Amlodipine 5mg & 10mg PD Tablets
Clinical Summary
Quick overview from the medicine insert
Indication
Used to treat hypertension and angina pectoris.
Dosage (summary)
Adults: Start with 5 mg once daily, may increase to 10 mg. Elderly: Same as adults. Kidney issues: Normal dose; consult for dialysis. Liver issues: May require lower starting dose.
Special Populations
- Elderly
- Renal impairment
- Hepatic impairment
Pregnancy & Breastfeeding
Contraindicated in pregnancy and breastfeeding.
Key Drug Interactions
- Grapefruit juice
- Ritonavir
- Ketoconazole
- Simvastatin
- Lithium
Contraindications
- Hypersensitivity to amlodipine
- Cardiogenic shock
- Recent heart attack
- Unstable angina
- Severe hypotension
- Aortic stenosis
Common side effects
- Headache
- Dizziness
- Flushing
- Swelling
- Nausea
Counselling Points
- Take at the same time daily
- Avoid grapefruit juice
- Do not stop without consulting a doctor
- May cause dizziness; avoid driving until effects are known
Serious warnings
- May cause severe allergic reactions
- Monitor for hypotension
- Risk of worsening chest pain if stopped suddenly
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Clinical Particulars
Section 4 of the official insert — extracted exactly as issued, no alterations
4. Possible side effects
AMLODIPINE 5/10 mg PD may have side effects. Not all side effects reported for AMLODIPINE 5/10 mg PD are included in this leaflet. Should your general health worsen, or if you experience any untoward effects while taking AMLODIPINE 5/10 mg PD please consult your healthcare provider for advice.
If any of the following happens, stop taking AMLODIPINE 5/10 mg PD and tell your doctor immediately or go to the casualty department at your nearest hospital:
- Swelling of the hands, feet, ankles, lips, mouth, or throat which may cause difficulty in swallowing or breathing
- rash or itching
- fainting.
These are all very serious side effects. If you have them, you may have had a serious allergic reaction to AMLODIPINE 5/10 mg PD. You may need urgent medical attention or hospitalisation.
Tell your doctor immediately or go the casualty department at your nearest hospital if you notice any of the following:
- slow heartbeat (bradycardia) or rapid heartbeat (tachycardia), palpitations, heart attack, abnormal heartbeat, chest pain
- low blood pressure (hypotension) with symptoms such as fainting or light-headedness
- high blood sugar levels (hyperglycaemia)
- jaundice (yellow discoloration of the skin and eyes)
- hepatitis, a liver condition, with symptoms such as stomach pain, fever, nausea, vomiting or loss of appetite
- weakness, fatigue, weight loss, headache (symptoms of a condition called vasculitis)
- kidney problems (passing less urine than is normal for you)
- pancreatitis (inflammation of the pancreas with symptoms such as stomach pain, increased heart rate and fever)
- severe skin reactions including blistering of the skin, mouth, eyes, and genitals, as these may be due to a serious allergic reaction known as Stevens-Johnson Syndrome (SJS) or toxic epidermal necrolysis (TEN).
These are all serious side effects. You may need urgent medical attention.
Tell your doctor if you notice any of the following:
Frequent side effects:
- headache, dizziness excess sleepiness
- flushing, swelling in any part of the body
- stomach pain, nausea
- ankle swelling, muscle cramps
- facial or arm oedema (fluid retention), fatigue, abnormal physical weakness, or lack of energy.
Less frequent side effects:
- Abnormal blood test results (decreased numbers of white blood cells, decrease in blood platelets which may result in unusual bruising or easy bleeding)
- mood changes, anxiety, depression, sleeplessness, confusion
- increased muscle tension, reduced sense of touch or sensation (numbness), tingling sensation in hands, feet, or lips (feeling of pins and needles), involuntary trembling (tremors), increased sweating, change taste perception (including loss of taste)
- blurred vision, worsening eyesight, double vision
- ringing in the ears (tinnitus)
- cough, inflammation of the mucous membrane in the nose (rhinitis), shortness of breath
- vomiting, dry mouth, swelling of the gums, altered bowel habits, constipation, diarrhoea, indigestion
- skin conditions such as rash, excessive skin pigmentation, hives, itchy skin, hair loss, erythema multiforme (large, symmetrical red blotches that appear all over the skin in a circular pattern)
- joint pain, back pain, muscle pain, muscle cramps or weakness, abnormal physical weakness, or lack of energy
- disorder in passing urine, increased need to urinate at night, increased number of times of passing urine
- problems with sexual performance, breast enlargement in men
- general feeling of discomfort, illness, or unease, general pain
- weight gain or loss.
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
Reporting of side effects: If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of AMLODIPINE 5/10 mg PD. You can also send an email directly to the company, [email protected], to ensure safety of the product.