertility, pregnancy and lactation

Pregnancy

As clinical data with pizotifen in pregnancy are very limited, it should only be administered under

compelling circumstances.

Lactation

Use in nursing mothers is not recommended.

4.7 Effects on ability to drive and use machines

Pizotifen may cause drowsiness, somnolence and dizziness. Therefore, caution should be exercised when

driving or using machines.

Patients being treated with Pizotifen and presenting with drowsiness (including somnolence and fatigue)

must be instructed to refrain from driving or engaging in activities where impaired alertness may put

themselves or others at risk.

4.8 Undesirable effects

The most commonly reported side-effects are appetite stimulating effect, increase in body weight and

drowsiness (including somnolence and fatigue).

Frequencies are defined as: very common (≥1/10); common (≥1/100, <1/10); uncommon ( ≥ 1/1000,

<1/100); rare ( ≥ 1/10,000, <1/1000); very rare ( <1/10,000), including isolated reports; not known

(cannot be estimated from the available data).

Immune system disorders

Rare

Hypersensitivity reactions, face oedema, urticaria and rash

Metabolism and nutrition disorders

Very common

Appetite stimulating effect and increase in body weight

Psychiatric disorders

Rare

Depression, CNS stimulation (e.g. aggression, agitation), hallucination, insomnia,

anxiety

Nervous system disorders

Common

Drowsiness (including somnolence) dizziness

Rare:

Paraesthesia

Very rare:

Seizures

Gastrointestinal disorders

Common

Nausea, dry mouth

Uncommon

Constipation

Musculoskeletal and connective tissue disorders

Rare

Myalgia, arthralgia

General disorders and administration site conditions

Common

Fatigue

Acute withdrawal reactions have been reported following abrupt cessation of Pizotifen therefore gradual

withdrawal is recommended. Withdrawal symptoms include anxiety, tremors, insomnia, nausea and loss

of consciousness.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows

continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are

asked to report any suspected adverse reactions via Yellow Card Scheme at

www.mhra.gov.uk/yellowcard.

4.9 Overdose

Symptoms: Drowsiness, dizziness, hypotension, dryness of the mouth, confusion, excitatory states (in

children), ataxia, nausea, vomiting, dyspnoea, cyanosis, tachycardia, convulsions (particularly in

children), coma, and respiratory paralysis.

Treatment:

Administration of activated charcoal is recommended; in case of very recent uptake, gastric lavage may

be considered. Severe hypotension must be corrected (CAVE: adrenaline may produce paradoxical

effects). If necessary, symptomatic treatment including monitoring of the cardiovascular and respiratory

systems. Excitatory states or convulsions may be treated with short acting benzodiazepines.

5. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: antimigraine drug, ATC code: N02C X01

Studies in experimental animals have indicated that pizotifen has strong anti-serotonin and anti-

tryptaminic properties, marked antihistaminic effects and some antagonistic activity against kinins. It also

possesses weak anti-cholinergic effects and sedative properties.

Pizotifen also possesses appetite-stimulating properties.

The prophylactic effect of pizotifen in migraine is associated with its ability to modify the humoral

mechanisms of headache.

It inhibits the permeability-increasing effect of serotonin and histamine on the affected cranial vessels,

thereby checking the transudation of plasmakinin so that the pain threshold of the receptors is maintained

at 'normal' levels. In the sequence of events leading to migraine attack, depletion of plasma serotonin

contributes to loss of tone in the extracranial vessels. Pizotifen inhibits serotonin re- uptake by the

platelets, thus maintaining plasma serotonin and preventing the loss of tone and passive distension of the

extracranial arteries.

5.2 Pharmacokinetic properties

Absorption

The absorption of pizotifen in man is fast (absorption half-life 0.5 to 0.8 hours) and nearly complete. The

absolute bioavailablility is 78%. Maximum blood levels are reached 5 hours after a single 2 mg oral

administration of pizotifen (parent compound and N-glucuronide-conjugate measured together).

Biotransformation

Pizotifen is extensively metabolised. Glucuronidation is the main route of biotransformation and the main

metabolite is the N-glucuronide-conjugate, accounting for at least 50% of the plasma and 60-70% of

urinary excreted radioactivity.

Distribution

Protein binding of pizotifen in human plasma in vitro amounts to 91%. The distribution volume in man is

833 L and 70 L for pizotifen and its N-glucuronide, respectively.

Elimination

About one-third of an orally applied dose is excreted via the biliary route into the faeces, a significant

proportion, corresponding to about 18% of the applied dose, representing parent drug, likely produced in

the intestine after biliary excretion of the N-glucuronide-conjugate. Less than 1% of the administered

dose of pizotifen is excreted unchanged in the urine, whereas up to 55% is excreted as metabolites.

Pizotifen is eliminated with a half life of approximately 23 hours (total radioactivity).

Unchanged pizotifen and the N-glucuronide have, as estimated from the excretion in the urine, a

comparable elimination half-life.

Special patient groups

In patients with kidney insufficiency, dosage adjustment may be necessary.

5.3 Preclinical safety data

There are no preclinical data of relevance to the prescriber which are additional to those in other sections

of the SPC.

6. Pharmaceutical particulars

6.1 List of excipients

Lactose monohydrate, cellulose microcrystalline, maize starch, Povidone K30, magnesium stearate,

silicon dioxide, hypromellose, macrogol 6000, talc, titanium dioxide (E171).

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

4 years.

6.4 Special precautions for storage

Do not store above 30° C. Store in the original package.

6.5 Nature and contents of container

White, opaque blister, 250 μ m PVC/40 gm

PVDC sealed to 25 μm aluminium foil/PVDC.

The blistered product is available in cartons containing 28, 30, 56, 60, 84, 90, 112 and 120 tablets. (Please

note that not all pack sizes may be marketed.)

6.6 Special precautions for disposal and other handling

Not applicable.

7. Marketing authorisation holder

Edmond Pharma Srl

Strada Statale dei Giovi 131

20037 Paderno Dugnano (MI)

Italy

8. Marketing authorisation number(s)

PL 14682/0001

9. Date of first authorisation/renewal of the authorisation

23 August 2001/ 13 March 2009

10. Date of revision of the text

October 2015

Legal category

Company Contact Details

Rivopharm UK Ltd

Address

30th Floor, 40 Bank Street, Canary Wharf, London, E14 5NR

Telephone

+44 (0)203 102 9660

Medical Information e-mail

[email

protected]

Medical Information Fax

+44 (0)1279 418 964

https://www.rivopharm.co.uk

Medical Information Direct Line

+44 (0)1279 406 759

Customer Care direct line

+44 (0)1279 406 759

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