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PARMID XL 10MG PROLONGED RELEASE TABLETS

Active substance: FELODIPINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Parmid® XL 5 mg and 10 mg Prolonged Release
Tablets

SZ00000LT000

Felodipine

Read all of this leaflet carefully before you start using 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 effect not listed in this leaflet.

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

1

What Parmid XL is and what it is used for

Parmid XL is used in the treatment of high blood pressure.

Parmid XL belongs to a group of medicines called calcium
antagonists. These medicines alleviate high blood pressure by
dilating the small blood vessels (the arteries) and facilitate the
heartʼs pumping work.

2

What you need to know before you take
Parmid XL

Do not take Parmid XL
• if you are allergic to felodipine, or any of the other ingredients
of this medicine (listed in section 6) or similar calcium channel
blockers (the so-called dihydropyridine derivates).
• if you are suffering from insufficient blood supply to your
tissues with symptoms like e.g. low blood pressure, low pulse,
fast heartbeat (shock, including cardiogenic shock).
Cardiogenic shock means shock due to severe heart troubles.
• if you have severe narrowing (stenosis) of the aorta or of the
heart valves (mitral or aortic valve).
• if you suffer from an enlarged heart muscle (hypertrophic
cardiomyopathy).
• if you have had a heart attack, i.e. a blood clot in the heart,
within the last 2 months.
• if you get heart-associated chest pain also at rest or with
minimal effort (unstable angina pectoris).
• if you suffer from a heart failure which was not stabilised by
medical measures (decompensated heart failure).
• if you have any other severe heart disease (e.g. severe heart
failure, heart muscle disease or severe valvular disorder).
• if you have a severe liver disease.
• if you are pregnant.

Take special care with Parmid XL
Talk to your doctor before taking Parmid XL, if you have any or
have had any medical condition especially the following:
• conduction disturbances in the heart
• heart failure which is in a stable condition
• increased heart beat rate
• if the heart valves of your left heart chamber are constricted
• mild to moderate reduced liver function
• severe renal failure
• atrioventricular conduction disturbances of 2nd or 3rd degree.
If treatment with Parmid XL is discontinued abruptly, a
hypertensive crisis may occur in individual cases.

As with other vasodilators, Parmid XL may, in rare cases,
precipitate significant low blood pressure with fast heart beat
(tachycardia) which in susceptible individuals may result in
insufficient blood supply of the heart (myocardial ischaemia). This
may lead to a heart attack.

If you are unsure if any of the above apply to you, please discuss
this with your doctor.
Other medicines and Parmid XL
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.

Certain other medicines can affect or be affected by Parmid XL.
Some of these medicines are:
• Cyclosporin, tacrolimus (medicines used after organ
transplants)
• Digoxin (medicinal products to strengthen cardiac power).

Medicines that can increase the amount of felodipine in the blood:
• Cimetidine (a medicine for stomach ulcers)
• Certain antibiotics such as erythromycin or telithromycin
(antibiotics)
• Ketoconazole or itraconazole (fungicidal agents)
• HIV protease inhibitors (antiviral medicines to treat HIV
infections, e.g. ritonavir).

Medicines that can reduce the amount of felodipine in the blood:
• Phenytoin or carbamazepine (medicines for epilepsy)
• Barbiturates (tranquillising agents and medicines used in the
treatment of epilepsy)
• Rifampicin (antibiotic)
• Natural remedies containing extract of St. Johnʼs wort
(Hypericum perforatum).

Medicines that can increase the effect of felodipine:
• Other medicines used in the treatment of high blood pressure,
e.g. beta-blockers, ACE-inhibitors and diuretics
• Medicine to treat depressions (tricyclic antidepressants)
• Hydrochlorothiazide (diuretic agent).
Parmid XL can enhance low potassium levels in the blood when
taken together with water tablets (diuretics).

Parmid XL with food and drink
Simultaneous intake of grapefruit or grapefruit juice has influence
on the effect of Parmid XL.

The concomitant intake of grapefruit juice should be avoided.

Pregnancy and breast-feeding
• Do not take Parmid XL if you are pregnant. Pregnancy must
be excluded before starting treatment with Parmid XL.
• The use of Parmid XL is not recommended in women who are
breast-feeding.

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
Because of individual variability, the ability to react can be so
altered that the ability to drive or operate machinery or work in an
unsupported position can be impaired. This applies especially at
the start of treatment, when the dosage is increased, when the
preparation is changed and in conjunction with alcohol.

Parmid XL contains lactose
If you have been told by your doctor that you have an intolerance
to some sugars, contact your doctor before taking this medicinal
product.

3

How to take Parmid XL

Always take this medicine for as long and exactly as your doctor
has told you. Check with your doctor or pharmacist if you are not
sure.
Continued on the next page >>

Artwork Proof Box
A healthy decision
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR,
United Kingdom.
T: 01276 698020
F: 01276 698324
W: www.uk.sandoz.com
E: sandoz.artwork@me.com

Ref: V048 product harmonisation + V050 (Nat. phase)
Proof no.
005.1

Date prepared:
21/01/2013

Prepared by:
TB

RA Approved?
Yes

Date approved:
21/01/2013

Approved by:
MS
Fonts:
Helvetica

Colours:
Black
Black 20%
Dimensions: 148 x 270 mm

PROPOSED
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Artwork/RA Checklist:
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Font size: 7pt
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Parmid XL should be taken once daily. Take the tablets whole
and not chewed or crushed with a glass of water. The tablets may
be taken on empty stomach or with a light meal, however a
high-fat meal should be avoided.




The recommended dose is:
If you are taking Parmid XL for high blood pressure, the
recommended starting dose is 5 mg once daily. If necessary, your
doctor may increase the dose to 10 mg once daily. The maximum
daily dose is 10 mg Parmid XL.

Rare (affects less than 1 out of 1,000 people)
• Nettle rash
• Fainting
• Vomiting
• Muscle pain, joint pain
• Erection disorders.

The tablets are not intended to be broken.






Children and adolescents, under 18 years
The use of Parmid XL is not recommended in children.

Elderly patients
The recommended initial dose should be adapted in the
elderly.
Impaired liver or kidney function
The dose should be adjusted according to the doctorʼs
prescription.

If you take more Parmid XL than you should
Contact your doctor or the nearest hospital casualty department
immediately. Take this leaflet or some tablets with you so that
people will know what you have taken.

The person concerned should lie down with his/her arms and legs
up (resting on a couple of cushions, for example). Symptoms of
an overdose are: extreme dizziness and/or feeling very
light-headed, caused by very low blood pressure, problems with
breathing, having to urinate very often.
If you forget to take Parmid XL
Take the missed dose as soon as you remember but never take
two doses in one day.

If you stop taking Parmid XL
Your doctor has told you how long you should take Parmid XL. If
you stop the treatment suddenly, your symptoms may come back.
Do not stop the treatment earlier than agreed without discussing
this with your doctor.
Parmid XL is usually used for long-term treatment.

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.

Contact an emergency room or a doctor immediately if the
following side effects occur:
Allergic reaction with swelling of the skin of face or extremities,
swelling of lips or tongue, swelling of the mucous membranes in
the mouth and throat, resulting in shortness of breath and difficulty
to swallow (angioedema). Contact an emergency room or a
doctor immediately if this occurs.
In isolated cases severe allergic reactions with blistering eruptions
of the skin and mucous membranes (exfoliative dermatitis) have
been observed.
Other possible side effects:

Very common (affects more than 1 out of 10 people)
• Tinnitus (ringing or buzzing in the ears) can occur, especially at
the beginning of treatment, when the dose is increased or if
high doses are administered. In general these reactions
disappear as the treatment continues
• Peripheral oedema (the degree of ankle swelling is depends
on the dose)
• Particularly at the beginning of treatment, angina pectoris
attacks may occur. In patients with pre-existing angina pectoris
there may be an increase in the frequency, duration and
severity of the attacks.
Common (affects less than 1 out of 10 people)
• Flushing, headache (especially at the beginning of treatment,
when the dose is increased or when high doses are
administered). In general these reactions disappear as the
treatment continues.
Uncommon (affects less than 1 out of 100 people)
• Dizziness
• Fatigue
• Low blood pressure
• A quicker or irregular heart beat
• Increased heart rate and breathing difficulties
• Restlessness
• Pins and needles





Uncontrolled shaking
Gastro-intestinal complaints (e.g. nausea, vomiting, diarrhoea,
constipation)
Weight gain
Sweating
Prickling and tingling sensation of the skin.

Very rare (affects less than 1 out of 10,000 people)
• Disturbances of liver function (elevated transaminase values)
• Fever
• Photosensitivity
• Inflammation in the blood vessels caused by the white blood
cells (Leucocytoclastic vasculitis)
• Enlarged breasts in men
• Heart attack
• Abnormally heavy menstruation
• Inflammation and swelling of the gums, which can be avoided
or reduced by good oral hygiene
• Increased need to urinate.
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.

5

How to store Parmid XL

Keep out of the sight and reach of children.

Do not use Parmid XL after the expiry date „EXP“ which is stated
on the packaging. The expiry date refers to the last day of that
month.
Do not store above 25 °C.
Shelf life in blisters: 4 years.

Do not throw away any medicine 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 Parmid XL contains
• The active substance is felodipine. One prolonged release
tablet contains 5 mg or 10 mg of felodipine.
• The other ingredients are: lactose monohydrate,
microcrystalline cellulose, hydroxypropylmethylcellulose,
magnesium stearate, sodium lauryl sulphate, macrogol 4000,
titanium dioxide (E171), iron oxide yellow (E172), iron oxide
red (E172).

What Parmid XL looks like and contents of the pack:
Parmid XL 5 mg Tablets are round, pale red to grey-red, biconvex
film-coated tablet with embossment “F5”.
Parmid XL 10 mg Tablets are round, pale red to grey-red,
biconvex film-coated tablet with embossment “F10”.
Your tablets come in
• original packs of 10, 20, 28, 30, 50, 56, 100 or 100 x 1
prolonged release tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.

Manufacter:
Salutas Pharma GmbH,
Otto-von-Guericke-Allee 139179, Barleben,
Germany
or

Salutas Pharma GmbH,
Dieselstrasse 5D-70839, Gerlingen,
Germany.

This leaflet was last revised in 01/2013.

SZ00000LT000

Artwork Proof Box
A healthy decision
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR,
United Kingdom.
T: 01276 698020
F: 01276 698324
W: www.uk.sandoz.com
E: sandoz.artwork@me.com

Ref: V048 product harmonisation + V050 (Nat. phase)
Proof no.
005.1

Date prepared:
21/01/2013

Prepared by:
TB

RA Approved?
Yes

Date approved:
21/01/2013

Approved by:
MS
Fonts:
Helvetica

Colours:
Black
Black 20%
Dimensions: 148 x 270 mm

PROPOSED
MOCK UP

Artwork/RA Checklist:
Product name
Strength/dosage

Font size: 7pt
Pack size
PL number
Storage

Warnings
Excipients
Braille

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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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