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AMOLYTE 5 MG TABLETS

Active substance(s): AMLODIPINE BESILATE

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Package leaflet: Information for the user
Amolyte 5mg tablets
Amolyte 10mg tablets

Amlodipine
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible
side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Amolyte is and what it is used for
2. What you need to know before you take Amolyte
3. How to take Amolyte
4. Possible side effects
5. How to store Amolyte
6. Contents of the pack and other information

1.

What Amolyte is and what it is used for

Amolyte contains the active substance amlodipine which belongs to a group of medicines
called calcium antagonists.
Amolyte is used to treat high blood pressure (hypertension) or a certain type of chest pain
called angina, a rare form of which is Prinzmetal's or variant angina.
In patients with high blood pressure your medicine works by relaxing blood vessels, so that
blood passes through them more easily. In patients with angina Amolyte works by improving
blood supply to the heart muscle which then receives more oxygen and as a result chest pain
is prevented. Your medicine does not provide immediate relief of chest pain from angina.

2.

What you need to know before you take Amolyte

DO NOT take Amolyte
• If you are allergic to amlodipine or any of the other ingredients of this medicine (listed in
section 6) or to any other calcium antagonists. This may be itching, reddening of the skin
or difficulty in breathing.
• If you have severe low blood pressure (hypotension).
• If you have narrowing of the aortic heart valve (aortic stenosis) or cardiogenic shock (a
condition where your heart is unable to supply enough blood to the body).
• If you suffer from heart failure after a heart attack.

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Warnings and precautions
Talk to your doctor or pharmacist before taking Amolyte if you have or have had any of the
following conditions:
• Recent heart attack
• Heart failure
• Severe increase in blood pressure (Hypertensive crisis)
• Liver disease
• You are elderly and your dose needs to be increased.
Children and adolescents
Amlodipine has not been studied in children under the age of 6 years. Amolyte should only be
used for hypertension in children and adolescents from 6 years to 17 years of age (see section
3). For more information, talk to your doctor.
Other medicines and Amolyte
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Amolyte may affect or be affected by other medicines, such as:
• ketoconazole, itraconazole (anti-fungal medicines)
• ritonavir, indinavir, nelfinavir (so called protease inhibitors used to treat HIV)
• rifampicin, erythromycin, clarithromycin (antibiotics)
• hypericum perforatum (St. John’s Wort)
• verapamil, diltiazem (heart medicines)
• dantrolene (infusion for severe body temperature abnormalities)
• simvastatin (used to reduce elevated cholesterol levels in the blood)
Amolyte may lower your blood pressure even more if you are already taking other medicines
to treat your high blood pressure.
Amolyte with food and drink
Grapefruit juice and grapefruit should not be consumed by people who are taking Amolyte.
This is because grapefruit and grapefruit juice can lead to an increase in the blood levels of
the active ingredient amlodipine, which can cause an unpredictable increase in the blood
pressure lowering effect of Amolyte
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
The safety of amlodipine in human pregnancy has not been established.
Breast-feeding
It is not known whether amlodipine is passed into breast milk.
Driving and using machines
Amolyte may affect your ability to drive or use machines. If the tablets make you feel sick,
dizzy or tired, or give you a headache, do not drive or use machines and contact your doctor
immediately.

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3.

How to take Amolyte

Always take this medicine exactly as your doctor has told you. Check with your doctor or
pharmacist if you are not sure.
The usual initial dose is 5 mg Amolyte once daily. The dose can be increased to 10 mg
Amolyte once daily.
The Amolyte 10 mg tablet can be divided into equal halves.
Your medicine can be taken before or after food and drinks. You should take your medicine at
the same time each day with a drink of water. Do not take Amolyte with grapefruit juice.
Use in children and adolescents
For children and adolescents (6 -17 years old), the recommended usual starting dose is 2.5 mg
a day. The maximum recommended dose is 5 mg a day.
Amlodipine 2.5 mg is not currently available and the 2.5 mg dose cannot be obtained with
Amolyte 5 mg tablets as these tablets are not manufactured to break into two equal halves.
It is important to keep taking the tablets. Do not wait until your tablets are finished before
seeing your doctor.
If you take more Amolyte than you should
Taking too many tablets may cause your blood pressure to become low or even dangerously
low. You may feel dizzy, lightheaded, faint or weak. If blood pressure drop is severe enough
shock can occur. Your skin could feel cool and clammy and you could lose consciousness.
Seek immediate medical attention if you take too many Amolyte tablets.
If you forget to take Amolyte
Do not worry. If you forget to take a tablet, leave out that dose completely. Take your next
dose at the right time. Do not take a double dose to make up for a forgotten dose.
If you stop taking Amolyte
Your doctor will advise you how long to take your medicine. Your condition may return if
you stop using your medicine before you are advised.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Visit your doctor immediately if you experience any of the following very rare, severe side
effects after taking this medicine.







