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CAPOTEN 25MG TABLETS

Active substance(s): CAPTOPRIL / CAPTOPRIL / CAPTOPRIL

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Package Leaflet: Information for the user

CAPOTEN™ 25mg Tablets
Captopril

Diecut

LFT CAPOTEN TAB

1267252A4
2/5: 0126725204
148 (x2) x 211,8 mm

8 pt
3

Product Name:

Product Code:
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Pag. 1/2

14.10.2015 Pollutri

Black
Printing Colours:

Technical Colours:

Anagni
Parisi Emiliano
Production Site:
CTM:
No

PAG 1

Yes /

PAG 3

UK

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following reactions stop taking Capoten and contact your doctor immediately:
• Swelling of the hands, face, lips or tongue.
• Difficulty in breathing.
• A sudden, unexpected rash or burning, red or peeling skin.
• Sore throat or fever.
• Severe dizziness or fainting.
• Severe stomach pain.
• Unusually fast or irregular heartbeat.
• Yellowing of the skin and/or eyes (jaundice).
Common side effects (affecting between 1 in 10 and 1 in 100 people)
• Sleep problems
• Dizziness
• Diarrhoea or constipation
• Itching
• Dry, irritating cough
• Rashes
• Upset stomach, feeling sick, vomiting, abdominal
• Hair loss
pain
• Changes in the way things taste
• Stomach ulcers
• Shortness of breath
• Dry mouth
Uncommon side effects (affecting between 1 in 100 and 1 in 1000 people)
• Pins and needles, numbness or tingling
• Headache
• Tiredness
• Fast, irregular, louder heartbeat
• Generally feeling unwell
• Chest pain
• Looking pale
• Low blood pressure
• Swelling of the eyes and lips (angioedema)
• Reduced blood flow to the hands and feet
• Loss of appetite
(e.g. Raynaud’s phenomenon)
• Flushing

2. What you need to know before you take Capoten
Do not take Capoten:
- if you are allergic to captopril or any of the other ingredients of this medicine (listed in section 6).
- if you are more than 3 months pregnant. (It is also better to avoid Capoten in early pregnancy – see
pregnancy section).
- if you have ever had an allergic reaction to any ingredients of Capoten or to any other medicines, including
other ACE inhibitors.
- if you have ever had a reaction which included swelling of the hands, lips, face or tongue where the cause
was unknown.
- if you suffer from any auto-immune disease (e.g. rheumatoid arthritis, systemic lupus erythematosus or
scleroderma).
- if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering
medicine containing aliskiren.
If any of the above affects you, or you are unsure if they do, tell your doctor who will be able to advise you.
Warnings and precautions
Talk to your doctor or pharmacist before taking Capoten.
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 Capoten’.
You must tell your doctor if you:
- think you are (or might become) pregnant. Capoten 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 pregnancy section).
- suffer from kidney disease.
- suffer from liver disease.

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1. What Capoten is and what it is used for
The name of this medicine is Capoten. Each tablet contains captopril (25mg) as the active ingredient.
Capoten belongs to the group of medicines called Angiotensin Converting Enzyme (ACE) Inhibitors. ACE
inhibitors work by helping to widen your blood vessels, which then make it easier for your heart to pump
blood through them.
Capoten is used to treat high blood pressure and certain heart conditions. If high blood pressure is left
uncontrolled it can increase the risk of heart disease or stroke. Capoten works by lowering your blood
pressure which reduces this risk.
Capoten can also help people whose heart no longer pumps blood as well as it once did.
This condition is known as heart failure.
Capoten may also be used to treat patients who recently suffered a heart attack. A heart attack happens
once one of the major blood vessels supplying blood to the heart muscle becomes blocked. This means that
the heart does not receive the oxygen it needs and the heart muscle becomes damaged.
In addition, Capoten can be used for the treatment of kidney disease in patients with diabetes.

