LISINOPRIL + HCT 20/12.5MG TABLETS

Active substance: LISINOPRIL DIHYDRATE

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PATIENT INFORMATION LEAFLET

Lisinopril + Hydrochlorothiazide 10/12.5mg and
20/12.5mg Tablets
Please read all of this leaflet carefully before you start taking this medicine.
Keep this leaflet. You may need to read it again.
If you have further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for you personally and you should not pass it on to other
people. It may harm them even if their symptoms are the same as yours.
If any of the side effects become serious or you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

In this leaflet:
1
2
3

1

What this medicine is and
what it is used for

Lisinopril + Hydrochlorothiazide Tablets contain
Lisinopril Dihydrate and Hydrochlorothiazide.
Lisinopril Dihydrate is one of a group of medicines
known as ACE (Angiotensin−Converting Enzyme)
Inhibitors. These work by expanding your blood
vessels making it easier for your heart to pump
blood to your body. Hydrochlorothiazide is one of
a group of medicines known as Diuretics. These
work by increasing the volume of urine you
produce, therefore reducing the water content of
your blood and in turn the volume of blood
circulating in your body.
Lisinopril + Hydrochlorothiazide Tablets are used
in the treatment or prevention of high blood
pressure (Hypertension). It is intended for patients
whose blood pressure is not adequately controlled
on Lisinopril or Hydrochlorothiazide alone.

2

4

What this medicine is and what it is used for
Before you take
How to take

Do not take Lisinopril + Hydrochlorothiazide
Tablets:
• If you are allergic (hypersensitive) to Lisinopril
Dihydrate, Hydrochlorothiazide, other
Sulphonamides, other ACE Inhibitors or any
of the other ingredients in the tablets (these
are listed in Section 6, Further information)
• If you have suffered from red, itchy swelling
of the eyes, lips, tongue, throat or hands
linked to previous treatment with an ACE
Inhibitor (Angioneurotic Oedema)
• If you suffer from fluid retention (Idiopathic
Angiodema)
• If you suffer from severe kidney problems or
narrowing of the arteries in the kidneys
• If you suffer from severe liver problems
• If you are more than 3 months pregnant.
(It is also better to avoid Lisinopril +
Hydrochlorothiazide in early pregnancy − see
pregnancy section)
Take special care with Lisinopril +
Hydrochlorothiazide − Tell your doctor if any
of the following apply to you:
• If you are due to have a surgical operation.
You should make sure that the anaesthetist
is aware you are taking Lisinopril +
Hydrochlorothiazide.
• If you are suffering from dehydration as a
result of diuretic treatment, low salt diet,
dialysis, diarrhoea or vomiting
• If you suffer from heart failure or other heart
problems
• If you suffer from kidney problems
• If you suffer from liver problems
• If you are on dialysis
• If you are diabetic
• If you are currently suffering from a cough
• You must tell your doctor if you think you are
(or might become) pregnant. Lisinopril +
Hydrochlorothiazide 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)
Taking other medicines
Please inform your doctor or pharmacist if you
are taking, or have recently taken, any other
medicines, including medicines obtained without
a prescription.
Medicines which may interact with Lisinopril +
Hydrochlorothiazide
• If you are due to have a surgical procedure.
You should make sure that the anaesthetist
is aware you are using Lisinopril +
Hydrochlorothiazide Tablets

Last modified: 03/11/08

Size:

148x360mm

6


















Taking Lisinopril + Hydrochlorothiazide with
food and drink
During treatment with Lisinopril +
Hydrochlorothiazide, it is advisable not to drink
alcohol.
Pregnancy and breast−feeding
Pregnancy
You must tell your doctor if you are
(or might become) pregnant. Your doctor will
normally advise you to stop taking Lisinopril +
Hydrochlorothiazide before you become
pregnant or as soon as you know you are
pregnant and will advise you to take another
medicine instead of Lisinopril + Hydrochlorothiazide.
Lisinopril + Hydrochlorothiazide 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. Lisinopril +
Hydrochlorothiazide is not recommended for
mothers who are breast−feeding, and your doctor
may choose another treatment for you if you
wish to breast−feed, especially if your baby is
newborn, or was born prematurely.
Driving or using machinery
Lisinopril + Hydrochlorothiazide Tablets can
cause dizziness and fainting. This is more likely
to occur at the start of treatment, when the dose
is changed or if you drink alcohol. If this is
experienced it is necessary to avoid driving or
operating machinery or pursuing any activity in
which full attention is required.
Important information about some of the
ingredients of Lisinopril+
Hydrochlorothiazide
Lisinopril + Hydrochlorothiazide contains
mannitol. This may have a mild laxative effect.
continued...

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Possible side effects
How to store
Further information

Medicines used to treat high blood pressure
e.g. Sotalol, Propanolol, Verapamil (Beta
Blockers/Calcium Channel Blockers)
Medicines used to increase frequency of
urination e.g. Spironolactone, Triamterence,
Amiloride (Diuretics)
Medicines used to treat depression e.g.
Amitriptyline (Tricyclic Antidepressant)
Medicines used to treat mood disorders e.g.
Lithium (Antipsychotic)
Medicines used to treat diabetes e.g. insulin
Medicines used to reduce the body’s
immunity when receiving organ transplant
e.g. Ciclosporin (Immunosuppressants)
Medicines used to treat infections e.g.
Trimethoprim, Amphotericin B
Calcium supplements e.g. Adcal, Cacit,
Calcichew
Medicines used to treat irregular heartbeats
e.g. Procainamide (Cardiac Glycosides)
Medicines used to control cholesterol levels
e.g. Cholestyramine, Colestipol, Lovastatin
Medicines used to reduce inflammation e.g.
Prednisolone, Corticotropin (Corticosteroids)
Medicines used to treat gout e.g. Allopurinol,
Probenecid
Muscle relaxants e.g. Tubocurarine
Non Steroidal Anti−Inflammatory Drugs
(NSAIDs) e.g. Acetylsalicylic Acid
Potassium−containing supplements or salt
substitutes
Medicines used to treat oral ulcers e.g.
Carbenoxolone
Medicines used to treat constipation e.g.
Bisacodyl, Senna (Stimulant Laxatives)



Before you take

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5

Date:

General Sales & Marketing:

Tillomed Code:

XXX

Approved:

Pharma Code:

XXX

Signature:

Amendments Required:
Date:

Reason for changes :
Tillomed Laboratories Ltd, 3 Howard Road Eaton Socon, St Neots, Cambs PE19 8ET, UK

Til-ver.3s

3



How to take

Always take Lisinopril + Hydrochlorothiazide
Tablets as your doctor has told you. You should
check with your doctor or pharmacist if you are
not sure.
• Lisinopril + Hydrochlorothiazide Tablets
should be swallowed whole and with sufficient
fluid (e.g. water).
Adults & Elderly
A maximum daily dose of 40 mg Lisinopril/25 mg
Hydrochlorothiazide should not be exceeded.
Patients with kidney problems
The recommended starting dose of Lisinopril is
5−10 mg.
Diuretic−treated patients
The diuretic should be discontinued 2 to 3 days
before taking Lisinopril + Hydrochlorothiazide. If
this is not possible, treatment should be started
with Lisinopril alone, in a 2.5 mg dose. These
patients should be carefully monitored.
Children
Lisinopril + Hydrochlorothiazide Tablets are not
recommended for children.
Do not change your dose unless your doctor
tells you to do so.
If you taken more Lisinopril +
Hydrochlorothiazide Tablets than you should
If you accidentally take too many tablets, contact
your doctor or nearest hospital emergency
department immediately for advice. Remember
to take this leaflet or any remaining tablets with
you.
If you forget to take Lisinopril +
Hydrochlorothiazide Tablets
Take it as soon as you remember, unless it is
nearly time for your next dose. If you miss a
dose do not take a double dose to make up for
a forgotten tablet.
If you stop taking/using Lisinopril +
Hydrochlorothiazide Tablets
It is important that you keep on taking Lisinopril +
Hydrochlorothiazide Tablets until the prescribed
dose has finished. Do not stop taking the tablets
even though you may feel better. Do not stop or
change your treatment before talking to your doctor.




























If any of the side effects gets serious or if
you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.

