PATIENT INFORMATION ARTICLE
SCHEDULING STATUS
S3
Product Name
AMLODIPINE 5 GDC tablets
AMLODIPINE 10 GDC tablets
Active Ingredient
Amlodipine besylate
Sugar Information
Sugar free.
Read Before Taking AMLODIPINE GDC
Read this information carefully before starting AMLODIPINE GDC.
Keep this information because it may be needed again. If further questions arise, ask a doctor, pharmacist, nurse or other healthcare provider.
AMLODIPINE GDC has been prescribed personally and should not be shared with other people. It may harm them, even if their symptoms are the same.
What Is in This Article
- What AMLODIPINE GDC is and what it is used for
- What you need to know before you take AMLODIPINE GDC
- How to take AMLODIPINE GDC
- Possible side effects
- How to store AMLODIPINE GDC
- Contents of the pack and other information
1. What AMLODIPINE GDC Is and What It Is Used For
AMLODIPINE GDC contains amlodipine, which belongs to a group of medicines called calcium antagonists.
AMLODIPINE GDC is used to treat:
| Condition | Description |
|---|---|
| High blood pressure | Also called hypertension |
| Angina pectoris | A type of chest pain |
| Prinzmetal’s or variant angina | A rare form of angina |
| Risk reduction | Used to reduce the risk of fatal and non-fatal heart disease or stroke |
AMLODIPINE GDC may be used alone or together with other medicines to treat these conditions.
2. What You Need to Know Before Taking AMLODIPINE GDC
Do Not Take AMLODIPINE GDC Tablets
Do not take AMLODIPINE GDC if any of the following apply:
| Do not take AMLODIPINE GDC if | Details |
|---|---|
| You are allergic to amlodipine | This includes sensitivity or a harmful reaction to amlodipine |
| You are allergic to dihydropyridine | Dihydropyridine is used to lower blood pressure |
| You are allergic to any other ingredient | See the contents section |
| You have severe low blood pressure | Symptoms may include light-headedness or dizziness |
| You have experienced shock | This may include cardiogenic shock, where blood pressure becomes so low that the heart does not work properly |
| You recently had a heart attack | This means within the past 28 days |
| Blood flow from the left side of your heart is obstructed | For example, aortic valve narrowing |
| You have unstable angina | Chest pain that may occur while resting |
| You take grapefruit juice with the medicine | Grapefruit may increase amlodipine levels |
| You are pregnant | AMLODIPINE GDC should not be used during pregnancy |
| You are breastfeeding | AMLODIPINE GDC should not be used while breastfeeding |
| You are younger than 6 years | AMLODIPINE GDC is not for children under 6 years |
Warnings and Precautions
Take Special Care With AMLODIPINE GDC
Tell your doctor before taking AMLODIPINE GDC if any of the following apply:
| Condition or situation |
|---|
| Heart failure |
| Severe increase in blood pressure, also called hypertensive crisis |
| Aortic stenosis |
| Use of antifungal medicines |
| Use of certain HIV medicines |
| Diabetes |
| Need for blood tests |
| Elderly age |
| Severe kidney problems |
| Liver problems |
| Low blood pressure |
| Other heart conditions |
| Porphyria |
| Planned procedure requiring general anaesthesia |
Aortic stenosis is a condition where the aortic valve between the left ventricle and the aorta becomes narrowed or thickened. Symptoms may include fatigue, faintness or fainting during exercise, and shortness of breath.
Children and Adolescents
AMLODIPINE GDC has not been studied in children under 6 years.
AMLODIPINE GDC should only be used for hypertension in children and adolescents from 6 years to 17 years.
Other Medicines and AMLODIPINE GDC
Always tell your healthcare provider if you are taking any other medicine, including complementary or traditional medicines.
AMLODIPINE GDC can interact with other medicines. Some medicines may make the effect and risk of adverse effects stronger, while others may make AMLODIPINE GDC less effective.
