Amlodipine Krka

Patient Information Leaflet

Amlodipine Krka 5 mg tablets, 10 mg tablets

Amlodipine
Generic medicine
Please read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Amlodipine Krka is and what it is used for
2. What you need to know before taking Amlodipine Krka
3. How to take Amlodipine Krka
4. Possible side effects
5. How to store Amlodipine Krka
6. Contents of the pack and other information

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) or a type of chest pain called angina, including a rare form known as Prinzmetal's angina or variant angina.
In patients with high blood pressure, your medicine works by relaxing the blood vessels, allowing blood to flow more easily. In patients with angina, Amlodipine Krka improves blood supply to the heart, thereby increasing oxygen delivery to the heart and helping to prevent chest pain. Your medicine does not provide immediate relief of angina-related chest pain.

2. What you should know before taking Amlodipine Krka

Do not take Amlodipine Krka

• If you are allergic to amlodipine, or to any of the excipients of this medicine (listed in section 6) or to other calcium antagonists. The reaction may consist of itching, skin redness or difficulty breathing
• If you have severe low blood pressure (hypotension)
• If you have severe narrowing of the heart's aortic valve (aortic stenosis) or cardiogenic shock (a condition in which the heart is unable to pump sufficient blood to the body)
• If you have heart failure following a heart attack.

Warnings and precautions
Talk to your doctor or pharmacist before taking Amlodipine Krka.
You must 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
• if you are elderly and your dose needs to be increased.

Children and adolescents
Amlodipine Krka has not been studied in children under 6 years of age. Amlodipine Krka should be used only for hypertension in children and adolescents aged 6 to 17 years (see section 3).
For further information, please consult your doctor.

Other medicines and Amlodipine Krka
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Amlodipine Krka may affect or be affected by other medicines, such as:

• ketoconazole, itraconazole (antifungal medicines)
• ritonavir, indinavir, nelfinavir (so-called protease inhibitors used in the treatment of HIV)
• rifampicin, erythromycin, clarithromycin (for infections caused by bacteria)
• Hypericum perforatum (St. John's wort)
• verapamil, diltiazem (medicines for the heart)
• dantrolene (infusion for severe abnormalities of body temperature)
• tacrolimus, sirolimus, temsirolimus and everolimus (medicines used to control the immune system response)
• simvastatin (used to reduce cholesterol in the blood)
• ciclosporin (an immunosuppressant). If you are already taking other medicines for high blood pressure, Amlodipine Krka may further reduce your blood pressure.

Amlodipine Krka with food and drink
Patients taking Amlodipine Krka must not consume grapefruit juice or grapefruit, as these may lead to increased blood levels of the active substance amlodipine, which could cause an unpredictable increase in the blood pressure-lowering effect of Amlodipine Krka.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
The safety of amlodipine during human pregnancy has not been established. If you think you may be pregnant or are planning a pregnancy, you must inform your doctor before taking Amlodipine Krka.

Breastfeeding
It has been shown that amlodipine passes into breast milk in small amounts. If you are breastfeeding or about to start breastfeeding, you must inform your doctor before taking Amlodipine Krka.

Driving and operating machinery
Amlodipine Krka may affect your ability to drive or operate machinery. If the tablets cause you
nausea, dizziness, tiredness, or headache, do not drive or operate machinery and contact your doctor
immediately.
Amlodipine Krka contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially “sodium-free”.

3. How to take Amlodipine Krka

Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The usual starting dose is 5 mg of Amlodipine Krka once daily. The dose may be increased to 10 mg of Amlodipine Krka once daily.
This medicine can be taken before or after food and drink. Take your medicine at the same time each day with a glass of water. Do not take Amlodipine Krka with grapefruit juice.

Use in children and adolescents
In children and adolescents (6–17 years), the recommended usual starting dose is 2.5 mg once daily. The recommended maximum dose is 5 mg once daily.
The 2.5 mg amlodipine dose is currently not available and can be obtained by breaking an Amlodipine Krka 5 mg tablet into two equal halves.

It is important that you continue taking the tablets. Do not wait until you have finished the tablets before seeing your doctor again.

If you take more Amlodipine Krka than you should
Taking too many tablets may cause an excessive and potentially dangerous drop in blood pressure.
You may experience dizziness, blurred vision, fainting, or weakness. If the drop in blood pressure is severe enough, shock may occur. Your skin may become cold and clammy, and you may lose consciousness. If you have taken too many Amlodipine Krka tablets, seek immediate medical help.

