Patient leaflet - Amlodipine Krka 5 mg tablets

1. What Amlodipine Krka is and what it is used for

Amlodipine Krka contains the active substance amlodipine which belongs to a group of medicines called calcium antagonists. Amlodipine Krka is used to treat high blood pressure (hypertension) in adults, adolescents and children aged 6 years or older, or a certain type of chest pain called angina in adults, 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 Krka works 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 Krka

Do not take Amlodipine Krka 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.
have severe low blood pressure (severe 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)
suffer from heart failure after an acute heart attack Warnings and precautions

Talk to your doctor or pharmacist before taking Amlodipine Krka. 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 Children and adolescents

Amlodipine Krka has not been studied in children under the age of 6 years. Amlodipine Krka should only 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 Krka

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

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

Amlodipine Krka with food and drink

Grapefruit juice and grapefruit should not be consumed by people who are taking Amlodipine Krka. 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 Krka. Pregnancy and breast-feeding

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

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 Krka.

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 Krka. Driving and using machines

Amlodipine Krka 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 Krka contains 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 Krka

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 Krka 5 mg once daily. The dose can be increased to Amlodipine Krka 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 Krka 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 only for indication hypertension. The maximum recommended dose is 5 mg a day. The 5 mg tablet can be divided into equal doses.

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 Krka 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 Krka 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 Krka

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 Krka

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.

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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 heart beat
Inflamed pancreas which may cause severe abdominal and back pain accompanied with feeling very unwell

The following other side effects have been also reported: The following very common side-effects have 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 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
- Confusion

Very rare: may affect up to 1 in 1

Decreased numbers of white bl platelets which may result in un (red blood cell damage)
Excess sugar in blood (hypergly
A disorder of the nerves which c numbness in hands or feet (peri
Swelling of the gums, bleeding
Abdominal bloating (gastritis)
Abnormal liver function, inflamm yellowing of the skin (jaundice), may have an effect on some me
Increased muscle tension (hype
Inflammation of blood vessels,
Sensitivity to light

Not known: frequency cannot be

Trembling, rigid posture, mask-l shuffling, unbalanced walk (extr Reporting of side effects

If you get any side effects, talk to includes any possible side effects also report side effects directly via https://yellowcard.mhra.gov.uk/ or the Google Play or Apple App Sto can help provide more informatio

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Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date refers to the last day of that month.

Store in the original package in order to protect from light. This medicinal product does not require any special temperature 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 Krka contains

The active substance is amlodipine.
Amlodipine Krka 5 mg tablets
Each tablet contains 5 mg amlodipine (as amlodipine besilate). Amlodipine Krka 10 mg tablets
Each tablet contains 10 mg amlodipine (as amlodipine besilate).
The other ingredients (excipients) are microcrystalline cellulose (E460), pregelatinised maize starch, sodium starch glycolate (type A), colloidal anhydrous silica and magnesium stearate (E470b).
See section 2 “Amlodipine Krka contains sodium”. What Amlodipine Krka looks like and contents of the pack

Amlodipine Krka 5 mg tablets

The tablets are white, round (diameter 8 mm), slightly biconvex with beveled edges, scored on one side. The tablet can be divided into equal doses.

Amlodipine Krka 10 mg tablets

The tablets are white, round (diameter 11 mm), slightly biconvex with beveled edges.

The tablets are available in carton boxes containing :

28, 30 and 90 tablets in blisters,
28 × 1, 30 × 1 and 90 × 1 tablet in perforated unit dose blisters. Not all pack sizes may be marketed.

Marketing Authorisation Holder:

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer: