Amlodipine 5mg Tablets
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Amlodipine 5mg Tablets Amlodipine 10mg Tablets
Amlodipine maleate
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 get 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
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1. What Amlodipine Tablets are and what they are used for
What this medicine does
Your doctor has prescribed Amlodipine Tablets 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.
Amlodipine is one of a group of medicines called calcium channel blockers (calcium antagonists).
In patients with high blood pressure, Amlodipine Tablets relaxes and opens blood vessels, improving the flow of blood and lowering blood pressure.
In patients with angina, Amlodipine Tablets work by improving blood supply and oxygen to the heart muscle.
Amlodipine may be used alone or in combination with other drugs used to treat high blood pressure and angina.
Amlodipine Tablets do not provide immediate relief of chest pain from angina.
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2. Before you take Amlodipine Tablets
Do not take Amlodipine Tablets:
• if you are allergic (hypersensitive) to amlodipine maleate, other dihydropyridine calcium antagonists, e.g. felodipine, nifedipine or nicardipine; or any of the other ingredients of Amlodipine Tablets (see Section 6 Further Information);
• if you have very low blood pressure;
• if you have had shock 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);
• if you have heart failure in the first 28 days after an acute heart attack;
• if the blood flow from the left side of your heart is obstructed (e.g. aortic valve narrowing);
• if you have unstable angina (chest pain which may occur when you are resting).
Talk to your doctor or pharmacist if any of the following apply to you:
• if you have heart failure;
• if you have problems with your liver;
• if you have problems with your kidneys and are undergoing dialysis (filtering of the blood using a machine);
• if you are under 18 years of age or over 60 years of age.
Safety and effectiveness have been studied in 6 - 17 year old boys and girls. Amlodipine Tablets have not been studied in children under the age of 6 years. For more information, talk to your doctor.
Using other medicines
Make sure your doctor knows if you are taking a medicine listed here:
• Diltiazem (used to treat high blood pressure): it may increase the effect of amlodipine.
• Ketoconazole and itraconazole (used to treat fungal infections): these medicines may increase the effect of amlodipine.
• Verapamil and diltiazem (heart medicines): these may increase the effect of amlodipine.
• Simvastatin (used to lower cholesterol): amlodipine increases levels of simvastatin in your blood.
• Ritonavir (used to treat HIV infections): it may increase the effect of amlodipine.
• Rifampicin (used in the treatment of tuberculosis): it may reduce the effect of amlodipine.
• St. John's Wort (a herbal remedy to treat depression): it may reduce the effect of amlodipine.
• Erythromycin or clarithromycin (antibiotics used to treat bacterial infections): it may increase the effect of amlodipine.
• Dantrolene (infusion for conditions of low body temperature): as use may cause an imbalance in your blood salt levels.
• Other medicines used to lower high blood pressure: if you take other medicines for reducing your blood pressure with amlodipine you may become dizzy or faint due to your blood pressure dropping too low.
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
• If you are pregnant, thinking of becoming pregnant, or breast-feeding, ask your doctor or pharmacist for advice before taking Amlodipine Tablets. You may be advised not to take Amlodipine Tablets by your doctor.
Taking with food and drink
• Do not eat grapefruit or drink grapefruit juice when taking your tablets. They may increase the effect of amlodipine.
Driving and using machines
• Do not drive or operate machinery if you feel dizzy, tired, sick or have a headache or double vision after taking Amlodipine Tablets
Important information about some of the other ingredients in Amlodipine Tablets
• Your 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 medicine.
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3.How to take Amlodipine Tablets
Always take Amlodipine Tablets exactly as your doctor has told you. 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 plenty of water;
• take them before, after or during your meal.
Adults including elderly
• The usual starting dose is 5mg once a day.
• The dose may be increased to a maximum daily dose of 10mg once a day.
Children and Adolescents (from 6 to 17 years of age)
• The usual starting dose is 2.5mg once a day.
• The dose may be increased to a maximum daily dose of 5mg once a day.
• Amlodipine 2.5mg Tablets are not currently available and the 2.5mg dose cannot be obtained with Amlodipine 5mg Tablets as these tablets are not manufactured to break into two equal halves.
Use in children under six years old is not recommended.
Patients with kidney problems
• The normal adult dose can be used.
• If you are undergoing dialysis (filtering of the blood using a machine) speak to your doctor or pharmacist before taking Amlodipine Tablets.
Patients with liver problems
• If you have problems with your liver speak to your doctor or pharmacist before taking Amlodipine Tablets.
