Amlodipine 10mg Tablets
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Amlodipine 10mg tablets
amlodipine
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 belongs to a group of medicines called dihydropyridine calcium channel blockers.
Amlodipine is used to treat:
- hypertension (high blood pressure)
- a certain type of chest pain called angina, including vasospastic except for unstable angina
In patients with high blood pressure, Amlodipine works by relaxing blood vessels, so that blood pressure is reduced. In patients with angina, Amlodipine works by improving blood and oxygen supply to the heart so that chest pain is prevented.
2. BEFORE YOU TAKE AMLODIPINE TABLETS Do not take Amlodipine tablets if you:
- are allergic (hypersensitive) to Amlodipine, other calcium channel blockers or any of the other ingredients of this medicine (see section 6). An allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue.
- have very low blood pressure
- have shock including cardiogenic shock (the heart is damaged and cannot supply enough blood to the body)
- have obstructed blood outflow from the left side of your heart
- have heart failure after an heart attack
Take special care with Amlodipine tablets (and speak to your doctor) if you:
- have extremely high blood pressure
- have heart failure
- have ever been told that your liver does not work very well. Amlodipine should be given with special care in these patients
- are elderly and your doctor has just increased the dose of Amlodipine
Taking other medicines
Amlodipine can affect the way some medicines work. Also some other medicines can affect the way Amlodipine works. Tell your doctor or pharmacist if you are taking:
• medicines which are known to affect the liver enzyme system (these enzymes help liver in the breakdown of drugs). These include:
- erythromycin (a medicine used for the treatment of bacterial infections)
- diltiazem [a medicine used to treat high blood pressure and angina (chest pain)]
- medicines used to treat fungal infections (ketoconazole or itraconazole )
- ritonavir (a medicine used for HIV infection)
- rifampicin (a medicine used to treat tuberculosis)
- St.John's wort (a herbal medicine used to treat mild depression)
• other medicines used to treat high blood pressure. Amlodipine may cause low blood pressure when combined with such medicines.
Taking Amlodipine tablets with food and drink
Amlodipine may be taken with or without food. The tablets should be swallowed whole with a glass of water.
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
Ask your doctor or pharmacist for advice before taking any medicine. Pregnancy:
Before starting treatment, you must tell your doctor if you are pregnant or if you intend to become pregnant. Amlodipine is not known to harm the unborn child, but has not been deemed as safe. It will be given to a pregnant woman only if it is absolutely necessary.
Breast-feeding:
It is not known whether Amlodipine enters breast milk. You are advised not to breastfeed when using Amlodipine.
Driving and using machines
Amlodipine tablets may cause dizziness, headache, tiredness and the feeling that you are about to be sick. Any of these side effects can reduce your ability to react. Do not drive or operate machinery if you are affected.
3. HOW TO TAKE AMLODIPINE TABLETS Dosage
Always take Amlodipine tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Adults and the elderly:
The usual starting dose is 5 mg once daily. This dose may be increased to a maximum dose of 10 mg once daily after 2-4 weeks, if required.
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 tablets 5 mg as these tablets are not manufactured to break into two equal halves.
Patients with kidney problems
In patients with kidney problems, the dosage of Amlodipine is usually not reduced. Amlodipine should be given with special care in patients on dialysis for kidney failure.
Patients with liver problems
Your doctor will decide your dosing regimen. Your response to treatment should be closely monitored. This is because the time taken for Amlodipine to leave the body is increased in patients with liver problems.
If you take more Amlodipine tablets than you should
Taking too many tablets may cause your blood pressure to become too low. Some symptoms of low blood pressure include dizziness, light headedness, occasional palpitations, blurred vision, confusion and sometimes fainting. If you have taken too much Amlodipine, contact your doctor, pharmacist or nearest hospital immediately.
If you forget to take Amlodipine tablets
If you miss a dose, take it as soon as possible. However, if it is nearly time for your next dose, skip the missed dose and carry on as before. Do not take a double dose to make up for a forgotten dose.
