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DARMIL 200MG TABLETS

Active substance(s): AMIODARONE HYDROCHLORIDE

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Patient Information Leaflet
Darmil 100mg Tablets
Darmil 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 Darmil 100mg Tablets or Darmil 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 stearate, and colloidal silica.
Pack sizes: The tablets are available in packs of 28 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: Crescent Pharma Limited, Units 3 & 4 Quidhampton
Business Units, Polhampton Lane, Overton, Hampshire, RG25 3ED, UK

WHAT IS THIS MEDICINE FOR?
Darmil 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 Darmil 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
If you are a breast-feeding mother, DO NOT take this medicine. You should limit your intake of
alcohol whilst taking this medicine.
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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.
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.
Contact 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 Darmil 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 D a r m i l Tablets;
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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 tablets after the expiry date on the pack.
Keep you tablets in a safe place where children cannot see or reach them. Do not store above 25ºC.
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.
Crescent Pharma Limited
Last revision date: November 2014

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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