Stemetil Injection Patient Information Leaflet

Important Contact Information

• For help with reading or understanding this leaflet, phone 0800 035 2525.

Introductory Information

• Read this leaflet before starting treatment.
• Keep the leaflet for reference.
• Consult your doctor, nurse, or pharmacist for further questions.
• Do not share this medicine with others.
• Report any side effects to your healthcare provider.

Contents Overview

1. What Stemetil Injection is and its Uses
2. Precautions Before Use
3. Administration Guidelines
4. Potential Side Effects
5. Storage Instructions
6. Pack Contents and Additional Information

1. What Stemetil Injection is and its Uses

• Contains prochlorperazine mesilate, a phenothiazine antipsychotic.
• Blocks certain chemicals in the brain.
• Uses:
  • Prevent nausea and vomiting.
  • Treat schizophrenia.
  • Manage mania (overactive behavior or thoughts).

2. Precautions Before Use

• Do not use if allergic to prochlorperazine or similar medicines.
• Not for children due to risk of dystonic reactions.

Warnings and Precautions:

• Discuss with healthcare provider if you have:
  • Heart, liver, kidney, thyroid issues.
  • Stroke history.
  • Enlarged prostate.
  • Parkinson’s disease, dementia, epilepsy, depression.
  • Adrenal gland tumors, muscle weakness (myasthenia gravis), or glaucoma.
  • Blood disorders, blood clots, and abnormal blood levels (potassium, calcium, magnesium).
  • Poor nutrition or alcohol problems.
  • Diabetes.
• Regular tests may be conducted by your doctor.

Drug Interactions:

• Inform about any other medications, including over-the-counter and herbal medicines.
• Particularly important:
  • Sedatives, barbiturates, antidepressants, Parkinson’s, epilepsy, heart, blood pressure medications, cytotoxics, antibiotics, anticholinergics, amphetamines, adrenaline, desferrioxamine, lithium.

Alcohol:

• Avoid alcohol to prevent enhanced effects and breathing difficulties.

Pregnancy and Breast-feeding:

• Not recommended during pregnancy or breastfeeding.
• Potential newborn effects if used in late pregnancy.

Driving and Machines:

• May cause drowsiness, avoid driving or operating machinery.

Composition:

• Sodium content is minimal.
• Contains sulphites; risk of allergic reactions, especially in asthmatics.

3. Administration Guidelines

• Administered by healthcare professionals.
• Given as a deep muscle injection.
• Dosage varies for schizophrenia/mania and nausea prevention.
• Not suitable for children.
• Contact a healthcare provider if unsure about dosage or missed doses.

4. Potential Side Effects

• Serious Reactions:
  • Allergic reactions, neuroleptic malignant syndrome, leucopenia, agranulocytosis, jaundice.
• Common Side Effects:
  • Heart problems, blood clots, muscle issues, vision or skin discoloration, dizziness, low sodium levels, hyperglycemia.
  • Report persistent or severe side effects.

Reporting Side Effects:

• Use the Yellow Card Scheme for reporting: www.mhra.gov.uk/yellowcard.

5. Storage Instructions

• Store out of children’s reach.
• Avoid using past expiry date.
• Protect from light; follow proper disposal measures.

6. Pack Contents and Additional Information

• Contains prochlorperazine mesilate (12.5 mg/ml).
• Additional ingredients listed.
• Available in ampoules (1 ml or 2 ml).
• Manufactured by SANOFI.

Contact Information:

• Marketing Authorisation Holder: Sanofi, Reading, UK.
• Manufacturer: SANOFI S.r.l., Italy.
• For further information, consult healthcare providers or the leaflet revision (01/2022).