PARMID XL 2.5MG PROLONGED-RELEASE TABLETS

Active substance: FELODIPINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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Parmid® XL 2.5 mg Prolonged-release Tablets

Felodipine

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.

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 derivatives).
• if you are suffering from insufficient blood supply to
your tissues with symptoms 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 had a heart attack 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.

Warnings and precaution
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
• severely reduced function of the left heart chamber
• mild to moderate reduced liver function
• severe renal failure.
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:
• Ciclosporin, 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
• 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.

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.

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The tablets are not intended to be broken.

The recommended dose is:
If you are taking Parmid XL for high blood pressure, the
recommended starting dose is 2 tablets Parmid XL
(5 mg felodipine) once daily. If necessary, your doctor
may increase the dose to 4 tablets Parmid XL (10 mg
felodipine) once daily, or he may consider an initial dose
of 1 tablet Parmid XL (2.5 mg felodipine).
The maximum daily dose is 4 tablets Parmid XL (10 mg
felodipine).
Children and adolescents
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).
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: may affect more than 1 in 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
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: may affect up to 1 in 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: may affect up to 1 in 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.
Rare: may affect up to 1 in 1,000 people
• Nettle rash
• Fainting
• Vomiting
• Muscle pain, joint pain
• Erection disorders.

Very rare: may affect up to 1 in 10,000 people
• Disturbances of liver function (elevated transaminase
values)
• Fever
• Enlarged breasts in men
• Heart attack
• Photosensitivity
• Inflammation in the blood vessels caused by the white
blood cells (Leucocytoclastic vasculitis)
• 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.
This medicinal product does not require any special
storage conditions.

Plastic container:
Do not store above 25 °C after first opening. Shelf-life
after first opening: 6 months.
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 2.5 mg of
felodipine.
• The other ingredients are:
Tablet core: lactose monohydrate, sodium
laurilsulfate, hypromellose, microcrystalline cellulose,
magnesium stearate.
Tablet coating: lactose monohydrate, hypromellose,
titanium dioxide (E171), macrogol 4000, iron oxide,
yellow (E172).

What Parmid XL looks like and contents of the pack
Parmid XL Prolonged-release Tablets are round, pale
yellow, biconvex film-coated tablets; embossment “2.5”
on one side of the tablet.
Your tablets come in
• blister packs of 7, 14, 20, 28, 30, 50, 56, 60, 100 and
112 prolonged-release tablets.
• plastic containers of 100 and 250 prolonged-release
tablets.
Not all pack sizes and pack types may be marketed.
Marketing Authorisation Holder
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.

Manufacturer
Salutas Pharma GmbH Otto-von-Guericke-Allee 1,
39179 Barleben, Germany OR
Lek Pharmaceuticals d.d., Verovškova 57, 1526
Ljubljana, Slovenia OR
LEK S.A, ul. Podlipie 16, 95-010 Stryków, Poland OR
LEK S.A, ul. Domaniewska 50 C, 02-672 Warsaw,
Poland.
This leaflet was last revised in 08/2012.

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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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