Amlodipine 10 Mg Tablets
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Amlodipine 5 mg Tablets Amlodipine 10 mg Tablets
Amlodipine (as amlodipine besilate)
Read all of this leaflet carefully before you start taking this medicine:
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others. It may harm them, even if their symptoms are the same as yours.
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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
Amlodipine Tablets are one of a group of medicines called calcium antagonists.
Amlodipine is used to treat high blood pressure and/or angina (a certain type of chest pain).
It can be taken on its own or used in combination with other medicines to help lower high blood pressure and/or treat angina.
In patients with high blood pressure Amlodipine Tablets work by relaxing blood vessels, so that blood passes through them more easily. In patients with angina Amlodipine Tablets improve blood supply to the heart muscle, which then receives more oxygen. As a result chest pain is prevented. Amlodipine Tablets do not provide immediate relief of chest pain from angina.
If anv of the above apply to vou. or if vou are not sure, tell vour doctor BEFORE starting treatment withAmlodioine Tablets. Your doctor may still want you to take the tablets.
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. This is especially important for medicines you may be taking for heart or blood pressure problems.
Taking Amlodipine Tablets with food and drink
The tablets should be taken with a glass of water with or without food.
Children
Safety and effectiveness have been studied in 6-17 year old boys and in girls. Amlodipine has not been studied in children under the age of 6 years. For more information, talk to your doctor.
Pregnancy and breast-feeding
Amlodipine should not be used in pregnancy, unless clearly needed, so if you are pregnant or thinking of becoming pregnant, please talk to you doctor before takingAmlodipine Tablets.
It is not known whether amlodipine enters breast milk, therefore you should stop breast- feeding whilst you are takingAmlodipine Tablets.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Amlodipine can make you feel dizzy, tired or sick, give you a headache or affect your vision. These side effects could make it difficult to concentrate. If you are affected you should not drive or use machinery.
Important information about some of the ingredients of Amlodipine Tablets
This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Do not take Amlodipine Tablets •
medicines e.g. felodipine, nicardipine, nifedipine etc, or to any of the other ingredients of Amlodipine Tablets (being allergic may caused itching, reddening of the skin or difficulty in breathing).
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ankle swelling)
caused shortness of breath or ankle swelling resting
bearing potential effective contraception is advised.
Take special care with Amlodipine Tablets
Tell your doctor BEFORE starting treatment with Amlodipine Tablets if:
pressure
shortness of breath or ankle swelling) because amlodipine can cause a build up of fluid on the lungs in patients with severe heart failure
to get rid of amlodipine
The usual dose of Amlodipine Tablets is one tablet daily.
Always take Amlodipine Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
You should take your tablets once daily in between meals. Swallow them whole with a glass of water.
Taking the tablets at the same time each day will give the best results and help you to remember to take them.
The usual starting dose is 5 mg once daily. Your doctor may increase this to a maximum dose of 10 mg once daily if needed.
Do not wait until your tablets are finished before seeing your doctor. Your doctor may wish to give you more Amlodipine Tablets.
In the elderly
As above. Your doctor will closely monitor you if the dose is increased.
Use in children
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.
Amlodipine 2.5 mg is not currently available and the 2.5 mg dose cannot be obtained with Amlodipine 5 mg Tablets as these tablets are not manufactured to break into two equal halves.
If you suffer from poor liver or kidney function you should talk to your doctor before taking Amlodipine. Your doctor may prescribe a lower dose for you.
If you take more Amlodipine Tablets than you should
Taking too many tablets at once may make you unwell. Even if several tablets are taken it may be dangerous. If you or someone else has taken too many amlodipine tablets you should contact your doctor or nearest hospital emergency department immediately. Take the packet with you so that the doctor can see how many tablets have been taken.
Taking too many Amlodipine Tablets can cause flushing and low blood pressure that may need treatment.
