Amlodipine 5mg Tablets
Out of date information, search anotherPRO-Gen
Pharma
Amlodipine 5 mg Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Active substance: amlodipine besilate
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 Amlodipine 5 mg tablets is and what it is used for
2. Before you take Amlodipine 5 mg tablets
3. How to take Amlodipine 5 mg tablets
4. Possible side effects
5. How to store Amlodipine 5 mg tablets
6. Further information
1. WHAT AMLODIPINE 5 MG TABLETS IS AND WHAT IT IS USED FOR
Amlodipine belongs to a group of medicines called calcium antagonists.
Amlodipine 5 mg tablets are used to treat:
• high blood pressure (hypertension)
• a certain type of chest pain called angina, including a rare form called Prinzmetal's or variant angina.
In patients with high blood pressure, amlodipine works by relaxing blood vessels so that blood passes through them more easily.
In patients with angina, amlodipine works by improving the blood supply to the heart muscle. The heart muscle then receives more oxygen and this prevents chest pain. Amlodipine tablets do not provide immediate relief of chest pain from angina.
Amlodipine tablets are suitable for patients with heart failure and a history of high blood pressure or angina.
2. BEFORE YOU TAKE AMLODIPINE 5 MG TABLETS Do NOT take Amlodipine 5 mg tablets:
■ H you are allergic (hypersensitive) to amlodipine, other calcium antagonists or any other ingredients of Amlodipine 5 mg tablets (see Section 6 - Further Information).
• if you have heart problems such as cardiogenic shock, narrowing of the aortic heart valve (aortic stenosis) or new or changing chest pain (unstable angina).
• if you are pregnant or breast feeding.
Take special care with Amlodipine 5 mg tablets:
• if you have had a heart attack in the past month
• if you have a sudden, severe rise in blood pressure that can lead to a stroke
• If you have liver disease
• if you are under 18 years of age
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.
Taking Amlodipine 5 mg tablets with food or drink
Amlodipine S mg tablets are unlikely to affect or to be affected by normal eating or drinking.
Pregnancy and breast-feeding
Do not take Amlodipine 5 mg tablets if you are pregnant or breast-feeding your baby. If you are a woman with childbearing potential, you must use effective contraception. Ask your doctor or pharmacist for more Information if you are unsure about this.
Driving and using machinery
Amlodipine S mg tablets may cause dizziness, headache, tiredness or feeling sick. If you are affected in this way, you must be careful v/hen driving or operating machinery.
Children
Safety and effectiveness have been studied in 6-17 year old boys and In girls Amlodipine S mg tablets has not been studied in children under the age of 6 years. For more information, talk to your doctor.
3. HOW TO TAKE AMLODIPINE 5 MG TABLETS
Always take Amlodipine 5 mg 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 (one tablet) of amlodipine once dally.This may be increased to 10 mg (two tablets) amlodipine daily.
Take your Amlodipine 5 mg tablets everyday, preferably at the same time each day.
Swallow the tablets with a glass of water.
You must not stop taking the tablets because they will help you to remain welL Make sure that you visit your doctor in plenty of time so that you do not run out of tablets.
For children (6-17 years old), the recommended usual starting dose is 23 mg a day. The maximum recommended dose is 5 mg a day
For copiules or tablets without a break-line: Amlodipine 2-5 mg is not currently available and the 23 mg dose cannot be obtained with Amlodipine 5 mg tables as these tablets are not manufactured to break into two equal halves
If you take more Amlodipine 5 mg tablets than you should
If you take too many tablets, tell your doctor immediately or go to your nearest hospital casualty department.
You might feel flushed and have a strong and fast heart beat You may get very low blood pressure, which can make you feel dizzy or faint It is dangerous to take several tablets at the same time.
If you forget to take Amlodipine S mg tablets
If you forget to take a tablet do not worry. Leave out the missed dose completely and take your next dose at the usual time.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
0*012011 *02034 |
Amlodipine 5 mg Tablets
4. POSSIBLE SIDE EFFECTS
Like all medicines, Amlodipine 5 mg tablets can cause side effects, although not everybody gets them.
The side effects are listed according to their frequencies.
Stop taking the medicine and contact your doctor or a hospital immediately if you get:
• symptoms or signs of an allergic reaction (sudden wheeziness or difficulty in breathing, swelling of the eyelids, face or lips, or rash or itching that affects the whole body)
• fainting or dizziness
• irregular or rapid heartbeat (arrythmia)
• crushing pain in your chest that seems to go down your left arm (signs of a beginning heart attack)
• unusual bruising and bleeding
Common side effects (occur in less than 1 in 10, but more than 1 in 100 patients treated)
• headache
• swelling (oedema), for example of the ankle
• feeling tired
• feeling sleepy
• stomach (abdominal) pain
• feeling sick (nausea)
• flushing
• a quicker or irregular heart beat (palpitations)
Tel your doctor if these effects cause you any problems or if they last for more than one week.
Uncommon side effects (occur in less than 1 in 100, but more than 1 in 1,000 patients treated)
• Itchy skin
• hair loss
• shortness of breath
• back pain
• chest pain
• being sick (vomiting)
• indigestion
• muscle cramps
• weakness
• difficulty sleeping
• altered bowel habit
• muscle or joint pain
• mood changes
• increased need to urinate
• changes In taste
• dry mouth
■ loss of pain sensation
• ringing in the ears
• increased sweating
• low blood pressure
• skin rash
• red or purplish patches on skin
• general feeling of discomfort or lack of well-being
• weight changes
• inability to obtain an erection
• enlarging of the male breasts
• visual disturbances
• increased sensitivity particularly on the skin
• pins and needles
• sneezing or runny rose
• trembling (tremor)
Very rare side effects (occur in less than 1 in 10,000 patients treated)
• raised, itchy bumps on skin (hives)
• abnormal blood tests for liver function
• inflammation of the liver
• yellowing of the skin
• blood disorders
• inflammation of the nerves
• inflammation of the blood vessels
• excess sugar in blood
• coughing
• swelling or soreness of the gums
• inflamed pancreas and stomach
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 AMLODIPINE 5 MG TABLETS
Keep out of the reach and sight of children.
Keep your medicine in a dry place.
Oo not use Amlodipine 5 mg tablets after the expiry date which is stated on the label The expiry date refers to the last day of that month.
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 Amlodipine 5 mg tablets contain
The active substance is amlodipine (as besilate).
One Amlodipine 5 mg tablet contains amlodipine besilate equivalent to 5 mg amlodipine.
The other ingredients are:
- microcrystalline cellulose
- dibasic calcium phosphate anhydrous
- sodium starch glycollate.
- magnesium stearate
What Amlodipine 5 mg tablets look like and contents of the pack
Amlodipine 5 mg tablets are white tablets. They are available In calendar packs of 28 tablets. Each pack contains two aluminium/PVC blister strips of 14 tablets.
Marketing Authorisation Holder PRO-Gen Pharma, Unit 5, Aragon Park Foster Avenue Dunstable LU55TA
Marketing Authoiisation Holder and Manufacturer
Helm AG, Nordkanalstrafle 28,
20097 Hamburg, Germany
This leaflet was last approved in April 2010
07 01 7011 10-203*