Amitrol 25

Amitrol 25

 Amitriptyline is a tricyclic antidepressant and an analgesic drug. It has marked   
  anticholinergic and sedative properties. It prevents the re-uptake, and hence the 
  inactivation of noradrenaline and serotonin at nerve terminals.
- After oral administration amitriptyline is absorbed slowly but completely. 
  Due to the often delayed gastrointestinal tract passage maximum plasma   
  concentrations are reached after 1 to 5 hours. 
- The mean absolute oral bioavailability is 53% .The plasma protein binding is 
  about 95%. 
- Amitriptyline is metabolized to main metabolite active nortriptyline.   
  Amitriptyline and the main metabolite nortriptyline pass across the placental 
  barrier. The elimination half-life after oral administration is about 25 hours.
- The excretion proceeds mainly with urine. The renal elimination of unchanged 
  amitriptyline is insignificant (about 2%).

- Each film coated tablet of Amitrol® contains: 
   Amitriptyline Hydrochloride                                     25 mg 

  Do not take Amitrol® :-   
- If you are allergic to Amitriptyline or any of the other ingredients of this 
- If you recently have had a heart attack (myocardial infarction).
- If you have heart problems such as disturbances in heart rhythm which are seen 
  on an electrocardiogram (ECG), heart block, or coronary artery disease.
- If you are taking medicines known as monoamine oxidase inhibitors (MAOIs).
- If you have taken MAOIs within the last 14 days.
- If you have taken moclobemide the day before.
- If you have a severe liver disease.
- In children under 6 years of age.

  Tell your doctor or pharmacist if you are taking or have recently taken any other 
  medicines, such as:
- Monoamine oxidase inhibitors (MAOIs) e.g. Phenelzine, Iproniazid, Isocarboxazid,
  Nialamide or Tranylcypromine (used to treat depression) or Selegiline (used to treat 
  Parkinson's disease). These should not be taken at the same time as Amitrol® Tablets.
- Adrenaline, Ephedrine, Isoprenaline, Noradrenaline, Phenylephrine and 
  Phenylpropanolamine (these may be present in cough or cold medicine, and in some 
- Medicine to treat high blood pressure for example calcium-channel blockers (e.g.  
  Diltiazem and Verapamil), Guanethidine, Bethanidine, Clonidine, Reserpine and 
- Anticholinergic drugs such as certain medicines to treat Parkinsons disease and 
  gastrointerstinal disorders (e.g. Atropine,Hyoscyamine).
- Thioridazine (used to treat schizophrenia).
- Tramadol (painkiller).
- Medicines to treat fungal infections (e.g. Fluconazole, Terbinafine, Ketoconazole, and 
- Sedatives (e.g. barbiturates).
- Antidepressants (e.g SSRIs (Fluoxetine, Paroxetine, Fluvoxamine), and bupropion).
- Medicines for certain heart conditions (e.g. beta blockers and antiarrhythmics).
- Cimetidine (used to treat stomach ulcers).
- Methylphenidate (used to treat ADHD).
- Ritonavir (used to treat HIV).
- Oral contraceptives.
- Rifampicin (to treat infections).
- Phenytoin and Carbamazepine (used to treat epilepsy).
- St. John´s Wort (hypericum perforatum) – a herbal remedy used for depressionn.
- You should also tell your doctor if you take or have recently taken medicine that 
  may affect the heart´s rhythm. e.g.:
- medicines to treat irregular heartbeats (e.g. Quinidine and Sotalol).
- Astemizole and Terfenadine (used to treat allergies and hayfever).
- medicines used to treat some mental illnesses (e.g. Pimozide and Sertindole).
- Cisapride (used to treat certain types of indigestion).
- Halofantrine (used to treat malaria).
- Methadone (used to treat pain and for detoxification).
- diuretics (“water tablets” e.g. Furosemide).

- Pregnancy: Use only if potential benefit outweighs risk.
- Breast Feeding: The amount secreted into breast milk is too small to be harmful.

- Common or very common. 
  Abdominal pain, fatigue, hypertension, mydriasis, oedema, palpitation,
  restlessness, stomatitis.
- Rare: Dysarthria, extrapyramidal symptoms, paralytic ileus, tremor.
- Very rare: Neuroleptic malignant syndrome, precipitation of angle-closure 

- A heart problem called “prolonged QT interval” (which is shown on your
  electrocardiogram, ECG) and heart rhythm disorders (rapid or irregular heart beat) 
  have been reported with Amitrol® Tablets.
  Tell your doctor if you:
- Have slow heart rate.
- Have heart failure.
- Are taking any other medication that may cause heart problems, or have a problem
  that gives you a low level of potassium or magnesium, or a high level of potassium in 
  your blood.
- Have a surgery planned as it might be necessary to stop the treatment with Amitrol®
  before you are given anaesthetics. In the case of acute surgery, the anaesthetist should
  be informed about the treatment of Amitrol® .
- Have an over active thyroid gland or receive thyroid medication.
- Thoughts of suicide and worsening of your depression.
  If you are depressed, you can sometimes have thoughts of harming or killing 
  yourself. These may be increased when first starting antidepressants, since these 
  medicines all take time to work, usually about two weeks but sometimes longer.
  You may be more likely to think like this:
• if you have previously had thoughts about killing or harming yourself.
• if you are a young adult. Information from clinical trials has shown an increased risk
  of suicidal behaviour in young adults (less than 25 years old) with psychiatric
  conditions who were  treated with an antidepressant.
  If you have thoughts of harming or killing yourself at any time, contact your doctor 
  or go to a hospital straight away.
  You may find it helpful to tell a relative or close friend that you are depressed, and 
  ask them to read this leaflet. You might ask them to tell you if they think your 
  depression or anxiety is getting worse, or if they are worried about changes in your 
- Tell your doctor if you have, or have had in the past, any medical problems,  
   especially if you have:
• narrow angle glaucoma (loss of vision due to abnormally high pressure in the eye)
• epilepsy, a history of convulsions or fits
• difficulty in passing urine
• enlarged prostate
• schizophrenia, bipolar disorder.
• pylorus stenosis (narrowing of the gastric outlet) and paralytic ileus (blocked intestine)
Driving and using machines:-
- This medicine may cause drowsiness and dizziness, especially in the beginning of the
  treatment. Do not drive or work with tools or machinery if you are affected.

- Blister of 10 tablets, pack of 3 blisters. 

- Store in a dry place, at a temperature below 25ºC and protect from light.