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PROCHLORPERAZINE MALEATE 3 MG BUCCAL TABLETS - Patient leaflet, side effects, dosage

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

Patient leaflet - PROCHLORPERAZINE MALEATE 3 MG BUCCAL TABLETS

How to use Prochlorperazine Maleate 3 mg Buccal Tablets

You must follow the instructions that your doctor has given you about how much and when to take Prochlorperazine Maleate 3 mg Buccal Tablets.

The usual dosage is one or two tablets twice a day for adults and children over 12 years of age.

Prochlorperazine Maleate 3 mg Buccal Tablets are not recommended for children under 12 years of age.

INSTRUCTIONS FOR USE

Please read carefully before taking the tablet.


PC – 2798

  • Place the tablet high up along your top gum, under the

upper lip either side of your mouth as indicated above. The tablet must not be swallowed whole or chewed.

  • The tablet will soften and adhere to the gum. Allow it to dissolve slowly and completely – this may take between 1 and 2 hours. Most people find that after a few minutes they no longer notice the tablet.
  • The tablet should not be moved about the mouth with the tongue as this will cause it to dissolve too quickly.
  • If you wear dentures, the tablet may be placed in any comfortable position between your lip and gum.

The tablet(s) is best taken after meals.

If you take more Prochlorperazine Maleate 3 mg Buccal Tablets than you should or if you accidentally take too many tablets you must seek medical attention immediately.

If you forget to take Prochlorperazine Maleate 3 mg Buccal Tablets

If you forget to take a dose do not double the dose next time. Just carry on taking the medicine as the doctor has told you.

4. possible side effects

Like all medicines, Prochlorperazine Maleate 3 mg Buccal Tablets can cause side effects, although not everybody gets them.

If you have a high temperature, pale complexion, muscle stiffness and changes in levels of alertness, you may have developed a serious condition called neuroleptic malignant syndrome. If you have these symptoms while taking the tablets, you should immediately inform your doctor.

Other side effects include:

  • drowsiness
  • dizziness
  • dry mouth
  • inability to sleep (insomnia)
  • agitation
  • mild skin reactions
  • low blood pressure (this makes you feel dizzy or faint, particularly when you stand up), particularly in elderly or volume depleted patients (those who have lost both water and salts from the body).
  • Blood clots in the veins especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing. If you notice any of these symptoms seek medical advice immediately.
  • In elderly people with dementia, a small increase in the number of deaths has been reported for patients taking medicines of the same type as Prochlorperazine Maleate 3 mg Buccal Tablets compared with those not taking these medicines.
  • local irritation to the gum and mouth may occur.
  • jaundice (yellowing of the skin and/or the whites of the eyes)
  • blood problems.
  • breast swelling (in men as well as in women)
  • abnormal movements, tremors and muscle rigidity, and unusual movements of the face and tongue.

These reactions are unlikely to happen with the low dose of prochlorperazine in this medicine.

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If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store

Keep all medicines out of reach and sight of children.

Keep the blisters in the outer carton in order to protect from light.

This medicinal product does not require any special temperature storage condition.

Do not use after the expiry date (EXP month/year) shown on the outer carton and blister.

The expiry date refers to the last day of that month.

  • 6. Further information

What Prochlorperazine Maleate 3 mg Buccal Tablets look like and contents of the pack

Prochlorperazine Maleate 3mg Buccal Tablets are Pale yellow to yellow, circular, biconvex uncoated tablets debossed with “P3” on one side and plain on the other side.

Prochlorperazine Maleate 3mg Buccal Tablets are available in blister packs containing 14, 15, 30, 50 and 60 tablets.

Marketing Authorisation Holder and Manufacturer:

MEDREICH PLC

Warwick House, Plane Tree Crescent,

Feltham TW13 7HF, UK

PL 21880/0122

This leaflet was last revised in 02/2014

[POM

121XXXX


2

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

The drug is classified in the ATC tree:

N NERVOUS SYSTEM DRUGS

N05 PSYCHOLEPTICS

N05A ANTIPSYCHOTICS

N05AB Phenothiazines with piperazine structure, antipsychotics

N05AB04 prochlorperazine

Frequently Asked Questions

What is Prochlorperazine Maleate used for?

Prochlorperazine Maleate is mainly used to treat severe nausea and vomiting, as well as certain mental health conditions such as schizophrenia.

How does Prochlorperazine Maleate work in the body?

This medication works by blocking dopamine receptors in the brain, which helps to control nausea and reduce symptoms of mental health disorders.

Can I use Prochlorperazine Maleate for anxiety?

Prochlorperazine is not typically prescribed for anxiety; it is primarily used for nausea and some psychiatric conditions. Consult your healthcare provider for appropriate anxiety treatments.

How should I take Prochlorperazine Maleate buccal tablets?

Place the buccal tablet between your gum and cheek. Allow it to dissolve completely without chewing or swallowing.

What should I do if I miss a dose of Prochlorperazine Maleate?

If you miss a dose, take it as soon as you remember unless it's almost time for your next dose. Do not double up on doses.

Are there any foods or drinks I should avoid while taking Prochlorperazine Maleate?

Avoid alcohol while taking this medication as it can increase side effects such as drowsiness and dizziness.

What are the common side effects of Prochlorperazine Maleate?

Common side effects include drowsiness, dizziness, dry mouth, blurred vision, and constipation. If side effects persist or worsen, contact your doctor.

Is Prochlorperazine Maleate safe during pregnancy?

It is important to discuss with your healthcare provider if you are pregnant or planning to become pregnant, as the safety of this medication during pregnancy has not been established.

Can I take other medications with Prochlorperazine Maleate?

Always inform your doctor about all medications you are currently taking, including over-the-counter drugs and supplements, to avoid potential interactions.

Does Prochlorperazine Maleate cause weight gain?

Some patients may experience weight gain while using antipsychotic medications like Prochlorperazine; however, this varies by individual.

How long does it take for Prochlorperazine Maleate to work?

You may start feeling relief from nausea within 30 minutes; however, it may take several days to notice improvement in psychiatric symptoms.

Can I stop taking Prochlorperazine Maleate suddenly?

Do not stop taking this medication abruptly without consulting your healthcare provider, as it may lead to withdrawal symptoms or worsening conditions.

What should I do if I experience severe side effects from Prochlorperazine Maleate?

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

Is there a generic version of Prochlorperazine Maleate available?

Yes, there are generic versions available that contain the same active ingredient and work similarly to the brand name product.

Can children take Prochlorperazine Maleate buccal tablets?

Prochlorperazine is typically not recommended for children under 2 years old. Always consult a pediatrician before giving any medication to children.

How should I store Prochlorperazine Maleate tablets?

Store the tablets at room temperature away from moisture and heat, and keep them out of reach of children.

Are there any special precautions to be aware of before taking Prochlorperazine Maleate?

Tell your doctor if you have liver problems, heart issues, Parkinson's disease or a history of seizures before starting this medication.

Will Prochlorperazine Maleate interact with herbal supplements?

Herbal supplements may interact with this medication. Always inform your healthcare provider about any herbal products you are using.

How often can I take Prochlorperazine Maleate buccal tablets?

The dosing schedule depends on your specific condition; follow your doctor's instructions regarding how often to use the buccal tablets.

Does insurance cover Prochlorperazine Maleate prescriptions?

Coverage varies by insurance plan; check with your insurance provider to understand coverage options for medications like Prochlorperazine Maleate.