Patient leaflet - Amlodipine Hec Pharm 5 mg tablets

1. What Amlodipine HEC Pharm is and what it is used for

Amlodipine HEC Pharm contains the active substance amlodipine which belongs to a group of medicines called calcium antagonists.

Amlodipine HEC Pharm 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 HEC Pharm works by improving blood supply to the heart muscle which then receives

Amlodipine HEC Pharm 5 mg, 10 mg Tablets Filmtabletten Size: xx x xx mm

Date: 2026.04.01

Other medicines and Amlodipine HEC Pharm

more oxygen and as a result chest pain is prevented. This medicine does not provide immediate relief of chest pain from angina.

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

2. What you need to know before you take Amlodipine HEC Pharm

Do not take Amlodipine HEC Pharm

Amlodipine HEC Pharm 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)
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).
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)
If you suffer from heart failure after a heart attack.

Warnings and precautions

simvastatin (cholesterol lowering medicine)
cyclosporine (an immunosuppressant)

Talk to your doctor or pharmacist before taking Amlodipine HEC Pharm.

You should inform your doctor if you have or have had any of the following conditions:

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

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

Taking Amlodipine HEC Pharm with food and drink Grapefruit juice and grapefruit should not be consumed by people who are taking Amlodipine HEC Pharm. 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 HEC Pharm.

Amlodipine HEC Pharm has not been studied in children under the age of 6 years. Amlodipine HEC Pharm 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.

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 HEC Pharm.

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

Driving and using machines

Amlodipine HEC Pharm 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 HEC Pharm contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, which means it is essentially ‘sodium-free’.

3. How to take Amlodipine HEC Pharm

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 HEC Pharm 5 mg once daily. The dose can be increased to Amlodipine HEC Pharm 10 mg once daily.

This medicine can be used before or after food and drinks. You should take this medicine at the same time each day with a drink of water. Do not take Amlodipine HEC Pharm 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. The 2.5 mg dose cannot be obtained with Amlodipine HEC Pharm 5 mg or 10 mg Tablets as these tablets are not manufactured to break into two equal halves.

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 HEC Pharm 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 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 HEC Pharm.

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 HEC Pharm

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 HEC Pharm

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.

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 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.

xxxxx

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 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 HEC Pharm

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 or carton. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

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 HEC Pharm contains

The active substance is amlodipine (as besilate).

Each tablet contains amlodipine besilate equivalent to 5 mg amlodipine.

Each tablet contains amlodipine besilate equivalent to 10 mg amlodipine.

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

What Amlodipine HEC Pharm looks like and contents of the pack

Amlodipine HEC Pharm 5 mg tablets are white or almost white round shaped tablets, debossed “7” on one side, and blank on the other side.

Amlodipine HEC Pharm 10 mg tablets are white or almost white round shaped tablets, debossed “11” on one side, and blank on the other side.

The tablets are provided in pack sizes of 20, 28, 30, 50, 60 and 100 tablets in PVC/PVDC/aluminium blister.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:

HEC Pharm GmbH

Wallstrasse 9-13

10179 Berlin, Germany

Manufacturer:

Formula Pharmazeutische und chemische Entwicklungs GmbH Goerzallee 305b

D-14167 Berlin, Germany

This leaflet was last revised in 04/2026.