Heart Health

“You can’t beat a healthy heart.”

High Blood Pressure Medication

Calcium Channel Blockers

PD-AmlodopineBesylate

SCHEDULING STATUS S3

PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM
PHARMA DYNAMICS AMLODIPINE BESYLATE 5 mg (each tablet contains amlodipine besylate equivalent to 5 mg amlodipine).
PHARMA DYNAMICS AMLODIPINE BESYLATE 10 mg (each tablet contains amlodipine besylate equivalent to 10 mg amlodipine).

Please read this information leaflet carefully before taking PHARMA DYNAMICS AMLODIPINE BESYLATE tablets:

  • Keep this information. You may need to read it again.
  • If you have any further questions, please ask your doctor or your pharmacist.
  • This medicine 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 PHARMA DYNAMICS AMLODIPINE BESYLATE CONTAINS

Active ingredients: Amlodipine besylate.

Inactive ingredients: Microcrystalline cellulose, pregelatinized starch, sodium starch glycollate, colloidal anhydrous silica, magnesium stearate.

WHAT PHARMA DYNAMICS AMLODIPINE BESYLATE IS USED FOR

PHARMA DYNAMICS AMLODIPINE BESYLATE tablets are used to treat:

  • mild to moderate high blood pressure
  • angina pectoris (chest pains)

BEFORE YOU TAKE PHARMA DYNAMICS AMLODIPINE BESYLATE

Do not take PHARMA DYNAMICS AMLODIPINE BESYLATE:
You are allergic to amlodipine, dihydropyridines, other calcium antagonists or any of the other ingredients in the tablets.

Take special care with PHARMA DYNAMICS AMLODIPINE BESYLATE:
Elderly patients and patients suffering from renal and liver impairment should be started in lower doses. Inform your doctor if you are suffering from kidney and liver diseases.

The safety of PHARMA DYNAMICS AMLODIPINE BESYLATE in children and patients suffering from porphyeria have not been established.

Inform your doctor if you are suffering from heart failure as your dosage may need to be adjusted.

Pregnancy and breast-feeding:
If you are pregnant or breast-feeding do not take this medicine until you have talked to your doctor. Consult your doctor immediately if you become pregnant while taking this medicine.

Driving and using machinery:
If you suffer from dizziness, headaches, tiredness or nausea make sure that you are well enough to drive or operate machinery, as your ability to react may be impaired.

Using other medicines with PHARMA DYNAMICS AMLODIPINE BESYLATE:

If you are taking other medicines on a regular basis, including complementary or traditional medicines, the use of PHARMA DYNAMICS AMLODIPINE BESYLATE with these medicines may cause undesirable interactions. Tell your doctor or pharmacist if you are taking any other medicines, including any you have bought at your pharmacy, supermarket or health food shop. Please consult your doctor, pharmacist or other healthcare professional for advice.

If you take other medicines for hypertension or angina such as nitroglycerin tablets under the tongue, long acting nitrates or beta-blockers with PHARMA DYNAMICS AMLODIPINE BESYLATE tablets, your blood pressure may decrease too much and you may feel very tired and weak.

HOW TO USE PHARMA DYNAMICS AMLODIPINE BESYLATE

Always take PHARMA DYNAMICS AMLODIPINE BESYLATE exactly as your doctor has instructed you. You should check with your doctor if you are unsure. If you have the impression that the effect of PHARMA DYNAMICS AMLODIPINE BESYLATE is too strong or too weak, talk to your doctor or pharmacist.

Do not stop taking your medicine without consulting your doctor first.

In patients suffering from hypertension, PHARMA DYNAMICS AMLODIPINE BESYLATE tablets may be used either on their own or in combination with other medicines for hypertension.

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

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

If you take more PHARMA DYNAMICS AMLODIPINE BESYLATE than you should:
In the event of an overdosage, 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.

If you forget to take PHARMA DYNAMICS AMLODIPINE BESYLATE:
If you forget to take a dose, take it as soon as you remember. Do not take a double or larger dose to make up for the forgotten individual doses. Continue to take the next tablet at the usual time.

POSSIBLE SIDE EFFECTS

PHARMA DYNAMICS AMLODIPINE BESYLATE can have side effects. Not all side effects reported for this medicine are included in this leaflet. Should your general health worsen while taking this medicine, please consult your doctor, pharmacist or other health care professional for advice.

If the following side effects occur, contact your doctor immediately or go to the nearest hospital:
An allergic reaction (angioedema): swelling of the face, lips, tongue or throat, or difficulty breathing or swallowing

If you experience any of the above mentioned effects, you have had a serious allergic reaction to PHARMA DYNAMICS AMLODIPINE BESYLATE. You may need urgent medical attention or hospitalization. This can occur less frequently.

Tell your doctor if you notice any of the following:

Frequent:

  • Heart palpitations.
  • Swelling of the ankles.
  • Dizziness; headache; somnolence.
  • Nausea; abdominal pain.
  • Fatigue; flushing.

Less frequent:

  • Fast and/or irregular heart tempo.
  • Hair loss; troubled breathing and coughing.

STORING AND DISPOSING OF PHARMA DYNAMICS AMLODIPINE BESYLATE

  • Store below 25°. Protect from light. Do not remove blisters from outer carton until required for use.
  • KEEP ALL MEDICINES OUT OF REACH OF CHILDREN.
  • Do not use the tablets after the expiry date printed on the bottle.
  • Return all unused medicine to your pharmacist.
  • Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).

PRESENTATION OF PHARMA DYNAMICS AMLODIPINE BESYLATE

Blister packs consisting of cold formed OPNAUPVC film and heat sealing aluminium foil; the pack size is 30 tablets.

IDENTIFICATOIN OF PHARMA DYNAMICS AMLODIPINE BESYLATE

PHARMA DYNAMICS AMLODIPINE BESYLATE 5 mg: White, round (diameter 8,0 mm), slightly biconvex, one side scored.

PHARMA DYNAMICS AMLODIPINE BESYLATE 10 mg: White, round (diameter 10,5 mm), slightly biconvex, one side scored.

REGISTRATION NUMBER

PHARMA DYNAMICS AMLODIPINE BESYLATE 5 MG:
47/7.1/0560

PHARMA DYNAMIC AMLODIPINE BESYLATE 10 MG:
47/7.1/0561

NAME AND ADDRESSOF REGISTRATION HOLDER

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

DATE OF PUBLICATION

30 November 2007
Version: PD9003A

Back to Top