If you take more Amlodipine Tablets than you should
• If you take more Amlodipine Tablets than your doctor has prescribed contact your nearest casualty department or tell your doctor/pharmacist immediately. Take this leaflet and any remaining tablets with you.
If you forget to take Amlodipine Tablets
• If you forget to take a dose at the right time, take it as soon as you remember. Then go on as before.
• Do not take double the amount to make up for the forgotten dose.
If you stop taking Amlodipine Tablets
• Do not stop taking Amlodipine Tablets suddenly.
• Speak to your doctor or pharmacist before you stop taking this medicine.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
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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;
• severe rashes that may involve blistering and peeling of the skin;
• increased heart rate;
• palpitations;
• changes in your blood, which may cause bruising or nosebleeds, or you may be more prone to infection;
• high levels of sugar in your blood (hyperglycaemia) that may make you feel thirsty or need to urinate more often;
• heart problems which include heart attack, changes in heart rate and rhythm;
• inflammation of the stomach;
• pancreatitis causing stomach or back pain, nausea, sickness, fever or a rapid pulse;
• inflammation of the liver (hepatitis);
• yellowing of the skin or whites of the eyes (jaundice).
Common side effects (affecting more than 1 in 100 people but fewer than 1 in 10 people)
• headache (especially at the beginning of treatment);
• flushing;
• feeling sick, stomach ache or pain;
• feeling tired or having no energy;
• dizziness and/or drowsiness;
• ankle swelling;
• swelling (oedema), including of the face, lips and eyes.
Uncommon side effects (affecting more than 1 in 1,000 people but fewer than 1 in 100 people)
• enlargement of breasts in men;
• feeling generally unwell with aches and pains;
• tremors (shaking);
• reduced sensitivity to touch;
• pins and needles, tingling, pricking or numbness sensations;
• changes in vision, including double vision;
• problems sleeping (insomnia);
• mood changes, including anxiety;
• depression;
• fainting;
• ringing or buzzing in the ear (tinnitus);
• low blood pressure;
• shortness of breath;
• nasal irritation (rhinitis);
• vomiting, indigestion, dry mouth, altered bowel habits, including diarrhoea and/or constipation;
• rash or local swelling causing wheals on the skin, itching, flaking or skin discolouration;
• hair loss (alopecia);
• increased sweating;
• muscle cramps;
• general, back, chest, muscle and/or joint pain;
• increased need to urinate (pass water), getting up in the night to urinate and changes in passing water;
• impotence (inability to obtain an erection);
• changes in bodyweight (increase or decrease);
• changes in taste sensation.
Rare side effects (affecting more than 1 in
10.000 people but fewer than 1 in 1,000 people)
• confusion.
Very rare side effects (affecting fewer than 1 in
10.000 people)
• isolated cases of severe allergic reactions (described above);
• increased tightness of the muscles;
• numbness in the fingers and toes;
• purple spotting on the skin (vasculitis);
• cough;
• swollen or sore gums;
• increases in some liver enzymes;
• problems with tremors, rigidity and or movement.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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.
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5. How to store Amlodipine Tablets
Keep out of the sight and reach of children.
Do not use after the expiry date stated on the carton and blister.
Do not store your tablets above 25°C. Store in the original package.
Do not use if you notice that the pack is damaged. Return them to your pharmacist.
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.
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6. Further information
What Amlodipine Tablets contain
- The active substance is amlodipine (as; maleate). Each tablet contains 5mg or 10mg of amlodipine.
- The other ingredients are lactose monohydrate, povidone K 30, povidone K 90, microcrystalline cellulose, crospovidone and sodium stearyl fumarate.
What Amlodipine Tablets look like and contents of the pack
• Amlodipine 5mg Tablets are white, round tablets.
• Amlodipine 10mg Tablets are white, round tablets with a break line on both sides. Breaking along the score line allows for dosing at a level of 5mg.
Each carton of Amlodipine Tablets contains either:
• 10, 20, 28, 30, 50, 98, 100 or 300 tablets of Amlodipine 5mg Tablets, or
• 10, 20, 28, 30, 50, 98 or 100 tablets of Amlodipine 10mg Tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Focus Pharmaceuticals Limited, Capital House, 1st Floor, 85 King William Street, London EC4N 7BL, UK.
Tel: 01283 495 280 Fax: 01283 495 290 Email: medinfo@focuspharma.co.uk
Manufacturer
MEDREICH PLC, Warwick House, Plane Tree Crescent, Feltham, TW13 7HF, UK
For any information about this medicinal product, please contact the Marketing Authorisation Holder, details provided above.
For information in large print, audio CD or BraillepTease telephone 01283 495 280 or email medinfo@focuspharma.co.uk