Amlodipine 5 Mg Tablets
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Amlodipine 5 mg and 10 mg Tablets
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 contain the active substance amlodipine (as besilate) which belongs to a group of medicines called calcium antagonists.
Amlodipine Tablets are 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. This may be itching, reddening of the skin or difficulty in breathing.
• If you have severe low blood pressure (hypotension)
• If you have a narrowing of the aortic heart valve (aortic stenosis) or cardiogenic shock (a condition where your heart is unable to supply enough blood to the body).
• If you suffer from heart failure after a heart attack
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
• Heart failure
• Severe increase in blood pressure (Hypertensive crisis)
• Liver disease
• You are elderly and your dose needs to be increased Use in children and adolescents
Amlodipine has not been studied in children under the age of 6 years. Amlodipine Tablets should only be used for hypertension in children and adolescents from 6 years to 17 years of age (see section 3). For more information, talk to your doctor.
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.
Amlodipine Tablets may be affected by other medicines such as:
- ketoconazole and 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)
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
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.
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, you must tell your doctor before you take Amlodipine Tablets.
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 TABLETS
Always take your medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The usual initial dose is one Amlodipine 5 mg Tablet, once daily. The dose can be increased to one Amlodipine 10 mg Tablet once daily.
Your medicine can be used before or after food and drinks. You should take your medicine at the same time each day. Swallow the tablet immediately with a glass of water. Do not take Amlodipine Tablets with grapefruit juice.
Use in children and adolescents
For children and adolescents (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 Tablets are not currently available. The 2.5 mg dose can be obtained with Amlodipine 5 mg Tablets as these tablets can be divided into two equal doses.
Amlodipine 10mg Tablets can also be divided into equal doses.
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 may cause your blood pressure to become low or even dangerously low. You may feel dizzy, lightheaded, faint or weak. If blood pressure drop is severe enough shock can occur. Your skin could feel cool and clammy and you could lose consciousness. Seek immediate medical attention if you take too many Amlodipine Tablets.
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 taking 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 the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Amlodipine Tablets can cause side effects, although not everybody gets them.
Visit your doctor immediately if you experience any of the following very rare, severe side effects after taking this medicine.
- Sudden wheeziness, chest pain, shortness of breath or difficulty in breathing
- Swelling of eyelids, face or lips
- Swelling of the tongue and throat which causes great difficulty breathing
- Severe skin reactions including intense skin rash, hives, reddening of the skin over your whole body, severe itching, blistering, peeling and swelling of the skin, inflammation of mucous membranes (Stevens Johnson Syndrome) or other allergic reactions
- Heart attack, abnormal heart beat
- Inflamed pancreas which may cause severe abdominal and back pain accompanied with feeling very unwell
The following common side-effects have been reported. If any of these cause you problems or if they last for more than one week, you should contact your doctor.
Common: affects 1 to 10 users in 100
- Headache, dizziness, sleepiness (especially at the beginning of treatment)
- Palpitations (awareness of your heart beat), 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: 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
- Sneezing/running nose caused by inflammation of the lining of the nose (rhinitis)
- Altered bowel habits, diarrhoea, constipation, indigestion, dry mouth, vomiting (being sick)
- Hair loss, increased sweating, itchy skin, red patches on skin, skin discolouration
- Disorder in passing urine, increased need to urinate at night, increased number of times of passing urine
- Inability to obtain an erection; discomfort or enlargement of the breasts in men
- Weakness, pain, feeling unwell
- Joint or muscle pain, muscle cramps, back pain
- Weight increase or decrease
Rare: affects 1 to 10 users in 10,000 - Confusion
Very rare: 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)
- Excess sugar in blood (hyperglycaemia)
- A disorder of the nerves which can cause weakness, tingling or numbness
- Cough, swelling of the gums
- Abdominal bloating (gastritis)
- Abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), liver enzyme increase which may have an effect on some medical tests
- Increased muscle tension
- Inflammation of blood vessels, often with skin rash
- 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.
5. HOW TO STORE AMLODIPINE TABLETS
Keep out of the reach and sight of children.
Do not use your medicine after the expiry date stated on the blisters and outer packaging. The expiry date refers to the last day of that month.
Do not store above 25°C. Store in the original packaging in order to protect from light and moisture. Keep the blister in the outer carton. Do not take these tablets if there are any signs of discolouration or deterioration of the tablets.
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 ingredient is amlodipine (as besilate).
Each 5 mg tablet contains amlodipine besilate equivalent to 5 mg amlodipine.
Each 10 mg tablet contains amlodipine besilate equivalent to 10 mg amlodipine.
• The other ingredients are microcrystalline cellulose, calcium hydrogen phosphate, sodium starch glycolate and magnesium stearate.
What Amlodipine Tablets look like and contents of the pack
• Amlodipine 5 mg Tablets are round white tablet, 8 mm in diameter. One side is slightly concave with a breakline and debossed “A5”. The other side is slightly convex and plain.
The tablets are packed in blisters and available in pack sizes of 15, 20, 28, 30, 50, 56, 84, 90, 98, 100, 112 and 300 tablets.
• Amlodipine 10 mg Tablets are round white tablet, 11 mm in diameter. One side is slightly concave with a breakline and debossed “A10”. The other side is slightly convex and plain.
The tablets are packed in blisters and available in pack sizes of 14, 15, 20, 28, 30, 50, 56, 84, 90, 98, 100 and 112 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Teva UK Limited, Eastbourne, BN22 9AG, UK
Manufacturer
TEVA Pharmaceutical Works Private Limited Company Pallagi ut 13, 4042 Debrecen,
Hungary
Or
TEVA Pharmaceutical Works Private Limited Company H-2100 Godollo, Tancsics Mihaly ut 82,
Hungary
Or
TEVA UK Ltd
Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG UK
Or
Pharmachemie B.V.
Swensweg 5, 2031 GA Haarlem The Netherlands
Or
TEVA Sante
Rue Bellocier, 89100 Sens France
Or
Teva Czech Industries s.r.o.
Ostravska 29, c.p. 305, 74770 Opava-Komarov Czech Republic
Or
Merckle GmbH
Ludwig-Merckle-StraBe 3, 89143 Blaubeuren Germany
This leaflet was last revised in September 2013.
PL 00289/1558 PL 00289/1559
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