AMLODIPINE 1 MG / ML ORAL SUSPENSION - patient leaflet, side effects, dosage

1. what amlodipine is and what it is used for

Amlodipine contains the active substance amlodipine which 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, including a rare form of angina called 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. what you need to know before you take amlodipine

Do NOT take Amlodipine:

• 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.

Warnings and precautions

Talk to your doctor or pharmacist before taking Amlodipine 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.

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.

Other medicines and Amlodipine

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

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 (medicine used to alter the way your immune system works)
• simvastatin (a 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.

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, whichcan cause an unpredictable increase in the blood pressure lowering effect of Amlodipine.

Pregnancy and breast-feeding

Pregnancy

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

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist 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 any medicine.

Driving and using machines

Amlodipine may affect your ability to drive or use machines. If the suspension makes you feel sick, dizzy or tired, or gives you a headache, do not drive or use machines and contact your doctor immediately.

3. how to take amlodipine

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

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

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. Immediately before each use shake the bottle 5 times and for at least 10 seconds, until the suspension is mixed thoroughly. Then, turn the bottle upside down and make sure that there is nothing deposited at its bottom.

The carton contains a bottle and a double-ended measuring spoon. One end of the spoon will give you 5 ml of the suspension and the other will give you 2.5 ml. Wash the spoon in warm water immediately after use and allow to dry.

• 2.5– 5 ml double-ended spoon

• 2.5 ml 5 ml

(Small end) (Large end)

Use in children and adolescents

For children and adolescents (6–17 years old), the recommended usual starting dose is 2.5 mg (2.5 ml) a day. The maximum recommended dose is 5 mg (5 ml) a day.

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

If you take more Amlodipine than you should

Taking too much Amlodipine 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 much Amlodipine.

If you forget to take Amlodipine

Do not worry. If you forget to take your medicine, 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 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, 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), toxic epidermal necrolysis or other allergic reactions.
• Heart attack, abnormal heart beat.
• Inflamed pancreas which may cause severe abdominal and back pain accompanied with feeling very unwell.

The following very common side-effect has been reported. If this causes you problems or if it lasts for more than one week, you should contact your doctor.

Very common: may affect more than 1 in 10 people

• Oedema (fluid retention).

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).
• Altered bowel habits, diarrhoea, constipation, indigestion.
• Tiredness, weakness.
• Visual disturbances, double vision.
• Muscle cramps.
• Ankle swelling.

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.
• Numbness or tingling sensation in your limbs; loss of pain sensation.
• Ringing in the ears.
• Low blood pressure.
• Sneezing/running nose caused by inflammation of the lining of the nose (rhinitis).
• Cough.
• Dry mouth, vomiting (being sick).
• Hair loss, increased sweating, itchy skin, red patches on skin, skin discoloration.
• 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.
• Pain, feeling unwell.
• Joint or muscle pain, 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.
• Excess sugar in blood (hyperglycaemia).
• A disorder of the nerves which can cause muscular weakness, tingling or numbness.
• Swelling of the gums.
• Bleeding 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.

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 Website: 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.

5. how to store amlodipine

• 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 label and carton after ‘EXP’. The expiry date refers to the last day of that month.
• Do not use this medicine after 30 days of first opening.
• 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.
• Do not store above 30oC.
• Do not freeze.
• Store the bottle in an upright position.
• Keep container in outer carton to protect from light.

6. contents of the pack and other information

What Amlodipine contains

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

The other ingredients are medium chain triglyceride, sucralose and colloidal anhydrous silica.

What Amlodipine looks like and contents of the pack Amlodipine is a colourless, clear to slightly hazy suspension. Amlodipine is available in a 150 ml amber glass bottle with a child-resistant cap and a double-ended measuring spoon. One end of the spoon will give you 5 ml of the suspension and the other will give you 2.5 ml.

Marketing Authorisation Holder

Essential Pharmaceuticals Ltd, 7 Egham Business Village, Crabtree Road, Egham, Surrey, TW20 8RB, United Kingdom.

Manufacturer

Delpharm Bladel B.V., Industrieweg 1, 5531 AD Bladel, the Netherlands.

This medicinal product is authorised in the Member States of the EEA under the following names:

This leaflet was last revised in March 2021.

UK Patent Number 2529605