Sudden wheeziness, chest pain, shortness of breath or difficulty in breathing
Swelling of eyelids, face or lips
Swelling of the tongue and throat which causes great difficulty breathing
Severe skin reactions including intense skin rash, hives, reddening of the skin over your
whole body, severe itching, blistering, peeling and swelling of the skin, inflammation of
mucous membranes (Stevens Johnson Syndrome) or other allergic reactions
Heart attack, abnormal heart beat

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Inflamed pancreas which may cause severe abdominal and back pain accompanied with
feeling very unwell

The following common side-effects have been reported. If any of these cause you problems or
if they last for more than one week, you should contact your doctor.
Common (may affect up to 1 in 10 people):
• Headache, dizziness, sleepiness (especially at the beginning of treatment)
• Palpitations (awareness of your heart beat), flushing
• Abdominal pain, feeling sick (nausea)
• Ankle swelling (oedema), tiredness
Other side-effects that have been reported include the following list. If any of these get
serious, or if you notice any side-effects not listed in this leaflet, please tell your doctor or
pharmacist.
Uncommon (may affect up to 1 in 100 people):
• Mood changes, anxiety, depression, sleeplessness
• Trembling, taste abnormalities, fainting, weakness
• Numbness or tingling sensation in your limbs; loss of pain sensation
• Visual disturbances, double vision, ringing in the ears
• Low blood pressure
• Sneezing/running nose caused by inflammation of the lining of the nose (rhinitis)
• Altered bowel habits, diarrhoea, constipation, indigestion, dry mouth, vomiting (being
sick)
• Hair loss, increased sweating, itchy skin, red patches on skin, skin discolouration
• Disorder in passing urine, increased need to urinate at night, increased number of times of
passing urine
• Inability to obtain an erection; discomfort or enlargement of the breasts in men
• Weakness, pain, feeling unwell
• Joint or muscle pain, muscle cramps, back pain
• Weight increase or decrease
Rare (may affect up to 1 in 1,000 people):
• Confusion
Very rare (may affect up to 1 in 10,000 people):
• Decreased numbers of white blood cells, decrease in blood platelets which may result in
unusual bruising or easy bleeding (red blood cell damage)
• Excess sugar in blood (hyperglycaemia)
• A disorder of the nerves which can cause weakness, tingling or numbness
• Cough
• Swelling of the gums
• Abdominal bloating (gastritis)
• Abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin
(jaundice), liver enzyme increase which may have an effect on some medical tests
• Increased muscle tension
• Inflammation of blood vessels, often with skin rash
• Sensitivity to light
• Disorders combining rigidity, tremor, and/or movement disorders

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Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
side effects not listed in this
leaflet. You can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this
medicine.
5.

How to store Amolyte

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after "EXP". The
expiry date refers to the last day of that month.
Store in the original package in order to protect from light.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist
how to throw away medicines you no longer use. These measures will help protect the
environment.

6.

Contents of the pack and other information

What Amolyte contains
The active substance is amlodipine (as besilate).
Amolyte 5mg tablets:
Each tablet contains 5 mg of amlodipine (as besilate)
• The other ingredients are: microcrystalline cellulose (E460), anhydrous calcium hydrogen
phosphate (E341), sodium starch glycolate, magnesium stearate (E470b).



Amolyte 10mg tablets:
Each tablet contains 10 mg of amlodipine (as besilate)
The other ingredients are: microcrystalline cellulose (E460), anhydrous calcium hydrogen
phosphate (E341), sodium starch glycolate, magnesium stearate (E470b).

What Amolyte looks like and contents of the pack
Amolyte 5mg tablets:
Amolyte 5 mg tablets are white, round tablets.
Blister packs with 7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 100 tablets.
Amolyte 10mg tablets:
Amolyte 10 mg tablets are white, round tablets with a break score on one side. The tablet can
be divided into equal halves.
Blister packs with 7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 100 tablets.
Not all pack sizes may be marketed.

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Marketing Authorisation Holder and Manufacturer
Genus Pharmaceuticals, Linthwaite, Huddersfield, HD7 5QH, UK.
This medicinal product is authorised in the Member States of the EEA under the
following names:
Austria:
Denmark:
Germany:
Spain:
Ireland:
The Netherlands:
Sweden:
United Kingdom:

Amlodipin besilat STADA 5 mg Tabletten
Amlodipin besilat STADA 10 mg Tabletten
Amlodistad
Amlodipin(besilat) AL 5 mg Tabletten
Amlodipin(besilat) AL 10 mg Tabletten
Amlodipino STADA Genéricos 5 mg comprimidos EFG
Amlodipino STADA Genéricos 10 mg comprimidos EFG
Amlodipine Clonmel 5 mg tablets
Amlodipine Clonmel 10 mg tablets
Amlodipine CF 5 mg, tabletten
Amlodipine CF 10 mg, tabletten
Amlodistad
Amolyte 5 mg tablets
Amolyte 10 mg tablets

This leaflet was last revised in April 2015

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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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