RAMIPRIL/AMLODIPINE 5 MG / 10 MG HARD CAPSULES - patient leaflet, side effects, dosage

Patient leaflet - RAMIPRIL/AMLODIPINE 5 MG / 10 MG HARD CAPSULES

1. what ramipril/amlodipine is and what it is used for

Ramipril/Amlodipine contains two active substances: ramipril and amlodipine. Ramipril belongs to a group of medicines called ACE inhibitors (Angiotensin Converting Enzyme inhibitors). Amlodipine belongs to a group of medicines called calcium antagonists.

Ramipril 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

Amlodipine works by:

relaxing and widening blood vessels, so that blood passes through them more easily

Ramipril/Amlodipine is used to treat hypertension (high blood pressure), in patients whose blood pressure is adequately controlled with amlodipine and ramipril given at the same time and at the same dose level as in Ramipril/Amlodipine, but as separate medicines.

2. what you need to know before you take ramipril/amlodipine

DO NOT take Ramipril/Amlodipine:

if you are allergic to ramipril, amlodipine (active substances), otherACE inhibitor medicines or any other calcium antagonists, or any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction may include itching, reddening of the skin or difficulty in breathing
if you have ever had a serious allergic reaction called “angioedema”. The signs include itching, hives (urticaria), red marks on the hands, feet and throat, swelling of the throat and tongue, swelling around
the eyes and lips, difficulty breathing and swallowing
if you are having dialysis or any other type of blood filtration. Depending on the machine that is used, Ramipril/Amlodipine may not be suitable for you
if you have kidney problems where the blood supply to your kidneys is reduced (renal artery stenosis) during the last 6 months of pregnancy (see section below on "Pregnancy and breast- feeding”)
if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren
if your blood pressure is abnormally low or unstable. Your doctor will need to make this assessment
if you have narrowing of the aortic heart valve (aortic stenosis) or cardiogenic shock (a condition where your heart is unable to supply enough blood to the body)
if you suffer from heart failure after a heart attack
if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a type of long term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling under the skin in an area such as the throat) is increased.

Do not take Ramipril/Amlodipine if any of the above apply to you. If you are not sure, talk to your doctor before taking Ramipril/Amlodipine.

Warnings and precautions

Talk to your doctor or pharmacist before taking Ramipril/Amlodipine. Tell your doctor if any of the situations listed below is applicable to you. If:

you have heart, liver or kidney problems
you have lost a lot of body salts or fluids through being sick (vomiting), having diarrhoea, sweating more than usual, being on a low salt diet, taking water tablets diuretics) for a long time or having had dialysis
you are going to have treatment to reduce your allergy to bee or wasp stings (desensitisation)
you are going to receive an anaesthestic. This may be given for an operation or any dental work. You may need to stop your Ramipril/Amlodipine treatment one day beforehand; ask your doctor for advice
you have high amounts of potassium in your blood (shown in blood test results)
you are taking medicines or have conditions which may decrease sodium levels in your blood
your doctor may carry out regular blood tests, particularly for checking the levels of sodium in your blood especially if you are elderly
you are taking any of the following medicines, the risk of angioedema (rapid swelling under the skin in area such as the throat) is increased:

o medicines used to prevent organ transplant rejection and for cancer (medicines belonging to the class of mTOR inhibitors, e.g. temsirolimus, sirolimus, everolimus)

o vildagliptin, a medicine used to treat diabetes

o racecadotril, a medicine used to treat diarrhoea

you have a collagen vascular disease such as scleroderma or systemic lupus erythematosus
you are taking any of the following medicines used to treat high blood pressure:

o an angiotensin II receptor blocker (ARBs – also known as sartans – for example valsartan, telmisartan, irbesartan), in particular if you have diabetes-related kidney problems

o aliskiren

you had severe increase in blood pressure (hypertensive crisis)
you are elderly and your dose needs to be increased
you developed a dry cough which is persistent for a long time
your blood pressure is not sufficiently lowered. Medicines of this type seem to be less effective in people of black origin

Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals. See also information under the heading “DO NOT take Ramipril/Amlodipine”.

If you suffer from sudden swelling of the lips and face, tongue and throat, neck, possibly also hands and feet, difficulty in swallowing or breathing, hives or hoarseness (‚angioedema‘). These could be signs of a severe allergic reaction. This may occur at any time during the treatment.

People of black origin may have a higher risk of suffering from this condition.

If you develop such symptoms you should let your doctor know immediately.

Children and adolescents

Ramipril/Amlodipine is not recommended for use in children and adolescents below 18 years of age because there is no information available in this population.

