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PIZOTIFEN 0.5 MG TABLETS BP - Patient leaflet, side effects, dosage

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Sources: Original (products.mhra.gov.uk)

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


Sources: Original (products.mhra.gov.uk)

The drug is classified in the ATC tree:

N NERVOUS SYSTEM DRUGS

N02 ANALGESICS

N02C ANTIMIGRAINE PREPARATIONS

N02CX Other antimigraine preparations in ATC

N02CX01 pizotifen

Frequently Asked Questions

What is Pizotifen 0.5 mg tablets used for?

Pizotifen 0.5 mg tablets are primarily used to prevent migraines and control cluster headaches.

How does Pizotifen work in the body?

Pizotifen works by blocking certain chemicals in the brain that trigger headaches and migraines.

Can Pizotifen be used for other types of headaches?

Yes, Pizotifen may help with other headache types as advised by your doctor, but it is mainly prescribed for migraines.

What should I do if I miss a dose of Pizotifen?

If you miss a dose, take it as soon as you remember. If it's almost time for your next dose, skip the missed dose and continue with your regular schedule.

Can I take Pizotifen if I am pregnant or breastfeeding?

You should consult your doctor before taking Pizotifen if you are pregnant or breastfeeding, as it may not be safe.

Are there any common side effects of Pizotifen?

Common side effects may include drowsiness, dry mouth, and increased appetite.

Is it safe to drink alcohol while taking Pizotifen?

It's advisable to avoid alcohol while taking Pizotifen, as it can increase drowsiness and other side effects.

How long does it take for Pizotifen to start working?

Pizotifen may take several days to weeks to show its full effect in reducing migraine frequency.

Can I stop taking Pizotifen suddenly?

You should not stop taking Pizotifen suddenly without consulting your doctor, as it may lead to withdrawal symptoms.

What foods or drinks should I avoid while taking Pizotifen?

While there are no specific food restrictions, it's best to maintain a healthy diet and stay hydrated to help manage headaches.

Can children use Pizotifen tablets?

Pizotifen is generally not recommended for children under the age of 2 years without medical advice. Always consult a pediatrician.

What should I tell my doctor before starting Pizotifen?

Inform your doctor about all medications you are taking, any allergies you have, and if you have any existing health conditions.

How should I store Pizotifen tablets?

Store Pizotifen tablets in a cool, dry place away from direct sunlight and out of reach of children.

Can I drive after taking Pizotifen?

Caution is advised when driving or operating machinery after taking Pizotifen as it may cause drowsiness.

What if I experience severe side effects from Pizotifen?

If you experience severe side effects such as difficulty breathing or swelling of the face, seek immediate medical attention.

Does Pizotifen affect my mood or mental health?

Some patients may experience mood changes; if you feel unusually depressed or anxious after starting the medication, contact your doctor.

Is there a generic version of Pizotifen available?

Yes, generic versions of Pizotifen may be available; ask your pharmacist for options.

Can my diet affect how well Pizotifen works?

While diet alone doesn't affect how well Pizotifen works, maintaining a balanced diet can contribute positively to overall health and headache management.

Where can I find more information about migraine prevention with medications like Pizotifen?

For more information about migraine prevention medications like Pizotifen, consult reputable medical websites or speak with your healthcare provider.

Are there alternative treatments to consider if I'm not responding well to Pizotifen?

If you're not responding well to Pizotafen, discuss alternative treatments with your doctor; they may suggest other medications or therapies that could work better for you.