Patient leaflet - PIZOTIFEN 0.5 MG TABLETS BP
3. how to take pizotifen tablets
Always take Pizotifen Tablets exactly as your doctor has told you to do so. You should check with your doctor or pharmacist if you are not sure.
Dosage:
The usual dosage for Pizotifen Tablets is:
Adults and elderly patients
The usual starting dose is 1.5 mg daily. This may be taken as one 1.5 mg tablet at night or as
three divided doses of 0.5 mg tablets.
Do not take more than 3 mg (two 1.5 mg tablets or six 0.5 mg tablets) in a single dose.
Do not take more than 4.5 mg (three 1.5 mg tablets or nine 0.5 mg tablets) in a day.
Children (aged 2 years and over)
The usual dose can be up to 1.5 mg daily. This must be given as two or three smaller doses. Do
not give children more than 1.0 mg in a single dose.
Special populations: Renal and hepatic impairment
Caution is required in patients with renal or hepatic impairment and dosage adjustment may be necessary
Pizotifen Tablets are not recommended for children under 2 years.
Method of administration
Pizotifen Tablets should be swallowed with a glass of water. Keep taking the tablets until your doctor tells you to stop.
If you take more Pizotifen Tablets than you should
If you have accidentally taken more than the recommended or prescribed dose, contact your nearest hospital casualty department or tell your doctor or pharmacist immediately. Remember to take the pack and any remaining tablets with you.
The most common signs of overdose are a fall in blood pressure (causing dizziness and lightheadedness), uncontrolled muscle movements, drowsiness, dry mouth, confusion, excitatory states (particularly in children), nausea (feeling sick), shortness in breath and a blue skin colour, vomiting (being sick), a forceful and rapid heart-beat, convulsions (particularly in children), coma and sudden stoppage of breathing
If you forget to take Pizotifen Tablets
If you miss a dose do not worry. Take another as soon as you remember and then go on as before. Do not take a double dose to make up for a forgotten dose.
If you stop taking Pizotifen Tablets
Do not stop taking Pizotifen Tablets even if your headaches stop, as they may come back if you stop taking the tablets. If you stop taking Pizotifen Tablets suddenly you may experience withdrawal symptoms. Your doctor will tell you how to reduce and then stop this medicine.
Withdrawal symptoms include anxiety, tremor (shakes), insomnia (difficulty sleeping), anxiety, nausea (feeling sick) and loss of consciousness.
If you have any further questions about this product ask your doctor or pharmacist.
4. possible side effects
Like all medicines, Pizotifen Tablets can cause side effects, although not everybody gets them. If you get any of the following symptoms after taking these tablets you should contact your doctor or pharmacist immediately:
Rare (affecting 1 to 10 people in 10,000)
- any allergic reaction such as a rash, sudden wheeziness, difficulty in breathing or dizziness, swelling of the eyelids, face, lips or throat
- urticaria (hives)
The following side effects have also been reported:
Very common (affecting more than 1 in 10 people):
- increased appetite, weight increase
Common (affecting 1 to 10 people in 100):
- drowsiness or a strong desire to sleep
- fatigue (tiredness)
- dizziness
- nausea (feeling sick)
- dry mouth
Uncommon (affecting 1 to 10 people in 1000)
- constipation
Rare (affecting 1 to 10 people in 10,000)
- Depression
- Restlessness (particularly in children)
- difficutly sleeping (insomnia)
- anxiety
- aggression
- agitation
- hallucinations (seeing, feeling and hearing things that are not there)
- ‘Pins and needles’ or a sensation of tingling and prickling of skin
- Muscle and joint pain
Very rare (affecting less than 1 person in 10,000)
- Seizures (fits)
Unknown:
- Hepatic enzyme increased, jaundice, hepatitis
- Muscle cramp
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 United Kingdom Yellow Card Scheme Website:. By reporting side effects you can help provide more information on the safety of this medicine.
5. how to store pizotifen tablets
Keep all medicines out of the sight and reach of children.
Do not take this medicine after the expiry date (Exp.) stated. The expiry date refers to the last day of that month.
Do not store these tablets above 30°C. Store in the original packaging. Keep in the outer carton. 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.
-
6. FURTHER INFORMATION
What Pizotifen Tablets look like and the contents of the pack:
Pizotifen Tablets are white, round convex film-coated tablets.
Pizotifen 0.5mg tablets are marked ‚P‘ on one side and plain on the other.
Pizotifen 1.5mg tablets are marked ‚PZ‘ on one side and plain on the other
Your medicine is available in packs of 28, 30, 56, 60, 84, 90, 112 and 120 (not all pack sizes may be marketed).
Marketing Authorisation Holder: Fannin (UK) Limited, DCC Vital, Westminster Industrial Estate, Repton Road, Measham, DE12 7DT, England.
Manufacturer responsible for batch release:
Kent Pharmaceuticals Limited, Unit 200, Westminster 42, Westminster Industrial Estate, Repton Road, Measham, Swadlincote, DE12 7DT, U.K.
Kent Pharmaceuticals Limited, Joshna House, Crowbridge Road, Orbital Park, Ashford, Kent, TN24 0GR, U.K.
This leaflet was last revised in 04/2019. chxp092fua