Other medicines and Ramipril/Amlodipine

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Tell your doctor if you are taking any of the following medicines. They can make Ramipril/Amlodipine work less well:

medicines used to relieve pain and inflammation e.g. NonSteroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen, indomethacin or acetylsalicylic acid
medicines used for the treatment of low blood pressure, shock, cardiac failure, asthma or allergies e.g. ephedrine, noradrenaline or adrenaline. Your doctor will need to check your blood pressure
rifampicin (antibiotic to treat tuberculosis)
St. John's Wort (Hypericum perforatum – used to treat depression)

Tell your doctor if you are taking any of the following medicines. They can increase the chance of getting side effects if you take them with Ramipril/Amlodipine:

erythromycin, clarithromycin (antibiotics – used for the treatment of infections caused by bacteria)
medicines which are most often used to avoid rejection of transplanted organs (sirolimus, everolimus and other medicines belonging to the class of mTOR inhibitors). See section “Warnings and precautions”
medicines used to relieve pain and inflammation e.g. NonSteroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen, indomethacin or acetylsalicylic acid
water tablets (diuretics) such as furosemide
potassium supplements (including salt substitutes), potassium-sparing diuretics such as

o spironolactone, triamterene, amiloride and other medicines that can increase the amout of potassium in your blood (e.g. trimethoprim and co-trimoxazole (also known as trimethoprim/sulfamethoxazole) for infections caused by bacteria; ciclosporin, an immunosuppressant medicine used to prevent organ transplant rejection; and heparin, a medicine used to thin blood to prevent clots)

steroid medicines for inflammation e.g. prednisolone
allopurinol (used to lower the uric acid in your blood)
procainamide (for heart rhythm problems)
ketoconazole, itraconazole (anti-fungal medicines)
ritonavir, indinavir, nelfinavir (protease inhibitors used to treat HIV)
verapamil, diltiazem (medicines to treat heart disorders or high blood pressure)
dantrolene (infusion for severe body temperature abnormalities)
vildagliptin (used to treat diabetes)
racecadotril (used to treat diarrhoea)

Your doctor may need to change your dose and/or take other precautions:

if you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see also information under the headings “DO NOT take Ramipril/Amlodipine” and “Warnings and precautions”)

Please tell your doctor if you are taking any of the following medicines. They may be affected by Ramipril/Amlodipine:

medicines for diabetes such as oral glucose lowering medicines and insulin. Ramipril/Amlodipine may lower your blood sugar amounts. Check your blood sugar amounts closely while taking Ramipril/Amlodipine
lithium (for mental health problems). Ramipril/Amlodipine may increase the amount of lithium in your blood. Your lithium amount will need to be closely checked by your doctor
simvastatin (a cholesterol lowering medicine). Ramipril/Amlodipine may increase the amount of simvastatin in your blood

If any of the above apply to you (or you are not sure), talk to your doctor before taking Ramipril/Amlodipine.

Ramipril/Amlodipine with food, drink and alcohol Ramipril/Amlodipine may be taken with or without food. Drinking alcohol with Ramipril/Amlodipine may make you feel dizzy or light-headed. If you are concerned about how much you can drink while you are taking Ramipril/Amlodipine, discuss this with your doctor as medicines used to reduce blood pressure and alcohol can have additive effects.

Grapefruit juice or grapefruit should not be consumed by people who are taking Ramipril/Amlodipine.

This is because grapefruit and grapefruit juice can lead to an increase in the blood levels of the active ingredient amlodipine, which can cause an unpredictable increase in the blood pressure lowering effect of Ramipril/Amlodipine.

Pregnancy and breast-feeding and fertility

Pregnancy

You must not take Ramipril/Amlodipine during the second and third trimester of pregnancy. During the first trimester of pregnancy the use is not recommended.

If you become pregnant while on Ramipril/Amlodipine tell your doctor immediately. A switch to a suitable alternative treatment should be carried out in advance of a planned pregnancy.

Breast-feeding

You should not take Ramipril/Amlodipine if you are breastfeeding.

Amlodipine, one of the two active ingredients of Ramipril/Amlodipine, has been shown to pass into breast milk in small amounts. If you are breast-feeding or about to start breast-feeding you must tell your doctor before taking Ramipril/Amlodipine.

Fertility

There is no sufficient data regarding the potential effect on fertility.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Ramipril/Amlodipine may affect your ability to drive or use machines. If Ramipril/Amlodipine makes you feel sick, dizzy or tired, or gives you a headache, do not drive or use machines and contact your doctor immediately. This can happen especially at the start of treatment, or when changing over from other preparations.

