Patient leaflet - Amlodipine 2.5 mg tablets
what they are used for
Amlodipine tablets contain the active substance amlodipine (as besilate) which belongs to a group of medicines called calcium antagonists.
Amlodipine tablets are 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 this medicine works by relaxing blood vessels, so that blood passes through them more easily. In patients with angina Amlodipine tablets work by improving blood supply to the heart muscle which then receives more oxygen and as a result chest pain is prevented. This medicine does not provide immediate relief of chest pain from angina.
2.
What you need to know before
you take Amlodipine tablets
Do not take Amlodipine tablets
•
If you are allergic to Amlodipine tablets, or any
of the other ingredients of this medicine listed in section 6, or to any other calcium antagonists. Signs of allergic reactions may include 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 before taking Amlodipine tablets:
•
if you have or have had a recent heart attack
•
if you have or have had heart failure
•
if you have or have had a severe increase in blood
pressure (hypertensive crisis)
•
if you have or have had liver disease
•
if you are elderly and your dose needs to be
increased
Children and adolescents
Amlodipine tablets have not been studied in children under the age of 6 years. Amlodipine tablets 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 tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription. This includes herbal medicines.
Amlodipine tablets may affect or be affected by other medicines, such as:
•
ketoconazole, itraconazole (anti-fungal medicines)
•
ritonavir, indinavir, (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 tablets may lower your blood pressure even more if you are already taking other medicines to treat your high blood pressure.
Amlodipine tablets with food and drink
This medicine can be taken before or after food and drinks.
Grapefruit juice and grapefruit should not be consumed by people who are taking Amlodipine tablets. This is because grapefruit and grapefruit juice can lead to an increase in the blood levels of the active ingredient in Amlodipine tablets, which can cause an unpredictable increase in the blood pressure-lowering effect of Amlodipine tablets.
Pregnancy and breast-feeding
Pregnancy
The safety of Amlodipine tablets in human pregnancy has not been established. If you think you might be pregnant, or are planning to get pregnant, you must tell your doctor before you take Amlodipine tablets.
Breast-feeding
Amlodipine tablets have 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 tablets.
Driving and using machines
Amlodipine tablets 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.
Amlodipine tablets contain sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
3.
How to take Amlodipine tablets
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 5 mg once daily. The dose can be increased to 10 mg once daily.
You should take this medicine at the same time each day with a drink of water. Do not take Amlodipine tablets 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 once daily. The maximum recommended dose is 5 mg once daily. Amlodipine 5 mg tablets can be divided into halves to provide a 2.5 mg dose.
It is important to keep taking the tablets. Do not wait until your tablets are finished before seeing your doctor.
If you take more Amlodipine tablets than you should
If you accidentally take too many tablets, contact your doctor or nearest hospital emergency department immediately for advice. Remember to take this leaflet or any remaining tablets with you.
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.
Excess fluid may accumulate in your lungs (pulmonary oedema) causing shortness of breath that may develop up to 24-48 hours after intake.
If you forget to take Amlodipine tablets
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 Amlodipine tablets
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 have any further questions on the use of this medicine, ask your doctor or pharmacist.
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Amlodipine 2.5 mg, 5 mg and 10 mg
Tablets
amlodipine besilate
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Amlodipine Tablets
Package leaflet
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Folded size 25 x 150 mm
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 side effects after taking this medicine.
•
Allergic reactions:
- 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)
•
Heart attack, abnormal heartbeat
•
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 side effects 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 heartbeat)
•
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, fainting
•
Numbness or tingling sensation in your limbs, loss
of pain sensation
•
Ringing in the ears
•
Low blood pressure
•
Sneezing/runny nose caused by inflammation of
the lining of the nose (rhinitis)
•
Cough
•
Dry mouth, taste abnormalities
•
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
•
Feeling unwell
•
Pain, 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
Not known: frequency cannot be estimated from the available data
•
Trembling, rigid posture, mask-like face, slow movements and a shuffling, unbalanced walk
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 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 tablets
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 blister and the carton after “EXP”. The expiry date refers to the last day of that month.
This medicinal product does not require any special temperature storage condition. Store in the original package to protect from light
If the tablets become discoloured or show any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
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 Amlodipine tablets contain
•
The active substance is amlodipine (as besilate).
Each tablet contains amlodipine besilate equivalent to 2.5 mg, 5 mg or 10 mg amlodipine.
•
The other ingredients are Microcrystalline Cellulose,
Dibasic Calcium Phosphate Anhydrous, Sodium Starch Glycolate, Colloidal Silicon Dioxide, Magnesium Stearate
What Amlodipine tablets look like and contents of the pack
•
The 2.5 mg tablets are white to off-white, round
(Approx. 6 mm diameter), flat-faced, bevelled-edge tablets with “2.5” debossed on one side and “AM” on other side.
•
The 5 mg tablets are white to off-white, octagonal
(Approx. 8.80 mm length & 6.20 mm width), flat-faced, bevelled-edged scored tablets debossed with “5” on one side of the score line and “AM” on other side.
•
The 10 mg tablets are white to off-white, octagonal
(Approx. 11.00 mm length & 7.70 mm width), flat-faced, bevelled-edged tablets debossed with “10” on one side and “AM” on other side.
Pack size: Blister pack of 2 x 14 Tablets in one carton.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Tillomed Laboratories Limited
220 Butterfield, Great Marlings
Luton, LU2 8DL, United Kingdom
Manufacturers
Tillomed Laboratories Limited
220 Butterfield, Great Marlings
Luton, LU2 8DL, United Kingdom
Tillomed Malta Limited
Malta Life Sciences Park,
LS2.01.06 Industrial Estate,
San Gwann, SGN 3000, Malta
This leaflet was last revised in January 2026.
510522851GB01
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To get this information in large print or another format, please email medical.information@tillomed.com or call 0800 970 6115.
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