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CAPTOPRIL TABLETS BP 50MG

Active substance(s): CAPTOPRIL / CAPTOPRIL / CAPTOPRIL

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Package leaflet: Information for the user
Captopril 12.5, 25 & 50 mg Tablets
Captopril
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 signs of illness are the same as yours.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.

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

1.

What Captopril is and what it is used for

Captopril belongs to a group of drugs called Angiotensin Converting Enzyme Inhibitors known as
ACE inhibitors. These tablets are vasodilators which are drugs which widen the blood vessels,
making it easier for the heart to pump blood around the body. This helps lower blood pressure.
Captopril is used to treat:
 high blood pressure
 congestive heart failure, which is a condition where the heart no longer pumps blood as well as
it should. Captopril is usually taken together with another type of medicine called a diuretic
(“water tablet”), and in some cases with a medicine called digitalis to treat this condition.

2. What you need to know before you take Captopril
Do not take Captopril:
 if you are allergic to captopril, any other ACE inhibitors e.g. lisinopril, or any of the other
ingredients of this medicine (listed in section 6)
 if you or a member of your close family have a history of face or body swelling (angioneurotic
oedema) which may be related to the use of medicines
 if you are more than 3 months pregnant. (It is also better to avoid Captopril in early pregnancy –
see section 2: Pregnancy and breast-feeding.)
 if you have diabetes or impaired kidney function and you are treated with a blood pressure
lowering medicine containing aliskiren
Warnings and precautions
Talk to your doctor or pharmacist before taking Captopril:
 if you are suffering from or have recently suffered from severe vomiting or diarrhoea
 if you have low levels of sodium in the blood, or if you are on a low sodium diet
 if you suffer from chest pain (angina pectoris)
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 if you suffer from a disease of the blood vessels in the brain (cerebrovascular disease)
If any of the above apply to you, you are more likely to experience symptoms of low blood pressure
when you start taking this medicine (see sections 3: How to take Captopril and 4: Possible side
effects).
 if you suffer from any kind of kidney problem
 if you suffer from aortic stenosis which is a narrowing of opening of the aortic valve of the heart
which leads to breathlessness on exertion
 if you are diabetic
 if you are pregnant or planning to become pregnant. You must tell your doctor if you think you
are (or might become) pregnant. Captopril is not recommended in early pregnancy, and must
not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby
if used at that stage (see section 2: Pregnancy and breast-feeding)
 if you have collagen vascular disease (immune system disorder affecting tendons, bones and
connective tissues), as you will need to have regular blood tests
 if you suffer from aldosteronism which is an excessive hormone production from the adrenal
glands, usually caused by a tumour as Captopril should be avoided
 if you have acute hypertensive crisis (onset of end organ dysfunction involving the heart or
brain due to high blood pressure) as Captopril should be avoided
 if you are undergoing LDL (low density lipoprotein) apheresis, a blood treatment for very high
cholesterol
 if you are undergoing desensitisation to insect poison (e.g. bee or wasp sting)
 if you are to have major surgery requiring an anaesthetic as your blood pressure may be
affected.
 if you are taking any of the following medicines used to treat high blood pressure:
- an angiotensin II receptor blocker (ARBs) (also known as sartans – for example valsartan,
telmisartan, irbesartan), in particular if you have diabetes-related kidney problems.
- aliskiren
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 Captopril’.
 If 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:
- sirolimus, everolimus and other medicines belonging to the class of mTOR inhibitors (used to
avoid rejection of transplanted organs)
Older people over 65 years of age and those patients with any of the following conditions
should undergo additional check-ups to monitor their kidney function before starting treatment with
Captopril Tablets:
 salt and/or body fluid deficiencies
 severe hypertension (high blood pressure), or high blood pressure due to kidney disease
 severe congestive heart failure
 kidney problems.
Some Afro-Caribbean patients who are taking Captopril Tablets as the only treatment for high
blood pressure may have a reduced response to the medication. This may mean that the dose
prescribed by the doctor may need to be higher than the usual recommended dose.
Tell your doctor you are taking Captopril tablets before you have any blood or urine tests,
because the tablets may affect the results of some of these tests (for example, a false positive result
in urine tests for acetone).