3. how to take ramipril/amlodipine

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

If you have the impression that the effect of Ramipril/Amlodipine is too strong or too weak, talk to your doctor or pharmacist.

Method of administration

Take this medicine by mouth at the same time of the day, before or after your meal.Swallow the capsule whole with liquid.

Do not take Ramipril/Amlodipine with grapefruit juice.

Dosage

The doctor will decide on the most suitable dose for you.

The maximum daily dose is 1 capsule Ramipril/Amlodipine 10 mg/10 mg (which contains a combination of 10 mg ramipril and 10 mg amlodipine).

Ramipril/Amlodipine should be taken once a day.

Use in children and adolescents

Ramipril/Amlodipine is not recommended for use in children and adolescents below 18 years of age because there is no information available in this population.

If you take more Ramipril/Amlodipine than you should Taking too many capsules may cause your blood pressure to become low or even dangerously low. You may feel dizzy, lightheaded, faint or weak. If blood pressure drop is severe enough shock can occur.

Your skin could feel cool and clammy and you could lose consciousness. Tell a doctor or go to the nearest hospital casualty department straight away. Do not drive to the hospital, get somebody else to take you or call for an ambulance. Take the medicine pack with you so the doctor knows what you have taken.

If you forget to take Ramipril/Amlodipine

If you forget to take a capsule, leave out that dose completely. Take your next dose at the usual time.

Do not take a double dose to make up for a forgotten dose.

If you stop taking Ramipril/Amlodipine

Your doctor will advise you how long to take your medicine for. Your condition may return if you stop using your medicine before you are advised to.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Ramipril/Amlodipine and see a doctor straight away if you notice any of the following serious side effects – you may need urgent medical treatment: swelling of the face, lips or throat which make it difficult to swallow or breathe, as well as itching and rashes. These could be signs of a severe allergic reaction to Ramipril/Amlodipine
severe skin reactions including rash, ulcers in your mouth, worsening of a pre-existing skin disease, reddening, blistering or detachment of skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme) or other allergic reactions

The frequencies of the above mentioned side effects are classified as not known (frequency cannot be estimated from the available data).

Tell your doctor immediately if you experience:

faster heart rate, uneven or forceful heartbeat (palpitations), chest pain, tightness in your chest or more serious problems including heart attack and stroke. The frequencies of these side effects are common (palpitation), uncommon (chest pain, tightness in chest, faster heart rate, heart attack) or not known (stroke)
shortness of breath or a cough. These are common side effects and could be signs of lung problems
bruising more easily, bleeding for longer than normal, any sign of bleeding (e.g. bleeding from the gums), purple spots, blotching on the skin or getting infections more easily than usual, sore throat and fever, feeling tired, faint, dizzy or having pale skin. These can be signs of blood or bone marrow problems and are rare side effects
severe stomach pain which may reach through to your back. This could be a sign of pancreatitis (inflammation of the pancreas). It is an uncommon side effect
fever, chills, tiredness, loss of appetite, stomach pain, feeling sick, yellowing of your skin or eyes (jaundice). These can be signs of liver problems such as hepatitis (inflammation of the liver) or liver damage. The frequency of these side effects are not known

Other side effects

Please tell your doctor if any of the following gets serious or lasts longer than a few days.

Very common (may affect more than 1 in 10 people) ankle swelling (oedema)

Common (may affect up to 1 in 10 people)

sleepiness (especially at the beginning of treatment)
palpitations (awareness of your heartbeat), flushing
headache or feeling tired
feeling dizzy. This is more likely to happen when you start taking Ramipril/Amlodipine or start taking a higher dose
fainting, hypotension (abnormally low blood pressure), especially when you stand or sit up quickly
dry tickly cough, inflammation of your sinuses (sinusitis) or bronchitis, shortness of breath
abdominal pain, stomach or gut pain, diarrhoea, indigestion, feeling or being sick, altered bowel habits (including diarrhoea or constipation), heartburn
skin rash with or without raised area
chest pain
weakness
cramps or pain in your muscles
blood tests showing more potassium than usual in your blood