Possible side effects

Like all medicines, Lisinopril + Hydrochlorothiazide
Tablets can cause side effects, although not
everybody gets them.
Stop taking Lisinopril + Hydrochlorothiazide
Tablets and seek medical advice immediately
if you develop the following:


Severe allergic reaction e.g. itching, rash,
wheezing, swelling of hands, face, lips,
tongue, mouth, throat or eyelids (Anaphylaxis)

Common side effects (affects 1−10 users in 100)
• Dizziness (Vertigo)
• Headache
• Feeling tired (Fatigue)
• Dry and persistent cough
• Low blood pressure (Hypotension)
Uncommon side effects (affects 1−100 users in
1000)
• Diarrhoea
• Feeling sick (Nausea)
• Being sick (Vomiting)
• Indigestion (Dyspepsia)
• Inflammation of the pancreas (Pancreatitis)
• Dry mouth (Xerostomia)
• Skin rashes
• Gout
• Feeling your heartbeat (Palpitations)
• Chest pain
• Muscular spasm
• Tingling or numbness in the hand or feet
(Paraesthesia)
• General weakness (Asthenia)
• Inability to maintain an erection (Impotence)
Other side effects
• Fever
• Muscle pain (Myalgia)
• Pain in the joints (Arthralgia)
• Abnormal sensitivity of the skin to sunlight
(Photosensitisation)
• Loss of appetite
• Constipation

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Keep out of the reach and sight of children.
Store in the original package.
Do not use Lisinopril + Hydrochlorothiazide
Tablets after the expiry date which is stated on
the carton/pouch after "EXP". The expiry date
refers to the last day of that month.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.

Further information

6

What Lisinopril + Hydrochlorothiazide
contains:
The active substances are Lisinopril Dihydrate
and Hydrochlorothiazide
Other ingredients are:
Calcium hydrogenphosphate dihydrate,
croscarmellose sodium, mannitol, maize starch,
magnesium stearate and ferric oxide red (E 172).
What Lisinopril + Hydrochlorothiazide looks
like and contents of the pack:
Lisinopril + Hydrochlorothiazide Tablets are pink,
round, biconvex tablets with a score notch on
one side.
Lisinopril + Hydrochlorothiazide are available
in:
Lisinopril + Hydrochlorothiazide Tablets are
available in packs of: 14, 28, 30, 50, 56, 98, 100,
400
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Roger Oakes Ltd
Allstoe House, Church Lane
Greetham, Rutland
LE15 7NF
Manufacturer:
Salutas Pharma GmbH,
Otto−Von−Guericke−Allee 1,
39179 Barleben,
Germany
Product Licence Number:
Lisinopril + Hydrochlorothiazide 10/12.5mg
Tablets
PL 11311/0235
Lisinopril + Hydrochlorothiazide 20/12.5mg
Tablets
PL 11311/0236

The leaflet was revised in February 2011

Phone

0800 970 6115

148x360mm

Til-ver.3s

Regulatory:

Colour:
Pantone Black CVC

Approved:

Prepared by: Shehzad

No

Date:

Amendments Required:

Signature:
Rog−ver.1

Software: Adobe illustrator 9 (windows)

Amendments Required:

QA:

Information Provided by: Angela
PL No.

Approved:
Signature:

Task Allocated: Angela

Keyline: Yes

for help

Lisinopril + Hydrochlorothiazide
20/12.5mg Tablets
PIL
148 x 370 mm
Font SansSerif − Min. Text 8pt
Till−Ver.3s
02/02/11
Pantone Black CVC

Last modified: 03/11/08

Size:

How to store

5

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

4

Liver failure or other liver disorders including
jaundice (yellowing of skin and eyes)
Inflammation of the salivary glands
(Sialoadenitis)
Blurred/disturbed vision
Skin rashes with the formation of wheals
(Urticaria)
Severe skin disorders including Stevens−
Johnson Syndrome
Shortness of breath or difficulty in breathing
Pneumonia
High blood sugar levels (Hyperglycaemia)
Restlessness
Kidney failure
Disrupted heart rhythm (Arrhythmia)
Heart attack (Myocardial Infarction)
Stroke
Faster heartbeat (Tachycardia)
Reddening of the face
Tingling or numbness in the fingers, toes,
ears or nose (Raynauds Phenomenon)
Abdominal pain
Mood changes
Confusion
Abnormal sense of taste (Dysgeusia)
Sleep disorders
Cold−like symptoms; sneezing, itchiness,
blocked/runny nose (Rhinitis/Sinusitis)
Hair loss (Alopecia)
Excessive sweating (Diaphoresis)
Itching (Pruritus)
Passing urine less frequently (Oliguria)
Looking pale and feeling tired (Anaemia)

Date:

General Sales & Marketing:

Tillomed Code:

XXX

Approved:

Pharma Code:

XXX

Signature:

Amendments Required:
Date:

Reason for changes :
Tillomed Laboratories Ltd, 3 Howard Road Eaton Socon, St Neots, Cambs PE19 8ET, UK

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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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