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AMLODIPINE 2MG/ML ORAL SOLUTION

Active substance(s): AMLODIPINE BESILATE

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Package Leaflet: Information for the user

Amlodipine 2mg/ml Oral Solution
Read all of this leaflet carefully before you start taking this medicine.
n Keep this leaflet. You may need to read it again.
n If you have any further questions, ask your doctor or pharmacist.
n This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are
the same as yours.
n If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor
or pharmacist.
In this leaflet:
1. What Amlodipine Oral Solution is and what it is used for
2. Before you take Amlodipine Oral Solution
3. How to take Amlodipine Oral Solution
4. Possible side effects
5. How to store Amlodipine Oral Solution
6. Further information

1. What Amlodipine Oral Solution is and what it is used for
The name of your medicine is Amlodipine 2mg/ml Oral Solution (called Amlodipine in this leaflet). Amlodipine belongs to a
group of medicines called calcium antagonists.
Amlodipine 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 Amlodipine 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. Before you take Amlodipine Oral Solution
Do not take Amlodipine if:
n you are allergic (hypersensitive) to Amlodipine, or any of the other ingredients of your medicine listed in section 6, or to any
other calcium antagonists. This may be itching, reddening of the skin or difficulty in breathing
n you have severe low blood pressure (hypotension)
n 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)
n you suffer from heart failure after a heart attack.
Take special care with Amlodipine
You should inform your doctor if you have or have had any of the following conditions:
n recent heart attack
n heart failure
n severe increase in blood pressure (Hypertensive crisis)
n liver disease
n you are elderly and your dose needs to be increased.
Use in children and adolescents
Amlodipine has not been studied in children under the age of 6 years. Amlodipine 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.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained
without a prescription.
Amlodipine may affect or be affected by other medicines, such as:
n ketoconazole, itraconazole (anti-fungal medicines)
n ritonavir, indinavir, nelfinavir (so called protease inhibitors used to treat HIV)
n rifampicin, erythromycin, clarithromycin (antibiotics)
n hypericum perforatum (St. John’s Wort)
n verapamil, diltiazem (heart medicines)
n dantrolene (infusion for severe body temperature abnormalities)
n simvastatin (a cholesterol lowering medicine).
Amlodipine may lower your blood pressure even more if you are already taking other medicines to treat your high blood
pressure.
Taking Amlodipine with food and drink
Grapefruit juice and grapefruit should not be consumed by people who are taking Amlodipine. 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 Amlodipine.
Pregnancy
n The safety of amlodipine in human pregnancy has not been established.
n If you think you might be pregnant, or are planning to get pregnant, you must tell your doctor before you take Amlodipine.
Breast-feeding
n It is not known whether Amlodipine is passed into breast milk. If you are breast-feeding or about to start breast-feeding you
must tell your doctor before taking Amlodipine.
n Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Amlodipine may affect your ability to drive or use machines. If this medicine makes you feel sick, dizzy or tired, or gives you a
headache, do not drive or use machines and contact your doctor immediately.
Amlodipine Oral Solution contains liquid maltitol and glycerol.
n Amlodipine contains liquid maltitol (a type of sugar). If your doctor has told you that you cannot tolerate some sugars, talk
to your doctor before taking this medicine.
n Amlodipine contains glycerol. This may cause headache, stomach upset and diarrhoea.

3. How to take Amlodipine Oral Solution
Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not
sure.
Taking this medicine
n This medicine contains 2 milligram (2mg) of Amlodipine in each 1 millilitre (1ml) of solution.
n Take this medicine by mouth.
n Do NOT shake the bottle before use.
n Your medicine can be used 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 Amlodipine with grapefruit juice.
Measuring your dose
Instructions for use
n Open the bottle: press the cap and turn it anticlockwise (Figure 1).
n Separate the syringe adaptor from the syringe and insert the adaptor securely into the bottle neck (Figure 2).
n Take the syringe and put it in the adaptor opening (Figure 3).

n
n





Turn the bottle upside down (Figure 4).
Fill the syringe with a small amount of solution by pulling the plunger down (Figure 4A). Then push the plunger upward in
order to remove any possible bubbles (Figure 4B). Finally, pull the plunger down to the graduation mark corresponding to
the quantity in millilitres (ml) prescribed by your doctor. The top flat edge of the plunger should be in line with the
graduation mark you are measuring to (Figure 4C).

n

Turn the bottle the right way up (Figure 5A).
Remove the syringe from the adaptor (Figure 5B).
n Put the end of the syringe into your mouth and push the plunger slowly back in to take the medicine.
n Wash the syringe with water and let it dry before you use it again (Figure 6).
n Close the bottle with the plastic screw cap - leave the syringe adaptor in the bottle.
n

Adults
The usual initial dose of Amlodipine is 5mg (2.5ml) once daily. The dose can be increased to 10mg (5ml) once daily.
Use in children and adolescents
For children and adolescents (6-17 years old), the recommended usual starting dose is 2.5mg (1.25ml) a day. The maximum
recommended dose is 5mg (2.5ml) a day.
It is important to keep taking this medicine. Do not wait until you have finished this medicine before seeing your doctor.
If you take more Amlodipine than you should
Taking too much medicine may cause your blood pressure to become low or even dangerously low.
You may feel dizzy, lightheaded, faint or weak. If the 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 much medicine.
Continued overleaf

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If you forget to take Amlodipine
n Do not worry. If you forget to take a dose, leave out that dose completely. Take your next dose at the right time.
n Do not take a double dose to make up for a missed dose.
If you stop taking Amlodipine
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, Amlodipine 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.
n sudden wheeziness, chest pain, shortness of breath or
difficulty in breathing
n swelling of eyelids, face or lips
n swelling of the tongue and throat which causes great difficulty breathing
n 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
n heart attack, abnormal heart beat
n 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: affects 1 to 10 users in 100
n headache, dizziness, sleepiness (especially at the beginning of treatment)
n palpitations (awareness of your heart beat), flushing
n abdominal pain, feeling sick (nausea)
n 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: affects 1 to 10 users in 1,000
n mood changes, anxiety, depression, sleeplessness
n trembling, taste abnormalities, fainting, weakness
n numbness or tingling sensation in your limbs; loss of pain sensation
n visual disturbances, double vision, ringing in the ears
n low blood pressure
n sneezing/running nose caused by inflammation of the lining of the nose (rhinitis)
n altered bowel habits, diarrhoea, constipation, indigestion, dry mouth, vomiting (being sick)
n hair loss, increased sweating, itchy skin, red patches on skin, skin discoloration
n disorder in passing urine, increased need to urinate at night, increased number of times of passing urine
n inability to obtain an erection, discomfort or enlargement of the breasts in men
n weakness, pain, feeling unwell
n joint or muscle pain, muscle cramps, back pain
n weight increase or decrease.
Rare: affects 1 to 10 users in 10,000
n confusion.
Very rare: affects less than 1 user in 10,000
n decreased numbers of white blood cells, decrease in blood platelets which may result in unusual bruising or easy bleeding
(red blood cell damage)
n excess sugar in blood (hyperglycaemia)
n a disorder of the nerves which can cause weakness, tingling or numbness
n cough, swelling of the gums
n abdominal bloating (gastritis)
n 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
n increased muscle tension
n inflammation of blood vessels, often with skin rash
n sensitivity to light
n disorders combining rigidity, tremor, and/or movement disorders.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or
pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You
can also report side effects directly (see details below). By reporting side effects you can help provide more information on the
safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace, IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie

5. How to store Amlodipine Oral Solution
n
n
n

Keep out of the reach and sight of children.
Store in a refrigerator (2-8°C). Keep the bottle stored upright.
Do not use after the expiry date (month, year) stated on the label and carton after EXP. The expiry date
refers to the last day of that month.
n Use within 30 days of opening.
n Do not use Amlodipine if you notice anything wrong with the medicine. Talk to your pharmacist.
n 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. Further information
What Amlodipine Oral Solution contains
n The active ingredient is amlodipine besilate. This medicine contains 2mg of amlodipine (as besilate) in each 1ml of solution.
n The other ingredients are glycerol (E422), liquid maltitol (E965) and purified water.
What Amlodipine Oral Solution looks like and contents of the pack
Your medicine is a clear, pale straw coloured viscous liquid.
It comes in a brown glass bottle holding 150ml of solution with a 5ml purple syringe and adaptor.
Marketing Authorisation Holder and Manufacturer
Rosemont Pharmaceuticals Ltd, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK.
This medicinal product is authorised in the Member States of the EEA under the following names:
UK, Ireland – Amlodipine 2mg/ml Oral Solution
France - Amlodipine Rosemont 2 mg/ml Solution Buvable
Germany - Amlodipin Rosemont 2 mg/ml Lösung zum Einnehmen
This leaflet was last revised in 02/2015
P0783

Amlodipine 2mg/ml Oral Solution

18.02.15

2mg/ml

TWO

P0783

2 of 2

N/A
-

YES

-

150ml

263

150 x 500mm (folded 150 x 37mm)
1

Black

Keyline

Expand view ⇕

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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