Patient leaflet - Amlodipine Bristol Lab 2.5 mg tablets
1. What Amlodipine is and what it is used for
- Amlodipine belongs to a group of medicines called calcium-channel blockers. Amlodipine 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.
- If you have high blood pressure amlodipine works by relaxing blood vessels, so that blood passes through them more easily.
- If you have angina, you may get chest pain when your heart cannot get enough blood. Amlodipine helps in preventing this by increasing blood supply to the heart. Amlodipine Bristol Lab 2.5mg Tablets do not work immediately to stop chest pain from angina.
2. What you need to know before you take Amlodipine
Do not take Amlodipine:
- If you are allergic to amlodipine or any other calcium channel blockers or any other ingredients of this medicine (these are listed in section 6). This may include itching, reddening of the skin or difficulty in breathing.
- If you have severe low blood pressure (hypotension).
- If you have 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.
Warnings and Precautions
Talk to your doctor or pharmacist before taking Amlodipine.
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
Other medicines and Amlodipine
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Amlodipine 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)
- Tacrolimus, sirolimus, temsirolimus, and everolimus (used to control your body’s immune response, enabling your body to accept the transplanted organ).
- Cyclosporine (an immunosuppressant)
Amlodipine may lower your blood pressure even more if you are already taking other medicines to treat your high blood pressure.
Use in children and adolescents
Amlodipine has not been studied in children under the age of 6 years. Amlodipine 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.
Amlodipine with food and drink
Grapefruit juice and grapefruit should not be consumed by people who are taking Amlodipine. 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.
Pregnancy and breast-feeding
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.
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.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Amlodipine 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.
Information on sodium content
This medicine contains less than 1mmol sodium (23 mg) per tablet, that is to say essentially (sodium-free).
3. How to take Amlodipine
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended initial dose is Amlodipine 5 mg once daily. The dose can be increased to
Amlodipine 10 mg once daily.
This medicine can be used before or after food and drinks. You should take this medicine at the same time each day with a drink of water. Do not take Amlodipine 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.
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 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 Bristol Lab 2.5mg Tablets.
Excess fluid may accumulate in your lungs (pulmonary oedema) causing shortness of breath that may develop up to 24-48 hours after intake.
If you forget to take Amlodipine
Do not worry and take the next dose at the right time. Do not take a double dose to make up for the forgotten dose.
Front
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If you stop taking Amlodipine
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 medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. STOP TAKING this medicine and see 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, toxic epidermal necrolysis) 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 very common side effect has been reported. If this causes you problems or if it lasts for more than one week, you should contact your doctor.
Very common: may affect more than 1 in 10 people
- Oedema (fluid retention)
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: may affect up to 1 in 10 people
- Headache, dizziness, sleepiness (especially at the beginning of treatment)
- Palpitations (awareness of your heart beat), flushing
- Abdominal pain, feeling sick (nausea)
- Altered bowel habits, diarrhoea, constipation, indigestion,
- Tiredness, weakness
- Visual disturbances, double vision
- Muscle cramps
- Ankle swelling
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: may affect up to 1 in 100 people
- Mood changes, anxiety, depression, sleeplessness
- Trembling, taste abnormalities, fainting
- Numbness or tingling sensation in your limbs, loss of pain sensation
- Ringing in the ears
- Low blood pressure
- Sneezing/running nose caused by inflammation of the lining of the nose (rhinitis) • Cough
- 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 • Pain, feeling unwell
- Joint or muscle pain, back pain
- Weight increase or decrease
Rare: may affect up to 1 in 1,000 people
- Confusion
Very rare: may affect up to 1 in 10,000 people
- 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
- Swelling of the gums
- Bleeding 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
Not known: frequency cannot be estimated from the available data
- trembling, rigid posture, mask-like face, slow movements and a shuffling, unbalanced walk.
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 Website: www.mhra.gov.uk/ yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Amlodipine
- Keep this medicine out of the sight and reach of children.
- Do not use this medicine after expiry date stated on the pack after ‘EXP’. The expiry date refers to the last day of that month.
- Do not store above 25ºC.
- Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Amlodipine Bristol Lab 2.5mg Tablets contain
- The active substance is Amlodipine (as besilate). Each tablet contains 2.5 mg of Amlodipine. • The other ingredients are calcium hydrogen phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, silica colloidal anhydrous and magnesium stearate.
What Amlodipine Bristol Lab 2.5mg Tablets look like and contents of pack
- Amlodipine Bristol Lab 2.5mg Tablets are white to off white, round biconvex, uncoated tablets marked ‘Y2’ on one side and plain on other side. The tablet dimensions are 6.0 mm Aluminium/PVDC coated PVC blister strips containing 14 tablets. Blister strips are packaged into an outer container to give a total of 28, 56, 84 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Bristol Laboratories Ltd,
Unit 3, Canalside, Northbridge Road,
Berkhamsted, Hertfordshire, HP4 1 EG, UK
Telephone: 0044 (0) 1442 200922
Fax: 0044 (0) 1442 873717
Email: info@bristol-labs.co.uk
Amlodipine Bristol Lab 2.5mg Tablets; PL 17907/0435
This leaflet was last revised in May 2022
To request a copy of this leaflet in Braille, large print or audio format, please contact the marketing authorisation holder at the address (or telephone, fax, email) above.
10 mm
V6 31-05-22 D0
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