Amlodipin Jubilant

Document: Amlodipin Jubilant tablet ENG PL change

PACKAGE LEAFLET: INFORMATION FOR THE USER

Amlodipin Jubilant 5 mg tablets

Amlodipin Jubilant 10 mg tablets

Amlodipine

Read all of this leaflet carefully before you start taking this medicine.

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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What Amlodipin Jubilant tablets are and what they are used for.

2. Before you take Amlodipin Jubilant tablets.

3. How to take Amlodipin Jubilant tablets.

4. Possible side effects.

How to store Amlodipin Jubilant tablets.

6. Further information.

1. WHAT AMLODIPIN JUBILANT TABLETS ARE AND WHAT THEY ARE USED FOR

Amlodipin Jubilant tablets contain the active substance amlodpine which belongs to a group of medicines called calcium antagonists.

Amlodipin Jubilant 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 agina.

In patients with high blood pressure, Amlodipin Jubilant tablets work by relaxing blood vessels, so that blood passes through them more easily.

In patients with angina, Amlodipin Jubilant tablets work by improving blood supply to the heart muscle which then receives more oxygen and as a result chest pain is prevented. Amlodipin Jubilant tablets do not provide immediate relief of chest pain from angina.

2. BEFORE YOU TAKE AMLODIPIN JUBILANT TABLETS

Do not take Amlodipin Jubilant tablets

if you are allergic (hypersensitive) to amlodipine, or any of the other ingredients of your 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.

Take special care with Amlodipin Jubilant 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 (hypertensive crisis)
liver disease
if you are elderly and your dose needs to be increased.

Use in children and adolescents

Amlodipin Jubilant tablets have not been studied in children under the age of 6 years. Amlodipin Jubilant 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.

Taking other medicines

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

Amlodipin Jubilant tablets 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)
simvastatin (cholesterol-lowering medicine)

Amlodipin Jubilant tablets may lower your blood pressure even more if you are already taking other medicines to treat your high blood pressure.

Taking Amlodipin Jubilant tablets with food and drink

Grapefruit juice and grapefruit should not be consumed by people who are taking Amlodipin Jubilant 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 Amlodipin Jubilant tablets.

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 Amlodipin Jubilant tablets.

Breast-feeding

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 Amlodipin Jubilant tablets.

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

Driving and using machines

Amlodipin Jubilant 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.

3. HOW TO TAKE AMLODIPIN JUBILANT TABLETS

Always take Amlodipin Jubilant tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual starting dose is 5 mg once daily. The dose can be increased to 10 mg 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 take Amlodipin Jubilant tablets with grapefruit juice.

Use in children and adolescents

For children (6 -17 years old), the recommended usual starting dose is 2.5 mg a day. The maximum recommended dose is 5 mg a day. Amlodipin Jubilant 2.5 mg tablets is currently not available and the 2.5 mg dose cannot be obtained with Amlodipin Jubilant 5 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 Amlodipin Jubilant 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 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 Amlodipin Jubilant tablets.

If you forget to take Amlodipin Jubilant 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 missed dose.

If you stop taking Amlodipin Jubilant tablets

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 product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Amlodipin Jubilant tablets can 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: affects 1 to 10 users in 100

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: affects 1 to 10 users in 1,000

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: affects 1 to 10 users in 10,000

Confusion

Very rare: affects less than 1 user in 10,000

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

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE AMLODIPIN JUBILANT TABLETS

Keep out of the reach and sight of children.

Do not use Amlodipin Jubilant tablets after the expiry date „EXP“ which is stated on the packaging. The expiry date refers to the last day of that month.

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

What Amlodipin Jubilant tablets contain

Amlodipin Jubilant 5 mg tablets

The active substance is amlodipine. Each tablet contains 5 mg of amlodipine (as besilate).
The other ingredients are microcrystalline cellulose, sodium starch glycollate, sodium acid citrate, magnesium stearate, croscarmellose sodium, crospovidone.

Amlodipin Jubilant 10 mg tablets

The active substance is amlodipine. Each tablet contains 10 mg of amlodipine (as besilate).
The other ingredients are microcrystalline cellulose, sodium starch glycollate, sodium acid citrate, magnesium stearate, croscarmellose sodium, crospovidone.

What Amlodipin Jubilant tablets look like and contents of the pack

The tablets our white, circular, biconvex and plain on both sides.

Pack sizes (blister):

Amlodipin Jubilant 5 mg tablets: 10, 20, 28, 30, 50, 98 and 100 tablets.

Amlodipin Jubilant 10 mg tablets: 10, 20, 28, 30, 50, 90, 98 and 100 tablets.

Not all pack sizes and pack types may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Jubilant Pharmaceuticals nv

Axxes Business Park – Guldensporenpark 22 – Block C

9820 Merelbeke

Belgium

Manufacturer

PSI supply nv