Phone contact: +39 0692708387
e-mail contact: artwork@grafimed.it
www.grafimed.it

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 or pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.
What is in this leaflet
1. What Capoten is and what it is used for
2. What you need to know before you take Capoten
3. How to take Capoten
4. Possible side effects
5. How to store Capoten
6. Contents of the pack and other information

Senso di svolgimento

3. How to take Capoten
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
The recommended doses are:
For the treatment of high blood pressure
The usual starting dose is 12.5 - 25mg twice a day. Your doctor may gradually increase this dose to
100 - 150mg a day. You may also need to be given other medicines to lower your blood pressure.
Older patients and those with kidney problems may be given a lower starting dose.
In heart failure
The usual starting dose is 6.25 – 12.5mg two or three times a day. Your doctor may gradually increase this
dose to a maximum of 150mg a day.
After a heart attack
The usual starting dose is 6.25mg, which will then be increased by your doctor to a maximum of 150mg a day.
For the treatment of diabetic patients with kidney disease
The usual dose is 75 - 100mg a day.
For children
The starting dose is 0.3mg/kg bodyweight, which may be increased gradually by the doctor.
For children with kidney problems, premature babies and newborn babies and infants
The starting dose should be 0.15mg/kg bodyweight.
Doctors sometimes prescribe different doses to the above and if this applies to you, you should discuss it
with your doctor.
The tablets can be broken in half for a 12.5mg dose or quarters for 6.25mg dose.
Sometimes patients may feel dizzy after taking the first one or two doses of Capoten. If this happens to you,
lie down until these symptoms disappear.
You should try to take Capoten at about the same time each morning. It can be taken before, during or after
meals.
Even if you feel well continue to take Capoten until your doctor tells you otherwise.
If you take more Capoten than you should
If you or any one else takes too many tablets you should go to your nearest hospital emergency department
or tell your doctor immediately. Take the carton and any remaining tablets you have with you.
If you forget to take Capoten
If you miss a dose do not worry. Just carry on taking your normal dose when the next one is due.
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

Diecut

LFT CAPOTEN TAB

1267252A4
2/5: 0126725204
148 (x2) x 211,8 mm

8 pt
3

Product Name:

Product Code:
Barcode Type:
Format/Dimension:
Tech. Drawing No.:

Min. Font Size Text:
Proof No.:
Pag. 2/2

14.10.2015 Pollutri

Black
Printing Colours:

Technical Colours:

Anagni
Parisi Emiliano
Production Site:
CTM:
No
Yes /
UK

1267252A4

Live Text:
Country:

PAG 4

6. Contents of the pack and other information
What Capoten contains
- The active substance is captopril (25mg).
- The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose and stearic acid.
What Capoten looks like and contents of the pack
The tablets come in a 25mg strength and in blister packs of 28 tablets with a new tablet appearance:
White, square, biconvex tablet, with embossed “25” on one side and cross scored on the other side.
The scoreline is to facilitate breaking for the ease of swallowing and to divide into equal doses of 12.5mg
(half tablet) or 6.25mg (quarter tablet).
Marketing Authorisation Holder and Manufacturer:
E R Squibb & Sons Ltd
Uxbridge Business Park,
Sanderson Road,
Uxbridge,
Middlesex UB8 1DH
Tel: 0800 7311736
Manufacturer:
Bristol-Myers Squibb, S.r.l.
Contrada Fontana del Ceraso
03012 Anagni (FR)
Italy
Date of last revision:
October 2015

Phone contact: +39 0692708387
e-mail contact: artwork@grafimed.it
www.grafimed.it

PAG 2

5. How to store Capoten
Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Store in the original package to protect from moisture, and make sure they do
not get too hot or damp; so do not leave your tablets near a radiator, on a window sill or in the bathroom.
Do not use this medicine after the expiry date which is stated on the carton. 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.