Medicines That May Increase the Effect or Side Effects of AMLODIPINE GDC
| Medicine or medicine group | Possible effect |
|---|---|
| Other medicines for high blood pressure | May lower blood pressure further and cause dizziness, blurred vision or fainting |
| Medicines used to treat diabetes | Doses may need adjustment |
| Lithium | May cause toxic lithium blood levels |
| Tacrolimus, sirolimus, temsirolimus and everolimus | Levels of these medicines may increase in the blood |
| Ciclosporin | Levels may need monitoring, especially after renal transplant |
| Simvastatin | Blood levels of simvastatin may increase |
| Quinidine or procainamide | May affect heart rhythm |
| Clarithromycin, erythromycin, ketoconazole, itraconazole or rifampicin | May alter amlodipine levels |
| Protease inhibitors such as ritonavir, saquinavir, indinavir, nelfinavir, amprenavir, lopinavir and atazanavir | May increase amlodipine levels |
| Grapefruit or grapefruit juice | May increase amlodipine levels and blood-pressure-lowering effects |
| Dantrolene | May affect potassium levels |
| Nitroglycerine, long-acting nitrates, beta-blockers, verapamil or diltiazem | May increase blood-pressure-lowering effects |
| Aldesleukin | May strengthen blood-pressure-lowering effects |
| Antipsychotic medicines | May strengthen blood-pressure-lowering effects |
| Sodium valproate | May increase amlodipine blood levels |
Medicines That May Reduce the Effect of AMLODIPINE GDC
| Medicine or medicine group | Possible effect |
|---|---|
| St John’s Wort | May reduce amlodipine levels and reduce blood-pressure-lowering effect |
| Carbamazepine, phenobarbital or phenytoin | May reduce the effect of AMLODIPINE GDC |
AMLODIPINE GDC With Food and Drink
AMLODIPINE GDC may be taken with or without food.
Grapefruit and grapefruit juice must not be taken with AMLODIPINE GDC because they may increase the level of amlodipine in the blood and increase the blood-pressure-lowering effect.
Pregnancy and Breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or other healthcare professional for advice before taking AMLODIPINE GDC.
If you are pregnant or become pregnant while taking AMLODIPINE GDC, stop taking it and contact your doctor as soon as possible.
AMLODIPINE GDC should not be used while breastfeeding.
Females of childbearing potential should ensure adequate contraceptive protection to avoid pregnancy.
Driving and Using Machines
AMLODIPINE GDC may have a minor or moderate effect on the ability to drive or use machines.
It may cause:
| Possible effect |
|---|
| Dizziness |
| Visual disturbances |
| Headache |
| Fatigue |
| Nausea |
| Impaired ability to react |
Do not drive, use machinery or perform tasks requiring alertness until you know how AMLODIPINE GDC affects you.
AMLODIPINE GDC Contains Sodium
AMLODIPINE GDC contains less than 1 mmol sodium, meaning it is essentially sodium-free.
3. How to Take AMLODIPINE GDC
Do not share medicines prescribed for you with others.
Always take AMLODIPINE GDC exactly as your doctor has told you. Check with your doctor or pharmacist if you are unsure.
Adults
The usual starting dose is 5 mg once daily, taken at the same time every day, with or without food.
If no improvement is seen after 10 to 14 days, the doctor may increase the dose to a maximum of 10 mg once daily.
Children and Adolescents
For children and adolescents aged 6 to 17 years, the recommended usual starting dose is 2,5 mg daily.
The maximum recommended dose is 5 mg daily.
The effect of AMLODIPINE GDC on blood pressure in patients younger than 6 years is not known.
Special Populations
| Patient group | Advice |
|---|---|
| Elderly people | Dose increases should be made with care |
| Patients with liver disease | Treatment should start at the lowest dose and be increased slowly |
| Patients with kidney disease | Dosage may need to be reduced in severe kidney disease |
Method of Administration
Swallow the tablets whole with a glass of water.
AMLODIPINE GDC may be taken with or without food.
Do not take AMLODIPINE GDC with grapefruit or grapefruit juice.
Tell your doctor or pharmacist if the effect of AMLODIPINE GDC seems too strong or too weak.
If You Take More AMLODIPINE GDC Than You Should
In the event of overdose, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.
Taking too many AMLODIPINE GDC tablets may cause blood pressure to become low or dangerously low.
Possible overdose symptoms include:
| Possible overdose symptoms |
|---|
| Dizziness |
| Light-headedness |
| Fainting |
| Weakness |
| Rapid heartbeat |
| Shock |
| Cool and clammy skin |
| Loss of consciousness |
| Shortness of breath due to pulmonary oedema |
Excess fluid may build up in the lungs and cause shortness of breath that can develop up to 24 to 48 hours after intake. Ventilatory support may be required.
If You Forget to Take AMLODIPINE GDC
Take AMLODIPINE GDC regularly at the same time each day.
If a dose is forgotten, take it as soon as remembered unless it is time for the next dose.
Do not take a double dose to make up for a forgotten dose.
If You Stop Taking AMLODIPINE GDC
Take AMLODIPINE GDC for as long as your doctor recommends.
Do not stop unless your doctor advises you to stop.
Your condition may return if treatment is stopped too early.