If you forget to take Amlodipine Krka
Do not worry. If you forget to take a tablet, simply skip the missed dose and take the next dose at the usual time. Do not take a double dose to make up for the forgotten dose.

If you stop taking Amlodipine Krka
Your doctor will tell you how long you should take your medicine. If you stop treatment before your doctor advises, your symptoms may return.

If you have any questions about the use of Amlodipine Krka, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Contact your doctor immediately if you experience any of the following serious, very rare side effects after taking this medicine:

• sudden breathlessness, chest pain, shortness of breath or difficulty breathing
• swelling of the eyelids, face or lips
• swelling of the tongue and throat causing severe breathing difficulties
• severe skin reactions including intense rash, hives, redness of the skin all over the body, severe itching, blisters, skin peeling and swelling, mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
• heart attack, irregular heartbeat
• inflammation of the pancreas which may cause severe abdominal and back pain accompanied by a feeling of malaise.

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 must contact your doctor:

Very common: may affect more than 1 in 10 people

• Edema (fluid retention)

Common: may affect up to 1 in 10 people

• headache, dizziness, drowsiness (particularly at the start of treatment)
• palpitations (awareness of heartbeat), hot flushes
• abdominal pain, feeling unwell (nausea)
• changes in bowel habits, diarrhoea, constipation, indigestion
• fatigue, weakness
• visual disturbances, double vision
• muscle cramps
• swelling of the ankles.

Other side effects have also been reported, including those listed below. If any of these side effects worsen, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.
Uncommon: may affect up to 1 in 100 people

• mood changes, anxiety, depression, drowsiness
• tremor, taste disturbances, fainting
• numbness or tingling sensation in the limbs, loss of pain sensation
• ringing in the ears
• low blood pressure
• sneezing/runny nose, caused by inflammation of the nasal lining (rhinitis)
• cough
• dry mouth, vomiting (when unwell)
• hair loss, increased sweating, itchy skin, red spots on the skin, skin discoloration
• problems passing urine, increased need to urinate at night, increased frequency of urination
• inability to achieve erection, discomfort or breast enlargement in men
• pain, feeling unwell

• muscle or joint pain, backache
• weight gain or weight loss.

Rare: may affect up to 1 in 1,000 people

• confusion.

Very rare: may affect up to 1 in 10,000 people

• reduced number of white blood cells in the blood, reduced platelet count leading to unusual bruising or more frequent bleeding (damage to red blood cells)
• excess sugar in the blood (hyperglycaemia)
• a nerve disorder that may cause weakness, tingling, or numbness
• swollen gums
• abdominal swelling (gastritis)
• abnormal liver function, liver inflammation (hepatitis), yellowing of the skin (jaundice), increased liver enzymes which may affect certain medical tests
• increased muscle tension
• inflammation of blood vessels, often accompanied by skin rash
• sensitivity to light
• disorders characterized by a combination of stiffness, tremor, and/or movement disturbances.

Not known: frequency cannot be estimated from the available data

• Tremor, rigid posture, facial rigidity, slow movements and shuffling, unbalanced gait

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, please consult your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store Amlodipine Krka

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 packaging after EXP. The
expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Pack contents and other information

What Amlodipine Krka contains

• The active substance is amlodipine. Amlodipine Krka 5 mg tablets: Each tablet contains 6.94 mg of amlodipine besylate equivalent to 5 mg amlodipine.

Amlodipine Krka 10 mg tablets
Each tablet contains 13.88 mg of amlodipine besylate equivalent to 10 mg of amlodipine.

• Other components (excipients) are: microcrystalline cellulose (E460), pregelatinized maize starch, sodium starch glycolate (type A), anhydrous colloidal silica (E551) and magnesium stearate (E470b). See Section 2 “Amlodipine Krka contains sodium”.

Description of the appearance of Amlodipine Krka and contents of the pack
Amlodipine Krka 5 mg tablets
The tablets are white, round, slightly biconvex, with bevelled edges, marked on one side, with a diameter of 8 mm. The tablet can be divided into two equal doses.
Amlodipine Krka 10 mg tablets
The tablets are white, round, slightly biconvex, with bevelled edges, with a diameter of 10 mm.
Amlodipine Krka 5 mg and 10 mg tablets are available in packs of 10, 14, 20, 28, 30, 50, 56, 60, 90, 98, 100, 200, 250 tablets and 100 x 1 tablet (unit-dose), packaged in blisters.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Local representative in Italy:
KRKA Farmaceutici Milano S.r.l., Viale Achille Papa 30, 20149 Milan, Italy
This medicinal product is authorized in the European Economic Area countries under the following
names: