Rampil 1,25 mg Capsules

RAMPIL belongs to a group of medicines called ACE inhibitors

RAMPIL works by:

• Decreasing your body’s production of substances that could raise your blood pressure.
• Making your blood vessels relax and widen.
• Making it easier for your heart to pump blood around your body.

RAMPIL can be used:

• To treat high blood pressure.
• To help your heart when it cannot pump enough blood to the rest of your body (heart failure).
• To reduce the amount of protein in the urine and the decline in kidney function in patients with diabetic kidney damage and increased blood pressure.
• To reduce the risk of you having a heart attack, stroke or death if you have an increased risk of heart disease, a history of stroke or blood circulatory problems.
• To reduce the risk of you having a heart attack, stroke or death if you have diabetes.

Do not take RAMPIL:

• if you are hypersensitive (allergic) to ramipril or any of the other ingredients of RAMPIL (listed in section 6).
• if you have previously suffered from angioedema (swelling of the face, lips or tongue).
• if you have heart problems.
• if you are taking potassium sparing diuretics such as spironolactone, triamterene or amiloride.
• if you have porphyria.
• if you have severe kidney impairment, impaired kidney function or kidney disease.
• if you are taking lithium as it may lead to toxic blood concentrations of lithium.
• if you are taking aliskiren - containing medicines (medicines used to treat high blood pressure).
• if you have kidney problems and/or are elderly and you are taking medicine used to treat bacterial infections (antibiotics) belonging to the fluoroquinolone group.
• if you are pregnant or breastfeeding.
• if you are on sacubitril/valsartan therapy, medicines used for the treatment of high blood pressure and heart failure.
• if you are undergoing extracorporeal treatment, a procedure where toxins are removed from the body to support or temporarily replace a vital organ.

RAMPIL is not recommended for use in children.

Warnings and precautions

Take special care with RAMPIL:

• if you are taking diuretics (water tablets) or if you are dehydrated. Your doctor may advise that dehydration be corrected before you start taking RAMPIL. This helps avoid symptoms of dizziness or light headedness, especially when you get up from a sitting or lying position.
• if you have fluid or electrolyte imbalances due to excessive perspiration, vomiting or diarrhoea, etc. The electrolyte imbalance must be corrected before you start treatment with RAMPIL.
• if you have diabetes mellitus (sugar diabetes) or if you have gout. These conditions may be made worse by RAMPIL.
• if you have a history of allergy or asthma. You may be at higher risk of an allergic reaction from RAMPIL.
• if you go for dialysis (procedure which removes waste products and excess fluid from your blood when your kidneys stop working properly).
• if you experience swelling of the face, lips, tongue or throat (angioedema), you may need emergency treatment and you should be monitored until these symptoms go away.
• if you have any heart disease as the reduction in blood pressure may aggravate it.
• if you have severe high blood pressure.
• if you have a severe autoimmune disease such as systemic lupus erythematosus (an inflammatory disease caused when the immune system attacks its own tissues) or scleroderma (chronic hardening and tightening of the skin and connective tissue) as RAMPIL may make these conditions worse.
• if you have bone marrow disorders.
• if you are taking medicines or have conditions which may increase potassium levels in your blood or decrease sodium levels in your blood. Your doctor may carry out regular blood tests, especially if you are elderly.
• if you have abnormal changes in the regular blood flow to the kidneys or kidney impairment.
• if you have impaired liver function.
• if you think that you are (or might become) pregnant.
• if you are going to undergo surgery or if you are going to receive anaesthesia, you should tell your doctor that you are taking RAMPIL.
• if your ethnic group is black, as you may be at an increased risk of having an allergic reaction to RAMPIL.
• if you have a non-productive, persistent cough, you should tell your doctor that you are taking RAMPIL.

The treatment of hypertension with RAMPIL must be carried out under regular medical supervision.

Children and adolescents

The safety and efficacy of RAMPIL in children has not been established.

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

RAMPIL may be taken alone or in combination with other medicines for high blood pressure.

The usual dose of RAMPIL is:

Treatment of high blood pressure:

Adults: Initial dose is 2,5 mg RAMPIL once daily (for patients not on diuretics). The dose should be adjusted according to blood pressure response. Dosage should be increased to 5 mg RAMPIL and up to a maximum of 10 mg once daily at intervals of 1 to 2 weeks. The dose range is 2,5 mg to 10 mg. The full therapeutic effect may take several weeks. Therefore, if the desired effect has not been achieved within 2 to 4 weeks the dose may be increased.

To reduce the risk of having a heart attack or stroke:

Adults: Initial dose is 2,5 mg RAMPIL once daily. This may be increased at intervals of 4 weeks until the therapeutic effect is reached. Adjustments should be based on clinical response. The increase should be implemented by doubling the dose after one week of treatment. Three weeks later, it should be doubled again to the normal maintenance dose of 10 mg once daily.

Non-diabetic kidney damage and kidney damage caused by diabetes:

Adults: Initial dose is 1,25 mg RAMPIL once daily. Adjustments should be based on clinical response. The dose, if increased, should be implemented by doubling the dose at intervals of two to three weeks. The maximum permitted daily dose is 10 mg.