4. Possible Side Effects
AMLODIPINE GDC can cause side effects.
Not all side effects reported for AMLODIPINE GDC are included here. If general health worsens while taking AMLODIPINE GDC, consult a doctor, pharmacist or other healthcare professional.
Side Effects Table
| Side-effect category | Side effects / symptoms | Recommended action |
|---|---|---|
| Very serious side effects | Swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty swallowing or breathing | Stop taking AMLODIPINE GDC and seek urgent medical attention immediately |
| Very serious side effects | Rash or severe itching | Stop taking AMLODIPINE GDC and seek urgent medical attention immediately |
| Very serious side effects | Fainting | Stop taking AMLODIPINE GDC and seek urgent medical attention immediately |
| Very serious skin reactions | Reddish target-like or circular patches on the trunk, central blisters, skin peeling, ulcers of the mouth, throat, nose, genitals or eyes, painful raw areas, fever or flu-like symptoms | Stop taking AMLODIPINE GDC and seek urgent medical attention immediately |
| Very serious skin reactions | Severe inflammation, scaling and extreme loss of skin over most of the body surface | Stop taking AMLODIPINE GDC and seek urgent medical attention immediately |
| Very serious side effects | Heart failure with chest pain, shortness of breath, fatigue, swollen legs and rapid heartbeat | Seek urgent medical attention |
| Very serious side effects | Severe liver problems or hepatitis, with fever, fatigue, loss of appetite, nausea, vomiting, abdominal pain, dark urine, light-coloured stools, joint pain and yellowing of the eyes or skin | Seek urgent medical attention |
| Serious side effects | Increased vulnerability to infections due to lowered white blood cells | Tell a doctor immediately or go to the nearest casualty department |
| Serious side effects | Easy bruising, abnormal bleeding gums, nosebleeds or internal bleeding due to low platelets | Tell a doctor immediately |
| Serious side effects | Bleeding during or after surgery, uncontrolled bleeding, blood vessel damage or haemorrhagic shock | Seek urgent medical attention |
| Serious side effects | Blood dyscrasias causing fever, chills, weakness, sore throat, mouth or throat sores, bleeding gums, bone pain, low blood pressure, fast heartbeat or difficulty breathing | Tell a doctor immediately |
| Serious side effects | Large symmetrical red blotches in circular patterns over the skin | Tell a doctor immediately |
| Serious side effects | High blood sugar levels | Tell a doctor |
| Serious side effects | Involuntary movements, excessive muscle stiffness or tremors | Tell a doctor |
| Serious side effects | Slow heartbeat, rapid heartbeat, irregular heartbeat or chest pain | Tell a doctor immediately |
| Serious side effects | Low blood pressure with fainting or light-headedness | Tell a doctor immediately |
| Serious side effects | Inflamed blood vessels with fever, fatigue, weight loss and muscle or joint pain | Tell a doctor immediately |
| Serious side effects | Pancreatitis with stomach pain, nausea, vomiting, fever, increased heart rate and upper-abdominal tenderness | Tell a doctor immediately |
| Serious side effects | Gastritis with stomach pain or upset, nausea, vomiting, fullness, loss of appetite, or blood in vomit or stool | Tell a doctor immediately |
| Serious side effects | Purple or reddish-purple spots or patches on the skin or mucous membranes caused by bleeding under the skin | Tell a doctor immediately |
| Serious side effects | Angioedema or Quincke oedema, with swelling under the skin involving the face, lips, tongue or throat | Seek urgent medical attention |
| Serious side effects | Kidney problems, such as passing less urine than normal | Tell a doctor immediately |
| Serious side effects | Difficulty achieving or maintaining erection in males | Tell a doctor |
| Frequent side effects | Dizziness, headache, sleepiness | Tell a doctor if troublesome |
| Frequent side effects | Flushing of the face, neck or upper chest | Tell a doctor if troublesome |
| Frequent side effects | Swelling commonly affecting the arms and legs | Tell a doctor if troublesome |
| Frequent side effects | Stomach pain, nausea, indigestion, diarrhoea or constipation | Tell a doctor if troublesome |
| Frequent side effects | Ankle swelling | Tell a doctor if troublesome |
| Frequent side effects | Swelling in any part of the body | Tell a doctor |
| Frequent side effects | Tiredness | Tell a doctor if persistent |
| Frequent side effects | Physical weakness or lack of energy | Tell a doctor if persistent |
