Pizotifen 0.5mg Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
PIZOTIFEN 0.5 mg & 1.5 mg TABLETS
Read all of this leaflet carefully before you start taking this medicine.
- 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 become serious, or if you notice any side effects not listed in this leaflet, please
^tell your doctor or pharmacist__j
1. What Pizotifen is for
2. Before you take Pizotifen
3. How to take Pizotifen
4. Possible side effects
5. How to store Pizotifen
6. Further information
Pizotifen belongs to groups of medicines known as antihistamines and antiserotonins. These work by blocking chemicals that act on the blood vessels in the brain.
Pizotifen tablets may be used to prevent headaches including classical migraine, common migraine or cluster headaches.
Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently taken, any other medicines, including medicines bought without a prescription.
This is because Pizotifen can affect the way some medicines work. Also, some medicines can affect the way Pizotifen works.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
• medicines to treat anxiety or help you sleep, such as Nitrazepam, Diazepam or Amobarbital sodium
• other antihistamines, including common cold preparations
• medicines to lower blood pressure, such as guanethidine
AVOID ALCOHOL whilst taking Pizotifen. This is because taking Pizotifen may make you drowsy and less alert than normal, and alcohol will increase these effects.
Pregnancy and breast-feeding
If you are pregnant, planning to become pregnant or are breast-feeding ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Pizotifen tablets may make you feel drowsy. Make sure you are not affected before you attempt to drive or use any tools or machines.
Important information about some of the ingredients in Pizotifen tablets
This medicine contains lactose (a type of sugar). If you have been told that you cannot digest or are intolerant to some sugars, talk to your doctor before taking this medicine.
Do not take Pizotifen and tell your doctor if you:
• are allergic to Pizotifen or any of the other ingredients in the tablets (listed in section 6 of this leaflet). The signs of an allergic reaction can include a rash, itching or swelling of the face, lips, throat or tongue.
• are a child under 2 years of age.
Do not take this medicine if the above applies to you. If
you are not sure, talk to your doctor or pharmacist before
taking Pizotifen.
Take special care with Pizotifen
Tell your doctor before you take this medicine if you:
• have glaucoma, (increased pressure in the eyeballs)
• suffer from any condition that may cause retention of urine such as an enlarged prostate gland
• have kidney problems
• have a history of epilepsy
If you are not sure if any of the above apply to you, talk to
your doctor or pharmacist before taking Pizotifen.
Always take Pizotifen tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Swallow the tablets with a glass of water.
Doses:
Adults and elderly:
The usual dose is 1.5 mg daily, taken either as a single dose at night or in three divided doses. This may be gradually increased up to a maximum of 4.5 mg daily, with no more than 3 mg given as a single dose.
Children aged 2 years and over
(Do not use the 1.5 mg tablet for this age group). The usual dose is up to a maximum of 1.5 mg daily, this should be taken in divided doses using the 0.5 mg tablets. A maximum single dose of 1 mg can be given at night.
If you take more Pizotifen than you should
If you, (or someone else), take too many tablets, contact your doctor or the nearest hospital casualty department immediately. Take this leaflet and the container with you so they know what has been taken.
Signs of an overdose may include drowsiness, dizziness, confusion, fits or excitement (particularly in children), difficulty in breathing or co-ordinating movements, fast heart beat, low blood pressure, dry mouth, feeling or being sick, blueness of the skin, coma or respiratory paralysis.
If you forget to take Pizotifen
Don't worry: just take it as soon as you remember. However, if it is nearly time for the next scheduled dose, skip the missed dose. Do not take a double dose (two doses at the same time) to make up for the forgotten one.
If you stop taking Pizotifen
Do not stop taking this medicine unless your doctor tells you to. Your symptoms may come back if treatment is stopped too early. You may have to stop taking this medicine gradually, your doctor will help you do this.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Keep out of the reach and sight of children.
Do not store above 30°C. Store in the original package.
Do not use these tablets after the expiry date, which is stated on the container. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Like all medicines, Pizotifen can cause side effects, although not everybody gets them.
STOP TAKING Pizotifen and see a doctor straight away if you have:
• an allergic reaction. The signs of an allergic reaction can include a rash, itching or swelling of the face, lips, throat or tongue
Tell your doctor if you get any of these side effects:
Very common (affects more than 1 in 10 users):
Increased appetite which may lead to weight gain
Common (affects less than 1 in 10 users):
Drowsiness, sleepiness, dizziness, dry mouth, feeling sick, tiredness
Uncommon (affects less than 1 in 100 users): Constipation
Rare (affects less than 1 in 1,000 users):
Pins and needles, muscle and joint pain, depression, anxiety, agitation, aggression, hallucinations, difficulty sleeping, sleep disorders
Very rare (affects less than 1 in 10,000 users):
Fits
What Pizotifen tablets contain
The active ingredient in these tablets is Pizotifen. Each tablet contains either 0.725 mg or 2.175 mg of the ingredient Pizotifen malate, which is equivalent to 0.5 mg and 1.5 mg of Pizotifen. The other ingredients are lactose monohydrate, cellulose microcrystalline, maize starch, povidone K30, magnesium stearate, silicon dioxide, hypromellose, macrogol, talc, titanium dioxide (El 71).
What Pizotifen tablets look like and contents of the pack
Pizotifen 0.5 mg tablets are white, round, flat, film-coated tablets, marked MP84 on one side.
Pizotifen 1.5 mg tablets are white, round, flat, film-coated tablets, marked MP85 on one side.
Both strengths of Pizotifen tablets come in blister packs of 28, 30, 56, 60, 84, 90,112 and 120 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Genethics Europe Limited,
41-43 Klimentos, Klimentos Tower,
Nicosia 1061, Cyprus
Manufacturer
Edmond Pharma S.R.L.,
Via dei Giovi 131,
Paderno Dugnano, Italy
For more information about this product, please contact the Marketing Authorisation Holder.
This leaflet was last revised in 03/2016
GE0046-0047/0/PIL/GE1