Treatment after you have had a heart attack:

Treatment with RAMPIL should be initiated in hospital three to ten days after a heart attack if the patient manifests with evidence of heart failure and is stable. Adults: 2,5 mg twice daily for two days. If well tolerated the dose may be increased to 5 mg RAMPIL twice daily. If you are unable to tolerate 2,5 mg initially, 1,25 mg RAMPIL twice daily may be given initially and later increased to 2,5 mg twice daily.

Dosing in high-risk individuals:

If you are using water tablets (diuretics): In order to minimise the possibility of sudden and severe blood pressure lowering which may occur within the first 1 to 5 hours after the initial dose of RAMPIL, diuretics should be discontinued 2 to 3 days before beginning therapy with RAMPIL. Where diuretic therapy cannot be discontinued, treatment with RAMPIL should be initiated with a 1,25 mg dose. Subsequent dosage adjustments will depend on the therapeutic response.

High blood pressure caused by abnormal changes in the regular blood flow to the kidneys: The dose should be lowered and you should be constantly monitored.

RAMPIL absorption is not affected by the presence of food. RAMPIL should be taken as a single daily dose at approximately the same time every day. Your doctor will tell you how long your treatment with RAMPIL will last. Do not stop treatment early. If you have the impression that the effect of RAMPIL is too strong or too weak, tell your doctor or pharmacist.

If you take more RAMPIL 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. The most likely symptoms of overdose include severe lowering of blood pressure, electrolyte imbalances, and renal failure.

If you forget to take RAMPIL: Do not take a double dose to make up for forgotten individual doses.

If you stop taking RAMPIL: Even when you feel better, do not stop taking RAMPIL. This medicine helps control high blood pressure. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke or kidney disease.

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

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

• Swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• rash and itching,
• fainting,
• blistering of skin, mouth, eyes and genitals as these may be due to a serious allergic reaction known as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN).

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

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

• heart problems including a heart attack, with symptoms such as chest pain, burning sensation in the chest, numbness or tingling in an arm or leg, any changes in the way your heart beats,
• difficulty in breathing,
• blood disorders which can make the skin pale and cause breathlessness, weakness, bruising, an increased risk of bleeding or make infections more likely,
• inflammation of the gastrointestinal tract, stomach, pancreas (pancreatitis), liver (hepatitis) including death of liver tissue or failure of the liver, blockage of flow of bile from the liver (cholestasis) with symptoms such as severe pain in the stomach and back, nausea, vomiting and yellowing of the skin and eyes or pale stools,
• inflammation or narrowing of your blood vessels with symptoms such as fever, fatigue, weight loss and muscle and joint pain,
• kidney failure with symptoms such as decreased urinary output, swelling due to fluid retention, nausea, fatigue and shortness of breath,
• nausea and vomiting, headache, confusion, weakness as your body may be retaining water instead of excreting it normally in urine.

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, unusual tiredness or weakness (fatigue), dizziness.
• low blood pressure (hypotension), especially when you stand or sit up quickly,
• dry tickly cough, inflammation of your sinuses (sinusitis) or bronchitis,
• stomach pain or discomfort, diarrhoea, indigestion, feeling or being sick (nausea and vomiting),
• muscle cramps, pain, weakness or spasms.

Less frequent side effects:

• balance problems, a feeling that the environment around you is spinning (vertigo),
• pins and needles,
• loss or change in the way things taste,
• sleep disturbances,
• feeling depressed, anxious, more nervous than usual or restlessness,
• blocked or runny nose, difficulty breathing or worsening of asthma,
• a swelling in your gut presenting with symptoms such as stomach pain, vomiting and diarrhoea,
• heartburn, constipation or dry mouth,
• problems with passing urine such as passing more water (urine) than usual,
• sweating more than usual,
• loss or decrease of appetite (anorexia),
• swollen arms and legs. This may be a sign of your body holding onto more water than usual,
• changes in your vision, blurred vision, pink eyes,
• pain in your joints,
• flushing, fever,
• inability to develop or maintain an erection, decrease in sexual desire in men or women,
• blood tests showing changes in the way your liver, pancreas or kidneys are working,
• feeling shaky or confused,
• worsening of a pre-existing skin disease, severe flaking or peeling of the skin, itchy lumps rash, blotches on your skin, increased sensitivity to sunlight,
• loosening or separation of your nail from its nail bed,
• disturbed hearing and ringing in your ears,
• feeling weak or having a loss of energy,
• hair loss.

Side effects with an unknown frequency:

• enlargement of the male breast tissue,
• disturbance in attention,
• painful sores or ulcers in your mouth,
• fingers and toes feeling numb or changing colour when you are cold (Raynaud’s phenomenon),
• slowed or impaired reactions,
• burning sensation,
• change in the way things smell.

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: https://www.sahpra.org.za/health-products-vigilance/ Aspen Pharmacare: E-mail: [email protected] Tel: 0800 118 088 / +27 (0)11 239 - 6200 By reporting side effects, you can help provide more information on the safety of RAMPIL.

Store all medicines out of reach of children. Store at or below 25 °C in tightly closed containers. Protect from light. Keep the blisters in the carton until required for use. Do not store in a bathroom. Do not use after the expiry date stated on the label. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).