Besyloc 5 mg/10 mg Tablets

BESYLOC contains name of amlodipine, one of a group of medicines called calcium channel blocking medicines (dihydropyridine calcium antagonists). BESYLOC may be used alone or in combination with other medicines used to treat high blood pressure and angina, a rare form of which is Prinzmetal's or variant angina. In patients with high blood pressure this medicine works by relaxing blood vessels, so that blood passes through them more easily. In patients with angina, BESYLOC work by improving blood supply to the heart muscle which then receives more oxygen and as a result chest pain is prevented. This medicine does not provide immediate relief of chest pain from angina.

Do not take BESYLOC:

• if you are hypersensitive (allergic) to amlodipine, dihydropyridine (used to lower blood pressure), or any of the other ingredients of BESYLOC (see section 6)
• if you suffer from severe hypotension (severe low blood pressure, symptoms include light headedness or dizziness)
• if you have previously experienced shock which could include cardiogenic shock (this is the term used when blood pressure becomes so low that your heart stops working properly and medical treatment is required)
• if you recently (within the past 28 days) suffered a heart attack
• if the blood flow from the left side of your heart is obstructed (e.g. aortic valve narrowing)
• if you have unstable angina (chest pain which may occur when you are resting)
• when taken with grapefruit juice (see take special care with BESYLOC)
• if you are pregnant or breastfeeding your baby
• if you are younger than 6 years of age.

Warnings and precautions

Special care should be taken with BESYLOC:

• if your doctor diagnosed you with severe high blood pressure
• if you suffer from aortic stenosis with symptoms such as fatigue, feeling faint or fainting when exercising and shortness of breath
• if you experience chest pain when taking BESYLOC
• if you suffer from diabetes
• if you need to undergo blood tests, as the use of BESYLOC may interfere with the results
• if you are an elderly patient
• if you suffer from severe kidney problems
• if you suffer from liver problems
• if you have low blood pressure or other heart conditions
• if you are taking anti-fungal medicine or certain HIV medicines as these may increase the blood pressure lowering effects of BESYLOC (see Other medicines and BESYLOC)
• if you are about to have a procedure where you would need general anaesthesia.

Children

The safety and efficacy of BESYLOC in children under the age of 6 years has not been established as the effect on blood pressure is not known.

Do not share medicines prescribed for you with any other person. Always take BESYLOC exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Adults: A usual starting dose of 5 mg BESYLOC once a day, taken at the same time every day with or without food. Grapefruit and grapefruit juice should be avoided. The tablets should be swallowed whole, with a glass of water. If no improvement is seen after 10 - 14 days, your doctor may increase the dose to the maximum of 10 mg BESYLOC per day (taken as a single dose). Your doctor will decide on the dose depending on your condition.

Use in children and adolescents

For children and adolescents (6 - 17 year old), the recommended usual starting dose is 2, 5 mg a day. The maximum recommended dose is 5 mg a day. The effect of BESYLOC on blood pressure in patients less than 6 years of age is not known.

Your doctor will tell you how long your treatment with BESYLOC will last. Do not stop treatment early because your condition may worsen. If you have the impression that the effect of BESYLOC is too strong or too weak, tell your doctor or pharmacist.

If you take more BESYLOC than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre. Symptoms of overdose may include:

• decreased blood pressure resulting in severe dizziness and fainting
• difficulty breathing, extreme shortness of breath, feeling of suffocating or drowning, cough that produces frothy sputum that may have blood in it, rapid, irregular heartbeat, anxiety, restlessness, cold and clammy skin, wheezing.

If you forget to take BESYLOC

If you forget to take BESYLOC, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue to take the tablet or tablets at the usual time. Do not take a double dose to make up for forgotten individual doses.

If you stop taking BESYLOC

It is important that you continue the course of treatment even if you begin to feel better after a few days. If your treatment with BESYLOC is stopped suddenly, your chest pain may worsen.

BESYLOC can have side effects. Not all side effects reported for BESYLOC are included in this leaflet. Should your general health worsen, or if you experience any untoward effects while using BESYLOC, please consult your doctor, pharmacist or other healthcare professional for advice.

If any of the following happens, stop using BESYLOC and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing
• rash or itching
• fainting
• jaundice (yellow discolouration of the skin and eyes).

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to BESYLOC. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• slow heartbeat (bradycardia) or rapid heartbeat (tachycardia), palpitations, heart attack
• low blood pressure (hypotension) with symptoms such as fainting or light-headedness
• high blood sugar levels (hyperglycaemia)
• 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)
• 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 Johnsons Syndrome, toxic epidermal necrolysis)
• 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).

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 and fatigue
• flushing
• nausea, stomach pain, change in bowel habits
• ankle swelling, swelling in any part of the body.

Less frequent side effects:

• joint pain, back pain, muscle cramps or weakness
• mood and/or sleep disorders, depression, anxiety
• reduced sense of touch or sensation (numbness)
• tingling sensation in hands, feet or lips (feeling of “pins and needles”)
• involuntary trembling (tremors), increased sweating
• muscle rigidity, slowness of movement, tremor, and irregular, jerky movements
• blurred vision, worsening eyesight
• ringing in the ears (tinnitus)
• cough
• inflammation of the mucous membrane in the nose (rhinitis)
• constipation, vomiting, diarrhoea, indigestion
• dry mouth, swelling of the gums
• passing more urine than is normal for you, especially at night
• skin conditions such as rash, excessive skin pigmentation, hives, itchy skin, hair loss
• change taste perception (including loss of taste)
• abnormal physical weakness or lack of energy, general feeling of discomfort, illness, or unease, general pain
• problems with sexual performance, enlarged breasts in men
• weight loss or weight gain.

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 or pharmacist. You can also report any side effects to SAHPRA via the (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 BESYLOC. You can also send an email directly to the company, [email protected], to ensure safety of the product.

Store all medicines out of reach of children. Store at or below 30 °C. Store in the original packaging (keep blisters in carton until required for use, protect from light). Do not use after the expiry date stated on the carton. Return all unused medicine to your pharmacist.

Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).