• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

The name of your medicine is Amlodipine 10mg/5ml Oral Solution but it will be referred to as Amlodipine throughout this leaflet.

1. What Amlodipine is and what it is used for
2. What you need to know before you take Amlodipine
3. How to take Amlodipine
4. Possible side effects
5. How to store Amlodipine
6. Contents of the pack and other information

• 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.
• You have severe low blood pressure (hypotension).
• 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).
• You suffer from heart failure after a heart attack.

Talk to your doctor or pharmacist before taking Amlodipine.

You should inform your doctor 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

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.

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:

• 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)
• Tacrolimus, sirolimus, temsirolimus, and everolimus (medicines used to alter the way your immune system works)
• Simvastatin (cholesterol lowering medicine)
• Cyclosporine (an immunosuppressant)

Amlodipine may lower your blood pressure even more if you are already taking other medicines to treat your high blood pressure.

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

The safety of amlodipine in human pregnancy has not been established.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Breast-feeding

Amlodipine has been shown to pass into breast milk in small amounts. If you are breast-feeding or about to start breast-feeding you must tell your doctor before taking Amlodipine.

Ask your doctor or pharmacist for advice before taking this medicine.

Fertility

The data on the effect of amlodipine on human fertility is not sufficient. In rats, amlodipine has shown adverse effects on male fertility.

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.

Methyl parahydroxybenzoate (E218): May cause an allergic reaction (possibly delayed).

Propylene Glycol (E1520): This medicine contains 780mg propylene glycol in each 5ml.

Sodium: This medicine contains less than 1 mmol sodium (23 mg) per 5ml, that is to say essentially 'sodium - free'.

Glycerol (E422): May cause headache, stomach upset and diarrhoea.

Your doctor will determine what dose is appropriate for you.

For Adults:

• The recommended initial dose is 5mg (2.5ml) once daily.
• The dose can be increased to 10mg (5ml) once daily.

‘It is recommended to use the lower strength (5mg/5ml) of Amlodipine when a lower dose (<5mg) is required.’

‘It is recommended to use the higher strength (10mg/5ml) of Amlodipine when a higher dose is required.’

For children and adolescents (6-17 years old):

• The recommended usual initial dose is 2.5mg (1.25ml) once daily, which is not attainable with this strength. The measuring spoon supplied does not have the required 1.25ml graduation mark.
• The dose can be increased to 5mg (2.5ml) once daily.
• The maximum recommended dose is 5mg (2.5ml) a day.

‘It is recommended to use the lower strength (5mg/5ml) of Amlodipine when a lower dose (<5mg) is required.’

‘It is recommended to use the higher strength (10mg/5ml) of Amlodipine when a higher dose is required.’

It is important to keep taking the medicine. Do not wait until your medicine is finished before seeing your doctor.

Amlodipine is not recommended for use in children under 6 years.

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.

• Use the 2.5-5ml double-ended spoon supplied in the pack to measure the required dose (see figure below).
• Swallow the solution.
• Wash the spoon with clean water after taking every dose.

2.5-5ml double-ended Spoon

Overdose may cause your blood pressure to become low or even dangerously low. You may feel dizzy, lightheaded, faint or weak. If your blood pressure drop is severe enough shock can occur. Your skin could feel cool and clammy and you could lose consciousness.

Excess fluid may accumulate in your lungs (pulmonary oedema) causing shortness of breath that may develop up to 24-48 hours after intake.

Seek immediate medical attention if you take too much Amlodipine.

Do not worry. If you forget a dose, 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.

Your doctor will advise you how long to take this medicine. Your condition may return if you stop using this medicine before you are advised.

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 Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

The active substance is amlodipine (as besilate).

Each 5ml of oral solution contains 5mg amlodipine (as besilate).

Each ml of oral solution contains 1mg amlodipine (as besilate).

The other ingredients are methyl parahydroxybenzoate (E218), propylene glycol (E1520), disodium phosphate anhydrous (E339), sodium dihydrogen phosphate dihydrate, purified water and glycerol (E422).

Amlodipine is a clear, greenish yellow coloured oral solution. It comes in an amber glass bottle with a child-resistant plastic cap. The pack also contains a 2.5-5ml double ended spoon.

Amlodipine is supplied in bottles containing 100ml, 150ml and 300ml of oral solution.

Not all pack sizes may be marketed.