| Less frequent side effects | Sleeplessness or mood changes including anxiety | Tell a doctor |
| Less frequent side effects | Depression, including persistent sadness and changes in thinking, sleep, eating or behaviour | Tell a doctor |
| Less frequent side effects | Trembling, distorted taste, reduced sensation, pins and needles, tingling, weakness, numbness or pain | Tell a doctor |
| Less frequent side effects | Visual disturbances, including double vision | Tell a doctor |
| Less frequent side effects | Ringing or noises in the ears | Tell a doctor |
| Less frequent side effects | Cough, shortness of breath, runny nose, sneezing or stuffiness | Tell a doctor |
| Less frequent side effects | Vomiting, dry mouth or swollen gums | Tell a doctor |
| Less frequent side effects | Increased liver enzymes | Tell a doctor |
| Less frequent side effects | Hair loss or skin discolouration | Tell a doctor |
| Less frequent side effects | Excessive sweating | Tell a doctor |
| Less frequent side effects | Itching, rash, red or pink spots, bumps or blotches | Tell a doctor |
| Less frequent side effects | Hives or raised red itchy rash that may sting or burn | Tell a doctor |
| Less frequent side effects | Increased skin sensitivity to the sun | Tell a doctor |
| Less frequent side effects | Back pain, muscle cramps, muscle pain, joint stiffness or weakness | Tell a doctor |
| Less frequent side effects | Frequent urination, especially at night | Tell a doctor |
| Less frequent side effects | Enlargement of male breasts | Tell a doctor |
| Less frequent side effects | Weight increase or decrease | Tell a doctor |
| Frequency unknown | Laboratory tests may incorrectly diagnose hyperaldosteronism as essential hypertension | Tell the healthcare provider that you are taking AMLODIPINE GDC |
| Side effects not listed | Any side effect not mentioned or any unexpected health change | Inform a doctor or pharmacist |
Reporting of Side Effects
If side effects occur, speak to a doctor, pharmacist or nurse.
Side effects may also be reported to SAHPRA through the Med Safety App and eReporting platform.
Reporting side effects helps provide more information on the safety of AMLODIPINE GDC.
Alternatively, Gulf Drug Company may be contacted.
5. How to Store AMLODIPINE GDC
Store all medicines out of reach of children.
Store AMLODIPINE GDC at or below 25 °C in a cool, dry place.
Protect from light and moisture.
Keep the container tightly closed.
Do not remove tablets from the container or blister until required for use.
Return unused or expired medicines to your pharmacist.
Do not dispose of unused medicine in drains or sewerage systems, including toilets.
6. Contents of the Pack and Other Information
What AMLODIPINE GDC Contains
The active substance is amlodipine besylate.
| Product | Active substance |
|---|---|
| AMLODIPINE 5 GDC | Each tablet contains amlodipine besylate equivalent to amlodipine 5 mg |
| AMLODIPINE 10 GDC | Each tablet contains amlodipine besylate equivalent to amlodipine 10 mg |
Other Ingredients
The other ingredients are:
| Other ingredients |
|---|
| Anhydrous dicalcium phosphate |
| Colloidal silicon dioxide |
| Magnesium stearate |
| Microcrystalline cellulose |
| Sodium starch glycollate |
What AMLODIPINE GDC Looks Like and Contents of the Pack
| Product | Description |
|---|---|
| AMLODIPINE 5 GDC | White to off-white, flat, round, bevel-edged tablet with a break line on one side, diameter approximately 8 mm |
| AMLODIPINE 10 GDC | White to off-white, flat, round, bevel-edged tablet with a break line on one side, diameter approximately 11 mm |
The break line is only to help with breaking the tablet for ease of swallowing and is not intended to divide the tablet into equal doses.
Pack Sizes
AMLODIPINE GDC is packed in:
| Pack type | Pack size |
|---|---|
| Push-through PVC/Al blister strips | 10 tablets per strip, packs of 30 tablets in a unit carton |
| White HDPE containers | 30, 100, 500 and 1000 tablets |
Holder of the Certificate of Registration
Gulf Drug Company (Pty) Ltd
22 Burnside Drive
Old Mill Industrial Park
Mount Edgecombe
4300
Tel: +27 31 538 8700
This Leaflet Was Last Revised In
19 August 2025
Registration Numbers
| Product | Registration number |
|---|---|
| AMLODIPINE 5 GDC | 41/7.1/0812 |
| AMLODIPINE 10 GDC | 41/7.1/0813 |
Medical Disclaimer
This article is intended as patient information based on the approved leaflet structure. It does not replace advice from a doctor, pharmacist, nurse or other healthcare provider. For regulated medical product use, follow the approved patient information leaflet and healthcare professional guidance.