If you stop taking Amlodipine tablets
It is important that you take this medicine until you finish the prescribed course. You should not stop the medicine just because you feel better. If you stop taking the medicine then your condition may worsen and may require hospitalisation.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Amlodipine tablets can cause side effects, although not everybody gets them.
The following side effects are important and will require immediate action if you experience them. You should stop taking Amlodipine and see your doctor immediately if the following symptoms occur:
Very rare side effects (affects less than 1 user in 10,000) include:
- Hypersensitivity (allergic) reactions such as rashes, itching, redness and swelling of lips, mouth, throat and eyes may occur
- abnormal / irregular heartbeats including slow or fast heartbeats
- serious allergic reaction which causes sudden swelling of the face or throat, difficulty in breathing and/or itching and skin rash
- severe rash that may include peeling of skin
- skin disorder with widespread scaling of the skin, often with hair loss
- serious illness with blistering of the skin, mouth, eyes and genitals
The following side-effects have also been reported:
Common side effects (affects 1 to 10 users in 100) include:
- sleepiness
- dizziness
- headache
- flushing of the face and feeling hot
- abdominal pain
- feeling sick
- swelling of ankles
- fluid retention
- feeling tired
Uncommon side effects (affects 1 to 10 users in 1,000) include:
- being unable to sleep
- mood changes (including anxiety)
- depression
- shaking
- altered sense of taste
- fainting
- reduced sense of touch or sensation
- numbness and tingling
- visual disturbances including double vision
- ringing in the ears
- quicker or irregular heart beat
- low blood pressure
- shortness of breath/ tightness of chest
- nasal stuffiness and/or runny nose
- vomiting
- digestive disorder
- altered bowel habits including diarrhoea and constipation
- dry mouth
- hair loss
- bruising and purple discolouring to the skin
- skin discolouration
- excessive sweating
- itching
- rash
- skin eruptions
- joint pain
- muscular pain
- muscle cramps
- back pain
- problems in passing urine
- waking up several times at night to urinate
- increased need to urinate
- inability to achieve or maintain an erection
- enlargement of the breasts in men
- chest pain
- feeling of weakness
- pain
- a general feeling of being unwell
- increase in weight
- decrease in weight
Rare side effects (affects 1 to 10 users in 10,000) include:
- confusion
Very rare side effects (affects less than 1 user in 10,000) include:
- reduction in the number of white blood cells which makes infections more likely
- reduction in blood platelets which increases risk of bleeding or bruising
- increase in blood sugar level
- increased muscle tone /tension
- problems in the nerves of the arms or legs
- heart attack
- cough
- inflammation of the pancreas which causes severe pain in the abdomen and back
- inflammation of the lining of stomach
- inflammation of the blood vessels
- enlargement of gums
- inflammation of the liver
- yellowing of the skin or whites of the eyes caused by liver problems
- changes in blood tests that check how your liver is working
- hives
- a skin reaction caused by exposure to sunlight
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 TABLETS
Keep out of the sight and reach of children.
This medicinal product does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the blister and carton after “Exp”
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 tablets contain
The active substance is amlodipine besilate. Each tablet contains amlodipine besilate, equivalent to 10 mg of amlodipine.
The other ingredients are: cellulose microcrystalline (E460), calcium hydrogen phosphate anhydrous (E341), sodium starch glycolate (Type A) and magnesium stearate (E572).
What Amlodipine tablets look like and contents of the pack
White to off white coloured round shaped flat faced bevelled edged tablets debossed with “S-482” on one side and plain on the other side.
Your medicine is available in blisters containing 10, 14, 20, 28, 30, 40, 56 and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Dawa Limited 5 Sandridge Close,
Harrow, Middlesex HA1 1XD,
United Kingdom.
Manufacturer
Drugsrus Limited 5 Sandridge Close,
Harrow, Middlesex HA1 1XD,
United Kingdom
This leaflet was last revised in 12/2014