Amlodipine 5mg Tablets
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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
Amlodipine Tablets belong to a group of medicines called calcium antagonists.
Your medicine is 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 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 Tablets work by improving blood supply to the heart muscle which then receives more oxygen and as a result chest pain is prevented. Your medicine does 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, or any of the other ingredients of your medicine listed in section 6, or to any other calcium antagonists. These may be itching, reddening of the skin or difficulty in breathing.
• You have a narrowing of the aortic heart valve (aortic stenosis), unstable angina pectoris or cardiogenic shock.
• You are pregnant or breast feeding.
• You have severe low blood pressure (hypotension)
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
• You are elderly and your dose needs to be increased Taking other medicines:
Please tell your doctor or pharmacist if you are taking or have recently taken any othermedicines, including medicines obtainedwithout a prescription.
Amlodipine 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 (a cholesterol lowering medicine)
Amlodipine tablets may lower your blood pressure even more if you are already taking other medicines to treat your high blood pressure
Taking Amlodipine Tablets with food and drink
Your medicine can be used before or after food. Grapefruit juice and grapefruit should not be consumed by people who are taking Amlodipine 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 Amlodipine Tablets.
Children
Safety and effectiveness have been studied in 6-17 year old boys and in girls. Amlodipine Tablets have not been studied in children under the age of 6 years. For more information, talk to your doctor.
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, tell your doctor before you take Amlodipine Tablets.
Women of child bearing potential should ensure that they use effective contraception.
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 Amlodipine tablets.
Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines
Amlodipine 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 AMLODIPINE
The usual dose of Amlodipine Tablets is one tablet daily.
It is best to take your medicine at the same time each day with a drink of water. Do not take Amlodipine Tablets with grapefruit juice.
Always take your medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are still not sure.
Use in children and adolescents
For children (6 -17 year 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 Tablets 5 mg 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 Amlodipine Tablets than you should
Taking too many tablets at once may make you unwell. If you take too many Amlodipine Tablets contact your doctor at once or go to the nearest hospital casualty department taking this leaflet or the outer carton with you.
If you forget to take Amlodipine 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 using Amlodipine 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 how to take this product, ask your doctor or pharmacist.
Like all medicines, Amlodipine Tablets can cause side effects, although not everybody gets them. Tell your doctor immediately if you experience any of the following symptoms after taking this medicine. Although they are very rare, the symptoms can be severe.
• Sudden wheeziness, difficulty in breathing, swelling of eyelids, face or lips, rash or itching (especially affecting the whole body).
• Swelling of the tongue and throat which causes great difficulty breathing
• Reddening of the skin over your whole body, severe itching, blistering, peeling and swelling of the skin, inflammation of mucous membranes (Stevens Johnsons Syndrome) or other allergic reactions
• Abnormal heartbeat
The following Common side-effects have been reported. If any of these cause problems or if they last more than a week, you should contact your doctor.
Common side effects: affects 1 to 10 users in 100
• Headache, dizziness, sleepiness (especially at the beginning of treatment)
• Palpitations (awareness of your heart heat), 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 side effects: 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
• Shortness of breath, sneezing/running nose caused by inflammation of the lining of the nose (rhinitis)
• Altered bowel habit, diarrhoea, constipation, indigestion, dry mouth, vomitting (being sick)
• Hair loss, increased sweating , itchy skin, red patches on skin, skin discoloration
• Disorder in passing urine, increased need to urinate especially at night, increased number oftimes of passing urine
• Inability to obtain an erection, discomfort or enlargement of the breasts in men
• Chest pain, weakness, pain, feeling unwell
• Joint or muscle pain, muscle cramps, back pain
• Weight increase or decrease
Rare side effects: affects 1 to 10 users in 10,000 • Confusion
Very rare side effects: 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)
• Severe skin reaction
• Excess sugar in blood (diabetes)
• Increased sensitivity of the skin, pins andneedles, loss ofpain sensation
• Heart attack
• Hives
• Abdominal bloating (gastritis)
• Cough, swelling of the gums
• Inflamed pancreas which may cause severe abdominal and hack pain accompanied with feeling very unwell
• Abnormal liver function, inflammation of the liver, yellowing of the skin (jaundice), liver enzyme increases which may have effect on some medical tests
• A disorder of the nerves which can cause weakness, tingling or numbness
• Increased muscle tension
• 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.
Keep out of the reach and sight of children.
Do not store above 25°C.
Keep in original carton to protect from light
Do not use your medicine after the expiry date which is stated on the pack. 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.
What Amlodipine Tablets contain
- The active substance is amlodipine (as amlodipine besilate). Each tablet contains 6.94 mg amlodipine besilate equivalent to 5 mg amlodipine or 13.88 mg amlodipine besilate equivalent to 10 mg amlodipine.
- The other ingredient(s) are:
Cellulose, microcrystalline Sodium starch glycolate (Type A)
Silica, colloidal anhydrous Magnesium stearate
What Amlodipine Tablets look like and contents of the pack
Amlodipine Tablets come in two strengths, 5mg and 1 Omg.
- 5mg tablets: “White to off white, octagonal, flat faced, beveled edge tablet, engraved with 'FDC' and '5' on one side and plain on other side.
- 10 mg tablets: “White to off white, round, flat faced, beveled edge tablet, engraved with 'FDC' and T O' on one side and plain on other side.
Amlodipine Tablets come in packs of 28 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
FDC Pharma
Unit 6, Fulcrum 1, Solent Way, Whiteley, Fareham, Hampshire, P015 7FE, UK
Manufacturer:
FDC International Ltd.,
Unit 6, Fulcrum 1, Solent Way, Whiteley, Fareham, Hampshire, P015 7FE, UK