Senso di svolgimento

Rare side effects (affecting between 1 in 1000 and 1 in 10,000 people)
• Mouth ulcers
• Drowsiness
• Changes in frequency of passing urine
• Kidney disorders or failure
Very rare side effects (affecting less than 1 in 10,000 people)
• Liver damage, inflammation of the liver or jaundice
• Impaired liver function and raised
• Muscle pain
liver enzymes
• Joint pain
• Confusion, depression, fainting
• Wheezing or difficulty breathing
• Mini-stroke
• Rashes or skin reactions
• Blurred vision
• Heart problems including
• Swelling of breast tissue in men
heart attack, and chest infections
• Fever
• Inflammation of the pancreas
• Sensitivity of the skin to light
• Runny nose
• Changes in levels of cells and/or chemicals in the
• Swollen tongue
blood or lymphatic systems (e.g. red or white blood
• Impotence
cells, sodium, potassium, sugars)
• Stevens-Johnson syndrome
(a serious illness with blistering of the skin
mouth, eyes and genitals)
If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist immediately. It will help if you make a note of what you experienced, when it
started and how long it lasted.
Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.

0126725204

- are undergoing dialysis.
- suffer from heart disease, in particular problems with the valves of the heart.
- have diabetes.
- have recently suffered from excessive vomiting or diarrhoea.
- are receiving immuno-suppressant therapy.
If you are to have desensitisation treatment for wasp or bee stings you should tell the doctor who is treating
you that you are taking Capoten.
If you are about to have treatment for the removal of cholesterol from your blood by a machine, (called LDL
apheresis) you should tell your doctor you are taking Capoten.
Tell your doctor you are taking Capoten tablets before you have any blood or urine tests as Capoten tablets
may interfere with the results of some tests.
Some Afro-Caribbean patients may require higher doses of Capoten to obtain an adequate reduction in
blood pressure.
Children and adolescents
Safety and effectiveness in children have not been established. Newborns and infants may be at greater risk
to the low blood pressure side-effects of Capoten.
Other medicines and Capoten
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
It is especially important to tell your doctor if you are taking any of the following:
- non steroidal anti-inflammatory painkillers NSAIDs (e.g. indomethacin, ibuprofen).
- immunosuppressants (e.g. azathioprine and cyclophosphamide).
- potassium supplements, salt substitutes containing potassium or any other medicines which can increase
potassium in your body, e.g. (amiloride, spironolactone).
- water tablets (diuretics).
- medicines for gout (e.g. allopurinol).
- medicines for diabetes (as the amount you need to use may have to be changed while taking Capoten),
- medicines that cause dilation of the blood vessels (e.g. minoxidil, clonidine).
- medicines to treat mental health problems including depression (such as lithium or amitriptyline).
- any other medicines to treat high blood pressure (e.g. beta-blockers such as propanolol, atenolol or
calcium channel blockers such as amlodipine, nifedipine).
- any medicine that may be used during and after a heart attack.
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 Capoten’ and ‘Warnings and precautions’.
Capoten with food and drink
Capoten can be taken with or without food. Your doctor may advise you to limit the amount of salt in your
diet while taking Capoten.
Moderate amounts of alcohol will not affect Capoten, however, you should check with your doctor first to
see if drinking is advisable for you.
Pregnancy and breastfeeding
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.
Pregnancy
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise
you to stop taking Capoten before you become pregnant or as soon as you know you are pregnant and will
advise you to take another medicine instead of Capoten. Capoten 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.
Breastfeeding
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 Capoten.
In the case of an older baby your doctor should advise you on the benefits and risks of taking Capoten whilst
breast-feeding, compared with other treatments.
If you are due to have surgery
Before surgery and anaesthesia (even at the dentist) you should tell your doctor or dentist that you are taking
Capoten as there may be a sudden fall in your blood pressure.
Driving and using machines
Capoten can affect your ability to drive, usually when you first start taking your medicine or if your doctor changes
your dose. If you do feel light-headed or dizzy when taking Capoten tablets, you should not drive or use machinery.
Capoten contains lactose
Capoten contains 25mg lactose which is a type of sugar. If you have been told by your doctor that you have
an intolerance to some sugars, contact your doctor before taking this medicinal product.

Expand Transcript

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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