Uncommon (may affect up to 1 in 100 people)

mood changes, sleeplessness
trembling, pain, feeling unwell
visual disturbances, double vision, blurred vison
ringing in the ears
sneezing/running nose caused by inflammation of the lining of the nose (rhinitis)
dry mouth
hair loss, increased sweating, itchy skin, red patches on skin, skin discoloration
difficulty in passing urine, increased need to urinate, especially at night, increased number of times passing urine
inability to obtain an erection, sexual inability in men, reduced sexual desire in men or women
discomfort or enlargement of the breasts in men
joint or muscle pain, back pain
weight increase or decrease
balance problems (vertigo)
itching and unusual skin sensations such as numbness, tingling, pricking, burning or creeping on your skin (paraesthesia), loss of pain sensation
loss or change in the way things taste
sleep problems
feeling depressed, anxious, more nervous than usual or restless
blocked nose, difficulty breathing or worsening of asthma
a swelling in your gut called “intestinal angioedema” presenting with symptoms like abdominal pain, vomiting and diarrhoea
loss or decrease of appetite (anorexia)
increased or irregular heartbeats
swollen arms and legs. This may be a sign of your body holding onto more water than usual
fever
an increased number of certain white blood cells (eosinophilia), found during a blood test
blood tests showing changes in the way your liver, pancreas or kidneys are working

Rare (may affect up to 1 in 1,000 people)

feeling shaky or confused
red and swollen tongue
severe flaking or peeling skin, itchy, lumpy rash
nail problems (e.g. loosening or separation of a nail from its bed)
skin rash or bruising
inflammation of blood vessels, often with skin rash
urticaria
blotches on your skin and cold extremities
red, itchy, swollen or watery eyes
disturbed hearing
blood tests showing a decrease in the number of red blood cells, white blood cells or platelets, or in the amount of haemoglobin

Very rare (may affect up to 1 in 10,000 people)

being more sensitive to the sun than usual
excess sugar in your blood (hyperglycaemia)
swelling of the gums
abdominal bloating (gastritis)
abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice)
increased muscle tension
sensitivity to light
disorders combining rigidity, tremor, and/or movement disorders

Not known (frequency cannot be estimated from the available data)

concentrated urine (dark in colour), feeling or being sick, muscle cramps, confusion and fits which may be due to inappropriate ADH (anti-diuretic hormone) secretion. If you have these symptoms contact your doctor as soon as possible
trembling, rigid posture, mask-like face, slow movements and a shuffling, unbalanced walk

Other side effects reported

Please tell your doctor if any of the following gets serious or lasts longer than a few days.

difficulty concentrating
blood tests showing too few blood cells in your blood
blood tests showing less sodium than usual in your blood
fingers and toes changing colour when you are cold and then tingling or feeling painful when you warm up (Raynaud's phenomenon)
slowed or impaired reactions
change in the way things smell
psoriasis

5. how to store ramipril/amlodopine

Do not store above 25°C.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister pack after EXP.

The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater <or household waste>. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other information

What Ramipril/Amlodipine contains

The active substances are ramipril and amlodipine:

Each Ramipril/Amlodipine 5 mg/5 mg hard capsules contains 5 mg ramipril and 5 mg amlodipine (as amlodipine besilate).

Each Ramipril/Amlodipine 5 mg/10 mg hard capsules contains 5 mg ramipril and 10 mg amlodipine (as amlodipine besilate).

Each Ramipril/Amlodipine 10 mg/5 mg hard capsules contains 10 mg ramipril and 5 mg amlodipine (as amlodipine besilate).

Each Ramipril/Amlodipine 10 mg/10 mg hard capsules contains 10 mg ramipril and 10 mg amlodipine (as amlodipine besilate).

The other ingredients are cellulose microcrystalline, hypromellose, crospovidone, glycerol dibehenate, gelatin and titanium dioxide (E171).

Ramipril/Amlodipine 5mg/5mg, 5mg/10mg and 10mg/10mg hard capsules also contains indigo carmine (E132).

What Ramipril/Amlodipine looks like and contents of the pack

Ramipril/Amlodipine 5mg/5mg hard capsules are light blue capsules, content is white or almost white powder or slightly compacted agglomerates; size of capsules is approximately 15.9 mm x 5.8 mm (No. 3.).

Ramipril/Amlodipine 5mg/10mg hard capsules are white body and blue cap, content is white or almost white powder or slightly compacted agglomerates; size of capsules is approximately 19,4 mm x 6,9 mm (No.1.).

Ramipril/Amlodipine 10mg/5mg hard capsules are white body and white cap, content is white or almost white powder or slightly compacted agglomerates; size of capsules is approximately 19,4 mm x 6,9 mm (No.1.).

Ramipril/Amlodipine 10mg/10mg hard capsules are blue capsules, content is white or almost white powder or slightly compacted agglomerates; size of capsules is approximately 19,4 mm x 6,9 mm (No.1.).

Ramipril/Amlodipine are available in blister packs containing 28, 30, 50, 56, 60, 98, 100, 200, 300 capsules.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing Authorisation Holder

Dawa Limited

5 Sandridge Close

Harrow

Middlesex

HA1 1XD

Manufacturer

Drugsrus Limited