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AMLODIPINE 5MG TABLETS

Active substance: AMLODIPINE MESILATE MONOHYDRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Amlodipine 5 mg and 10 mg Tablets
(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 Tablets are and what they are used for
2.
Before you take Amlodipine Tablets
3.
How to take Amlodipine Tablets
4.
Possible side effects
5.
How to store Amlodipine Tablets
6.
Further information.

1. WHAT AMLODIPINE TABLETS ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Amlodipine 5 mg or 10 mg Tablets. Amlodipine tablets contain the active ingredient amlodipine (as besilate).
Amlodipine belongs to a group of medicines called calcium channel blockers (calcium antagonists).
Your doctor has prescribed Amlodipine to treat:
high blood pressure (hypertension)
angina (severe pain in the chest which may travel into the jaw, neck and arms) including Printzmetal’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 works by improving blood supply to the heart muscle, which then receives more oxygen and, as a result, chest pain is prevented.
Patients may be given amlodipine tablets alone or with another medicine to treat their condition.
Amlodipine tablets do not provide immediate relief of chest pain from angina.

2. BEFORE YOU TAKE AMLODIPINE TABLETS
Do not take Amlodipine Tablets if you
- are allergic (hypersensitive) to amlodipine besilate, other dihydropyridine calcium antagonists. e.g. felodipine, nifedipine or nicardipine or any of the
other ingredients of amlodipine tablets
- have had a shock to the body which could include cardiogenic shock (this is the term used when blood pressure becomes so low that your heart stops
working properly and medical treatment is required)
- have a narrowed heart valve (e.g. aortic valve narrowing)
- have unstable angina (chest pain which may occur when you are resting excluding Printzmetal’s angina).
- are pregnant or breastfeeding
Take special care with Amlodipine Tablets
You should inform your doctor if you have or have had any of the following conditions:
- recent heart attack (within the last month)
- severe increase in blood pressure (Hypertensive crisis)
- liver disease.
Taking other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
If you go into hospital, let the medical staff know you are taking Amlodipine.
Taking Amlodipine Tablets with food and drink
Amlodipine is not affected by food; it can be taken before, during or after a meal.
Pregnancy
If you think you might be pregnant, or are planning to get pregnant, tell your doctor before you take amlodipine. Women of child bearing potential should
ensure that they use effective contraception.
Breast-feeding
You should not take Amlodipine if you are breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Amlodipine is unlikely to affect your ability to drive or use machines. However, in some patients this medicine can cause dizziness, tiredness and sight
disturbances and you should check that you are not affected before driving or performing skilled tasks.

3. HOW TO TAKE AMLODIPINE TABLETS
Always take Amlodipine Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Take your tablets as follows:
- once a day, at the same time each day
- swallow them whole with a glass of water
- tablets must not be chewed or crushed.
Adults including elderly
The usual starting dose of Amlodipine Tablet is 5 mg once a day.
The maximum daily dose of Amlodipine Tablets is 10 mg once a day.
Children and Adolescents
Amlodipine Tablets are not recommended for children under 18 years of age.
If you take more Amlodipine Tablets than you should
Contact your doctor. In the case of an overdose, contact the nearest hospital casualty department immediately. Take this leaflet and any remaining tablets
with you.
If you forget to take Amlodipine Tablets
It is important to take amlodipine tablets as directed by your physician. Do not take a double dose to make up for a forgotten dose. If you are worried, ask
your doctor or pharmacist for advice.
If you stop taking Amlodipine Tablets
Do not stop taking your tablets, even if you are feeling well, unless your doctor tells you.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
CP.AML.JNT.T.CP.V1P3

Pharmacode

KV97A

Customer: Cipla

Pharmacode

KV97A

Originated by: Kent Pharm

(Kent) Amlodipine
5 mg and 10 mg
Tablets

(Kent) Amlodipine
5 mg and 10 mg
Tablets

KV97A

Colours

Product: Amlodipine 5mg and 10mg Tablets PIL
Dimensions: 240mm x 428mm
Item Code: CP.AML.JNT.T.CP.V1P3
Proof No and Date: 3

