Darmil 100 Mg Tablets
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Amiodarone Hydrochloride 100mg Tablets Amiodarone Hydrochloride 200mg Tablets
THIS LEAFLET PROVIDES A SUMMARY OF THE INFORMATION AVAILABLE ON YOUR MEDICINE. PLEASE READ IT CAREFULLY BEFORE YOU START TO TAKE YOUR MEDICINE. IF YOU HAVE ANY QUESTIONS OR ARE NOT SURE OF ANYTHING ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET YOU MAY NEED TO READ IT AGAIN.
WHAT IS IN THIS MEDICINE?_
The name of your medicine is Amiodarone Hydrochloride 100mg Tablets or Amiodarone Hydrochloride 200mg Tablets.
Each 100mg tablet contains: Amiodarone Hydrochloride (active ingredient) 100mg Each 200mg tablets contains: Amiodarone Hydrochloride (active ingredient) 200mg. Both 100mg and 200mg tablets contain the following inactive ingredients: lactose, maize starch, povidone, pregelatinised starch, magnesium starch, and colloidal silica.
Pack sizes: The tablets are available in packs of 30 tablets.
WHAT IS AMIODARONE HYDROCHLORIDE?_
The active ingredient in your medicine is Amiodarone Hydrochloride. These tablets are part of a group of drugs known as antiarrhythmics that are used to prevent irregular heart beats.
MANUFACTURER: Rivopharm S.A., 6928 Manno, Lugano, Switzerland.
MARKETING AUTHORIZATION HOLDER: The Co-operative Pharmacy National Distribution Centre Limited, Enterprise Way, Meir Park, Stoke on Trent, ST3 7UN
WHAT IS THIS MEDICINE FOR?_
Amiodarone Hydrochloride Tablets are prescribed for the treatment of irregular or rapid heart rate.
WHAT DO I NEED TO KNOW BEFORE TAKING THIS MEDICINE?_
Please tell your doctor before you start to take your tablets if you:
• Have ever had a bad reaction to any of the ingredients listed in the “What is in this medicine?” section.
• are taking other medicines including ones that you have brought for yourself without a prescription (eg: treatment for hay fever and allergies). There are many other medicines which, if taken with Amiodarone Hydrochloride Tablets, can lead to a bad reaction. You must make sure that your doctor is aware of all other medicines that you are taking. If you are not sure, ask your pharmacist.
• are taking any other drugs for a heart condition.
• have or had any problems with your thyroid.
• are allergic to iodine.
• have liver or breathing problems.
• are pregnant or likely to become pregnant
This medicine must not be given to children, premature babies or neonates.
If you are a breast-feeding mother, DO NOT take this medicine.
You should limit your intake of alcohol whilst taking this medicine.
If you see another doctor or visit a hospital, remember to tell them what medicines you are already taking.
HOW MUCH OF THIS MEDICINE SHOULD YOU TAKE?_
You must take your tablets as instructed by your doctor. This label will tell you how many to take and how often to take them. The number of tablets you take is called the ‘dose’.
The most common adult dose for these tablets is 200mg three-times daily for the first week, followed by 200mg twice a day for the next week and then 200mg daily. In some patients this may be reduced to 100mg a day. The correct dose will have been decided by your doctor. If you are not sure ask your doctor or pharmacist.
Swallow the tablets whole with a glass of water.
Your doctor will tell you how many tablets to take.
There are only limited data on the efficacy and safety in children. Your doctor will decide on an appropriate dose.
If you forget to take a dose at the right time, take it as soon as you remember. Do not take two doses together. If it is almost time to take the next dose, wait until then and then carry on as before.
It can be dangerous to stop taking your tablets without your doctor’s advice.
WHAT TO DO IF YOU TAKE TOO MANY TABLETS_
It is important not to take too many tablets.
Consult your nearest hospital casualty department or your doctor for advice if you have swallowed too many tablets or if you think a child has swallowed any.
Take this leaflet, and any tablets that you still have to show the doctor.
WHAT UNWANTED EFFECTS CAN THIS MEDICINE HAVE?_
You may have some unwanted effects while you are taking your tablets. In particular amiodarone can have unwanted effects on the lungs, liver, thyroid gland, skin and nervous system, particularly when used for long periods. Tell your doctor as soon as possible if you suffer from any of the following:
• yellowing of the skin or the eyes (jaundice)
• extreme tiredness or restlessness.
• unusual loss or gain of weight.
• shortness of breath, persistent cough or fever.
• problems with circulation such as, pins and needles, weakness of hands or legs, cramps and loss of balance.
• difficulties with your vision.
• Chest pain or heart palpitations.
• other unusual or unexpected effects including fainting or blackouts.
If you are allergic to the tablets, you may get a skin rash.
The use of Amiodarone Hydrochloride Tablets may lead to you becoming sensitive to the sun. You should avoid exposure of your skin to direct sunlight or sun lamps. You should take sensible precautions when you are in the sun keeping exposed areas covered, or apply a total sun block to exposed areas of skin.
The following effects have been reported infrequently in patients taking Amiodarone Hydrochloride Tablets; headaches, disturbed sleep, nausea and vomiting, experience a metallic taste, painful swelling of the testicles, slow pulse, shakiness, hair loss, muscle pain and weakness, impotence, difficulty in walking or balancing, swelling of veins (you may also notice bruising) or nose bleeds. If you develop any of these symptoms and are worried about them, consult your doctor. During the time you are taking this medicine your doctor may ask you to attend for follow-up examinations.
If you feel unwell in any other way or you experience any other unwanted effect not mentioned above, tell you doctor as soon as possible.
HOW SHOULD YOU STORE YOUR MEDICINE?_
Do not take the tablet after the expiry date stated on the pack.
Keep you tablets in a safe place where children cannot see or reach them.
Do not store above 25°C.
Store in the original package. These tablets are sensitive to light.
You should take any tablets back to your pharmacist that are out of date or which you no longer need.
KEEP ALL MEDICINES OUT OF THE REACH OF CHILDREN.
REMEMBER: This medicine has been prescribed for you. Do not give it to anybody else even if their symptoms appear to be the same as yours, since it may be harmful to them.
Last revision date: December 2011