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Other medicines and Captopril
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, including medicines obtained without a prescription:
 “water tablets” (diuretics) e.g. furosemide, bendroflumethiazide, amiloride, spironolactone or
triamterene
 potassium supplements or salt substitutes containing potassium
 other drugs which can increase potassium in your body (such as heparin and co-trimoxazole also
known as trimethoprim/sulfamethoxazole)
 any non-steroidal anti-inflammatory painkillers e.g. ibuprofen, indomethacin
 other drugs for high blood pressure or to help the blood circulate around the body e.g. minoxidil
 allopurinol or probenecid, used for the treatment of gout
 procainamide, used for the treatment of irregular heart beats
 medication to treat diabetes e.g. sulphonylurea drugs (glibenclamide, tolbutamide), biguanide
drugs (metformin) or insulin
 any antacids e.g. aluminium hydroxide, sodium bicarbonate
 any sympathomimetics e.g. salbutamol, used to treat asthma, or ephedrine, phenylephrine which
may be used in some cough and cold or nasal decongestant medicines
 immunosuppressants e.g. azathioprine and cyclophosphamide
 corticosteroids such as beclometasone, budesonide, prednisolone, or hydrocortisone, used to
treat many conditions such as asthma, and inflammatory or allergic disorders
 lithium, used to treat certain mental illnesses
 any antipsychotic drugs for mental illness e.g. haloperidol, chlorpromazine, clozapine
 narcotic drugs for pain relief e.g. codeine, co-proxamol
 clonidine, used to treat migraine, menopausal flushing, or high blood pressure
 anaesthetic drugs.
 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”.
Your doctor may need to change your dose and/or to take other precautions:
• if you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see also information
under the headings ‘Do not take Captopril’ and ‘Warnings and precautions’)
Captopril with food and drink
 Do not drink alcohol whilst you are being treated with Captopril tablets.
Pregnancy, breast-feeding and 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. Your doctor will normally
advise you to stop taking Captopril before you become pregnant or as soon as you know you are
pregnant and will advise you to take another medicine instead of Captopril. Captopril is not
recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as
it may cause serious harm to your baby if used after the third month of pregnancy.
 Tell your doctor if you are breast-feeding or about to start breast-feeding. Breast-feeding
newborn babies (first few weeks after birth), and especially premature babies, is not
recommended whilst taking Captopril.
In the case of an older baby your doctor should advise you on the benefits and risks of taking
Captopril whilst breast-feeding, compared with other treatments.

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Driving and using machines
 Captopril may cause weariness, dizziness and fainting. If you are affected, do not drive or
operate machinery.
Captopril contains lactose
 Patients who are intolerant to lactose should note that Captopril tablets contain a small amount
of lactose. If you have been told by your doctor that you have an intolerance to some sugars,
contact your doctor before taking this medicine.

3. How to take Captopril
Always take this medicine exactly as your doctor has told you. Check with your doctor or
pharmacist if you are not sure.
Some patients may experience symptoms of low blood pressure when they start to take this
medicine (see sections 2: Warnings and precautions ‘Before you take Captopril’ and 4: Possible
side effects)
You may feel dizzy or light headed after taking the first one or two doses of Captopril. If this
happens to you, lie down until these symptoms disappear. Tell your doctor immediately if these
effects are severe, or if you continue to experience these effects.
The tablets should be swallowed preferably with a glass of water. The recommended dose is:
Adults
 High blood pressure
The usual initial dose is 12.5 mg twice a day. Your doctor may increase the dose up to 50mg twice a
day. In severe cases up to 150mg daily taken in divided doses may be prescribed.
 Heart failure
The usual initial dose is 6.25mg or 12.5mg. Your doctor may increase the dose up to a maximum of
150mg daily taken in divided doses.
Older people (older than 65 years)
 The usual initial dose is 6.25mg twice a day. Your doctor may increase the dose up to a
maximum of 100mg daily taken in divided doses.
Patients with liver or kidney problems
 If you have kidney or liver problems your doctor may prescribe a lower dose.
Use in children and adolescents
 Captopril may be used in premature infants in hospital, the doctor will calculate the appropriate
dose of Captopril for your infant based on the child’s body weight.
 Captopril is not recommended for use in children to treat mild or moderate high blood pressure.
If you take more Captopril than you should
If you (or someone else) swallow a lot of the tablets all together, or if you think a child has
swallowed any of the tablets contact your nearest hospital casualty department or your doctor
immediately.
An overdose is likely to cause low blood pressure, shock, near unconsciousness, slow heart beat and
problems with kidney function.
Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so
that they know which tablets were consumed.