03/01/14

Revision: Initiation
ARTWORK FOR SUBMISSION
Supersedes: n/a

Pantone
280

4. POSSIBLE SIDE EFFECTS
Like all medicines, Amlodipine Tablets can cause side effects although not everybody gets them.
If you experience the following side effects while taking your medicine, you should stop taking your tablets and tell your doctor straight away or go to the
casualty department of your nearest hospital.
- Swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in breathing
- itching, reddening or scaling of the skin
- appearance of large wheals on the skin
- heart attack.
The other observed effects are:
Common side effects (affecting up to 1 in 10 people)
- headache and facial flushing (especially at the beginning of treatment)
- palpitations
- chest pain
- feeling sick, stomach ache or pain, indigestion
- feeling tired, having no energy, dizziness.
Uncommon side effects (affecting less than 1 in 100 people)
- if you have heart problems these may seem worse at the beginning of treatment
- enlargement of breasts in men
- fainting, changes in taste, tremors (shaking), loss of sensitivity to touch or pain, tingling or numbness of the hands or feet and increased sweating
- sight disturbances
- problems sleeping, mood changes
- buzzing, hissing, whistling, ringing or other persistent noise in the ears
- chest pain
- low blood pressure
- shortness of breath or nasal irritation (rhinitis)
- vomiting, diarrhoea, constipation, indigestion, dry mouth
- rash, itching, unusual bleeding or bruising under the skin, allergic skin reactions or skin discolouration, hair loss
- back pain, muscle or joint pain
- increased need to urinate (pass water) particularly at night
- impotence (inability to obtain an erection)
- feeling unwell, unusual tiredness or weakness
- change in body weight.
Very rare side effects (affecting less than 1 in 10,000 people)
- isolated cases of severe allergic reactions (described above)
- severe skin reaction
- heart attack
- unusual heart beat, dangerously fast heart beat
- decreased platelets which may cause bruising or nosebleeds
- swelling and bleeding of the gums
- liver problems
- high liver enzymes detected by a blood test
- inflammation of the liver (hepatitis)
- yellowing of the skin or whites of the eyes (jaundice)
- high levels of sugar in your blood (hyperglycaemia) that may make you feel thirsty or need to urinate more often
- numbness in the fingers and toes
- purple spotting on the skin (vasculitis)
- cough
- inflammation of the stomach
- pancreatitis causing stomach or back pain, nausea, sickness, fever or a rapid pulse.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE AMLODIPINE TABLETS
Keep out of the sight and reach of children.
Do not use Amlodipine Tablets after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of that month.
Store below 25°C. Keep the blister in the outer carton in order to protect from light.
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 protect the environment.
6. FURTHER INFORMATION
What Amlodipine Tablets contain
- The active substance is Amlodipine (added as besilate).
- The other ingredients of the tablet are microcrystalline cellulose, Calcium hydrogen phosphate dihydrate, sodium starch glycollate, colloidal
anhydrous silica and magnesium stearate.
The tablets are available in two strengths. Each Amlodipine tablet contains either 5 milligrams or 10 milligrams of amlodipine added as amlodipine besilate.
Each 5mg tablet contains 6.94 mg amlodipine besilate equivalent to 5 mg amlodipine.
Each 10mg tablet contains 13.87 mg amlodipine besilate equivalent to 10 mg amlodipine.
This leaflet does not contain the complete information on Amlodipine. If you have any questions, or are not sure about anything, ask your doctor or pharmacist.
Remember: This medicine is for you. Only a doctor can prescribe it for you. Never give it to someone else. It may harm them even if their symptoms are
the same as yours.
What Amlodipine Tablets look like and contents of the pack
Amlodipine Tablets are presented in a blister pack of 28 tablets and come in 2 strengths.
- Amlodipine 5 mg Tablets are white to off white, round, tablets with “5” debossed on one side and plain on the other side.
- Amlodipine 10 mg Tablets are white to off white, round, tablets with “10” debossed on one side and plain on the other side.
Marketing Authorisation Holder
Cipla (EU) Limited, Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW, United Kingdom.
Manufacturer
Cipla (EU) Limited, 4th Floor, 1 Kingdom Street, London, W2 6BY, United Kingdom.
Distributor
Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT, United Kingdom.
This leaflet was last revised in December 2013.
CP.AML.JNT.T.CP.V1P3
KV97A

Customer: Cipla

Originated by: Kent Pharm

Colours

Product: Amlodipine 5mg and 10mg Tablets PIL
Dimensions: 240mm x 428mm
Item Code: CP.AML.JNT.T.CP.V1P3
Proof No and Date: 3

03/01/14

Revision: Initiation
ARTWORK FOR SUBMISSION
Supersedes: n/a

Pantone
280

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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