If you forget to take Amlodipine Tablets
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 forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
sugar levels; disorder of the nerves which can cause weakness; heart attack; irregular heartbeat; inflammation of the blood vessels; cough; inflammation of the stomach or pancreas; red patches on the skin.
Very rarely heart attacks, irregular heart beat or angina can occur in patients with heart disease. However, it is not certain that the Amlodipine causes these problems.
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.
Keep out of the reach and sight of children.
Do not use Amlodipine Tablets after the expiry date, which is stated on the label. The expiry date refers to the last day of that month.
Keep Amlodipine Tablets in a dry place.
Do not store above 25°C.
Keep in the original package.
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.
Like all medicines, Amlodipine Tablets can cause side effects, although not everybody gets them.
If you notice a rash, or swelling of the lips, face, tongue or throat tell your doctor immediately as these may be signs of an allergic reaction.
Very common side effects (More than 1 in 10 people are affected) Swelling of the ankles.
Common side effects (Between 1 in 10 and 1 in 100 people are affected):
Tiredness; dizziness; headache (especially at the start of the treatment); fast or irregular heart beat; facial flushing with heat sensation, especially at the start of treatment; stomach pain; nausea; indigestion; loss of strength.
Tell your doctor if these effects cause you any problems or if they last for more than one week.
Uncommon side effects (Between 1 in 100 and 1 in 1,000 people are affected):
Sleep problems; irritability; depression; aggravation of angina pectoris (may occur at the start of treatment) shakiness; fainting; pins & needles; problems with vision; ringing in the ears; low blood pressure; fast heart beat; difficulty in breathing; vomiting; constipation or diarrhoea; dry mouth; hair loss; bruising of the skin; changes in skin colouration; increased sweating; itching; rash; other skin eruptions; joint pain; muscle pain and cramps; back pain; increased need to urinate especially during the night; impotence; swelling of the breast tissue in men; chest pain; general pain; feeling generally unwell; changes in body weight; nettle rash (hives); swollen gums; runny nose.
Rare side effects (Between 1 in 1,000 and 1 in 10,000 people are affected)
Confusion, mood changes including anxiety; change in the way things taste; increased levels of liver enzymes in the blood; yellowish colouration of the skin; inflammation of the liver; swelling of the lips, face, tongue or throat; itching; rash; scaling of the skin; Steven Johnson syndrome; Quincke oedema.
Very rare side effects (Less than 1 in 10,000 people are affected): Reduction in the numbers of white blood cells which makes infections more likely; reduction in blood platelets which increases the risk of bruising or bleeding; allergic reactions; increased blood
What Amlodipine Tablets contain
microcrystalline cellulose, lactose monohydrate, magnesium stearate.
What Amlodipine Tablets looks like and contents of the pack
Amlodipine Tablets are white, round and flat notched on one-side and come in two strengths, 5 mg and 10 mg and in packs of:
10.20.28.30.60.100 or 500 tablets (Amlodipine 5 mg Tablets).
10.14.20.28.30.60.100 or 500 tablets (Amlodipine 10 mg Tablets). Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing authorisation holder:
Morningside Healthcare Ltd 115 Narborough Road, Leicester LE3 0PA,UK
Manufacturers:
West Pharma Produgoes Especialidades Farmaceuticas, S.A.
Rua Joao de Deus, n.011, Venda Nova, 2700 Amadora Portugal
Atlantic Pharma - Produgoes Farmaceuticas, S.A.
Rua da Tapada Grande, n.0 2, Abrunheira
2710-089 Sintra
Portugal
This medicinal product is authorised in the Member States of the EEAunderthefollowing names:
Italy: Amlodipina RKG 5 mg/10 mg compresse Portugal: Amlodipina Tecnimede 5 mg/10 mg comprimidos Spain: AmlodipinoTecnigen 5 mg/10 mg comprimidos EFG United Kingdom: Amlodipine 5 mg/10 mg tablets