Document: Amlodipine Vitabalans tablet ENG PL change

• Amlodipine Vitabalans tablet PL
• Amlodipine Vitabalans tablet ENG PL

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Package leaflet: Information for the user

Amlodipine Vitabalans 5 mg tablets

Amlodipine Vitabalans 10 mg tablets

amlodipine

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.

• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

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

2. What you need to know before you use Amlodipine Vitabalans

3. How to use Amlodipine Vitabalans

4. Possible side effects

6. Contents of the pack and otherinformation

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

Amlodipine Vitabalans 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 Vitabalansworks by improving blood supply to the heart muscle which then receives more oxygen and as a result chest pain is prevented. Your medicine does not provide immediate relief of chest pain from angina.

Do not take Amlodipine Vitabalans

• 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. Symptoms of 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 before takingAmlodipine Vitabalans.

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 Vitabalanshave not been studied in children under the age of 6 years. Amlodipine Vitabalansshould 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 Vitabalans

Tell your doctor or pharmacist if you are taking, have recently taken or might takeany other medicines.

Amlodipine Vitabalansmay 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)

• rifampicine, erythromycin, clarithromycin (antibiotics)

• hypericum perforatum (St. John’s Wort)

• verapamil, diltiazem (heart medicines)

• dantrolene (infusion for severe body temperature abnormalities)

• tacrolimus (medicine used to alter the way your immune system works)

• simvastatin (cholesterol lowering medicine)

• cyclosporine (an immunosuppressant)

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

Amlodipine Vitabalans with food and drink

Grapefruit juice and grapefruit should not be consumed by people who are takingAmlodipine Vitabalans. 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 ofAmlodipine Vitabalans.

Pregnancy, breast-feeding and fertility

The safety of amlodipine in human pregnancy has not been established. If you are pregnant, think you maybe pregnant or are planning to have a baby, askyour doctor or pharmacist for advice before taking this medicine.

It is not known whether amlodipine is passed into breast milk. If you are breast-feeding or about to start breast-feeding you must tell your doctor before taking Amlodipine Vitabalans.

Driving and using machines

Amlodipine 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.

Always take this medicineexactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The tablet can be divided into equal doses.

The usual initial dose is 5 mg Amlodipine Vitabalans once daily. The dose can be increased to 10 mg Amlodipine Vitabalans once daily.

Your medicine can be used before or after food and drinks. You should take your medicine at the same time each day with a drink of water. Do not takeAmlodipine Vitabalans 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.

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 Vitabalans 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 Vitabalans tablets.

If you forget to take Amlodipine Vitabalans

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 forgottendose.

If you stop taking Amlodipine Vitabalans

Your doctor will advise you how long to take your medicine. Your condition may return if you stop using your 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 medicinecan cause side effects, although not everybody gets them.

Visit your doctor immediately if you experience any of the following very rare, severe 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) 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 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)

• Ankle swelling (oedema), tiredness

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, weakness

• Numbness or tingling sensation in your limbs; loss of pain sensation

• Visual disturbances, double vision, ringing in the ears

• Low blood pressure

• Sneezing/running nose caused by inflammation of the lining of the nose (rhinitis)

• Altered bowel habits, diarrhoea, constipation, indigestion, 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

• Weakness, pain, feeling unwell

• Joint or muscle pain, muscle cramps, back pain

• Weight increase or decrease

Rare (may affect up to 1 in 1 000 people):

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 (red blood cell damage)

• Excess sugar in blood (hyperglycaemia)

• A disorder of the nerves which can cause weakness, tingling or numbness

• Cough, swelling of the 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

Reportingof side effects

If you getany side effects, talk toyour doctor or pharmacist.This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V.*By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Amlodipine Vitabalans

Keep this medicine out of the sight and reach of children.

Do not use this medicineafter the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month.

Keep the blister in the outer carton in order to protect from light.

Donot throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw awaymedicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Amlodipine Vitabalans contains

The active substance is amlodipine. Each tablet contains 5 mg or 10 mg of amlodipine as amlodipine besilate.

The other ingredients are microcrystalline cellulose, silica colloidal anhydrous, magnesium stearate and sodium starch glycolate (Type A).

What Amlodipine Vitabalans looks like and contents of the pack

What Amlodipine Vitabalans looks like:

Amlodipine Vitabalans 5 mg: white, round, convex tablets with a score on one side and logo “3”on the other side, diameter 9 mm.

Amlodipine Vitabalans 10 mg: white, round, convex tablets with a score on one side, diameter 9 mm.

The tablets can be divided into equal doses.

Pack sizes:

30, 60 and 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Vitabalans Oy

Varastokatu 8

13500 Hämeenlinna

FINLAND

Tel: +358 3 615 600

Fax: +358 3 618 3130

This medicinal product is authorised in the Member States of the EEA under the following names:

Amlodipine Vitabalans (German, Denmark, Estonia, Finland, Lithuania, Latvia, Norway, Poland, Sweden)

Amlodipin Vitabalans (Czech Republic, Hungary, Slovenia, Slovakia)

This leaflet was last revisedin 2016-04-01.