Amiodarone GP

Amiodarone GP

amiodarone

Manufacturer:

Lab Medinfar

Distributor:

CNW
Full Prescribing Info
Contents
Amiodarone hydrochloride.
Description
A medication in the form of tablets for oral administration.
Each tablet contains 200 mg of Amiodarone hydrochloride as the active substance.
Excipients/Inactive Ingredients: Amiodarone GP tablets also contain the following inactive ingredients: Corn starch, lactose monohydrate, povidone (K90), magnesium stearate, silica, colloidal anhydrous, Pregelatinised starch, purified water.
Action
Amiodarone belongs to a group of medicines called anti-arrhythmics (Class III).
It works by controlling the uneven beating of the heart (called "arrhythmias"). Taking the tablets helps the heartbeat to return to normal.
Indications/Uses
Amiodarone GP 200 mg tablets is indicated in the following situations: Treat uneven heartbeats where other medicines either have not worked or cannot be used.
Treat an illness called Wolff-Parkinson-White Syndrome.
Treat atrial fibrillation or flutter, Amiodarone are used only when other medicines cannot be used.
Treat fast heartbeats which may happen suddenly and may be uneven. Amiodarone are used only when other medicines cannot be used.
Dosage/Direction for Use
Swallow the tablets whole. Do not crush or chew the tablets.
The doctor will prescribe a dose of Amiodarone GP 200 mg tablets suitable for the patient, given the condition and other medication being taken. The dosage of this medication must be strictly respected; do not change the dose or discontinue treatment.
Keep taking Amiodarone GP tablets until the doctor tells to stop. Administration of Amiodarone GP tablets should not be stopped just because the patient feels better. If this medicine has been stopped, the uneven heartbeats may come back. This could be dangerous.
Adults: Loading dosage: The usual starting dose is 200mg (one Amiodarone GP Tablet) three times each day for one week.
Maintenance dosage: The dose will then be lowered to 200mg twice each day for one week.
The dose will then be lowered to 200mg once each day, until the patient has been told otherwise.
In some cases, the doctor may then decide to either increase or lower the amount to take each day. This will depend on how the patient reacts to this medicine.
Children and adolescents: Amiodarone GP Tablets should not be given to children and adolescents.
Elderly: The doctor may give a lower dose of Amiodarone GP Tablets. Also, the doctor should check the patient's blood pressure and thyroid function regularly.
What should be done in case of a forgotten dose?: If a dose has been forgotten, it must be taken as soon as remembered. However, if it is nearly time for the next dose, skip the missed dose.
Do not take a double dose to make up for a forgotten tablet.
Overdosage
If the patient has taken more Amiodarone GP Tablets than necessary, tell a doctor or go to a hospital casualty department straightaway. Take the medicine pack. This is so the doctor knows what the patient has taken. The following effects may happen: feeling dizzy, faint or tired, confusion, slow heartbeat, damage to the liver or being sick.
Contraindications
Do not take Amiodarone GP 200 mg tablets: In case of: Allergic (hypersensitivity) to iodine, amiodarone or to any of its components list in Description; Sinus bradycardia or sinoatrial heart block; Any other problems with heartbeat and lack of fitted pacemaker; Thyroid problems; Pregnant or breast-feeding.
Special Precautions
Tell the doctor about any health problems the patient may have, or has ever had, and about the patient's allergies.
Undesirable effects are usually dose related. The minimum effective maintenance dose should be carefully established, so as to prevent or minimize undesirable effects.
Amiodarone should be used with caution in patients with heart failure.
Amiodarone should be used with caution in patients with liver problems. Routine monitoring of liver function tests (transaminases) is advised during treatment.
Any problems with lungs or have asthma.
Any problem with eyesight. This includes an illness called 'optic neuritis'.
A pacemaker or implantable cardioverter defibrillator (ICD).
Blistering or peeling of the skin around the lips, eyes, mouth, nose and genitals, flu-like symptoms and fever. This could be a condition called Steven-Johnson syndrome.
Severe blistering rash in which layers of the skin may peel off to leave large areas of raw exposed skin over the body. The patient may also feel generally unwell, has a fever, chills and aching muscles (Toxic Epidermal Necrolysis).
Protect the skin from sunlight. Amiodarone can cause photosensitivity, therefore patients should be instructed to avoid exposure to sun and to use protective measures during therapy.
Anesthesia: the anesthetist should be informed that the patient is taking amiodarone before surgery.
Important information about some of the ingredients of Amiodarone GP 200mg tablets: Amiodarone GP 200 mg tablets include lactose in its composition. For this reason, patients with rare hereditary problems of galactose intolerance, lactase deficiency or glucose malabsorption syndrome should not take this medicine.
Iodine is present in Amiodarone hydrochloride, Iodine can cause problems to the thyroid.
Driving or operating machinery while taking this medicine: The patient may have blurred eyesight after taking this medicine. If this happens, do not drive or use any tools or machines.
Use In Pregnancy & Lactation
Pregnancy: Tell the doctor before taking this medicine if the patient is pregnant, might become pregnant or may be pregnant. Amiodarone is not normally given during pregnancy.
Lactation: Do not take if breast-feeding or planning to breast-feed. This is because small amounts of this medicine may pass into the mothers' milk.
Adverse Reactions
Like all medicines, Amiodarone GP 200 mg tablets can cause side effects. If any of these or other side effects not previously listed occur, please tell the doctor or pharmacist.
Stop taking Amiodarone GP Tablets and see a doctor or go to hospital if: The patient has an allergic reaction. The signs may include: a rash, swallowing or breathing problems, swollen eyelids, face, lips, throat or tongue.
The patient has blistering or peeling of the skin around the lips, eyes, mouth, nose and genitals, flu-like symptoms and fever. This could be a condition called Stevens-Johnson syndrome.
The patient has a severe blistering rash in which layers of the skin may peel off to leave large areas of raw exposed skin over the body. The patient may also feel generally unwell, has a fever, chills and aching muscles (Toxic Epidermal Necrolysis).
The patient has inflammation of the skin characterised by fluid filled blisters (bullous dermatitis).
The patient has flu-like symptoms and a rash on the face followed by an extended rash with a high temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes (DRESS).
Common: Yellowing of the skin or eyes (jaundice), feeling tired or sick, loss of appetite, stomach pain or high temperature. These can be signs of liver problems or damage, which can be very dangerous.
Difficulty breathing or tightness in the chest, coughing which will not go away, wheezing, weight loss and fever. This could be due to inflammation of the lungs which can be very dangerous.
Uncommon: Heartbeat becomes even more uneven or erratic. This can lead to heart attack, so go to hospital straight away.
Very rare: Loss of eyesight in one eye or eyesight becomes dim and colorless. Eyes may feel sore or tender and feel painful to move. This could be an illness called 'optic neuropathy' or 'neuritis'.
Heartbeat becomes very slow or stops beating. If this happens go to hospital straight away.
Stop taking Amiodarone GP Tablets and see a doctor straight away if for any of the following serious side effects: Uncommon: Feeling numb or weak, tingling or burning feelings in any part of the body.
Very rare: Skin rash caused by narrow or blocked blood vessels (called 'vasculitis').
Headache (which is usually worse in the morning or happens after coughing or straining), feeling sick (nausea), fits, fainting, eyesight problems or confusion can occur. These could be signs of problems with the brain.
Moving unsteadily or staggering, slurred or slow speech.
Feeling faint, dizzy unusually tired and short of breath. These could be signs of a very slow heartbeat (especially in people over 65 years old) or other problems with the heart's natural beat.
Not Known: Chest pain and shortness of breath and irregular heartbeat. These could be signs of a condition called "Torsade de pointes".
Some cases of bleeding in the lungs have been reported in patients taking Amiodarone Tablets. Tell the doctor straight away if the patient coughs up any blood.
Tell the doctor as soon as possible for any of the following side effects: Very common: Blurred eyesight or seeing a colored halo in dazzling light.
Common: Feeling extremely restless or agitated, weight loss, increased sweating and being unable to stand the heat. This could be signs of an illness called 'hyper-thyroidism'.
Feeling extremely tired, weak or 'run-down', weight gain, being unable to stand the cold, constipation and aching muscles. These could be signs of an illness called 'hypo-thyroidism'.
Trembling when arms or legs are moved.
Blue or grey marks on parts of the skin exposed to sunlight, especially the face.
Uncommon: Muscle cramps, stiffness or spasm.
Very rare: Swelling of the testicles.
Red, scaly patches of skin, loss of hair or loosening of nails (called 'exfoliative dermatitis').
Feeling tired, faint, dizzy or having pale skin. These could be signs anaemia.
The patient may bleed or bruise more easily than usual. This could be because of blood disorder (called 'thrombocytopenia').
Feeling unwell, confused or weak, feeling sick (nausea), loss of appetite, feeling irritable. This could be an illness called 'syndrome of inappropriate anti-diuretic hormone secretion' (SIADH).
Not Known: Severe stomach pain which may reach through to the back. This could be a sign of pancreatitis.
Tell the doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days: Very common: Feeling sick (nausea) or being sick (vomiting).
Change in the way things taste.
Changes in the amount of liver enzymes at the beginning of treatment. This can be seen in blood tests.
Burning more easily in the sun.
Common: Slightly slower heartbeat; Nightmares; Problems sleeping; Constipation; Scaly and itchy rash (eczema).
Uncommon: Dry mouth.
Very rare: Headache; Balance problems, feeling dizzy (vertigo); Difficulty in getting or maintaining an erection or in ejaculating; Hair loss, balding; Skin rash; Skin redness during radio-therapy.
Not Known: Hives (itchy, lumpy rash).
Granulomas, small red lumps on the skin or inside the body which are seen by X-ray.
Feeling less hungry.
Movements that cannot be controlled, mainly of the tongue, mouth, jaw, arms and legs (Parkinsonism).
Feeling confused or seeing or hearing thins that are not there.
A distorted sense of smell (parosmia).
Drug Interactions
It is important to tell the doctor if the patient is taking or has recently taken any other medicines, including medicines obtained without a prescription.
In particular, do not take this medicine and tell the doctor, if the patient is taking: Other medicines for an uneven heartbeat (such as sotalol, quinidine, procainamide, disopyramide or bretylium).
Medicines for infections (such as intra-venous erythromycin, co-trimoxazole, moxifloxacin or pentamidine).
Medicines for Schizophrenia (such as chlorpromazine, thioridazine, fluphenazine, pimozide, haloperidol, amisulpride or sertindole).
Medicines for other mental illnesses (such as lithium, doxepin, maprotiline or amitriptyline).
Medicines for malaria (such as quinine, mefloquine, chloroquine or halofantrine).
Medicines used for hay fever, rashes or other allergies called antihistamines (such as terfenadine, astemizole or mizolastine).
Medicines for hepatitis C treatment (such as sofosbuvir, daclatasvir, simeprevir or ledipasvir).
Tell the doctor if the patient is taking any of the following medicines: Medicines that lengthen the heartbeat (the QT interval) such as medicines for infection (such as clarithromycin, ciprofloxacin, ofloxacin or levofloxacin).
Medicine for heart problems called Beta-blocker (such as propranolol).
Medicine called Calcium channel blockers - for chest pain (angina) or high blood pressure (such as diltiazem or verapamil).
Medicines for constipation (laxatives) (such as bisacodyl or senna).
Medicines for high cholesterol (statins) such as simvastatin or atorvastatin (Do not exceed 20 mg simvastatin daily with amiodarone).
The following medicines can increase the chance of getting side effects, when taken with Amiodarone GP 200 mg tablets: Amphotericin (when given directly into a vein) - used for fungal infections.
Medicines for inflammation (corticosteroids) such as hydrocortisone, betamethasone or prednisolone.
Water tablets (diuretics).
General anesthetics or high dose oxygen - used during surgery.
Tetracosactide - used to test some hormone problems.
Ciclsporin and tacrolimus - used to help prevent rejection transplants.
Medicines for impotence such as sildenafil, tadalafil or vardenafil.
Fentanyl - used for pain relief.
Ergotamine - used for migraines.
Midazolam - used to relieve anxiety or to help relax before surgery.
Colchicine - used for the treatment of gout.
Flecainide - another medicine used for uneven heartbeats. The doctor should monitor the treatment and may half the dose of Flecainide.
Lidocaine - used as an anesthetic.
Warfarin - used to stop the blood from clotting.
Digitalis - used for some heart conditions.
Dabigatran - used to thin the blood.
Taking this medicine with food and drink: Do not drink grapefruit juice while taking this medicine, it can increase the chance of getting side effects.
Limit the amount of alcohol intake, it will increase the chance of having problems with the liver.
Storage
Do not store above 25°C.
Store the tablets in the original package in order to protect form light.
MIMS Class
ATC Classification
C01BD01 - amiodarone ; Belongs to class III antiarrhythmics.
Presentation/Packing
Tab 200 mg x 10's, 30's, 60's.
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