Heart Health

“You can’t beat a healthy heart.”

High Blood Pressure Medication

Calcium Channel Blockers

AmlocRGB

SCHEDULING STATUS S3

PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM
AMLOC 5 mg tablets
AMLOC 10 mg tablets

Please read this patient information leaflet carefully before using AMLOC

  • Keep this information.  You may need to read it again.
  • If you have any further questions, please ask your doctor or your pharmacist.
  • AMLOC has been prescribed for you personally and you should not share your medicine with other people.  It may harm them, even if their symptoms are the same as yours.

WHAT AMLOC CONTAINS

AMLOC 5 mg:
Active ingredient: 5 mg amlodipine as the maleate salt

AMLOC 10 mg:
Active ingredient: 10 mg amlodipine as the maleate salt

AMLOC 5 / 10 mg:
Inactive ingredients: microcrystalline cellulose, pregelatinised starch, sodium starch glycollate, silica colloidal anhydrous and magnesium stearate

WHAT AMLOC IS USED FOR

AMLOC is used for:

  • Treating high blood pressure (hypertension) or a certain type of chest pain called angina pectoris.

BEFORE YOU TAKE AMLOC

Do not take AMLOC:

  • If you are allergic (hypersensitive) to amlodipine, other calcium antagonists or any of the other ingredients in the tablets (see WHAT AMLOC CONTAINS).
  • You suffer from low blood pressure (light headedness or dizziness), or any other heart condition.
  • You recently (within the past 28 days) suffered a heart attack.

Take special care with AMLOC:

  • If your doctor diagnosed you with very severe high blood pressure.
  • If you suffer from liver problems.
  • If you suffer from kidney problems.
  • If you have porphyria (a group of disorders that result in a buildup of chemicals called porphyrins in your body). 
  • If you are younger than 18 years of age.

Taking AMLOC with food or drink:
AMLOC can be taken with or without food.

Pregnancy and Breastfeeding
DO NOT use AMLOC if you are pregnant or suspect that you are pregnant.  Contact your doctor immediately.

DO NOT use AMLOC if you are breastfeeding your baby.

Driving and using machinery:
AMLOC may impair your ability to drive and use machinery. Take care if you feel dizzy, tired or drowsy while using AMLOC.

Taking other medicines with AMLOC: 

  • Consult with your doctor or pharmacist or healthcare professional for advice if you need to take any other medicines. If you are taking other medicines on a regular basis, including complementary or traditional medicines, the use of AMLOC with these medicines may cause undesirable interactions.

       Consult your doctor or pharmacist before taking such medicines.

  • Do not take AMLOC if you take other medicines for hypertension (high blood pressure) or angina (chest pains) such as nitroglycerin tablets under the tongue, long acting nitrates or beta-blockers as your blood pressure may decrease too much and you may feel very tired and weak.

HOW TO TAKE AMLOC

The usual starting dose is 5 mg AMLOC once a day.  If no improvement is seen after 10 -14 days, your doctor may increase the dose to the maximum of 10 mg AMLOC per day (taken as a single dose).

If you suffer from liver problems or are an elderly person, your doctor will decide the most suitable dose for you.

The dose of AMLOC will be different for different patients and may depend on a number of things, including what the medicine is being used for, and whether or not other medicines are also being taken.

In patients suffering from high blood pressure, AMLOC tablets may be used either on their own or in combination with other medicines for high blood pressure.

If you have any questions about the proper dose of AMLOC, ask your doctor.

If you take more AMLOC than you should:
In the event of overdose, contact your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre immediately. Take this leaflet and any remaining tablets with you, so that the doctor knows what you have taken.

Your doctor will treat the symptoms of the side effects which may include marked and probably prolonged systemic hypotension (low blood pressure).

If you forget to take your AMLOC:
Take the missed dose as soon as possible.  However, if it is almost time for your next dose, continue to take the next tablet at the usual time.  Do not take a double dose. 

POSSIBLE SIDE EFFECTS

AMLOC may have side effects.  Not all side effects reported for AMLOC are included in this leaflet. 

Should your general health worsen while taking AMLOC, please consult your doctor, pharmacist or other healthcare professional for advice.

Check with your doctor if any of the following side effects continue or are bothersome which may occur frequently:

Headache, drowsiness, irregular heartbeat, swelling, stomach pain and fatigue.

Less frequent side effects that may occur include the following:

  • Allergic reactions including itching skin, rash.
  • Swelling around the lips and eyes.
  • High blood sugar levels.
  • Sensation of numbness or tingling on the skin.
  • Involuntary trembling.
  • Sleeplessness, mood changes.
  • Dry mouth, increased sweating.
  • Flushing.
  • Visual disturbances and ringing in the ear.
  • Chest pain, back pain, muscle pain.
  • Low blood pressure, dizziness.
  • Nausea, constipation, diarrhoea, vomiting.

STORING AND DISPOSING OF AMLOC

  • Store below 25 °C.
  • KEEP ALL MEDICINES OUT OF REACH AND SIGHT OF CHILDREN.
  • Do not use after the expiry date printed on the label or carton.
  • Return all unused medicine to your pharmacist.
  • Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).

PRESENTATION OF AMLOC

AMLOC 5 mg: Opaque PVC / Aluminium foil blisters of 30 tablets.

AMLOC 10 mg: Opaque PVC / Aluminium foil blisters of 30 tablets.

IDENTIFICATION OF AMLOC

AMLOC 5 mg tablets are white, round, slightly biconvex, scored on one side and bevel-edged. Diameter: 8,00 mm.

AMLOC 10 mg tablets are white, round, slightly biconvex, scored on one side and bevel-edged. Diameter: 10,00 mm.

REGISTRATION NUMBERS

AMLOC 5 mg: 38/7.1/0183

AMLOC 10 mg 38/7.1/0147

NAME AND ADDRESS OF THE REGISTRATION HOLDER

Pharma Dynamics (Pty) Ltd
1st Floor Grapevine House, Steenberg Office Park
Silverwood Close,
Westlake, 7945
Cape Town, South Africa

DATE OF PUBLICATION

August 2011
Version: PD9002A

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