Ramipril 1.25 mg Capsules

Ramipril 2.5 mg Capsules

Ramipril 5 mg Capsules

Ramipril 10 mg Capsules

(Ramipril)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Ramipril Capsules is and what it is used for
2. What you need to know before you take Ramipril Capsules
3. How to take Ramipril Capsules
4. Possible side effects
5. How to store Ramipril Capsules
6. Contents of the pack and other information

Ramipril Capsules contains a medicine called ramipril. This belongs to a group of medicines called ACE inhibitors (Angiotensin Converting Enzyme Inhibitors).

Ramipril Capsules work 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

Ramipril Capsules can be used for:

• Treating high blood pressure (hypertension)
• Reducing the risk of having a heart attack or stroke
• Reducing the risk or delaying worsening of kidney problems (with or without diabetes)
• Treating heart failure
• Treatment following a heart attack complicated with heart failure

Do not take Ramipril Capsules if you:

• Are allergic to ramipril, any other ACE inhibitor, or any of the ingredients (see section 6)
• Have ever had a serious allergic reaction called “angioedema”
• Have taken or are taking sacubitril/valsartan
• Are on dialysis or other blood filtration
• Have kidney problems with reduced blood supply (renal artery stenosis)
• Are in the last 6 months of pregnancy
• Have abnormally low or unstable blood pressure
• Have diabetes or impaired kidney function treated with aliskiren-containing medicine
• Are taking racecadotril, mTOR inhibitors (e.g. temsirolimus, sirolimus, everolimus), or vildagliptin

Warnings and precautions

Talk to your doctor or pharmacist before taking Ramipril Capsules if you:

• Have heart, liver or kidney problems
• Have lost a lot of salts or fluids (vomiting, diarrhoea, sweating, low-salt diet, long-term diuretics, dialysis)
• Are undergoing bee/wasp sting desensitisation
• Will receive an anaesthetic
• Have high potassium levels
• Are taking medicines or have conditions that reduce blood sodium levels
• Are on mTOR inhibitors, vildagliptin, racecadotril, or sacubitril/valsartan
• Have collagen vascular disease (e.g. scleroderma, lupus)
• Are pregnant, might become pregnant, or are breast-feeding (see “Pregnancy and breast-feeding”)
• Are taking angiotensin II receptor blockers (sartans) or aliskiren

Your doctor may check your kidney function, blood pressure, and electrolytes regularly.

Children and adolescents

Not recommended for use in those under 18 years; safety and efficacy not established.

Other medicines and Ramipril Capsules

Tell your doctor or pharmacist if you are taking any other medicines:

May make Ramipril less effective:

• NSAIDs (e.g. ibuprofen, indometacin, aspirin)
• Pressor agents (e.g. ephedrine, noradrenaline, adrenaline)

May increase side effect risk:

• Sacubitril/valsartan
• Ciclosporin, chemotherapy agents
• Diuretics (e.g. furosemide)
• Potassium supplements or potassium-sparing diuretics
• Steroids (e.g. prednisolone)
• Allopurinol, procainamide
• mTOR inhibitors, vildagliptin, racecadotril
• ARBs or aliskiren

May be affected by Ramipril:

• Diabetes medicines (insulin, oral agents)
• Lithium

Ramipril Capsules with food, alcohol

• Alcohol may increase dizziness or light-headedness
• Can be taken with or without food

Pregnancy and breast-feeding

Do not take during pregnancy (especially after 13 weeks) or while breast-feeding. Tell your doctor if you are pregnant or planning a pregnancy.

Driving and using machines

You may feel dizzy, especially when starting treatment or after a dose increase. If affected, do not drive or use machinery.

Always take exactly as your doctor has told you.

• Take by mouth at the same time each day with water
• Do not crush or chew the capsules

Dosage:

• High blood pressure: start 1.25 mg or 2.5 mg once daily; adjust up to 10 mg once daily
• Risk reduction (heart attack/stroke): start 2.5 mg once daily; usual 10 mg once daily
• Kidney protection: start 1.25 mg or 2.5 mg once daily; usual 5 mg–10 mg once daily
• Heart failure: start 1.25 mg once daily; adjust up to 10 mg daily (preferably divided doses)
• After heart attack: start 1.25 mg once daily to 2.5 mg twice daily; usual 10 mg daily (preferably divided)
• Elderly: start lower dose and titrate more slowly

If you take too much

Go to your nearest casualty department immediately (do not drive yourself). Take the medicine pack with you.

If you forget a dose

Take it when you remember unless it is almost time for your next dose. Do not double up.

If you stop taking Ramipril Capsules

Do not stop without consulting your doctor or pharmacist.

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

Stop and see a doctor straight away if you:

• Develop swelling of face, lips, throat (angioedema)
• Have severe skin reactions (Stevens–Johnson syndrome, toxic epidermal necrolysis)

Tell your doctor immediately if you experience:

• Chest pain, palpitations, heart attack, stroke
• Shortness of breath, cough (lung problems)
• Easy bruising/bleeding, fever, sore throat (blood/bone marrow issues)
• Severe stomach pain (pancreatitis)
• Jaundice, liver inflammation or damage

Other side effects

Common (up to 1 in 10)

• Headache, tiredness
• Dizziness, fainting, low blood pressure
• Dry cough, sinusitis, bronchitis
• Stomach pain, diarrhoea, indigestion, nausea, vomiting
• Skin rash, chest pain, muscle cramps or pain
• Elevated potassium in blood tests

Uncommon (up to 1 in 100)

• Vertigo, paraesthesia
• Taste changes, sleep problems, mood changes
• Asthma worsening, intestinal angioedema
• Heartburn, constipation, dry mouth
• Increased urination, sweating, anorexia
• Flushing, blurred vision, joint pain
• Sexual dysfunction, eosinophilia
• Abnormal liver/pancreas/kidney tests

Rare (up to 1 in 1,000)

• Shakiness, confusion, red/swollen tongue
• Severe skin peeling, nail problems
• Hearing disturbances, weakness
• Blood cell count changes

Very rare (up to 1 in 10,000)

• Sun sensitivity

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.

• Keep out of sight and reach of children.
• Do not store above 25 °C. Store in original packaging.
• Do not use after the expiry date on the carton or blister.
• Do not dispose via wastewater or household waste; ask your pharmacist how.

What Ramipril Capsules contain

• Active substance: Ramipril
• Other ingredients: Pregelatinised starch, gelatin, polyethylene glycol, iron oxides (E 172), titanium dioxide (E 171), plus colourants in specific strengths as listed in section 6.

What Ramipril Capsules look like and pack sizes

• 1.25 mg: Light grey cap (“R”) and 1.25 on body.
• 2.5 mg: Light green cap (“R”) and 2.5 on body.
• 5 mg: Green cap (“R”) and 5 on body.
• 10 mg: Dark green cap (“R”) and 10 on body.
• Pack sizes: Blisters of 7, 21, 28, 30, 50 or 100 capsules (not all sizes marketed).

Marketing Authorisation Holder & Manufacturer

Brown & Burk UK Ltd

5 Marryat Close, Hounslow West, Middlesex TW4 5DQ, United Kingdom

This leaflet was last updated in June 2020.