Patient leaflet - Amlodipine 5 mg tablets

1. What Amlodipine tablets are and what they are used for

Amlodipine tablets contain the active substance amlodipine 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 (hypersensitive) 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 tablets. 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 (hypersensitive 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 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 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.

Amlodipine tablets with food and drink

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 amlodipine, which can cause an unpredictable increase in the blood pressure lowering eﬀect of Amlodipine tablets.

Pregnancy and breast-feeding

Pregnancy

The safety of amlodipine 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 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 tablets.

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

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 or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

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

This medicine can be used before or after food and drink. 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 a day. The maximum recommended dose is 5 mg a day. 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

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 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 many Amlodipine tablets. 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.

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.

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 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 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, 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
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
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
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 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.

5. How to store Amlodipine tablets

Keep this medicine out of the sight and reach of children. This medicinal product does not require any special storage conditions. Do not use this medicine after the expiry date which is stated on the blister and carton after “EXP”. The expiry date refers to the last day of that month.

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 in Amlodipine 5 mg and 10 mg tablets is amlodipine (as besilate).

Each Amlodipine 5 mg tablet contains amlodipine besilate, equivalent to 5 mg of amlodipine.

Each Amlodipine 10 mg tablet contains amlodipine besilate, equivalent to 10 mg of amlodipine.

The other ingredients are cellulose microcrystalline (E460), calcium hydrogen phosphate anhydrous (E341), sodium starch glycolate (Type A) and magnesium stearate (E572).

What Amlodipine tablets look like and contents of the pack

Amlodipine 5 mg tablets are white to oﬀ-white, elongated octagon, ﬂat faced bevelled edged tablets, debossed with “5” on one side and plain on the other side.

Amlodipine 10 mg tablets are white to oﬀ-white, round, ﬂat faced bevelled edged tablets, debossed with “10” on one side and plain on the other side.

Amlodipine 5 mg and 10 mg tablets are available in blister packs of 10, 14, 20, 28, 30, 40, 56 or 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Dawa Limited,

5 Sandridge Close,

Harrow, Middlesex,

HA1 1XD, United Kingdom.

Manufacturer

Drugsrus Limited,