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If you forget to take Captopril
If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the
next one. Do not take a double dose to make up for a forgotten dose.
If you stop taking Captopril
Do not stop taking your medicine without talking to your doctor first even if you feel better.
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 the tablets and tell your doctor immediately or go to the casualty department at your
nearest hospital if the following happens:
 an allergic reaction causing swelling of the lips, face or neck leading to severe difficulty in
breathing, or severe skin rash or hives.
This is a very serious but rare side effect. You may need urgent medical attention or
hospitalisation.
Tell your doctor immediately if any of the following happens:
 severe low blood pressure (a common side effect of ACE inhibitor type medicines), which can
cause dizziness, weakness, problems with your vision and in rare cases fainting and
unconsciousness. This is more likely to occur in patients suffering with certain other conditions
(see section 2: Warnings and precautions ‘Before you take Captopril’)
 a serious illness with blistering of the skin, mouth, eyes and genitals (Stevens-Johnson
Syndrome)
 severe blistering and peeling of large areas of the skin (toxic epidermal necrolysis)
 inflammation of the liver (hepatitis) which causes fever, tiredness, loss of appetite, aching
muscles and joints and yellowing of the skin and whites of the eyes (jaundice)
 inflammation of the pancreas (pancreatitis) which causes sudden severe abdominal pain, back
pain and nausea
 any signs of infection e.g. fever, sore throat, swollen glands.
The following side effects have been reported at the approximate frequencies shown:
Common may affect up to 1 in 10 people
 sleep disorders
 problem with your sense of taste
 dizziness
 dry and un-productive cough
 difficulty breathing
 abdominal pain, feeling or being sick, diarrhoea, upset stomach, constipation, dry mouth
 skin rash, itchy skin, hair loss

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Uncommon may affect up to 1 in 100 people
 irregular or fast heart beat, angina (pain in the chest)
 low blood pressure
 Raynaud’s syndrome (poor circulation which makes the toes and fingers numb and pale)
 flush, pale skin colour
 swelling of the lips, face or neck
 feeling tired or weak
Rare may affect up to 1 in 1,000 people)
 eating disorders
 drowsyness, headache, pins and needles
 sinus problems or cold like symptoms, bronchitis (inflammation of the lungs)
 inflammation of the mouth, swelling of the bowel that can cause abdominal pain, diarrhoea with
beeing sick
 kidney problems including kidney failure, production of large or very small amounts of urine,
increased need to urinate more often
Very rare may affect up to 1 in 10,000 people
 changes in blood composition such as decrease in the numbers of red or white blood cells, or
decrease in the number of platelets may be found in the results of blood tests
 any signs of infection e.g. fever, sore throat, swollen glands.
 high levels of serum potassium, low blood sugar
 confusion, depression
 rapid loss of brain function e.g. because of the bleeding in the brain
 blurred vision
 heart problems including heart attack
 bronchospasms (tightness in the chest)
 stuffy or runny nose
 allergic alveolitis/eosinophilic pneumonia (inflammation of the alveoli within the lung)
 swollen tongue,
 open sores in the lining of the stomach or the first part of the gut that cause abdominal pain and
fullness
 results of liver function tests may show increases of liver enzymes or bilirubin
 hives
 sensitivity to light
 inflammatory skin disease that cause redness of the skin flaking
 muscle and joint pain
 impotence (difficulty getting or keeping an erection)
 breast enlargement in men
 fever
 protein in the urine, decrease of serum sodium, haemoglobin, haematocrit, increased urea or
creatinine in the blood
The following side effects have also been reported:
 increase in the numbers of white blood cells
 ringing in the ears
 indigestion, intestinal obstruction where the intestines become blocked
 psoriasis like symptoms (patches of thickened and sore skin)
 separation of the nails from the nail bed

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balance disorders
inflammation of blood vessels

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet.
You can also report side effects directly via the national reporting system listed in Appendix V*. By
reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Captopril
Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Store in the original pack in order to protect from moisture
Do not use this medicine after the expiry date which is stated on the outer packaging. 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 Captopril tablets contain:
 The active substance is captopril 12.5, 25 or 50 mg.
 The other ingredients are lactose monohydrate, microcrystalline cellulose, pregelatinised maize
starch and stearic acid.
What Captopril tablets look like and contents of the pack:
 Captopril 12.5 mg is a white round flat bevel edged tablet marked 7C1 with a breakline
 Captopril 25 mg is a white biconvex tablet marked 7C2 with a double breakline.
 Captopril 50 mg is a white round bevel edged tablet marked 7C3 with a breakline.
 Captopril tablets are available packed in blister strips or in plastic bottles in pack sizes of 14,
20, 21, 28, 30, 56, 60, 84, 100, 112, 120 or 168 tablets. The product is additionally available in
plastic bottles in pack sizes of 50, 250, 500, 1000, or 5000 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
[To be completed nationally].
This medicinal product is authorised in the Member States of the EEA under the following
names:
[To be completed nationally].
This leaflet was last revised in: [To be completed nationally]

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THIS IS A REPRESENTATION OF AN ELECTRONIC RECORD THAT WAS SIGNED ELECTRONICALLY AND THIS
PAGE IS THE MANIFESTATION OF THE ELECTRONIC SIGNATURE

Teva Pharmaceuticals Europe B.V
1.3.1 pil-eu clean

APPROVALS
Signed by
Prasad Lende

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Server Date
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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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